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Next-Generation Sequencing Market Size to Reach US$ 31,411.3 Mn, Introduction of Rapid Sequencing Technologies Drives the Market: Fortune Business…

August 17, 2020 11:38 ET | Source: Fortune Business Insights

Pune, Aug. 17, 2020 (GLOBE NEWSWIRE) -- The global next-generation sequencing market is forecast to exhibit a remarkable CAGR as the next-generation sequencing platform allows effective sequencing of millions of DNA molecules. Fortune Business Insights in a new report, titled Next-Generation Sequencing: Global Market Analysis, Insights and Forecast, 2019-2026 offers a detailed analysis of the competitive landscape and market dynamics.

The demand for cost-effective, accurate, and fast DNA sequencing technologies is increasing and this is further giving rise to the dominance of next-generation sequencing platforms. This will further give rise to advanced sequencing technologies for clinical purposes, which is anticipated to drive the market. Increasing advancements in bioinformatics are likely to increase the adoption of next-generation sequencing platforms to facilitate the diagnosis of rare diseases.

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As per the report, the global market is expected to rise at a ferocious CAGR of 22.2% between 2018 and 2026. In 2018, the market was worth US$ 6,335.2 Mn and the market will be a howling success as it is projected to reach US$ 31,411.3 Mn by 2026. The demand for next-generation sequencing methodologies is increasing rapidly across several applications such as diagnostics, clinical research among others.

The global economy is in absolute turmoil because of the COVID-19 pandemic outbreak. Some industries remain largely unaffected by the outbreak, some are thriving, but most are in doldrums. Although the healthcare industry is flourishing, certain markets within the industry are experiencing staggered growth. Wading through these troubled times is a difficult task and Fortune Business Insights aims at equipping your business with the most comprehensive market insights, collated and analyzed by our expert and experienced research team.

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Demand for Next-Generation Sequencing Services to Rise at a High Pace

Next-generation sequencing products encompass instruments, consumables, and software. According to the findings from the report, the next-generation sequencing product segment is anticipated to lead the market over the forecast period. This is ascribable to some primary factors such as new product launches, high usage of consumables, and easy availability.

Apart from next-generation sequencing products, next-generation sequencing services are expected to grow at a higher CAGR during the forecast period. The need for novel platforms regarding advancements in bioinformatics and fast DNA data interpretation are paving way for start-ups, especially for next-generation sequencing services. With the introduction of next-generation sequencing, the cost of sequencing has reduced over the years.

This is positively impacting the growth of this segment. Furthermore, the adoption of next-generation sequencing-based testing is increasing across the world. This, coupled with attractive healthcare reimbursement policies, is expected to drive the segments growth in the projected period.

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North America Leads the Way Owing to Active Government Support

Among regions, North America is anticipated to lead the global next-generation sequencing market through the forecast duration. Rapid developments in precision medicine, next-generation DNA sequencing, and diagnostics are creating growth opportunities for the market. The market is likely to expand as companies in the biotechnology sector are continuously involving in research and development (R&D) activities, which fuels the market demand. Adapative Technologies developed a next-generation sequencing diagnostic test called ClonoSEQ for patients suffering from acute lymphoblastic leukemia or ALL and minimal residual disease or MRD. The test received FDA approval in September 2018, which in turn, contributes to the growth of the market in North America.

Increasing investments in precision medicine and a growing number of strategic collaborations are driving the market in Europe. Driven by these factors, the market in this region is expected to expand in the forecast period. Apart from these two regions, Asia Pacific is expected to expand at a remarkable growth on account of rising geriatric population and growing awareness about reproductive health.

Saphetor SA and Swift Biosciences Inc.s Partnership Aims to Target Next-Generation Sequencing Panels

Strategic partnerships and new product launches are increasingly adopted by companies as these help them to maintain their position in the market. Some of the industry developments are mentioned below:

Companies such as Illumina, Inc., Thermo Fisher Scientific Inc., and F. Hoffmann-La Roche Ltd are likely to lead in the global next-generation sequencing market. This is mainly on account of their strong geographical presence and diversified product portfolio. Moreover, Illumina was leading in the global market owing to its rising product sales. New product launches also helped the company to strengthen its market position.

Some of the other players functioning in the global market are Agilent Technologies, Inc., BGI, PerkinElmer Inc., QIAGEN, Eurofins Scientific, PierianDx, Macrogen, Inc. among others.

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Next-Generation Sequencing Market Segmentation:

By Type

Products

Instruments & Software

Consumables

Services

By Application

Diagnostics

Research

Others

By End User

Research Institutes

Healthcare Facilities & Diagnostic Centers

Pharmaceutical & Biotechnological Companies

Contract Research Organization (CROs)

By Geography

North America (the USA and Canada)

Europe (UK, Germany, France, Italy, Spain, and Rest of Europe)

Asia Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)

Latin America (Brazil, Mexico, and Rest of Latin America)

Middle East & Africa (South Africa, GCC, and Rest of the Middle East & Africa)

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Next-Generation Sequencing Market Size to Reach US$ 31,411.3 Mn, Introduction of Rapid Sequencing Technologies Drives the Market: Fortune Business...

Brain Stimulators Market: Rise in incidence of neurological disorders is expected to drive the market – BioSpace

Brain stimulation therapy is a procedure to treat certain mental disorders. Brain stimulation therapies involve activating or inhibiting brain activity directly with electricity. Electricity is provided directly by invasive or non-invasive brain stimulators placed on the scalp. Brain stimulators investigate the effects of electricity on basic processes such as gene expression and other aspects of molecular biology, neurochemical regulation, functional brain activity, sensorimotor function, and cognitive and affective processes. The stimulation technique uses a probe to outline patterns of neural connectivity in the brain and provides the information of brain activity in the form of graphs. The functioning of brain stimulators depends on battery powered adapter for the display of output on the patient monitor. Moreover, the system incorporates visual indicators of performance in order to provide the physicians an optimal performance. However, new developments in computer technology and rapidly growing cranial stimulation technique allows the scientific community to focus on the best practice within the medical industry, which is paving the way for early diagnosis and treatment of mental diseases.

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The global brain stimulators market is driven by rapid development in technology, funding for digital health companies, rise in incidence of neurologicaldisorders, increase in government support for research & development, and adverse effects of present diagnostic & drug therapies. According to the U.S. Food and Drug Administration, deep brain stimulators were approved for treatment of movement disorders such as essential tremor, Parkinson's disease and dystonia, and recently, obsessive-compulsive disorder. Rise in prevalence of Parkinson's disease, epilepsy, dystonia, and other chronic pain is expected to drive the global brain stimulators market. However, long approval time, high cost of research & development and devices, and lack of awareness are factors expected to restrain the global brain stimulators market during the forecast period.

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The global brain stimulators market can be segmented based on product type, end-user, application, and region. In terms of product type, the market can be classified into transcranial magnetic stimulators, electroconvulsive therapy stimulators, deep brain stimulators, and others. Based on application, the global brain stimulators market can be categorized into Parkinsons disease, essential tremor, dystonia, and others. In December 2017, Boston Scientific Corporation received the U.S. Food and Drug Administration (FDA) approval for the sale of Vercise Deep Brain Stimulation (DBS) System to treat the symptoms of Parkinsons disease (PD), a degenerative condition that affects more than one million people in the U.S. and 10 million globally. Hence, deep brain stimulators as an invasive device will be more prominently used in the near future. In terms of end-user, the market can be divided into diagnostic laboratories, clinics, hospitals, and others.

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Geographically, the global brain stimulators market can be segmented into North America, Europe, Asia Pacific, and Rest of the World. North America dominated the global market due to advanced technology used in medical devices, increase in incidence of mental illnesses among the geriatric population, significant awareness, and high per capita health care expenditure. Early-phase diagnosis, treatment of disease, and after surgery effects drive the biotechnology and medical device market which in turn is expected to propel the brain stimulators market in North America. Europe was the second largest market for brain stimulators due to favorable government policies regarding health care infrastructure, high incidence of brain diseases due to environmental conditions, and awareness programs about different types of brain disorders.The market in Asia Pacific is likely to grow at a rapid pace due to increase in the geriatric population, rise in awareness among people, and increase in per capita expenditure. Additionally, economic growth supports improvement in health care infrastructure in developing countries such as India, China, Brazil, and South Africa. Hence, these factors are expected to contribute to the growth of the brain stimulators market in Asia Pacific and Rest of the World.

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Major players operating in the global brain stimulators market include Medtronic plc, Boston Scientific Corporation, Abbott Laboratories, Aleva Neurotherapeutics SA, Deep Brain Innovations, LLC, and SceneRay.

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

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Brain Stimulators Market: Rise in incidence of neurological disorders is expected to drive the market - BioSpace

Global digital PCR market size was USD 224.9 million in 2018 and is projected to reach USD 799.1 million by 2026, exhibiting a CAGR of 17.2% during…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Digital PCR market.

Trusted Business Insights presents an updated and Latest Study on Digital PCR Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Digital PCR market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Digital PCR Market Size, Share & Industry Analysis, By Type (Droplet Digital PCR, Chip-based Digital PCR, and Others), By Product (Instruments and Reagents & Consumables), By Indication (Infectious Diseases, Oncology, Genetic Disorders, and Others), By End User (Hospitals & Clinics, Pharmaceutical & Biotechnology Industries, Diagnostic Centers, and Aca-demic & Research Organizations), and Regional Forecast, 2020-2029(Includes COVID-18 Business Impact)

The global digital PCR market size was USD 224.9 million in 2018 and is projected to reach USD 799.1 million by 2026, exhibiting a CAGR of 17.2% during the forecast period.

We have updated Digital PCR Market with respect to COVID-19 Impact. Inquire before buying

Digital PCR is a biotechnological advancement of conventional PCR. It is a high-throughput absolute quantitative method that provides a sensitive and reproducible way of measuring the amount of DNA or RNA in a sample. The rise in prevalence of infectious diseases, cancer, and genetic disorders, coupled with new product launches, increasing acquisitions, and the rise in the adoption of dPCR by reference laboratories are the key factors likely to drive the market growth during the forecast period. Moreover, increasing technological advancements in digital PCR are projected to boost the global demand for dPCR products in the upcoming years.

MARKET TRENDS

Shift of Healthcare Providers from Droplet to Chip-based Digital PCR will Drive the Market The shift from droplet to chip-based digital PCR for diagnosis of various diseases has been pivotal in the advancement of dPCR devices. In commercially available droplet dPCR, the droplets have to be transferred manually, leading to underestimation of the targets. Moreover, these kits also poses a risk of cross-contamination during the transfer of the sample. On the other hand, in chip-based digital polymerase chain reaction, droplets always run in channels, reducing the risk of cross-contamination. This innovation is likely to increase its adoption for the diagnosis of various diseases in near future. Increasing incidence of infectious diseases and the growing prevalence of cancer are propelling the shift of healthcare providers for diagnosis of these conditions through chip-based digital PCR devices. This is projected to further propel the market growth during the forecast period.

MARKET DRIVERS

Technological Advancements in dPCR to Boost the Market Growth Digital polymerase chain reaction (PCR) is the refinement of conventional PCR that can be used to directly quantify and clonally amplify nucleic acids. Increasing research and development activities and growing demand for innovative devices have led to the introduction of various such technologically advanced devices offering great benefits to the Digital PCR market. The introduction of such innovative devices such as droplet, chip-based, beam, and crystal dPCR by key market players is anticipated to drive the global market growth during the forecast period. For instance, in November 2019, Bio-Rad Laboratories, Inc. announced the launch of QX ONE Droplet Digital PCR System, which provides an absolute measurement of target DNA molecules with more accuracy, precision, and sensitivity.

Growing Adoption of dPCR Over Real-time PCR to Boost the Market Globally Digital PCR helps to deliver a complete measure of target nucleic acid molecules than the relative measure achieved from the real-time PCR. This absolute DNA quantification allows for reproducibility, sensitivity, and precision, further enabling researchers to quantify smaller differences and precisely measure minor variants. These advantages are leading to growing adoption of dPCR over conventional and other PCR methods, which is likely to augment the digital PCR market growth during the forecast period.

MARKET RESTRAINT

High Cost of Digital PCR Devices and Lack of Awareness in Emerging Countries to Hamper Growth

Despite the increasing incidence of infectious diseases, cancer, and genetic disorders worldwide, and high prevalence of these conditions in emerging countries, the adoption digital polymerase chain reaction techniques is limited in these regions. This is attributable to the lack of awareness about the dPCR and its advanced types in less-developed countries. In addition to this, the high cost of these devices further restricts the market penetration. However, initiatives taken by leading players to enhance the awareness about the availability of dPCR for the diagnosis of various diseases, establishment of strong distribution network, and increased new product launches are likely to create lucrative growth opportunities for the expansion of the market in emerging regions.

SEGMENTATION

By Type Analysis

Droplet Digital PCR Dominated the Global Market

Based on type, the digital PCR market is segmented into droplet, chip-based, and others. The droplet digital polymerase chain reaction segment dominated the market in 2018. Technological advances along with various new product launches by key players have been instrumental in the dominance of droplet dPCR in the global market. For instance, in August 2018, Merck KGaA launched the BioReliance Droplet dPCR Technology for cell and gene therapy development.

Chip-based digital PCR segment is projected to register a significant CAGR during the forecast period. These dPCR devices overcome the cross-contamination drawback of droplet digital PCR leading to the increasing preference of healthcare providers for chip-based dPCR. This factor is projected to fuel the demand for this dPCR type, and drive the digital polymerase chain reaction market growth during the forecast period.

By Product Analysis

Instruments Segment to Generate the Highest Revenue During the Forecast Period In terms of product, the market is segmented into instruments, reagents & consumables. the instruments segment emerged dominant owing to their high costs. The reagents segment held comparatively low market share due to small volumes of reagents required for analysis. However, the segment is expected to grow at a significantly high growth rate owing to growing number of diagnostic procedure globally.

By Indication Analysis

Clinically Proven Effectiveness of dPCR in Infectious Diseases to Aid Dominance of the Segment In terms of indication, the market is segmented into infectious diseases, oncology, genetic disorders, and others. Among them, the infectious diseases segment is anticipated to dominate the dPCR market. The clinically proven potential advantages of droplet dPCR in diagnosis of infectious diseases, including viral, bacterial, and parasitic infections is a primary reason for the dominance of this segment in the global polymerase chain reaction (PCR) market. According to an article published by the National Center for Biotechnology Information (NCBI), dPCR provides a more sensitive, accurate, and reproducible detection of pathogens and is a better choice than real-time polymerase chain reaction for clinical applications. Oncology is among the other major indication areas for dPCR. Growing prevalence of the condition, along with the introduction of new product launches in the market is expected to drive the segment during the forecast period.

By End User Analysis

Higher Adoption of dPCR devices by Diagnostic Centers to Enable Dominance of the Segment Based on end-user, the dPCR market segments include hospitals & clinics, pharmaceutical & biotechnology industries, diagnostic centers, and academic & research organizations. The emergence of diagnostic centers for infectious diseases, genetic diseases and other conditions in developed and emerging countries is attracting a large patient pool suffering from chronic and acute conditions. The increasing number of diagnostic centers and favorable reimbursement support provided by these settings are some of the major factors responsible dominance of the segment. These are some of the factors that are responsible for the dominance of this segment throughout the forecast period.

REGIONAL ANALYSIS

The dPCR market size in North America stood at USD 96.5 million in 2018. The market in the region is characterized by high prevalence and diagnosis rates for infectious diseases. Besides this, high awareness among patient population towards new diagnostic options and availability of advanced dPCR devices in the region, are helping the region dominate the market. Moreover, the rising incidence of various types of cancer and metabolic diseases requiring advanced diagnosis and therapies are fueling the market growth in Europe. For instance, according to GLOBOCAN 2018, around 4,229,662 new cancer cases were reported in Europe. The market in Asia-Pacific is projected to register a comparatively higher CAGR during the forecast period. Growing patient awareness regarding advanced digital polymerase chain reaction devices and new product launches by market players, are projected to drive the digital polymerase chain reaction (dPCR) market in Asia Pacific during the forecast period. The market in Latin America and the Middle East & Africa is currently in nascent stage. However, the developing healthcare infrastructure in these regions and growing prevalence of infectious and genetic diseases are projected to increase the demand for the digital polymerase chain reaction products during the forecast period.

KEY INDUSTRY PLAYERS

Diverse Portfolio of Leading Players and Strong Focus on Partnerships and Acquisition to Strengthen Their Market Position

Competition landscape of the digital PCR market is consolidated with few players holding the dominant share. Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., and Sysmex Inostics are some of the leading industry players. A diversified product portfolio of droplet and chip-based digital PCR along with constant innovations by the companies, leading to new product introductions, are prominent factors responsible for the dominance of these companies. Moreover, increasing focus on partnerships and acquisition strategies in the dPCR is likely to attract more digital PCR market revenue in the future. January 2017 Bio-Rad Laboratories, Inc. acquired RainDance Technologies with an aim to expand their product portfolio in dPCR and liquid biopsy.

LIST OF KEY COMPANIES PROFILED:

KEY INDUSTRY DEVELOPMENTS:

July 2019 Sysmex Inostics launched OncoBEAM test which uses BEAMing enhanced digital PCR for liquid biopsy for cancer patients.

January 2019 QIAGEN announced plans for a global launch in 2020 of a new series of digital PCR platforms. This is based on the technology developed by FORMULATRIX combined with QIAGENs assay development expertise.

REPORT COVERAGE

The report provides a detailed analysis of the market and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the Digital PCR market report encompasses several factors that have contributed to the growth of the market over the recent years.

Report Scope & Segmentation

Segmentation

By Type

By Product

By Indication

By End User

By Geography

Looking for more? Check out our repository for all available reports on Digital PCR in related sectors.

Quick Read Table of Contents of this Report @ Digital PCR Market Size, Share & Industry Analysis, By Type (Droplet Digital PCR, Chip-based Digital PCR, and Others), By Product (Instruments and Reagents & Consumables), By Indication (Infectious Diseases, Oncology, Genetic Disorders, and Others), By End User (Hospitals & Clinics, Pharmaceutical & Biotechnology Industries, Diagnostic Centers, and Aca-demic & Research Organizations), and Regional Forecast, 2020-2029(Includes COVID-18 Business Impact)

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Global digital PCR market size was USD 224.9 million in 2018 and is projected to reach USD 799.1 million by 2026, exhibiting a CAGR of 17.2% during...

Global mucopolysaccharidosis treatment market size was USD 1.98 billion in 2018 and is projected to reach USD 4.37 billion by 2026, exhibiting a CAGR…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Mucopolysaccharidosis Treatment market.

Trusted Business Insights presents an updated and Latest Study on Mucopolysaccharidosis Treatment Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Mucopolysaccharidosis Treatment market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Mucopolysaccharidosis Treatment Market Size, Share & Industry Analysis, By Treatment (Enzyme Replacement Therapy (ERT), and Others), By Disease Type (Mucopolysaccharidosis Type I, Mucopolysaccharidosis Type II, Mucopolysaccharidosis Type IV A, Mucopolysaccharidosis Type VI, and Others), By Route of Administration (Intravenous, and Intracerebroventricular (ICV)), By End User (Hospitals, Specialty Clinics, and Others), and Regional Forecast, 2020-2029(Includes COVID-18 Business Impact)

The global mucopolysaccharidosis treatment market size was USD 1.98 billion in 2018 and is projected to reach USD 4.37 billion by 2026, exhibiting a CAGR of 10.4% during the forecast period.

We have updated Mucopolysaccharidosis Treatment Market with respect to COVID-19 Impact. Inquire before buying

MPS, also known as mucopolysaccharidosis, refers to a group of key rare metabolic disorders which is caused by the absence, deficiency or malfunctioning of lysosomal enzymes called glycosaminoglycan (GAGs). This inability to completely down the sugar, leads to the abnormal accumulation of certain compounds such as dermatan sulfate, heparan sulfate, and keratan sulfate, which interferes with normal cell function of the body. One of the characteristic symptoms of MPS is the presence of severe neurological symptoms that are present in several types of MPS such as Hunter syndrome and Sanfilippo syndrome and a number of clinical stage companies are involved in the R&D of new therapeutics for the management of these symptoms.MARKET TRENDSIncreasing R&D for Rare Diseases to Drive the Market GrowthMarket trends present in the mucopolysaccharidosis (MPS) treatment market is the increasing number of pipeline candidates from major companies in the therapeutic area of rare diseases or orphan diseases. Since, mucopolysaccharidosis is considered to be a potentially serious orphan disease group, some prominent clinical stage biopharmaceutical companies such as ArmaGen and REGENXBIO Inc. are involved in the clinical trials for new therapeutics. This increasing initiatives into the development of rare diseases therapies is due to the fact that development of major blockbuster drugs is more possible in these rare diseases as compared to the conventional pharmaceutical portfolios. Another driving factor for this trend is that the pharmaceutical companies are mandated to conduct larger outcome studies for conventional medications or therapies. This is applicable for therapies to treat diseases such as heart disease and diabetes in comparison to rare disorders such as the several disease types of mucopolysaccharidosis. This is projected to further positively drive the mucopolysaccharidosis treatment market growth during the forecast period.

MARKET DRIVERS

Need for Advanced Therapeutics Due to Unmet Clinical Needs and Better Treatment Outcomes to Propel Market GrowthThe lack of presence of a wide range of therapeutics for the patients, which has led to the creation of the monopoly of one type of therapy, enzyme replacement therapy is the most critical driver for the market growth. For instance, for the treatment of mucopolysaccharidosis type II (Hunter syndrome), Elaprase is the most commonly used therapeutic, an enzyme replacement therapy (ERT). This ERT is a prohibitively expensive therapy option and often patients from developing countries cannot easily access this therapeutic due to cost constraints. Other therapeutics for MPS treatment include Vimizim (elosulfase alfa) which is administered for the treatment of MPS IV A (Morquio syndrome) and which at the time of launch in the market is estimated to cost US$ 380,000 for the disorders annual treatment. Hence, due to the six-figure costs of most of the enzyme replacement therapy (ERT), the patients in the emerging countries such as India, often cannot afford these therapeutics despite increasing initiatives for improved access from various governments. Anticipated launches of cheaper alternatives and advanced therapeutics is anticipated to drive the growth of the global MPS treatment market during the forecast period.Another critical driving factor is the increasing need for advanced therapeutics due to unmet clinical needs and better treatment outcomes. During the current period therapeutics, such as Elaprase, and ALDURAZYME are not capable of crossing the blood-brain barrier, a key requirement for effective management of the disorder. So, these therapeutics are not able to appropriately address the neurological symptoms and complications of the patients of mucopolysaccharidosis (MPS), who are most severely affected. For instance, in the patients of Hunter syndrome with the most severe symptoms, which affects approximately two-thirds of the total patient population, the neurological symptoms are severely disabling. The therapeutics used currently are not able to treat the neurological symptoms, thus a significant proportion of the population remains in the need for appropriate treatment. This is anticipated to propel the demand for effective therapeutics which aid in the management of all types of the symptoms of the mucopolysaccharidosis and drive the growth of the MPS treatment market size during the forecast period.Increasing Number of Clinical Stage Candidates in R&D Pipelines of Major Players to Drive MarketThere is a significant number of pipeline candidates for the development of advanced therapeutics for an increasing number of rare disorders and the several types of mucopolysaccharidosis is one of the key disease groups for these companies due to the severity of the disease. According to the National Organization for Rare Disorders (NORD) (NORD), the prevalence of all disease types of mucopolysaccharidosis is estimated to be 1 in 25,000 births. In April 2019, it was reported that in Japan, an estimated 150 individuals suffered from mucopolysaccharidosis type II (Hunter syndrome). Such driving factors are further leading to the presence of prominent and important pipeline candidates. ArmaGen, Denali Therapeutics, and REGENXBIO Inc., all have pipeline candidates for the various types of MPS in various stages of clinical trials. The above factors combined with the need for advanced therapeutics is further anticipated to drive the demand for these therapeutics and stimulate the MPS market growth.MARKET RESTRAINTHigh Cost Therapeutics Coupled with Poorer Diagnosis Rates and Low Treatment Rates in Emerging Countries to Restrain the Market In recent times, globally due to sophistication in diagnostics, there is a higher prevalence of MPS in several countries which includes emerging regions such as Asia, there are certain factors that are restraining the widespread usage of these therapies. Due to the high costs associated with enzyme replacement therapies (ERT), which is the mainstay treatment for MPS, one of the major factors limiting the growth of the market is low levels treatment rates in emerging countries. This severely limits the number of patients undergoing treatment, and a significant proportion of the patients of MPS are left without treatment due to their inability to afford treatment. Often, these therapies are not available to the patients in the developing countries due to lack of awareness and also options for the payment of these therapies. The governments in these countries often do not have appropriate awareness regarding these diseases and do not adequately reimburse them. Another key limiting factor is the delays associated with the diagnosis of mucopolysaccharidosis. A study published in 2018, in the Orphanet Journal of Rare Diseases, indicated that there is a failure to shorten the diagnostic delay in the two ultra-orphan diseases of mucopolysaccharidosis types I and mucopolysaccharidosis type III. Factors as such are further expected to restrain the market growth.SEGMENTATIONBy Treatment AnalysisEnzyme Replacement Therapy (ERT) is Expected to Dominate the Global MarketBased on treatment, the global market is segmented into enzyme replacement therapy (ERT), and others. The primary treatment for lysosomal storage disorders, a group of disorders to which MPS belongs, is enzyme replacement therapy (ERT). These enzyme replacement therapies, aim to replace or generate the missing or deficient enzyme in the body, due to which mucopolysaccharidosis occurs. Hence, the enzyme replacement therapy (ERT) segment dominated the mucopolysaccharidosis treatment market share in 2018. The only major therapeutics approved by the regulatory agencies globally treatment of MPS, is enzyme replacement therapy (ERT). For example, in case of mucopolysaccharidosis type II (Hunter syndrome), the only two approved products are Elaprase and Hunterase which are both ERTs, and have been instrumental in the dominance of this segment in the global market.The others segment is anticipated to grow at a comparatively stronger CAGR. The mucopolysaccharidosis (MPS) treatment market growth during the forecast period is anticipated to be driven by the growing number of clinical trials involving the usage of the hematopoietic stem cell transplant (HSCT). Other than stem cell transplantation, a number of prominent clinical stage biopharmaceutical companies are conducting trials on gene therapy including Sangamo Therapeutics, which has a pipeline candidate for Hunter syndrome.By Disease Type Analysis To know how our report can help streamline your business, Speak to Analyst var get_chart_name1=

MPS II (Hunter Syndrome) to Dominate the Disease Type due to Presence of Key Products In terms of disease type, the market is segmented into mucopolysaccharidosis type I also known as Hurler syndrome/Hurler-Scheie syndrome/Scheie syndrome, mucopolysaccharidosis type II also known as Hunter syndrome, mucopolysaccharidosis type IV A also known as Morquio A syndrome, mucopolysaccharidosis Type VI also known as MaroteauxLamy syndrome, and others. The mucopolysaccharidosis type II (Hunter Syndrome) is expected to dominate the market due to the presence of key products such as Hunterase and Elaprase. Both of these products accounts for a significant portion of the market revenue share. The other segments in the global mucopolysaccharidosis treatment market which includes mucopolysaccharidosis type I, mucopolysaccharidosis type IV A and mucopolysaccharidosis Type VI, all of which have key products offerings attributable to them. Such factors are anticipated to drive the market during the forecast period.The others segment includes mucopolysaccharidosis type VII (Sly syndrome) whose product offering of MEPSEVII (vestronidase alfa-vjbk) is anticipated to register a strong growth rate during the forecast period. Growing prevalence of the mucopolysaccharidosis types, along with introduction of major enzyme replacement therapy (ERT) products in the market, is expected to drive the growth of the segment during the forecast period.By Route of Administration AnalysisPresence of Major Therapeutics in Intravenous Form to Aid Dominance of the SegmentIn terms of route of administration, the market is segmented into intravenous, and intracerebroventricular (ICV). The intravenous type is anticipated to account for the majority of the revenue share of the route of administration segment, because most of the therapeutics for MPS treatment are to be administered through intravenous injections only. For example, the most prominent therapeutic for Hunter syndrome, Elaprase is administered intravenously. Intravenous therapeutics holds a monopoly over the mucopolysaccharidosis treatment market and is anticipated to hold control over its market share in the forecast period.The only other approved therapeutic that is not in an intravenous form and the route of administration is intracerebroventricular (ICV), is Hunterase. Growing approvals in other countries of these therapeutic, along with anticipated introduction in other countries across the globe, is expected to drive the growth of the segment during the forecast period.By End User AnalysisIncreased Need for Administration of Therapeutics at Hospitals to Enable Dominance of the SegmentOn the basis of end user, the market is segmented into hospitals, specialty clinics, and others. The key factor aiding in the dominance of hospitals segment is that the therapeutics used in MPS treatment can often be administered by trained medical professionals who can administer these therapeutics in settings such as hospitals with care and proper guidelines. This allows for the proper adherence to the MPS treatment guidelines and administration of critical therapeutics which have to be administered intravenously, in a safe environment to manage the increased risk of infusion site infections.Growing number of specialty clinics, due to increasing need for specialist care of a higher degree for the treatment and management of several types of mucopolysaccharidosis (MPS) patients, are some of the major factors responsible for this segments dominance forecast period. Also, a number of these specialty clinics are based in the developed countries, resulting in a strong market revenue share. Also, the increasing government initiatives such as the Brazilian Governments initiative for the setting up of treatment guidelines is also anticipated to contribute to the segments growth.

REGIONAL ANALYSISNorth

segmentation(get_label12,get_values2,chartid);The mucopolysaccharidosis (MPS) treatment market size in North America stood at USD 1,019.4 million in 2018. Some of the characteristics of this market is higher diagnosis and treatment rates for a number of rare disorders, coupled with adequate reimbursement policies for these therapeutics. These factors, coupled with higher awareness among patient population towards advanced treatment options, increasing diagnostic sophistication, presence of significant clinical trials, and the presence of major clinical stage biopharmaceutical companies are their pipeline candidates, are responsible for highest share of the region in the global market. The market in Europe is anticipated to account for the second largest revenue share during the forecast period. The presence of key products in the region such as Elaprase and ALDURAZYME, is anticipated to drive the demand for MPS treatment in Europe during 2019-2026. Asia-Pacific is projected to register the highest CAGR during the forecast period. Anticipated launch of some therapeutics such as Hunterase in Japan in Asia Pacific, the upcoming product launches in the region due to increased regulatory applications for approvals, and the presence of a strong potential patient population base in the region, together are projected to fuel the mucopolysaccharidosis (MPS) treatment market growth in Asia Pacific during forecast period. The rest of the world market comprises of Latin America and the Middle East & Africa and is currently in nascent stage. However, developing healthcare infrastructure in these regions, increased government initiatives and growing awareness of rare disorders is projected to fuel the mucopolysaccharidosis treatment market demand during forecast period.KEY INDUSTRY PLAYERSKey Product Offerings and Core Focus on Mucopolysaccharidosis of Shire (Takeda Pharmaceutical Company Limited) and BioMarin, to Propel the Company to a Leading Position Competition landscape of mucopolysaccharidosis (MPS) treatment market depicts a competitive landscape dominated by a few key players. Shire (now owned by Takeda Pharmaceutical Company Limited), whose prominent product of Elaprase commands a strong revenue share, and BioMarin are some of the key market players. For example, the product offering of Shire (Takeda Pharmaceutical Company Limited) of Elaprase (idursulfase), its efficiency in terms of treatment outcomes and also its indispensability in treatment of MPS II, are prominent factors responsible for the dominance of the company in the mucopolysaccharidosis treatment. BioMarin has the key product offerings of ALDURAZYME, VIMIZIM, and NAGLAZYME in its product portfolio, covering three types of mucopolysaccharidosis.However, ArmaGen, and REGENXBIO Inc., are some of the prominent clinical stage biopharmaceutical companies such who have entered the clinical trials with their potential drug candidates. This is projected to positively impact the global market as these companies are poised to gain market share during the forecast period through key regulatory approvals.LIST OF KEY COMPANIES PROFILED :Shire (Takeda Pharmaceutical Company Limited)Denali TherapeuticsArmaGenREGENXBIO Inc.Sangamo TherapeuticsBioMarinLysogeneAbeona Therapeutics Inc.Ultragenyx PharmaceuticalGenzyme CorporationOthersKEY INDUSTRY DEVELOPMENTS:February 2020 Lysogene, a key clinical stage biopharmaceutical company, received the FDA fast track designation for the pipeline candidate of LYS-SAF302 gene therapy in MPS IIIA, also known as the Sanfilippo syndrome.April 2019 Abeona Therapeutics, a key integrated leader in cell and gene therapy development, received the FDA Fast Track Designation for their pipeline candidate of ABO-101 for the treatment of Sanfilippo syndrome type B or MPS IIIB.August 2018 Ultragenyx announced the approval of Mepsevii (vestronidase alfa) in Europe for the treatment of mucopolysaccharidosis VII, also known as Sly syndrome.REPORT COVERAGEThe mucopolysaccharidosis treatment market report provides a detailed analysis of the market and focuses on key aspects such as prevalence of key mucopolysaccharidosis types by key regions (2018), pipeline analysis, key industry developments, regulatory scenario- by key regions, overview of emerging treatments for mucopolysaccharidosis, and reimbursement scenario by key regions. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over the recent years.

Report Scope & Segmentation

ATTRIBUTEDETAILSStudy Period 2015-2026Base Year 2018Forecast Period 2019-2026Historical Period 2015-2017Unit Value (USD billion)SegmentationBy TreatmentEnzyme Replacement Therapy (ERT)OthersBy Disease TypeMucopolysaccharidosis Type IMucopolysaccharidosis Type IIMucopolysaccharidosis Type IV AMucopolysaccharidosis Type VIOthersBy Route of Administration IntravenousIntracerebroventricular (ICV)By End User HospitalsSpecialty ClinicsOthersBy GeographyNorth America (U.S. and Canada)Europe (U.K., Germany, France, Italy, Spain, and Rest of Europe)Asia-Pacific (Japan, China, India, South Korea, and Rest of Asia-Pacific)Rest of the World

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Quick Read Table of Contents of this Report @ Mucopolysaccharidosis Treatment Market Size, Share & Industry Analysis, By Treatment (Enzyme Replacement Therapy (ERT), and Others), By Disease Type (Mucopolysaccharidosis Type I, Mucopolysaccharidosis Type II, Mucopolysaccharidosis Type IV A, Mucopolysaccharidosis Type VI, and Others), By Route of Administration (Intravenous, and Intracerebroventricular (ICV)), By End User (Hospitals, Specialty Clinics, and Others), and Regional Forecast, 2020-2029(Includes COVID-18 Business Impact)

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Global mucopolysaccharidosis treatment market size was USD 1.98 billion in 2018 and is projected to reach USD 4.37 billion by 2026, exhibiting a CAGR...

Global Huntington’s Disease Treatment Market- Industry Analysis and Forecast (2019-2027)- By Drug Type, Treatment, End-Users, and Region. – Good…

Theglobal Huntingtons disease treatment marketwas valued US$ 1.53 Bn in 2019 and is expected to reach 3.23 Bn by 2027, at a CAGR of 46.68% during a forecast period.

Market Introduction:

Huntingtons disease is a rare genetic condition that affects the brain and results in the degeneration of the nerve cells. It occurs between the age of 30 and 50 and worsens with time. The disorder usually becomes fatal after 20 years of its occurrence. The symptoms of the targeted disorder include depression, mood swings, amnesia, involuntary movement, and weight loss. It is associated with Parkinsons disease and Alzheimers as well as other health complications. Huntingtons disease can be diagnosed through CT scans and MRIs.

The report study has analyzed the revenue impact of COVID-19 pandemic on the sales revenue of market leaders, market followers, and disrupters in the report, and the same is reflected in our analysis.

Market Drivers and Restraints:

Growth and advancement in the treatment process and machinery used to treat such disease are the leading factors for market growth. On-going scientific research responsible for awareness about Huntingtons disease amongst the population is considered as one of the major factors driving the growth of Huntingtons disease therapeutics market. Medical needs across the globe are seeking the attention of scientists and researchers to develop a therapy for Huntingtons disease. Furthermore, high investment by the pharmaceutical companies involved in the R&D sector to develop innovative and curative drugs for the disease is fuelling the growth of the global HD treatment market as there is no proper treatment available. Besides, the presence of alternative therapies, including speech therapy, psychotherapy, and physiotherapy strongly contributed and increased the potential of the market growth for Huntingtons disease therapeutics.

However, due to the presence of stringent regulation and policies, the number of approved drugs is limited, hampering the availability of the drug in the market whereby, hindering the market growth in the coming years.

Huntingtons Disease Treatment Market Segment analysis:

Based on the drug type segment, tetrabenazine is expected to dominate the overall market demand in the coming forecast as it is the only drug approved by the US FDA for the treatment of chorea in Huntingtons disease. Tetrabenazine provides significant benefits in the treatment of chorea associated with HD. Health-care providers need to screen patients carefully before initiating treatment with this medication due to the adverse effects of tetrabenazine. In the future, additional long-term and comparative studies would be useful for further clarification of the role of tetrabenazine in the treatment of HD-associated chorea. According to IQVIA, US sales of tetrabenazine tablets 12.5 mg and 25 mg were ~$ 0.119 Bn in the year 2019, projected to show significant growth during the forecasted period.

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Huntingtons Disease Treatment Market Regional Analysis:

Regionally, North America is expected to dominate Huntingtons disease treatment market, the US is the major contributor with a reported market share of ~ 65.59% in the base year and is estimated to show steady growth during the forecasted period. The on-going R&D activities and investment by pharmaceutical companies in the region are projected to run the innovation of highly effective and improved drugs for the treatment of Huntingtons disorder. Furthermore, advancement in technology and the presence of numerous vendors based on small and large sales are majorly participating to invest in this market will boost the market growth in the coming years.

On the other hand, Europe is expected to show substantial market growth owing to its economic stability. Europe is estimated to hold the second-largest share in the market owing to the growing aging population along with rising research and development activities aiming at Huntingtons disease in the region.

The objective of the report is to present a comprehensive analysis of the Global Huntingtons Disease Treatment Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers, and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.

Recent Advances in the Treatment of Huntingtons Disease: Targeting DNA and RNA:

Recent developments in gene therapy, including antisense oligonucleotides, small interfering RNAs, and gene editing are bringing new hope to the Huntingtons community. This step is expected to contribute to the market growth on another level in terms of value.

The report also helps in understanding Global Huntingtons Disease Treatment Market dynamics, structure by analysing the market segments and project the Global Huntingtons Disease Treatment Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Huntingtons Disease Treatment Market make the report investors guide.

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Scope of Huntingtons Disease Treatment Market

Global Huntingtons Disease Treatment Market, By Drug Type

Tetrabenazine Antidepressants Antipsychotic Drugs Tranquilizers Others Global Huntingtons Disease Treatment Market, By Treatment

Symptomatic therapy Disease-modifying therapy Global Huntingtons Disease Treatment Market, By End-Users

Hospital Clinics Online Pharmacies Retail Pharmacies Others Global Huntingtons Disease Treatment Market, By Region

North America Europe Asia Pacific Latin America Middle East & Africa Key Players Operating the Huntingtons Disease Treatment Market

Alnylam Pharmaceuticals Inc AmpliPhi Biosciences Corp Ceregene Inc Lundbeck Prana Biotechnology Limited Teva Pharmaceutical Industries Ltd Cortex Pharmaceuticals Inc Vertex Pharmaceuticals Incorporated Auspex Pharmaceuticals SOM Biotech GlaxoSmithKline Siena Biotech Raptor Pharmaceutical Pfizer Palobiofarma Omeros Ipsen Valeant Pharmaceuticals International Inc

MAJOR TOC OF THE REPORT

Chapter One: Huntingtons Disease Treatment Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Huntingtons Disease Treatment Market Competition, by Players

Chapter Four: Global Huntingtons Disease Treatment Market Size by Regions

Chapter Five: North America Huntingtons Disease Treatment Revenue by Countries

Chapter Six: Europe Huntingtons Disease Treatment Revenue by Countries

Chapter Seven: Asia-Pacific Huntingtons Disease Treatment Revenue by Countries

Chapter Eight: South America Huntingtons Disease Treatment Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Huntingtons Disease Treatment by Countries

Chapter Ten: Global Huntingtons Disease Treatment Market Segment by Type

Chapter Eleven: Global Huntingtons Disease Treatment Market Segment by Application

Chapter Twelve: Global Huntingtons Disease Treatment Market Size Forecast (2019-2026)

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After years of protest, a top hospital ended intersex surgeries. For activists, it took a deep toll. – USA TODAY

Kate Sosin, The 19th Published 8:35 p.m. ET Aug. 10, 2020 | Updated 3:12 p.m. ET Aug. 11, 2020

This story was published in partnership with The 19th, a nonprofit, nonpartisan newsroom reporting on gender, politics and policy.

Eugene Robinson recovered from his double mastectomy on a hospital porch in Durham, North Carolina. It was August 1956, and as a Black child in the Jim Crow South, Robinson wasnt allowed to heal next to White patients.

Sarah Robinson, Eugenes mother, brought a daughter to the hospital. She returned home with a son. It was his third of four surgeries. Two of his nine siblings had undergone similar operations, but his relatives never talked about the fact that androgen insensitivity syndrome, a genetic intersex condition, ran in the family.

Nearly 65 years later, Sean Saifa Wall, 41, sifts through Robinsons medical records, looking for answers about his uncles story that might shed light on his own. Wall, like Robinson, is intersex.

Sean Saifa Wall is a co-founder of the Intersex Justice Project, which has protested intersex surgeries at Lurie Children's Hospital of Chicago for years. Since the 1960s, medical convention has been that intersex variances should be "corrected," often through a combination of surgeries and hormone therapy starting from infancy or before a child can consent.(Photo: Sarah-Ji/Intersex Justice Project)

Intersex is an umbrella term for people with variations in sex characteristics that dont fit neatly in the binary of male or female. Some intersex people are born with varying reproductive anatomy or sex traits some develop them later in life.About 1.7 percentof people are born intersex, according to a 2000 report byDr. Anne Fausto-Sterling.

Since the 1960s, medical convention has been that intersex variations should be corrected, often through a combination of painful surgeries and hormone therapy starting from infancy or before a child can consent. But on July 28, the Ann and Robert H. Lurie Childrens Hospital of Chicago became the first hospital in the United States to suspend the operations. The news comes after a three-year campaign against the hospital led by Wall and Pidgeon Pagonis, co-founders of the Intersex Justice Project.

Activists have been protesting intersex surgeries since 1996, when a group demonstrated outside the American Academy of Pediatrics convention in Boston. Since then,the U.N. has condemned the surgeries,which remain legal in almost every country in the world,as irreversible and unnecessary procedures that can cause permanent infertility and lifelong pain, incontinence, loss of sexual sensation, and mental suffering.

Wall knows that pain intimately.

Wall came out as gay at age 14. Then, he came out as transgender. In both cases, his mom lost it, he said. She was like, Why do you want to wear mens clothes, mens underwear?

But Walls oldest aunt reminded his mom about his intersex uncle, now deceased. His aunt said, Do you not remember playing with Queen Esther as a child?

And my mom was like, Whos that? And shes like, 'Thats Gene.

Wall says the memory blew my moms mind for seven years she had a sister. Looking back, she did remember Esther.

Eight of his family members were intersex, Wall says. The more that Wall started to talk about himself, the more his family opened up about their own histories.

Up until the time he was 13, Walls mom resisted doctors insistence that he have surgery to remove undescended testes, he says. She saw his older intersex siblings suffer through their own operations and thought they were unnecessary.

They told my mom that the testes were cancerous, Wall said. So his mom agreed to the surgery. Wall never had cancer.

He had spent two years under the care of a doctor that he says studied him, asking him questions about whether or not hormones made him less gay. Still, it wasnt until college, while doing a Yahoo internet search, that Wall pieced together that he is intersex.

I was so angry, he said. I was like, Oh, this is not fair. Its not right.' I didnt talk about it for a while. I would tell people here and there, but I didnt talk about it publicly because I had so much shame.

I was so angry. ... I would tell people here and there, but I didnt talk about it publicly because I had so much shame.

When he was 25, he started taking testosterone, something he wanted to do as a trans person to confirm his gender. But he wasnt metabolizing the testosterone the way most people on the hormone do.

I think I felt really suicidal, he said, referring to people constantly misgendering him. But I knew that if I took my own life, that no one would ever know what happened to me, and no one would ever know my side of the story.

Thats when Wall decided to start organizing for intersex rights.

For 19 years, Lurie patient Pidgeon Pagonis also believed they had survived ovarian cancer. The surgeries and exams started before Pagonis could remember, at 6 months old. They had another operation when they were 3 or 4 years old, and another when they were 10.

Pidgeon Pagonis, co-founder of the Intersex Justice Project, at a protest in 2017.(Photo: Sarah-Ji/Intersex Justic Project)

Since I was like 11 they would always just lift my shirt off, touch my chest and then pull my pants down and look at my vulva area, Pagonis recalls. And then theyd ask me questions like, How are you? How are your grades?

Pagonis thought that because of the cancer, they would never be able to have a baby. In truth, Pagonis never had cancer. Years of intersex surgeries to make their body conform to the idea of the female sex had left them unable to feel most sexual sensation.

They spent 18 years in and out of Lurie for surgeries, hormones and exams. Doctors would ask Pagonis if they had questions. Pagonis wanted to know why they were experiencing puberty differently than other kids.

I didnt know I had a vaginoplasty, and I didnt know I was intersex, Pagonis said. I did not know I had a castration, and I did not know I had a clitorectomy at that point. I thought I survived cancer.

Pagonis attended college practically in the shadow of the hospital at DePaul University, watching doctors come and go as they studied for finals. It wasnt until they learned about intersex issues at DePaul that they realized that all those visits to Lurie hadnt been about cancer at all.

I just thought these were my doctors that I had to go to because I had cancer when I was a kid, Pagonis said. And also, I was so unlucky that I had this urethra problem.

No other major U.S. hospital has ever stated that they dont perform intersex surgeries, so Lurie was far from the only institution performing such procedures. However, Lurie has enjoyed a sterling reputation among LGBTQ+ people since 2013, when it opened one of the first pediatric gender clinics in the nation under the leadership of Dr. Robert Garofalo, a nationally renowned expert in transgender health. Under Garofalos leadership in the Gender & Sex Development Program, Lurie became thefirst hospital in the United Statesto adopt a trans-inclusive policy for its young patients.

That prestige made Lurie a prime target for a campaign to end intersex surgeries. Intersex activists have long pointed to a disconnect between the gender-affirming care for trans and non-binary youth at the hospital and surgeries done on intersex children without their knowledge or consent.

The truth of the matter is they are very distinct and separate populations in many ways, said Garofalo. But there are areas where there are some overlaps.

And those cast a pall on the gender clinic as calls to end the surgeries overwhelmed its social media channels.

The Intersex Justice Project Pagonis and Walls organization of intersex activists of color led its first protests against Lurie in 2017 and again in 2018, when the Androgen Insensitivity Syndrome-Differences of Sex Development Support Group held its conference in Chicago. About 70 people showed up to protest outside Lurie. Since that time, Lurie has been the target of a relentless campaign to end the surgeries, and protests outside the hospital have only grown.

In July, Pose star Indya Moore excoriated the hospital for using their image to promote LGBTQ+ inclusion.

You cannot stand W/ trans ppl & step ON intersex ppl! Moorewrote on Twitter. The tweet set off a firestorm of bad press for the hospital as an old petition against the surgeries at Lurie racked up 45,000 signatures.

Garofalo said the hospital has long been revising its polices on intersex care, but it had never apologized for the harm those surgeries had caused.

I mean, the truth of the matter is that it has been uncomfortable for me at times, conceded Garofalo, who does not oversee intersex care at the hospital.

On July 28, the same day the hospital announced it was suspending the surgeries, the hospital apologized.

We empathize with intersex individuals who were harmed by the treatment that they received according to the historic standard of care, and we apologize and are truly sorry, the hospitalstatedin a letter signed by President and CEO Dr. Thomas Shanley. When it comes to surgery, we are committed to reexamining our approach.

Intersex is an umbrella term for people with variations in sex characteristics that dont fit neatly in the binary of male or female. About 1.7 percentof people are born intersex, according to a 2000 report byDr. Anne Fausto-Sterling.(Photo: Oleksii Liskonih, Getty Images/iStockphoto)

A number of staffers within Lurie pushed for an end to the surgeries, most notably transgender research coordinator Dr. Ellie Kim, who publicly criticized the practice.

I really owe Ellie a debt of gratitude for really stepping forward and not being shy about her thoughts on the matter, Garofalo said. And to that extent, Im really proud to be where Im at.

Luries end to intersex surgeries marks a watershed moment for intersex rights. Lurieis rankedamong the top pediatric hospitals in the nation, and intersex rights activists hope that other hospitals follow suit.

But for advocates like Wall, the campaign has also taken a deep toll. Pagonis and Wall garnered support and educated the public by sharing intimate personal stories. Its largely considered disrespectful for reporters to ask transgender people about their surgeries or genitalia. Intersex activists dont have that luxury yet, says Hans Lindahl, director of communications for youth intersex organization InterAct.

Something that we say a lot is that we have not yet had our Laverne Cox moment, said Lindahl. Were still so under the purview of being medicalized that I think theres a pressure that we almost have to tell these stories at this point in our movement in order to get people to listen.

For Pagonis and Wall, that has meant revealing details about their own traumas, sexual experiences, anatomy and family histories.

And largely lost in this moment is the history of intersex surgery itself. Intersex operations were born out of gynecology, a practice developed byJames Marion Sims, who performed brutal experiments on enslaved Black women without anesthesia. Although intersex surgeries were popularized in the 1960s, doctors had been doing them for years before, as Walls family history shows.

Wall says his family was already harassed as a Black family in the segregated South. But a Black family with three kids whose sex characteristics varied meant they were tormented endlessly.

So for me, my intersex story comes out of this legacy thats rooted in the South, thats rooted in North Carolina, Wall said. By the time this intersex variation appeared in my family, there was knowledge and awareness of it, but people didnt talk about it, because there was shame and stigma and secrecy.

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After years of protest, a top hospital ended intersex surgeries. For activists, it took a deep toll. - USA TODAY

Global Bleeding Disorders Treatment Market- Industry Analysis and forecast 2019 2027: By Indication, Product Type, and Region. – Good Night, Good…

Global Bleeding Disorders Treatment Marketsize was valued at US$ XX Bn. In 2019 and the total revenue is expected to grow at CAGR of 8.1% from 2020 to 2027, reaching nearly US$ XX Bn.

The report study has analyzed the revenue impact of COVID -19 pandemic on the sales revenue of Market leaders, Market followers, and Market disrupters in the report, and the same is reflected in our analysis.

Definition:

Bleeding disorders are a group of disorders in which the human body is inefficient to clot the blood. This is either hereditary or deficiency of blood clotting factors in blood called platelets. Bleeding disorder treatments help these patients with the formulation of platelets through medications, replacement therapy, and taking some precautions on their part to avoid the risk of bleeding.

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Market Dynamics:

In 2019, the Bleeding disorders treatment market was valued at approximately US$ 9,687.11 million and is expected to grow further. Significant factors for the growth of this market are increased patient population, investment in R&D for the availability of advanced molecular drug formulas, the focus of the big companies in the development of recombinant products for efficient treatment. But this growth will be hindered by the exorbitant cost of treatment and limited reimbursement policies. In December 2018, the FDA approved emicizumab-kxwh as prophylaxis for patients with hemophilia A with or without factor VIII (FVIII) inhibitors. This drug was first approved in 2017 for patients with hemophilia A with FVIII inhibitors.

Market Segmentation:

Among the several types of bleeding disorders, Hemophilia A and Von Willebrand Disease are the most commonly seen in the patient-population. The former is a rare disorder mostly affecting the males while the latter in inherited and is high among the Americans. By the type of drugs used for treatment, Plasma-derived Coagulation products and Recombinant Coagulation products are largely used for treatment. In the 1950s, the plasma-derived products were widely used but it faced adversity due to the spread of HIV and the Hepatitis virus in the 1980s through plasma transfusion. Post-1980s, the recombinant products were used and still these are going through a phase of development.

Region-wise Analysis:

The Bleeding disorders treatment market is dominant in North America, valued at US$ 3.57 bn. in 2019, and will continue with growth since about 1% of the US population is affected by bleeding disorders due to iron deficiency and they are availing the prophylaxis treatment for it. This is complemented with the high presence of major companies in North America. This is followed by Europe, where the growth in the bleeding disorder treatment market is due to high R&D investment facilitating technological advancement and innovations.

Competitive Landscape:

The competitive landscape section in the Bleeding Disorders Treatment market offers a deep dive into the profiles of the leading players operating in the global market landscape. It offers captivating insights on the key developments, differential strategies, and other crucial aspects about the companies having a stronghold in the Bleeding Disorders Treatment market. Gene therapy trials are conducted in the Boston Childrens Hospital to treat Hemophilia in children.

The objective of the report is to present a comprehensive analysis of the Global Bleeding Disorders Treatment Market including all the stakeholders of the industry. The past and current status of the industry with the forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers, and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the Market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers. The report also helps in understanding Global Bleeding Disorders Treatment Market dynamics, structure by analyzing the Market segments and projects the Global Bleeding Disorders Treatment Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Bleeding Disorders Treatment Market make the report investors guide.

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Scope of the Global Bleeding Disorders Treatment Market

Global Bleeding Disorders Treatment Market, by Disease Type

Hemophilia A Hemophilia B Von Willebrand Disease Liver Disease Others Global Bleeding Disorders Treatment Market, Drug Type

Plasma-derived Coagulation Factor Concentrates o Factor VIII o Factor IX o Factor for Von Willebrand Disease o Activated Prothrombin Complex Concentrate Recombinant Coagulation Factor Concentrates o Factor VIII o Factor for Von Willebrand Disease o Factor IX Desmopressin Antifibrinolytics Fibrin Sealants Others Global Bleeding Disorders Treatment Market, By End User

Hospitals Clinics Academic Institutions Global Bleeding Disorders Treatment Market, By Region

Asia Pacific North America Europe Latin America Middle East Africa Key players operating in Global Bleeding Disorders Treatment Market

Shire Bayer AG Biogen Inc. CSL Behring Novo Nordisk Pfizer Inc. Grifols Baxter International Inc. Alnylam Pharmaceuticals, Inc. Xenetic Biosciences, Inc. Bristol-Myers Squibb Company Octapharma Sanofi Amgen, Inc. Bioverativ Janssen Global Services, LLC Cangene Corporation BDI Pharma Sun Pharmaceutical Industries Ltd. Ferring Pharmaceuticals Roche Pharmaceuticals

MAJOR TOC OF THE REPORT

Chapter One: Bleeding Disorders Treatment Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Bleeding Disorders Treatment Market Competition, by Players

Chapter Four: Global Bleeding Disorders Treatment Market Size by Regions

Chapter Five: North America Bleeding Disorders Treatment Revenue by Countries

Chapter Six: Europe Bleeding Disorders Treatment Revenue by Countries

Chapter Seven: Asia-Pacific Bleeding Disorders Treatment Revenue by Countries

Chapter Eight: South America Bleeding Disorders Treatment Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Bleeding Disorders Treatment by Countries

Chapter Ten: Global Bleeding Disorders Treatment Market Segment by Type

Chapter Eleven: Global Bleeding Disorders Treatment Market Segment by Application

Chapter Twelve: Global Bleeding Disorders Treatment Market Size Forecast (2019-2026)

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Advanced Wound Care Management Market: Chronic wounds to be highly lucrative segment – BioSpace

Transparency Market Research (TMR) has published a new report titled, Advanced Wound Care Management Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20182026. According to the report, theglobal advanced wound care management marketwas valued at US$ 8.5 Bn in 2016 and is projected to expand at a CAGR of 5.8% from 2018 to 2026. Surge in incidence of chronic wounds and trauma cases is anticipated to boost the demand for advanced wound care management during the forecast period. North America and Europe are projected to dominate the global advanced wound care management market owing to higher rate of adoption and awareness regarding wound care management. Asia Pacific, Latin America, and Middle East & Africa are potential markets for advanced wound care management. The market in Asia Pacific is expected to expand at a CAGR of 6.3% from 2018 to 2026.

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Cost-effective advanced wound care management to treat complex wounds to drive global market

Increase in trauma and accident cases across the globe drives the advanced wound care management market. According to the World Health Organization (WHO), road accidents account for around 1.25 million deaths across the globe each year. Additionally, the number of patients with chronic wounds is rising rapidly across the world. This is likely to increase the number of surgical procedures; consequently, propelling the global advanced wound care management market.

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Chronic wounds to be highly lucrative segment

Chronic wounds is an emerging segment of the advanced wound care management market. In the chronic wounds segment, the ulcers sub-segment holds a prominent share. Venous leg ulcers account for 80% of all leg ulcers. Moreover, the chronic wounds segment is likely to hold major share due to high cost of therapy across the globe. As per a paper published by NCBI (National Center for Biotechnology Information), in May 2014, the annual burden of venous leg ulcers in the U.S. is nearly US$ 14.9 Bn, which includes indirect costs (productivity loss) as well. The diabetic foot ulcer sub-segment of the advanced wound care products market is expanding at a significant CAGR.

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Hospitals & clinics to be notably promising segment

In terms of end-user, the global advanced wound care management market has been segmented into hospitals & clinics, ambulatory surgical centers (ASCs), home health care, and others. The hospitals & clinics segment held major share of the global market in 2017. Expansion of the segment can be attributed to the availability of multiple service options and devices and tie-ups with health care companies in order to enhance health care product and service offerings. Moreover, hospitals are the preferred choice due to availability of advanced technology and better health care services. The home health care segment is expanding at a high growth rate, especially in developed economies, due to rise in geriatric population and increasing health care infrastructure and support. Moreover, rise in demand for advanced wound care management in home care settings for geriatric patients is projected to drive the segment.

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North America expected to dominate global market

In terms of region, the global advanced wound care management market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global advanced wound care management market in 2017. The market in North America was valued at US$ 3.2 Bn in 2017 owing to a highly developed health care sector, increase in awareness among health care providers about advanced wound care management, and continuous evolution of wound care management. Advanced wound care management market offers significant growth potential in the region. The advanced wound care management market in Asia Pacific is anticipated to expand at a CAGR of 6.3% during the forecast period due to increase in awareness about advanced wound care products and expansion of the health care sector in countries such as China, Japan, and India. Moreover, technological advancements and increase in rate of adoption of advanced wound care management products are expected to propel the market in the region during the forecast period.

Smith & Nephew plc, Acelity L.P., Inc. and Mlnlycke Health Care AB anticipated to lead global market

The global advanced wound care management market is highly fragmented in terms of number of players providing different products. Key players in the global advanced wound care management market include Smith & Nephew plc, Acelity L.P., Inc., Mlnlycke Health Care AB, ConvaTec Inc., B. Braun Melsungen AG, Coloplast A/S, 3M Healthcare, Integra LifeSciences Corporation, Cardinal Health, PAUL HARTMANN AG, BSN Medical, Hollister Incorporated, Organogenesis Inc., and Medline Industries, Inc. Expansion of product portfolio through mergers and acquisitions is a key strategy followed by several global players. In December 2015, Acelity L.P., Inc. announced the acquisition of Spiracur, Inc., expanding its offering in disposable, portable, mechanical NPWT (Negative-pressure wound therapy) technology, and allowing sales and service channels to boost the expansion of the SNaP therapy system to patients and their care teams across the world who need access to NPWT devices.

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Advanced Wound Care Management Market: Chronic wounds to be highly lucrative segment - BioSpace

Investigation and management of erythrocytosis – CMAJ

KEY POINTS

Primary erythrocytosis or autonomous production of excess erythrocytes most commonly occurs due to polycythemia vera (PV), a myeloproliferative neoplastic process that may be asymptomatic or may present with thrombosis, constitutional or vasomotor symptoms, or splenomegaly.

Secondary erythrocytosis, which is more common than PV, has a broad differential diagnosis that includes hypoxic lung disease, cyanotic congenital heart disease, medications (e.g., testosterone) and erythropoietin-producing malignant disorders.

Differentiating between PV and secondary erythrocytosis requires clinical evaluation and specialized investigations including measurement of the serum erythropoietin level and Janus kinase 2 mutation testing.

To reduce the risk of thrombosis, most patients with PV are treated with low-dose acetylsalicylic acid and phlebotomy to achieve a target hematocrit value of less than 0.45, whereas patients at high risk for thrombosis may receive cytoreductive therapy.

Treatment of secondary erythrocytosis should be directed at the underlying cause, and phlebotomy is not routinely recommended.

Erythrocytosis refers to an erythrocyte count above the sex-specific normal range and can be subclassified into relative erythrocytosis, caused by a reduction in plasma volume (hemoconcentration), or absolute erythrocytosis, caused by increased erythrocyte mass. Primary erythrocytosis refers to autonomous production of erythrocytes, typically from a myeloproliferative neoplasm (polycythemia vera [PV]). In contrast, secondary erythrocytosis is caused by a physiologically appropriate response to elevated serum erythropoietin levels.

Up to 4% of ambulatory men and 0.4% of ambulatory women in Canada have erythrocytosis, based on hemoglobin levels greater than 165 g/L or 160 g/L, respectively.1 Differentiating PV from other causes of erythrocytosis is critical because early recognition and treatment of PV can prevent many of its vasomotor and thrombotic complications. Polycythemia vera is rare, with an incidence and prevalence of 0.84 and 22 per 100 000, respectively.2,3 Although the prevalence of secondary erythrocytosis is difficult to estimate, it is higher than that of PV. Secondary erythrocytosis affects 6%8% of patients with chronic obstructive pulmonary disease4 and 2%8% of patients with obstructive sleep apnea.5,6

In this review, we summarize a contemporary approach to differentiating PV from other causes of erythrocytosis, and review the natural history, diagnosis and management of PV (Box 1).

We reviewed current guidelines on the management of polycythemia vera. For questions regarding the diagnostic investigation of erythrocytosis and the utility of specific laboratory tests such as the erythropoietin level, we searched MEDLINE to January 2020 for terms such as polycythemia vera, erythrocytosis or secondary erythrocytosis AND diagnosis, erythropoietin level, bone marrow biopsy and JAK2. We considered original research and review articles published between 2010 and January 2020, and searched reference lists of selected articles to identify additional studies of interest. We specifically reviewed landmark randomized trials in polycythemia vera such as the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) study,7 the European Collaboration on Low-Dose Aspirin in Polycythemia Vera (ECLAP) study,8 the Randomized Study of Efficacy and Safety in Polycythemia Vera with JAK Inhibitor INCB018424 versus Best Supportive Care (RESPONSE),9 the RESPONSE-210 and older studies conducted by the Polycythemia Vera Study Group.

Relative erythrocytosis results from any condition that reduces plasma volume, such as gastrointestinal fluid losses or diuretic use. Absolute erythrocytosis can be driven by a clonal bone marrow disease (PV) or be secondary to another disease, including a physiologic response to increased erythropoietin secondary to hypoxia, drugs11 or erythropoietin-producing solid tumours12,13 (Box 2). Congenital causes of erythrocytosis include high-oxygenaffinity hemoglobins, erythropoietin receptor mutations and alterations in oxygen-sensing molecular pathways.

Hypoxia-driven

Generalized tissue hypoxia

Smoking

Carbon monoxide poisoning

Hypoxic lung disease

Obstructive sleep apnea

Right to left cardiopulmonary shunt (e.g., cyanotic congenital heart disease)

High altitude

Local renal hypoxia

Drug-associated

Testosterone

Erythropoietin

Pathologic erythropoietin production

Miscellaneous

Erythrocytosis after renal transplantation

Idiopathic erythrocytosis*

Polycythemia vera is a myeloproliferative neoplasm characterized by increased erythrocyte mass, thrombosis and vasomotor symptoms. A gain-of-function mutation in Janus kinase 2 (JAK2) underlies 98% of PV cases.15

The history-taking and physical examination should be directed toward ruling out relative erythrocytosis and then distinguishing between primary and secondary erythrocytosis. For secondary erythrocytosis, this includes a review of cardiac, respiratory and abdominal signs and symptoms. Patients should be asked about tobacco smoking, medications (especially androgenic steroids, including testosterone11), exposure to carbon monoxide and symptoms of obstructive sleep apnea. A full cardiopulmonary examination should be completed, and the abdomen should be examined for organomegaly or erythropoietin-producing intraabdominal tumours (e.g., hepatocellular or renal cell carcinoma).

Oxygen saturation less than 92% on room air by pulse oximetry suggests that erythrocytosis is secondary to hypoxic cardiopulmonary disease.14 Some causes of hypoxia may present with a normal or falsely elevated oxygen saturation value (e.g., obstructive sleep apnea, high-oxygen-affinity hemoglobins, or carboxyhemoglobinemia from tobacco smoking or carbon monoxide poisoning).

The World Health Organization diagnostic criteria for PV were updated in 2016 (Box 3).16 Patients with PV may have symptoms of splenomegaly, constitutional symptoms or vasomotor symptoms such as headache, visual disturbances or light-headedness. Two specific symptoms for myeloproliferative neoplasms are pruritus and erythromelalgia.15 Pruritus is often aquagenic and may be debilitating. Erythromelalgia is a recurrent burning sensation accompanied by erythema and warmth, most commonly affecting the hands.

Diagnosis of polycythemia vera requires all 3 major criteria OR the first 2 major criteria and the minor criterion

Major criteria

Hemoglobin level > 165 g/L in men, > 160 g/L in women OR hematocrit > 0.49 in men, > 0.48 in women OR increased erythrocyte mass

Bone marrow biopsy showing hypercellularity for age with trilineage growth (panmyelosis) including prominent erythroid, granulocytic and megakaryocytic proliferation with pleomorphic, mature megakaryocytes*

Presence of JAK2 V617F or JAK2 exon 12 mutation

Minor criterion

* Bone marrow biopsy is not required for patients with sustained absolute erythrocytosis, defined as a hemoglobin level greater than 185 g/L in men (hematocrit 0.55) or greater than 165 g/L in women (hematocrit 0.50) if the third major criterion and the minor criterion are met.

Initial tests to differentiate primary from secondary erythrocytosis include a complete blood count, peripheral blood film, renal and liver function tests, and determination of the ferritin level.14 Erythrocyte mass can be measured directly to confirm absolute erythrocytosis by nuclear isotope dilution, but this test is not widely available in Canada.1 As PV is associated with panmyelosis (expansion of all myeloid elements of the bone marrow), patients often have mild to moderate leukocytosis and thrombocytosis rather than isolated erythrocytosis.15 Many patients with PV are iron deficient at diagnosis owing to erythroid expansion and altered iron metabolism. 17 A low mean erythrocyte volume and low ferritin level (< 3545 ng/mL) support a diagnosis of iron deficiency.18 Baseline abdominalpelvic imaging is indicated when the clinical examination for splenomegaly gives equivocal findings or when endogenous erythropoietin production is suspected.19

The serum erythropoietin level can differentiate between primary and secondary erythrocytosis. In a cohort study of 125 patients, a low erythropoietin level (< 2.9 mU/mL) was specific (92%) and moderately sensitive (64%) for the diagnosis of PV.20 A high erythropoietin level (> 15.1 mU/mL) was specific (98%) but had poor sensitivity (47%) for the diagnosis of secondary erythrocytosis.20

Ninety-five percent of patients with PV have a V617F point mutation in exon 14 of JAK2.21 JAK2 V617F-negative PV is rare, and mutations in exon 12 of JAK2 account for most of these cases.22 The JAK2 V617F mutation is not specific to PV; it can also be seen in other myeloproliferative neoplasms including essential thrombocythemia and primary myelofibrosis.21 Some cases of PV with iron deficiency may resemble essential thrombocythemia. 17 In these cases, erythrocytes are microcytic, the hemoglobin level is low or within normal limits, and there is marked thrombocytosis.

Our approach to sequencing investigations is adapted from Canadian consensus recommendations1 and a British guideline for the diagnosis and management of PV14 (Figure 1). Front-line tests are selected based on the pretest probability of PV and the availability of JAK2 mutation testing.

Practical diagnostic approach to erythrocytosis. *Some clinicians order determination of the erythropoietin level and JAK2 V617F mutation testing concurrently in settings when there is a high probability of diagnosing polycythemia vera. Bone marrow biopsy is required to meet the World Health Organization 2016 diagnostic criteria16 if the hemoglobin level is less than 185 g/L (hematocrit 0.55) in men or less than 165 g/L (hematocrit 0.50) in women.

In the primary care setting, where the probability of PV is low, clinical evaluation for secondary causes of erythrocytosis paired with a high erythropoietin level can rule out PV in most patients. In hematology clinics, where the probability of PV is higher, erythropoietin level and JAK2 V617F mutation testing are done concurrently. Patients with a low or normal erythropoietin level and no JAK2 V617F mutation are further evaluated with JAK2 exon 12 mutation testing (on peripheral blood or marrow aspirate, based on local practice) and a bone marrow biopsy.14 Findings on bone marrow biopsy in a patient with PV are shown in Figure 2.

Bone marrow biopsy specimen of a patient with polycythemia vera. (A) Hypercellularity for age and panmyelosis (expansion of all myeloid elements of the bone marrow) (hematoxylineosin, 40 magnification). (B) Panmyelosis and pleomorphic megakaryocytes (hematoxylineosin, 200 magnification). Images courtesy of Dr. Catherine Ross, Pathology and Molecular Medicine, Juravinski Hospital, Hamilton, Ontario.

When no diagnosis is made, selected patients with onset of erythrocytosis at a young age or compatible family history should undergo testing for high-oxygen-affinity hemoglobins, and gene sequencing for mutations involving the erythropoietin receptor or oxygen-sensing pathways.14,23 Idiopathic erythrocytosis is a diagnosis of exclusion.

Investigations for secondary erythrocytosis should be symptom-directed and may include chest radiography, overnight oximetry for suspected sleep apnea, pulmonary function tests for hypoxic lung disease, venous blood gas sampling (carboxyhemoglobin level) and echocardiography to rule out right to left cardiac shunting. Abdominalpelvic imaging can help exclude an erythropoietin-producing tumour or conditions associated with local renal hypoxia (Box 2). Neuroimaging to rule out meningioma or cerebellar hemangioblastoma should be ordered for patients with unexplained neurologic symptoms as these tumours have been associated with autonomous erythropoietin production.14

There are no established criteria for referral to a hematologist. Patients with a low or normal erythropoietin level and negative findings on investigation for secondary erythrocytosis are typically referred to a general internist or hematologist to arrange additional investigations starting with JAK2 V617F testing (Figure 1). Internists or hematologists often manage patients who require phlebotomy. Referral to a hematologist is warranted for women with PV who desire pregnancy, patients who are refractory or intolerant to treatment with hydroxyurea, and patients with no diagnosis despite extensive appropriate investigations.

The goals of treatment of PV are to reduce the risk of arterial and venous thromboembolism, and minimize symptoms.14 Unfortunately, existing treatments do not successfully reduce the risk of transformation to myelofibrosis or acute leukemia.

Thrombosis in PV is common and highly morbid. Up to 15% of patients with newly diagnosed PV have a history of arterial or venous thromboembolism.15,24 Patients with PV have venous thrombosis at unusual sites, such as the splanchnic or cerebral veins.25 A meta-analysis of observational studies showed that more than 15% of patients with splanchnic vein thrombosis or BuddChiari syndrome are later diagnosed with a myeloproliferative neoplasm.26

In a cohort of 1638 patients with PV, cardiovascular mortality accounted for 45% of all deaths over more than 4000 person-years of follow-up.27 The 2 most important predictors of cardiovascular events were age greater than 65 years and prior thromboembolism. Patients with neither, 1 or both risk factors experienced 2.5, 5.0 and 10.9 cardiovascular events per 100 person-years, respectively. Treatment guidelines classify patients as being at high risk for thromboembolism if they are more than 60 or 65 years old or have a history of thrombosis, or both.14,28 Patients who meet neither of these criteria are considered to be at low risk.

Patients with PV are treated with daily low-dose acetylsalicylic acid (ASA) and phlebotomy to achieve a target hematocrit value of less than 0.45 based on the results of 2 randomized trials.14,28 Patients are monitored regularly (every 36 mo) for symptoms, treatment complications, cardiovascular events and disease progression.

In the European Collaboration on Low-Dose Aspirin in Polycythemia Vera (ECLAP) study,8 518 patients with PV were randomly allocated to receive low-dose ASA (100 mg/d) or placebo. Acetylsalicylic acid reduced the composite outcome of nonfatal myocardial infarction, nonfatal stroke, venous thrombosis or death from cardiovascular causes by 60% (relative risk [RR] 0.40, 95% confidence interval [CI] 0.180.91), with no statistically significant increase in major bleeding.

In the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) study, 365 adults with PV were randomly allocated to a low hematocrit target (< 0.45) or a less-intensive hematocrit target (0.450.50).7 The primary outcome of death from cardiovascular causes or major thrombotic events was observed in 5 of 182 patients (2.7%) in the low-hematocrit group compared to 18 of 183 patients (9.8%) in the higher-hematocrit group (RR 3.91, 95% CI 1.196.12), with no significant difference in adverse events between the groups.

Most patients with an indication for anticoagulation therapy should receive an anticoagulant in place of ASA. A multicentre observational study of 2510 patients with PV showed that patients who received both an anticoagulant and ASA had a fourfold increased risk of bleeding (95% CI 2.576.94) compared to those who received either treatment alone or no treatment.29 We could not identify any high-quality data comparing warfarin to direct anticoagulants for oral use in PV.30 The British guideline recommends that cardiovascular risk factors, including blood pressure, lipid control, and counselling around smoking cessation and weight loss, be addressed in all patients.14

Observational studies suggest that patients with high-risk PV benefit from cytoreductive therapy in addition to low-dose ASA therapy and phlebotomy.14,28 In North America, hydroxyurea (hydroxycarbamide), an orally administered antimetabolite chemotherapy drug that causes myelosuppression, is used owing to its known efficacy, low cost, oral formulation and acceptable toxicity profile (discussed below). A study showed that 51 patients with PV treated with hydroxyurea had a lower incidence of thrombosis at 2 years than historical controls treated with phlebotomy alone (7% v. 14%).31 Some clinicians titrate the dosage of hydroxyurea to achieve peripheral blood count remission (hematocrit < 45% without phlebotomy, platelet count 400 109/L and leukocyte count < 10 109/L).32 Response definitions for PV have been created for use in clinical trials, but their routine application to clinical practice is not evidence-based.32 Other clinicians titrate the dosage of hydroxyurea to minimize the need for phlebotomy. An observational study showed that patients receiving hydroxyurea who needed 3 or more phlebotomy procedures per year had a significantly higher rate of thrombosis than those who required fewer phlebotomy procedures (21% v. 5% at 3 yr, p < 0.001).33

Alternatives to hydroxyurea include pegylated interferon or busulfan. The former can be used safely during pregnancy and induces molecular remission in some patients; for these reasons, it is often used as front-line therapy for young patients or women desiring pregnancy.34

Ruxolitinib, an orally administered JAK1 and JAK2 inhibitor, is a second-line agent for patients who are refractory or intolerant to hydroxyurea.9,10 The Randomized Study of Efficacy and Safety in Polycythemia Vera with JAK Inhibitor INCB018424 versus Best Supportive Care (RESPONSE) investigators randomly allocated 222 such patients with splenomegaly to ruxolitinib versus best available therapy.9 The composite primary outcome of hematocrit control and at least a 35% reduction in spleen volume was achieved in 20.9% of the patients in the ruxolitinib arm, compared to 0.9% of those in the best-available-therapy arm (p < 0.001). The RESPONSE-2 investigators enrolled similar patients without splenomegaly and found that a higher proportion of ruxolitinib-treated patients than patients who received best available therapy achieved hematocrit control (62% v. 19%, p < 0.001).10

Hydroxyurea is well tolerated, but common adverse effects include complications from cytopenia, oral and leg ulcers, gastrointestinal upset, drug fever, and skin and nail changes. An international retrospective cohort study of 1545 patients with PV showed that hydroxyurea does not increase the incidence of leukemia.15

Ruxolitinib is the most effective treatment for pruritus in PV. A phase III randomized trial showed that patients treated with ruxolitinib were more likely to experience alleviation of pruritus than those who received hydroxyurea (54% v. 32%, p = 0.03).35 Other treatments for pruritus are supported by lower-quality evidence, mostly from case series. These include selective serotonin reuptake inhibitors, interferon , psoralen and ultraviolet A, and antihistamines.36

The prevalence of PV among females of reproductive age is less than 0.3 per 100 000,37 so management recommendations are based on case series or extrapolated from essential thrombocythemia. 5,34 The hematocrit is maintained in the normal range for gestation.5 Women without a contraindication receive low-dose ASA throughout pregnancy, and interferon is used for women who require cytoreductive therapy. Thromboprophylaxis with low-molecular-weight heparin, in addition to ASA, may be beneficial for selected patients at high risk.5,28

Treatment should be directed at the underlying cause. There is no definitive evidence that the risk of thromboembolism is increased in patients with secondary erythrocytosis, and, therefore, phlebotomy is not recommended routinely.38 We direct the reader to a recently published guideline on the management of secondary erythrocytosis,5 which recommends the following approach:

Long-term oxygen therapy should be considered in patients with hypoxic lung disease.

Testosterone should be discontinued in patients with moderate to severe testosterone-induced erythrocytosis and can be resumed at lower dosages once the hematocrit normalizes11,39

Erythrocytosis after renal transplantation should be treated with an angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker.

Patients with cyanotic congenital heart disease or high-oxygen-affinity hemoglobins have physiologic erythrocytosis and should be under specialist care. These patients are at risk for thrombosis, although optimal target hematocrit values are unknown.

Idiopathic erythrocytosis is a diagnosis of exclusion that carries a low risk of thrombosis and bleeding.40 However, some experts recommend an arbitrary target hematocrit value of 0.450.55 for patients with symptomatic hyperviscosity or a history of thrombosis.5

Secondary erythrocytosis can be distinguished from PV in most patients with a focused clinical evaluation and, where available, determination of the erythropoietin level and JAK2 V617F mutation testing. Goals of treatment in PV are to alleviate symptoms, reduce the risk of thromboembolism, and monitor patients for transformation to myelofibrosis or acute leukemia. The majority of patients with PV should be treated with low-dose ASA and phlebotomy to achieve a target hematocrit value of less than 0.45. Cytoreduction, most commonly with hydroxyurea, should be considered in patients at high risk for thrombosis. Treatment of secondary erythrocytosis should be directed at the underlying cause.

Competing interests: Christopher Hillis received grant funding from Novartis Oncology and personal fees from Novartis Oncology, Bristol Myers Squibb and Celgene outside the submitted work. Mark Crowther serves on the advisory boards of Servier Canada, Asahi Kasei Corporation and Precision BioLogic, and the data safety and monitoring board of Bayer. He has received speaking fees from Pfizer, CSL Behring and Diagnostica Stago. He has equity ownership in Alnylam Pharmaceuticals. He is also the Leo Pharma Chair in Thromboembolism Research at McMaster University. No other competing interests were declared.

This article has been peer reviewed.

Contributors: Siraj Mithoowani conceived of the work. Siraj Mithoowani and Marissa Laureano drafted the manuscript, and Mark Crowther and Christopher Hillis revised it critically for important intellectual content. All of the authors made substantial contributions to the design of the work, approved the final version to be published and agreed to be accountable for all aspects of the work.

Funding: Siraj Mithoowani is supported by a CanVECTOR fellowship. The CanVECTOR Network receives grant funding from the Canadian Institutes of Health Research (funding reference CDT-142654).

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Investigation and management of erythrocytosis - CMAJ

Juvenile Macular Degeneration (Stargardt Disease) Treatment Market Size, Top Manufacturers, Product Types, Applications and Specification, Forecast to…

Global Juvenile Macular Degeneration (Stargardt Disease) Treatment market- Report defines the vital growth factors, opportunities and market segment of top players during the forecast period from 2019 to 2025. The report Juvenile Macular Degeneration (Stargardt Disease) Treatment offers a complete market outlook and development rate during the past, present, and the forecast period, with concise study, Juvenile Macular Degeneration (Stargardt Disease) Treatment market effectively defines the market value, volume, price trend, and development opportunities. The comprehensive, versatile and up-to-date information on Juvenile Macular Degeneration (Stargardt Disease) Treatment market is provided in this report.

The latest research report on Juvenile Macular Degeneration (Stargardt Disease) Treatment market encompasses a detailed compilation of this industry, and a creditable overview of its segmentation. In short, the study incorporates a generic overview of the Juvenile Macular Degeneration (Stargardt Disease) Treatment market based on its current status and market size, in terms of volume and returns. The study also comprises a summary of important data considering the geographical terrain of the industry as well as the industry players that seem to have achieved a powerful status across the Juvenile Macular Degeneration (Stargardt Disease) Treatment market.

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segment by Type, the product can be split into Stem Cell Therapy Gene Therapy Others Market segment by Application, split into Hospitals Eye Clinics Others

Market segment by Regions/Countries, this report covers North America Europe China Japan Southeast Asia India Central & South America

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Complete Analysis of the Juvenile Macular Degeneration (Stargardt Disease) Treatment Market:

Comprehensive assessable analysis of the industry is provided for the period of 2019-2025 to help investors to capitalize on the essential market opportunities.

The key findings and recommendations highlight vital progressive industry trends in the global Juvenile Macular Degeneration (Stargardt Disease) Treatment market, thereby allowing players to improve effective long term policies

A complete analysis of the factors that drive market evolution is provided in the report.

To analyze opportunities in the market for stakeholders by categorizing the high-growth segments of the market

The numerous opportunities in the Juvenile Macular Degeneration (Stargardt Disease) Treatment market are also given.

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Furthermore, Global Juvenile Macular Degeneration (Stargardt Disease) Treatment Market following points are involved along with a detailed study of each point:

Generation of this Global Juvenile Macular Degeneration (Stargardt Disease) Treatment Industry is tested about applications, types, and regions with price analysis of players that are covered.

Revenue, sales are planned for this Juvenile Macular Degeneration (Stargardt Disease) Treatment market, including with various essentials along yet another facet is assessed in this section for foremost regions.

In continuation using earnings, this section studies consumption, and global Juvenile Macular Degeneration (Stargardt Disease) Treatment market. This area also sheds light on the variance between ingestion and distribution. Export and Juvenile Macular Degeneration (Stargardt Disease) Treatment significance data are provided in this part.

In this section, key players have been studied depending on product portfolio, their Juvenile Macular Degeneration (Stargardt Disease) Treatment market company profile, volume, price, price, and earnings.

Juvenile Macular Degeneration (Stargardt Disease) Treatment market analysis aside from business, the information, and supply, contact information from manufacturers, consumers and providers can also be presented. Additionally, a feasibility study to asset and SWOT analysis for endeavors have been contained.

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Juvenile Macular Degeneration (Stargardt Disease) Treatment Market Size, Top Manufacturers, Product Types, Applications and Specification, Forecast to...