Stem Cell Clinic

Global Contract Cell and Gene Therapy Manufacturing Market Report 2020-2026: CDMO Categorization – Primed for Business Model Disruption – Benzinga

DUBLIN, Nov. 24, 2020 /PRNewswire/ -- The "Global Contract Cell and Gene Therapy Manufacturing Market 2020-2026 - Supply Chain Optimization and Decentralized Manufacturing to Expand the Industry" report has been added to ResearchAndMarkets.com's offering.

This research service focuses on the critical role being played by CDMOs in not only supporting new product research and development but also in creating standardized manufacturing protocols.

Additionally, the study explores different cross-sections of the market and discusses market dynamics for autologous and allogeneic solutions for cell and gene therapies and for products being manufactured for clinical trial use and for commercial markets. The variability in market dynamics, manufacturing protocols, and business models across cross-sections is high. Therefore, the study also covers the emergence of non-traditional CDMOs that have thrived as a result of this variability.

The cell and gene therapy segment is one of the fastest growing segments in the biopharmaceutical space. While the science behind the therapy has grown by leaps and bounds on the back of decades worth of research, manufacturing has unfortunately lagged behind.

To fully harness the curative potential of these therapies and ensure greater reach and affordability to patients, it is imperative that aggressive investments in manufacturing technology and capacity are made today. Investments in manufacturing technology advancements including automation, single-use technologies, and GMP-in-a-box, will not only enable operational efficiency gains but also reduce project costs, generating benefits which can be transferred directly to the patients.

A large part of this growth in the cell and gene therapy product pipeline is being driven by small and mid-sized biotechs that depend on CDMOs to mitigate product development risks and diffuse infrastructure investments to be able to build future products pipeline.

The study also provides a comprehensive and critical analysis of nationally coordinated efforts towards infrastructure development and the rise of academic institutes and hospitals in meeting not only the demand from clinics, but also the demand of the commercial market.

The study also analyses the growth of specialist CDMOs focusing on vectors and plasmids, for instance. The captures the regional outlook for growth based on the currently installed capacities as well as the pipeline investments being made towards expansion. Lastly, the study tracks growth opportunities across the entire product development spectrum from supply chain to upstream and downstream manufacturing.

Key Topics Covered:

1. Strategic Imperatives

2. Growth Opportunity Analysis - CGT CDMO Market

3. Growth Opportunity Universe - CGT CDMO Market

4. Next Steps

For more information about this report visit https://www.researchandmarkets.com/r/kmx4o3

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Contract Cell and Gene Therapy Manufacturing Market Report 2020-2026: CDMO Categorization - Primed for Business Model Disruption - Benzinga

Internet hawkers of stem cell therapies raising red flags – Ophthalmology Times

This article was reviewed by Ajay E. Kuriyan. MD, MS

Patients have been blinded or have experienced retinal detachments after treatment with so-called stem cell therapies such as intravitreal injections of autologous stem cells that are not FDA approved for many ocular conditions across the US and that were marketed directly to patients.

Ajay Kuriyan, MD, MS, and colleagues had previously identified 40 such business with 70 clinics in the US that advertise these treatments directly to consumers.

Related: Improve patient comfort with intravitreal injections

He explained that the FDA began to issue permanent injunctions against these company, including US Stem Cell Clinic, LLC, US Stem Cell Inc., and the Cell Surgical Network Corporation.

Currently, the FDA has regulatory authority over such companies and since June 2019, has been issuing orders to prevent them from developing or distributing stromal vascular fraction products that are not FDA approved, he explained.

In light of this kind of marketing activity, Adam Ross-Hirsch, MD, first author of the study under discussion, and colleagues set out to determine the scope of U.S.-based businesses advertising and administering cell therapy for ocular conditions, by looking at the businesses public websites to see what has changed since they first published their findings in 2017.1

The investigators identified these business by searching the Internet using specific keywords, such as clinic locations, marketed ocular conditions, types of cell therapy offered, routes of administration, affiliation with credentialed physician, safety language, and treatment costs.

Related: Intravitreally injected hRPCs improve vision in retinitis pigmentosa cases

Results The results of the analysis showed that 13 companies had removed their advertisements for ocular conditions, and 6 discontinued their URLs.

However, despite these findings, the total number of companies promoting treatment remained almost the same as the first study.

A total of 39 businesses with 62 clinics were identified by August 2019; 14 of these and 20 clinics were newly identified, Dr. Ross-Hirsch reported.

Most of the clinics were in Texas (n=12), California (n=11), Florida (n=10), and Illinois (n=10). When the investigators compared these numbers of clinics to those previously identified, the number in California decreased by 48% and the ones in Texas more than doubled, he said.

Thirty of the 39 companies reported that they were affiliated with at least 1 credentialed physician. Six businesses claimed to be associated with ongoing clinical trials, however, only 2 were registered on the clinicaltrials.gov website.

Related: Stem cell transplantation: Restoring vision in AMD may be possible

Most of the identified companies did not show their treatment fees, but of the 4 that did the costs ranged from $4,000 to $12,000/treatment. Consultation fees ranged from $350 to $800 when they were listed.

All businesses marketed treatments for ocular diseases that included age-related macular degeneration [AMD], optic neuritis, retinitis pigmentosa [RP], diabetic retinopathy, and glaucoma, he said. Most claimed to be able to treat AMD followed by RP.

The cell therapies most often advertised were autologous adipose-derived stem cells followed by autologous bone marrow-derived stem cells, which was similar to the previous study.

Related: Exploring novel gene therapy approaches to treat ocular disease

Making claims In commenting on the findings, Kuriyan said, These websites contained various claims regarding the safety and the FDA, but the language contained variable and vague claims about the safety of the various cell therapies.

Examples of the language were the following: not approved or evaluated by the FDA, participation in patient funded clinical research, use of FDA or institutional review board approved equipment and/or protocols for cell isolation, and use of FDA guidelines for minimally manipulated same-day procedures intended for homologous use.

Ten companies did not mention the FDA, while other claims were that the advertised therapies were safe under FDA regulation and no knowledge in the current literature of serious harm transpiring due to the use of these products, he emphasized.

Related: Stem cells for dry AMD with GA show promise in early study

These companies identified in the study have the potential to leverage a faade of scientific legitimacy to capitalize on patients understandable desperation for effective sight-restoring therapies. Stem cell therapy is an area of active, intense, and scientifically rigorous research. In the future, it may safely and effectively treat a number of ocular conditions, Kuriyan stated.

Lacking evidence These companies persist despite the absence of high-quality evidence of the efficacy of the treatment, FDA approval of the procedures, the increasing regulatory oversight and legal action against some of these companies, and evidence of severe visual loss as a result of the procedures.

Based on these findings, the investigators concluded that these companies persist in their US-based direct-to-consumer marketing of cell therapies for ocular conditions. Related: Exploring safety of stem cells for dry AMD

Ross-Hirsch emphasized the importance of both counseling by ophthalmologists and optometrists for patients as a safeguard against these companies and as stem cell therapies enter well-designed trials and evidence-based practice and federal regulation. However, regulation remains limited.

Conclusion Direct marketing of cell therapies persists in the US. As of August 2019, at least 39 such companies are operating in the US. Current federal regulation is limited and the marketing on the internet is pervasive.

Counseling will serve as a safeguard for patients and become increasingly important as stem cell therapies enter well-designed clinical trials and possibly evidence-based practice. Read more by Lynda Charters

Reference 1. Nirwan RS, Albini TA, Sridhar J, et al. Assessing cell therapy clinics offering treatment of ocular conditions using direct-to-consumer marketing in the United States. Ophthalmology 2019;126:1350-1355.

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Internet hawkers of stem cell therapies raising red flags - Ophthalmology Times

Details are everything: Where is Ottawas COVID-19 vaccination plan? – The Globe and Mail

Inside Oxford Vaccine Group's laboratories in Oxford, England, on Nov. 19, 2020.

ANDREW TESTA/The New York Times News Service

Prime Minister Justin Trudeau engaged in a strange bit of misdirection on Tuesday when he said Canada would not be among the first countries to receive COVID-19 vaccinations, because it no longer has any domestic production capacity for vaccines.

The United States, the United Kingdom and Germany are all aiming to start inoculating people in a matter of weeks, based on the fact the manufacturers of some of the leading vaccine candidates have production capacity on their shores.

Canada, on the other hand, will have to wait until the early months of 2021, Mr. Trudeau said.

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Its puzzling why he would mention something that, on the surface, is worrisome to Canadians, but in fact applies to most of the world.

The only Western country with any kind of a guarantee that it will be able to begin inoculations in December is the U.S., and thats because the Pfizer/BioNTech and Moderna vaccines two of the three closest to approval will first roll out there.

Germany has a deal, along with Italy, the Netherlands and France, with AstraZeneca that could see it share 400 million doses of the promising Oxford vaccine by the end of this year.

The U.K. could have the Oxford vaccine by then, too, but it will not have access to the Pfizer and Moderna vaccines until next year.

As well, all the leading manufacturers are busy creating non-U.S. supply chains that will begin delivery early in 2021.

Its not even true that Canada has no domestic production capacity for traditional vaccines. And the feds earlier this year funded expansions at two vaccine facilities; one in Montreal was supposed to be capable of producing 250,000 doses a month by November and two million by next year. However, there just is no immediate capacity to make the vaccines developed by Moderna and Pfizer, which use a groundbreaking gene therapy.

Ottawa probably should have spent more on a bigger domestic production facility and pushed for it to be built faster. But the federal government was aggressive in ordering close to 400 million doses from multiple manufacturers, while those vaccines were still in testing and development. By contracting for far more doses than Canada will ever need, Ottawa bought a kind of insurance policy. Assuming the manufacturers honour the contracts, there should be more than enough to go around.

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So why did Mr. Trudeau alarm the population and arm the opposition?

Its hard to explain, unless you look at the debate over Canadas ability to quickly get its hands on a new vaccine as a distraction from a more pressing issue: Ottawas glaring lack of a plan to distribute and administer those millions of doses.

In the U.K., the government has designated 1,250 local health clinics as injection sites that will give the first available vaccines to vulnerable people, such as the elderly, as early as next month.

It is also setting up at least 42 mass vaccination sites, such as conference centres, which if all goes well will begin serving the rest of the population beginning in January.

In the U.S., the federal government has hired a retired general who ran the armys supply chain to distribute vaccines to injection sites in each state on a per capita basis. The doses will come with prepackaged kits containing syringes, wipes and personal protective equipment.

And in Canada? We get platitudes from Health Minister Patty Hajdu about how the government is working around the clock to come up with a concrete plan with the provinces and territories.

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Given the poor job Ottawa and the provinces have done on testing and tracing, which have the same logistical challenges, theres reason to be concerned that when vaccines arrive, their distribution will be haphazard.

Tell us: Who is in charge of distribution at the federal level? Who are their counterparts in the provinces and territories? Who will get inoculated first? Will the vaccines be allocated to provinces on a per capita basis or by some other formula?

Where will the vaccines be delivered? In pharmacies? Hospitals? Temporary sites in hockey arenas? Who will staff them? What other infrastructure is needed?

Canadians have no clue about any of these things. And right now there is zero concrete evidence that their governments do either.

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Details are everything: Where is Ottawas COVID-19 vaccination plan? - The Globe and Mail

Impact of Covid 19 On Brain Tumor Treatment Market 2020 Industry Challenges Business Overview And Forecast Research Study 2026 – The Market Feed

Overview for Brain Tumor Treatment Market Helps in providing scope and definitions, Key Findings, Growth Drivers, and Brain Tumor Treatment Industry Various Dynamics.

The global Brain Tumor Treatment market focuses on encompassing major statistical evidence for the Brain Tumor Treatment industry as it offers our readers a value addition on guiding them in encountering the obstacles surrounding the market. A comprehensive addition of several factors such as global distribution, manufacturers, market size, and market factors that affect the global contributions are reported in the study. In addition the Brain Tumor Treatment study also shifts its attention with an in-depth competitive landscape, defined growth opportunities, market share coupled with product type and applications, key companies responsible for the production, and utilized strategies are also marked.

This intelligence and 2026 forecasts Brain Tumor Treatment industry report further exhibits a pattern of analyzing previous data sources gathered from reliable sources and sets a precedented growth trajectory for the Brain Tumor Treatment market. The report also focuses on a comprehensive market revenue streams along with growth patterns, analytics focused on market trends, and the overall volume of the market.

Moreover, the Brain Tumor Treatment report describes the market division based on various parameters and attributes that are based on geographical distribution, product types, applications, etc. The market segmentation clarifies further regional distribution for the Brain Tumor Treatment market, business trends, potential revenue sources, and upcoming market opportunities.

Download PDF Sample of Brain Tumor Treatment Market report @ https://hongchunresearch.com/request-a-sample/71373

Key players in the global Brain Tumor Treatment market covered in Chapter 4: Bristol Myers Squibb Antisense Pharma Dr. Reddys Laboratories Ltd Genetech U.S.A Hoffmann- La Roche AstraZeneca plc Merck & Co Mankind Pharma Novartis AG Macleods Pharmaceutical Limited Pfizer, Inc.

In Chapter 11 and 13.3, on the basis of types, the Brain Tumor Treatment market from 2015 to 2026 is primarily split into: Tissue Engineering Immunotherapy Gene Therapy Other Therapies

In Chapter 12 and 13.4, on the basis of applications, the Brain Tumor Treatment market from 2015 to 2026 covers: Hospitals and Clinics Treatment Center Others

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13: North America (Covered in Chapter 6 and 13) United States Canada Mexico Europe (Covered in Chapter 7 and 13) Germany UK France Italy Spain Russia Others Asia-Pacific (Covered in Chapter 8 and 13) China Japan South Korea Australia India Southeast Asia Others Middle East and Africa (Covered in Chapter 9 and 13) Saudi Arabia UAE Egypt Nigeria South Africa Others South America (Covered in Chapter 10 and 13) Brazil Argentina Columbia Chile Others

The Brain Tumor Treatment market study further highlights the segmentation of the Brain Tumor Treatment industry on a global distribution. The report focuses on regions of North America, Europe, Asia, and the Rest of the World in terms of developing business trends, preferred market channels, investment feasibility, long term investments, and environmental analysis. The Brain Tumor Treatment report also calls attention to investigate product capacity, product price, profit streams, supply to demand ratio, production and market growth rate, and a projected growth forecast.

In addition, the Brain Tumor Treatment market study also covers several factors such as market status, key market trends, growth forecast, and growth opportunities. Furthermore, we analyze the challenges faced by the Brain Tumor Treatment market in terms of global and regional basis. The study also encompasses a number of opportunities and emerging trends which are considered by considering their impact on the global scale in acquiring a majority of the market share.

The study encompasses a variety of analytical resources such as SWOT analysis and Porters Five Forces analysis coupled with primary and secondary research methodologies. It covers all the bases surrounding the Brain Tumor Treatment industry as it explores the competitive nature of the market complete with a regional analysis.

Brief about Brain Tumor Treatment Market Report with [emailprotected]https://hongchunresearch.com/report/brain-tumor-treatment-market-2020-71373

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Brain Tumor Treatment Market

Chapter Four: Players Profiles

Chapter Five: Global Brain Tumor Treatment Market Analysis by Regions

Chapter Six: North America Brain Tumor Treatment Market Analysis by Countries

Chapter Seven: Europe Brain Tumor Treatment Market Analysis by Countries

Chapter Eight: Asia-Pacific Brain Tumor Treatment Market Analysis by Countries

Chapter Nine: Middle East and Africa Brain Tumor Treatment Market Analysis by Countries

Chapter Ten: South America Brain Tumor Treatment Market Analysis by Countries

Chapter Eleven: Global Brain Tumor Treatment Market Segment by Types

Chapter Twelve: Global Brain Tumor Treatment Market Segment by Applications 12.1 Global Brain Tumor Treatment Sales, Revenue and Market Share by Applications (2015-2020) 12.1.1 Global Brain Tumor Treatment Sales and Market Share by Applications (2015-2020) 12.1.2 Global Brain Tumor Treatment Revenue and Market Share by Applications (2015-2020) 12.2 Hospitals and Clinics Sales, Revenue and Growth Rate (2015-2020) 12.3 Treatment Center Sales, Revenue and Growth Rate (2015-2020) 12.4 Others Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Brain Tumor Treatment Market Forecast by Regions (2020-2026) continued

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List of tables List of Tables and Figures Table Global Brain Tumor Treatment Market Size Growth Rate by Type (2020-2026) Figure Global Brain Tumor Treatment Market Share by Type in 2019 & 2026 Figure Tissue Engineering Features Figure Immunotherapy Features Figure Gene Therapy Features Figure Other Therapies Features Table Global Brain Tumor Treatment Market Size Growth by Application (2020-2026) Figure Global Brain Tumor Treatment Market Share by Application in 2019 & 2026 Figure Hospitals and Clinics Description Figure Treatment Center Description Figure Others Description Figure Global COVID-19 Status Overview Table Influence of COVID-19 Outbreak on Brain Tumor Treatment Industry Development Table SWOT Analysis Figure Porters Five Forces Analysis Figure Global Brain Tumor Treatment Market Size and Growth Rate 2015-2026 Table Industry News Table Industry Policies Figure Value Chain Status of Brain Tumor Treatment Figure Production Process of Brain Tumor Treatment Figure Manufacturing Cost Structure of Brain Tumor Treatment Figure Major Company Analysis (by Business Distribution Base, by Product Type) Table Downstream Major Customer Analysis (by Region) Table Bristol Myers Squibb Profile Table Bristol Myers Squibb Production, Value, Price, Gross Margin 2015-2020 Table Antisense Pharma Profile Table Antisense Pharma Production, Value, Price, Gross Margin 2015-2020 Table Dr. Reddys Laboratories Ltd Profile Table Dr. Reddys Laboratories Ltd Production, Value, Price, Gross Margin 2015-2020 Table Genetech U.S.A Profile Table Genetech U.S.A Production, Value, Price, Gross Margin 2015-2020 Table Hoffmann- La Roche Profile Table Hoffmann- La Roche Production, Value, Price, Gross Margin 2015-2020 Table AstraZeneca plc Profile Table AstraZeneca plc Production, Value, Price, Gross Margin 2015-2020 Table Merck & Co Profile Table Merck & Co Production, Value, Price, Gross Margin 2015-2020 Table Mankind Pharma Profile Table Mankind Pharma Production, Value, Price, Gross Margin 2015-2020 Table Novartis AG Profile Table Novartis AG Production, Value, Price, Gross Margin 2015-2020 Table Macleods Pharmaceutical Limited Profile Table Macleods Pharmaceutical Limited Production, Value, Price, Gross Margin 2015-2020 Table Pfizer, Inc. Profile Table Pfizer, Inc. Production, Value, Price, Gross Margin 2015-2020 Figure Global Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Global Brain Tumor Treatment Revenue ($) and Growth (2015-2020) Table Global Brain Tumor Treatment Sales by Regions (2015-2020) Table Global Brain Tumor Treatment Sales Market Share by Regions (2015-2020) Table Global Brain Tumor Treatment Revenue ($) by Regions (2015-2020) Table Global Brain Tumor Treatment Revenue Market Share by Regions (2015-2020) Table Global Brain Tumor Treatment Revenue Market Share by Regions in 2015 Table Global Brain Tumor Treatment Revenue Market Share by Regions in 2019 Figure North America Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Europe Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Asia-Pacific Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Middle East and Africa Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure South America Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure North America Brain Tumor Treatment Revenue ($) and Growth (2015-2020) Table North America Brain Tumor Treatment Sales by Countries (2015-2020) Table North America Brain Tumor Treatment Sales Market Share by Countries (2015-2020) Figure North America Brain Tumor Treatment Sales Market Share by Countries in 2015 Figure North America Brain Tumor Treatment Sales Market Share by Countries in 2019 Table North America Brain Tumor Treatment Revenue ($) by Countries (2015-2020) Table North America Brain Tumor Treatment Revenue Market Share by Countries (2015-2020) Figure North America Brain Tumor Treatment Revenue Market Share by Countries in 2015 Figure North America Brain Tumor Treatment Revenue Market Share by Countries in 2019 Figure United States Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Canada Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Mexico Brain Tumor Treatment Sales and Growth (2015-2020) Figure Europe Brain Tumor Treatment Revenue ($) Growth (2015-2020) Table Europe Brain Tumor Treatment Sales by Countries (2015-2020) Table Europe Brain Tumor Treatment Sales Market Share by Countries (2015-2020) Figure Europe Brain Tumor Treatment Sales Market Share by Countries in 2015 Figure Europe Brain Tumor Treatment Sales Market Share by Countries in 2019 Table Europe Brain Tumor Treatment Revenue ($) by Countries (2015-2020) Table Europe Brain Tumor Treatment Revenue Market Share by Countries (2015-2020) Figure Europe Brain Tumor Treatment Revenue Market Share by Countries in 2015 Figure Europe Brain Tumor Treatment Revenue Market Share by Countries in 2019 Figure Germany Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure UK Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure France Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Italy Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Spain Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Russia Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Asia-Pacific Brain Tumor Treatment Revenue ($) and Growth (2015-2020) Table Asia-Pacific Brain Tumor Treatment Sales by Countries (2015-2020) Table Asia-Pacific Brain Tumor Treatment Sales Market Share by Countries (2015-2020) Figure Asia-Pacific Brain Tumor Treatment Sales Market Share by Countries in 2015 Figure Asia-Pacific Brain Tumor Treatment Sales Market Share by Countries in 2019 Table Asia-Pacific Brain Tumor Treatment Revenue ($) by Countries (2015-2020) Table Asia-Pacific Brain Tumor Treatment Revenue Market Share by Countries (2015-2020) Figure Asia-Pacific Brain Tumor Treatment Revenue Market Share by Countries in 2015 Figure Asia-Pacific Brain Tumor Treatment Revenue Market Share by Countries in 2019 Figure China Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Japan Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure South Korea Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Australia Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure India Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Southeast Asia Brain Tumor Treatment Sales and Growth Rate (2015-2020) Figure Middle East and Africa Brain Tumor Treatment Revenue ($) and Growth (2015-2020) continued

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Impact of Covid 19 On Brain Tumor Treatment Market 2020 Industry Challenges Business Overview And Forecast Research Study 2026 - The Market Feed