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Blockchain offers advanced therapy tracking – Bioprocess InsiderBioProcess – BioProcess Insider

Hataali blockchain technology used to secure supply chain in the UK could lead to a standardized infrastructure for cell and gene therapy tracking, says ATMPS.

ATMPS, a spin out from Farmatrust and the creator of the Hataali platform, tested the blockchain solution alongside the UKs University Hospitals Birmingham NHS Foundation Trust (UHB).

UHB is home to the Midlands and Wales Advanced Therapy Treatment Centre, which is comprised of partners from the NHS, academia and industry. The center, one of three across the UK, delivers advanced therapies to UK patients.

Image: iStock/ipopba

Hataali was tested alongside the UHBs system, where it was found that the blockchain platform was interoperable, with ATMPS suggesting that its platform had become the first functional blockchain solution for advanced therapeutic products.

The platform is utilized to record scheduling and ordering data for advanced therapy medicinal product (ATMP) treatments within a blockchain system that enables secure and confidential sharing of data between partners.

The solution allows for the activities of manufacturers, clinics, hospitals, and specialist couriers to be shared digitally, as well as being able to provide a regulatory audit trail. Essentially, a digital chain of records is created that allows for communication along each step of the supply chain.

In terms of what benefits this provides over existing platforms and the level of information available to stakeholders, a spokesperson for ATMPS outlined: Its not just an improvement on, say, serialization, as it gives on open access window to access user appropriate data e.g. doctors can better plan appointments, regulators can be secure in the supply chain conditions, and patients and innovators can know exactly where the treatment is, and crucially be alerted if there is a problem.

Now that the trial is complete, ATMPS plans to use this initial rollout as an example to widen the use of the platform. The spokesperson described the partnership with UHB as just the start of the process, with the platform designed to be multi-treatment, multi-site and multi-stakeholder.

This sees ATMPS considering the next stage for the platform being UK-wide utilization. Eventually, however, the company foresees a global structure whereby each new advanced therapy that gets approved in various markets enters a standardized infrastructure.

For Hataali itself, this means that the developers have already created the platform to function across time zones and to include multiple languages.

The patent for the platform is currently still pending, which means that rivals could potentially create an alternative platform based on the same premise.

There are already existing tracking platforms available on the market, though their scope through the supply chain is more limited, such as TrakCels supply chain monitoring technology that is able to track manufacturing processes in real-time for cell and gene therapies.

However, the spokesperson for ATMPS was unconcerned about potential rivals, Our solution is unique in that it is the only vein-to-vein solution out there that uses a blockchain foundation. So, even while its patent pending, I dont think we will see many investors trying to bring forward a competitive solution, they explained.

Furthermore, blockchain is complicated technically and any platform developed with this market in mind is required to be compliant with HIPAA and GDPR regulations, they added.

ATMPS spokesperson observed that those working in blockchain hold the ethos and mindset that collaborating and competing is the best way to push forward their own company, and healthcare more broadly.

They concluded, We are always keen to explore joint opportunities and to work with other solution providers that are operating in this novel specialist area, and we have no problem with anyone working or integrating with us, competitors or not.

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Blockchain offers advanced therapy tracking - Bioprocess InsiderBioProcess - BioProcess Insider

Flexion Therapeutics Reports Third-Quarter 2020 Financial Results and Recent Business Highlights – GlobeNewswire

November 04, 2020 16:01 ET | Source: Flexion Therapeutics, Inc.

BURLINGTON, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial results and recent business highlights for the quarter ended September30, 2020.

Throughout the third quarter, we saw strong execution across all areas of our business, and we were particularly pleased to achieve $23.7million in ZILRETTA net sales, said Michael Clayman, M.D., President and Chief Executive Officer of Flexion Therapeutics. We firmly believe that ZILRETTA can play an increasingly prominent role in helping the millions of patients who confront osteoarthritis knee pain, and our confidence in its long-term potential has only grown. Furthermore, during the quarter we made outstanding progress with our pipeline of innovative product candidates. We advanced FX201, our investigational intra-articular gene therapy product candidate for osteoarthritis, into the second cohort of the Phase 1 safety and tolerability study, and we remain on track to file an IND and potentially initiate clinical trials for FX301, our locally administered peripheral nerve block candidate for control of postoperative pain in 2021.

Third-Quarter Results & Financial Highlights

The Company reported a net loss of $24.6million for the third quarter of 2020, compared to a net loss of $38.2million for the same period of 2019. Net sales of ZILRETTA were $23.7million and $21.8million for the three months ended September 30, 2020 and 2019, respectively.

Cost of sales was $5.1million and $2.9million for the three months ended September 30, 2020 and 2019, respectively. For the three months ended September 30, 2020, cost of sales included $2.0million for the actual cost of units sold and $3.1million of unabsorbed overhead associated with the voluntary, temporary suspension of manufacturing activities at Patheon due to COVID19 impacts on sales of ZILRETTA. For the three months ended September30, 2019, cost of sales was comprised of $1.8million related to the actual cost of units sold, $0.9million related to unabsorbed manufacturing costs and $0.2million of period costs and other adjustments.

Research and development expenses were $10.1million and $20.9million for the three months ended September30, 2020 and 2019, respectively. The decrease in research and development expenses of $10.8million was primarily due to a decrease of $5.9million in development expenses for ZILRETTA due to a reduction in ZILRETTA life cycle management activities, a decrease in $2.9million in portfolio expansion-related expenses as the upfront payment for the purchase of XEN402 from Xenon Pharmaceuticals occurred in the third quarter of 2019, as well as a decrease of $1.4million in salary and other employee-related costs and stock-based compensation expense related to lower headcount.

Selling, general and administrative expenses were $27.3million and $32.1million for the three months ended September30, 2020 and 2019, respectively. Selling expenses were $19.3million and $23.9million for the three months ended September30, 2020 and 2019, respectively. The year-over-year decrease of $4.6million was primarily due to the expense reduction measures taken in response to COVID19; in particular, the elimination of live presence at industry conferences, reductions in in-person physician speaker programs and reductions in select marketing programs and materials, as well as a reduction in travel expenses due to physician office limitations and travel guidelines and restrictions at the state and local level. General and administrative expenses were $8.0million and $8.2million for the three months ended September30, 2020 and 2019, respectively, which represents a decrease of $0.2million.

Flexion expects full-year 2020 total operating expenses (including cost of sales, research and development, and selling, general and administrative) will be in the range of $172million to $182million.

Interest income was $0.1million and $0.7million for the three months ended September30, 2020 and 2019, respectively. Interest expense was $5.1million and $4.7million for the three months ended September30, 2020 and 2019, respectively.

As of September30, 2020, the Company had approximately $185.3million in cash, cash equivalents and marketable securities compared with $136.7million as of December31, 2019. Based on the Companys current operating plan and assuming purchasing activity at physician practices, clinics and certain medical centers or hospitals that administer ZILRETTA continue to return to pre-COVID19 levels, Flexion believes that its current cash, cash equivalents and marketable securities will be sufficient to fund operations into 2022.

Recent News & Business Updates

Indication and Select Important Safety Information for ZILRETTA

Indication:ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee.

Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

Contraindication:ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

Adverse Reactions:The most commonly reported adverse reactions (incidence 1%) in clinical studies included sinusitis, cough, and contusions.

Please seeZilrettaLabel.comfor full Prescribing Information.

About ZILRETTA (triamcinolone acetonide extended-release injectable suspension) On October6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting OA-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonidea commonly administered, short-acting corticosteroidwith a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at http://www.zilretta.com.

About FX201 (humantakinogene hadenovec) FX201 is a novel, intra-articular gene therapy product candidate that utilizes a helper-dependent adenovirus [HDAd] vector based on human serotype 5 (Ad5) that is designed to transfer a gene to cells in the joint to produce an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), under the control of an inflammation-sensitive promoter. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, Flexion believes FX201 holds the potential to provide long-term pain relief and functional improvement, and to modify the disease.

About FX301 (funapide formulated in a proprietary thermosensitive hydrogel) FX301 is a locally administered NaV1.7 inhibitor product candidate, known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective and durable pain relief while preserving motor function and anticipates initiating clinical trials in 2021.

About Osteoarthritis (OA) of the Knee OA, also known as degenerative joint disease, affects more than 30million Americans and accounts for more than $185billion in annual expenditures. In 2017, approximately 15million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, approximately five million OA patients receive either a corticosteroid (immediate-release or extended-release) or hyaluronic acid intra-articular injection to manage their knee pain.

About Flexion Therapeutics Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. The Company's core values are focus, ingenuity, tenacity, transparency and fun. Please visitflexiontherapeutics.com.

Forward-Looking StatementsThis release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts are forward looking statements, including, but not limited to, statements relating to the future of Flexion; expectations related to Flexions expenses for the year ended December31, 2020, and cash runway; timing and plans with respect to clinical trials; expected impacts from COVID-19 and the timing and duration of such impacts; the long-term potential of ZILRETTA; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA and our product candidates. These forward-looking statements are based on managements expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the fact that the impacts and expected duration of the COVID19 pandemic are uncertain and rapidly changing; risk that we may not achieve expense expectations for 2020; the potential for unexpected expenditures or cash requirements; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized or adopted; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to clinical trials, including potential delays, safety issues, or negative results; risks related to key employees, markets, economic conditions, health care reform, prices, and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in our Quarterly Report on Form10-Q for the quarter ended June30, 2020, filed with the SEC on August5, 2020, and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Contact:

Scott Young Vice President, Corporate Communications & Investor Relations T: 781-305-7194 syoung@flexiontherapeutics.com

Julie Downs Associate Director, Corporate Communications & Investor Relations T: 781-305-7137 jdowns@flexiontherapeutics.com

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Flexion Therapeutics Reports Third-Quarter 2020 Financial Results and Recent Business Highlights - GlobeNewswire

Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer | Small Molecules | News…

Details Category: Small Molecules Published on Thursday, 05 November 2020 11:36 Hits: 85

Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. 17.7 months with bevacizumab alone

One in two women with advanced ovarian cancer has an HRD-positive tumour

LONDON, UK I November 5, 2020 I AstraZeneca and MSDs Lynparza (olaparib) has been approved in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.

Ovarian cancer is the fifth most common cause of cancer death in the EU and the five-year survival rate is approximately 45%, due partly because women are often diagnosed with advanced disease (Stage III or IV).1-3

The approval by the European Commission was based on a biomarker subgroup analysis of the PAOLA-1 Phase III trial which showed Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.

Isabelle Ray-Coquard, principal investigator of the PAOLA-1 Phase III trial and medical oncologist, Centre Lon Brard and President of the GINECO group, Paris, France, said: For women with advanced ovarian cancer, the goal of 1st-line treatment is to delay disease progression for as long as possible with the intent of achieving long-term remission. Unfortunately, once a patients cancer recurs, it historically has been incurable. Lynparza together with bevacizumab has demonstrated an impressive median progression-free survival benefit of more than three years and is poised to become the standard of care for eligible patients with HRD-positive tumours in the EU.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Women treated with Lynparza in combination with bevacizumab in the PAOLA-1 Phase III trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis. HRD status can help physicians select a personalised 1st-line treatment regimen for patients to substantially delay relapse in this devastating disease.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target this disease. The EU approval reinforces that HRD-positive tumours represent a distinct subset of advanced ovarian cancer and HRD testing is critical for women in this setting.

The PAOLA-1 Phase III trial showed thatLynparza,in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition ofLynparzaimproved PFS to a median of 37.2 months versus 17.7 with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. The data from the PAOLA-1 trial was published inThe New England Journal of Medicinein 2019.

Further results recently presented at the European Society for Medical Oncology Virtual Congress 2020 showed a statistically significant improvement in the key secondary endpoint of the time to second disease progression (PFS2). Lynparza with bevacizumab provided benefit beyond first disease progression, improving PFS2 to a median of 50.3 months versus 35.3 with bevacizumab alone.

The full EU indication is for Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.

Lynparzain combination with bevacizumab isapproved in the USand in several other countries as a 1st-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.

Financial considerations

Following this approval for Lynparza in the EU, AstraZeneca will receive a regulatory milestone payment from MSD of $25m, anticipated to be booked as collaboration revenue during the fourth quarter of 2020.

Ovarian cancer

In 2018, there were nearly 68,000 new cases of ovarian cancer diagnosed in the EU and around 45,000 deaths.3Approximately 50% of ovarian cancers are HRD-positive including BRCA1/2 mutation.4,5Approximately 15% of ovarian cancers have a BRCA1/2 mutation.6 The primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.7-9

Homologous recombination deficiency

HRD, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.10

PAOLA-1

PAOLA-1 is a double-blinded Phase III trial testing the efficacy and safety ofLynparzaadded to standard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab.AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US, the EU and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (BRCAm and other HRR gene mutations). Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the worlds first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio ofnew medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. EuroHealth. (2018). Ovarian Cancer: The Silent Killer. Available at: https://eurohealth.ie/policy-brief-women-and-ovarian-cancer-in-the-eu-2018/ [Accessed October 2020].

2. ECIS. (2020).Estimates of cancer incidence and mortality in 2020, for all cancer sites. Available here [Accessed October 2020].

3. The World Health Organization. IARC. Globocan. (2018). Available at: http://gco.iarc.fr/ [Accessed October 2020].

4. Moschetta et al. (2016). BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer. Annals of Oncology, 27(8), pp.1449-1455.

5. Bonadio et al. (2018). Homologous recombination deficiency in ovarian cancer: a review of its epidemiology and management. Clinics, 73(Suppl 1): e450s.

6. Ramus. (2009). The Contribution of BRCA1 and BRCA2 to Ovarian Cancer. Molecular Oncology, 3(2), pp.138150.

7. Raja et al. (2012). Optimal first-line treatment in ovarian cancer. Annals on Oncology. 23 Suppl 10, x118-127.

8. NHS Choices, Ovarian Cancer Available at: https://www.nhs.uk/conditions/ovarian-cancer/treatment/ [Accessed October 2020].

9. Ledermann et al. (2013). Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 24, pp.vi24-vi32.

10. Moore, K. (2018). Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. New England Journal of Medicine, 379(26), pp.2495-2505.

SOURCE: AstraZeneca

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Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer | Small Molecules | News...

Predictive Biomarkers Market Growth Sales Revenue Analysis 2020-2025 – The Think Curiouser

This report also researches and evaluates the impact of Covid-19 outbreak on the Predictive Biomarkers industry, involving potential opportunity and challenges, drivers and risks. We present the impact assessment of Covid-19 effects on Predictive Biomarkers and market growth forecast based on different scenario (optimistic, pessimistic, very optimistic, most likely etc.).

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segment by Type, the product can be split into Hormone Therapy Immunotherapies Targeted Therapy Monoclonal Antibody Therapy Gene Therapy

Market segment by Application, split into Hospitals Diagnostic Centers Oncology Clinics Research Institutes

Based on regional and country-level analysis, the Precision Cancer Therapies market has been segmented as follows: North America United States Canada Europe Germany France U.K. Italy Russia Nordic Rest of Europe Asia-Pacific China Japan South Korea Southeast Asia India Australia Rest of Asia-Pacific Latin America Mexico Brazil Middle East & Africa Turkey Saudi Arabia UAE Rest of Middle East & Africa

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Chapter 2: Evaluating the leading manufacturers of the global Predictive Biomarkers market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Predictive Biomarkers market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

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Predictive Biomarkers Market Growth Sales Revenue Analysis 2020-2025 - The Think Curiouser

Retinitis Pigmentosa (Retinitis) Market Report 2020 (COVID-19 Impact Analysis) By Segmentations, Key Company Profiles & Demand Forecasts to 2020 …

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Key Companies Sanofi Amgen Amarantus Bioscience Holdings Acucela Applied Genetic Technologies Corp Asklepios BioPharmaceutical Astellas Pharma Caladrius Biosciences Dompe Farmaceutici SpA Dormant Projects GenSight Biologics SA Grupo Ferrer Internacional SA ID Pharma InFlectis BioScience Ionis Pharmaceuticals Mimetogen Pharmaceuticals Ms Science Corp Nanovector srl Novartis AG Novelion Therapeutics ProQR Therapeutics ReNeuron Group Plc SanBio Shire (Takeda Pharmaceutical) Spark Therapeutics Market by Type General Treatment Traditional Chinese Medicine Gene Therapy The Surgical Treatment Others Market by Application Hospitals Eye Clinics Others

By Region

Asia-Pacific[China, Southeast Asia, India, Japan, Korea, Western Asia]

Europe[Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland]

North America[United States, Canada, Mexico]

Middle East & Africa[GCC, North Africa, South Africa]

South America[Brazil, Argentina, Columbia, Chile, Peru]

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Some Points from Table of Content

Global Retinitis Pigmentosa (Retinitis) Market Status (2015-2019) and Forecast (2020-2025) by Region, Product Type & End-Use

Chapter 1 Market Overview

Chapter 2 Key Companies

Chapter 3 Global Market Status and Future Forecast

Chapter 4 Asia-Pacific Market Status and Future Forecast

Chapter 5 Europe Market Status and Future Forecast

Chapter 6 North America Market Status and Future Forecast

Chapter 7 South America Market Status and Future Forecast

Chapter 8 Middle East & Africa Market Status and Future Forecast

Chapter 9 Market Features

9.1 Product Features

9.2 Price Features

9.3 Channel Features

9.4 Purchasing Features

Chapter 10 Investment Opportunity

10.1 Regional Investment Opportunity

10.2 Industry Investment Opportunity

Chapter 11 Coronavirus Impact

11.1 Impact on Industry Upstream

11.2 Impact on Industry Downstream

11.3 Impact on Industry Channels

11.4 Impact on Industry Competition

11.5 Impact on Industry Obtain Employment

Chapter 12 Conclusion

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Points Covered in the Report

The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.

The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 12 years data history and forecast.

The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.

Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.

The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Impact of Covid-19 in Retinitis Pigmentosa (Retinitis) Market:Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost every country around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Retinitis Pigmentosa (Retinitis) market in 2020. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor/outdoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

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Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030 – PRnews Leader

The success of approved stem cell therapies has caused a surge in interest of biopharma developers in this field; many innovator companies are currently progressing proprietary leads across different phases of clinical development, with cautious optimism

Roots Analysis has announced the addition of Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent)) report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link

Key Market Insights

Over 280 stem cell therapies are under development, most of which are allogeneic products More than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cells It is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regions Within these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015 More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domain Presently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030 The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

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Key Questions Answered

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visit https://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html

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Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030 - PRnews Leader

Cancer Stem Cell Therapeutics Market Outlooks 2020: Size, Cost Structures, Growth rate and Industry Analysis to 2027 – Eurowire

Cancer Stem Cell Therapeutics Market Report

The research study on the Global Cancer Stem Cell Therapeutics Market is a thorough investigation of the value and supply chain of the market and offers all-inclusive data about the industry. The report also covers insightful information about pricing, cost, value, capacity, gross revenue, and profit margins with reference to historical analysis and forecast estimation. The report also strives to identify demands and trends in different sectors of the Cancer Stem Cell Therapeutics market in major geographies of the world.

The Cancer Stem Cell Therapeutics market has witnessed dynamic changes in trends and demands owing to the ongoing COVID-19 pandemic. The report provides a detailed outlook on how the pandemic has affected the key segments of the Cancer Stem Cell Therapeutics industry. The report includes an in-depth impact analysis of the COVID-19 pandemic on the overall Cancer Stem Cell Therapeutics industry and covers a futuristic impact scenario.

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The report studies the market dynamics to identify and scrutinize the strategic initiatives and tactics undertaken by the industry players in order to gain a robust footing in the market and to achieve a substantial global position. It provides exhaustive analysis and imparts insightful data to help the readers understand the Cancer Stem Cell Therapeutics industry in detail and gain a competitive advantage over other players. The report also provides strategic recommendations to new and emerging players to help them formulate better entry and investment strategies.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Merck KGA, LONZA Group AG, Novartis, Osiris Therapeutics, Pfizer, Pfizer, Stemline Therapeutics Inc., STEMCELL Technologies, and Thermo Fischer Scientific Inc.

The report offers a comprehensive analysis of the Cancer Stem Cell Therapeutics market inclusive of product portfolio, categories, applications, and a comprehensive analysis of the value chain structure. The study investigates several factors influencing the growth of the market and provides a competitive advantage to the readers.

The Cancer Stem Cell Therapeutics market report is an investigative study that provides insights into opportunities, limitations, and barriers encountered by the companies that influence or hinder the growth of the industry. Overall the report provides valuable information and an overview of the market scenario to gain a better understanding of the market.

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Treatment Type: (Revenue, USD Million; 20162026)

Disease Type: (Revenue, USD Million; 20162026)

Application: (Revenue, USD Million; 20162026)

End Use: (Revenue, USD Million; 20162026)

The report covers an extensive regional analysis and market estimation in each region and covers key geographical regions such as North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa.

To read more about the report, visit @ https://www.reportsanddata.com/report-detail/cancer-stem-cell-therapeutics-market

Key Point Summary of the Report:

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Cancer Stem Cell Therapeutics Market Outlooks 2020: Size, Cost Structures, Growth rate and Industry Analysis to 2027 - Eurowire

Biologics Safety Testing Market Research Report by Test Type, by Application – Global Forecast to 2025 – Cumulative Impact of COVID-19 – Yahoo Finance…

Globe Newswire

Dublin, Nov. 05, 2020 (GLOBE NEWSWIRE) -- The "Technology Landscape, Trends and Opportunities in the Global Flexible Packaging Market" report has been added to ResearchAndMarkets.com's offering. This report analyzes technology maturity, degree of disruption, competitive intensity, market potential, and other parameters of various technologies in the flexible packaging market. The technologies in flexible packaging have undergone significant change in recent years, with semi flexible packaging to advance flexible packaging. The rising wave of new technologies such as bio plastics based flexible packaging are creating significant potential in food and beverage, cosmetic and toiletries, and healthcare applications, due to their better protection and recycling benefits.In this market, various technologies, such as plastic film based flexible packaging, aluminium based flexible packaging, paper based flexible packaging, and bio plastic based flexible packaging technologies are used in various applications. Growing demand for bio-based PLA films in various applications and increased shelf life of the products are creating new opportunities for various flexible packaging technologies.The study includes technology readiness, competitive intensity, regulatory compliance, disruption potential, trends, forecasts and strategic implications for the global flexible packaging technology by application, technology, and region.Some of the flexible packaging companies profiled in this report include Bemis Company, Mondi, Huhtamaki Group, Amcor Limited, and BASF.This report answers the following 9 key questions: Q.1 What are some of the most promising and high-growth technology opportunities for the flexible packaging market?Q.2 Which technology will grow at a faster pace and why?Q.3 What are the key factors affecting dynamics of different technologies? What are the drivers and challenges of these technologies in flexible packaging market?Q.4 What are the levels of technology readiness, competitive intensity and regulatory compliance in this technology space?Q.5 What are the business risks and threats to these technologies in flexible packaging market?Q.6 What are the latest developments in flexible packaging technologies? Which companies are leading these developments?Q.7 Which technologies have potential of disruption in this market?Q.8 Who are the major players in this flexible packaging market? What strategic initiatives are being implemented by key players for business growth?Q.9 What are strategic growth opportunities in this flexible packaging technology space? Key Topics Covered: 1. Executive Summary2. Technology Landscape2.1. Technology Background and Evolution2.2. Technology and Application Mapping2.3. Supply Chain3. Technology Readiness3.1. Technology Commercialization and Readiness3.2. Drivers and Challenges in Flexible Packaging Technologies3.3. Competitive Intensity3.4. Regulatory Compliance4. Technology Trends and Forecasts analysis from 2013-20244.1. Flexible Packaging Opportunity4.2. Technology Trends (2013-2018) and Forecasts (2019-2024)4.2.1. Plastic Film based Flexible Packaging4.2.2. Aluminium based Flexible Packaging4.2.3. Paper based Flexible Packaging4.2.4. Bio Plastic based Flexible Packaging4.3. Technology Trends (2013-2018) and Forecasts (2019-2024) by Application Segments4.3.1. Food and Beverage4.3.1.1. Plastic Film based Flexible Packaging4.3.1.2. Aluminium based Flexible Packaging4.3.1.3. Paper based Flexible Packaging4.3.1.4. Bio Plastic based Flexible Packaging4.3.2. Healthcare4.3.3. Cosmetics and Toiletries4.3.4. Other5. Technology Opportunities (2013-2024) by Region5.1. Flexible Packaging Market by Region5.2. North American Flexible Packaging Market5.3. European Flexible Packaging Market5.4. APAC Flexible Packaging Market5.5. ROW Flexible Packaging Market6. Latest Development and Innovation in Flexible Packaging Technologies7. Companies/Ecosystem7.1. Product Portfolio Analysis7.2. Market Share Analysis7.3. Geographical Reach8. Strategic Implications8.1. Implications8.2. Growth Opportunity Analysis8.2.1. Growth Opportunities for the Flexible Packaging Market by Material Technology8.2.2. Growth Opportunities for the Flexible Packaging Market by Application8.2.3. Growth Opportunities for the Flexible Packaging Market by Region8.3. Emerging Trends in the Flexible Packaging Market8.4. Disruption Potential8.5. Strategic Analysis8.5.1. New Product Development8.5.2. Capacity Expansion of the Flexible Packaging Market8.5.3. Mergers, Acquisitions, and Joint Ventures in the Flexible Packaging Market9. Company Profiles of Leading Players9.1. Bemis Company9.2. Mondi9.3. Huhtamaki Group9.4. Amcor Limited9.5. BASF For more information about this report visit https://www.researchandmarkets.com/r/xp7gvs Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research. CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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Biologics Safety Testing Market Research Report by Test Type, by Application - Global Forecast to 2025 - Cumulative Impact of COVID-19 - Yahoo Finance...

Global Regenerative Medicine Market (2020 to 2025) – Industry Trends, Share, Size, Growth, Opportunity and Forecast – ResearchAndMarkets.com -…

DUBLIN--(BUSINESS WIRE)--The "Regenerative Medicine Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025" report has been added to ResearchAndMarkets.com's offering.

The global regenerative medicine market grew at a CAGR of around 16% during 2014-2019. Looking forward, the publisher expects the global regenerative medicine market to continue its strong growth during the next five years.

Regenerative medicine refers to a branch of biomedical sciences aimed at restoring the structure and function of damaged tissues and organs. It involves the utilization of stem cells that are developed in laboratories and further implanted safely into the body for the regeneration of damaged bones, cartilage, blood vessels and organs. Cellular and acellular regenerative medicines are commonly used in various clinical therapeutic procedures, including cell, immunomodulation and tissue engineering therapies. They hold potential for the effective treatment of various chronic diseases, such as Alzheimer's, Parkinson's and cardiovascular disorders (CVDs), osteoporosis and spinal cord injuries.

The increasing prevalence of chronic medical ailments and genetic disorders across the globe is one of the key factors driving the growth of the market. Furthermore, the rising geriatric population, which is prone to various musculoskeletal, phonological, dermatological and cardiological disorders, is stimulating the market growth. In line with this, widespread adoption of organ transplantation is also contributing to the market growth. Regenerative medicine minimizes the risk of organ rejection by the body post-transplant and enhances the recovery speed of the patient.

Additionally, various technological advancements in cell-based therapies, such as the development of 3D bioprinting techniques and the adoption of artificial intelligence (AI) in the production of regenerative medicines, are acting as other growth-inducing factors. These advancements also aid in conducting efficient dermatological grafting procedures to treat chronic burns, bone defects and wounds on the skin. Other factors, including extensive research and development (R&D) activities in the field of medical sciences, along with improving healthcare infrastructure, are anticipated to drive the market further.

Companies Mentioned

Key Questions Answered in This Report:

Key Topics Covered:

1 Preface

2 Scope and Methodology

3 Executive Summary

4 Introduction

4.1 Overview

4.2 Key Industry Trends

5 Global Regenerative Medicine Market

5.1 Market Overview

5.2 Market Performance

5.3 Impact of COVID-19

5.4 Market Forecast

6 Market Breakup by Type

6.1 Stem Cell Therapy

6.1.1 Market Trends

6.1.2 Market Forecast

6.2 Biomaterial

6.2.1 Market Trends

6.2.2 Market Forecast

6.3 Tissue Engineering

6.3.1 Market Trends

6.3.2 Market Forecast

6.4 Others

6.4.1 Market Trends

6.4.2 Market Forecast

7 Market Breakup by Application

7.1 Bone Graft Substitutes

7.1.1 Market Trends

7.1.2 Market Forecast

7.2 Osteoarticular Diseases

7.2.1 Market Trends

7.2.2 Market Forecast

7.3 Dermatology

7.3.1 Market Trends

7.3.2 Market Forecast

7.4 Cardiovascular

7.4.1 Market Trends

7.4.2 Market Forecast

7.5 Central Nervous System

7.5.1 Market Trends

7.5.2 Market Forecast

7.6 Others

7.6.1 Market Trends

7.6.2 Market Forecast

8 Market Breakup by End User

8.1 Hospitals

8.1.1 Market Trends

8.1.2 Market Forecast

8.2 Specialty Clinics

8.2.1 Market Trends

8.2.2 Market Forecast

8.3 Others

8.3.1 Market Trends

8.3.2 Market Forecast

9 Market Breakup by Region

9.1 North America

9.2 Asia Pacific

9.3 Europe

9.4 Latin America

9.5 Middle East and Africa

10 SWOT Analysis

11 Value Chain Analysis

12 Porters Five Forces Analysis

13 Price Analysis

14 Competitive Landscape

14.1 Market Structure

14.2 Key Players

14.3 Profiles of Key Players

For more information about this report visit https://www.researchandmarkets.com/r/erd0e3

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Global Regenerative Medicine Market (2020 to 2025) - Industry Trends, Share, Size, Growth, Opportunity and Forecast - ResearchAndMarkets.com -...

Stem Cell Media Market Projected to Witness Vigorous Expansion by 2027 – The Think Curiouser

Bigmarketresearch, one of the worlds prominent market research firms has released a new report on GlobalStem Cell Media Market.The report contains crucial insights on the market which will support the clients to make the right business decisions. This research will help both existing and new aspirants for Stem Cell Media market to figure out and study market needs, market size, and competition. The report talks about the supply and demand situation, the competitive scenario, and the challenges for market growth, market opportunities, and the threats faced by Top key players.

The global Stem Cell Media market is expected to witness a promising growth in the next few years. The rising level of competition among the leading players and the rising focus on the development of new products are likely to offer promising growth opportunities throughout the forecast period. The research study on the global Stem Cell Media market offers a detailed overview, highlighting the key aspects that are expected to enhance the growth of the market in the near future. The key segmentation and the competitive landscape of the market have also been mentioned at length in the research study.

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The report also includes the impact of ongoing global crisis i.e.COVID-19on the Stem Cell Media market and what the future holds for it. The published report is designed using a vigorous and thorough research methodology andbigmarketresearchis also known for its data accuracy and granular market reports.

This report studies the Stem Cell Media market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Stem Cell Media market by product type and applications/end industries. These details further contain a basic summary of the company, merchant profile, and the product range of the company in question. The report analyzes data regarding the proceeds accrued, product sales, gross margins, price patterns, and news updates relating to the company.

Market drivers, restraints, challenges, and opportunities have been discussed in detail.Market players have been discussed and profiles of leading players including: Thermo Fisher STEMCELL Technologies Merck Millipore Lonza GE Healthcare Miltenyi Biotec Corning CellGenix Takara PromoCell

The key product type,the Stem Cell Media market is primarily split into Pluripotent Stem Cell Culture Hematopoietic Stem Cell Culture Mesenchymal Stem Cell Culture

Based on type, the global market is segmented into the following sub-markets with annual revenue for 2015-2025 (historical and forecast) included in each section.

The end users/applications listed in the report are: Scientific Research Industrial Production

Based on application, the global market is segmented into the following sub-markets with annual revenue for 2019-2025 (historical and forecast) included in each section.

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This report estimates the market size in terms of volume and value. This has been broken down into component regions and further into countries within those regions. This report covers North America, Europe, Middle East & Africa and Asia-Pacific and South America.

The report helps to identify the main Stem Cell Media market players. It assists in analyzing Stem Cell Media market competitive environment, including company overview, company total revenue, market opportunities, value, production sites and facilities, SWOT analysis, product details. The study also reveals the sales, revenue and market share for each market player included in this report for the period of 2015-2020. It also helps to ascertain the growth drivers and future prospects for the forecast timeline.

Conclusively, this report is a one stop reference point for the industrial stakeholders to get Stem Cell Media market forecast of till 2025. This report helps to know the estimated market size, market status, future development, growth opportunity, challenges, and growth drivers of by analyzing the historical overall data of the considered market segments.

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Stem Cell Media Market Projected to Witness Vigorous Expansion by 2027 - The Think Curiouser