Regenerative Therapies Market Analysis | Coherent Market Insights

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2. Regenerative Therapies Market Analysis (2020-2027) • Regenerative therapies deliver specific types of cells or cell products to diseased tissues or organs to restore tissue and organ function. Materials used in regenerative therapies release growth factors and cytokines back into the damaged tissue to aid the healing process. • The global regenerative therapies market is estimated to account for US$ 10,421.5 Mn in terms of value in 2019 and is expected to reach US$ 45,940.7 Mn by the end of 2027

3. Global Regenerative Therapies Market: Drivers • Increasing prevalence of cardiovascular diseases (CVDs) is expected to propel growth of the global regenerative therapies market over the forecast period. For instance, according to the American Heart Association's Heart and Stroke Statistics 2019 Update, around 48% of all adults in the U.S. suffered from some type of CVD in 2016. • Moreover, increasing focus on tissue-cell and stem cell research is also expected to aid in growth of the market. For instance, in March 2020, researchers from Dankook University and Catholic University, South Korea, reported investigation of the types and degrees of physical and psychological discomfort experienced by hematopoietic stem cell donors before, during, and after the donation process.

4. s • Allograft held dominant position in the global regenerative therapies market in 2019, accounting for 57.7% share in terms of value, followed by xenograft and alloplast, respectively.

5. Global Regenerative Therapies Market: Restraints • Lack of standardized guidelines on tissue and bio-medical engineering is expected to hinder growth of the global regenerative therapies market. Lack of standardized guidelines on biomedical and tissue engineering and stem-cell research across regions is hampering production and approval of regenerative therapies. This in turn increases cost burden of regulatory approval for product makers. • Moreover, high gestation period and time-to-market due to lengthy clinical trials is also expected to limit growth of the market. A prime pitfall in development of new innovative regenerative therapies is lengthy clinical trial process. The process becomes lengthy due to acute dearth in availability of clinical trial subjects, who usually do not want to participate in such trials. Long gestation period often leads to abandonment of clinical trials midway, creating both financial as well as loss of ideas.

6. Global Regenerative Therapies Market: Opportunities  • Development of new regenerative techniques is expected to offer lucrative growth opportunities for players in the market. For instance, simple hip decompression is a new regenerative technique for patients with early-stage osteonecrosis of the hip. It is a less invasive outpatient procedure in which a surgeon makes a small hole outside the hip and taps into the diseased area. • Adoption of 3D printing technology in regenerative therapies is expected to aid in growth of the market. For instance, in February 2020, researchers from Wake Forest School of Medicine, U.S. reported investigation of the effects of neural cell integration into the bioprinted skeletal muscle construct to accelerate functional muscle regeneration in vivo.

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8. Market Trends/Key Takeaways • In the U.S., the prevalence of cancer is increasing, thereby aiding in growth of the market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. • Regenerative therapies are used for the treatment of various skin diseases. For instance, in March 2020, RenovaCare, Inc., a developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, announced that its SkinGun is being used to apply regenerative cells in a preclinical study of new gene therapies, underway at King’s College London.

9. Regulations • U.S. • HCT/Ps – Two Regulatory Tiers • Tissue (“361 HCT/P”) • Section 361 of PHS Act • Premarket review and approval not required; Product regulated solely under Tissue Regulations to control communicable disease (21 CRF 1271) • Establishment registration and product listing required (21 CRF 1271 -Subpart B) • Therapeutic (“351 HCT/P”) • Sections 351 and 361 of PHS Act, FD and C Act • Product regulated under Tissue Regulations and premarket review requirements (21 CFR Parts 1271, 600, 200, 312, 812(if device)) • Regulatory path: can be BIOLOGIC or DEVICE

10. 2005: FDA banned the use of Baytril – a fluoroquinoloneantibiotic – also known as enrofloxacin – in chicken and turkey. The antibiotic leads to the emergence of antibiotic resistant bacteria such as Campylobacter in humans, as its chemical composition is similar to that of Cipro – a human antibiotic – which is a common prescription drug to treat foodborne illnesses in humans. 2012: Maryland banned the usage of arsenic-based drugs in chicken feed. However, it is used across other states in the U.S. The drug received FDA approval as its arsenic content is within safe limits for human consumption. 2014: The FDA directed 26 major pharmaceutical companies in the U.S. to cease production of weight-gain drugs for animals by December 2016. It further directed the companies to stop OTC sales of antimicrobials such as Roxarsone (sold under the brand 3-Nitro) administered to livestock through feed and water, which are also used in human medicine. The objective of this move is to reduce health risks associated with the consumption of antimicrobial treated meat products. Ractopamine hydrochloride – a growth promoter drug – is banned in Europe and 160 other countries such as China, Taiwan, Russia, India, Turkey, Iran, Egypt, Kenya and Zimbabwe. However, its use is permitted in the U.S., Brazil and Canada to increase muscle production in swine, turkey and cattle. Since December 2012, meat imports in Russia from countries such as the U.S. is subject to ractopamine-free certification.

11. Value Chain Analysis

12. Global Regenerative Therapies Market: Competitive Landscape   • Major players operating in the global regenerative therapies market include, Shire Pharmaceuticals, Kinetic Concepts, Inc., Mesoblast Ltd., Nuo Therapeutics (Cytomedix Inc.), Advanced Cell Technology, Inc., BioStem Life Sciences, Akron Biotechnology, LLC, Organovo Holdings Inc., Orgenesis Inc., Pluristem Therapeutics Inc., Genzyme, Athersys, Inc., RenovaCare, Inc., and Cytori Therapeutics, Inc.

13. Global Regenerative Therapies Market: Competitive Landscape   • Major players in the market are also focused on expanding their capabilities. For instance, in March 2020, Akron Biotechnology, LLC announced its expansion to a second manufacturing facility in the US. • Major players in the market are also focused on adopting collaboration strategies to expand their product portfolio. For instance, in March 2020, Pluristem Therapeutics Inc. collaborated with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin for R&D in potential treatment for respiratory and inflammatory intratissue complications caused by covid-19.

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