The Growing Landscape of Regenerative Medicines: Opportunities and Challenges

Regenerative Medicine Market by Product (Stem Cell [Autologous, Allogenic], Immunotherapy, Gene Therapy, Tissue Engineering), Application (Musculoskeletal, Cancer, Dermatology, Wound care, Cardiovascular Diseases, Eye Disorders) - Global Forecast to 2028

The Global Regenerative Medicine Market in terms of revenue was estimated to be worth $16.0 Billion in 2023 and is poised to reach $49.0 Billion by 2028, growing at a CAGR of 25.1% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.

This is mainly due to various factors such as rising emphasis on personalized medicine, rising partnerships and collaborations by major market players, increased therapeutic area scope and rise in regenerative medicine regulatory approvals. However, the legal and ethical concerns associated with regenerative medicine along with the growing high treatment cost are predicted to cause market growth barriers.

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The regenerative medicine market is predicted to grow at a CAGR of 25.1% during the forecast period of 2023 to 2028. The important factors impacting market growth are the increasing focus on personalized medicine, and the emerging applications in new therapeutic areas. Increasing collaborations and partnerships by major market players and increasing regulatory approvals in regenerative medicine are expected to provide lucrative growth of the market in the near future.

Cell therapy segment accounted for the largest share of the regenerative medicine industry

Based on product, the regenerative medicine market is segmented into gene therapy, cell therapy (stem cell therapy [cell transplantations, stem cell therapy products {Autologous stem cell therapy, allogenic stem cell therapy] cell-based immunotherapy products), and tissue engineering products. The cell therapy segment accounted for the largest share of the regenerative medicine market in 2022. The high adoption of stem cell therapy is a key contributor to the growth of this segment. The growing applications of hematopoietic stem cell transplantations (HSCT) are expected to drive the growth of the cell therapy market.

Musculoskeletal disorder wins the largest share of therapeutic areas

Based on therapeutic area, the regenerative medicine market is classified into oncology, neurology, musculoskeletal disorders, ophthalmology, cardiovascular diseases, dermatology & wound care and other applications. In 2022, the musculoskeletal disorders segment accounted for the largest share of the global regenerative medicine market. Rise in the orthopedic disorders prevalence along with increasing musculoskeletal regeneration research can be attributed to the rising growth rate of this segment.

During the forecast period, North America exhibited the most rapid growth.

The largest share of the global regenerative medicine market was of North America, closely followed by Europe and then the Asia Pacific. This can be accredited to the growth of stem cell research, healthcare sector expansion, and the increase in the adoption of stem cell therapy and cell immunotherapies for  cancer and other chronic diseases treatment.

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Key Market Players:

Novartis AG (Switzerland), Biogen, Inc. (US), Sarepta Therapeutics, Inc. (US), Gilead Sciences, Inc. (US), Amgen Inc. (US), Smith+Nephew (UK), MEDIPOST Co., Ltd. (Korea), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), CORESTEM, Inc (South Korea), Vericel Corporation (US), MIMEDX Group, Inc. (US), Organogenesis Inc. (US), Medtronic (Ireland), Bristol-Myers Squibb Company (US), Orthocell Ltd. (Australia), Mesoblast Ltd. (Australia), BioRestorative Therapies, Inc. (US), Pluristem Therapeutics Inc. (US), TEGOSCIENCE (South Korea), ANTEROGEN.CO.,LTD. (South Korea), Bluebird bio, Inc. (US), Stempeutics Research Pvt Ltd. (India), Sibiono GeneTech Co. Ltd. (China), Aspect Biosystems Ltd. (Canada), and Athersys, Inc. (US).

Market Dynamics

Drivers

  • Growing focus on personalized medicine
  • Emerging applications in new therapeutic areas
  • Increasing collaborations and partnerships by major market players
  • Increasing regulatory approvals in regenerative medicine

Restraints

  • Lack of long-term data
  • Ethical and legal concerns and high cost of treatments

 Opportunities

  • Harnessing the potential of 3D printing
  • Integration with artificial intelligence and big data
  • Growing number of organ transplants

 Challenges

  • Lack of favorable reimbursement policies across various regions

Recent Developments of Regenerative Medicine Industry:

  • In December 2023, the U.S. FDA greenlit a historic treatment, Casgevy (CRISPR Therapeutics.). This first-ever cell-based gene therapy tackled sickle cell disease in patients 12+ and marked a revolutionary step in gene therapy with its novel genome editing tech.
  • In January 2023, Sarepta and Catalent entered into a commercial supply agreement for Catalent to manufacture delandistrogene moxeparvovec (SRP-9001) (ELEVIDYS), Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne Muscular Dystrophy (DMD).
  • In August 2023, Gilead Sciences and Tentarix Biotherapeutics entered into three multi-year collaborations to leverage Tentarix's Tentacles platform for the discovery and development of innovative, multi-functional protein-based therapies for cancer and inflammatory diseases.
  • In December 2023, Bristol-Myers Squibb received approval for ABECMA for patients with relapsed or refractory multiple myeloma with at least two prior treatments, including specific medications in Japan.

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