Regenerative Medicine Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global regenerative medicine market, valued at US$13.5 billion in 2022, is forecasted to grow at a robust CAGR of 25.1%, reaching US$16.0 billion in 2023 and an impressive US$49.0 billion by 2028. Market growth 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 concrns associated with regenerative medicine along with the growing high treatment cost are predicted to cause market growth barriers.

Regenerative Medicine Market Size, Dynamics & Ecosystem

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Global Regenerative Medicine Market Dynamics

Driver: Focus on Personalized Medicine

The global market is expected to benefit from the focus on personalized medicines. Precision medicine is an approach to medical treatment that tailors therapeutics, and interventions for individual patients or a subpopulation based on their unique genetic, environmental, and lifestyle characteristics. In 2022, the FDA approved 12 personalized medications, representing approximately 34% of all newly approved therapeutic molecular entities. Personalized treatments account for at least a quarter of new drug approvals since 2015. Moreover, five new gene or cell-based therapies were approved in 2022. These include treatment of rare genetic disorders with few other treatment options – beta thalassemia, hemophilia B, and cerebral adrenoleukodystrophy, refractory multiple myeloma, and certain types of non-muscle invasive bladder cancer.

Restraint: Ethical and Legal concerns and high cost of regenerative medicines

Several ethical issues are associated with the use of stem cells, as these cells are derived by destroying the human embryo. The human embryo is viewed as a potential life, and destroying it is considered unethical even if it can save a human life. Such concerns related to embryonic stem cells for developing stem cell therapy are factors restraining market growth globally. Furthermore, the adoption of stem cells in Middle Eastern countries raises ethical considerations rooted in cultural, religious, and social perspectives. Religious beliefs, particularly in Islam, may influence opinions on the use of embryonic stem cells, posing a challenge as it involves the destruction of embryos. Additionally, due to budget constraints, various research institutes and small-scale companies find it difficult to afford expensive products. In emerging economies, underdeveloped infrastructure facilities and low healthcare expenditure restrict the use of advanced equipment.

Opportunity: Harnessing the Potential of 3D Printing

Technological advancements play a pivotal role in propelling the growth of the tissue engineering market, fostering innovation and expanding the scope of applications within the field. The continual evolution of materials science, bioengineering techniques, and imaging technologies has enabled researchers and engineers to develop sophisticated tissue-engineered products with enhanced functionalities. 3D bioprinting is used for the development of biostructure for orthopedic tissues, bones, and associated organs. In 3D bioprinting, a small unit of living cells, biomaterials, and biochemicals are positioned with the functional components to form tissue like 3D structures. The 3D bioprinting technology offers various advantages, including accurate cell distribution, scalability, high-resolution cell deposition, and cost-effectiveness.

Challenge: Lack of favorable reimbursement policies across various regions

The global market faces a significant hurdle in its growth trajectory due to inadequate or lack of reimbursement policies. The absence of clear reimbursement frameworks for regenerative therapies poses a challenge for both healthcare providers and patients. The inconsistent and complex nature of reimbursement policies across various regions hampers the widespread adoption of these innovative treatments. This factor is likely to restrain the growth of the market.

Regenerative Medicine Market Segmentation & Geographical Spread

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The cell therapy segment of regenerative medicine industry commanded market share.

On the basis of product, the regenerative medicine market is segmented into gene therapy, cell therapy (stem cell therapy [cell transplantations, stem cell therapy products {autologous therapy, allogenic therapy] cell-based immunotherapy products), and tissue engineering products. The cell therapy segment dominated the market in 2022. The rising cell therapy production facilities GMP certification approvals is one of the many factors driving the growth of this segment.

Muskuloskeletal disorders segment of the regenerative medicine industry is likely to grow at significant CAGR during the forecast period.

Based on therapeutic area, the regenerative medicine market is classified into ophthalmology, oncology, neurology, musculoskeletal disorders, cardiovascular diseases, dermatology & wound care and other applications. In 2022, the musculoskeletal disorders segment captured the highest share of the global market due to the increasing prevalence of orthopedic disorders and rise in musculoskeletal regeneration research.

Asia Pacific region of the regenerative medicine industry is predicted to exhibit highest CAGR during the forecast period of 2023-2028.

There are six main regional segmentations for the regenerative medicine market—North America, Europe, the Asia Pacific, Latin America, Middle East and Africa. In 2022, North America dominated the global market with the highest market share. Rising investments in tissue engineering, stem cell banking, and drug discovery, coupled with an expanding healthcare sector and high adoption of cell immunotherapies for cancer and chronic diseases and stem cell therapy, are driving the North American market's robust growth. Additionally, Asia Pacific exhibited the highest CAGR which can be attributed to the rising new technologies demand, increasing per capita income and increasing burden of chronic diseases.

Key players in the regenerative medicine market include 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), and CORESTEM, Inc (South Korea).

Regenerative Medicine Market Report Scope

This report categorizes the regenerative medicine market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Cell therapy
• Stem cell therapy
  • Cell transplantations
  • Stem cell therapy products
    • Autologous therapy
    • Allogenic therapy
• Cell-based immunotherapy products
• Gene therapy
• Tissue engineering

By Therapeutic Area

• Oncology
• Musculoskeletal disorders
• Dermatology & wound care
• Cardiovascular diseases
• Ophthalmology
• Neurology
• Other applications

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East
• Africa

Recent Developments of Regenerative Medicine Market

• 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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