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Regenerative medicine is a branch of medicine that focuses on the regeneration of damaged or diseased tissues and organs. It involves the use of stem cells, tissue engineering, and biologics such as growth factors, cytokines, and extracellular matrices to develop treatments for conditions that are currently incurable. Regenerative medicine has the potential to revolutionize medical care by providing novel treatments for diseases and injuries that cannot be treated using conventional approaches. The goal of regenerative medicine is to restore damaged tissues and organs to their normal function and structure, thus allowing patients to live longer and healthier lives.

Currently, Regenerative medicine market is projected to reach USD 40.6 billion by 2027 from USD 12.2 billion in 2022, at a CAGR of 27.2% during the forecast period. The major factors driving the growth of the regenerative medicine market are the availability of funding and rising investments in R&D, increasing clinical trials for stem cells and CAR-T cell therapies, and rising advancements in tissue engineered products.

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Market Growth Drivers

·         Rising prevalence of chronic diseases, genetic disorders, and cancer

·         Rising investments in regenerative medicine research

·         Growing pipeline of regenerative medicine products

Market Restraints

·         Ethical concerns related to the use of embryonic stem cells in research & development

·         High cost of cell and gene therapies

Industry Opportunities:

·         Implementation of the 21st Century Cures Act

·         Rising demand for organ transplantations

The prominent players operating in the regenerative medicine Industry are Novartis AG (Switzerland), Biogen (US), Sarepta Therapeutics, Inc. (US), Gilead Sciences, Inc. (US), Amgen, Inc. (US), Smith & Nephew plc (UK), Medipost Co., Ltd. (South Korea), JCR Pharmaceuticals Co., Ltd (Japan), Takeda Pharmaceutical Company (Japan), CORESTEM, Inc (South Korea), Vericel Corporation (US), MIMEDX (US), Organogenesis Inc. (US), Medtronic plc (US), Orthocell Ltd. (Australia), Mesoblast Ltd (Australia), BioRestorative Therapies, Inc (US), Pluri Inc. (Israel),  Tegoscience  (South Korea), Anterogen Co., Ltd. (South Korea), bluebird bio, Inc. (US), APAC Biotech (India), Shenzhen SiBiono Genetech Co., Ltd. (China), Aspect Biosystems (Canada), and Athersys, Inc. (US)

Novartis AG (Switzerland)

Novartis AG (Switzerland) was the leading player in the regenerative medicine market, with a share of ~25-27% in 2021. The company offers two gene therapy products—KYMRIAH and ZOLGENSMA. Globally, the company has strong distribution channels and a good brand image. As a result, KYMRIAH registered significant growth in 2018—KYMRIAH registered sales of USD 587 million in 2021, a rise from 24% in 2020. ZOLGENSMA registered sales of USD 1,351 million in 2021, up from 47% in 2020. Novartis has strong distribution channels in the US. As a result, in 2021, the company generated 32.6% of its total revenue from the US alone.

Biogen (US)

Biogen (US) is the second-leading player in the regenerative medicine market. However, the revenue of SPINRAZA is declining year on year. A decline in demand primarily brought on the decline in SPINRAZA revenue because of heightened competition in the US and Germany and a decline in pricing in the US and the RoW markets, which were only partially offset by an uptick in sales volumes in Latin America and some distributor markets.

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Recent Developments

·         In 2022, Novartis announces collaboration with Alnylam to explore targeted therapy to restore liver function.

·         In 2020, AbbVie acquired Allergan to enhance its product portfolio in immunology, hematologic oncology, neuroscience, and Allergan aesthetics.

·         In 2022, MiMedx announced the launch of Axiofill, an Extracellular Matrix (ECM) Particulate product derived from human placental tissue. Axiofill is a human placental-derived particulate product available for surgical recovery procedures.