Tissue Engineering Segment, by Product Type to Account Largest Share in Regenerative Medicine Market during 2025-2031

According to our new research study on "Regenerative Medicine Market Forecast to 2031 - Global Analysis - by Type, Product Type, and Application," the market was valued at US$ 20.55 billion in 2024 to US$ 75.16 billion by 2031; the market is expected to register a CAGR of 20.3% during 2025-2031. The regenerative medicine market growth is attributed to the rising prevalence of chronic disorders, an aging population, and the introduction of advanced regenerative therapies.

Regenerative medicine uses stem cells and technologies such as engineered biomaterials and gene editing to repair or replace damaged cells, tissues, or organs. Stem cell-based methods are currently being developed in laboratories worldwide, and some have already progressed to clinical trials. Introducing such regenerative therapies drives their adoption in clinical and medical settings as new disease treatments and drug development processes.

In July 2025, FibroBiologics, Inc., a clinical-stage biotechnology company, announced the filing of a patent application with the United States Patent and Trademark Office covering methods of generating multipotent cells from fibroblasts found in donor tissue for clinical applications. In February 2025, Cellino announced a collaboration with Mass General Brigham's Gene and Cell Therapy Institute (GCTI) to launch the world's first hospital-based autologous induced pluripotent stem cell (iPSC) Foundry. This initiative, powered by Cellino's AI-driven Nebula technology, aims to establish a nationwide network of decentralized biomanufacturing hubs. These hubs will deliver personalized cell and tissue therapies directly at the point of care.

Government regulations, particularly those from the US Food and Drug Administration (FDA) and the European Commission (EC) in the European Union, facilitate the approval of regenerative therapies through specialized regulatory pathways and designations. These measures accelerate the development and market access of these therapies as well as ensure their safety and effectiveness. Regenerative therapies, including cell and gene therapies, are governed by the FDA's Center for Biologics Evaluation and Research (CBER). These therapies are categorized as biological products and require a Biologics License Application (BLA) for marketing approval under the Public Health Service Act. CBER has established specialized offices and guidelines to address advanced regenerative therapies' unique scientific and regulatory challenges.

From 2024 to 2025, the FDA accelerated the approval process for cell and gene therapies, focusing on innovation and monitoring. As per the FDA and the American Society of Gene and Cell Therapy, the Gene, Cell, & RNA Therapy Landscape report published in 2024, 32 gene therapies, which include genetically modified cell therapies, received approval as of June 2024. In March 2024, CT-053 (developed by CARsgen) was approved by National Medical Products Administration (NMPA) for treating myeloma in China, and in January 2024, Beqvez (by Pfizer) was approved for hemophilia B in Canada. 28 RNA therapies and 68 non-genetically modified cell therapies have been approved, including Amtagvi, which was approved in the US for the treatment of melanoma.

Based on product type, the regenerative medicine market is segmented into cell based products, gene therapy and tissue engineering. The cell based products segment held a largest regenerative medicine market share in 2024, and gene therapy segment is expected to register a highest CAGR during 2025-2031. Cell-based therapies use living cells to either treat or prevent diseases. They work by replacing damaged cells, restoring function, or modulating the body's cells. These therapies can involve various cells, including stem and differentiated cells, and can be either autologous-using the patient's cells-or allogeneic-using cells from a donor.

More than 360 clinical trials focusing on cell-based therapies are being studied to interpret the potential of these therapies for treating disease indications. Recent advancements in cell-based products in regenerative medicine focus on innovative stem cell therapies, bioengineered tissue substitutes, and advanced delivery systems designed to enhance tissue regeneration, repair, and treatment of degenerative diseases. Approved cell therapies, including Novartis' Kymriah and Gilead's Yescarta, represent milestone CAR-T therapies, showing benefits for cancer treatment and highlighting the broader clinical impact of cell-based regenerative medicine beyond tissue repair.

Companies such as Lonza and Catalent are investing in state-of-the-art facilities to meet the growing demand for cell-based treatments. Also, Charles River Laboratories is investing in technologies to streamline manufacturing processes, aiming to reduce production timelines by up to 60%. This acceleration is essential to meet the demand for personalized therapies. As manufacturing capabilities advance and regulatory landscapes evolve, these therapies become integral to modern healthcare.

Based on application, the market is segmented into oncology, neurological disorders, wound healing and skin regeneration, ophthalmology, orthopedics and musculoskeletal, immunology, genetic disorders, and others. The oncology segment held the largest regenerative medicine market share in 2024, and the same segment is estimated to register the higher CAGR during 2025-2031. Regenerative medicine in oncology is transforming cancer care through advanced cellular, gene, and immune-based therapies. For instance, autologous and allogeneic CAR-T cell therapies, engineered to redirect a patient's own immune cells toward tumor antigens. These approaches have achieved remarkable success, particularly in hematologic malignancies: CAR-T treatments targeting antigens like CD19 and BCMA have produced sustained remissions in conditions such as acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and multiple myeloma. According to the Alliance for Regenerative Medicine, as of 2022, over 922 clinical trials underway. Additionally, oncology-related applications account for roughly 48-50 % of all cell and gene therapy clinical trials globally as of August 2023. Innovations targeting solid tumors now include novel delivery systems such as injectable hydrogels that locally deliver CAR-T cells into solid tumors and carry cytokines to overcome immune suppression. Moreover, emerging technologies such as tumor organoid-on-a-chip enable personalized modeling and high-throughput testing of immunotherapies on patient-derived tumors, promising more tailored and effective interventions.

Bristol-Myers Squibb Co; Novartis AG; Johnson & Johnson; Daiichi Sankyo Co Ltd; Takeda Pharmaceutical Co Ltd; Japan Tissue Engineering Co., Ltd; Bluebird Bio Inc; JCR Pharmaceuticals Co. Ltd; Vertex Pharmaceuticals Inc; Ferring Pharmaceuticals; CSL Behring LLC; and BioMarin Pharmaceutical Inc are among the leading companies operating in the global regenerative medicine market.

Companies operating in the regenerative medicine market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the regenerative medicine market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall regenerative medicine market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

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