U.S. Regenerative Medicine Market Size, Share & Trends Analysis Report By Product (Cell-based Immunotherapies, Gene Therapies), By Therapeutic Category, And Segment) - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2024-2033

U.S. Regenerative Medicine Market Size and Growth

The U.S. regenerative medicine market size was valued at USD 17.19 billion in 2023 and is projected to surpass around USD 80.74 billion by 2033, registering a CAGR of 16.73% over the forecast period of 2024 to 2033.

U.S. Regenerative Medicine Market Key Takeaways

• The oncology segment held the largest market share of 31.15% in 2023.
• The cardiovascular segment is expected to witness a considerable CAGR during the forecast period
• The therapeutics segment held the largest market share of 75.19% in 2023.
• The bank segment is expected to witness the fastest CAGR from 2024 to 2033

U.S. Regenerative Medicine Market Growth 

The growth can be attributed to factors such as increasing investments in the regenerative medicine domain and a growing focus on launching new centers for regenerative medicine. Moreover, the developments in gene therapy, cell therapy, and tissue-engineered products in the country are expected to fuel further competition.

U.S. accounted for over 55% of the global regenerative medicine market in 2023. Academic and medical centers are providing funding to improve the regenerative medicine sector in the country. For instance, in October 2022, Cedars-Sinai was granted a 5-year, USD 8 million funding from California’s stem cell agency to establish a new clinic to improve training and research in regenerative medicine. Due to easy access to data through genomic, proteomic, and Electronic Health Record (EHR) databases, numerous companies are investigating various cell-based therapies to aid in the treatment of previously untreatable conditions.

Furthermore, the growing demand for robust therapies to address the rising cancer prevalence is contributing to growth in clinical trial numbers. Moreover, leading firms are investigating and developing pipeline products for diabetes & neurological disorders, such as Parkinson’s & Alzheimer’s diseases, cancers, and cardiovascular diseases, including myocardial infarction, heart failure, and ischemic heart diseases. Hence, the rising prevalence of these diseases increased the investments to improve the treatment of regenerative medicines.

Technological advancements such as stem cells, tissue engineering, and nanotechnology have made regenerative medicines a highly lucrative field of science. For instance, the wide acceptance of cell-based therapies in orthopedic surgeries significantly contributed to the overall stem cell market revenue. This can be attributed to stem cells forming an integral part of therapies based on regenerative medicine. Stem cells have been proven to accelerate treatment outcomes, expanding their usage. This has created multiple potential avenues for stem cell therapies that span orthopedics and other specialties.

U.S. Regenerative Medicine Market Report Scope

U.S. Regenerative Medicine Market By Therapeutic Category Insights

The oncology segment held the largest market share of 31.15% in 2023. The increasing prevalence of cancer coupled with combinational approaches using stem cells, immunotherapy, and gene therapy is expected to influence segment growth over the forecast period. Moreover, companies are developing various cell-based and gene therapies for cancer. Furthermore, many government organizations and industrial companies are investing in cancer research & expansion of regenerative medicines, including cell & gene therapies.  

The cardiovascular segment is expected to witness a considerable CAGR during the forecast period owing to increasing prevalence of Cardiovascular Diseases (CVD) and the rising demand for products to treat these disorders. In addition, advancements in regenerative medicines and cell-based therapies have accelerated growth of the segment. The companies are undertaking various strategies to expand their pipelines in this segment and promoting further growth.

U.S. Regenerative Medicine Market By Product Insights

The therapeutics segment held the largest market share of 75.19% in 2023. Over the years, geriatric population of U.S. has witnessed significant growth which resulted in a higher incidence of degenerative and age-related disorders. The rising prevalence of these disorders with unmet medical needs, such as diabetes, cancer, and NDs, including Age-related Macular Degeneration (AMD), has prompted researchers to create alternative treatment options such as cell therapy. Demand for such therapies is further anticipated to increase significantly owing to advances in stem & progenitor cell therapies and their high potential in treating a broad range of conditions.

The bank segment is expected to witness the fastest CAGR from 2024 to 2033 owing to its usage of large-scale collection, preparation, provision, research, and storage of stem cells. In recent years, the number of private cord blood banks has witnessed a rapid rise. This can be attributed to the availability of guidelines on using stem cells and umbilical cords for research purposes. Moreover, companies are undertaking various strategies to promote biobanking. The rapid adoption of private cord blood banking by people in the country is expected to significantly contribute to segment growth.  

U.S. Regenerative Medicine Market Recent Developments

• In May 2023, Canon entered into the regenerative medicine space with the acquisition of cell culture manufacturer Kyoto Seisakusho
• In September 2022, Bluebird Bio, Inc. received accelerated approval from the U.S. FDA to decrease the course of neurological dysfunction in 4 to 17 year-old boys with early, and active Cerebral Adrenoleukodystrophy (CALD)
• In January 2022, REGENXBIO, Inc. announced the approval of its Investigational New Drug Application by the U.S. FDA to evaluate RGX-202, a one-time gene therapy used for the treatment of Duchenne muscular dystrophy in a first-in-human clinical trials.

Key U.S. Regenerative Medicine Company Insights

Some prominent U.S. regenerative medicine market companies include Vitrolife; AstraZeneca; F. Hoffmann-La Roche Ltd.; Integra LifeSciences: Astellas Pharma Inc.; COOK BIOTECH; Merck KGaA; Vericel Corporation; Novartis Pharmaceuticals Corporation; bluebird bio, Inc.; and Bristol-Myers Squibb Company. Key market companies are adopting multifaceted strategies to remain in competition in the ever-evolving market setting.

They are initiating strategic M&A activities, partnerships, and collaborations with other market players and academic institutions intending to exchange knowledge and accelerate innovations. In addition, key players are undertaking various strategies, such as collaborations with Contract Manufacturing Organizations (CMOs), to sustain their market position. These companies are also prioritizing regulatory navigation, to ensure on-time approvals and access to the market.

U.S. Regenerative Medicine Market Top Key Companies:

• AstraZeneca plc
• F. Hoffmann-La Roche Ltd.
• Integra Lifesciences Corp.
• Astellas Pharma, Inc.
• Cook Biotech, Inc.
• Bayer AG
• Pfizer, Inc.
• Merck KGaA
• Abbott
• Vericel Corp.
• Novartis AG
• GlaxoSmithKline (GSK)

U.S. Regenerative Medicine Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Regenerative Medicine market.

By Product 

• Therapeutics
  • Primary Cell-based Therapeutics
    • Dermatology
    • Musculoskeletal
    • Surgical
    • Dental
    • Others
  • Stem Cell & Progenitor Cell-based Therapeutics
    • Autologous
    • Allogenic
    • Others
  • Cell-based Immunotherapies
  • Gene Therapies
• Tools
• Banks
• Services

By Therapeutic Category 

• Dermatology
• Musculoskeletal
• Immunology & Inflammation
• Oncology
• Cardiovascular
• Ophthalmology
• Others