U.S. Regenerative Medicine Market Size, Share, Analysis, By Product (Cell Therapy, Gene Therapy, Tissue Engineering, and Platelet Rich Plasma), By Application (Orthopedics, Wound Care, Oncology, Rare Diseases, and Others), By End User (Hospitals, Clinics, and Others), and Country Forecast, 2024-2032

The U.S. regenerative medicine market size was worth USD 14.50 billion in 2023 and is projected to grow at a CAGR of 33.9% during the forecast period.

Regenerative medicine aims to repair or regenerate damaged tissues or organs using various techniques such as cell therapy, gene therapy, tissue engineering, and platelet rich plasma. In these therapies, the patient's or donor's cell, tissue, or genetic material is used. The product adoption is high in the U.S., owing to the rising prevalence of chronic diseases, which has surged the demand for technologically advanced treatment options.

The U.S. is one of the key countries actively investing in the emerging field of regenerative medicine. Many public and private organizations support this emerging field's research and development activities through research grants and funding to introduce effective novel solutions for treating various diseases.

• According to a news article published by UC Davis Health in May 2022, the California Institute for Regenerative Medicine (CIRM) is investing more than USD 11 million to fund a clinical trial testing a cell therapy to help throat cancer patients heal from the side effects of radiation therapy.

Such investments will encourage market players to upscale their research and development activities to introduce novel products in the market. The outbreak of COVID-19 impacted the market growth negatively. This was due to a reduction in surgical and medical intervention, which limited the patient population in availing this treatment regime.

LATEST TRENDS

Rise in Strategic Initiatives to Expand R&D Activities

One of the most prevalent trends observed in this market is the strategic initiatives such as mergers, acquisitions, partnerships, and collaborations made by the market players to expand their research and development capabilities. These strategic alliances help to bridge the gap between expectations and realities of converting regenerative medicine technologies into clinical practices. It has made its way into clinical practice with materials such as living cells and protein, enzymes, antibodies, antibody-drug conjugates (ADC), and gene and cellular components that have produced life-saving therapies to treat a range of different diseases such as diabetes, arthritis, cancer, and several rare genetic diseases.

• In March 2023, Artisan Bio entered a research collaboration with Takeda to leverage Artisan’s genome editing technology. In this agreement, Artisan will receive funding for its genome editing tool to help Takeda in the research and development of its cell therapy programs. Takeda will develop, manufacture and commercialize any potential resulting cell therapy product.

Such strategic initiatives will help incorporate advanced technology in providing a more comprehensive solution to treating chronic diseases, subsequently improving treatment outcomes.   

DRIVING FACTORS

Increasing Number of Clinical Trials to Drive the Market Growth

The investment in R&D activities is increasing to accelerate the clinical studies of pipeline candidates, especially in mesenchymal stem cell therapy. For instance, in March 2021, Brainstorm Cell Therapeutics Inc., reported positive topline data for phase 2 clinical trial of NurOwn (MSC-NTF cells) as a treatment for progressive multiple sclerosis (MS). NurOwn are autologous MSC-NTF cells derived from bone marrow mesenchymal stem cells (MSCs).  

Many studies have shown therapeutic potential of cell therapy in treating neurological disorders, cardiac ischemia, diabetes, and bone and cartilage diseases. Therefore, increasing R&D investments and clinical studies of these therapies with therapeutic potential for a wide range of diseases will broaden the scope of new product launches, leading to U.S. regenerative medicine market growth.

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In 2023, 1,958,310 new cancer cases and 609,820 cancer deaths were projected to occur in the U.S., according to the American Cancer Society 2023 Report.

RESTRAINING FACTORS

Stringent Regulatory Scenario May Hinder the Market Growth

One of the critical factors impeding market growth is the stringent regulatory scenario for regenerative medicine in the U.S. The regulatory frameworks are based on those established for conventional drug regulations, and bodies specific to the industry are still under development, resulting in numerous regulatory grey areas. The field's relative novelty and limited favorable regulations may influence the interest of biopharmaceutical companies in investing and diverting their R&D focus in this market.

• In October 2021, the U.S. FDA placed a clinical hold on all five clinical trials of AlloCAR T due to chromosomal abnormalities detected in a single patient were not related to the manufacturing or gene editing processes for Allogene Therapeutics. After a four-month investigation, it was found that the abnormality detected in a patient in the ALPHA2 study was unrelated to Allogene's manufacturing process and held no clinical significance.

Market players are investing heavily in introducing novel regenerative medicine therapies. However, such delays in clinical trial process increase the companies’ R&D expenses, restraining them from further investment.

SEGMENTATION

By Product Analysis

By product, the U.S. regenerative medicine market is segmented into cell therapy, gene therapy, tissue engineering, and platelet rich plasma.

The cell therapy segment dominated the U.S. regenerative medicine market share in 2022. Certain factors driving the growth of the cell therapy segment include the increased approvals in stem cell research and rising R&D initiatives to develop therapeutic options for chronic diseases, subsequently propelling the demand for the product.

• In February 2022, Janssen Pharmaceutical Companies of Johnson & Johnson received the U.S. FDA approval for Carvykti, a CAR T-cell therapy to treat adults with R/R multiple myeloma (RRMM).

By Application Analysis

Based on application, the U.S. market is segmented into orthopedics, wound care, oncology, rare diseases, and others.

The orthopedics segment held a major share of the regenerative medicine market share in 2022. Some of the factors responsible for the segment growth are the increasing prevalence of orthopedic diseases, rising demand for tissue-engineered products for bone and tissue repairs, and the growing demand for innovative treatment methods to reduce the length of stay. Moreover, the availability of tissue-engineered products such as scaffolds, biomatrixes, grafts, and others used for treating age-related diseases encourages the market players to expand their offerings in this segment and augment the market growth.

• According to the Arthritis Foundation 2021 report, juvenile arthritis affects almost 300,000 kids younger than 16 years of age in the U.S. every year.

By End User Analysis

Based on end user, the market is segmented into hospitals, clinics, and others.

The hospitals segment accounted for the largest share in the U.S. regenerative medicine market in 2022. The dominance of this segment is attributed to the rising demand for organ transplantation. Increasing awareness about embryonic stem cell reservations and their therapeutic uses propels the demand for stem cell banks. And to meet this growing demand, various hospitals are investing in developing in-house stem cell cord banks and development of stem cell therapies. Furthermore, collaboration amongst government hospitals and institutes to conduct R&D activities will likely augment the segment growth.

• In April 2023, a New York based hospital Mount Sinai, launched Institute for Regenerative Medicine. The Institute will focus on advancing and coordinating the research and training of regenerative biology and medicine in broad areas across Mount Sinai's basic science and clinical departments.

KEY INDUSTRY PLAYERS

In terms of competitive landscape, the U.S. market is fragmented. Novartis AG has a strong presence in the cell and gene therapy market, owing to approved cell therapy and gene therapy products that are Kymriah and Zolgensma, respectively. The company is focused on getting regulatory approvals for its CAR-T cell therapy product for multiple indications.

Stryker acquired Wright Medical Group N.V. to strengthen its biologics portfolio and dominate the tissue engineering market. Platelet rich plasma is highly fragmented but some major players, such as Zimmer Biomet and Terumo Corporation have established their presence in the market. Some of the market's emerging key players include CRISPR Therapeutics, bluebird bio, Inc., and Orchard Therapeutics plc, among others, are actively investing in accelerating the development of their pipeline candidates.

LIST OF KEY COMPANIES PROFILED:

• Integra LifeSciences Corporation (U.S.)


• Bristol-Myers Squibb Company (U.S.)


• Tissue Regenix (U.K.)


• Smith & Nephew (U.K.)


• Novartis AG (Switzerland)


• Allergan Aesthetics (AbbVie Inc.) (U.S.)


• MIMEDX Group, Inc. (U.S.)


• Stryker (U.S.)


• American CryoStem Corporation (U.S.)


• Kite (Gilead Sciences, Inc.) (U.S.)


• AlloSource (U.S.)


• bluebird bio, Inc. (U.S.)


• CRISPR Therapeutics (Switzerland)


• Janssen Global Services, LLC (Johnson & Johnson Services, Inc.) (Belgium)


• Tegoscience (South Korea)

KEY INDUSTRY DEVELOPMENTS: 

• October 2022 – AlloSource received a multi-year contract from the Biomedical Advanced Research and Development Authority (BARDA). AlloSource will supply allograft skin for crisis preparedness in the event of mass casualty burn incidents and support the U.S. government.


• August 2022 – The U.S. FDA approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.


• June 2022 – Bristol Myers Squibb Company received the U.S. FDA approval for CAR T cell Therapy Breyanzi for patients with primary refractory or relapsed Large B-cell Lymphoma (LBCL) who are not eligible for transplant.

REPORT COVERAGE

An Infographic Representation of U.S. Regenerative Medicine Market

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The U.S. regenerative medicine market report provides a detailed analysis of the industry. It focuses on key aspects such as the prevalence of chronic diseases in the U.S., and pipeline analysis. Additionally, it includes an overview of technological advancements, new product launches, key industry developments, and the impact of COVID-19 on the market. Besides this, the report offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market over recent years.

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