Regenerative Medicine Market Size, Share & Trends Analysis Report By Product (Cell-based Immunotherapies, Gene Therapies), By Therapeutic Category (Cardiovascular, Oncology), And Segment Forecasts, 2021 - 2027

Report Overview

The global regenerative medicine market size was valued at USD 27.29 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 11.27% from 2021 to 2027. The emergence of gene therapy coupled with the developments in stem cell and tissue engineering are expected to fuel the market growth. In addition, increasing regulatory approvals for advanced therapy medicinal products have propelled the market growth. The ongoing COVID-19 pandemic created lucrative opportunities for the operating players owing to the urgent need for the development of new therapies against SARS-COV-2. Several initiatives are being implemented in the cell and gene therapy manufacturing industry, including the T-cell therapy space.

For instance, based on the previous research insights, Singapore-based Duke-NUS medical school’s emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection. The presence of several programs and continuous investments by government and private agencies to support R&D also accelerate the industry's progress. Like National Institutes of Health (NIH) supports the scientific research community through NIH Regenerative Medicine Program, NIH Stem Cell Libraries & Projects, NIH Stem Cell Unit, and others. Similarly, initiatives adopted by market players to raise finance for the R&D of regenerative medicine support the market progression.

In addition, companies are collaborating to strengthen their R&D capabilities to develop and commercialize innovative therapies to ensure their availability to their customers locally or worldwide. For instance, in July 2021, Pharming Group N.V. and Orchard Therapeutics collaborated for the development and commercialization of OTL-105, an investigational ex vivo autologous Hematopoietic Stem Cell (HSC) gene therapy for the treatment of Hereditary Angioedema (HAE).

Moreover, technological advancements in stem cell-based therapies have revolutionized the perspective of researchers toward regenerative medicine. Advances in stem cell therapy have accelerated the developments in regenerative medicine. For instance, haematogenic stem cells currently are being used to treat leukemia and blood disorders. Also, nanotechnology is a powerful tool for engineering stem cells and regenerative medicine. With the introduction of new technology, nanofabrication techniques can now allow researchers to develop nanofiber scaffolds.

Product Insights

The therapeutics segment accounted for the maximum revenue share of more than 56% in 2020 and is anticipated to continue its dominance throughout the forecast period. Among therapeutics vertical, primary cell-based therapies are the most developed therapeutics available due to their usage for different therapeutic indications and early adoption of these therapies in clinical application.

The stem cell &progenitor cell-based therapies segment is expected to register the fastest CAGR over the forecast years due to high investments in stem cell research coupled with redrafting in regulatory policies for their use in clinical applications. Allogenic stem cell-based therapies are estimated to account for the largest revenue share whereas autologous therapies are characterized with one of the fastest CAGRs.

Key vendors with specialized technology provide management, manufacturing, characterization, engineering, and quality control services along with other facilities for clinical trials and other research associated with the development of regenerative therapies. Hence, with a rise in R&D and clinical trials of regenerative medicines, the services segment is projected to witness rapid growth.

Therapeutic Category Insights

The application of regenerative therapies is maximum in the oncology segment, thus, it captured the largest revenue share of more than 31% revenue share in 2020. High cancer prevalence has resulted in the implementation of efficient cancer treatment options. Various government organizations, as well as private companies, have made high investments in cancer research and the development of regenerative & advanced cell therapies. Global efforts to reduce the cancer burden are also anticipated to drive the segment growth.

On the other hand, the presence of a strong product portfolio coupled with increasing incidences of musculoskeletal disorders is anticipated to boost the revenue of the musculoskeletal segment. The introduction of efficient regenerative solutions in form of stem cells and tissue engineering to restore the tissues and regain functional strength has led to the rapid development of the segment. Safe and potentially officious treatments are available in regenerative and cell-based therapies for the segment.

Furthermore, various novel approaches in developmental phases promote tissue engineering. This includes the use of biomaterials and drug delivery systems, which stimulate and control the immune system and influence cell replication. Increased complexity of the wound healing process with severe diseases, such as diabetes and HIV, has encouraged R&D approaches in the dermatology segment.

Regional Insight

North America dominated the global market in 2020with a revenue share of more than 45%. This is attributed to the presence of a significant number of key players in the U.S. The availability of advanced technologies and the presence of research institutes that are involved in the development of novel therapeutics are attributive to the high number of clinical trials in this region.

Availability of funds as well as several initiatives by the government & private organizations contributes to the highest revenue flow from the U.S. For instance, the “2020: A New Vision” initiative of the U.S. Department of Health and Human Services recognizes regenerative medicine at the forefront of healthcare.

Asia Pacific is predicted to witness the fastest CAGR over the forecast period owing to the expansion of infrastructure and facilities to accelerate stem cell research in the emerging economies of the region. In Japan, the Ministry of Health, Labor and Welfare approved Regenerative Medicine law in April 2013, which propelled the clinical development of regenerative and cell-based therapies. Similarly, the Chinese government has approved several research activities related to human embryonic stem cells that have encouraged researchers to explore the clinical potential of these cells.

Key Companies & Market Share Insights

Key companies invest heavily in the development of regenerative therapies to meet the demand for unmet clinical needs. The market is highly competitive as the companies are focusing on the introduction of therapies for oncology & age-related degenerative disorders. Moreover, collaborative efforts & strategic agreements for product development and technology sharing are expected to drive the market.

The market has witnessed a considerable number of mergers & acquisitions including Agilis Biotherapeutics’ acquisition by PTC Therapeutics and Quethera & Universal Cells’ acquisition by Astellas. The entry of well-established pharmaceutical companies in this field is anticipated to trigger more M&A activities. Some of the prominent companies in the global regenerative medicine market are:

• 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)

• Baxter International, Inc.

• Boehringer Ingelheim

• Amgen Inc.

• Cesca Therapeutics, Inc.

• U.S. Stem Cell, Inc.

• Bristol-Myers Squibb

• Eli Lilly and Company

• NuVasive, Inc.

• Organogenesis, Inc.

• MiMedx Group, Inc.

• Takara Bio, Inc.

• Osiris Therapeutics, Inc.

• Corline Biomedical AB

Regenerative Medicine Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2027. For the purpose of this study, Grand View Research has segmented the global regenerative medicine market report on the basis of product, therapeutic category, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2027)

  • Therapeutics 

    • Primary Cell-based Therapeutics

      • Dermatology

      • Musculoskeletal

      • Surgical

      • Dental

      • Others

    • Stem Cell & Progenitor Cell-based Therapeutics

      • Autologous

      • Allogeneic

      • Others

    • Cell-based Immunotherapies

    • Gene Therapies

  • Tools

  • Banks

  • Services

• Therapeutic Category Outlook (Revenue, USD Million, 2018 - 2027)

  • Dermatology

  • Musculoskeletal

  • Immunology & Inflammation

  • Oncology

  • Cardiovascular

  • Ophthalmology

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2027)

  • North America 

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • Middle East & Africa

    • South Africa