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.
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.
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.
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 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
Report Attribute |
Details |
Market size value in 2021 |
USD 30.62 billion |
Revenue forecast in 2027 |
USD 57.08 billion |
Growth rate |
CAGR of 11.27% from 2021 to 2027 |
Base year for estimation |
2020 |
Historical data |
2018 - 2019 |
Forecast period |
2021 - 2027 |
Quantitative units |
Revenue in USD million/billion and CAGR from 2021 to 2027 |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Segment coverage |
Product, therapeutic category, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East Africa |
Country scope |
U.S.; Canada; Germany; U.K.; China; Japan; Brazil; South Africa |
Companies profiled |
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 |
Customization scope |
If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of the customization |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
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
b. The global regenerative medicine market size was estimated at USD 27.29 billion in 2020 and is expected to reach USD 30.62 billion in 2021.
b. The global regenerative medicine market is expected to grow at a compound annual growth rate of 11.27% from 2021 to 2027 to reach USD 57.08 billion by 2027.
b. North America dominated the regenerative medicine market with a share of 45.53% in 2020. This is attributable to the availability of advanced technologies and the presence of research institutes involved in the development of novel therapeutics in the region.
b. Some key players operating in the regenerative medicine market include Integra LifeSciences Corporation; MiMedx Group, Inc.; AstraZeneca; F. Hoffmann-La Roche Ltd; Merck & Co., Inc.; Pfizer Inc.; and Baxter.
b. Key factors that are driving the market growth include the presence of a strong pipeline portfolio and a high number of clinical trials, high economic impact of regenerative medicine and technological advances in regenerative medicine.
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Biopharmaceutical innovators are at the forefront of the human response to the coronavirus pandemic. A significant number of major biotech firms are in the midst of a race to investigate the Sars-Cov-2 genome and prepare a viable vaccine for the same. As compared to the speed of response to SARS/MERs etc, the biotech entities are investigating SARs-Cov-2 at an unprecedented rate and a considerable amount of funds are being put into the R&D. With multiple candidates in trial, the public and private sectors are anticipated to work in unison for the foreseeable period, until a vaccine is developed for Covid-19. The report will account for Covid19 as a key market contributor.
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