The global regenerative medicine market size was estimated at USD 1,792.1 million in 2016. In recent years, regenerative medicine has emerged with promising approaches to treat complicated degenerative disorders as well as to support & restore the function of tissues and cells in other therapies. Rising prevalence of neurodegenerative, orthopedic, oncology, and genetic diseases coupled with advances in gene therapy, tissue engineering, and nanotechnology to support regenerative therapies are expected to boost revenue growth.
The industry has been witnessed to have a very strong pipeline with YoY increase in the number of products gaining approval for clinical application as well as the number of products entering into investigational trials for potential analysis. Growth is restricted due to regulatory and ethical issues in associated fields such as stem cells (SC) and gene editing. However, introduction of changes in regulatory policies and rise in demand for effective therapies to treat complicated disorders is projected to reduce the impact of these barriers over the forecast period.
UK regenerative medicine market revenue by product type, 2014 - 2025 (USD Million)
In addition, high investments by government and private organizations that support R&D, further encourage industry progress. Initiatives by government organizations to support stem cell & regenerative medicine R&D by providing funds and infrastructure facilities along with initiating various programs is expected to influence growth.
For instance, National Institutes of Health (NIH) supports scientific research community through NIH Regenerative Medicine Program, International SC Research, State Initiatives for Stem Cell Research, NIH SC Unit, NIH SC Libraries & Projects, and NIH SC Translation Laboratory.
Active participation by key companies is witnessed through strategic collaborations with academic institutes, government organizations, and major pharmaceutical & biotechnology companies. These initiatives are projected to make significant contributions in market expansion.
Considerable number of therapies in clinical trials are a collaborative effort of the market entities. Furthermore, key players are engaged in partnerships with universities to support development and gain commercial rights over innovative therapies.
Emerging technological advances in cell-based and gene therapies are attributed to be the major contributors to the industry progress. Introduction of flexible regulatory environment to conduct cell therapy research is expected to make lucrative contribution in market growth. IPSCs have witnessed rapid adoption in stem cell R&D to develop solutions for unmet clinical needs to treat complicated disorders.
On the contrary, regulatory restrictions to use HESC along with stringent regulatory norms that govern their application limits the market growth. However, identifying the potential clinical applications in countries such as U.S., UK, China, and Japan have introduced changes in their regulatory policies to encourage research. Thus, the industry is projected to reflect accelerated growth over the forecast period.
Gene therapy is projected to witness increased adoption in research owing to advances in gene sequencing and editing technology. Introduction of CRISPR and Cas gene technology that would to accelerate speed and enhance efficacy of gene-related research are expected to encourage use of gene therapy in treatment of genetic, metabolic, and degenerative disorders. Limited growth in gene therapy and Genetically Modified (GM) cell therapy is attributive to stringent regulatory restrictions pertaining the use of this technology.
Furthermore, advances in tissue engineering technology such as 3D printing of cells and tissues on scaffolds for transplant to restoring structural and functional characteristics of damaged cells, tissues, and organs is expected to make lucrative contributions towards market growth.
Dermatology is estimated to have largest share in revenue generation. This high contribution is attributive to presence of easy grafting techniques for dermatological wounds and diseases. Skin, being an organ with great cell replication characteristics, provides various types of stem cells from its different layers. Presence of broad range of product portfolio from patches to cure small injuries to matrix and grafts for chronic wounds and burns is expected to continue to dominate market through to the forecast period.
Owning to rise in demand for functional and structural restoration therapies along with rising incidences of bone & joint disorders, musculoskeletal segment is estimated to witness fastest growth. Rising prevalence of osteoarthritis with increase in geriatric population is anticipated to accelerate the segment growth.
Global regenerative market revenue by therapeutic category, 2016 (%)
Oncology is observed to be most promising segment owing to presence of strong pipeline of products and high investments in oncology research to treat as well as support treatment of various types of cancer, especially in incidences of cancer relapse. High incidence along with rising expenditure in treatment of oncology diseases have accelerated the developmental efforts in this segment. However, challenges in clinical trials are also high for this therapeutic category.
North America is estimated with highest share in revenue owing to presence of major players and rapid advances in technology along with high investments in stem cell & oncology research. Rapid uptake of advanced technology by the population is another significant factor contributing to the largest share.
Furthermore, active presences of organizations such as Alliance for Regenerative Medicine, National Institutes of Health, National Cancer Institute, International Society for Stem Cell Research, and National Stem Cell Foundation that promote R&D of regenerative medicine is expected to further accelerate growth in this region. Thereby, the region is projected to continue dominating the market through introduction of novel products.
Asia Pacific is projected to witness fastest growth over forecast period owing to high investments in healthcare research by the emerging economies in the region. Advances in stem cell research and presence of flexible regulatory environment for clinical adoption of cell-based regenerative therapies, China and Japan are expected to reflect rapid industrial progress.
In addition, availability of well-developed infrastructure and research facilities along with investments by government and private companies to support development of novel approaches is expected to further boost revenue growth. For instance, approvals to carry out research on human embryonic stem cells in China has encouraged researchers to explore the clinical potential of these cells. Thus, Asia Pacific is attributed to fastest growth over the forecast period.
The global regenerative medicine market is observed to be highly competitive and fragmented. The major players include Integra LifeSciences Corporation,MiMedx Group, Inc, AstraZeneca, F. Hoffmann-La Roche Ltd, Merck & Co., Inc., Pfizer Inc., Baxter and Nuvasive, Inc. These entities are observed to have high investments in development of regenerative therapies to capture the untapped potential by innovating novel therapies to meet the demand for unmet clinical needs.
In addition, key players are witnessed to focus on oncology & age-related degenerative disorders to compete in the market. Collaborative efforts & strategic agreements for technology sharing and product development have also been observed. Thereby, the industry witnesses a strong pipeline of products in clinical trials, which eventually are expected to drive revenue generation.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2017 - 2025
Revenue in USD Million and CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Central & South America, Middle East & Africa
U.S., Canada, Germany, UK, China, Japan, Brazil, South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional & country levels and provides an analysis on the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global regenerative medicine market on the basis of product, therapeutic categories, and region:
Product Type Outlook (Revenue, USD Million, 2014 - 2025)
Therapeutic Category Outlook (Revenue, USD Million, 2014 - 2025)
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Middle East & Africa
Recommendation and review posted by G. Smith