Regenerative Medicine Market Size & Forecast
The Regenerative Medicine Market is projected to reach $78.53 billion by 2031 at a CAGR of 20% from 2024 to 2031. The growth of this market is driven by factors such as the increasing approvals of regenerative medicine, advances in regenerative medicine, the rising incidences of target diseases, the increasing applications of regenerative medicine in newer therapy areas, and increasing funding for the development of these medicines.
Furthermore, the increasing demand for personalized medicine, the rising demand for organ transplants, and the increasing number of drugs in the pipeline are expected to create market growth opportunities.
Regenerative Medicine Market Growth Drivers
Increasing Approvals of Regenerative Medicine
Regenerative medicine harnesses the body’s inherent healing capabilities to restore, repair, or cultivate damaged or diseased tissues. The regenerative medicine field has witnessed a surge in interest in recent years, driven by its promising applications in oncology, cardiovascular diseases, neurological disease, and other medical domains. With the increasing application areas of regenerative medicine, regulatory bodies are approving the use of regenerative medicine for different diseases. Some recent instances of such approvals are as follows:
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In December 2023, Vertex Pharmaceuticals Incorporated (U.S.) received approval from the U.S. FDA for CASGEVY, a cell-based gene therapy designed for the treatment of sickle cell disease (SCD) in patients aged 12 years and older.
- In April 2023, Gamida Cell Ltd. (U.S.) received the U.S. FDA for Omisirge (omidubicel-onlv), an allogeneic cell therapy indicated for use in patients aged 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning. The therapy aims to reduce the time to neutrophil recovery and the incidence of infection.
Increasing Incidence of Neurodegenerative Disorders
Regenerative medicine is proving to be an effective therapy for various medical conditions, including cardiovascular diseases, ophthalmic diseases, oncology, neurological diseases, immunology & inflammation, musculoskeletal diseases, dermatological diseases, and others. The growing incidence of these target diseases is a key driver for market growth.
Neurodegenerative disorders, characterized by neuron loss, represent a significant portion of these conditions. Major neurodegenerative disorders include Alzheimer's disease and other memory disorders, Parkinson's disease, Ataxia, and Huntington's disease.
The rising prevalence of Alzheimer’s Disease, in particular, is expected to fuel the demand for regenerative medicine. According to the Alzheimer's Association (U.S.), a non-profit organization dedicated to Alzheimer’s disease care, research, and support, the prevalence of Alzheimer’s disease in the population aged 65 and older is projected to increase to 6.9 million in 2024, compared to 6.2 million in 2021.
Stem cell therapy has emerged as a promising treatment for Alzheimer's disease. It has the potential to reduce the deposition of amyloid β-protein (Aβ), thereby alleviating symptoms of memory loss.
Regenerative Medicine Market Trends
Utilization of 3D Bioprinting in Regenerative Medicine
3D bioprinting is a cutting-edge technique in regenerative medicine, utilizing biomaterials and cells, as opposed to traditional polymers and metals, to fabricate functional 3D tissues. This technology has gained prominence in recent years for its ability to create highly specialized tissue models, complementing conventional tissue engineering methods.
In tissue engineering, 3D bioprinting plays a crucial role in assembling living cells, biochemicals, or biomaterials into functional tissue-like structures. 3D bioprinting enables the integration of engineered tissue with natural tissue, facilitating the restoration of organ and tissue function.
3D bioprinting is gradually replacing traditional technologies due to its advantages. Unlike conventional methods, 3D bioprinting ensures accurate scaffold creation and proper interaction of cell lines. Moreover, it enables the fabrication of tissue components from patients' stem cells, thereby reducing the risk of rejection and graft-versus-host reactions, leading to increased adoption of this innovative approach.
Integration of AI Tools in the Development of Regenerative Medicine
The conventional methods employed in cell-based therapies and regenerative medicine face numerous challenges, including the management of vast datasets, increasing data complexity, and susceptibility to manual errors. As a result, there is a growing inclination towards leveraging AI for data analysis to discern patterns within data and formulate therapies.
In tissue engineering, AI algorithms play a pivotal role in identifying associations and patterns in cellular interactions and behavior, enabling predictions regarding cell behavior in diverse environments. This information is then utilized to refine and devise tissue engineering strategies aimed at developing functional tissues and organs.
Moreover, AI is undergoing testing for its applicability in biomanufacturing for regenerative medicine. For instance, in April 2024, researchers at Northeastern University (U.S.) introduced a framework proposing the integration of AI in the large-scale manufacturing of pluripotent stem cells. These manufactured stem cells hold potential applications in treating diseases such as Alzheimer’s or Parkinson’s, combating cancer, repairing spinal cord injuries, or mitigating the effects of aging.
Regenerative Medicine Market Opportunity
Rising Demand for Organ Transplants
The global demand for organ transplantation is steadily rising due to various factors, including the prevalence of chronic diseases, genetic disorders, accidental injuries, and physical trauma to organs. According to the U.S. Health Resources & Services Administration, as of March 2024, there were 106,441 patients in the U.S. awaiting organ donation.
Regenerative medicine techniques, such as stem cell therapy and tissue engineering, play a crucial role in repairing or regenerating damaged organs, thereby reducing reliance on donor organs and enhancing transplant outcomes. While the development of organs in vitro is still in its nascent stage, regenerative medicine presents an opportunity for organ development using a patient's own cells, thereby reducing the likelihood of rejection and the need for donor organs.
Regenerative Medicine Market Analysis: Key Findings
By Product: In 2024, the Cell Therapies Segment to Dominate the Regenerative Medicine Market
Based on product, the regenerative medicine market is segmented into gene therapy, cell therapy, and tissue engineering. In 2024, the cell therapy segment is expected to account for the largest share of 50.6% of the regenerative medicine market. This segment’s large market share can be attributed to the extensive utilization of cell therapies in treating various conditions such as cancer, autoimmune diseases, cardiovascular ailments, and other chronic illnesses. The rising prevalence of chronic diseases has led to a surge in the adoption of cell therapies. According to the Centers for Disease Control and Prevention, 6 out of 10 adults in the U.S. have at least one chronic condition, with 4 in 10 adults affected by two or more. Cell therapy addresses chronic diseases by either replacing damaged tissue with healthy counterparts or by stimulating tissue repair and regeneration. The segment's dominance is further bolstered by technological advancements, increased approvals for cell therapy, and a growing body of positive clinical outcomes associated with regenerative cells.
However, the gene therapy segment is projected to register the highest growth rate of 25.1% during the forecast period of 2024–2031. The growth of this segment can be attributed to the rising prevalence of genetic disorders and cancer. According to the National Heart, Lung, and Blood Institute, sickle cell anemia affects more than 100,000 people in the U.S. and 20 million people worldwide. Additionally, advancements in gene therapy manufacturing, increasing research funding for gene therapy development, and the rising number of clinical trials and approvals for gene therapy contribute to the segment’s growth. According to the Alliance for Regenerative Medicine (U.S.), an international organization for regenerative medicine, the number of gene therapy products in Phase I clinical trials reached 173 during the third quarter of 2023, an increase from 95 in the fourth quarter of 2022.
By Application: In 2024, the Oncology Segment to Dominate the Regenerative Medicine Market
Based on application, the regenerative medicine market is segmented into cardiovascular diseases, Ophthalmic diseases, oncology, neurological diseases, immunology & inflammation, musculoskeletal diseases, dermatological diseases, and other applications. In 2024, the oncology segment is expected to account for the largest share of 33% of the regenerative medicine market. This segment's large market share can be attributed to the increasing prevalence of cancer, the growing demand for personalized therapies, and recent approvals for cancer therapy.
Regenerative medicine offers various approaches, such as stem cell therapy, gene therapy, and tissue engineering, for treating cancer. These approaches provide personalized treatment options and help minimize the risk of side effects associated with traditional cancer treatments. Additionally, the rising funding for cancer treatment research contributes to the growth of this segment. For instance, in February 2024, BioNTech SE (Germany) invested USD 200 million in Autolus Therapeutics (U.K.) and established a strategic collaboration to support the cancer therapy pipeline.
By End User: In 2024, the Hospital & Clinics Segment to Dominate the Regenerative Medicine Market
Based on end user, the regenerative medicine market is segmented into hospitals & clinics and ambulatory surgical centers. In 2024, the hospitals & clinics segment is expected to account for the larger share of the regenerative medicine market. This segment’s large market share can be attributed to the rising number of patient visits to hospitals, the growing number of hospitals, and the availability of advanced technological resources within these healthcare facilities. Additionally, funding is often provided to hospitals & clinics to establish dedicated regenerative medicine facilities. For instance, in October 2022, California's stem cell agency granted USD 8 million to Cedars-Sinai (U.S.), a non-profit teaching hospital and multi-specialty academic health science center. This grant aims to establish an Alpha Stem Cell Clinic, enhancing patient access to stem cell therapy.
Geographical Analysis
In 2024, North America is expected to account for the largest share of the 53.3% of regenerative medicine market. North America’s significant market share can be attributed to the increasing prevalence of target diseases such as cancer and cardiovascular diseases, growing funding for the development of regenerative medicine, the presence of key market players in the region, and the rising number of clinical trials. According to the Alliance for Regenerative Medicine (U.S.), an international organization for regenerative medicine, North America witnessed a notable increase in the number of clinical trials, reaching 394 trials during the third quarter of 2023 from 339 trials in the fourth quarter of 2022. Similarly, the number of developers engaged in cell therapy manufacturing in North America increased from 272 to 435 during the same period. This surge in clinical trials and the involvement of key players in the development of regenerative medicine contribute to North America’s significant market share.
However, the market in Asia-Pacific is projected to register the highest CAGR of 22% during the forecast period. The growth of this regional market can be attributed to the rising prevalence of target diseases, the growing adoption of stem cell technology, supportive government policies promoting the development of regenerative medicine, and increased funding and research and development (R&D) initiatives in this field. According to the Alliance for Regenerative Medicine (U.S.), investment in regenerative medicine in the Asia-Pacific region surged to USD 2.1 billion in the fourth quarter of 2023, up from USD 0.9 billion in the third quarter of the same year.
Regenerative Medicine Market: Key Companies
The report offers a competitive landscape based on an extensive assessment of the offerings and geographic presence of leading market players and the key growth strategies adopted by them over the past few years. The key players operating in the regenerative medicine market are Novartis AG (Switzerland), Biogen Inc. (U.S.), AstraZeneca plc (U.K.), F. Hoffmann-La Roche AG (Switzerland), Integra Life Sciences (U.S.), Sarepta Therapeutics, Inc. (U.S.), Bayer AG (Germany), Amgen Inc. (U.S.), CORESTEMCHEMON Inc. (South Korea), Smith & Nephew plc (U.K.), GSK plc (U.K.), Takeda Pharmaceutical Company Limited (Japan), Astellas Pharma (Japan), Medtronic plc (Ireland), AbbVie Inc. (U.S.), Bristol Myers Squibb (U.S.), Cook Group Incorporated (U.S.), Pfizer Inc. (U.S.), Merck KGaA (Germany), and Vericel Corporation (U.S.).
Regenerative Medicine Market Overview: Latest Developments from Key Industry Players
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In October 2023, Immatics (Germany) was granted a Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA Center for Biologics Evaluation and Research (CBER) for its IMA203 TCR-T program. This therapy is approved for treating various cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer.
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In October 2023, Bayer AG (Germany) opened a cell therapy manufacturing facility in Berkeley, California, with an investment of USD 250 million.
- In July 2022, Astellas Pharma (Japan) and Mogrify Limited (U.K.) signed a collaborative research agreement focusing on in vivo regenerative medicine approaches to combat sensorineural hearing loss. Astellas is funding the research and providing adeno-associated virus (AAV)-based genetic medicine, while Mogrify contributes its bioinformatics platform expertise to the collaboration.
Regenerative Medicine Market Research Summary
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Particulars
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Details
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Number of Pages
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230
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Format
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PDF
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Forecast Period
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2024-2031
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Base Year
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2023
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CAGR
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20%
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Estimated Market Size (Value)
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$78.53 billion by 2031
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Segments Covered
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By Product
- Gene Therapy
- Cell Therapy
- Stem Cell Therapy
- Autologous Therapy
- Allogenic Therapy
- Platelet Rich Plasma Therapy
- Cell-based Immunotherapy
- CAR T Cell Therapy
- Other Cell-based Immunotherapies
- Tissue-Engineering
(Note: Other cell-based immunotherapies majorly include NK Cell Therapy and Dendritic Cell Therapy)
By Application
- Cardiovascular Disease
- Ophthalmic Diseases
- Oncology
- Neurological Diseases
- Immunology & Inflammation
- Musculoskeletal Diseases
- Dermatological Diseases
- Other Applications
(Note: Other applications majorly include wound care, orthopedics, and sports injuries.)
By End User
- Hospitals & Clinics
- Ambulatory Surgical Centers
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Countries Covered
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North America (U.S. and Canada), Europe (Germany, France, U.K., Italy, Spain, Denmark, Switzerland, and Rest of Europe), Asia-Pacific (China, Japan, India, South Korea, Australia, and Rest of Asia-Pacific), Latin America (Brazil, Mexico, Rest of Latin America), and Middle East & Africa
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Key Companies
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Novartis AG (Switzerland), Biogen Inc. (U.S.), AstraZeneca plc (U.K.), F. Hoffmann-La Roche AG (Switzerland), Integra Life Sciences (U.S.), Sarepta Therapeutics, Inc. (U.S.), Bayer AG (Germany), Amgen Inc. (U.S.), CORESTEMCHEMON Inc. (South Korea), Smith & Nephew plc (U.K.), GSK plc (U.K.), Takeda Pharmaceutical Company Limited (Japan), Astellas Pharma (Japan), Medtronic plc (Ireland), AbbVie Inc. (U.S.), Bristol Myers Squibb (U.S.), Cook Group Incorporated (U.S.), Pfizer Inc. (U.S.), Merck KGaA (Germany), and Vericel Corporation (U.S.)
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Key questions answered in the regenerative medicine market report:
