Regenerative Medicine Market by Product (Stem Cell [Autologous, Allogenic], Immunotherapy, Gene Therapy, Tissue Engineering), Application (Musculoskeletal, Cancer, Dermatology, Wound care, Cardiovascular Diseases, Eye Disorders) & Region - Global Forecast to 2028
Market Growth Outlook Summary
The global regenerative medicine market growth forecasted to transform from USD 16.0 billion in 2023 to USD 49.0 billion by 2028, driven by a CAGR of 25.1%. Market growth is mainly due to various factors such as rising emphasis on personalized medicine, rising partnerships and collaborations by major market players, increased therapeutic area scope and rise in regenerative medicine regulatory approvals. However, the legal and ethical concrns associated with regenerative medicine along with the growing high treatment cost are predicted to cause market growth barriers.
Regenerative Medicine Market Size, Dynamics & Ecosystem
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Global Regenerative Medicine Market Dynamics
Driver: Focus on Personalized Medicine
The global market is expected to benefit from the focus on personalized medicines. Precision medicine is an approach to medical treatment that tailors therapeutics, and interventions for individual patients or a subpopulation based on their unique genetic, environmental, and lifestyle characteristics. In 2022, the FDA approved 12 personalized medications, representing approximately 34% of all newly approved therapeutic molecular entities. Personalized treatments account for at least a quarter of new drug approvals since 2015. Moreover, five new gene or cell-based therapies were approved in 2022. These include treatment of rare genetic disorders with few other treatment options – beta thalassemia, hemophilia B, and cerebral adrenoleukodystrophy, refractory multiple myeloma, and certain types of non-muscle invasive bladder cancer.
Restraint: Ethical and Legal concerns and high cost of regenerative medicines
Several ethical issues are associated with the use of stem cells, as these cells are derived by destroying the human embryo. The human embryo is viewed as a potential life, and destroying it is considered unethical even if it can save a human life. Such concerns related to embryonic stem cells for developing stem cell therapy are factors restraining market growth globally. Furthermore, the adoption of stem cells in Middle Eastern countries raises ethical considerations rooted in cultural, religious, and social perspectives. Religious beliefs, particularly in Islam, may influence opinions on the use of embryonic stem cells, posing a challenge as it involves the destruction of embryos. Additionally, due to budget constraints, various research institutes and small-scale companies find it difficult to afford expensive products. In emerging economies, underdeveloped infrastructure facilities and low healthcare expenditure restrict the use of advanced equipment.
Opportunity: Harnessing the Potential of 3D Printing
Technological advancements play a pivotal role in propelling the growth of the tissue engineering market, fostering innovation and expanding the scope of applications within the field. The continual evolution of materials science, bioengineering techniques, and imaging technologies has enabled researchers and engineers to develop sophisticated tissue-engineered products with enhanced functionalities. 3D bioprinting is used for the development of biostructure for orthopedic tissues, bones, and associated organs. In 3D bioprinting, a small unit of living cells, biomaterials, and biochemicals are positioned with the functional components to form tissue like 3D structures. The 3D bioprinting technology offers various advantages, including accurate cell distribution, scalability, high-resolution cell deposition, and cost-effectiveness.
Challenge: Lack of favorable reimbursement policies across various regions
The global market faces a significant hurdle in its growth trajectory due to inadequate or lack of reimbursement policies. The absence of clear reimbursement frameworks for regenerative therapies poses a challenge for both healthcare providers and patients. The inconsistent and complex nature of reimbursement policies across various regions hampers the widespread adoption of these innovative treatments. This factor is likely to restrain the growth of the market.
Regenerative Medicine Market Segmentation & Geographical Spread
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The cell therapy segment of regenerative medicine industry commanded market share.
On the basis of product, the regenerative medicine market is segmented into gene therapy, cell therapy (stem cell therapy [cell transplantations, stem cell therapy products {autologous therapy, allogenic therapy] cell-based immunotherapy products), and tissue engineering products. The cell therapy segment dominated the market in 2022. The rising cell therapy production facilities GMP certification approvals is one of the many factors driving the growth of this segment.
Muskuloskeletal disorders segment of the regenerative medicine industry is likely to grow at significant CAGR during the forecast period.
Based on therapeutic area, the regenerative medicine market is classified into ophthalmology, oncology, neurology, musculoskeletal disorders, cardiovascular diseases, dermatology & wound care and other applications. In 2022, the musculoskeletal disorders segment captured the highest share of the global market due to the increasing prevalence of orthopedic disorders and rise in musculoskeletal regeneration research.
Asia Pacific region of the regenerative medicine industry is predicted to exhibit highest CAGR during the forecast period of 2023-2028.
There are six main regional segmentations for the regenerative medicine market—North America, Europe, the Asia Pacific, Latin America, Middle East and Africa. In 2022, North America dominated the global market with the highest market share. Rising investments in tissue engineering, stem cell banking, and drug discovery, coupled with an expanding healthcare sector and high adoption of cell immunotherapies for cancer and chronic diseases and stem cell therapy, are driving the North American market's robust growth. Additionally, Asia Pacific exhibited the highest CAGR which can be attributed to the rising new technologies demand, increasing per capita income and increasing burden of chronic diseases.
Key players in the regenerative medicine market include Novartis AG (Switzerland), Biogen, Inc. (US), Sarepta Therapeutics, Inc. (US), Gilead Sciences, Inc. (US), Amgen Inc. (US), Smith+Nephew (UK), MEDIPOST Co., Ltd. (Korea), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), and CORESTEM, Inc (South Korea).
Regenerative Medicine Market Report Scope
|
Report Metric |
Details |
|
Market Revenue Size in 2023 |
USD 16.0 Billion |
|
Projected Revenue Size by 2028 |
USD 49.0 Billion |
|
Industry Growth Rate |
Poised to Grow at a CAGR of 25.1% |
|
Market Driver |
Focus on Personalized Medicine |
|
Market Opportunity |
Harnessing the Potential of 3D Printing |
This report categorizes the regenerative medicine market to forecast revenue and analyze trends in each of the following submarkets:
By Product
- Cell therapy
-
Stem cell therapy
- Cell transplantations
-
Stem cell therapy products
- Autologous therapy
- Allogenic therapy
- Cell-based immunotherapy products
- Gene therapy
- Tissue engineering
By Therapeutic Area
- Oncology
- Musculoskeletal disorders
- Dermatology & wound care
- Cardiovascular diseases
- Ophthalmology
- Neurology
- Other applications
By Region
-
North America
- US
- Canada
-
Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
-
Asia Pacific
- Japan
- China
- India
- South Korea
- Australia
- Rest of Asia Pacific
-
Latin America
- Brazil
- Rest of Latin America
- Middle East
- Africa
Recent Developments of Regenerative Medicine Market
- In December 2023, the U.S. FDA greenlit a historic treatment, Casgevy (CRISPR Therapeutics.). This first-ever cell-based gene therapy tackled sickle cell disease in patients 12+ and marked a revolutionary step in gene therapy with its novel genome editing tech.
- In January 2023, Sarepta and Catalent entered into a commercial supply agreement for Catalent to manufacture delandistrogene moxeparvovec (SRP-9001) (ELEVIDYS), Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne Muscular Dystrophy (DMD).
- In August 2023, Gilead Sciences and Tentarix Biotherapeutics entered into three multi-year collaborations to leverage Tentarix's Tentacles platform for the discovery and development of innovative, multi-functional protein-based therapies for cancer and inflammatory diseases.
- In December 2023, Bristol-Myers Squibb received approval for ABECMA for patients with relapsed or refractory multiple myeloma with at least two prior treatments, including specific medications in Japan.
Frequently Asked Questions (FAQ):
What is the projected growth rate of the global regenerative medicine market between 2023 and 2028?
The global regenerative medicine market is expected to grow from USD 16.0 billion in 2023 to USD 49.0 billion by 2028, at a compound annual growth rate (CAGR) of 25.1%, driven by advancements in personalized medicine, expanding therapeutic areas, and increasing regulatory approvals.
What are the key drivers of the regenerative medicine market?
Key drivers of the regenerative medicine market include the growing focus on personalized medicine, technological advancements in 3D printing and bioengineering, increasing partnerships, and expanded therapeutic applications in areas like oncology, neurology, and musculoskeletal disorders.
What challenges does the regenerative medicine market face?
Challenges in the regenerative medicine market include ethical concerns related to the use of embryonic stem cells, high treatment costs, inadequate reimbursement policies, and legal restrictions, particularly in certain religious and cultural contexts.
Which therapeutic areas dominate the regenerative medicine market?
Musculoskeletal disorders currently dominate the regenerative medicine market, with a significant focus on treatments for orthopedic conditions. Other key therapeutic areas include oncology, neurology, dermatology & wound care, and cardiovascular diseases.
What role does 3D printing play in the regenerative medicine market?
3D printing is revolutionizing the regenerative medicine market by enabling the development of biostructures for orthopedic tissues, bones, and organs. This technology enhances precision in cell distribution, scalability, and cost-efficiency, driving innovation in tissue engineering.
Which regions are expected to experience significant growth in the regenerative medicine market?
The Asia Pacific region is expected to exhibit the highest growth rate in the regenerative medicine market from 2023 to 2028, driven by increasing healthcare investments, rising demand for advanced therapies, and a growing burden of chronic diseases.
Who are the major players in the global regenerative medicine market?
Key players in the global regenerative medicine market include Novartis AG, Biogen Inc., Gilead Sciences, Amgen Inc., Sarepta Therapeutics, Smith+Nephew, MEDIPOST Co., JCR Pharmaceuticals, Takeda Pharmaceutical Company, and CORESTEM Inc.
What recent advancements have impacted the regenerative medicine market?
Recent advancements in the regenerative medicine market include the FDA's approval of CRISPR-based gene therapy for sickle cell disease and major collaborations in gene therapy and protein-based treatments for cancer and inflammatory diseases.
How do reimbursement policies impact the regenerative medicine market?
Inadequate reimbursement policies hinder the growth of the regenerative medicine market, as the absence of clear frameworks limits patient access to advanced therapies. This issue is particularly prominent in emerging economies with underdeveloped healthcare infrastructure.
What are the major opportunities for growth in the regenerative medicine market?
Key opportunities for growth in the regenerative medicine market include the expanding use of 3D printing technology, increased FDA approvals for personalized treatments, and the rising demand for cell and gene therapies, particularly in oncology and musculoskeletal applications.
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This study involved four major activities in estimating the current size of the regenerative medicine market. Exhaustive secondary research was carried out to collect information on the market, its peer markets, and its parent market. These findings, assumptions, and sizing were then validated with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation procedures were used to estimate the market size of segments and subsegments.
Secondary Research
Secondary research was used mainly to identify and collect information for the extensive technical, market-oriented, and commercial study of the regenerative medicine market. The secondary sources used for this study include the Alliance for Regenerative Medicine (ARM), American Society for Cell Biology (ASCB), Centre for Commercialization of Regenerative Medicine (CCRM), European Society of Gene & Cell Therapy (ESGCT), National Center for Biotechnology Information (NCBI), Annual Reports, SEC Filings, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis. These sources were also used to obtain key information about major players, global product revenues, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives. Secondary data was collected and analyzed to arrive at the overall size of the global regenerative medicine market, which was validated through primary research.
Primary Research
In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, among other experts, to obtain and verify the critical qualitative and quantitative information as well as assess future prospects of the market. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The following is a breakdown of the primary respondents:
Note: Tiers are defined based on a company’s total revenue. As of 2022, Tier 1 = >USD 1 Bn, Tier 2 = USD 500 Mn to USD 1 Bn, and Tier 3 <USD 500 Mn.
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
The global size of the regenerative medicine market was estimated through multiple approaches. A detailed market estimation approach was followed to estimate and validate the value of the market and other dependent submarkets. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
- The major players in the industry and market have been identified through extensive primary and secondary research.
- The product and company revenues generated from the regenerative medicine business of players operating in the market have been determined through secondary research and primary analysis.
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Market Size Estimation Methodology-Bottom-up approach
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Top-down Approach-
Data Triangulation
After estimating the overall market size from the market size estimation process, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Regenerative medicine refers to a branch of medical science that focuses on repairing, replacing, or regenerating damaged or diseased cells, tissues, or organs to restore normal function. This field employs various approaches, including stem cell therapy, gene therapy, tissue engineering, and other advanced techniques, to promote the body's natural healing processes.
Key Stakeholders
- Regenerative medicine product manufacturing companies
- Healthcare service providers (including hospitals & specialty clinics)
- National and regional research boards and organizations
- Research & development organizations
- Clinical research organizations (CROs)
- Research laboratories & academic institutes
- Market research & consulting firms
The main objectives of this study are as follows:
- To define, describe, and forecast the regenerative medicine market by product, therapeutic area, and region
- To provide detailed information regarding the major factors influencing the market growth (such as drivers, restraints, opportunities, and challenges)
- To analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the overall regenerative medicine market
- To provide detailed information about global product revenues.
- To analyze the opportunities for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments with respect to five regions: North America (U.S., Canada), Europe (Germany, UK, France, Italy, Spain, Rest of Europe), the Asia Pacific (China, Japan, India, Australia, South Korea, Rest of Asia Pacific), Latin America (Brazil, Rest of Latin America), the Middle East and Africa
- To profile the key players and analyze their market shares and core competencies
- To track and analyze competitive developments, such as product launches, pipeline products (Phase 3 Regenerative medicines clinical trials molecules), partnerships, agreements, collaborations, expansions, and strategic alliances
- To benchmark players within the market using the proprietary “Company Evaluation Matrix” framework, which analyzes market players on various parameters within the broad categories of business and product excellence strategy.
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report with additional efforts:
- Product-Level Information
Country-wise Information:
- Analysis for additional countries (up to five)
Company Information:
- Detailed analysis and profiling of additional key market players across the globe
Generating Response ...
Growth opportunities and latent adjacency in Regenerative Medicine Market
According to your study, what would be the expected growth rate in the Regenerative Medicine Market by 2030?
Based on Regenerative Medicine By Products segment, which products are expected to witness the highest growth rate in the future?