Regenerative Medicine Market Size, Share, Forecast, & Trends Analysis by Product Application End User

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Regenerative Medicine Market Size, Share, Forecast, & Trends Analysis by Product (Gene Therapy, Stem Cell, Tissue Engineering) Application (Musculoskeletal, Cancer, Cardiovascular, Immunology, Dermatology, Ophthalmology) End User-Global Forecast to 2031

The global regenerative medicine market is projected to reach $37.27 billion by 2031 at a CAGR of 21.5% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities.

The growth of the global regenerative medicine market is driven by increasing approvals for new regenerative medicines, advancements in regenerative medicine, the rising incidence of chronic diseases, increasing funding for regenerative medicine development, and the growing applications of regenerative medicine in newer therapeutic areas. However, high treatment costs and ethical issues related to stem cells restrain the growth of this market.

Furthermore, the rising demand for personalized medicines, the increasing number of organ transplant procedures, and the strong product pipeline for regenerative medicines are expected to generate market growth opportunities. However, unfavorable reimbursement policies, complexities in the manufacture of regenerative medicines, and the lack of standardized frameworks for the safety & efficacy of regenerative medicines are major challenges in the global regenerative medicine market.

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry in the last three to four years (2020-2024). The key players operating in the regenerative medicine market are Novartis AG (Switzerland), Biogen Inc. (U.S.), Kite Pharma, Inc. (U.S.), Spark Therapeutics, Inc. (U.S.), Integra LifeSciences Corporation (U.S.), Sarepta Therapeutics, Inc. (U.S.), Takeda Pharmaceutical Company Limited (Japan), Amgen Inc. (U.S.), CORESTEMCHEMON Inc. (South Korea), Smith & Nephew plc (England), Vertex Pharmaceuticals Incorporated (U.S.), CSL Behring, LLC (U.S.), Janssen Global Services, LLC (U.S.), Medtronic plc (Ireland), AbbVie Inc. (U.S.), Bristol-Myers Squibb Company (U.S.), Ferring Pharmaceuticals A/S (Sweden), Pfizer Inc. (U.S.), bluebird bio Inc. (U.S.), and Vericel Corporation (U.S.).

Among all the products studied in this report, the cell therapy segment is projected to register the highest CAGR of 25.0% during the forecast period. The cell therapy segment is further segmented into stem cell therapy, cell-based immunotherapy, and platelet-rich plasma therapy. Cell-based immunotherapy is projected to register the highest CAGR during the forecast period. The rapid growth of this segment is attributed to the increasing cancer prevalence, rising awareness regarding the use of CAR T-cell therapy, and rising number of approvals & clinical trials for cell-based immunotherapy. The funding for the development of cell-based immunotherapy is also increasing, further driving the market growth. For instance, in May 2024, German Cancer Aid provided a $2.8 million (€2.6 million) grant to the Leibniz Institute for Immunotherapy (LIT) and University Hospital Regensburg (UKR) (Germany). The funding was earmarked for a clinical study focused on the use of stem-like CAR T-cells to treat patients with advanced lymphomas.

Among all the applications studied in this report, the oncology segment is projected to register the highest CAGR of 26.5% during the forecast period. 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.

Among all the end users studied in this report, the hospitals and clinics segment is projected to register the highest CAGR during the forecast period. Hospitals & clinics have developed infrastructure and highly skilled healthcare professionals, are easily accessible, and offer advanced treatments, including various therapies. Hence, patients are more inclined toward visiting hospitals & clinics. Many hospitals are also launching dedicated units for regenerative medicine, driving market growth. For instance, in April 2023, Jaslok Hospital (India) opened a Restorative and Regenerative Medicine Department aimed at treating complex diseases. This department offers orthobiologics for various cell-based treatments for bone and joint disorders, as well as platelet-rich plasma therapies for orthopedic, vascular, and cosmetic applications.

An in-depth analysis of the geographical scenario of the global regenerative medicine market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. Asia-Pacific is projected to register the highest CAGR of 25.0% during the forecast period. In 2024, Japan is expected to account for the largest share of the regenerative medicine market in Asia-Pacific. The large market share of Japan is attributed to the large population base aged 65 and older, government initiatives for the adoption of regenerative medicine, and supportive regulatory framework for the approval of regenerative medicine. For instance, Japan has implemented a conditional approval system for regenerative medicine, allowing companies to bring new therapies to market more quickly. The national healthcare system also covers these new therapies, providing further incentives for foreign companies to introduce their products in Japan.

Scope of the Report:

Regenerative Medicine Market Assessment-by Product

Gene Therapy
Cell Therapy
- Stem Cell Therapy
Autologous Therapy
Allogenic Therapy
- Platelet Rich Plasma Therapy
- Cell-based Immunotherapy
Tissue Engineering

Regenerative Medicine Market Assessment-by Application

Cardiology
Ophthalmology
Oncology
Neurology
Immunology & Inflammation
Musculoskeletal
Dermatology
Other Applications

Note: Other Applications include wound care, orthopedics, and blood disorders

Regenerative Medicine Market Assessment-by End User

Hospitals & Clinics
Ambulatory Surgical Centers

Regenerative Medicine Market Assessment-by Geography

North America
- U.S.
- Canada
Europe
- Germany
- France
- U.K
- Italy
- Spain
- Switzerland
- Netherlands
- Sweden
- Rest of Europe
Asia-Pacific
- China
- Japan
- India
- South Korea
- Australia
- Rest of Asia-Pacific
Latin America
- Brazil
- Mexico
- Rest of Latin America
Middle East & Africa

Product Code: MRHC - 1041181

1. Introduction

1.1. Market Definition & Scope
1.2. Market Ecosystem
1.3. Currency and Limitations
1.4. Key Stakeholders

2. Research Methodology

2.1. Research Process
2.2. Data Collection and Validation Process
- 2.2.1. Secondary Research
- 2.2.2. Primary Research/Interviews With Key Opinion Leaders from the Industry
2.3. Market Sizing & Forecasting
- 2.3.1. Market Size Estimation Approach
- 2.3.2. Growth Forecast Approach
- 2.3.3. Market Share Analysis
2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

4.1. Overview
4.2. Factors Affecting Market Growth
- 4.2.1. Drivers
  - 4.2.1.1. Approvals for New Regenerative Medicines
  - 4.2.1.2. Increasing Funding for Regenerative Medicine Development
  - 4.2.1.3. Increasing Applications of Regenerative Medicine in Newer Therapy Areas
- 4.2.2. Restraints
  - 4.2.2.1. Ethical Issues Related to Stem Cells
- 4.2.3. Opportunities
  - 4.2.3.1. Rising Demand for Personalized Medicines
- 4.2.4. Challenges
  - 4.2.4.1. Complexities in the Manufacture of Regenerative Medicines
- 4.2.5. Factor Analysis
4.3. Trends
- 4.3.1. Utilization of 3D Bioprinting in Regenerative Medicine
- 4.3.2. Integration of AI Tools in Regenerative Medicine Development
- 4.3.3. Induced Pluripotent Stem Cells
4.4. Regulatory Analysis
- 4.4.1. North America
  - 4.4.1.1. U.S.
  - 4.4.1.2. Canada
- 4.4.2. Asia-Pacific
  - 4.4.2.1. Japan
  - 4.4.2.2. China
  - 4.4.2.3. India
- 4.4.3. Europe
- 4.4.4. Middle East & Africa
- 4.4.5. PRP Qualification Criteria
4.5. Porter's Five Forces Analysis
- 4.5.1. Bargaining Power of Suppliers
- 4.5.2. Bargaining Power of Buyers
- 4.5.3. Threat of Substitutes
- 4.5.4. Threat of New Entrants
- 4.5.5. Degree of Competition
4.6. Investment and Funding Scenario
4.7. Pipeline Analysis

5. Regenerative Medicine Market Assessment-by Product

5.1. Overview
5.2. Cell Therapy
- 5.2.1. Cell-based Immunotherapy
- 5.2.2. Stem Cell Therapy
  - 5.2.2.1. Allogenic Therapy
  - 5.2.2.2. Autologous Therapy
- 5.2.3. Platelet-rich Plasma Therapy
5.3. Gene Therapy
5.4. Tissue Engineering Products

6. Regenerative Medicine Market Assessment-by Application

6.1. Overview
6.2. Musculoskeletal
6.3. Oncology
6.4. Ophthalmology
6.5. Immunology & Inflammation
6.6. Neurology
6.7. Dermatology
6.8. Cardiology
6.9. Other Applications

7. Regenerative Medicine Market Assessment-by End User

7.1. Introduction
7.2. Hospitals & Clinics
7.3. Ambulatory Surgical Centers

8. Regenerative Medicine Market Assessment-by Geography

8.1. Overview
8.2. North America
- 8.2.1. U.S.
- 8.2.2. Canada
8.3. Europe
- 8.3.1. Germany
- 8.3.2. U.K.
- 8.3.3. France
- 8.3.4. Switzerland
- 8.3.5. Italy
- 8.3.6. Spain
- 8.3.7. Netherlands
- 8.3.8. Sweden
- 8.3.9. Rest of Europe
8.4. Asia-Pacific
- 8.4.1. Japan
- 8.4.2. China
- 8.4.3. Australia
- 8.4.4. India
- 8.4.5. South Korea
- 8.4.6. Rest of Asia-Pacific
8.5. Latin America
- 8.5.1. Brazil
- 8.5.2. Mexico
- 8.5.3. Rest of Latin America
8.6. Middle East & Africa

9. Competition Analysis

9.1. Overview
9.2. Key Growth Strategies
9.3. Competitive Benchmarking
9.4. Competitive Dashboard
- 9.4.1. Industry Leaders
- 9.4.2. Market Differentiators
- 9.4.3. Vanguards
- 9.4.4. Emerging Companies
9.5. Market Share Analysis (2023)
- 9.5.1. Novartis AG (Switzerland)
- 9.5.2. Kite Pharma, Inc. (U.S.)
- 9.5.3. Biogen, Inc. (U.S.)
- 9.5.4. Bristol-Myers Squibb Company (U.S.)
- 9.5.5. Janssen Global Services, LLC (U.S.)

10. Company Profiles (Business Overview, Financial Overview, Product Portfolio, Strategic Developments, SWOT Analysis*)

10.1. Novartis AG
10.2. Kite Pharma, Inc. (A Subsidiary of Gilead Sciences, Inc.)
10.3. Janssen Global Services, LLC (A Subsidiary of Johnson & Johnson)
10.4. Bristol-Myers Squibb Company
10.5. Biogen Inc.
10.6. Smith & Nephew Plc
10.7. Amgen Inc.
10.8. Vericel Corporation
10.9. Integra Lifesciences Holdings Corporation
10.10. Pfizer Inc.
10.11. AbbVie Inc.
10.12. Sarepta Therapeutics, Inc.
10.13. Spark Therapeutics, Inc. (A Subsidiary of F. Hoffmann-La Roche Ag)
10.14. CORESTEMCHEMON, Inc.
10.15. CSL Behring, LLC (A Subsidiary of CSL Limited)
10.16. Takeda Pharmaceutical Company Limited
10.17. Ferring Pharmaceuticals
10.18. Medtronic plc
10.19. Bluebird Bio, Inc.
10.20. Vertex Pharmaceuticals Incorporated

(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)

11. Appendix

11.1. Available Customization
11.2. Related Reports