재생의료 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the regenerative medicine market size is projected to be USD 32.62 billion in 2025, USD 39.87 billion in 2026, and reach USD 91.94 billion by 2031, growing at a CAGR of 18.19% from 2026 to 2031.

This report is Segmented by Product Type (Cell Therapy, Gene Therapy, and More), Therapeutic (Oncology, Musculoskeletal Disorders, and More), Material (Synthetic Materials, Biologically Derived Materials, and More), End User (Hospitals, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Regenerative Medicine Market Trends and Insights

Rising Chronic Disease Burden

Non-communicable diseases caused 43 million deaths worldwide in 2021, and diabetes prevalence rose 16% to 537 million adults by 2024, prompting payers to prioritize therapies that regenerate beta-cell function over lifelong insulin dependence. Musculoskeletal disorders are projected to impair 78 million U.S. adults by 2030, opening a USD 12 billion annual opportunity for cartilage-repair products that can defer joint-replacement surgery. Hematologic malignancies illustrate the shift: five-year overall survival for diffuse large B-cell lymphoma surpassed 50% with CAR-T, compared with 15% on salvage chemotherapy, enlarging the patient cohort eligible for successive regenerative interventions. Cardiovascular programs trail oncology in revenue but demonstrated a 37% reduction in major adverse events after allogeneic mesenchymal stem-cell infusion, suggesting a move toward curative adjuncts to ventricular-assist devices. As populations age and multimorbidity increases, demand for durable, one-time treatments underpins the growth trajectory of the regenerative medicine market.

Accelerating Approvals & Reimbursement of Cell/Gene Therapies

The U.S. FDA cleared eight regenerative medicine advanced therapies in 2024, including the first solid-tumor CAR-T therapy for synovial sarcoma. Meanwhile, the European Medicines Agency granted conditional approval for the first ex vivo therapy for metachromatic leukodystrophy that same year. CMS expanded National Coverage Determination 110.23 to include allogeneic stem cell transplants for myelodysplastic syndrome, adding approximately 15,000 Medicare beneficiaries and USD 450 million in annual reimbursement. A new Transitional Coverage for Emerging Technologies rule promises provisional Medicare payment within six months of FDA clearance, compressing the commercialization gap that once slowed uptake. Thirty-five state Medicaid programs now pool risk under the Cell and Gene Therapy Access Model, collectively funding treatments priced above USD 2 million for the treatment of sickle-cell disease. China's regulator approved six domestic CAR-T products in 2024, priced 60% below Western benchmarks, catalyzing adoption across 18 provincial hospitals.

High Therapy Cost & Limited Payer Coverage

Autologous CAR-T products are listed at USD 373,000-515,000, and total care can reach USD 1.2 million once hospitalization and adverse-event management are factored in. These costs, which 40% of U.S. commercial insurers rejected in 2024 due to concerns about patient churn, are high. Hemophilia gene therapies, for USD 3.5 million, require a decade-long amortization, a commitment that many payers view as risky, given the limited durability data. Medicaid prior-authorization rules in 15 U.S. states mandate failure of two earlier regimens, delaying access by four to six months, and excluding patients with deteriorating conditions. In emerging markets, out-of-pocket expenses exceed annual household income by over ten times, restricting uptake to a narrow, affluent cohort. While outcome-based contracts that rebate 50-80% of price upon non-response mitigate payer risk, they introduce revenue volatility that complicates fundraising, as shown by Bluebird Bio's discounted USD 450 million cash call in 2024.

Other drivers and restraints analyzed in the detailed report include:

1. Advances in Stem-Cell Bioprocessing Scalability
2. AI-Enabled Closed-System Manufacturing Cuts Cost of Goods
3. Multi-Jurisdiction Regulatory Complexity

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Gene therapy, the fastest-advancing product type, is projected to log a 20.73% CAGR through 2031, driven by viral-vector intensification that increased AAV titers fourfold at Lonza's Houston campus in 2025. Cell therapy still dominates revenue, capturing 47.81% in 2025 thanks to 18,000 patients treated with commercial CAR-T products that year. Allogeneic CAR-T platforms in late-phase trials promise 48-hour manufacturing cycles, down from two weeks, positioning off-the-shelf products to erode the market share of autologous products. Platelet-rich plasma remains a niche but profitable option, with 22% of U.S. insurers reimbursing orthopedic injections.

Cell therapy's near-term growth hinges on label expansions into earlier-line hematologic settings and the first solid-tumor approval achieved in 2024, while stem-cell subsegments benefit from Japan's iPSC scale-up initiative. Gene-therapy pipelines are diversifying from hemophilia and retinal disorders into neurodegeneration and metabolic diseases, thanks to platform manufacturing guidance that reduces the number of validation steps. Tissue-engineering firms pursue modular scaffolds that accept CRISPR-edited cells, creating hybrid products that blur traditional segment boundaries in the regenerative medicine market. Together, these dynamics maintain robust investment across modalities, even as gene therapy outpaces the field in terms of velocity.

Neurological disorders are projected to grow at a 22.08% CAGR, the fastest therapeutic rate, propelled by AAV-GDNF vectors in Phase III Parkinson's trials and by Bluebird Bio's broader U.S. coverage for Lenti-D in cerebral adrenoleukodystrophy. Oncology remains the revenue anchor, accounting for 34.52% of 2025 sales; however, its growth moderates as hematologic indications saturate and solid-tumor biology poses immunosuppressive barriers. Musculoskeletal segments expand steadily on rising osteoarthritis prevalence, while wound-care revenues accelerate following Affinity's commercial launch.

Oncology's next leg of growth hinges on tumor-microenvironment modulators and dual-target CAR architectures aimed at sarcoma and glioblastoma. In neurology, real-world durability data will determine payer acceptance of high-priced one-time therapies versus chronic small-molecule regimens. Cardiovascular ventures pivot to allogeneic mesenchymal cells that integrate with mechanical devices, pursuing adjunct indications rather than standalone cures. Collectively, therapeutic diversification insulates the overall regenerative medicine market growth from the volatility of single indications.

Complete Report Scope:

• By Product Type
  • Cell Therapy
    • Autologous
    • Allogeneic
    • Stem Cell Therapy
      • Embryonic Stem Cell
      • Adult Stem Cell
      • Induced Pluripotent Stem Cell
  • Gene Therapy
    • Viral Vector-based
    • Non-viral Vector-based
  • Tissue Engineering
    • Scaffolds
    • Biomaterials
    • Engineered Tissue Constructs
  • Platelet-Rich Plasma
• By Therapeutic
  • Oncology
  • Musculoskeletal Disorders
  • Wound Care & Dermatology
  • Cardiovascular Diseases
  • Neurology
  • Ophthalmology
  • Other Therapeutics
• By Material
  • Synthetic Materials
    • Biodegradable Polymers
    • Hydrogel Materials
    • Artificial Vascular Graft Materials
  • Biologically Derived Materials
    • Collagen
    • Xenogeneic Materials
  • Genetically Engineered Materials
    • DNA Vectors
    • 3-D Polymer Technology
  • Pharmaceuticals (Small Molecule & Biologic)
• By End User
  • Hospitals
  • Specialty Clinics
  • Academic & Research Institutes
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America captured 44.16% of the 2025 revenue, supported by CMS rules that reimburse CAR-T for multiple lines of hematologic cancers and by the Transitional Coverage for Emerging Technologies pathway, which guarantees provisional payment within six months of FDA approval. Outcome-based contracts adopted by 22 health systems mitigate budget impact and foster broader patient access. Canada negotiated 40% pricing concessions through volume commitments, while Mexico granted two CAR-T approvals but faces affordability constraints due to out-of-pocket costs exceeding USD 200,000.

The Asia-Pacific, the fastest-growing region at a 23.76% CAGR, benefited from six domestic CAR-T approvals in China, priced at CNY 1.2 million (USD 165,000), accelerating adoption across 18 provincial hospitals. Japan's conditional approvals of four iPSC-derived therapies shorten timelines by three years, and India's 18-month Phase I-II path wooed USD 2.1 billion in foreign direct investment to Hyderabad and Bengaluru CDMO clusters. Singapore's 90-day review rule draws high-value manufacturing into Tuas Biomedical Park, while South Korea's lower CAR-T production costs unlock export opportunities to Southeast Asia.

Europe held 22.8% of 2025 revenue, underpinned by conditional Lenmeldy approval and national outcome-based contracts that tied reimbursement to six-month remission rates. The United Kingdom's expanded Early Access to Medicines Scheme brings forward revenue by 18 months, and Germany's rebate model spurs value-based competition among suppliers. Italy and Spain capped gene-therapy expenditures via managed-entry agreements that still provide full access to pediatric indications. In the Middle East and Africa, sandbox incentives account for 4.6% of revenue, with reliance on these incentives being particularly notable in the UAE, and limited approvals are available in South Africa. Meanwhile, South America's 3.9% share is concentrated in Brazil's high-complexity centers due to cost barriers.

Overall, the regenerative medicine market exhibits regional divergence, with reimbursement depth driving growth in North America, cost innovation fueling growth in the Asia-Pacific, and managed-entry agreements moderating expansion in Europe. Supply-chain localization - AAV suites in China, iPSC factories in Japan, and bio-printing hubs in the United States - further anchor production to the fastest-growing demand centers.

1. AlloSource
2. Anterogen Co., Ltd.
3. Athersys, Inc.
4. bluebird bio
5. Bristol-Myers Squibb
6. Baxter
7. CORESTEM Inc.
8. CRISPR Therapeutic
9. Gilead Sciences
10. Humacyte
11. Integra LifeSciences
12. Lonza Group
13. Medtronic
14. Mesoblast Limited
15. MiMedx Group
16. Novartis
17. Organogenesis
18. Osiris Therapeutics
19. Rocket Pharmaceuticals
20. Smiths Group
21. Stryker
22. Takeda Pharmaceutical Co.
23. Vericel

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Chronic Disease Burden
  • 4.2.2 Accelerating Approvals & Reimbursement of Cell/Gene Therapies
  • 4.2.3 Advances in Stem-Cell Bioprocessing Scalability
  • 4.2.4 AI-Enabled Closed-System Manufacturing Cuts Cost of Goods
  • 4.2.5 Regulatory Sandboxes Attracting FDI
  • 4.2.6 Battlefield Bioprinting Spin-Offs for Civilian Trauma Care
• 4.3 Market Restraints
  • 4.3.1 High Therapy Cost & Limited Payer Coverage
  • 4.3.2 Multi-Jurisdiction Regulatory Complexity
  • 4.3.3 Viral-Vector Supply Bottlenecks
  • 4.3.4 Non-Biologic Molecular Alternatives Shrinking Addressable TAM
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Product Type
  • 5.1.1 Cell Therapy
    • 5.1.1.1 Autologous
    • 5.1.1.2 Allogeneic
    • 5.1.1.3 Stem Cell Therapy
      • 5.1.1.3.1 Embryonic Stem Cell
      • 5.1.1.3.2 Adult Stem Cell
      • 5.1.1.3.3 Induced Pluripotent Stem Cell
  • 5.1.2 Gene Therapy
    • 5.1.2.1 Viral Vector-based
    • 5.1.2.2 Non-viral Vector-based
  • 5.1.3 Tissue Engineering
    • 5.1.3.1 Scaffolds
    • 5.1.3.2 Biomaterials
    • 5.1.3.3 Engineered Tissue Constructs
  • 5.1.4 Platelet-Rich Plasma
• 5.2 By Therapeutic
  • 5.2.1 Oncology
  • 5.2.2 Musculoskeletal Disorders
  • 5.2.3 Wound Care & Dermatology
  • 5.2.4 Cardiovascular Diseases
  • 5.2.5 Neurology
  • 5.2.6 Ophthalmology
  • 5.2.7 Other Therapeutics
• 5.3 By Material
  • 5.3.1 Synthetic Materials
    • 5.3.1.1 Biodegradable Polymers
    • 5.3.1.2 Hydrogel Materials
    • 5.3.1.3 Artificial Vascular Graft Materials
  • 5.3.2 Biologically Derived Materials
    • 5.3.2.1 Collagen
    • 5.3.2.2 Xenogeneic Materials
  • 5.3.3 Genetically Engineered Materials
    • 5.3.3.1 DNA Vectors
    • 5.3.3.2 3-D Polymer Technology
  • 5.3.4 Pharmaceuticals (Small Molecule & Biologic)
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Clinics
  • 5.4.3 Academic & Research Institutes
  • 5.4.4 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 AlloSource
  • 6.3.2 Anterogen Co., Ltd.
  • 6.3.3 Athersys, Inc.
  • 6.3.4 bluebird bio
  • 6.3.5 Bristol-Myers Squibb
  • 6.3.6 Baxter International Inc.
  • 6.3.7 CORESTEM Inc.
  • 6.3.8 CRISPR Therapeutics
  • 6.3.9 Gilead Sciences (Kite Pharma)
  • 6.3.10 Humacyte Inc.
  • 6.3.11 Integra LifeSciences Holdings Corporation
  • 6.3.12 Lonza Group
  • 6.3.13 Medtronic
  • 6.3.14 Mesoblast Limited
  • 6.3.15 MiMedx Group
  • 6.3.16 Novartis AG
  • 6.3.17 Organogenesis Holdings Inc.
  • 6.3.18 Osiris Therapeutics
  • 6.3.19 Rocket Pharmaceuticals
  • 6.3.20 Smith & Nephew plc
  • 6.3.21 Stryker Corporation
  • 6.3.22 Takeda Pharmaceutical Co.
  • 6.3.23 Vericel Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment