조직공학 및 재생의료 시장 예측(-2032년) : 제품별, 재료 종류별, 치료 접근 방식별, 서비스 모델별, 용도별, 최종사용자별, 지역별 분석

According to Stratistics MRC, the Global Tissue Engineering and Regeneration Market is accounted for $39.94 billion in 2025 and is expected to reach $133.39 billion by 2032 growing at a CAGR of 18.8% during the forecast period. Tissue engineering and regeneration refer to creating functional biological materials that help repair, replace, or enhance injured tissues and organs. The discipline merges biomaterials, therapeutic cells, and signaling molecules to guide natural regeneration and rebuild structure and function. Using engineering and biological science, it focuses on designing scaffolds, supporting cell activity, and driving tissue restoration. Its use extends across wound care, bone and cartilage repair, dental restoration, heart tissue regeneration, and organ reconstruction, addressing medical needs unmet by natural healing processes.

According to the Global RA Network, arthritis affects over 350 million people worldwide, and projections suggest that by 2040, approximately 78 million U.S. adults will suffer from the condition.

Market Dynamics:

Driver:

Rising prevalence of chronic diseases

The rising incidence of chronic illnesses such as diabetes, cardiovascular disorders, and musculoskeletal conditions is significantly increasing the need for advanced tissue engineering solutions. These diseases often lead to tissue damage or organ failure, intensifying demand for regenerative therapies. Growing aging populations further amplify the prevalence of degenerative disorders, supporting wider adoption of engineered tissues. As a result, regenerative medicine is becoming a central component of modern healthcare pathways. This accelerating disease burden serves as a strong catalyst for market expansion.

Restraint:

Complex and unclear regulatory pathways

Companies often struggle to meet diverse approval standards for biomaterials, engineered tissues, and combination products. Lengthy clinical validation processes further slow commercialization efforts. Regulatory ambiguity increases compliance costs and delays market entry for innovative therapies. Developers must invest heavily in documentation, quality systems, and regulatory consultations to avoid setbacks. These challenges can restrict product launches and limit broader market growth.

Opportunity:

Harnessing the potential of 3D bioprinting

Advances in printing technologies allow improved control over cell placement, scaffold architecture, and material composition. This innovation enhances the development of functional tissues for transplantation and drug testing. The technique also supports faster prototyping, reducing development timelines for regenerative products. As 3D bioprinting becomes more accessible, it is driving collaborations between biotech firms, research institutes, and material developers. Its expanding potential positions it as a major growth engine for the market.

Threat:

Fragmented or inadequate reimbursement policies

Many therapies fall under emerging or undefined categories, making coverage decisions unpredictable. Limited insurance support discourages both clinics and patients from choosing regenerative treatments. Manufacturers face difficulties demonstrating cost-effectiveness due to varying evaluation criteria. These gaps slow down clinical uptake and hinder large-scale commercialization. Without stronger reimbursement structures, market progression may remain constrained.

Covid-19 Impact:

The pandemic initially disrupted supply chains and delayed elective procedures, affecting demand for tissue-engineered products. Research activities in several institutions were temporarily halted, slowing innovation cycles. However, Covid-19 highlighted the importance of advanced biomaterials and regenerative tools for healing and recovery. The crisis accelerated government and private investments in biomedical research. Post-pandemic rebuilding has driven renewed interest in regenerative medicine for chronic condition management.

The scaffolds & biomaterials segment is expected to be the largest during the forecast period

The scaffolds & biomaterials segment is expected to account for the largest market share during the forecast period, due to its foundational role in tissue engineering processes. These components provide essential structural support for cell attachment and tissue formation. Growing innovation in biodegradable polymers, hydrogels, and bioactive materials is expanding their application range. Their high usage in research, clinical studies, and commercial therapies strengthens the segment's market position. Increasing preference for customizable and biocompatible materials further drives demand.

The biotechnology companies segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the biotechnology companies segment is predicted to witness the highest growth rate, as they rapidly advance R&D in regenerative therapies. Their strong focus on novel biomaterials, cell therapies, and engineered tissues fuels accelerated innovation. Many firms are entering strategic partnerships with hospitals and academic institutions to scale breakthroughs. Increased venture funding is enabling expansion into clinical trials and commercialization pathways. These companies are also adopting cutting-edge technologies such as 3D bioprinting and stem cell engineering.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, due to its strong healthcare infrastructure and high technological adoption. The region benefits from extensive research funding and active participation from leading universities. Regulatory frameworks supporting regenerative medicine further encourage product development. Rising chronic disease cases in the U.S. and Canada increase the need for advanced tissue therapies. Presence of major biotech companies strengthens the ecosystem for innovation and commercialization.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by growing healthcare investments and expanding biomedical research. Countries such as China, Japan, and India are rapidly adopting regenerative technologies. Government initiatives promoting biotechnology and tissue engineering are accelerating market penetration. Rising patient populations with chronic and degenerative conditions create strong demand for advanced therapies. Increasing collaborations between global players and regional institutes boost developmental activities.

Key players in the market

Some of the key players in Tissue Engineering and Regeneration Market include Organogen, Mesoblast, Stryker Co, CollPlant B, Integra Lif, Baxter Int, Medtronic, Merck KGa, Zimmer Bi, Corning In, BICO, Lonza Gro, Organovo, 3M Comp, and Tissue Re.

Key Developments:

In October 2025, Merck has entered into a partnership with Promega Corporation, a global life science solutions and service leader based in Madison, Wisconsin in the US, to co-develop novel technologies that advance drug screening and discovery. The agreement unites Merck's strength in organoids and synthetic chemistry with Promega's market leading assay and reporter technologies. Together, the companies aim to develop assays capable of tracking cellular activity in real time using an innovative reporter system within three-dimensional (3D) cell cultures.

In December 2024, 3M and US Conec Ltd. announced a strategic licensing agreement for 3M(TM) Expanded Beam Optical Interconnect technology, a solution to meet the performance and scalability needs of next-generation data centers and advanced network architectures. The collaboration combines advanced optical technology from 3M with US Conec's expertise in high-density connectivity systems, expanded beam optics, and precision manufacturing to help deliver innovative solutions tailored to the evolving demands of modern networks.

Products Covered:

• Scaffolds & Biomaterials
• Cells & Cell Banks
• Bio-inks & Consumables
• Bioreactors & Culture Systems
• Diagnostics & Monitoring Tools
• CDMO / Contract Services
• Other Products

Material Types Covered:

• Natural Polymers
• Synthetic Polymers
• Ceramics & Bioactive Glasses
• Composites
• Hydrogels / ECM Mimetics

Therapy Approaches Covered:

• Cell Therapy-Based
• Scaffold-Guided
• Acellular Biologics / Secretome
• Combination Products
• Synthetic Tissue Substitutes

Service Models Covered:

• Off-the-Shelf Product
• Personalized/autologous Therapies
• Contract Development & Manufacturing
• Research Services & Licensing

Applications Covered:

• Orthopedic
• Cardiovascular
• Dermatology & Wound Healing
• Neural
• Ophthalmology
• Urology & Nephrology
• Gastrointestinal & Hepatic
• Dental & Maxillofacial
• ENT & Reconstructive

End Users Covered:

• Hospitals & Surgical Centers
• Research Institutes & Academia
• Biotech & Pharma Companies
• CROs / CDMOs
• Diagnostic Labs
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 Application Analysis
• 3.8 End User Analysis
• 3.9 Emerging Markets
• 3.10 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Tissue Engineering and Regeneration Market, By Product

• 5.1 Introduction
• 5.2 Scaffolds & Biomaterials
• 5.3 Cells & Cell Banks
• 5.4 Bio-inks & Consumables
• 5.5 Bioreactors & Culture Systems
• 5.6 Diagnostics & Monitoring Tools
• 5.7 CDMO / Contract Services
• 5.8 Other Products

6 Global Tissue Engineering and Regeneration Market, By Material Type

• 6.1 Introduction
• 6.2 Natural Polymers
• 6.3 Synthetic Polymers
• 6.4 Ceramics & Bioactive Glasses
• 6.5 Composites
• 6.6 Hydrogels / ECM Mimetics

7 Global Tissue Engineering and Regeneration Market, By Therapy Approaches

• 7.1 Introduction
• 7.2 Cell Therapy-Based
• 7.3 Scaffold-Guided
• 7.4 Acellular Biologics / Secretome
• 7.5 Combination Products
• 7.6 Synthetic Tissue Substitutes

8 Global Tissue Engineering and Regeneration Market, By Service Models

• 8.1 Introduction
• 8.2 Off-the-Shelf Product
• 8.3 Personalized/autologous Therapies
• 8.4 Contract Development & Manufacturing
• 8.5 Research Services & Licensing

9 Global Tissue Engineering and Regeneration Market, By Application

• 9.1 Introduction
• 9.2 Orthopedic
• 9.3 Cardiovascular
• 9.4 Dermatology & Wound Healing
• 9.5 Neural
• 9.6 Ophthalmology
• 9.7 Urology & Nephrology
• 9.8 Gastrointestinal & Hepatic
• 9.9 Dental & Maxillofacial
• 9.10 ENT & Reconstructive

10 Global Tissue Engineering and Regeneration Market, By End User

• 10.1 Introduction
• 10.2 Hospitals & Surgical Centers
• 10.3 Research Institutes & Academia
• 10.4 Biotech & Pharma Companies
• 10.5 CROs / CDMOs
• 10.6 Diagnostic Labs
• 10.7 Other End Users

11 Global Tissue Engineering and Regeneration Market, By Geography

• 11.1 Introduction
• 11.2 North America
  • 11.2.1 US
  • 11.2.2 Canada
  • 11.2.3 Mexico
• 11.3 Europe
  • 11.3.1 Germany
  • 11.3.2 UK
  • 11.3.3 Italy
  • 11.3.4 France
  • 11.3.5 Spain
  • 11.3.6 Rest of Europe
• 11.4 Asia Pacific
  • 11.4.1 Japan
  • 11.4.2 China
  • 11.4.3 India
  • 11.4.4 Australia
  • 11.4.5 New Zealand
  • 11.4.6 South Korea
  • 11.4.7 Rest of Asia Pacific
• 11.5 South America
  • 11.5.1 Argentina
  • 11.5.2 Brazil
  • 11.5.3 Chile
  • 11.5.4 Rest of South America
• 11.6 Middle East & Africa
  • 11.6.1 Saudi Arabia
  • 11.6.2 UAE
  • 11.6.3 Qatar
  • 11.6.4 South Africa
  • 11.6.5 Rest of Middle East & Africa

12 Key Developments

• 12.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 12.2 Acquisitions & Mergers
• 12.3 New Product Launch
• 12.4 Expansions
• 12.5 Other Key Strategies

13 Company Profiling

• 13.1 Organogenesis
• 13.2 Mesoblast Limited
• 13.3 Stryker Corporation
• 13.4 CollPlant Biotechnologies
• 13.5 Integra LifeSciences
• 13.6 Baxter International
• 13.7 Medtronic plc
• 13.8 Merck KGaA
• 13.9 Zimmer Biomet
• 13.10 Corning Incorporated
• 13.11 BICO
• 13.12 Lonza Group
• 13.13 Organovo Holdings
• 13.14 3M Company
• 13.15 Tissue Regenix