South Korea Cell and Gene Therapy Manufacturing Market Forecast to 2035 | 29.56% CAGR Unlocks a USD 7.54 Billion Opportunity in CDMO Capacity and GMP Expansion
Dublin, Oct. 01, 2026 (GLOBE NEWSWIRE) -- "South Korea Cell and Gene Therapy Manufacturing Market by Type of Therapy, Type of Scale, Type of Mode, Type of Workflow, Type of Process, Type of Technology, End User, Region of Manufacturing and Sales Forecast - Trends and Forecast Till 2035" has been added to ResearchAndMarkets.com's offering.
The South Korea cell and gene therapy manufacturing market is projected to increase from USD 1,826.0 million in the current year to USD 7,538.0 million by 2035, expanding at a CAGR of 29.56% during the forecast period. Growth is supported by large-scale capacity investments, regulatory reform, public funding, rising demand for contract manufacturing, and the development of specialized infrastructure for advanced therapies.
South Korea is becoming one of the fastest-growing cell and gene therapy manufacturing hubs in Asia-Pacific. Its expanding ecosystem supports cell processing, vector production, fill and finish operations, analytical and quality testing, and commercial-scale supply under stringent good manufacturing practice (GMP) requirements. Songdo in Incheon and Osong in Chungcheongbuk-do are expected to remain the country's principal bio-clusters.
MARKET GROWTH AND INDUSTRY TRENDS
Major pharmaceutical and biopharmaceutical companies are strengthening South Korea's advanced therapy manufacturing capabilities. Samsung Biologics operates more than 845,000 liters of installed biologics capacity across five plants in Songdo, with over 90% of its manufacturing conducted domestically. SK Group has expanded through SK Pharmteco and SK Bioscience, including the acquisitions of Yposkesi in France and IDT Biologika in Germany.
Lotte Biologics is investing close to KRW 4.6 trillion in three production plants and an integrated bio campus in Songdo. Specialized companies are also increasing capacity. GC Cell operates GMP-certified infrastructure supporting research, development, commercial supply, its allogeneic CAR-NK and NK cell therapy portfolio, and third-party CDMO services. CHA Biotech's subsidiary, Matica Biolabs, is developing end-to-end cell and gene therapy manufacturing capabilities and has partnered with TiCARos to manufacture the CAR-T candidate TC091.
International participation is further enhancing the South Korea cell and gene therapy manufacturing market. Thermo Fisher Scientific opened a dedicated Cell and Gene Therapy Vision Centre in South Korea in May 2025, while Bayer designated the country as a strategic clinical development hub for its Asia-Pacific cell and gene therapy programs. These investments are expected to encourage technology transfer, workforce development, and additional manufacturing partnerships.
REGULATORY AND FUNDING SUPPORT
The Act on the Safety and Support of Advanced Regenerative Medical Practice and Advanced Biopharmaceuticals has supported market development since 2019. The framework permits conditional commercial approval for qualifying products that have completed Phase II clinical trials. Recent regulatory changes governing advanced regenerative medicine are also expected to accelerate clinical entry and increase downstream manufacturing demand.
Public investment remains an important market catalyst. South Korea's Ministry of Health and Welfare has allocated more than USD 1.2 billion to regenerative medicine and cell therapy infrastructure. The Ministry of Trade, Industry and Energy has also proposed close to USD 461 million for advanced biopharmaceutical manufacturing technology development.
MARKET DRIVERS AND CHALLENGES
Key growth drivers include increasing demand for GMP-certified manufacturing, rising cell and gene therapy pipelines, capital investment by domestic conglomerates, and greater reliance on contract development and manufacturing organizations. Pharmaceutical and biotechnology companies are using domestic and multinational CDMOs to secure specialized capacity while limiting the cost of proprietary facility development.
Market expansion may be constrained by the shortage of professionals trained in advanced therapy bioprocessing, quality control, and regulatory compliance. Establishing GMP-certified facilities also requires substantial capital. Manufacturers serving international markets must align production systems and documentation with requirements established by authorities such as the US FDA and EMA. South Korea additionally competes with China and Japan, which currently hold larger shares of Asia-Pacific manufacturing capacity.
KEY MARKET SEGMENTS
COMPETITIVE LANDSCAPE
Companies active in the South Korea cell and gene therapy manufacturing market include Bayer, Celltrion, CHA Biotech (Matica Biolabs), Daewoong Pharmaceutical, GC Cell, Hanmi Pharmaceutical, Lotte Biologics, MEDIPOST, Samsung Biologics, SK Bioscience, SK Pharmteco, and Thermo Fisher Scientific.
REPORT COVERAGE
The report provides market sizing, revenue forecasts, opportunity analysis, manufacturing capacity assessments, regulatory analysis, company profiles, and reviews of partnerships, investments, facility expansions, and capacity additions. It evaluates the market by therapy, scale, mode, workflow, process, technology, end user, and manufacturing region. The study also includes Porter's Five Forces Analysis and an assessment of market drivers, restraints, opportunities, and challenges.
KEY QUESTIONS ADDRESSED
REPORT BENEFITS
The report helps established companies, emerging entrants, investors, manufacturers, and service providers evaluate revenue opportunities and formulate market entry, expansion, partnership, and capacity strategies. Additional benefits include complementary Excel Data Packs for analytical modules, 15% free content customization, a detailed walkthrough session with the research team, and a free updated report when the purchased edition is 6-12 months old or older.
Key Topics Covered:
1. PREFACE
1.1. Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
1.5. Key Questions Answered
1.6. Chapter Outlines
2. RESEARCH METHODOLOGY
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Database Building
2.3.1. Data Collection
2.3.2. Data Validation
2.3.3. Data Analysis
2.4. Project Methodology
2.4.1. Secondary Research
2.4.1.1. Annual Reports
2.4.1.2. Academic Research Papers
2.4.1.3. Company Websites
2.4.1.4. Investor Presentations
2.4.1.5. Regulatory Filings
2.4.1.6. White Papers
2.4.1.7. Industry Publications
2.4.1.8. Conferences and Seminars
2.4.1.9. Government Portals
2.4.1.10. Media and Press Releases
2.4.1.11. Newsletters
2.4.1.12. Industry Databases
2.4.1.13. Roots Proprietary Databases
2.4.1.14. Paid Databases and Sources
2.4.1.15. Social Media Portals
2.4.1.16. Other Secondary Sources
2.4.2. Primary Research
2.4.2.1. Introduction
2.4.2.2. Types
2.4.2.2.1. Qualitative
2.4.2.2.2. Quantitative
2.4.2.3. Advantages
2.4.2.4. Techniques
2.4.2.4.1. Interviews
2.4.2.4.2. Surveys
2.4.2.4.3. Focus Groups
2.4.2.4.4. Observational Research
2.4.2.4.5. Social Media Interactions
2.4.2.5. Stakeholders
2.4.2.5.1. Company Executives (CXOs)
2.4.2.5.2. Board of Directors
2.4.2.5.3. Company Presidents and Vice Presidents
2.4.2.5.4. Key Opinion Leaders
2.4.2.5.5. Research and Development Heads
2.4.2.5.6. Technical Experts
2.4.2.5.7. Subject Matter Experts
2.4.2.5.8. Scientists
2.4.2.5.9. Doctors and Other Healthcare Providers
2.4.2.6. Ethics and Integrity
2.4.2.6.1. Research Ethics
2.4.2.6.2. Data Integrity
2.4.3. Analytical Tools and Databases
3. MARKET DYNAMICS
3.1. Forecast Methodology
3.1.1. Top-Down Approach
3.1.2. Bottom-Up Approach
3.1.3. Hybrid Approach
3.2. Market Assessment Framework
3.2.1. Total Addressable Market (TAM)
3.2.2. Serviceable Addressable Market (SAM)
3.2.3. Serviceable Obtainable Market (SOM)
3.2.4. Currently Acquired Market (CAM)
3.3. Forecasting Tools and Techniques
3.3.1. Qualitative Forecasting
3.3.2. Correlation
3.3.3. Regression
3.3.4. Time Series Analysis
3.3.5. Extrapolation
3.3.6. Convergence
3.3.7. Forecast Error Analysis
3.3.8. Data Visualization
3.3.9. Scenario Planning
3.3.10. Sensitivity Analysis
3.4. Key Considerations
3.4.1. Demographics
3.4.2. Market Access
3.4.3. Reimbursement Scenarios
3.4.4. Industry Consolidation
3.5. Robust Quality Control
3.6. Key Market Segmentations
3.7. Limitations
4. MACRO-ECONOMIC INDICATORS
4.1. Chapter Overview
4.2. Market Dynamics
4.2.1. Time Period
4.2.1.1. Historical Trends
4.2.1.2. Current and Forecasted Estimates
4.2.2. Currency Coverage
4.2.2.1. Overview of Major Currencies Affecting the Market
4.2.2.2. Impact of Currency Fluctuations on the Industry
4.2.3. Foreign Exchange Impact
4.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
4.2.3.2. Strategies for Mitigating Foreign Exchange Risk
4.2.4. Recession
4.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
4.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
4.2.5. Inflation
4.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
4.2.5.2. Potential Impact of Inflation on the Market Evolution
4.2.6. Interest Rates
4.2.6.1. Overview of Interest Rates and Their Impact on the Market
4.2.6.2. Strategies for Managing Interest Rate Risk
4.2.7. Commodity Flow Analysis
4.2.7.1. Type of Commodity
4.2.7.2. Origins and Destinations
4.2.7.3. Values and Weights
4.2.7.4. Modes of Transportation
4.2.8. Global Trade Dynamics
4.2.8.1. Import Scenario
4.2.8.2. Export Scenario
4.2.9. War Impact Analysis
4.2.9.1. Russian-Ukraine War
4.2.9.2. Israel-Hamas War
4.2.10. COVID Impact / Related Factors
4.2.10.1. Global Economic Impact
4.2.10.2. Industry-specific Impact
4.2.10.3. Government Response and Stimulus Measures
4.2.10.4. Future Outlook and Adaptation Strategies
4.2.11. Other Indicators
4.2.11.1. Fiscal Policy
4.2.11.2. Consumer Spending
4.2.11.3. Gross Domestic Product (GDP)
4.2.11.4. Employment
4.2.11.5. Taxes
4.2.11.6. R&D Innovation
4.2.11.7. Stock Market Performance
4.2.11.8. Supply Chain
4.2.11.9. Cross-Border Dynamics
5. EXECUTIVE SUMMARY
6. INTRODUCTION
6.1. Chapter Overview
6.2. Overview of South Korea Cell and Gene Therapy Manufacturing
6.2.1. Key Benefits of South Korea Cell and Gene Therapy Manufacturing
6.2.2. Key Applications of the South Korea Cell and Gene Therapy Manufacturing
6.2.3. Challenges Associated with South Korea Cell and Gene Therapy Manufacturing
6.3. Future Perspective
7. REGULATORY SCENARIO
8. COMPREHENSIVE DATABASE OF LEADING PLAYERS
9. COMPETITIVE LANDSCAPE
9.1. Chapter Overview
9.2. South Korea Cell and Gene Therapy Manufacturing: Overall Market Landscape
9.2.1. Analysis by Year of Establishment
9.2.2. Analysis by Company Size
9.2.3. Analysis by Location of Headquarters
9.2.4. Analysis by Type of Therapy
9.2.5. Analysis by Type of Scale
9.2.6. Analysis by Type of Mode
9.2.7. Analysis by Type of Workflow
9.2.8. Analysis by Type of Process
9.2.9. Analysis by Type of Technology
9.2.10. Analysis by End User
9.2.11. Analysis by Region of Manufacturing
10. PORTER'S FIVE FORCES ANALYSIS
11. COMPANY COMPETITIVENESS ANALYSIS
12. STARTUP ECOSYSTEM IN THE SOUTH KOREA CELL AND GENE THERAPY MANUFACTURING MARKET
12.1. South Korea Cell and Gene Therapy Manufacturing: Market Landscape of Startups
12.1.1. Analysis by Year of Establishment
12.1.2. Analysis by Company Size
12.1.3. Analysis by Company Size and Year of Establishment
12.1.4. Analysis by Location of Headquarters
12.1.5. Analysis by Company Size and Location of Headquarters
12.1.6. Analysis by Ownership Structure
12.2. Key Findings
13. COMPANY PROFILES
13.1. Chapter Overview
13.2. Bayer
13.2.1. Company Overview
13.2.2. Company Mission
13.2.3. Company Footprint
13.2.4. Management Team
13.2.5. Contact Details
13.2.6. Financial Performance
13.2.7. Operating Business Segments
13.2.8. Product Portfolio
13.2.9. MOAT Analysis
13.2.10. Recent Developments and Future Outlook
13.3. Celltrion
13.4. CHA Biotech (Matica Biolabs)
13.5. Daewoong Pharmaceutical
13.6. GC Cell
13.7. Hanmi Pharmaceutical
13.8. Lotte Biologics
13.9. MEDIPOST
13.10. Samsung Biologics
13.11. SK Bioscience
13.12. SK Pharmteco
13.13. Thermo Fisher Scientific
14. RECENT DEVELOPMENTS
14.1. Chapter Overview
14.2. Recent Funding
14.3. Recent Partnerships
14.4. Other Recent Initiatives
15. GLOBAL SOUTH KOREA CELL AND GENE THERAPY MANUFACTURING MARKET
15.1. Chapter Overview
15.2. Key Assumptions and Methodology
15.3. Trends Disruption Impacting Market
15.4. Demand Side Trends
15.5. Supply Side Trends
15.6. Global South Korea Cell and Gene Therapy Manufacturing Market, Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
15.7. Multivariate Scenario Analysis
15.7.1. Conservative Scenario
15.7.2. Optimistic Scenario
15.8. Investment Feasibility Index
15.9. Key Market Segmentations
16. MARKET OPPORTUNITIES BASED ON TYPE OF THERAPY
16.1. Chapter Overview
16.2. Key Assumptions and Methodology
16.3. Revenue Shift Analysis
16.4. Market Movement Analysis
16.5. Penetration-Growth (P-G) Matrix
16.6. South Korea Cell and Gene Therapy Manufacturing Market for Cell Therapy: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
16.7. South Korea Cell and Gene Therapy Manufacturing Market for Gene Therapy: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
16.8. Data Triangulation and Validation
16.8.1. Secondary Sources
16.8.2. Primary Sources
16.8.3. Statistical Modeling
17. MARKET OPPORTUNITIES BASED ON TYPE OF SCALE
17.1. Chapter Overview
17.2. Key Assumptions and Methodology
17.3. Revenue Shift Analysis
17.4. Market Movement Analysis
17.5. Penetration-Growth (P-G) Matrix
17.6. South Korea Cell and Gene Therapy Manufacturing Market for Precommercial / R&D Scale Manufacturing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
17.7. South Korea Cell and Gene Therapy Manufacturing Market for Commercial Scale Manufacturing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
17.8. Data Triangulation and Validation
17.8.1. Secondary Sources
17.8.2. Primary Sources
17.8.3. Statistical Modeling
18. MARKET OPPORTUNITIES BASED ON TYPE OF MODE
18.1. Chapter Overview
18.2. Key Assumptions and Methodology
18.3. Revenue Shift Analysis
18.4. Market Movement Analysis
18.5. Penetration-Growth (P-G) Matrix
18.6. South Korea Cell and Gene Therapy Manufacturing Market for Contract Manufacturing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
18.7. South Korea Cell and Gene Therapy Manufacturing Market for In-House Manufacturing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
18.8. Data Triangulation and Validation
18.8.1. Secondary Sources
18.8.2. Primary Sources
18.8.3. Statistical Modeling
19. MARKET OPPORTUNITIES BASED ON TYPE OF WORKFLOW
19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Revenue Shift Analysis
19.4. Market Movement Analysis
19.5. Penetration-Growth (P-G) Matrix
19.6. South Korea Cell and Gene Therapy Manufacturing Market for Cell Processing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.7. South Korea Cell and Gene Therapy Manufacturing Market for Cell Banking: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.8. South Korea Cell and Gene Therapy Manufacturing Market for Process Development: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.9. South Korea Cell and Gene Therapy Manufacturing Market for Fill & Finish Operations: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.10. South Korea Cell and Gene Therapy Manufacturing Market for Analytical & Quality Testing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.11. South Korea Cell and Gene Therapy Manufacturing Market for Raw Material Testing: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.12. South Korea Cell and Gene Therapy Manufacturing Market for Vector Production: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.13. South Korea Cell and Gene Therapy Manufacturing Market for Other Workflow: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
19.14. Data Triangulation and Validation
19.14.1. Secondary Sources
19.14.2. Primary Sources
19.14.3. Statistical Modeling
20. MARKET OPPORTUNITIES BASED ON TYPE OF PROCESS
20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Revenue Shift Analysis
20.4. Market Movement Analysis
20.5. Penetration-Growth (P-G) Matrix
20.6. South Korea Cell and Gene Therapy Manufacturing Market in Upstream Process: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
20.7. South Korea Cell and Gene Therapy Manufacturing Market in the Downstream Process: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
20.8. Data Triangulation and Validation
21. MARKET OPPORTUNITIES BASED ON TYPE OF TECHNOLOGY
21.1. Chapter Overview
21.2. Key Assumptions and Methodology
21.3. Revenue Shift Analysis
21.4. Market Movement Analysis
21.5. Penetration-Growth (P-G) Matrix
21.6. South Korea Cell and Gene Therapy Manufacturing Market in Fluorescence-Activated Cell Sorting (FACS): Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
21.7. South Korea Cell and Gene Therapy Manufacturing Market in Enzyme-Linked Immunosorbent Assay (ELISA): Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
21.8. South Korea Cell and Gene Therapy Manufacturing Market in Chromatography: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
21.9. South Korea Cell and Gene Therapy Manufacturing Market in Next-Generation Sequencing (NGS): Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
21.10. South Korea Cell and Gene Therapy Manufacturing Market in Polymerase Chain Reaction (PCR): Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
21.11. South Korea Cell and Gene Therapy Manufacturing Market in Other Technologies: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
21.12. Data Triangulation and Validation
22. MARKET OPPORTUNITIES BASED ON END USER
22.1. Chapter Overview
22.2. Key Assumptions and Methodology
22.3. Revenue Shift Analysis
22.4. Market Movement Analysis
22.5. Penetration-Growth (P-G) Matrix
22.6. South Korea Cell and Gene Therapy Manufacturing Market in Pharmaceutical Companies: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
22.7. South Korea Cell and Gene Therapy Manufacturing Market in Biopharmaceutical / Biotechnological Companies: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
22.8. South Korea Cell and Gene Therapy Manufacturing Market in Contract Manufacturing Organizations: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
22.9. Data Triangulation and Validation
23. MARKET OPPORTUNITIES BASED ON REGION OF MANUFACTURING
23.1. Chapter Overview
23.2. Key Assumptions and Methodology
23.3. Revenue Shift Analysis
23.4. Market Movement Analysis
23.5. Penetration-Growth (P-G) Matrix
23.6. South Korea Cell and Gene Therapy Manufacturing Market in Incheon (Songdo): Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
23.7. South Korea Cell and Gene Therapy Manufacturing Market in Chungcheongbuk-do (Osong): Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
23.8. South Korea Cell and Gene Therapy Manufacturing Market in Seoul Capital Area: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
23.9. South Korea Cell and Gene Therapy Manufacturing Market in Rest of South Korea: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
23.10. Data Triangulation and Validation
24. ADJACENT MARKET ANALYSIS
25. KEY WINNING STRATEGIES
26. VALUE CHAIN ANALYSIS
27. STRATEGIC RECOMMENDATIONS
28. INSIGHTS FROM PRIMARY RESEARCH
29. REPORT CONCLUSION
30. TABULATED DATA
31. LIST OF COMPANIES AND ORGANIZATIONS
32. CUSTOMIZATION OPPORTUNITIES
33. SUBSCRIPTION SERVICES
34. AUTHOR DETAILS
A selection of companies mentioned in this report includes, but is not limited to:
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