세포 및 유전자 치료 제조 서비스 시장 : 유형, 적응증, 용도 및 최종 사용자별 - 세계 예측(2025-2030년)

The Cell & Gene Therapy Manufacturing Services Market was valued at USD 17.34 billion in 2023, expected to reach USD 19.98 billion in 2024, and is projected to grow at a CAGR of 15.81%, to USD 48.45 billion by 2030.

Cell and gene therapy manufacturing services encompass a wide range of processes involved in producing cell-based and gene-modified therapies. These services include cell culture, viral vector production, genetic modification, quality control, and regulatory compliance. The necessity for such services arises from the rapid advancements in personalized medicine and biotechnology that drive demand for tailored therapies targeting specific genetic diseases, cancers, and other conditions. Their application spans across clinical and commercial manufacturing, serving multiple end-use industries such as healthcare providers, pharmaceutical companies, and research institutions. The market's growth is influenced by key factors such as increasing investments in R&D, technological advancements, and rising prevalence of chronic diseases. Significant opportunities lie in automation and digitalization of manufacturing processes, improved scalability solutions and innovations in non-viral vectors, which can enhance safety and cost-effectiveness. However, market growth can face challenges such as high development costs, complex regulatory landscapes, and logistical issues surrounding the transport and storage of cell and gene therapies. A potential area for innovation is the development of closed-system manufacturing technologies to minimize contamination risk and improve efficiency. Expanding partnerships between manufacturers and biotech companies could accelerate adoption and foster a robust supply chain. Understanding these dynamics provides valuable insight into the market's flexible yet complex nature. The competitive landscape requires companies to stay abreast of evolving technologies and regulatory guidelines. To leverage growth opportunities, stakeholders should prioritize collaborative efforts, focus on optimizing production processes, and invest in new technologies like CRISPR and AI-driven analytics. Overall, while the market shows robust potential, navigating its inherent challenges requires strategic foresight and agility.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Cell & Gene Therapy Manufacturing Services Market

The Cell & Gene Therapy Manufacturing Services Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • High Incidence of Cancer and Other Target Diseases
  • Increasing Investments in Pharmaceutical R&D and Advanced Technologies by CDMOs
  • Focus on the Personalized Medicine with the Rising Tendency Towards Early Disease Diagnosis
• Market Restraints
  • High Operational Costs Associated With Cell & Gene Therapy Manufacturing Services
• Market Opportunities
  • Emergence of Advanced Analytical Technologies in Development of Cell & Gene Therapy
  • Improvement in the Supply Chain of Cell & Gene Therapy Manufacturing
• Market Challenges
  • Quality Control and Contamination Issues in Cell & Gene Therapy Production

Porter's Five Forces: A Strategic Tool for Navigating the Cell & Gene Therapy Manufacturing Services Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Cell & Gene Therapy Manufacturing Services Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Cell & Gene Therapy Manufacturing Services Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Cell & Gene Therapy Manufacturing Services Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Cell & Gene Therapy Manufacturing Services Market

A detailed market share analysis in the Cell & Gene Therapy Manufacturing Services Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Cell & Gene Therapy Manufacturing Services Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Cell & Gene Therapy Manufacturing Services Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Key Company Profiles

The report delves into recent significant developments in the Cell & Gene Therapy Manufacturing Services Market, highlighting leading vendors and their innovative profiles. These include uBriGene Biosciences Inc., Bluebird Bio, Inc., Cell Therapies Pty Ltd., Merck KGaA, Catalent, Inc., Miltenyi Biotec B.V. & Co. KG, Nikon Corporation, Takara Holdings Inc., Charles River Laboratories International, Inc., General Electric Company, Cell and Gene Therapy Catapult, Boehringer Ingelheim International GmbH, c-LEcta GmbH, Advanced BioScience Laboratories, Inc., Thermo Fisher Scientific, Inc., Novartis AG, Cell-Easy SAS, Samsung Biologics Co., Ltd, Recipharm AB, FUJIFILM Diosynth Biotechnologies, Resonac Corporation, Exmoor Pharma Concepts Limited, AGC Biologics, Bio-Techne Corporation, Wuxi Apptec Co., Ltd., Lonza Group, Minaris Regenerative Medicine GmbH, Oxford Biomedica PLC, and F. Hoffmann-La Roche Ltd..

Market Segmentation & Coverage

This research report categorizes the Cell & Gene Therapy Manufacturing Services Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Type, market is studied across Cell Therapy and Gene Therapy. The Cell Therapy is further studied across Allogeneic, Autologous, and Viral Vector. The Allogeneic is further studied across Allogeneic Hematopoietic Stem Cells, Allogeneic Induced Pluripotent Stem Cells, Allogeneic Mesenchymal Stem Cells, Allogeneic Natural Killer Cells, and Allogeneic T-cells. The Autologous is further studied across Autologous Hematopoietic Stem Cells, Autologous Mesenchymal Stem Cells, Autologous Natural Killer Cells, and Autologous T-cells. The Viral Vector is further studied across Adeno-associated Virus Vectors and Retroviral Vectors. The Gene Therapy is further studied across Non-viral Vector and Oligonucleotides.
• Based on Indication, market is studied across Cardiovascular Diseases, Central Nervous System Disorders, Infectious Diseases, Oncology Diseases, Ophthalmology Diseases, and Orthopedic Diseases.
• Based on Application, market is studied across Clinical Manufacturing and Commercial Manufacturing.
• Based on End-User, market is studied across Academic & Research Institutes and Pharmaceutical & Biotechnology Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. High Incidence of Cancer and Other Target Diseases
    • 5.1.1.2. Increasing Investments in Pharmaceutical R&D and Advanced Technologies by CDMOs
    • 5.1.1.3. Focus on the Personalized Medicine with the Rising Tendency Towards Early Disease Diagnosis
  • 5.1.2. Restraints
    • 5.1.2.1. High Operational Costs Associated With Cell & Gene Therapy Manufacturing Services
  • 5.1.3. Opportunities
    • 5.1.3.1. Emergence of Advanced Analytical Technologies in Development of Cell & Gene Therapy
    • 5.1.3.2. Improvement in the Supply Chain of Cell & Gene Therapy Manufacturing
  • 5.1.4. Challenges
    • 5.1.4.1. Quality Control and Contamination Issues in Cell & Gene Therapy Production
• 5.2. Market Segmentation Analysis
  • 5.2.1. Type: Applications of autologous mesenchymal stem cells for tissue repair and anti-inflammatory treatments
  • 5.2.2. Indication: Growing potential of oncology therapies for personalized medicine in patients with various malignancies
  • 5.2.3. Application: Significant benefits of customized cell & gene therapy manufacturing services for early-stage products
  • 5.2.4. End-User: Higher preferences for cost-effective services from academic and research institutes
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Cell & Gene Therapy Manufacturing Services Market, by Type

• 6.1. Introduction
• 6.2. Cell Therapy
  • 6.2.1. Allogeneic
    • 6.2.1.1. Allogeneic Hematopoietic Stem Cells
    • 6.2.1.2. Allogeneic Induced Pluripotent Stem Cells
    • 6.2.1.3. Allogeneic Mesenchymal Stem Cells
    • 6.2.1.4. Allogeneic Natural Killer Cells
    • 6.2.1.5. Allogeneic T-cells
  • 6.2.2. Autologous
    • 6.2.2.1. Autologous Hematopoietic Stem Cells
    • 6.2.2.2. Autologous Mesenchymal Stem Cells
    • 6.2.2.3. Autologous Natural Killer Cells
    • 6.2.2.4. Autologous T-cells
  • 6.2.3. Viral Vector
    • 6.2.3.1. Adeno-associated Virus Vectors
    • 6.2.3.2. Retroviral Vectors
• 6.3. Gene Therapy
  • 6.3.1. Non-viral Vector
  • 6.3.2. Oligonucleotides

7. Cell & Gene Therapy Manufacturing Services Market, by Indication

• 7.1. Introduction
• 7.2. Cardiovascular Diseases
• 7.3. Central Nervous System Disorders
• 7.4. Infectious Diseases
• 7.5. Oncology Diseases
• 7.6. Ophthalmology Diseases
• 7.7. Orthopedic Diseases

8. Cell & Gene Therapy Manufacturing Services Market, by Application

• 8.1. Introduction
• 8.2. Clinical Manufacturing
• 8.3. Commercial Manufacturing

9. Cell & Gene Therapy Manufacturing Services Market, by End-User

• 9.1. Introduction
• 9.2. Academic & Research Institutes
• 9.3. Pharmaceutical & Biotechnology Companies

10. Americas Cell & Gene Therapy Manufacturing Services Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Cell & Gene Therapy Manufacturing Services Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Cell & Gene Therapy Manufacturing Services Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Fujifilm to Invest USD 200 Million to Expand
  • 13.3.2. eXmoor Pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities
  • 13.3.3. Thermo Fisher Scientific Opens Cell Therapy Facility at UCSF to Accelerate Development of Breakthrough Therapies

Companies Mentioned

• 1. uBriGene Biosciences Inc.
• 2. Bluebird Bio, Inc.
• 3. Cell Therapies Pty Ltd.
• 4. Merck KGaA
• 5. Catalent, Inc.
• 6. Miltenyi Biotec B.V. & Co. KG
• 7. Nikon Corporation
• 8. Takara Holdings Inc.
• 9. Charles River Laboratories International, Inc.
• 10. General Electric Company
• 11. Cell and Gene Therapy Catapult
• 12. Boehringer Ingelheim International GmbH
• 13. c-LEcta GmbH
• 14. Advanced BioScience Laboratories, Inc.
• 15. Thermo Fisher Scientific, Inc.
• 16. Novartis AG
• 17. Cell-Easy SAS
• 18. Samsung Biologics Co., Ltd
• 19. Recipharm AB
• 20. FUJIFILM Diosynth Biotechnologies
• 21. Resonac Corporation
• 22. Exmoor Pharma Concepts Limited
• 23. AGC Biologics
• 24. Bio-Techne Corporation
• 25. Wuxi Apptec Co., Ltd.
• 26. Lonza Group
• 27. Minaris Regenerative Medicine GmbH
• 28. Oxford Biomedica PLC
• 29. F. Hoffmann-La Roche Ltd.