세계의 첨단 치료제(ATMP) CDMO 시장 : 제품별, 단계별, 적응증별, 최종 사용자별 - 예측(2025-2030년)

The Advanced Therapy Medicinal Products CDMO Market was valued at USD 7.54 billion in 2023, expected to reach USD 8.74 billion in 2024, and is projected to grow at a CAGR of 17.06%, to USD 22.74 billion by 2030.

Advanced Therapy Medicinal Products (ATMPs) Contract Development and Manufacturing Organizations (CDMOs) play a pivotal role in the biotechnology and pharmaceutical sectors, offering essential services in the development and production of innovative therapies such as gene therapies, cell therapies, and tissue-engineered products. The necessity for ATMPs is underscored by the rising demand for personalized medicine and the advancement of treatments for otherwise incurable diseases, which has exponentially driven the application and end-use scope within oncology, rare diseases, neurology, and regenerative medicine. Key growth influencers in this market include technological advancements in cell processing, an increasing number of clinical trial projects, and favorable regulatory frameworks that expedite product approval processes. However, potential opportunities remain within the enhancement of scalable manufacturing processes and automation technologies. To capitalize on these opportunities, investment in facilitating partnerships with biotech firms focusing on nanoscale solutions and digital infrastructure for production analytics could be vital. Nonetheless, market growth is challenged by high manufacturing costs, stringent regulatory requirements, and a shortage of skilled workforce which may impact timely production and delivery of therapies. Moreover, limitations such as supply chain complexities and the nascent stage of many ATMP technologies create further obstacles. The best avenues for innovation and research could be in enhancing bioreactor technologies, improving gene editing tools, and optimizing cold chain logistics to support the stability and distribution of ATMPs. Emphasizing collaborations with academic institutions and biotech innovators may also drive technological breakthroughs. The market is dynamic, with high growth potential rooted in both therapeutic advancements and technological augmentations, but necessitates strategic navigation through regulatory and logistical challenges to sustain competitive leverage and maximize market share.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Advanced Therapy Medicinal Products CDMO Market

The Advanced Therapy Medicinal Products CDMO 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
  • Proliferation in prevalence of rare diseases with growing emergence of novel infectious diseases
  • Rising numbers of clinical trials for development of advanced therapy medicinal products
  • Increasing investments in pharmaceutical research and development worldwide
• Market Restraints
  • High cost associated with outsourcing ATMP solutions
• Market Opportunities
  • Adoption of advanced technologies by advanced therapy medicinal products CDMOs
  • Strategic alliance and expansion activities for R&D of advanced therapy medicinal products
• Market Challenges
  • Stringent governmental rules and regulations for ATMP approvals and commercialization

Porter's Five Forces: A Strategic Tool for Navigating the Advanced Therapy Medicinal Products CDMO Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Advanced Therapy Medicinal Products CDMO 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 Advanced Therapy Medicinal Products CDMO Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Advanced Therapy Medicinal Products CDMO 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 Advanced Therapy Medicinal Products CDMO Market

A detailed market share analysis in the Advanced Therapy Medicinal Products CDMO 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 Advanced Therapy Medicinal Products CDMO Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Advanced Therapy Medicinal Products CDMO 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.

Strategy Analysis & Recommendation: Charting a Path to Success in the Advanced Therapy Medicinal Products CDMO Market

A strategic analysis of the Advanced Therapy Medicinal Products CDMO Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Advanced Therapy Medicinal Products CDMO Market, highlighting leading vendors and their innovative profiles. These include Abzena, Advanced Therapies, Inc. by WuXi AppTec, AGC Inc., Aldevron, Almac Group, Arranta Bio Holdings, LLC, Bio Elpida, BlueReg, Catalent Inc., CELONIC Group, CGT Catapult, Charles River Laboratories International, Inc., Coriolis Pharma Research GmbH, Eurofins Scientific SE, FUJIFILM Corporation, Lonza Group, Minaris Regenerative Medicine, Oxford Biomedica PLC, Patheon by Thermo Fisher Scientific Inc., Rentschler Biopharma SE, REPROCELL Inc., RoslinCT, Samsung Biologics, and VIVEBIOTECH S.L..

Market Segmentation & Coverage

This research report categorizes the Advanced Therapy Medicinal Products CDMO Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Products, market is studied across Cell Therapy, Gene Therapy, and Tissue Engineered.
• Based on Phase, market is studied across Phase I, Phase II, Phase III, and Phase IV.
• Based on Indication, market is studied across Cardiology, Central Nervous System, Dermatology, Endocrine, Metabolic, Genetic, Gastroenterology, Hematology, Immunology & Inflammation, Infectious Disease, Musculoskeletal, Oncology, and Ophthalmology.
• Based on End-Users, market is studied across Academic and Research Institutions, Biotechnology & Pharmaceutical Companies, Clinical Research Organizations (CROs), and Hospitals and Clinics.
• 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. Proliferation in prevalence of rare diseases with growing emergence of novel

infectious diseases

• 5.1.1.2. Rising numbers of clinical trials for development of advanced therapy medicinal products
• 5.1.1.3. Increasing investments in pharmaceutical research and development worldwide
• 5.1.2. Restraints
  • 5.1.2.1. High cost associated with outsourcing ATMP solutions
• 5.1.3. Opportunities
  • 5.1.3.1. Adoption of advanced technologies by advanced therapy medicinal

products CDMOs

• 5.1.3.2. Strategic alliance and expansion activities for R&D of advanced therapy medicinal products
• 5.1.4. Challenges
  • 5.1.4.1. Stringent governmental rules and regulations for ATMP approvals and

commercialization

• 5.2. Market Segmentation Analysis
• 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. Advanced Therapy Medicinal Products CDMO Market, by Products

• 6.1. Introduction
• 6.2. Cell Therapy
• 6.3. Gene Therapy
• 6.4. Tissue Engineered

7. Advanced Therapy Medicinal Products CDMO Market, by Phase

• 7.1. Introduction
• 7.2. Phase I
• 7.3. Phase II
• 7.4. Phase III
• 7.5. Phase IV

8. Advanced Therapy Medicinal Products CDMO Market, by Indication

• 8.1. Introduction
• 8.2. Cardiology
• 8.3. Central Nervous System
• 8.4. Dermatology
• 8.5. Endocrine, Metabolic, Genetic
• 8.6. Gastroenterology
• 8.7. Hematology
• 8.8. Immunology & Inflammation
• 8.9. Infectious Disease
• 8.10. Musculoskeletal
• 8.11. Oncology
• 8.12. Ophthalmology

9. Advanced Therapy Medicinal Products CDMO Market, by End-Users

• 9.1. Introduction
• 9.2. Academic and Research Institutions
• 9.3. Biotechnology & Pharmaceutical Companies
• 9.4. Clinical Research Organizations (CROs)
• 9.5. Hospitals and Clinics

10. Americas Advanced Therapy Medicinal Products CDMO Market

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

11. Asia-Pacific Advanced Therapy Medicinal Products CDMO 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 Advanced Therapy Medicinal Products CDMO 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
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Abzena
• 2. Advanced Therapies, Inc. by WuXi AppTec
• 3. AGC Inc.
• 4. Aldevron
• 5. Almac Group
• 6. Arranta Bio Holdings, LLC
• 7. Bio Elpida
• 8. BlueReg
• 9. Catalent Inc.
• 10. CELONIC Group
• 11. CGT Catapult
• 12. Charles River Laboratories International, Inc.
• 13. Coriolis Pharma Research GmbH
• 14. Eurofins Scientific SE
• 15. FUJIFILM Corporation
• 16. Lonza Group
• 17. Minaris Regenerative Medicine
• 18. Oxford Biomedica PLC
• 19. Patheon by Thermo Fisher Scientific Inc.
• 20. Rentschler Biopharma SE
• 21. REPROCELL Inc.
• 22. RoslinCT
• 23. Samsung Biologics
• 24. VIVEBIOTECH S.L.