Cell & Gene Therapy Biomanufacturing CDMO Market by Component, Phase (Phase 1, Phase 2, Phase 3), Indication

Description

List of Tables

The Cell & Gene Therapy Biomanufacturing CDMO Market was valued at USD 338.12 million in 2023, expected to reach USD 485.47 million in 2024, and is projected to grow at a CAGR of 32.53%, to USD 2,428.90 million by 2030.

Cell and gene therapy biomanufacturing Contract Development and Manufacturing Organizations (CDMOs) represent a crucial segment in the biopharmaceutical industry, focusing on the bespoke production of advanced, personalized therapies targeting genetic diseases and cancers. This market segment is driven by the increasing prevalence of chronic diseases, advancements in gene editing technologies like CRISPR, and growing investments in biotech research and development. The necessity of CDMOs stems from the complex and resource-intensive nature of cell and gene therapy production, which requires specialized facilities, technical expertise, and compliance with stringent regulatory standards. Applications of these therapies are vast, spanning cancer treatment, rare genetic disorders, and regenerative medicine, with end-use primarily in hospitals, research institutes, and biotech companies. Key growth drivers include the rising approval rates of cell and gene therapies by regulatory bodies, technological advancements in manufacturing processes, and increasing public and private funding. Potential opportunities lie in expanding partnerships with biotech firms, enhancing manufacturing capabilities with automation and AI, and scaling production to meet increasing demand. Recommendations for companies include investing in state-of-the-art facilities, training a skilled workforce, and collaborating with research institutions for continuous innovation. However, market expansion is constrained by high production costs, logistical challenges in therapy delivery, and regulatory barriers. Furthermore, the high cost of therapies limits immediate patient accessibility, while ethical concerns regarding genetic modification may delay broader acceptance. Areas ripe for innovation include developing cost-effective production strategies, improving supply chain logistics, and discovering novel therapeutic applications. Research into allogeneic therapies and improving the precision of gene editing technologies could streamline production and lower costs. The market is characterized by rapid evolution, necessitating agile strategies and adaptive business models to leverage emerging trends and overcome existing challenges effectively.

KEY MARKET STATISTICS
Base Year [2023]	USD 338.12 million
Estimated Year [2024]	USD 485.47 million
Forecast Year [2030]	USD 2,428.90 million
CAGR (%)	32.53%

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Cell & Gene Therapy Biomanufacturing CDMO Market

The Cell & Gene Therapy Biomanufacturing 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
- Growing number of R&D activities in cellular and genetic engineering and therapies
- Increasing need for genetic treatments to cure chronic and genetic disorders
- Rising number of collaborative activities between CDMOs and major players
Market Restraints
- High cost of CDMO services
Market Opportunities
- Efforts by CDMOs to incorporate digitalization and AI technologies
- Rising number of biotechnology and pharmaceutical startups
Market Challenges
- Complex regulations surrounding genetic and cell research

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

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Cell & Gene Therapy Biomanufacturing 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 Cell & Gene Therapy Biomanufacturing CDMO Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Cell & Gene Therapy Biomanufacturing 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 Cell & Gene Therapy Biomanufacturing CDMO Market

A detailed market share analysis in the Cell & Gene Therapy Biomanufacturing 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 Cell & Gene Therapy Biomanufacturing CDMO Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Cell & Gene Therapy Biomanufacturing 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 Cell & Gene Therapy Biomanufacturing CDMO Market

A strategic analysis of the Cell & Gene Therapy Biomanufacturing 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 Cell & Gene Therapy Biomanufacturing CDMO Market, highlighting leading vendors and their innovative profiles. These include AGC Biologics, Almac Group, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, Catalent Inc.,, Charles River Laboratories International Inc., Danaher Corporation, Endress+Hauser Group Services AG, FUJIFILM Diosynth Biotechnologies, GC Corporation, General Electric Company, Getinge AB, Infors AG, Lonza Group Ltd, Merck KGaA, Miltenyi Biotec B.V. & Co. KG, Patheon Inc., PCI Pharma Services, Pfizer CentreOne, PIERRE GUERIN, Recipharm AB, Samsung Biologics, Sartorius AG, Thermo Fisher Scientific, uBriGene, WuXi Advanced Therapies, and WuXi AppTec.

Market Segmentation & Coverage

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

Based on Component, market is studied across Cell Therapy, Plasmid DNA, and Viral Vector.
Based on Phase, market is studied across Phase 1, Phase 2, Phase 3, and Phase 4.
Based on Indication, market is studied across Cancer, Cardiovascular Disease, Genetic Disorders, Infectious Disease, and Neurological Disorders.
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?

Product Code: MRR-5C6F41F5AF94

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. Growing number of R&D activities in cellular and genetic engineering and therapies
  - 5.1.1.2. Increasing need for genetic treatments to cure chronic and genetic disorders
  - 5.1.1.3. Rising number of collaborative activities between CDMOs and major players
- 5.1.2. Restraints
  - 5.1.2.1. High cost of CDMO services
- 5.1.3. Opportunities
  - 5.1.3.1. Efforts by CDMOs to incorporate digitalization and AI technologies
  - 5.1.3.2. Rising number of biotechnology and pharmaceutical startups
- 5.1.4. Challenges
  - 5.1.4.1. Complex regulations surrounding genetic and cell research
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. Cell & Gene Therapy Biomanufacturing CDMO Market, by Component

6.1. Introduction
6.2. Cell Therapy
6.3. Plasmid DNA
6.4. Viral Vector

7. Cell & Gene Therapy Biomanufacturing CDMO Market, by Phase

7.1. Introduction
7.2. Phase 1
7.3. Phase 2
7.4. Phase 3
7.5. Phase 4

8. Cell & Gene Therapy Biomanufacturing CDMO Market, by Indication

8.1. Introduction
8.2. Cancer
8.3. Cardiovascular Disease
8.4. Genetic Disorders
8.5. Infectious Disease
8.6. Neurological Disorders

9. Americas Cell & Gene Therapy Biomanufacturing CDMO Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Cell & Gene Therapy Biomanufacturing CDMO Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Cell & Gene Therapy Biomanufacturing CDMO Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
12.4. Strategy Analysis & Recommendation

Companies Mentioned

1. AGC Biologics
2. Almac Group
3. Becton, Dickinson and Company
4. Bio-Rad Laboratories, Inc.
5. Bio-Techne Corporation
6. Catalent Inc.,
7. Charles River Laboratories International Inc.
8. Danaher Corporation
9. Endress+Hauser Group Services AG
10. FUJIFILM Diosynth Biotechnologies
11. GC Corporation
12. General Electric Company
13. Getinge AB
14. Infors AG
15. Lonza Group Ltd
16. Merck KGaA
17. Miltenyi Biotec B.V. & Co. KG
18. Patheon Inc.
19. PCI Pharma Services
20. Pfizer CentreOne
21. PIERRE GUERIN
22. Recipharm AB
23. Samsung Biologics
24. Sartorius AG
25. Thermo Fisher Scientific
26. uBriGene
27. WuXi Advanced Therapies
28. WuXi AppTec