세계의 세포 및 유전자 치료 CDMO 시장 예측(-2030년) : 치료 유형별, 서비스 유형별, 기술별, 최종 사용자별 및 지역별 분석

According to Stratistics MRC, the Global Cell and Gene Therapy CDMO Market is accounted for $6.48 billion in 2024 and is expected to reach $31.14 billion by 2030 growing at a CAGR of 29.9% during the forecast period. A cell and gene therapy CDMO (Contract Development and Manufacturing Organization) is a specialized service provider that supports biopharmaceutical companies in the development, manufacturing, and commercialization of cell. These organizations offer end-to-end services, including process development, clinical and commercial manufacturing, and regulatory support. By partnering with CDMOs, biotech firms can outsource complex and resource-intensive tasks, enabling them to focus on research, innovation, and product launch while ensuring regulatory compliance and scalable production.

Market Dynamics:

Driver:

Increasing demand for cell and gene therapies

The increasing demand for cell and gene therapies in biotech companies focus on creating novel treatments for genetic disorders, cancers, and chronic diseases, they rely on CDMOs for expertise in complex processes like gene editing, viral vector production, and cell culture. CDMOs help meet the rising demand by offering scalable manufacturing, regulatory compliance, and faster time to market, enabling biotech firms to focus on research and innovation without the heavy investment in infrastructure, thereby accelerating the market's growth.

Restraint:

High costs and complex manufacturing processes

High costs and complex manufacturing processes requires highly specialized facilities and equipment, driving up operational costs. Additionally, the need for stringent quality control measures and personalized manufacturing processes further increases expenses. These factors can make it challenging for CDMOs to achieve economies of scale, limiting their profitability and hindering market growth. Consequently, the high costs associated with cell and gene therapy manufacturing can create barriers to entry for new players and limit the availability of these therapies to patients, hampering the market growth.

Opportunity:

Collaborations and partnerships

Collaborations and partnerships in Biopharma companies, academic institutions, and CDMOs work together to accelerate research, streamline clinical development, and scale manufacturing. These alliances enable faster innovation, cost-sharing, and risk mitigation, particularly in the complex and high-cost development of cell and gene therapies. By leveraging each partner's strengths, collaborations foster efficient technology transfer, regulatory support, and market entry, ultimately propelling the growth and success of the CDMO market.

Threat:

Regulatory and quality failures

The Cell and Gene Therapy CDMO Market is susceptible to several negative effects such as increased costs, reputational harm, delayed product development, restricted market access, and legal concerns due to regulatory and quality failures. CDMOs' capacity to draw in new business and partnerships may be hampered by non-compliance, which may result in penalties, recalls, and shutdowns. Moreover, poor quality might undermine CDMOs' credibility and shrink their prospective clientele thereby, hindering the market growth.

Covid-19 Impact

The COVID-19 pandemic has significantly impacted the Cell and Gene Therapy CDMO market by causing disruptions in supply chains, clinical trials, and regulatory processes. Many CDMOs faced delays in project timelines due to restrictions on laboratory access and workforce shortages. However, the pandemic also accelerated investments in bio manufacturing capabilities and the adoption of digital technologies, enhancing operational efficiency. The demand for rapid therapeutic responses to emerging health crises highlighted the importance of flexible and scalable CDMO services.

The cell therapy segment is expected to be the largest during the forecast period

The cell therapy segment is projected to account for the largest market share during the projection period, by offering groundbreaking treatments for conditions like cancer, autoimmune disorders, and degenerative diseases. Cell therapies, such as CAR-T and stem cell treatments, require highly specialized which many biotech companies outsource to CDMOs. The growing demand for personalized and regenerative medicine, coupled with the challenges of scaling production for clinical use, has led to increased reliance on CDMOs. This segment's rapid advancements and regulatory approvals further boost market growth.

The viral vectors segment is expected to have the highest CAGR during the forecast period

The viral vectors segment is projected to have the highest CAGR in the viral vectors market during the extrapolated period, due to their essential role in delivering therapeutic genes into target cells. As the demand for innovative gene therapies grows, viral vectors, such as adenoviruses, lentiviruses, and adeno-associated viruses, have become vital tools for effective gene transfer. CDMOs specializing in viral vector production provide essential services, including development, manufacturing, and quality control, which are crucial for clinical trials and commercialization. Additionally, advancements in vector design and production techniques enhance efficacy and safety, further driving demand and encouraging biopharmaceutical companies to collaborate with CDMOs for their expertise in this area.

Region with largest share:

The Asia Pacific region is projected to account for the largest market share during the forecast period due to increased investments in biotechnology, improving healthcare infrastructure, and rising demand for innovative therapies. Countries like China, Japan, and India are emerging as key players, benefiting from government initiatives promoting research and development. The region's diverse patient population offers ample opportunities for personalized medicine, while local CDMOs are expanding their capabilities to cater to both domestic and international clients. Collaborations with global pharmaceutical companies further enhance the region's competitiveness in the cell and gene therapy landscape.

Region with highest CAGR:

During the estimation period, the North America region is forecasted to record the highest growth rate, owing to significant investments in research and development. The region boasts a robust infrastructure, advanced technologies, and a high concentration of biotechnology companies and academic institutions. Additionally, regulatory support from agencies like the FDA has accelerated the approval process for cell and gene therapies. The rising prevalence of genetic disorders further fuels demand for tailored therapies, positioning North America as a key player in this rapidly growing market.

Key players in the market

Some of the key players profiled in the Cell and Gene Therapy CDMO Market include Aldevron, Atara Biotherapeutics, Inc., Bluebird Bio, Inc., Bristol-Myers Squibb (Celgene), Catalent, Inc., Cytiva (part of GE Healthcare), Fujifilm Diosynth Biotechnologies, Kite Pharma (a Gilead Company), Lonza Group AG, NantKwest, Inc., Novartis AG, Paragon Bioservices, Inc., Pioneer BioTech, Precision BioSciences, Inc., Regenative Labs, Roche, Sangamo Therapeutics, Inc., Thermo Fisher Scientific Inc., VivaCell Biotechnology and WuXi AppTec.

Key Developments:

In October 2024, Lonza completed acquisition of large-scale Biologics site in Vacaville, one of the largest biologics manufacturing facilities in the world. Acquisition extends Lonza's US Biologics footprint with a significant presence on the West Coast, complementing its existing global manufacturing network.

In September 2024, Lonza and Vertex signed a long-term commercial supply agreement for CASGEVY(R). By this Vertex will leverage Lonza's scientific, regulatory and manufacturing expertise, global manufacturing network, and Lonza will manufacture CASGEVY(R) at the state-of-the-art cGMP cell therapy manufacturing facilities, with plans to expand to its Portsmouth (US) facility.

In May 2024, Catalent and Siren Biotechnology entered into partnership a strategic partnership to support the development and manufacturing of Siren Biotechnology's AAV immuno-gene therapies. This partnership demonstrates Catalent commitment to a robust manufacturing process that will move therapeutic programs into the clinic as quickly as possible.

Type of Therapies Covered:

• Cell Therapy
• Gene Therapy
• Other Type of Therapies

Service Types Covered:

• Process Development
• Manufacturing
• Analytical Services
• Quality Assurance and Quality Control (QA/QC)
• Regulatory Support
• Fill and Finish Operations

Technologies Covered:

• Viral Vectors
• Non-Viral Methods
• Stem Cell Technology
• T-cell Receptor
• Other Technologies

End Users Covered:

• Biopharmaceutical Companies
• Research Institutes
• Academic Institutions
• Government Organizations
• Biotechnology Start-ups

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 2022, 2023, 2024, 2026, and 2030
• 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 Technology Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 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 Cell and Gene Therapy CDMO Market, By Type of Therapy

• 5.1 Introduction
• 5.2 Cell Therapy
  • 5.2.1 Autologous Cell Therapy
  • 5.2.2 Allogeneic Cell Therapy
  • 5.2.3 CAR-T Cell Therapy
• 5.3 Gene Therapy
  • 5.3.1 In Vivo Gene Therapy
  • 5.3.2 Ex Vivo Gene Therapy
• 5.4 Other Type of Therapies

6 Global Cell and Gene Therapy CDMO Market, By Service Type

• 6.1 Introduction
• 6.2 Process Development
• 6.3 Manufacturing
  • 6.3.1 Cell Culture
  • 6.3.2 Vector Manufacturing
  • 6.3.3 Purification
  • 6.3.4 Formulation
• 6.4 Analytical Services
• 6.5 Quality Assurance and Quality Control (QA/QC)
• 6.6 Regulatory Support
• 6.7 Fill and Finish Operations

7 Global Cell and Gene Therapy CDMO Market, By Technology

• 7.1 Introduction
• 7.2 Viral Vectors
  • 7.2.1 Adenoviral Vectors
  • 7.2.2 Lentiviral Vectors
  • 7.2.3 Adeno-Associated Viral Vectors
• 7.3 Non-Viral Methods
  • 7.3.1 CRISPR/Cas9
  • 7.3.2 Transposons
  • 7.3.3 Plasmid DNA
• 7.4 Stem Cell Technology
• 7.5 T-cell Receptor
• 7.6 Other Technologies

8 Global Cell and Gene Therapy CDMO Market, By End User

• 8.1 Introduction
• 8.2 Biopharmaceutical Companies
• 8.3 Research Institutes
• 8.4 Academic Institutions
• 8.5 Government Organizations
• 8.6 Biotechnology Start-ups

9 Global Cell and Gene Therapy CDMO Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Aldevron
• 11.2 Atara Biotherapeutics, Inc.
• 11.3 Bluebird Bio, Inc.
• 11.4 Bristol-Myers Squibb (Celgene)
• 11.5 Catalent, Inc.
• 11.6 Cytiva (part of GE Healthcare)
• 11.7 Fujifilm Diosynth Biotechnologies
• 11.8 Kite Pharma (a Gilead Company)
• 11.9 Lonza Group AG
• 11.10 NantKwest, Inc.
• 11.11 Novartis AG
• 11.12 Paragon Bioservices, Inc.
• 11.13 Pioneer BioTech
• 11.14 Precision BioSciences, Inc.
• 11.15 Regenative Labs
• 11.16 Roche
• 11.17 Sangamo Therapeutics, Inc.
• 11.18 Thermo Fisher Scientific Inc.
• 11.19 VivaCell Biotechnology
• 11.20 WuXi AppTec