Cell & Gene Therapy Manufacturing Services Market by Type (Cell Therapy, Gene Therapy), Indication (Cardiovascular Diseases, Central Nervous System Disorders, Infectious Diseases), Application, End-User - Global Forecast 2024-2030
The Cell & Gene Therapy Manufacturing Services Market size was estimated at USD 17.34 billion in 2023 and expected to reach USD 19.98 billion in 2024, at a CAGR 15.81% to reach USD 48.45 billion by 2030.
Cell and gene therapy manufacturing services encompass the specialized production processes required for the development and commercialization of cell and gene therapies. The scope of these services includes a comprehensive array of production activities such as the sourcing of raw materials, cell processing, gene transfection or vector integration, culturing, harvesting, purification, quality control, and final product formulation. As cell and gene therapies are widely considered a critical component in modern therapeutic development, the importance of robust, compliant, and scalable manufacturing capabilities becomes critical. The cell and gene therapy manufacturing services market is rapidly expanding, with the increasing prevalence of genetic disorders and cancers, advances in molecular biology, and significant investments from both the public and private healthcare sectors. Collaboration between academic institutions, biotech firms, and service providers further propels the market growth. Despite the growth, the market faces several challenges, including high costs of production, stringent and evolving regulatory requirements, and the complexity of manufacturing processes. The necessity for specialized facilities and skilled personnel increases operational challenges, and ensuring consistent quality and scalability remains a significant hurdle. However, the market is ripe with opportunities, particularly in the development of automation and closed-system manufacturing to improve efficiency and reduce contamination risks. Breakthroughs in cell and gene therapy are promising for personalized medicine, thus creating lucrative opportunities for specialized cell and gene therapy manufacturing services.
Regional Insights
In the Americas, the market for cell and gene therapy manufacturing services is experiencing robust growth. This upsurge is primarily driven by a well-established biotech ecosystem, substantial investments in research and development, and a favorable regulatory environment. Moreover, the presence of established market players and the high adoption rate of advanced therapies are catalyzing the market in America. The EMEA region is witnessing a significant expansion in the cell and gene therapy manufacturing service market, with Europe being at the forefront. The growth in the European Union is supported by strong governmental support, advanced healthcare infrastructure, and increasing collaborations between academic and industrial sectors. The Middle East and Africa are also showing growth potential, with increasing investment in healthcare infrastructure and a growing interest in advanced therapeutic modalities. The Asia-Pacific region is a rapidly emerging market in cell and gene therapy manufacturing services, driven by growing healthcare expenditures and a rising number of local companies entering the space. Technological advancements and increasing partnerships with Western companies are further propelling the market forward in this region.
Market Insights
Market Dynamics
The market dynamics represent an ever-changing landscape of the Cell & Gene Therapy Manufacturing Services Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
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
Market Segmentation Analysis
Type: Applications of autologous mesenchymal stem cells for tissue repair and anti-inflammatory treatments
Indication: Growing potential of oncology therapies for personalized medicine in patients with various malignancies
Application: Significant benefits of customized cell & gene therapy manufacturing services for early-stage products
End-User: Higher preferences for cost-effective services from academic and research institutes
Market Disruption Analysis
Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Cell & Gene Therapy Manufacturing Services Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Cell & Gene Therapy Manufacturing Services Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Recent Developments
Fujifilm to Invest USD 200 Million to Expand
FUJIFILM Corporation announces a strategic investment of USD 200 million to enhance its cell therapy contract development and manufacturing (CDMO) services, responding to the rapidly growing market. This funding is allocated to two principal subsidiaries, FUJIFILM Cellular Dynamics, Inc. and FUJIFILM Diosynth Biotechnologies.
eXmoor Pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities
eXmoor Pharma announced the inauguration of its state-of-the-art cell and gene therapy center, located in Bristol, which is purpose-built to facilitate the scaling of next-generation CGTs, advancing them from clinical trials to patient reach. Equipped with four expansive grade C processing modules, the facility boasts a process-agnostic architecture suitable for various CGT productions, complete module segregation, and substantial bioreactor capacity. This encompasses options such as two 200L systems for viral vectors or allogeneic therapies and accommodation for five autologous cell therapy stations.
Thermo Fisher Scientific Opens Cell Therapy Facility at UCSF to Accelerate Development of Breakthrough Therapies
Thermo Fisher Scientific Inc., alongside the University of California, San Francisco (UCSF), has embarked on an ambitious endeavor to expedite the development of advanced cell therapies. This collaboration is facilitated by the strategic positioning of their state-of-the-art cGMP facility, which is stationed in close proximity to the UCSF Medical Center at Mission Bay. Offering comprehensive services from process and analytical development to clinical and commercial production, Thermo Fisher and UCSF aim to trailblaze advancements in the treatment of diseases, even extending to autoimmune disorders.
Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Cell & Gene Therapy Manufacturing Services Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.
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 Advanced BioScience Laboratories, Inc., AGC Biologics, Bio-Techne Corporation, Bluebird Bio, Inc., Boehringer Ingelheim International GmbH, c-LEcta GmbH, Catalent, Inc., Cell and Gene Therapy Catapult, Cell Therapies Pty Ltd., Cell-Easy SAS, Charles River Laboratories International, Inc., Exmoor Pharma Concepts Limited, F. Hoffmann-La Roche Ltd., FUJIFILM Diosynth Biotechnologies, General Electric Company, Lonza Group, Merck KGaA, Miltenyi Biotec B.V. & Co. KG, Minaris Regenerative Medicine GmbH, Nikon Corporation, Novartis AG, Oxford Biomedica PLC, Recipharm AB, Resonac Corporation, Samsung Biologics Co., Ltd, Takara Holdings Inc., Thermo Fisher Scientific, Inc., uBriGene Biosciences Inc., and Wuxi Apptec Co., 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:
Type
Cell Therapy
Allogeneic
Allogeneic Hematopoietic Stem Cells
Allogeneic Induced Pluripotent Stem Cells
Allogeneic Mesenchymal Stem Cells
Allogeneic Natural Killer Cells
Allogeneic T-cells
Autologous
Autologous Hematopoietic Stem Cells
Autologous Mesenchymal Stem Cells
Autologous Natural Killer Cells
Autologous T-cells
Viral Vector
Adeno-associated Virus Vectors
Retroviral Vectors
Gene Therapy
Non-viral Vector
Oligonucleotides
Indication
Cardiovascular Diseases
Central Nervous System Disorders
Infectious Diseases
Oncology Diseases
Ophthalmology Diseases
Orthopedic Diseases
Application
Clinical Manufacturing
Commercial Manufacturing
End-User
Academic & Research Institutes
Pharmaceutical & Biotechnology Companies
Region
Americas
Argentina
Brazil
Canada
Mexico
United States
California
Florida
Illinois
New York
Ohio
Pennsylvania
Texas
Asia-Pacific
Australia
China
India
Indonesia
Japan
Malaysia
Philippines
Singapore
South Korea
Taiwan
Thailand
Vietnam
Europe, Middle East & Africa
Denmark
Egypt
Finland
France
Germany
Israel
Italy
Netherlands
Nigeria
Norway
Poland
Qatar
Russia
Saudi Arabia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom
Please Note: PDF & Excel + Online Access - 1 Year
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. Market Trend Analysis
5.4. Cumulative Impact of High Inflation
5.5. Porter’s Five Forces Analysis
5.5.1. Threat of New Entrants
5.5.2. Threat of Substitutes
5.5.3. Bargaining Power of Customers
5.5.4. Bargaining Power of Suppliers
5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis
6. Cell & Gene Therapy Manufacturing Services Market, by Type
6.1. Introduction
6.2. Cell Therapy
6.3. Gene Therapy
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