Cell And Gene Therapy CDMO Market Overview
Cell and Gene Therapy CDMO Market was valued at US$ 4.4 Billion in 2024 and is projected to grow at a CAGR of 28.90%to reach US$ 44.7 Billion by 2034.
Cell and gene therapy (CAGT) is an overlapping field of biomedical research and treatment used to treat and prevent diseases, which seeks to modify genetic material. Cell therapy includes the transfer of cells, while gene therapy involves the transfer of genetic material. Cell and gene therapies are used in treating various diseases like heart disease, cancer, diabetes, neurological disorders, and infectious diseases. CAGT has potential for addressing the root cause of genetic and acquired diseases. CAGT provides concepts and techniques that can be used in reproductive potential and remodeling, and gene regulation.
CDMO (Contract Development and Manufacturing Organization) serves the pharmaceutical industry by offering comprehensive services in both the drug development and manufacturing processes to clients. The rising burden of cancer diseases, chronic diseases, and infectious diseases has given growth to CAGT, which has led to a rise in demand for CDMOs. New product launches, approval of the product, favorable regulatory support, rising demand for CAR-T cell therapy products, and outsourcing have become major contributors to target market growth. However, growth in CAGT has had a positive impact on target market growth.
Cell And Gene Therapy CDMO Market Dynamics
The rising prevalence of cancer diseases has become a major factor in cell and gene therapy CDMO market growth. Different types of cancer are on the rise due to poor and unhealthy lifestyles. Breast cancer, lung cancer, liver and kidney cancer, and pancreatic cancer are on the rise. For instance, according to Center for Disease and Control and Prevention (CDC), In the United States in 2019, 1,752,735 new cancer cases were reported and 599,589 people died of cancer. For every 100,000 people, 439 new cancer cases were reported and 146 people died of cancer.
Rising demand for CDMOs from emerging pharmaceutical and biotech companies
Rising demand for CDMOs from emerging pharma and biotech companies has boosted the target market's growth. The rise in the number of clinical trials has become a major driver of target market expansion. According to Food and Drug Administration (FDA) there are around 50 ongoing clinical trials in cell and gene therapy by major and emerging biotech or pharma companies. Further, outsourcing provides advantages such as a reduction in investment risks, expert knowledge, advance tools and technology, increasing productivity and efficiency, reducing labor work, and ideal for startups and small businesses. Rising demand for novel biologics has given rise to CAGT, one of the fastest-growing areas of the biopharmaceutical industry. As till January 2023, Food and Drug Administration (FDA) has approved 621 biologics products.
Restrains:
Some challenges faced by CDMOs, are cost pressure, fierce competition, consolidation, and constant technological innovations, which may hamper the market growth. The wrong innovative CDMO solution provider may lead to a bad customer experience and variations in the standards of customer service may lead to quality problems. Further, it may also may lead to less control over the production process, which act as a challenges and disadvantages of CDMOs.
Cell And Gene Therapy CDMO Market Segmentation
Cell and Gene Therapy CDMO Market is segmented based on service area, indication, phase, and region.
Service Area Insight
On the basis of service area, the Cell and Gene Therapy CDMO market is segmented into cell therapy, plasmid DNA, viral vectors, and others. Cell therapy is expected to dominate the target market growth due to presence of 27 Food and Drug Administration (FDA) approved cell therapies. For instance, KYMRIAH (tisagenlecleucel), by Novartis, CAR-T cell therapy was approved in 2022 for B-cell acute lymphoblastic leukemia (B-Cell ALL).
Indication Insights
On the basis of indication, the Cell and Gene Therapy CDMO market is segmented into Cancer, Cardiovascular Disease, Infectious Disease, Genetic Disorders, and Neurological Disorders.
Cancer disease show significant share in the target market, as there has been recently approved cell based gene therapy for Adult patients with Multiple Myeloma in year of 2021. Further, according to National Cancer Institute, myeloma accounted for approximately 1.8% all new cancer cases in United States in 2020.
Phase Insights
On the basis of phase, Cell and Gene Therapy CDMO market is segmented into Phase 1, Phase 2, Phase 3, and Phase 4. There are currently over 1000 of ongoing clinical trials, among which around 443 cell and gene therapies are in Phase 2, which supports the significant share of segment Phase 2 in the market.
Regional Insights:
On the basis of region, the cell and gene therapy CDMO market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America market is estimated to witness a significantly high revenue share over the forecast period, owing to advance healthcare infrastructure, along with increased awareness about cell and gene therapy.
Further, Asia Pacific show highest growing CAGR over the forecast period, due to rising cancer and chronic disease prevalence in the region. As Asia Pacific region represents 42% i.e (61) of 144 new clinical trials in 2022. However, European pipeline has trickled to 16 new clinical trials started in H1 2022.
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Attribute |
Details |
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Base year for estimation |
2023 |
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Forecast period |
2024 – 2034 |
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Market representation |
Revenue in USD Billion & CAGR from 2024 to 2034 |
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Market Segmentation |
By Service Area - Cell Therapy, Plasmid DNA, Viral Vector, and others By Indication - Cancer, Cardiovascular Disease, Infectious Disease, Genetic Disorders, Neurological Disorders By Phase - Phase 1, Phase 2, Phase 3, Phase 4
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Regional scope |
North America - U.S., Canada Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, Rest of Latin America Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa |
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Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Segments Covered in the Report:
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2022 to 2032. For the purpose of this study, has segmented the Cell and Gene Therapy CDMO Market report based on service area, indication, phase and region:
Cell and Gene Therapy CDMO Market, By Service Area:
- Cell Therapy
- Plasmid DNA
- Viral Vector
- Others
Cell and Gene Therapy CDMO Market, By Indication:
- Cancer
- Cardiovascular Disease
- Infectious Disease
- Genetic Disorders
- Neurological Disorders
Cell and Gene Therapy CDMO Market, By Phase:
- Phase 1
- Phase 2
- Phase 3
- Phase 4
Cell and Gene Therapy CDMO Market, By Region:
- North America
- U.S.
- Canada
- Europe
- Germany
- UK
- France
- Russia
- Italy
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
Cell And Gene Therapy CDMO Market Key Players
Catalent Inc.,
Catalent is a multinational company and a leading partner for pharmaceutical industry in developing and manufacturing new treatment for patients in all over the world. Catalent offer services like analytical testing, drug formulation, clinical packaging, clinical and commercial manufacturing, regulatory consulting, and others.
Lonza Group is a Swiss multinational manufacturing company founded in 1897, which is headquartered in Basel. Lonza is a fully integrated CDMO which offers innovative development & manufacturing services and technologies from drug discovery to market supply.
- Recipharm AB
Recipharm AB is founded in 1995 and headquartered in Stockholm, Sweden. Recipharm AB is one of the largest pharmaceutical CDMOs in the world which offers end to end development & manufacturing services with variety of dosage forms.
- WuXi Advanced Therapies
WuXi Advanced Therapies is founded in 2004, and headquartered in Greater Philadelphia Area, Great Lakes, NorthEastern US. WuXi Advanced Therapies is a streamlined CDMO and Integrated Laboratory Testing Service Platforms.
- Pfizer CentreOne
Pfizer CentreOne is a global CDMO backed by Pfizer resources & leading supplier of specialty APIs and intermediates. Pfizer CentreOne is specialized in developing and manufacturing of large molecule biologics, small molecule APIs, oral solids and others.
- Charles River Laboratories International Inc.
Charles River Laboratories International Inc., is specialized in cell therapy & gene therapy services for biotech, pharma and medical device industries. It also provides outsourcing services for R&D activities and support drug discovery, manufacturing, clinical support, etc.
- Patheon Inc.
Patheon is the contract development manufacturing organization which offer services like clinical trials solution, biologics, small API molecule, logistics, cGMP plasmids, viral vectors, and commercial manufacturing & packaging.
- Almac Group
Almac Group is an established contract devlopment & manufacturing orgnaization which provides extensive range of integrated services across drug development lifecycle to biotechnology and pharmaceutical sectors world wide. Almac Group offer innovative services like cllinical trial supply, biomarker discovery, research & development, API manufacture, development & commercialisation, formulation development, and IRT to commercial scale manufacture.
- FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is a leading and global CDMO in biopharmaceutical industry. Fujifilm offer solutions in pharmaceutical manufacturing from pre-clincial investigations, process development to porduction of commercial cGMP
- PCI Pharma Services
PCI Pharma Services, is a provider of integrated pharmaceutical development services. PCI Pharma Services offer clinical trial services which includes, clinical trial manufacturing, pharmaceutical development, packaging design, clinical packaging, primary and secondary packaging, etc.
Cell And Gene Therapy CDMO Market Key Issues Addressed
Recent Development:
- In January 2023, Catalent Inc., launched a new case management service. A new service has been launched to address the unique challenges that come with the safe and timely delivery of advanced therapies to patients. Case Management Service provides the company’s deep expertise, leadership, and extensive capabilities in cell and gene therapy manufacturing with robust packaging and clinical supply services.
- In January 2023, Charles River Laboratories International Inc. announced a viral vector CDMO partnership with Rznomics Inc. for initiating the development of RNA-based anticancer gene therapy in liver cancer patients. This partnership will offer a stepping stone for Charles River to solidify its foothold in the global CDMO space.
- In July 2022, Lonza has planned to spend $518 million on a large-scale fill-finish manufacturing plant in Stein, Switzerland. A new manufacturing plant is expected to be completed in 2026. This plant will offer integrated, end-to-end CDMO services.
In January 2022, FUJIFILM Corporation announced an agreement to acquire a cell therapy manufacturing facility from Atara Biotherapeutics Inc., for USD 100 million to expand its Advanced Therapies CDMO Business. Fujifilm Diosynyth Biotechnologies will operate this new site.
Cell And Gene Therapy CDMO Market Company Profile
- Catalent Inc. *
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Lonza Group
- Recipharm AB
- Wuxi Advanced Therapies
- Pfizer CentreOne
- Charles River Laboratories International Inc.
- Patheon Inc.
- Almac Group
- FUJIFILM Diosynth Biotechnologies
- PCI Pharma Services
Cell And Gene Therapy CDMO Market Table of Contents
- Research Objective and Assumption
- Preface
- Research Objectives
- Study Scope
- Years Considered for the study
- Assumptions
- Abbreviations
- Research Methodology
- Research data
- Primary Data
- Primary Interviews
- Primary Breakdown
- Key data from Primary Sources
- Key Thickness Insights
- Secondary Data
- Major Secondary Sources
- Secondary Sources
- Market Estimation
- Top-Down Approach
- Approach for estimating Market Share by Top-Down Analysis (Supply Side)
- Bottom-Up Approach
- Approach for estimating market share by Bottom-up Analysis (Demand Side)
- Market Breakdown and Data Triangulation
- Research Assumptions
- Market Preview
- Executive Summary
- Key Findings—Global Outlook for medical carts Strategies
- Key Questions this Study will Answer
- Market Snippet, By Service Area
- Market Snippet, By Indication
- Market Snippet, By Phase
- Market Snippet, By Region
- Opportunity Map Analysis
- Executive Summary—3 Big Predictions
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restrains
- Market Opportunities
- Market Trends
- DR Impact Analysis
- PEST Analysis
- Porter’s Five Forces Analysis
- Opportunity Orbit
- Market Investment Feasibility Index
- Macroeconomic Factor Analysis
- Market Dynamics
- Cell and Gene Therapy CDMO Market, By Service Area
- Overview
- Market Value and Forecast (US$ Bn), and Share Analysis (%), 2022 – 2032
- Y-o-Y Growth Analysis (%), 2022 – 2032
- Segment Trends
- Cell Therapy
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Plasmid DNA
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Viral Vector
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Others
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Overview
- Cell and Gene Therapy CDMO Market, By Indication, 2022 – 2032, (US$ Bn)
- Overview
- Market Value and Forecast (US$ Bn), and Share Analysis (%), 2022 – 2032
- Y-o-Y Growth Analysis (%), 2022 – 2032
- Segment Trends
- Cancer
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Cardiovascular Disease
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Infectious Disease
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Genetic Disorders
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Neurological Disorders
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Overview
- Cell and Gene Therapy CDMO Market, By Phase, 2022 – 2032, (US$ Bn)
- Overview
- Market Value and Forecast (US$ Bn), and Share Analysis (%), 2022 – 2032
- Y-o-Y Growth Analysis (%), 2022 – 2032
- Segment Trends
- Phase 1
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Phase 2
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Phase 3
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Phase 4
- Overview
- Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
- Overview
- Cell and Gene Therapy CDMO Market, By Region, 2022 – 2032, (US$ Bn)
- Overview
- Market Value and Forecast (US$ Bn), and Share Analysis (%), 2022 – 2032
- Y-o-Y Growth Analysis (%), 2022 – 2032
- Regional Trends
- North America
- Market Size and Forecast (US$ Bn), By Service Area, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Indication, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Phase, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
- U.S.
- Canada
- Europe
- Market Size and Forecast (US$ Bn), By Service Area, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Indication, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Phase, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
- UK
- France
- Germany
- Russia
- Italy
- Rest of Europe
- Asia Pacific
- Market Size and Forecast (US$ Bn), By Service Area, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Indication, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Phase, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
- India
- Japan
- South Korea
- China
- Rest of Asia Pacific
- Overview
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- Latin America
- Market Size and Forecast (US$ Bn), By Service Area, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Indication, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Phase, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
- Latin America
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- Brazil
- Mexico
- Rest of Latin America
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- Middle East & Africa
- Market Size and Forecast (US$ Bn), By Service Area, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Indication, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Phase, 2022 – 2032
- Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
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- GCC
- Israel
- South Africa
- Rest of Middle East
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- Competitive Landscape
- Heat Map Analysis
- Market Presence and Specificity Analysis
- Company Profiles
- Catalent Inc.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Lonza Group
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Recipharm AB
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Wuxi Advanced Therapies
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Pfizer CentreOne
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Charles River Laboratories International Inc.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Patheon Inc.
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- Almac Group
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- FUJIFILM Diosynth Biotechnologies
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- PCI Pharma Services
- Company Overview
- Product Portfolio
- Key Highlights
- Financial Performance
- Business Strategies
- The Last Word
- Future Impact
- About Us
- Contact
FAQs
The Cell and Gene Therapy CDMO Market is segmented into service area, indication, phase and region.
Cell and Gene Therapy CDMO Market is driven by factors like rising prevalence of cancer diseases, rising demand for CDMOs from emerging pharmaceutical and biotech companies, rising expenses of R&D activities, and wide benefits.
By region, the Cell and Gene Therapy CDMO market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The North America market is estimated to witness a significantly high revenue share over the forecast period.
The key players operating the Cell and Gene Therapy CDMO Market includes, Catalent Inc., Lonza Group, Recipharm AB, Wuxi Advanced Therapies, Pfizer CentreOne, Charles River Laboratories International Inc., Patheon Inc., Almac Group, FUJIFILM Diosynth Biotechnologies, PCI Pharma Services, and others.