Cell And Gene Therapy Contract Development And Manufacturing Organization Market Size
| Study Period | 2018-2029 |
| Market Size (2024) | USD 3.18 Billion |
| Market Size (2028) | USD 6.90 Billion |
| CAGR (2024 - 2029) | 16.73 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Cell And Gene Therapy Contract Development And Manufacturing Organization Market Analysis
The Cell And Gene Therapy Contract Development And Manufacturing Organization Market size is estimated at USD 3.18 billion in 2024, and is expected to reach USD 6.90 billion by 2028, growing at a CAGR of 16.73% during the forecast period (2024-2028).
Many clinical trials for cell and gene therapies experienced delays due to disruptions in patient recruitment, monitoring, and regulatory processes caused by the pandemic. Moreover, the urgency to combat the pandemic has led to increased investment and focus on biopharmaceuticals, including cell and gene therapies, and this has accelerated research and development efforts in the field. Many CDMOs with expertise in cell and gene therapy manufacturing have pivoted their resources and capabilities to support vaccine production. For instance, in November 2022, SK Bioscience, a CDMO company, extended its partnership with Novavax for the COVID-19 vaccine and has also secured additional CMO and CDMO partners. The increased demand for COVID-19 vaccines has led to more outsourced manufacturing agreements for CDMOs, which has contributed to the market's growth.
The major factors driving the growth of the market are the increasing burden of chronic diseases, high investment in the development of cell and gene therapy, and the rise in preclinical and clinical activities around viral vector-based gene therapy.
Cell and gene therapy is effective in the management of several chronic diseases, including cancer, cardiac diseases, neurological, and infectious diseases. Pharmaceutical companies are also extensively engaged in developing novel therapeutics for these diseases, which is likely to increase the demand for cell and gene therapy CDMO market. The increasing burden of chronic diseases is creating demand for advanced therapies, thereby boosting market growth. For instance, according to the Centers for Disease Control and Prevention (CDC) data of 2023, each year in the United States, about 6,000 babies are born with Down syndrome, which is about 1 in every 700 babies born. Moreover, according to the World Heart Federation data published in May 2022, cardiovascular disease, including heart disease and stroke, is the most common non-communicable disease globally, responsible for nearly 18.6 million deaths, of which more than three-quarters occur in low- and middle-income countries. Hence, the high burden of chronic diseases such as Down syndrome and communicable diseases that require cell and gene therapy is projected to contribute to the market growth over the forecast period.
The growing collaboration and partnerships between biopharmaceutical companies and CDMOs are anticipated to provide an opportunity for market players in the growth of the cell and gene therapy CDMO services market over the forecast period. For instance, in May 2023, AGC Biologics announced the launch of its BravoAAV and ProntoLVV viral vector platforms offering flexible and accelerated vector development and manufacturing for cell and gene therapy programs. AGC Biologics' new platforms capitalize on their extensive expertise in lentiviral vector (LVV) and adeno-associated viral vector (AAV) development, manufacturing, and analytical experience spanning three decades. These platforms provide rapid, effective, and consistent clinical and commercial GMP production and release capabilities. Additionally, in October 2022, ABL, a CDMO, and RD-Biotech signed a strategic partnership to cover cell and gene therapy GMP manufacturing. This collaboration is likely to bring together RD-Biotech’s plasmid DNA (pDNA) GMP manufacturing services with ABL’s viral vector GMP manufacturing.
Hence, the growing burden of chronic diseases and strategic activities undertaken by the market players are expected to boost the market over the forecast period. However, complex manufacturing processes, regulatory challenges, and the high cost of research are expected to boost the market over the forecast period.
Cell And Gene Therapy Contract Development And Manufacturing Organization Market Trends
Neurological Disorders Segment is Expected to Hold a Significant Share Over the Forecast Period
Cell and gene therapy CDMO plays a crucial role in advancing therapies for neurological diseases through their specialized services. CDMOs often have specialized knowledge and expertise in cell and gene therapy, which is particularly important in the complex field of neurological treatments. They typically have advanced manufacturing facilities equipped with the necessary technology and infrastructure to handle the specific requirements of cell and gene therapies for neurological conditions.
The rising burden of neurological diseases is one of the key factors for increasing demand for cell and gene therapeutics and, thus, for CDMO, as the development and manufacturing of cell and gene therapy is complex and requires expertise. For instance, according to the World Health Organisation's data updated in February 2022, around 50 million people worldwide suffer from epilepsy every year. Further, according to the World Alzheimer's Report of 2023, an estimated 6.7 million Americans aged 65 and older will be living with Alzheimer’s dementia in 2023, and this is expected to increase to 13.8 million by 2060. Thus, the growing burden of neurological diseases will likely contribute to the segment growth.
Further, market players in cell and gene therapy CDMO services are utilizing various strategies such as expansion of services, mergers, acquisitions, and agreements to improve their market position. For instance, in June 2023, the New Hope Research Foundation and Forges Biologics, a CDMO, announced a development and cGMP manufacturing partnership to advance the Foundation’s novel gene therapy, NHR01, into Phase I/II clinical trials for patients with GM2 gangliosidosis. Similarly, in September 2022, Charles River Laboratories International, Inc. and Cure AP-4 announced a manufacturing collaboration to provide High Quality (HQ) plasmid DNA for Cure AP-4’s Phase I/II gene therapy trials against Adapter-Protein 4 Hereditary Spastic Paraplegia (AP-4 HSP).
Hence, the growing burden of neurological diseases and strategic activities by the market players is expected to boost the segment growth over the forecast period.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
In North America, the cell and gene therapy CDMO market is expected to grow owing to factors such as established research facilities, high investment in R&D for cell and gene therapy, and the growing burden of chronic diseases.
According to the data from the American Cancer Society in 2023, it is estimated that about 13% or 1 in 8 women in the United States are expected to develop invasive breast cancer during their lives. Hence, the high incidence of cancer in the nation is predicted to raise the need for novel cell and gene therapy, which would ultimately lead to a growth in R&D activities and CDMO services for the development of new drugs, thereby boosting the market growth over the forecast period.
Moreover, the increase in research and development activities and the presence of favorable healthcare infrastructure are fueling the growth of the overall regional market to a large extent. For instance, in March 2023, Remedium Bio and Biovian Oy collaborated to work together on the development of Remedium's innovative disease-modifying AAV gene therapy for Osteoarthritis. This agreement aims to advance the research and production of groundbreaking therapy, potentially offering new treatment options for patients with Osteoarthritis. Additionally, in November 2022, Charles River Laboratories International, Inc. expanded its cell therapy CDMO facility in Memphis, United States. The expanded space is suitable for clinical and commercial cell therapy manufacturing. This increase in the growth of the CDMO sector facilitates the increasing cell and gene therapy manufacturing services, thereby propelling the growth of the market.
Thus, the factors mentioned above, such as the increasing prevalence of cancer and the development by various companies, are expected to drive the growth of the market in this region.
Cell And Gene Therapy Contract Development And Manufacturing Organization Industry Overview
The market for cell and gene therapy contract development and manufacturing organizations is moderately competitive, with the presence of both small and large players who are involved in strategic activities such as the expansion of services, partnerships, collaborations, as well as mergers, and acquisitions. Catalent, Inc., Lonza, Wuxi Biologics, and Recipharm Ab are among the notable key players in this market.
Cell And Gene Therapy Contract Development And Manufacturing Organization Market Leaders
-
Catalent Inc
-
Lonza Group
-
Recipharm AB
-
Charles River Laboratories International Inc
-
Wuxi Advanced Therapies
*Disclaimer: Major Players sorted in no particular order
Cell And Gene Therapy Contract Development And Manufacturing Organization Market News
- March 2023: Porton Advanced Solutions Ltd. partnered with DanausGT Biotechnology Co., Ltd. as an end-to-end gene and cell therapy service provider. Porton Advanced will provide DanausGT with comprehensive solutions, including plasmids, viruses, and cell therapy products. By combining Porton Advanced's expertise with DanausGT's proprietary CRISPR/AAV technology, the collaboration accelerated the development of cutting-edge cell and gene therapy therapeutics.
- March 2023: Charles River Laboratories Inc. launched a Helper Plasmid to streamline the manufacturing process of AAV vectors. This development aimed to enhance efficiency and simplify the production of AAV vectors, a crucial component in gene therapy manufacturing.
Cell And Gene Therapy Contract Development And Manufacturing Organization Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definitions
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
-
4.2 Market Drivers
- 4.2.1 Rise In Preclinical and Clinical Activities Around Cell and Gene Therapies
- 4.2.2 Growing Burden of Genetic Diseases and Cancer
- 4.2.3 Increasing Research and Development Investment for Cell and Gene Therapy
-
4.3 Market Restraints
- 4.3.1 Limitations in Analytical Methods for Large-scale AAV Biomanufacturing
- 4.3.2 Complex Manufacturing Process and Regulatory Challenges
-
4.4 Porter's Five Forces Analysis
- 4.4.1 Bargaining Power of Suppliers
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Threat of New Entrants
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value – USD)
-
5.1 By Product
- 5.1.1 Cell Therapy
- 5.1.1.1 Stem-cell Based
- 5.1.1.2 Non Stem-cell Based
- 5.1.1.3 Other Therapies
- 5.1.2 Gene Therapy
- 5.1.2.1 Viral Vectors
- 5.1.2.2 Non-viral Vectors
-
5.2 By Stage
- 5.2.1 Pre-clinical
- 5.2.2 Clinical
- 5.2.3 Commercial
-
5.3 By Indication
- 5.3.1 Oncology
- 5.3.2 Cardiovascular Diseases
- 5.3.3 Infectious Diseases
- 5.3.4 Genetic Diseases
- 5.3.5 Neurological Diseases
- 5.3.6 Others Indications
-
5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 United Kingdom
- 5.4.2.2 Germany
- 5.4.2.3 France
- 5.4.2.4 Spain
- 5.4.2.5 Italy
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 India
- 5.4.3.2 Japan
- 5.4.3.3 China
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of the Middle East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
-
6.1 Company Profiles
- 6.1.1 Catalent Inc
- 6.1.2 Lonza Group
- 6.1.3 Recipharm AB
- 6.1.4 Wuxi Advanced Therapies
- 6.1.5 Pfizer CentreOne
- 6.1.6 Charles River Laboratories International Inc
- 6.1.7 Patheon Inc
- 6.1.8 Almac Group
- 6.1.9 FUJIFILM Diosynth Biotechnologies
- 6.1.10 The Discovery Labs
- 6.1.11 BIOCENTRIQ
- 6.1.12 PCI Pharma Services
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityCell And Gene Therapy Contract Development And Manufacturing Organization Industry Segmentation
As per the scope of the report, cell and gene therapy contract development and manufacturing organization (CDMO) services refer to specialized offerings provided by companies that support the development, production, and testing of cell and gene therapies. These therapies involve the use of living cells or genetic material to treat diseases. The cell and gene therapy contract development and manufacturing organization market is segmented by product (cell therapy and gene therapy), source (pre-clinical, clinical, and commercial), indication (oncology, cardiovascular disease, infectious disease, genetic disorders, neurological disorders, and other indications), and geography (North America, Europe, Asia-Pacific, the Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally.
The report offers the value (in USD) for the above segments.
| By Product | Cell Therapy | Stem-cell Based |
| Non Stem-cell Based | ||
| Other Therapies | ||
| By Product | Gene Therapy | Viral Vectors |
| Non-viral Vectors | ||
| By Stage | Pre-clinical | |
| Clinical | ||
| Commercial | ||
| By Indication | Oncology | |
| Cardiovascular Diseases | ||
| Infectious Diseases | ||
| Genetic Diseases | ||
| Neurological Diseases | ||
| Others Indications | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | United Kingdom |
| Germany | ||
| France | ||
| Spain | ||
| Italy | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | India |
| Japan | ||
| China | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of the Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Cell And Gene Therapy Contract Development And Manufacturing Organization Market Research FAQs
How big is the Cell And Gene Therapy Contract Development And Manufacturing Organization Market?
The Cell And Gene Therapy Contract Development And Manufacturing Organization Market size is expected to reach USD 3.18 billion in 2024 and grow at a CAGR of 16.73% to reach USD 6.90 billion by 2028.
What is the current Cell And Gene Therapy Contract Development And Manufacturing Organization Market size?
In 2024, the Cell And Gene Therapy Contract Development And Manufacturing Organization Market size is expected to reach USD 3.18 billion.
Who are the key players in Cell And Gene Therapy Contract Development And Manufacturing Organization Market?
Catalent Inc, Lonza Group, Recipharm AB, Charles River Laboratories International Inc and Wuxi Advanced Therapies are the major companies operating in the Cell And Gene Therapy Contract Development And Manufacturing Organization Market.
Which is the fastest growing region in Cell And Gene Therapy Contract Development And Manufacturing Organization Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2023-2029).
Which region has the biggest share in Cell And Gene Therapy Contract Development And Manufacturing Organization Market?
In 2023, the North America accounts for the largest market share in Cell And Gene Therapy Contract Development And Manufacturing Organization Market.
What years does this Cell And Gene Therapy Contract Development And Manufacturing Organization Market cover, and what was the market size in 2023?
In 2023, the Cell And Gene Therapy Contract Development And Manufacturing Organization Market size was estimated at USD 2.65 billion. The report covers the Cell And Gene Therapy Contract Development And Manufacturing Organization Market historical market size for years: 2018, 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Cell And Gene Therapy Contract Development And Manufacturing Organization Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Cell And Gene Therapy Contract Development And Manufacturing Organization Industry Report
Statistics for the 2024 Cell And Gene Therapy Contract Development And Manufacturing Organization market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Cell And Gene Therapy Contract Development And Manufacturing Organization analysis includes a market forecast outlook to for 2024 to 2028 and historical overview. Get a sample of this industry analysis as a free report PDF download.
Cell And Gene Therapy Contract Development And Manufacturing Organization Market Report Snapshots
- Cell And Gene Therapy Contract Development And Manufacturing Organization Market Size
- Cell And Gene Therapy Contract Development And Manufacturing Organization Market Share
- Cell And Gene Therapy Contract Development And Manufacturing Organization Market Trends
- Cell And Gene Therapy Contract Development And Manufacturing Organization Companies
