Cell And Gene Therapy Contract Development And Manufacturing Organization Market Size (2024 - 2029)

The cell and gene therapy contract development and manufacturing organization market is projected to experience significant growth, driven by the increasing demand for advanced therapies to manage chronic diseases. The market's expansion is supported by heightened investment in biopharmaceuticals and the strategic pivot of many organizations to focus on vaccine production during the pandemic. Collaborations between biopharmaceutical companies and contract development and manufacturing organizations are expected to further enhance market opportunities. Despite challenges such as complex manufacturing processes and regulatory hurdles, the market is poised for growth due to the rising need for innovative therapeutics and the development of new viral vector platforms.

Market Size of Cell And Gene Therapy Contract Development And Manufacturing Organization Industry

Cell And Gene Therapy Contract Development And Manufacturing Organization Market Summary
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

Cell And Gene Therapy Contract Development And Manufacturing Organization Market 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 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
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
Europe
United Kingdom
Germany
France
Spain
Italy
Rest of Europe
Asia-Pacific
India
Japan
China
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of the Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Cell And Gene Therapy Contract Development And Manufacturing Organization Market Size Summary

The cell and gene therapy contract development and manufacturing organization (CDMO) market is poised for significant growth, driven by the increasing prevalence of chronic diseases and the rising demand for advanced therapeutic solutions. The market is experiencing a surge in activity due to the heightened focus on biopharmaceuticals, spurred by the COVID-19 pandemic, which has led to accelerated research and development efforts. CDMOs have adapted by expanding their capabilities to support vaccine production, thereby increasing outsourced manufacturing agreements. This shift has contributed to the market's expansion, as pharmaceutical companies invest heavily in developing novel therapeutics for conditions such as cancer, cardiac, neurological, and infectious diseases. The complexity of manufacturing processes and the need for specialized expertise in cell and gene therapy are key factors propelling the demand for CDMO services.

Strategic collaborations and partnerships between biopharmaceutical companies and CDMOs are further enhancing market growth, with companies like AGC Biologics and ABL forging alliances to advance viral vector development and GMP manufacturing. The market is characterized by a mix of small and large players engaging in mergers, acquisitions, and service expansions to strengthen their positions. North America, in particular, is witnessing robust growth due to established research facilities, substantial R&D investments, and a favorable healthcare infrastructure. The high incidence of diseases such as cancer is driving the need for innovative therapies, thereby boosting CDMO services. Notable players in the market include Catalent, Inc., Lonza, Wuxi Biologics, and Recipharm AB, all of which are actively involved in strategic initiatives to capitalize on the growing demand for cell and gene therapy solutions.

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Cell And Gene Therapy Contract Development And Manufacturing Organization Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Rise In Preclinical and Clinical Activities Around Cell and Gene Therapies

      2. 1.2.2 Growing Burden of Genetic Diseases and Cancer

      3. 1.2.3 Increasing Research and Development Investment for Cell and Gene Therapy

    3. 1.3 Market Restraints

      1. 1.3.1 Limitations in Analytical Methods for Large-scale AAV Biomanufacturing

      2. 1.3.2 Complex Manufacturing Process and Regulatory Challenges

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Bargaining Power of Suppliers

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Threat of New Entrants

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value – USD)

    1. 2.1 By Product

      1. 2.1.1 Cell Therapy

        1. 2.1.1.1 Stem-cell Based

        2. 2.1.1.2 Non Stem-cell Based

        3. 2.1.1.3 Other Therapies

      2. 2.1.2 Gene Therapy

        1. 2.1.2.1 Viral Vectors

        2. 2.1.2.2 Non-viral Vectors

    2. 2.2 By Stage

      1. 2.2.1 Pre-clinical

      2. 2.2.2 Clinical

      3. 2.2.3 Commercial

    3. 2.3 By Indication

      1. 2.3.1 Oncology

      2. 2.3.2 Cardiovascular Diseases

      3. 2.3.3 Infectious Diseases

      4. 2.3.4 Genetic Diseases

      5. 2.3.5 Neurological Diseases

      6. 2.3.6 Others Indications

    4. 2.4 Geography

      1. 2.4.1 North America

        1. 2.4.1.1 United States

        2. 2.4.1.2 Canada

        3. 2.4.1.3 Mexico

      2. 2.4.2 Europe

        1. 2.4.2.1 United Kingdom

        2. 2.4.2.2 Germany

        3. 2.4.2.3 France

        4. 2.4.2.4 Spain

        5. 2.4.2.5 Italy

        6. 2.4.2.6 Rest of Europe

      3. 2.4.3 Asia-Pacific

        1. 2.4.3.1 India

        2. 2.4.3.2 Japan

        3. 2.4.3.3 China

        4. 2.4.3.4 Australia

        5. 2.4.3.5 South Korea

        6. 2.4.3.6 Rest of Asia-Pacific

      4. 2.4.4 Middle East and Africa

        1. 2.4.4.1 GCC

        2. 2.4.4.2 South Africa

        3. 2.4.4.3 Rest of the Middle East and Africa

      5. 2.4.5 South America

        1. 2.4.5.1 Brazil

        2. 2.4.5.2 Argentina

        3. 2.4.5.3 Rest of South America

Cell And Gene Therapy Contract Development And Manufacturing Organization Market Size FAQs

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.

In 2024, the Cell And Gene Therapy Contract Development And Manufacturing Organization Market size is expected to reach USD 3.18 billion.

Cell and Gene Therapy Contract Development and Manufacturing Organization Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)