Large Molecules Drug Substance CDMO Market Size (2024 - 2029)

The Large Molecules Drug Substance CDMO Market is projected to experience significant growth over the forecast period, driven by factors such as the increasing approval of drug molecules, a rise in chronic and infectious diseases, and a growing demand for biologics and biosimilars. The market's expansion is further supported by increased R&D investments by pharmaceutical companies and strategic initiatives like facility expansions and mergers and acquisitions by market players. These developments aim to enhance production capabilities and meet the rising demand for large molecule drug substances. However, challenges such as compliance issues in outsourcing and evolving conditions in developing countries may hinder the market's growth.

Market Size of Large Molecules Drug Substance CDMO Industry

Large Molecules Drug Substance CDMO Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 11.14 Million
Market Size (2029) USD 18.76 Million
CAGR (2024 - 2029) 8.60 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Medium

Major Players

Large Molecules Drug Substance CDMO Market Major Players

*Disclaimer: Major Players sorted in no particular order

Large Molecules Drug Substance CDMO Market Analysis

The Large Molecules Drug Substance CDMO Market size is estimated at USD 11.14 million in 2024, and is expected to reach USD 18.76 million by 2029, growing at a CAGR of 8.60% during the forecast period (2024-2029).

The market is driven by the increasing approval of molecules for drugs, the rising incidence of chronic and infectious diseases, the growing demand for biologics and biosimilars, and the increasing R&D investment by pharmaceutical companies for large molecules.

The increasing investment for the facility expansion that provides the large molecules of drug substance CDMO services is expected to boost the market during the forecast period. For instance, in January 2022, Alcami, a CDMO, reported a USD 10 million investment to expand its laboratory operation in Durham, North Carolina. The investment sought to expand the laboratory by over 6700 ft², incorporating state-of-the-art equipment. It aimed to bolster extensive molecule characterization capabilities for biologics at various development stages. The facility would support both parenteral manufacturing projects and independent analytical clients.

Moreover, strategic activities by the market players, such as mergers and acquisitions and partnership and services expansion, are expected to contribute to the market during the forecast period. For instance, in May 2023, Aurigene Pharmaceutical Services Limited, a subsidiary of Dr. Reddy's Laboratories, reported the construction of a new and advanced facility that will be used to develop and manufacture therapeutic proteins, antibodies, and viral vectors. This facility will be complemented by exclusive access to a large-scale GMP manufacturing facility with a drug substance capacity of 15,000 liters and fill-finish capabilities, allowing for seamless production of commercial quantities.

In September 2022, FUJIFILM Diosynth embarked on an expansion of its sizable microbial manufacturing facility in Billingham, the United Kingdom. The project, spanning an area of 1858 square meters (20,000 sq. ft), will cater to the increasing need for microbial development and production.

Hence, all the above factors mentioned, such as increasing investment for the production of large molecules of drug substances and strategic initiatives taken by the market players, are anticipated to grow the market during the forecast period. However, compliance issues while outsourcing and changing scenarios within developing countries are expected to restrain the market's growth during the forecast period.

Large Molecules Drug Substance CDMO Industry Segmentation

As per the scope of the report, the large molecules drug substance contract development and manufacturing organization (CDMO) market refers to the pharmaceutical and biotechnology industry sector that provides outsourcing services for developing and manufacturing large molecule drugs. Large molecules typically include proteins, peptides, monoclonal antibodies, and other biologically derived substances. The CDMO market for large molecules of drug substances is segmented by service, contract development, source, and geography. By services, the market is segmented into contract manufacturing and contract development. The market is segmented by source, such as mammalian, microbial, and others. By end user, the market is segmented as biotech companies, research institutes, and other end users. The market is segmented by geography as North America, Europe, Asia-Pacific, 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 Service
Contract Manufacturing
Clinical
Commercial
Contract Development
Cell Line Development
Process Development
By Sources
Mammalian
Microbial
Others
By End User
Biotech Companies
Research Institutes
Others
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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Large Molecules Drug Substance CDMO Market Size Summary

The Large Molecules Drug Substance CDMO Market is poised for significant growth over the forecast period, driven by factors such as the increasing approval of drug molecules, the rising prevalence of chronic and infectious diseases, and the growing demand for biologics and biosimilars. The market is further bolstered by substantial investments in research and development by pharmaceutical companies focusing on large molecules. Strategic expansions and investments in facilities, such as those by Alcami and FUJIFILM Diosynth, are expected to enhance production capabilities and support the development of complex biologics. Additionally, strategic activities like mergers, acquisitions, and partnerships, exemplified by Aurigene Pharmaceutical Services and Lotte Biologics, are anticipated to contribute to market growth by expanding service offerings and production capacities.

North America is expected to maintain a significant market share, driven by extensive drug approvals, high demand for novel therapeutics, and substantial investments in advanced technologies by pharmaceutical and biotech firms. The region's market growth is supported by increased R&D investments and the approval of biologics products, with key players like Catalent and Thermo Fisher Scientific leading the charge through facility expansions and strategic partnerships. The competitive landscape is characterized by the presence of several global and regional companies, all vying to enhance their capabilities in large molecule drug substance production. As the market evolves, the benefits offered by CDMOs in cell line development and strategic initiatives by market participants are expected to further propel market expansion.

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Large Molecules Drug Substance CDMO Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Large Molecule Drug Approvals

      2. 1.2.2 Rising Incidence Of Infectious Diseases and Increasing Demand for Biologics and Biosimilars

      3. 1.2.3 Rising R&D Investment by The Pharmaceutical for Large Molecules

    3. 1.3 Market Restraints

      1. 1.3.1 Stringent Government Regulations

      2. 1.3.2 Compliance Issues with Outsourcing

    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 Service

      1. 2.1.1 Contract Manufacturing

        1. 2.1.1.1 Clinical

        2. 2.1.1.2 Commercial

      2. 2.1.2 Contract Development

        1. 2.1.2.1 Cell Line Development

        2. 2.1.2.2 Process Development

    2. 2.2 By Sources

      1. 2.2.1 Mammalian

      2. 2.2.2 Microbial

      3. 2.2.3 Others

    3. 2.3 By End User

      1. 2.3.1 Biotech Companies

      2. 2.3.2 Research Institutes

      3. 2.3.3 Others

    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

Large Molecules Drug Substance CDMO Market Size FAQs

The Large Molecules Drug Substance CDMO Market size is expected to reach USD 11.14 million in 2024 and grow at a CAGR of 8.60% to reach USD 18.76 million by 2029.

In 2024, the Large Molecules Drug Substance CDMO Market size is expected to reach USD 11.14 million.

Large Molecules Drug Substance CDMO Market Size & Share Analysis - Growth, Trends & Forecasts (2024 - 2029)