Large Molecule Drug Substance CDMO Market (By Service: Contract Manufacturing, Contract Development; By Source; By End-user) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2023-2032

The global large molecule drug substance CDMO market was surpassed at USD 11.61 billion in 2022 and is expected to hit around USD 32.32 billion by 2032, growing at a CAGR of 9.16% from 2023 to 2032.

Report Highlights

• The contract manufacturing segment dominated the market and accounted for a revenue share of over 65.02% in 2022. 
• The contract development segment is expected to expand at the fastest CAGR of 10.93% over the forecast period. 
• In 2022, biotech companies held the largest revenue share of over 40.07%. 
• The mammalian source segment dominated the global market and accounted for a revenue share of more than 55.06% in 2022. 
• Asia Pacific held the largest revenue share of over 35.07% in 2022 and is projected to register the fastest CAGR over the forecast period. 

Rising incidence of infectious diseases and high demand for novel therapeutics are the key factors driving the market.

Contract manufacturing is one of the major steps in large molecule production and accounts for a sizable portion of the large molecule drug substance market. The mode of manufacturing is an important factor to consider because it represents the sector's outsourcing and in-house activities. Companies are now choosing to outsource services due to high costs and delays in time. This has resulted in a greater proportion of large molecules being outsourced by the firms. A contract development and manufacturing organization (CDMO) is a company that provides a comprehensive range of services to the pharmaceutical industry from drug development to manufacturing. CDMOs provide critical services by incorporating third-party projects and offering their knowledge, development, and manufacturing capabilities.

Prior to the COVID-19 pandemic, large molecule drug investment was increasing as it offers a plethora of new treatment options. The valuation of biologics became clearer during the race to develop therapeutics and vaccines against the SARS-CoV-2 virus. The demand for both high-volume and high-quality CGMP drug substance and drug product manufacturing services has risen dramatically, particularly for CDMOs capable of providing a wide range of COVID vaccine technologies and, to a lesser extent, therapeutic monoclonal antibody products.

Service Insights

The contract manufacturing segment dominated the market and accounted for a revenue share of over 65.02% in 2022. This segment is further divided into target identification and screening, target validation and functional informatics, lead identification and candidate optimization, and preclinical development. Indian pharmaceutical companies have extensive experience in contract manufacturing, and recent quality-control scrutiny is driving significant improvements in manufacturing standards.

The contract development segment is expected to expand at the fastest CAGR of 10.93% over the forecast period. The segment is further divided into cell line development and process development. The top CDMOs provide services for large molecules including upstreaming processing and down streaming processing and a portfolio of analytical methods for protein characterization and bioassays.

End-user Insights

In 2022, biotech companies held the largest revenue share of over 40.07%. This can be attributed to increased R&D investments in the biopharmaceutical sector as well as an increase in diseases for which biotech companies are conducting extensive research. In addition, biotech firms are using mergers and acquisitions, regional expansion, product/service portfolio expansion, and competitive pricing as key strategies to stay competitive and gain a larger market share.

The others segment is expected to expand at the fastest CAGR of 10.73% over the forecast period. It includes pharma companies, government research institutes, and academic institutes. Traditionally, pharmaceutical companies focused on small molecules, whereas biotechnology firms focused on large molecules but now big pharma companies are more concerned with large than small molecules.

Source Insights

The mammalian source segment dominated the global market and accounted for a revenue share of more than 55.06% in 2022. The mammalian segment is estimated to expand at the fastest rate over the forecast period. This category will expand as more complex biologics, such as bi- and tri-specific antibodies, and antibody-drug conjugates are evolved. mAbs and their synthetic equivalents have received significant funding due to their effectiveness in treating a variety of diseases, including cancer. mAbs have traditionally been created from mammalian therapies to treat diseases such as these.

The microbial source segment is anticipated to register the second-fastest CAGR during the forecast period. Microbial systems are widely used for producing recombinant proteins for therapeutic purposes. Around 650 protein drugs have been approved worldwide to date, among which about 400 were obtained from microbial recombinant technologies. Moreover, approximately 1/3 of biologics approved for manufacturing are produced by microbial sources, which are primarily used by CDMOs to produce cytokines, hormones, enzymes, and MABs. These factors are supporting segment growth.

Regional Insights

Asia Pacific held the largest revenue share of over 35.07% in 2022 and is projected to register the fastest CAGR over the forecast period. A large patient base, lower overall costs, a skilled workforce, and changes in the regulatory scenario are the key factors driving the regional market growth. The region is seen as the most appealing for contract manufacturing. Asia Pacific countries have a sizable patient base and the potential for highly skilled medical professionals. The cost of manufacturing and running a clinical trial is considerably low compared to western countries. Additionally, companies such as Boehringer Ingelheim and Wuxi Biologics are continually working to extend their services in this region. For instance, in November 2020, Wuxi Biologics launched a biologics integrated innovation center in Hangzhou, Zhejiang province, China. This center will provide a wide range of services from process development to manufacturing. These aforementioned factors are expected to contribute to the regional market growth.

North America is expected to witness growth in the years to come due to large R&D investments in the U.S. For instance, the Pharmaceutical Research and Manufacturers of America reported in 2022 that American pharmaceutical companies spent $102.3 billion on R&D in 2021, of which 79.6 billion were spent domestically and 22.7 billion were spent overseas. As of September 2022, the USFDA had approved 39 biosimilar drugs. Furthermore, the presence of a large number of players such as Catalent, Cambrex Corporation, LabCorp Drug Development, and Fujifilm Diosynth Biotechnologies drives the market. For instance, in April 2022, Catalent announced a multi-year investment worth USD 350 million at its Bloomington, Indiana facility to broaden large molecule drug product and drug substance manufacturing capabilities.

Key Players

• Eurofins Scientific 
• WuXi Biologics
• Samsung Biologics
• Catalent, Inc.
• Rentschler Biopharma SE
• AGC Biologics
• Recipharm AB
• Siegfried Holding AG
• Boehringer Ingelheim
• FUJIFILM Diosynth Biotechnologies

Market Segmentation

• By Service Outlook
• Contract Manufacturing

• Clinical

• Commercial

• Contract Development

• Cell Line Development

• Process Development

• By Source Outlook
• Mammalian
• Microbial
• Others
• By End-user Outlook
• Biotech Companies
• CRO
• Others
• By Regional Outlook
• North America

• U.S.

• Canada

• Europe

• U.K.

• Germany

• France

• Italy

• Spain

• Denmark

• Sweden

• Norway

• Rest of Europe

• Asia Pacific

• JapanChina

• India

• Australia

• Thailand

• South Korea

• Rest of Asia Pacific

• Latin America

• Brazil

• Mexico

• Argentina

• Rest of Latin America

• Middle East & Africa

• South Africa

• Saudi Arabia

• UAE

• Kuwait

• Rest of Middle East and Africa