Large Molecule Drug Substance Cdmo Market

The market size of the global contract development and manufacturing organization (CDMO) for large molecule drug substances reached USD 11.5 billion in 2022 and is projected to grow at a CAGR of 9.3% from 2023 to 2030. The market is driven by factors such as increasing approvals of large molecule drugs, particularly by the FDA, the growing prevalence of infectious diseases, rising demand for innovative therapeutics, and significant investments by pharmaceutical and biotech companies in advanced technologies to form partnerships with CDMOs. The value of large molecule drug investments was already rising before the COVID-19 pandemic, offering numerous new treatment possibilities. However, during the pandemic, the importance of biologics became even more apparent in the race to develop therapeutics and vaccines against the SARS-CoV-2 virus. This resulted in a substantial increase in demand for CGMP drug substance and product manufacturing services, especially from CDMOs capable of offering various COVID vaccine technologies and, to a lesser extent, therapeutic monoclonal antibody products.

Nevertheless, the pandemic necessitated the adoption of new technologies in distribution logistics, vaccine production, monoclonal antibody manufacturing, and diagnostic testing. It emphasized the significance of local contract pharmaceutical services based in the US and the need for close collaboration among academia, manufacturers, drug innovators, and regulatory agencies to deliver treatments to patients. As CDMOs strive to develop COVID-19-related therapies in 2021, there is expected to be a continued constraint on large molecule (drug substance and drug product) production capacity and supply chains.

The development of large molecule drugs is divided into two stages: drug substance (DS) development, which includes the creation of master and working cell banks, process development, and scale-up, and drug product (DP) development, which involves filling the drug substance into primary containers. Regulatory authorities, including the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), provide guidance on the characterization and measurement of drug performance and quality. ICH Q6 specifically focuses on establishing specifications for both DS and DP for new chemical entities.

Developing an effective and safe large molecule drug substance while managing costs and development time is a challenging task. Formulation development encounters numerous difficulties due to the complexity and delicacy of large molecule active compounds. Overcoming these challenges and meeting deadlines have become key drivers for CDMOs in the early stages of drug development. There are various innovative technologies available to drug developers that aid in stabilization and protection of the large molecule drug substance, such as encapsulation and the use of buffers.

Service Insights:

The contract manufacturing segment was the dominant segment in the market, accounting for over 65.0% of the revenue in 2022. It 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 has led to significant improvements in manufacturing standards.

The contract development segment is expected to have the highest compound annual growth rate (CAGR) of 10.9% over the forecast period. It is further divided into cell line development and process development. Top CDMOs offer services for large molecules, including upstream processing, downstream processing, and a portfolio of analytical methods for protein characterization and bioassays.

End-user Insights:

In 2022, biotech companies held the largest revenue share, accounting for over 40.0%. This can be attributed to increased research and development (R&D) investments in the biopharmaceutical sector and the growing number of diseases being extensively researched by biotech companies. Biotech firms are utilizing strategies such as mergers and acquisitions, regional expansion, product/service portfolio expansion, and competitive pricing to remain competitive and increase their market share.

The "others" segment is expected to have the highest CAGR of 10.7% over the forecast period. It includes pharmaceutical companies, government research institutes, and academic institutes. While traditional pharmaceutical companies focused on small molecules and biotechnology firms focused on large molecules, big pharma companies are now placing more emphasis on large molecules than small molecules.

Source Insights:

The mammalian source segment dominated the global market, accounting for a revenue share of over 55.0% in 2022. It is projected to have the fastest growth rate over the forecast period. This segment will expand as more complex biologics, such as bi- and tri-specific antibodies and antibody-drug conjugates, are developed. Monoclonal antibodies (mAbs) and their synthetic equivalents have received significant funding due to their effectiveness in treating various diseases, including cancer. Mammalian therapies have traditionally been used to develop mAbs for such diseases.

The microbial source segment is expected to register the second-highest CAGR during the forecast period. Microbial systems are widely used for producing recombinant proteins for therapeutic purposes. To date, around 650 protein drugs have been approved worldwide, with approximately 400 of them obtained from microbial recombinant technologies. Additionally, about one-third of biologics approved for manufacturing are produced using microbial sources, primarily for cytokines, hormones, enzymes, and mAbs. These factors contribute to the growth of this segment.

Regional Insights:

Asia Pacific held the largest revenue share of over 35.0% in 2022 and is projected to have the fastest CAGR over the forecast period. Factors driving the regional market growth include a large patient base, lower overall costs, a skilled workforce, and changes in the regulatory scenario. The region is considered highly attractive for contract manufacturing, with Asia Pacific countries having a substantial patient base and potential for highly skilled medical professionals. The cost of manufacturing and conducting clinical trials is significantly lower compared to Western countries. Companies like Boehringer Ingelheim and Wuxi Biologics are actively expanding their services in this region, with Wuxi Biologics launching a biologics integrated innovation center in China in November 2020. These factors are expected to contribute to the growth of the regional market.

North America is expected to witness growth in the coming years due to significant R&D investments in the United States. American pharmaceutical companies spent $102.3 billion on R&D in 2021, with a large portion allocated domestically. The presence of major players such as Catalent, Cambrex Corporation, LabCorp Drug Development, and Fujifilm Diosynth Biotechnologies also drives the market. For example, Catalent announced a multi-year investment of USD 350 million in April 2022 to expand large molecule drug product and drug substance manufacturing capabilities at its facility in Bloomington, Indiana.

Key Companies & Market Share Insights

Key market players employed strategies such as mergers, acquisitions, and partnerships to maintain their market share. For example, in September 2022, FUJIFILM Diosynth announced the expansion of its large-scale microbial manufacturing facility in Billingham, U.K. This expansion aims to cater to the increasing demand for microbial development and manufacturing. Some notable players in the global market for large molecule drug substance CDMOs include:

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

Global Large Molecule Drug Substance CDMO Market Segmentation

The report provides revenue growth forecasts at the global, regional, and country levels. It also offers an analysis of the latest industry trends and opportunities within each of the sub-segments from 2018 to 2030. The global large molecule drug substance CDMO market report is segmented based on service, source, end-user, and region, as analyzed by MarketDigits.

Service Outlook (Revenue, USD Million, 2018 - 2030)
• Contract Manufacturing
o Clinical
o Commercial
• Contract Development
o Cell Line Development
o Process Development

Source Outlook (Revenue, USD Million, 2018 - 2030)
• Mammalian
• Microbial
• Others

End-user Outlook (Revenue, USD Million, 2018 - 2030)
• Biotech Companies
• CRO
• Others

Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
o U.S.
o Canada
• Europe
o U.K.
o Germany
o France
o Italy
o Spain
o Denmark
o Sweden
o Norway
o Rest of Europe
• Asia Pacific
o JapanChina
o India
o Australia
o Thailand
o South Korea
o Rest of Asia Pacific
• Latin America
o Brazil
o Mexico
o Argentina
o Rest of Latin America
• Middle East & Africa
o South Africa
o Saudi Arabia
o UAE
o Kuwait
o Rest of Middle East and Africa