Large Molecule Drug Substance CDMO Market Size, Share & Trends Analysis Report By Services (Contract Manufacturing, Contract Development), By Source (Mammalian, Microbial), By End-user, And Segment Forecasts, 2022 - 2030

Report Overview

The global large molecule drug substance CDMO market size was valued at USD 10.7 billion in 2021 and is anticipated to grow at a compound annual growth rate (CAGR) of 8.6% during the forecast period. Increasing large molecule drug approvals, primarily with the FDA, rising incidence of infectious diseases, and high demand for novel therapeutics, as well as higher capital investments by pharma and biotech firms in advanced technologies for establishing partnerships with CDMOs, are the key factors driving the market growth. Large molecule drug investment was increasing before the COVID-19 pandemic as they offer a plethora of new treatment options. During the race to develop therapeutics and vaccines against the SARS-CoV-2 virus, the value of biologics became even more evident.

The demand for both high-volume and high-quality CGMP drug substance and drug product manufacturing services has risen dramatically, especially for CDMOs capable of providing a broad range of COVID-19 vaccine technologies and, to a smaller extent, therapeutic monoclonal antibody products. However, to combat the pandemic, new technologies were adopted and implemented in distribution logistics, vaccine production, monoclonal antibody manufacturing, and diagnostic testing. The pandemic highlighted the importance of more local, U.S.-based contract pharma services, as well as intimately aligning academia, manufacturers, drug innovators, and regulatory agencies to deliver treatments to patients.

As CDMOs race to generate COVID-19-related therapies in 2021, large molecule (drug substance and drug product) production capacity and supply chain would then remain constrained. Large molecules drug development is separated into two sections: Drug Substance (DS) development, which involves the development of master and working cell banks, manufacturing process development, and scale-up, and Drug Product (DP) development, which also contains the filling of the drug substance into to the primary container. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), like all regulatory authorities, provides some level of guidance regarding the characterization and measurement of drug performance & quality.

ICH Q6 is concerned with establishing specifications for both DS and DP for new chemical entities. Developing a large molecule drug substance that is both effective and safe while also keeping costs and development time under control is a difficult task. Due to the complexity and fragility of large molecule active compounds, formulation development faces a host of difficulties. Overcoming difficulties and meeting deadlines have become key drivers for CDMOs in the early stages of drug development. There are numerous innovative technologies available to drug developers that aid in stabilization and can protect the large molecule drug substance, such as encapsulation and the use of buffers.

Services Insights

On the basis of services, the global market has been further categorized into contract manufacturing and contract development. The contract manufacturing services segment dominated the global market and accounted for the largest share of more than 67.5% of the overall revenue in 2021. This segment is further sub-segmented into target identification & screening, target validation & functional informatics, lead identification & candidate optimization, and preclinical development. A lot of Indian pharmaceutical companies have extensive experience in contract manufacturing, and recent quality-control scrutiny is driving significant improvements in the manufacturing standards. The contract development segment is expected to rise with the fastest CAGR during the forecast period.

This is mainly due to the outsourcing of the service by the pharmaceutical & biotech companies to CDMOs. Drug development is an inherently complex matter, which has been exacerbated by the introduction of large molecules. Despite massive R&D expenditures, the return on investment has been declining for some time. The large molecule drugs are expensive to develop, manufacture, and copy, making generics difficult to develop. Furthermore, the segment is divided into cell line development and process development. The top CDMOs provide the services for large molecules that includes upstreaming processing & down streaming processing, a portfolio of analytical methods for protein characterization, and Bioassays.

End-user Insights

On the basis of end-users, the global market has been further divided into biotech companies, Contract Research Organizations (CROs), and others. The biotech companies end-user segment dominated the global market in 2021 and accounted for the largest share of more than 44.00% of the overall revenue. The high share of this segment can be attributed to the increased investments in research & development in the biopharmaceutical sector as well as arise in disease incidences for which, a number of biotech companies are conducting extensive research.

In addition, biotech companies are using mergers & acquisitions, regional expansions, service portfolio expansions, and competitive pricing as key strategies to stay competitive and gain a larger market share.The others end-user segment is expected to rise with the fastest CAGR during the forecast period. This segment includes pharma companies, government & research institutes, and academic institutes. Traditionally, pharmaceutical companies concentrated on small molecules, whereas biotechnology firms concentrated on large molecules but now big pharma companies are more concerned with large molecules than small molecules.

Source Insights

On the basis of sources, the global market has been further categorized into mammalian, microbial, and others. The mammalian source segment dominated the global market and accounted for the maximum share of more than 55.00% of the overall revenue in 2021. The mammalian segment is estimated to expand further at the fastest growth rate maintaining its leading market position throughout 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. Microbes have made enormous contributions to human health and well-being. They are capable of producing secondary metabolites, that also constitute 50% of the pharmaceuticals on the market. Microorganisms are a rich source of diverse chemical bioactive metabolites, and they have produced some of the pharmaceutical industry’s most important products. Secondary metabolites from microbes are already being used for purposes other than antifungal, antibacterial, and antiviral infections. Immuno suppressants, for example, have transformed medicine by making organ transplantation feasible. Microbial metabolites are also one of the most important cancer chemotherapeutic agents.

Regional Insights

North America dominated the global market and accounted for the largest revenue share of 41.1% in 2021. Heavy R&D investments have occurred in the U.S. and are expected to increase further in the coming years. According to Congressional Budget Office (CBO) publication, in 2019, USD 11 billion was spent on large molecules by the U.S. In December 2020, the FDA approved only 29 biosimilar drugs. Furthermore, the presence of a large number of players, such as Catalent, Cambrex Corp., LabCorp Drug Development, and Fujifilm Diosynth Biotechnologies, drives the market growth. In April 2022 Catalent announced a USD 350 million multi-year investment at its Bloomington, Indian a facility to broaden large molecule drug product and drug substance manufacturing capabilities.

Asia Pacific is projected to be the fastest-growing regional market during the forecast period. The region has a huge patient population. Moreover, the availability of a low-cost, skilled workforce and changes in the regulatory scenario are other key factors driving the market growth. For instance, India is an outstanding country for the CDMO industry as it has approval from the FDA for a large number of drug items and a highly skilled workforce. As the access to medical care improves in emerging economies and the number of generic manufacturers in India grows, the business of local CDMOs would then skyrocket, as India can handle a massive variety of products quite cost-effectively. Essentially, the expansion of the country’s healthcare infrastructure is assisting the market’s growth.

Key Companies And Market Share Insights

Mergers, acquisitions, and partnerships among others are the key strategies adopted by most companies to maintain their market share. For instance, in June 2020, FUJIFILM Corp. invested approximately USD 778 billion in FUJIFILM Diosynth Biotechnologies’ Denmark site, CDMO for biologics and advanced therapies. The capital investment would double the Denmark site’s existing drug substance manufacturing capability, would broaden its capabilities to include fill/finish, and improve its existing assembly, packaging services, and labeling. Some prominent players in the global large molecule drug substance CDMO market include:

• Eurofins Scientific

• WuXi Biologics

• Samsung Biologics

• Catalent, Inc.

• Cambrex Corp.

• AGC Biologics

• Recipharm AB (publ)

• Siegfried Holding AG

• LabCorp Drug Development

• FUJIFILM Diosynth Biotechnologies

Large Molecule Drug Substance CDMO Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global large molecule drug substance CDMO market report based on services, source, end-user, and region:

• Services Outlook (Revenue, USD Million, 2018 - 2030)

  • Contract Manufacturing

    • Target Identification & Screening

    • Target Validation & Functional Informatics

    • Lead Identification & Candidate Optimization

    • Preclinical Development

  • Contract Development

    • Cell Line Development

    • 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

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE