Global Large Molecule Drug Substance CDMO Market Size, Share & Industry Trends Analysis Report By Application (Mammalian, Microbial and Others), By Service (Contract Manufacturing and Contract Development), By End-user, By Regional Outlook and Forecast, 2022 - 2028

Analysis of Market Size & Trends

The Global Large Molecule Drug Substance CDMO Market size is expected to reach $19.2 billion by 2028, rising at a market growth of 8.7% CAGR during the forecast period.

Contract development and manufacturing organization (CDMO) that provide services for processing large molecule or biologics drug substances are referred to as large molecule drug substance CDMO. These are companies that assist customers in drug discovery via manufacturing abilities by providing services and, thus, also help the pharmaceutical industry.

Large molecules are proteins that tend to have a therapeutic effect. These are highly complex, and most biologics are composed of approximately 1300 or more amino acids. These are prepared so that they resemble human proteins. The rise in molecule drug approvals, growing infectious disease prevalence, and increasing favorability for innovative therapeutics demand more CDMO setups for the rapid development and manufacturing of drugs.

Therefore, CDMOs' research, knowledge, and manufacturing abilities are highly necessary to proceed with drug development. As such, many CDMOs engage in integrating third-party ventures, which are also propelled by biotech and pharma companies' assistance through financial and technological assets. Most customers also expect CDMOs to offer their expertise even after manufacturing, like in commercial launches.

This is mainly because CDMO’s customer base has expanded beyond the big pharmaceutical companies to smaller biotech firms. Additionally, many smaller biotech companies focus extensively on evolving their drug pipelines without any manufacturing experience. Therefore, taking help from CDMOs in development and manufacturing operations also enables the early incorporation of smaller biotech firms’ operations.

COVID-19 Impact Analysis

Some governments imposed regulations that resulted in the procurement of sufficient volumes of therapeutics and vaccines that were produced locally. However, production capacities were still not at their maximum because of supply chain and lockdown constraints. Disrupted supply chains interfered with the procurement of goods needed in the production processes, like the single-use plastic bags, which CDMOs use in the reactors. In addition, the lockdown constraints introduced a reduction in the workforce. These constraints resulted in a significant increase in the lead times, which increased up to four times. The delayed production and increased demand further helped in the growth of the CDMOs. Therefore, the pandemic positively impacted the large molecule drug substance CDMO market.

Market Growth Factors

Increasing Research And Development Of Biologics And Biosimilars

Since the pandemic, numerous businesses have been making significant investments in the creation of biologics and biosimilar compounds. Presently, biologics such as peptides, proteins, and monoclonal antibodies in the discovery stage are making up almost half of the candidates intended to be used as therapeutics. Biopharmaceutical businesses are increasingly putting their resources into research and development, and as a result, many novel biologics are either being developed or are in the pipeline. Hence, all of these factors aid in the growth of the large molecule drug substance CDMO market.

Growing Cardiovascular Diseases (CVD) And CVD-Induced Deaths

According to a paper published in the Journal of the American College of Cardiology that examined the total severity of cardiovascular disease (CVD) burden, the amount of people who die from (CVD) is steadily increasing. This number also includes one-third of all deaths globally in 2019. The statistics highlight the urgent need for nations to set up affordable public health initiatives that are affordable and focused on lowering heart disease risk through modifiable behaviors.

Market Restraining Factor

Complex Analytical Characterization Of Biologics And Strict Parameters And Regulations

The characterization of large molecules is extremely challenging. Biopharmaceutical companies are needed to characterize in numerous ways, including stability, purity, and function. Large molecules routinely demand a combination of many low and high-resolution techniques to validate the particle's structure efficiently. Additionally, numerous post-translational modifications (PTMs) are produced by large molecules during the recombinant synthesis method. Hence, the rise in R&D and investments in product development are boosting the growth and advancement of the large molecule drug substance CDMO market.

Application Outlook

Based on application, the large molecule drug substance CDMO market is categorized into mammalian, microbial, and others. The microbial segment procured a considerable growth rate in the large molecule drug substance CDMO market in 2021. Microbial systems are mostly utilized in the production of recombinant proteins to be used in therapeutic processes. As most of the drugs available in the market are produced through recombinant technologies, they propel the growth of microbial systems.

Service Outlook

On the basis of service, the large molecule drug substance CDMO market is divided into contract manufacturing and contract development. The contract manufacturing segment acquired the largest revenue share in the large molecule drug substance CDMO market in 2021. Contract manufacturing performs various functions like target screening and identification, functional informatics and target validation, preclinical development, and candidate optimization and lead identification.

End-User Outlook

Based on end-user, the large molecule drug substance CDMO market is segmented into biotech companies, CRO, and others. The CRO segment witnessed a considerable growth rate in the large molecule drug substance CDMO market in 2021. The clinical research organization needs the CDMOs assistance with the laboratory, clinical, preclinical, and discovery services. In addition, the rising demand for treatments of various diseases and disorders has also increased the volume of research to be conducted.

Large Molecule Drug Substance CDMO Market Report Coverage

Report Attribute	Details
Market size value in 2021	USD 10.8 Billion
Market size forecast in 2028	USD 19.2 Billion
Base Year	2021
Historical Period	2018 to 2020
Forecast Period	2022 to 2028
Revenue Growth Rate	CAGR of 8.7% from 2022 to 2028
Number of Pages	278
Number of Tables	501
Report coverage	Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Competitive Landscape, Companies Strategic Developments, Company Profiling
Segments covered	Application, Service, End-user, Region
Country scope	US, Canada, Mexico, Germany, UK, France, Russia, Spain, Italy, China, Japan, India, South Korea, Singapore, Malaysia, Brazil, Argentina, UAE, Saudi Arabia, South Africa, Nigeria
Growth Drivers	Increasing Research And Development Of Biologics And Biosimilars Growing Cardiovascular Diseases (CVD) And CVD-Induced Deaths
Restraints	Complex Analytical Characterization Of Biologics And Strict Parameters And Regulations

Regional Outlook

On the basis of region, the large molecule drug substance CDMO market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The Asia Pacific segment garnered the maximum revenue share in the large molecule drug substance CDMO market in 2021. A skilled workforce, compliable regulations, and lower overall costs are the main factors that propel the outsourcing of large molecule drug substances to the CDMOs of this region. The presence of a considerable consumer base present in this region has increased the need for improved medicines and treatment techniques.

Free Valuable Insights: Global Large Molecule Drug Substance CDMO Market size to reach USD 19.2 Billion by 2028

KBV Cardinal Matrix - Large Molecule Drug Substance CDMO Market Competition Analysis

The major strategies followed by the market participants are Partnerships. Based on the Analysis presented in the Cardinal matrix; Boehringer Ingelheim International GmbH is the forerunner in the Large Molecule Drug Substance CDMO Market. Companies such as FUJIFILM Diosynth Biotechnologies Texas LLC, WuXi Biologics (Cayman), Inc., Eurofins Scientific SE are some of the key innovators in Large Molecule Drug Substance CDMO Market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Eurofins Scientific SE, WuXi Biologics (Cayman), Inc, Catalent, Inc., Boehringer Ingelheim International GmbH, FUJIFILM Diosynth Biotechnologies Texas LLC (Fujifilm Corporation), Samsung Biologics Co., Ltd. (Samsung Group), Rentschler Biopharma SE, AGC Biologics, Inc. (AGC, Inc.), Recipharm AB (EQT AB), and Siegfried Holding AG.

Recent Strategies Deployed in Large Molecule Drug Substance CDMO Market

» Partnerships, Collaborations and Agreements:

• Oct-2022: WuXi partnered with Toregem BioPharma, a Japan-based biotechnology company, primarily into providing therapeutic agents meant for designing dental regenerative medicines. The partnership involves developing TRG035, an antibody meant for the treatment of congenital adentia. The partnership aligns with WuXi's aim to help global partners innovate new biologics solutions for patients worldwide.
• Oct-2022: FUJIFILM Diosynth Biotechnologies collaborated with RoosterBio, a US-based biotechnology company, primarily into providing stem cell products. The collaboration involves GMP manufacturing of exosome and cell therapies. The collaboration allows FUJIFILM to offer comprehensive cell therapy CDMO services to its customers.
• Dec-2021: WuXi partnered with ImmuneOncia, a South-Korea based Biotechnology Company, primarily into providing immunotherapies intended for the treatment of different types of cancer. The partnership involves leveraging WuXi's cell line development, bioassay development, cell culture development, and biologics manufacturing to develop bio specific antibodies. The antibody targets Programmed death-ligand 1 (PD-L1), and Cluster of Differentiation 47 (CD47).
• Sep-2021: Boehringer teamed up with Twist Bioscience, a US-based synthetic biology company. The collaboration involves combining Twist’s skill in generating potent, diverse therapeutic antibodies and Boehringer's expertise in drug discovery and development, which would enhance Boehringer's ability to better serve its clients and patients.
• Apr-2021: Samsung Biologics teams up with TG Therapeutics, a US-based biotechnology company. The collaboration involves expansion of contract manufacturing for TG Therapeutics' ublituximab, an antigen meant for use in lymphoma, leukemia, and multiple sclerosis. This collaboration aligns with Samsung Biologics' vision to better serve humanity by bringing required treatments to the patients.
• Jan-2021: Boehringer partnered with Google, a US-based global technology company. The partnership involves integrating Boehringer's competence in computer-based drug design and silico modeling with Google's expertise in algorithms and quantum computers to work on R & D. The partnership aims to advance R & D processes, thereby introducing more medical developments.
• Oct-2020: WuXi collaborated with AB2 Bio, a Switzerland-based drug development and discovery company. The collaboration involves advancing Commercial-Scale Manufacturing of Tadekinig alfa, an IL-18 binding protein meant for monogenic Hemophagocytic Lymphohistiocytosis (HLH). Based on the agreement, AB2 Bio would transfer commercial manufacturing of Tadekinig alfa to WuXi.
• Sep-2020: Samsung Biologics signed an agreement with AstraZeneca, a UK-based public company, primarily into marketing drugs for several diseases including, gastrointestinal, respiratory, cancer, etc. The agreement involves Samsung Biologics providing large-scale manufacturing of drug substances and drug products supporting AstraZeneca's biologics therapeutics. The agreement aligns with Samsung Biologics' purpose to support clients bring out innovative solutions.
• May-2020: Rentschler Biopharma collaborated with Genmab, a Denmark-based biotechnology company. The collaboration involves a business model that aligns with the expansion strategy of Rentschler Biopharma’s U.S. site in Milford, MA, and aims to manufacture and process the development of bispecific antibodies built on Genmab’s DuoBody® technology platform.
• Feb-2020: Catalent signed a contract with Zumutor Biologics, a US-based biotechnology company, primarily into providing NK cell therapeutics. The agreement involves manufacturing Zumutor’s ZM008 meant for solid tumor treatment.

» Acquisitions and Mergers:

• Aug-2022: Catalent acquired Metrics Contract Services (Metrics), a US-based organization, primarily into providing contract development and manufacturing services for the medical sector. The acquisition advances Catalent's ability to better serve its clients, particularly those clients with R & D pipelines having rare, orphan, diseases for oncology and other therapeutic areas.
• Apr-2022: Catalent took over a manufacturing facility in Oxfordshire from Vaccine Manufacturing and Innovation Centre UK Limited (VMIC Ltd.). The new facility enables Catalent to join forces with the biomedical science community, thereby furnishing opportunities to reshape innovation, and ideas into treatment for patients.
• Feb-2022: Recipharm took over GenIbet, a Portuguese company, primarily into providing CDMO services. The acquisition strengthens Recipharm's plan to expand in the Biologics market, particularly in drug substance manufacturing of novel ATMPs.
• Feb-2022: Recipharm took over Arranta Bio, a US-based company, primarily into supporting the development of health therapies. This acquisition forms a keystone in Recipharm’s plan to furnish drug developers with CDM services. Moreover, the acquisition expands Recipharm's presence in the US.
• Jan-2022: Samsung Biologics acquired the remaining share of Biogen in Samsung Bioepis, a Joint Venture between Biogen and Samsung Biologics. The acquisition would advance development in therapeutics R&D and biosimilars.
• Dec-2021: Eurofins acquired Genetic Lab, a Japanese company, primarily into pathological diagnostics services. This acquisition complements Eurofins' global network of clinical diagnostic laboratories and further boosts Eurofins' Asia expansion.
• Sep-2021: Boehringer took over Abexxa Biologics, a US-based biotechnology company. The acquisition strengthens Boehringer's devotion towards the discovery of tumor-antigen, and Abexxa's expertise in antigen discovery and antibody generation complements Boehringer's current approach to enable immune-targeting of cancer cells.
• Aug-2021: AGC Biologics acquired a commercial facility in Longmont, Colorado, USA from Novartis Gene Therapies. The acquisition expands AGC's manufacturing capacity supporting its global end-to-end Cell and Gene Therapy (C&GT) offerings and further expanding cell and gene therapy presence in the US.
• Feb-2020: Siegfried took over two manufacturing sites in Spain from Novartis. This acquisition expands Siegfried's global manufacturing network and aligns with its corporate strategy EVOLVE. The two new manufacturing facilities complement Siegfried's current operations in drug products.

» Geographical Expansions:

• Nov-2022: WuXi opened a new manufacturing facility in Fengxian, Shanghai. The facility is a Contract Research, Development, and Manufacturing (CRDMO) center, which would provide end-to-end services including process development, drug product development, analytical development, clinical drug substance, etc. The CRDMO center would enhance manufacturing and development capacity and would support the development of new biologics programs.
• Oct-2022: WuXi expanded its manufacturing facilities network, by opening a new facility in Shijiazhuang, Hebei Province, China. The new facility is a Contract Research, Development and Manufacturing Organization (CRDMO) center, named MFG8. MFG8 aligns with the company's foundation for commencing any project within 4 weeks and allows WuXi to better serve evolving needs for drug substance services.
• Oct-2022: Catalent expanded its geographical footprint by setting up a new facility in Kansas City, Missouri. The expansion includes setting up two new analytical development laboratories to fulfill evolving demands of assay development.

Scope of the Study

Market Segments Covered in the Report:

By Application

• Mammalian
• Microbial
• Others

By Service

• Contract Manufacturing
  • Commercial
  • Clinical
• Contract Development
  • Cell Line Development
  • Process Development

By End-user

• Biotech Companies
• CRO
• Others

By Geography

• North America
  • US
  • Canada
  • Mexico
  • Rest of North America
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Singapore
  • Malaysia
  • Rest of Asia Pacific
• LAMEA
  • Brazil
  • Argentina
  • UAE
  • Saudi Arabia
  • South Africa
  • Nigeria
  • Rest of LAMEA

Key Market Players

List of Companies Profiled in the Report:

• Eurofins Scientific SE
• WuXi Biologics (Cayman), Inc
• Catalent, Inc.
• Boehringer Ingelheim International GmbH
• FUJIFILM Diosynth Biotechnologies Texas LLC (Fujifilm Corporation)
• Samsung Biologics Co., Ltd. (Samsung Group)
• Rentschler Biopharma SE
• AGC Biologics, Inc. (AGC, Inc.)
• Recipharm AB (EQT AB)
• Siegfried Holding AG