Large Molecule Drug Substance CDMO Market

Large Molecule Drug Substance CDMO Market Outlook 2032 

The global large molecule drug substance CDMO market size was USD 8.4 Billion in 2023 and is likely to reach USD 16.5 Billion by 2032, expanding at a CAGR of 7.8% during 2024–2032. The market growth is attributed to the ­­rising demand for novel biologics.

Contract manufacturing is a significant part of large molecule drug substance production, with companies outsourcing services due to high costs and delays. CDMOs are contract development and manufacturing organizations that process large molecules or biologics pharmacological substances, aiding in the discovery of new drugs through production capabilities. Healthcare contract development and manufacturing organizations offer comprehensive services, including drug development and manufacturing, by incorporating third-party projects and their knowledge.

The market for large molecule drugs is driven by FDA approvals, rising infectious disease prevalence, demand for novel therapeutics, and increased capital investments. The COVID-19 pandemic highlighted the importance of biologics, particularly in COVID-19 vaccines and therapeutic monoclonal antibody products. Therefore, the demand for high-volume quality CGMP drug substance and product manufacturing services has surged across the globe.

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Impact of Artificial Intelligence (AI) in the Large Molecule Drug Substance CDMO Market

Artificial Intelligence (AI) is revolutionizing the large molecule drug substance CDMO Market by improving process development, quality control, regulatory compliance, data-driven decision-making, and personalized medicine advancements. AI algorithms analyze historical data, enabling CDMOs to identify patterns, predict challenges, and optimize process parameters for new drugs.

Real-time monitoring of production processes minimizes errors and ensures consistent product quality. AI also guides CDMOs in meeting regulatory requirements, reducing compliance risks. Data-driven decision-making enables CDMOs to make informed decisions about resource allocation, pricing strategies, and capacity planning.

Large Molecule Drug Substance CDMO Market Dynamics

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Major Drivers

Rising demand for novel biologics is driving the market significantly. The pharmaceutical industry is witnessing a surge in the development of complex biologics, particularly monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). Biologic drugs offer high target specificity, enhanced efficacy, and improved treatment options as compared to traditional small molecule drugs, driving the large molecule drug substance CDMO market due to their potential to reduce side effects.

Existing Restraints

Stringent government regulation and a decline in licensing of biologics in advanced countries is expected to restrain the global market in the coming years. The high cost of compliance, lengthy approval process, and declining biologics licensing in developed markets is imposing constrains to the market. CDMOs need to adhere to strict regulations set forth by regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Emerging Opportunities

New manufacturing technologies, such as continuous manufacturing and single-use bioreactors, are streamlining production processes, offering fast turnaround times and potentially lower costs. Personalized medicine and gene therapies are promising, and CDMOs adapt their capabilities to handle small-scale production runs. Some CDMOs are also offering contract R&D services, providing a one-stop shop for drug development and production.

Scope of the Large Molecule Drug Substance CDMO Market Report

The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Large Molecule Drug Substance CDMO Market Segment Insights

Service Segment Analysis

Based on service, the market is bifurcated into contract development and contract manufacturing. The contract development segment is further divided into cell line development, upstream process development, downstream process development, analytical method development & validation, and preclinical studies. The contract manufacturing segment is further segmented into microbial fermentation, mammalian cell culturing, protein purification, and final formulation.

The contract manufacturing segment held a large share in the global market in 2023, owing to high volume and lower risk of technical challenges. Contract manufacturing deals with large-scale production of already developed drug substances. This inherently involves higher volumes as compared to contract development activities which focus on creating and optimizing the production process itself. Furthermore, established manufacturing processes for successful drugs enable CDMOs to produce them repeatedly for extended periods, generate recurring revenue, driving the segment.

The contract development segment is anticipated to expand at a substantial CAGR during the forecast period, owing to the rising demand for the novel therapies. Moreover, the focus on the efficiency and speed as well as technological advancements is driving the segment. Advancements in areas such as gene editing and gene therapy are creating new avenues for drug development. These novel approaches often require specialized expertise and facilities, which many pharmaceutical companies do not possess in-house. This creates a strong growth opportunity for CDMOs offering contract development services.

Source Segment Analysis

On the basis of source, the global market is segregated into mammalian, microbial, and others. The mammalian segment is anticipated to register a considerable CAGR in over the predicted period, owing to the rising demand for complex biologics. Furthermore, the rising efficacy and specificity of mammalian source as compared to drug produced from microbial sources is boosting the segment. Additionally, the increasing number of technological advancements in mammalian cell line engineering and culture techniques are enabling the efficient production of complex biologics, propelling the segment.

The microbial segment is expected to rise significantly during the forecast period, owing to the increasing number of drug launch consisting of secondary metabolites extracted from microbes. Microbes have produced some of the most important medicinal molecules, as a rich source of bioactive chemical metabolites. Secondary metabolites from microorganisms are already used for a number of reasons, aside from the treatment of bacterial, viral, and fungal infections.

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End-user Segment Analysis

On the basis of end-user, the large molecule drug substance CDMO market is segmented into biotech companies, CRO, academic institution, and small pharmaceutical companies. The biotech companies segment registers a robust growth rate in 2023, due to the high R&D investments. Focus of biotech companies on core competencies in drug discovery and early development is driving the segment. Furthermore, the increasing outsourcing of manufacturing capabilities of particularly small biotech companies is boosting the segment.  

The academic institution segment is expected to expand at a significant growth rate during the forecast period, owing to increased government funding for research in areas of gene therapeutics and rare diseases is expected to boost the segment significantly during the forecast period. Personalized medicine approaches often require small-scale and customized drug production runs. CDMOs cater to these needs, making them a valuable partner for institutions and companies involved in personalized medicine research.

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Regional Analysis

In terms of region, the global large molecule drug substance CDMO market is classified as Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa. North America dominates the global market in 2023, owing to increasing number of drug approvals. Moreover, the growing investments in R&D activities is expected to propel the regional market. For instance,

• In December 2020, Food and Drug Administration (FDA) approved 29 biosimilar medications for which the US spent USD 11 Billion on large molecules.

Presence of major market players in North America is fueling the market remarkably in this region. Increasing product launch by these strong market players and collaborations among them is expected to present opportunities in the market in the coming years. For instance,

The market in Asia Pacific is projected to grow at a significant pace in the coming years, owing to increasing number of developmental activities. Moreover, the highly skilled workforce in CDMO sector in India & China is expected to propel the market in this region during the forecast period. The rising number of product approvals by Food and Drug Administration (FDA) is presenting a robust opportunity for the regional market. Additionally, the increasing focus on R&D activities and generic manufacturers in India with affordable product options is boosting the market in Asia Pacific.

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Segments

The large molecule drug substance CDMO market has been segmented on the basis of

Service

• Contract Development
  • Cell line Development
  • Upstream Process Development
  • Downstream Process Development
  • Analytical Method Development & Validation
  • Preclinical studies
• Contract Manufacturing
  • Microbial Fermentation
  • Mammalian Cell Culturing
  • Protein Purification
  • Final Formulation

Source

• Mammalian
• Microbial
• Others

End-user

• Biotech Companies
• CRO & Academic Institution
• Small Pharmaceutical Companies

Region

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• AGC Biologics, Inc.
• Catalent, Inc.
• Eurofins Scientific SE
• FUJIFILM Diosynth Biotechnologies Texas LLC
• LabCorp Drug Development
• Lonza Group
• Recipharm AB (publ)
• Samsung Biologics Co., Ltd.
• Siegfried Holding AG
• WuXi Biologics (Cayman), Inc.

Competitive Landscape

Key players competing in the global large molecule drug substance CDMO market are

AGC Biologics, Inc.; Catalent, Inc.; Eurofins Scientific SE; FUJIFILM Diosynth Biotechnologies Texas LLC; LabCorp Drug Development; Lonza Group; Recipharm AB (publ); Samsung Biologics Co., Ltd.; Siegfried Holding AG; and WuXi Biologics (Cayman), Inc.

These companies adopted development strategies including mergers, acquisitions, partnerships, collaboration, product launches, and production expansion to expand their consumer base globally. For instance,

• In October 2022, WuXi partnered with Toregem BioPharma, a Japan-based biotechnology company, primarily to supply medicinal substances for the development of dental regeneration medications. As part of the partnership, an antibody called TRG035 is expected to be developed to treat congenital dementia. The partnership aligns with WuXi's mission to support international partners in creating ground-breaking biologics solutions for patients across the globe.

• In October 2022, RoosterBio, a US-based biotechnology company, and FUJIFILM Diosynth Biotechnologies partnered specifically to supply stem cell products. The partnership includes cell therapies and GMP exosome production. Through the partnership, FUJIFILM is able to provide its clients full-service CDMO solutions for cell therapy.

• In September 2021, Twist Bioscience, a synthetic biology company in the US, and Boehringer collaborated. By combining the experience of Twist Bioscience in drug discovery and development with its ability to create strong, diverse therapeutic antibodies, Boehringer is expected to be well equipped to serve its customers and patients as a result of this agreement.