Global Large Molecule Drug Substance CDMO Market Size & Trends Report Segmented by Service (Contract Manufacturing, Contract Development), Source (Mammalian, Microbial), End-user (CRO, Biotech Companies), & Regional Forecast to 2030
The large molecule drug substance CDMO market is anticipated to expand at a CAGR of ~9% during the forecast period. Key drivers of this growth include increasing demand for biosimilars and biologics, technological advancement in bioprocessing, increasing FDA & EMA approvals for large molecule drugs, rising incidence of chronic and infectious diseases, growing investments in biologics manufacturing by pharma and biotech companies, and expanding biotech sectors in emerging markets. To learn more about the research report, download a sample report.
Report Overview
Large molecule drug substances are biologic drugs, characterized by their complex molecular structures and production using living cells. Examples include monoclonal antibodies, recombinant proteins, vaccines, gene therapies, and cell-based therapies. A contract development and manufacturing organization (CDMO) offers outsourced services for drug development and production, managing processes such as cell line development, process optimization, upstream and downstream processing, formulation, analytical testing, and regulatory compliance. A large molecule drug substance CDMO is a specialized company that provides contract-based services for the development and manufacturing of biological drug substances, supporting pharmaceutical and biotechnology companies in bringing complex therapeutics to market.
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Growing demand for biosimilars and biologics drives market growth
Large molecule drugs, or biologics, are complex therapies derived from living organisms, making their development and manufacturing inherently challenging. Unlike small molecule chemical APIs, which are often formulated as oral medications, biologics are predominantly administered as parenteral drug products due to their structural complexity and sensitivity. The growing demand for biologic therapies, particularly antibody-based treatments, is driven by their ability to effectively target and manage rare diseases such as various cancers, Crohn’s disease, multiple sclerosis, and cystic fibrosis.
At the same time, the expiration of patents on blockbuster biologics has fueled the rapid expansion of the biosimilar market, as pharmaceutical companies seek cost-effective alternatives to high-priced biologic therapies. Regulatory bodies such as the FDA and EMA have streamlined biosimilar approval pathways, further accelerating biosimilar development and increasing the demand for specialized large-molecule manufacturing expertise. This is where CDMOs play a pivotal role. These specialized service providers offer state-of-the-art infrastructure, advanced technical expertise, and highly skilled personnel required for the intricate processes involved in biologics and biosimilar manufacturing. As the adoption of large molecule drugs continues to transform the pharmaceutical industry, CDMOs enable scalable, cost-efficient, and regulatory-compliant production, driving sustained market growth.
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Increasing approval from FDA & EMA for large molecule drugs fuels its demand
The pharmaceutical industry has increasingly shifted its focus from small molecules to biologics, recognizing their superior efficacy in treating chronic and rare diseases such as cancer, autoimmune disorders, and genetic conditions. To accelerate the availability of these life-saving large-molecule drugs, regulatory agencies like the FDA and EMA have implemented fast-track approval pathways. Programs such as the FDA’s Breakthrough Therapy Designation, Fast Track, and Priority Review expedite the review process for promising biologics, while the EMA’s PRIME (Priority Medicines) designation facilitates quicker approvals for innovative treatments addressing unmet medical needs.
The rise in orphan drug approvals has further contributed to the growing number of biological drug approvals, particularly for rare and ultra-rare diseases. A June 2024 report by Aptitude Health revealed that over half of FDA and EMA approvals in Q2 2024 were for biologics or biosimilars, underscoring this trend.
Additionally, the expiration of patents for blockbuster biologics like Humira, Herceptin, and Avastin has driven an increase in biosimilar approvals, as regulatory bodies seek to enhance market competition and reduce healthcare costs. Initiatives such as the FDA’s Biosimilar Action Plan (BAP) and the EMA’s streamlined biosimilar approval pathways have simplified regulatory processes, facilitating faster approvals. The surge in FDA and EMA approvals for large-molecule drugs reflects the rapid evolution of the biologics and biosimilar market. With advancements in regulatory pathways, scientific innovation, and increased investment in biopharmaceutical research, this trend is expected to persist, further driving demand for large molecule drug manufacturing and reshaping the future of healthcare.
Competitive Landscape Analysis
The global large molecule drug substance CDMO market is marked by the presence of established and emerging market players such as Eurofins Scientific; WuXi Biologics; Samsung Biologics; Catalent, Inc.; Rentschler Biopharma SE; AGC Biologics; Recipharm AB; Siegfried Holding AG; Boehringer Ingelheim; Thermo Fisher Scientific; and FUJIFILM Diosynth Biotechnologies among others. Some of the key strategies adopted by market players include new service development, strategic partnerships and collaborations, and investments.
Report Scope
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Report Scope |
Details |
|
Base Year Considered |
2024 |
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Historical Data |
2023 – 2024 |
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Forecast Period |
2025 – 2030 |
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Growth Rate |
~9% |
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Market Drivers |
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Attractive Opportunities |
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Segment Scope |
Service, Source, and End-user |
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Regional Scope |
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Key Companies Mapped |
Eurofins Scientific; WuXi Biologics; Samsung Biologics; Catalent, Inc.; Rentschler Biopharma SE; AGC Biologics; Recipharm AB; Siegfried Holding AG; THermo Fisher Scientific; Boehringer Ingelheim; and FUJIFILM Diosynth Biotechnologies |
|
Report Highlights |
Market Size & Forecast, Growth Drivers & Restraints, Trends, Competitive Analysis |
Market Segmentation
This report by Medi-Tech Insights provides the size of the global large molecule drug substance CDMO market at the regional- and country-level from 2023 to 2030. The report further segments the market based on service, source, and end-user.
- Market Size & Forecast (2023-2030), By Service, USD Million
- Contract Manufacturing
- Clinical
- Commercial
- Contract Development
- Cell Line Development
- Process Development
- Market Size & Forecast (2023-2030), By Source, USD Million
- Mammalian
- Microbial
- Others
- Market Size & Forecast (2023-2030), By End-user, USD Million
- CRO
- Biotech Companies
- Others
- Market Size & Forecast (2023-2030), By Region, USD Million
- North America
- US
- Canada
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Rest of Asia Pacific
- Latin America
- Middle East & Africa
- North America
Key Strategic Questions Addressed
- What is the market size & forecast of the large molecule drug substance CDMO market?
- What are the historical, present, and forecasted market shares and growth rates of various segments and sub-segments of the large molecule drug substance CDMO market?
- What are the key trends defining the market?
- What are the major factors impacting the market?
- What are the opportunities prevailing in the market?
- Which region has the highest share in the global market? Which region is expected to witness the highest growth rate in the next 5 years?
- Who are the major players operating in the market?
- What are the key strategies adopted by players?
- Introduction
- Introduction​
- Market Scope​
- Market Definition​
- Segments Covered​
- Regional Segmentation​
- Research Timeframe​
- Currency Considered​
- Study Limitations​
- Stakeholders​
- List of Abbreviations​
- Key Conferences and Events (2025-2026)​
- Research Methodology​
- Secondary Research​
- Primary Research​
- Market Estimation​
- Bottom-Up Approach​
- Top-Down Approach​
- Market Forecasting​
- Executive Summary
- Large Molecule Drug Substance CDMO Market Snapshot (2025-2030)​
- Segment Overview​
- Regional Snapshot​
- Competitive Insights ​
- Market Overview
- Market Dynamics
- Drivers
- Increasing demand for biosimilars and biologics
- Technological advancement in bioprocessing
- Increasing FDA & EMA approvals for large molecule drugs
- Rising incidence of chronic and infectious diseases
- Growing investments in biologics manufacturing by pharma and biotech companies
- Expanding biotech sectors in emerging markets
- Restraints​
- High costs associated with advanced manufacturing technologies
- Complex analytical characterization of biologics
- Stringent government regulatory regulations
- Opportunities
- Increasing focus on personalized medicine
- Expansion in cell and gene therapy manufacturing
- Increased strategic collaborations & partnerships between pharmaceutical companies and CDMOs
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- Key Market Trends​
- Growing usage of AI, machine learning, and predictive analytics in biomanufacturing
- Rising demand for mRNA-based therapeutics
- Adoption of single-use bioprocessing technologies
- Unmet Market Needs​
- Industry Speaks​
- Key Market Trends​
- Global Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By Service, USD Million
- Introduction​
- Contract Manufacturing
- Clinical
- Commercial
- Contract Development
- Cell Line Development
- Process Development
- Global Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By Source, USD Million
- Introduction​
- Mammalian
- Microbial
- Others
- Global Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By End-user, USD Million
- Introduction​
- CRO
- Biotech Companies
- Others
- Global Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By Region, USD Million
- Introduction​
- North America Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By Country, USD Million​
- US​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Canada​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- US​
- Europe Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By Country, USD Million​
- UK ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Germany ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- France
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Italy ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Spain ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Rest of Europe ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- UK ​
- Asia Pacific (APAC) Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), By Country, USD Million​
- China ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Japan ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- India ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Rest of Asia Pacific ​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- China ​
- Latin America (LATAM) Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), USD Million​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Middle East & Africa (MEA) Large Molecule Drug Substance CDMO Market Size & Forecast (2023-2030), USD Million​
- Market Size & Forecast, By Service (USD Million)​
- Market Size & Forecast, By Source (USD Million)
- Market Size & Forecast, By End-user (USD Million)​
- Competitive Landscape
- Key Players and their Competitive Positioning
- Key Player Comparison
- Segment-wise Player Mapping
- Market Share Analysis (2024)
- Company Categorization Matrix
- Dominants/Leaders
- New Entrants
- Emerging Players
- Innovative Players
- Key Strategies Assessment, By Player (2022-2025)
- New Service Launches
- Partnerships, Agreements, & Collaborations
- Mergers & Acquisitions
- Geographic Expansion
- Key Players and their Competitive Positioning
- Company Profiles* (Business Overview, Financial Performance**, Products Offered, Recent Developments)
- Eurofins Scientific
- WuXi Biologics
- Samsung Biologics
- Catalent, Inc.
- Rentschler Biopharma SE
- AGC Biologics
- Recipharm AB
- Siegfried Holding AG
- Boehringer Ingelheim
- FUJIFILM Diosynth Biotechnologies
- Other Prominent Players
  Note: *Indicative list
  **For listed companies
The study has been compiled based on extensive primary and secondary research.
Secondary Research (Indicative List)
Primary Research
To validate research findings (market size & forecasts, market segmentation, market dynamics, competitive landscape, key industry trends, etc.), extensive primary interviews were conducted with both supply and demand-side stakeholders.
Supply Side Stakeholders:
- Senior Management Level: CEOs, Presidents, Vice-Presidents, Directors, Chief Technology Officers, Chief Commercial Officers
- Mid-Management Level: Product Managers, Sales Managers, Brand Managers, R&D Managers, Business Development Managers, Consultants
Demand Side Stakeholders:
- Stakeholders from CROs, Biotech Companies, and Others
Breakdown of Primary Interviews
Market Size Estimation
Both ‘Top-Down & Bottom-Up Approaches’ were used to derive market size estimates and forecasts.
Data Triangulation
Research findings derived through secondary sources & internal analysis were validated with Primary Interviews, the Internal Knowledge Repository, and the Company’s Sales Data.
