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.
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.
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.
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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.
About Medi-Tech Insights
Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services in the areas of market assessments, due diligence, competitive intelligence, market sizing and forecasting, pricing analysis & go-to-market strategy. Our methodology includes rigorous secondary research combined with deep-dive interviews with industry-leading CXO, VPs, and key demand/supply side decision-makers.
Contact:
Ruta Halde
Associate, Medi-Tech Insights
+32 498 86 80 79
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