The biologics drug substance manufacturing market is witnessing substantial expansion, largely due to the growing prevalence of chronic diseases, which is driving the need for biologics development and production. This upward trend is further supported by advancements in manufacturing technology, increased research and development efforts, and a wave of new product launches by major industry players.
LAS VEGAS, Feb. 5, 2025 -- DelveInsight's Biologics Drug Substance Manufacturing Market Insights report provides the current and forecast market analysis, individual leading biologics drug substance manufacturing companies' market shares, challenges, biologics drug substance manufacturing market drivers, barriers, trends, and key market biologics drug substance manufacturing companies in the market.
Key Takeaways from the Biologics Drug Substance Manufacturing Market Report
- As per DelveInsight estimates, North America is anticipated to dominate the global biologics drug substance manufacturing market during the forecast period.
- In the biologics type segment of the biologics drug substance manufacturing market, the monoclonal antibodies category accounted for the largest market share in 2024.
- Notable biologics drug substance manufacturing companies such as Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, and several others, are currently operating in the biologics drug substance manufacturing market.
- In September 2024, Samsung Biologics launched biologics' innovative development platforms – S-AfuCHOTM and S-OptiChargeTM. S-AfuCHOTM is an innovative cell line platform designed to produce fucosylated antibodies, which demonstrate enhanced antibody-dependent cellular cytotoxicity (ADCC) activity, leading to increased therapeutic efficacy. In parallel, S-OptiChargeTM serves as an upstream process platform capable of modulating a molecule's charge variant distribution.
- In June 2024, Bionova Scientific, a U.S.-based biologics contract development and manufacturing organization (CDMO) within the Asahi Kasei Group, announced plans to establish a new facility in Texas. This expansion aims to enhance its capabilities in biologics manufacturing and support the growing demand for biopharmaceutical products.
- In January 2024, Enzene Biosciences announced the launch of its first manufacturing site in the United States, situated in Hopewell, near Princeton, New Jersey. The company has leased 54,000 square feet of space to accommodate multiple manufacturing lines utilizing its continuous manufacturing technology platform, EnzeneX™. This facility is designed to integrate Enzene's patented EnzeneX™ platform, allowing for efficient and scalable production of biologics.
To read more about the latest highlights related to the biologics drug substance manufacturing market, get a snapshot of the key highlights entailed in the Global Biologics Drug Substance Manufacturing Market Report
Biologics Drug Substance Manufacturing Overview
Biologics drug substance manufacturing is a highly complex and tightly regulated process that involves the production of therapeutic proteins, monoclonal antibodies, vaccines, and other biologics derived from living cells. Unlike small molecule drugs, biologics are large, structurally intricate molecules produced using cell culture systems such as Chinese Hamster Ovary (CHO) cells, bacterial or yeast expression systems. The process typically involves upstream processing, where cell lines are cultivated in bioreactors under controlled conditions to maximize yield, followed by downstream processing, which includes purification steps such as chromatography and ultrafiltration to ensure high purity and efficacy. Stringent quality control and adherence to Good Manufacturing Practices (GMP) are crucial at every stage to ensure consistency, safety, and efficacy of the final drug substance.
Scaling up biologics manufacturing from lab-scale to commercial production presents significant challenges, including maintaining cell viability, optimizing yields, and ensuring batch-to-batch consistency. Advances in single-use bioreactors, process intensification, and automation have helped streamline manufacturing while improving flexibility and cost efficiency. Regulatory agencies such as the FDA and EMA impose strict guidelines on manufacturing practices, requiring extensive characterization, validation, and risk mitigation strategies to minimize variability and contamination risks. As biologics continue to dominate the pharmaceutical market, innovations in continuous manufacturing, cell-free synthesis, and AI-driven process optimization are shaping the future of biologics drug substance manufacturing, making it more scalable, efficient, and accessible for global patient needs.
Biologics Drug Substance Manufacturing Market Insights
In 2024, North America held the largest share of the biologics drug substance manufacturing market among all regions. This growth is primarily fueled by a rising patient population affected by chronic diseases like cancer and diabetes. Additionally, the increasing geriatric population, which is more prone to such conditions, further accelerates market expansion. Key contributors to this trend include heightened research and development efforts by leading companies and the growing adoption of biologic drugs.
To strengthen their market presence, major industry players are actively establishing biologics manufacturing facilities in the region. For example, in July 2024, BeiGene Ltd. inaugurated its flagship U.S. facility in Hopewell, New Jersey, within the Princeton West Innovation Campus. This advanced site integrates state-of-the-art biologics manufacturing with a clinical research and development center, reinforcing BeiGene's position as a leader in oncology innovation. Spanning approximately 400,000 square feet, the facility is designed for commercial-scale biologic drug production and allows for future expansion. Such developments are expected to further propel market growth in North America.
To know more about why North America is leading the market growth in the biologics drug substance manufacturing market, get a snapshot of the Biologics Drug Substance Manufacturing Market Outlook
Biologics Drug Substance Manufacturing Market Dynamics
The biologics drug substance manufacturing market is experiencing rapid growth, driven by increasing demand for biologic therapies, including monoclonal antibodies, cell and gene therapies, and recombinant proteins. With the rising prevalence of chronic diseases such as cancer, autoimmune disorders, and rare genetic conditions, pharmaceutical companies are investing heavily in biologics development and production. Unlike small-molecule drugs, biologics require complex manufacturing processes involving living cells, stringent quality controls, and specialized infrastructure, making the market highly competitive and capital-intensive.
A key trend in the market is the growing reliance on contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). Many biotech companies, particularly small and mid-sized firms, lack the resources to build and operate large-scale biologics manufacturing facilities. As a result, they partner with specialized CDMOs that offer end-to-end services, from cell line development to commercial-scale production. This has led to increased investments in CDMO capacity expansion, with major players enhancing their capabilities in advanced bioprocessing technologies, single-use systems, and continuous manufacturing.
Regulatory dynamics also play a crucial role in shaping the market. Regulatory agencies like the FDA and EMA have stringent guidelines for biologics manufacturing, ensuring product safety, efficacy, and consistency. Recent advancements in biosimilar regulations have further influenced the market, creating opportunities for companies to develop cost-effective alternatives to expensive biologics. However, navigating regulatory requirements remains a challenge, requiring significant expertise in Good Manufacturing Practices (GMP), process validation, and analytical characterization.
Technological innovations are transforming the biologics manufacturing landscape. Advances in cell culture techniques, bioreactor design, and automation are improving productivity, scalability, and cost efficiency. The adoption of artificial intelligence (AI) and machine learning in bioprocess optimization is further streamlining manufacturing workflows, reducing batch failures, and enhancing yield. Additionally, the shift toward personalized medicine is driving demand for flexible manufacturing solutions, including modular facilities and decentralized production models.
Despite the strong growth potential, challenges such as high production costs, supply chain constraints, and talent shortages persist. The complexity of biologics manufacturing requires a highly skilled workforce, and the industry faces a shortage of professionals with expertise in bioprocess engineering and regulatory compliance. Companies are addressing these challenges by investing in workforce development programs, expanding automation, and improving supply chain resilience through strategic partnerships. As the biologics market continues to expand, addressing these challenges will be crucial for sustaining long-term growth and innovation.
Get a sneak peek at the biologics drug substance manufacturing market dynamics @ Biologics Drug Substance Manufacturing Market Dynamics Analysis
Report Metrics | Details |
Coverage | Global |
Study Period | 2022–2032 |
Biologics Drug Substance Manufacturing Market CAGR | ~11% |
Biologics Drug Substance Manufacturing Market Size by 2032 | USD 968 Million |
Key Biologics Drug Substance Manufacturing Companies | Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, among others |
Biologics Drug Substance Manufacturing Market Assessment
- Biologics Drug Substance Manufacturing Market Segmentation
- Biologics Drug Substance Manufacturing Market Segmentation By Biologics Type: Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others
- Biologics Drug Substance Manufacturing Market Segmentation By Manufacturing: In-house and Outsourced
- Biologics Drug Substance Manufacturing Market Segmentation By Production Source: Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation
- Biologics Drug Substance Manufacturing Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
- Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View
Which MedTech key players in the biologics drug substance manufacturing market are set to emerge as the trendsetter explore @ Biologics Drug Substance Manufacturing Companies
Table of Contents
1 | Biologics Drug Substance Manufacturing Market Report Introduction |
2 | Biologics Drug Substance Manufacturing Market Executive Summary |
3 | Competitive Landscape |
4 | Regulatory Analysis |
5 | Biologics Drug Substance Manufacturing Market Key Factors Analysis |
6 | Biologics Drug Substance Manufacturing Market Porter's Five Forces Analysis |
7 | Biologics Drug Substance Manufacturing Market Layout |
8 | Biologics Drug Substance Manufacturing Market Company and Product Profiles |
9 | KOL Views |
10 | Project Approach |
11 | About DelveInsight |
12 | Disclaimer & Contact Us |
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