Biologics Drug Substance Manufacturing - Market Insights, Competitive Landscape, and Market Forecast - 2032

Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence chronic diseases and technological advancements in biologics manufacturing

The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032. The market for biologics drug substance manufacturing is experiencing significant growth, primarily driven by the increasing prevalence of chronic diseases, which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.

Biologics Drug Substance Manufacturing Market Dynamics:

The growing prevalence of chronic disease is expected to drive the market growth. According to recent data provided by GLOBOCAN in 2023, the estimated new number of cancer cases was 20 million in 2022, and the projection is estimated to increase to 32.6 million by 2045 around the world.

Furthermore, according to recent data from Cancer Research UK in 2023, over 385,000 new cancer cases are reported annually in the United Kingdom. This alarming statistic underscores the urgent need for effective treatment options. Biologics are recognized as a promising and innovative approach for addressing various cancer types, significantly contributing to the growing demand for biologic drugs.

The data from the International Diabetes Federation in 2023, indicates that approximately 537 million adults aged 20 to 79 were living with diabetes in 2021. This figure is projected to escalate to 643 million by 2030 and 783 million by 2045 globally.

According to the data from World Obesity Federation in 2022, it was projected that, approximately 1 billion people, representing 1 in 5 women and 1 in 7 men, will be living with obesity by 2023 across the globe. This rise in obesity is closely linked to the increasing incidence of chronic diseases, which require long-term and continuous treatment. As a result, there is a consistent demand for biologic drugs, significantly driving market growth.

The growing adoption of biologics, particularly vaccines, is expected to significantly propel market growth. According to the data from the World Health Organization in July 2024, approximately 84% of infants worldwide; around 108 million received three doses of the diphtheria-tetanus-pertussis (DTP3) vaccine in 2023, providing crucial protection against infectious diseases. This increasing utilization and acceptance of vaccines is driving demand for biologics drug substance manufacturing, thereby fostering market expansion.

Key players in the market are focusing on innovative technologies to enhance biologics manufacturing. For instance, in October 2024, Forge Biologics announced the launch of its FUEL(TM) manufacturing platform, designed to offer AAV gene therapy developers a more efficient and accelerated foundation for production as they advance new programs and target a broader range of diseases.

Additionally, major players are expanding their capabilities in biologics manufacturing through strategic mergers and acquisitions. For instance, in October 2024, Lonza completed its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, California, from Roche for USD 1.2 billion. This acquisition significantly enhances Lonza's capacity for mammalian manufacturing in the United States. Such strategic moves by key players are expected to further stimulate market growth.

However, the high development and production costs of biologics and stringent regulatory requirements, among others are some of the key constraints that may limit the growth of the biologics drug substance manufacturing market.

Biologics Drug Substance Manufacturing Market Segment Analysis:

Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the biologics type segment of the biologics drug substance manufacturing market, the monoclonal antibodies category is estimated to account for the largest market share in the biologics drug substance manufacturing market in 2024. This can be attributed to the growing prevalence of cancer and infectious diseases, among other factors. According to recent data from the Global Burden of Disease (2023), approximately 1 in 20 people globally suffer from chronic respiratory diseases. Furthermore, data from GLOBOCAN indicates that in 2022, there were an estimated 2.48 million new cases of trachea, bronchus, and lung cancer worldwide, with projections expected to rise to 4.25 million by 2045. Monoclonal antibodies are increasingly utilized in targeted cancer therapy, making the rising prevalence of cancer a significant driver of demand for these biologics. Consequently, this heightened demand is propelling the capabilities of biologics drug substance manufacturing, leading to robust market growth.

Major players in the market are increasingly focusing on the development of innovative technologies to enhance their monoclonal antibody manufacturing capabilities. For instance, in April 2024, Evotec Biologics launched the J.CHO(TM) high expression system, designed for the continuous manufacturing of antibodies. As part of Evotec Biologics' advanced continuous bioprocessing platform, J.CHO(TM) optimizes both clinical and commercial biologics production processes by delivering higher productivity and ensuring the high quality of complex antibody formats, including candidate antibodies, Fc-fusions, and bispecific antibodies. This innovation is expected to significantly contribute to the efficiency and effectiveness of monoclonal antibody manufacturing, thereby promoting market growth.

North America is expected to dominate the overall biologics drug substance manufacturing market:

North America is projected to account for leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.

According to the American Cancer Society's Cancer Facts & Figures in 2024, nearly 2 million new cancer cases were expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023.

According to the data from the GLOBOCAN in 2024, North America saw an estimated number of 2,673,174 million new cases of cancer in 2022, with forecasts indicating a rise to 3,828,805 million by 2045. Chronic conditions such as cancer and autoimmune diseases can be treated with biologics and specialty drugs, which are complex molecules and require advanced manufacturing processes. Therefore, the increasing prevalence of cancer is driving the market growth.

Also, according to data from the American Diabetes Association (2023), approximately 38.4 million people, or 11.6% of the population, were living with diabetes in 2021 in the United States. Among these individuals, 29.7 million had received a diagnosis, while an estimated 8.7 million were undiagnosed. The rising prevalence of such conditions has driven demand for more effective treatments. Biologics are increasingly used in these areas due to their specificity and lower toxicity compared to small-molecule drugs.

The growing number of chronic diseases such as cancer requires the development of novel biological drugs for effective treatment, which leads to increased biological drug substance manufacturing, thereby driving the market growth.

Key players in the region are actively establishing biological manufacturing facilities to strengthen their market position. For instance, in July 2024, BeiGene Ltd. announced the opening of its flagship U.S. facility in Hopewell, N.J., located at the Princeton West Innovation Campus. This facility boasts state-of-the-art biologics manufacturing capabilities, alongside a clinical research and development center that enhances the company's reputation as an oncology innovator. The site features approximately 400,000 square feet dedicated to commercial-stage biologic pharmaceutical manufacturing, with the capacity for future expansion. Such activities are expected to drive the market growth in the region.

Therefore, the above-mentioned factors will contribute to the growth of the biologics drug substance manufacturing market in North America.

Biologics Drug Substance Manufacturing Market Key Players:

Some of the key market players operating in the biologics drug substance manufacturing market include 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 others.

Recent Developmental Activities 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(TM). This facility is designed to integrate Enzene's patented EnzeneX(TM) platform, allowing for efficient and scalable production of biologics.
• In October 2023, WuXi Biologics announced the launch of its new proprietary bioprocessing platform, WuXiUITM. This ultra-intensified, fed-batch solution is designed to enhance the productivity and quality of various CHO (Chinese Hamster Ovary) and other mammalian cell lines, as well as different product modalities. The WuXiUITM platform significantly improves both productivity and quality while reducing the cost of goods sold (COGS) in commercial manufacturing.

Key Takeaways from the Biologics Drug Substance Manufacturing Market Report Study

• Market size analysis for current Biologics Drug Substance Manufacturing Market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the Biologics Drug Substance Manufacturing market.
• Various opportunities available for the other competitors in the Biologics Drug Substance Manufacturing Market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current Biologics Drug Substance Manufacturing market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for Biologics Drug Substance Manufacturing market growth in the coming future?

Target Audience who can be benefited from this Biologics Drug Substance Manufacturing Market Report Study

• Biologics Drug Substance Manufacturing product providers
• Research organizations and consulting companies
• Biologics Drug Substance Manufacturing related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders dealing in Biologics Drug Substance Manufacturing
• Various end-users who want to know more about the Biologics Drug Substance Manufacturing Market and the latest technological developments in the Biologics Drug Substance Manufacturing Market.

Frequently Asked Questions for the Biologics Drug Substance Manufacturing Market:

1. What are Biologics Drug Substance Manufacturing?

• Biologics drug substance manufacturing is the process of producing biologic drugs, which are medicines made from living organisms. This includes growing cells to produce proteins, purifying those proteins, and preparing them for use in treatments, like vaccines or therapies for diseases.

2. What is the market for Biologics Drug Substance Manufacturing?

• The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032.

3. What are the drivers for the Biologics Drug Substance Manufacturing market?

• The biologics drug substance manufacturing market is poised for significant growth, driven by factors such as the rising prevalence of chronic diseases which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.

4. Who are the key players operating in the Biologics Drug Substance Manufacturing market?

• Some of the key market players operating in the biologics drug substance manufacturing market include 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 others.

5. Which region has the highest share in the Biologics Drug Substance Manufacturing market?

• North America is projected to account for the leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.