GMP Biologics Market size was valued at USD 68.1 billion in 2024 and is anticipated to surpass USD 425.6 billion by 2037, registering a CAGR of 16.5% during the forecast timeline i.e. 2025-2037. In 2025, the industry size of GMP biologics is evaluated at USD 79.3 billion.
The GMP biologics market is witnessing substantial growth, driven by multiple synergies underscoring the growing demand for high-quality and compliant biologic products. The growing prevalence of chronic diseases such as cancer and autoimmune disorders fuels the demand for innovative biological therapies. Moreover, higher regulatory standards with improved safety and product efficacy complement the investments with state-of-the-art GMP manufacturing facilities. For instance, in December 2024, WuXi Biologics reported significant achievements at its state-of-the-art greenfield location in Dundalk, Ireland. At its MFG7 drug material suite, the plant has successfully finished several 16,000-liter Process Performance Qualification (PPQ) runs.
In addition, the GMP biologics activities also the consumption due to higher uptake of customized or personalized therapy along with progress in biologics pipelines offered by established Pharma players and more newly formed companies. For instance, in August 2024, the development of NECVAX-NEO1, an oral, bacterial DNA vaccine intended to target tumor neoantigens unique to each patient, was advanced by a collaboration between AGC Biologics and NEC BioTherapeutics. By utilizing the biotechnology capabilities of both businesses, this significant and exciting partnership seeks to improve the development of customized cancer treatments. Hence, scientific innovation and regulatory rigors align with the needs of the market.
Growth Drivers
Challenges
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
16.5% |
|
Base Year Market Size (2024) |
USD 68.1 billion |
|
Forecast Year Market Size (2037) |
USD 425.6 billion |
|
Regional Scope |
|
Application (Hospitals, Clinics, Others)
Hospitals segment is projected to dominate GMP biologics market share of over 61.6% by 2037. Advanced biologics, such as monoclonal antibodies, gene therapies, and individualized treatments, are mainly administered through hospitals, especially in the treatment of conditions such as cancer, autoimmune disorders, and genetic diseases. As these conditions are on the rise and better managed in hospitals. For instance, in January 2024, the National Institutes of Health stated that nearly 10 million people died from cancer in 2020. By 2040, the incidence of cancer is predicted to increase by more than 40%. Between 2020 and 2050, the estimated global cost of cancer will exceed USD 25 trillion.
Type (Monoclonal Antibodies, Polyclonal Antibody)
Based on type, the monoclonal antibodies segment is likely to dominate the GMP biologics market during the forecast timeline because it is highly utilized in most of chronic and deadly diseases which comprise cancerous diseases, auto-immune conditions, and infective diseases. Advancements in mAb production technologies, increasing demand for targeted therapies, and increasing regulatory approvals enhance the rate of adoption in the market for mAbs. For instance, in September 2023, based on KBI's SUREtechnology platform for efficient, safe, and cost-effective monoclonal antibody (mAb) development and manufacturing SUREmAb was introduced by KBI Biopharma, Inc.,. SUREmAb is a vertically integrated global offering created to reduce development timelines for international biopharmaceutical manufacturers.
Our in-depth analysis of the global market includes the following segments:
|
Application |
|
|
Type |
|
North America Market Statistics
North America GMP biologics market is projected to dominate revenue share of over 46.4% by 2036. The market is expanding due to the advancements in companion diagnostics and personalized medicine. In addition, the use of monoclonal antibodies and biosimilars, technological developments in bioprocessing, and a growing emphasis on customized care is growing. Hence, the demand for biological products rise as a result of these developments, which make treatments more efficient and targeted.
U.S. GMP biologics market is exponentially growing attributable to a noticeable increase in research and development activities pertaining to biopharmaceuticals. For instance, in June 2024, Bionova Scientific decided to open a new business line offering services utilizing plasmid DNA and build a facility specifically for this purpose in Texas, U.S. It has gained additional growth prospects by expanding well-established businesses such as PlanovaTM virus removal filters and entering the CRO (contract research organization) and CDMO (contract development and manufacturing organization) industries while utilizing its clientele and strong brand.
Canada GMP biologics market is witnessing a notable growth owing to the expansion of manufacturing facilities in advancements of biologics. For instance, in September 2024, Eurofins CDMO Alphora Inc. announced plans to construct a new GMP Biologics manufacturing facility (50,000 sq ft facility) in Mississauga, Ontario. This facility aims to manufacture monoclonal Antibodies (mAbs) and protein therapies for clinical and commercial applications. In addition, this investment is supported by the Federal Government of Canada and a contribution through the Strategic Initiative Fund (SIF). The facility is designed to bolster Canada’s biomanufacturing capabilities while strengthening the biologics ecosystem and employment base in Canada.
Asia Pacific Market Analysis
The Asia Pacific is expected to be the fastest-growing GMP biologics market throughout 2037. Top manufacturing facilities, supply networks, and research institutes are all part of the region's robust infrastructure, which is essential for the production and distribution of biologics. This region's growth is also aided by robust regulatory policies that support the approval and commercialization of biological drugs. In addition, the need for GMP-compliant production is being driven by the development of novel biologics for a range of therapeutic purposes.
India GMP biologics market is expected to grow significantly due to the regulatory measures and supportive policies of government to innovate and develop biotechnologies in medical field. For instance, in June 2024, The European Medicines Agency (EMA) has given Biocon Biologics Ltd (BBL), permission to produce the biosimilar Bevacizumab at its brand-new, state-of-the-art, multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru. This approval will greatly expand the ability to meet the needs of patients in all European markets.
GMP biologics market in China is experiencing remarkable growth opportunities and is expected to intensify country’s operations in biologics. For instance, in August 2023, WuXi Biologics conducted its first scale-up to 2,000L drug substance (DS) GMP manufacturing by utilizing their ultra-intensified fed-batch platform, WuXiUITM. This resulted in a four-fold increase in productivity over the conventional fed-batch process. In addition, advancements in biologics boost the ecosystem to elicit the developments and better outcomes.
The strong presence of pharmaceutical companies in the GMP biologics market are shaping the landscape through managing dynamism with growing demand of novel and efficient drugs. For instance, in May 2024, Immunity Bio, Inc., announced a partnership with the Serum Institute of India (SII) for BCG availability, this gives the company a substantial initial supply of ANKTIVA for use in clinical trials and commercial settings prior to the full operation of its own fill-finish and drug substance manufacturing facilities in New York and California.
Here's the list of some key players:
Author Credits: Radhika Pawar
Copyright © 2025 Research Nester. All Rights Reserved
FREE Sample Copy includes market overview, growth trends, statistical charts & tables, forecast estimates, and much more.
Have questions before ordering this report?