Global Market Size, Forecast, and Trend Highlights Over 2025-2037
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.
GMP Biologics Sector: Growth Drivers and Challenges
Growth Drivers
- Advancement in biotechnology: A crucial growth catalyst within the GMP biologics market is advancement in biotechnologies. It allows a capacity for producing more innovative and effective therapeutic solutions. For instance, in April 2024, developing a new class of treatments for cancer and rare disease patients, Poseida Therapeutics, Inc. announced that it will showcase advancements in its unique non-viral genetic engineering and delivery platform to treat rare diseases. Such advancements into biological drugs are effective alongside complex medicinal conditions that used to be undiagnosed thus opening out large markets in GMP-compliant biologics.
- Increased outsourcing to contract manufacturers: Out-sourcing for contract manufacturers also forms one of the most promising growth drivers in the GMP biologics market. Manufacturing requires specified skills and therefore is economical in costs. For instance, in October 2024, Samsung Biologics announced a contract manufacturing agreement with a pharmaceutical company based in Asia valued at USD 1.24 billion. This contract will introduce high-quality and efficient biopharmaceuticals. As a result, it gives them access to best-in-class manufacturing capabilities with reduction of time-to-market. In addition, the concentration of core competence is ensured by being strictly compliant with regulatory requirements.
Challenges
- Risk of contamination: The significant issue with the GMP biologics market is contamination, mainly because of the complexity and sensitivity of the production process of biologics. Such drugs, being products of living organisms, demand a highly controlled environment to avoid microbial, particulate, or viral contamination. Small deviations from the strict cleanliness protocol can compromise product quality and patient safety, resulting in costly recalls and regulatory penalties. In accordance, maintaining strict measures of contamination control at every stage of the production process is very complex and operationally and financially burdensome for firms in the biologics industry.
- Long development timelines: The notable challenge of the market is long development time, mainly since the development process of a biologic product is complex and very time-consuming. Biologics, on the other hand, involves much research, clinical testing, and rigorous scale-up processes for safety, efficacy, and regulatory compliance. The requirement for high-precision optimization in cell culture, protein expression, and purification processes as well as protracted regulatory approval procedures extends the development cycles of biologic therapies by several years. Such delayed timelines reduce the times for market entry and increase financial burdens.
GMP Biologics Market: Key Insights
|
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 |
|
GMP Biologics Segmentation
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 |
|
Want to customize this research report as per your requirements? Our research team will cover the information you require to help you take effective business decisions.
Customize this ReportGMP Biologics Industry - Regional Synopsis
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.
Companies Dominating the GMP Biologics Landscape
- Novartis AG
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- Pfizer Inc.
- Sanofi
- GlaxoSmithKline plc
- Johnson & Johnson
- Eli Lilly and Company
- Samsung Biologics Co. Ltd.
- WuXi AppTec
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:
In the News
- In November 2024, Aurobindo Pharma subsidiary CuraTeQ Biologics has obtained a GMP certificate of compliance from the European Medicines Agency (EMA) for its biosimilars production facility.
- In March 2024, Aragen Biologics Pvt Ltd., announced that the first phase of its biologics manufacturing facility in Bangalore, India (USD 30 million investment) is now operational. In order to manufacture a novel anticancer monoclonal antibody (mAb), it has also completed its first small-scale manufacturing project for a US organization.
Author Credits: Radhika Pawar
- Report ID: 6963
- Published Date: Jan 10, 2025
- Report Format: PDF, PPT
