The GMP Biologics Market Size is valued at USD 52.3 Bn in 2023 and is predicted to reach USD 153.9 Bn by the year 2031 at an 14.6% CAGR during the forecast period for 2024-2031.
The term "Good Manufacturing Practice" (GMP) Biologics describes the manufacture of biologic pharmaceuticals by strict legal requirements intended to guarantee the effectiveness, safety, and quality of the final product. The World Health Organization (WHO) and other organizations have established GMP standards, which require biologic manufacturing processes to be controlled and recorded to minimize hazards like contamination and guarantee uniformity between production batches. The GMP criteria for biologics are distinct from those for other medical goods because of their unique characteristics.
For instance, The European Medicines Agency (EMA) is responsible for the evaluation and supervision of medicines within the European Union. To ensure the consistent quality and safety of medicinal products, the EMA has established detailed Good Manufacturing Practices (GMP) guidelines. These guidelines outline the specific requirements for the manufacturing, testing, and release of medicinal products, including biologics. By setting these standards, the EMA ensures that products meet stringent quality criteria, safeguarding public health across the EU. The primary factors influencing the GMP Biologics market include the increased use of biosimilars and monoclonal antibodies, technological developments in bioprocessing, and an increasing emphasis on customized treatment. Because of their great specificity and potency, monoclonal antibodies in particular are becoming more and more significant in the treatment of a wide range of diseases, including autoimmune disorders and cancer.
Competitive Landscape
Some of the Major Key Players in the GMP Biologics Market are
- Amgen Inc.
- Hoffmann-La Roche Ltd
- AbbVie Inc.
- AstraZeneca plc
- Merck KGaA
- Creative Diagnostics
- Fisher Bioservices (Thermo Fisher Scientific)
- Polpharma Biologics
- Intertek
- HemaCare
- AGC
- AstraZeneca plc
- Merck KGaA
- Sanofi
- GlaxoSmithKline plc
- Johnson & Johnson
- Pfizer Inc.
- Novartis AG
- Eli Lilly and Company
- Samsung Biologics Co. Ltd.
- WuXi AppTec
- Lonza Group Ltd.
- Rentschler Biopharma SE
- Boehringer Ingelheim International GmbH
- Celltrion Inc
- Catalent Inc.
Market Segmentation
The GMP Biologics Market is segmented based on the type, and application. Based on the type, the market is divided into monoclonal antibodies and polyclonal antibodies. Based on the application market is categorized into hospitals, clinics, and others.
The Monoclonal Antibodies Segment Is Expected To Have The Highest Growth Rate During The Forecast Period
Based on the monoclonal antibodies, the market segment into monoclonal antibodies and polyclonal antibodies. Among these, the monoclonal antibodies segment is expected to have the highest growth rate during the forecast period. makes them better for treating a range of illnesses, especially chronic ailments and oncology. It is anticipated that this market would remain dominant because to the continuous progress in biopharmaceutical research and the growing need for customized treatment. Because of their ability to precisely target particular antigens, monoclonal antibodies (MAbs) are extensively used in hospitals and clinical settings to improve treatment outcomes and reduce side effects. Because polyclonal antibodies may recognize many epitopes, they are important in research and diagnostics but have a limited market share in GMP biologics. They are useful in many different applications due to their broad reactivity and reduced production costs, but their market expansion is constrained when compared to highly effective and specific monoclonal antibodies.
The Hospital Segment Dominates The Market
Based on the application, the market is segmented into hospitals, clinics, and others. Among these, the hospital segment dominates the market. Among these, the hospital segment dominates the market. This is because hospitals are primary centers for advanced treatments, including those involving biologics, such as monoclonal antibodies, gene therapies, and other specialized treatments. Hospitals usually have the infrastructure and resources necessary for administering complex biological therapies, which require precise handling, storage, and administration.
North America Have The Largest Market Share During Forecast Period
North America has the largest market share during the forecast period. Due to the existence of multiple reputable biopharmaceutical businesses and a strong regulatory environment that promotes the development of biologic drugs. The region boasts a robust infrastructure, including world-class research institutions, manufacturing facilities, and supply chains, which are essential for the production and distribution of biologics.
Recent Developments:
- In March 2024, Thermo Fisher Scientific Inc. has expanded its clinical trial network throughout Europe by opening a new ultra-cold clinical and commercial facility in the EU, which will aid in hastening the development of cutting-edge treatments. Pharma and biopharma customers can receive end-to-end assistance for high-value medicines, such as cell and gene therapies, biologics, antibodies, and vaccines, throughout the clinical supply chain from the recently established current good manufacturing practice (cGMP) facility located in Bleiswijk, Netherlands.
- In Jan 2023, Creative Diagnostics raised its monoclonal antibody capabilities and offerings to global customers, including over 1,000 targets, carrier-free formulations, and conjugated antibodies. The company provided raw materials, antibodies, and reagents for the biotechnology industry.
- In June 2020, HemaCare, declared that the introduction of the GMPrime cryopreserved leukopak has increased the range of GMP-compliant cellular material in its inventory. HemaCare's well-liked cryopreserved leukopak for research usage (HemaPrimeTM) now has QA review added to it since the GMP-compliant cryopreserved leukopak comes with a Certificate of Analysis that has been quality assurance (QA) evaluated.
GMP Biologics Market Report Scope
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Report Attribute |
Specifications |
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Market Size Value In 2023 |
USD 52.3 Bn |
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Revenue Forecast In 2031 |
USD 153.9 Bn |
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Growth Rate CAGR |
CAGR of 14.6% from 2024 to 2031 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
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Historic Year |
2019 to 2023 |
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Forecast Year |
2024-2031 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Type and Application |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
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Competitive Landscape |
Amgen Inc., F. Hoffmann-La Roche Ltd, AbbVie Inc., AstraZeneca plc, Merck KGaA, Creative Diagnostics, Fisher Bioservices (Thermo Fisher Scientific), Polpharma Biologics, Intertek, HemaCare, AGC, AstraZeneca plc, Merck KGaA, Sanofi, GlaxoSmithKline plc, Johnson & Johnson, Pfizer Inc., Novartis AG, Eli Lilly and Company, Samsung Biologics Co. Ltd., WuXi AppTec, Lonza Group Ltd., Rentschler Biopharma SE, Boehringer Ingelheim International GmbH, Celltrion Inc, Catalent Inc. |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
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