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.
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.
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.
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 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.
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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. |
Global GMP Biologics Market- By Type
Global GMP Biologics Market – By Application
Global GMP Biologics Market – By Region
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
