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.
| Report Attribute | Specifications |
| Market Size Value In 2023 | USD 52.3 Bn |
| Revenue Forecast In 2031 | USD 153.9 Bn |
| Growth Rate CAGR | CAGR of 14.6% from 2024 to 2031 |
| Quantitative Units | Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
| Historic Year | 2019 to 2023 |
| Forecast Year | 2024-2031 |
| Report Coverage | The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
| Segments Covered | By Type and Application |
| Regional Scope | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Country Scope | U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
| 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. |
| Customization Scope | Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
| 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-
This study employed a multi-step, mixed-method research approach that integrates:
This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.
Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.
Secondary data for the market study was gathered from multiple credible sources, including:
These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.
Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.
Primary interviews for this study involved:
Interviews were conducted via:
Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.
All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.
The data validation process included:
This ensured that the dataset used for modelling was clean, robust, and reliable.
The bottom-up approach involved aggregating segment-level data, such as:
This method was primarily used when detailed micro-level market data were available.
The top-down approach used macro-level indicators:
This approach was used for segments where granular data were limited or inconsistent.
To ensure accuracy, a triangulated hybrid model was used. This included:
This multi-angle validation yielded the final market size.
Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.
Given inherent uncertainties, three scenarios were constructed:
Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.