GMP Testing Market Research Report Information By Service Type (Product Validation Testing, Bioanalytical Services, Packaging and Shelf-Life Testing, And Other Service Types), By End-Use (Pharmaceutical and Biopharmaceutical Companies And Medical Devices Companies), And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2032

Global GMP Testing Market Overview

GMP Testing Market Size was valued at USD 1.9 Billion in 2023. The GMP Testing Market industry is projected to grow from USD 2.0 Billion in 2024 to USD 3.2 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.00% during the forecast period (2024 - 2032). Increasing the focus on product safety and technological advancements are the key market drivers enhancing the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

GMP Testing Market Trends

• Increasing Consumer Awareness and Expectations Drive Market Growth

One of the main factors propelling the market CAGR in the GMP testing market is the growing customer expectation and awareness. A significant shift in consumer behavior has resulted from the broad availability of digital technologies. Customers are also given information about the products they use, including information on the materials and the moral dilemmas surrounding their production. As a result of this growing awareness, standards for product efficacy, safety, and quality have increased, especially in sectors like food and healthcare. Moreover, buyers are increasingly prepared to pay more for goods that promise these characteristics, putting more pressure on producers to fulfil quality standards. GMP testing services give companies in such a market an authentic way to show their dedication to quality and safety. Purchase decisions may be influenced and trusted by third-party GMP certification. Increased consumer knowledge and expectations are, therefore, a key factor in the growth of the GMP testing services industry.

Rapid technological improvements in analytical methodologies and equipment are also a major industry driver. Moreover, the development of cutting-edge technologies such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry, and Next-Generation Sequencing enables more precise, efficient, and thorough testing processes. These technologies enable a better understanding of product composition and potential contaminants, which is critical for assuring quality and safety. Furthermore, the use of this modern technology allows GMP testing services to deliver more exact and timely results. This efficiency shortens product development time and allows producers to detect and address any quality issues swiftly, lowering the risk of product recalls or legal action. Furthermore, organizations are increasingly relying on GMP testing services that use cutting-edge technology to achieve ever-increasing quality standards.

Moreover, the pharmaceutical and biopharmaceutical sectors' new drug development is expected to drive market growth in this area. According to the International Federation of Pharmaceutical Manufacturers and Associations' "Facts & Figures Report 2021," 24 were in Phase I, 34 in Phase II, and 23 in Phase III trials. According to the same report, the European Medicines Agency (EMA) granted conditional marketing clearance for Pfizer-BioNTech, Janssen, Moderna, and AstraZeneca's COVID-19 vaccines in March 2021. The US Food and Drug Administration (FDA) has also approved COVID-19 vaccines from Pfizer BioNTech, Janssen, and Moderna.

According to the Food and Drug Administration (FDA) Drug Recall Statistics published in July 2021, roughly 1,279 medications are recalled each year worldwide, with 94% of FDA drug recalls occurring in the United States and 4% in Canada. The FDA issued 12,028 drug recalls in the United States between 2012 and 2021. It requires GMP testing of production plants and a guarantee of public safety before they may be marketed. Thus, driving the GMP Testing Market revenue.

GMP Testing Market Segment Insights

GMP Testing Service Type Insights

The GMP Testing Market segmentation, based on Service Type, includes product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. In 2023, the product validation testing segment dominated the global GMP Testing Service Market, and this trend is likely to continue over the forecast period. The segment's growth is being driven by increased demand for higher-quality and safer service management. In addition, the growing number of medicine production plants has an impact on market segment growth. The bioanalytical service sector is predicted to hold the biggest market share during the forecast period, owing to an increasing emphasis on the development of bioanalytical testing services, which is a key driver of market growth.

Figure 1: GMP Testing Market, by Service Type, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

GMP Testing End-use Insights.

The GMP Testing Market segmentation, based on End-use, includes Pharmaceutical and Biopharmaceutical Companies and Medical Devices Companies. Pharmaceutical and biopharmaceutical companies accounted for the vast majority of the worldwide market in 2023. The segment's growth is being driven by greater innovation and the introduction of new services. The pharmaceutical and biopharmaceutical industry segment is expected to expand during the forecast period, owing to biopharmaceutical companies' preference to outsource manufacturing in markets where they lack expertise at various stages of the value chain, particularly at the end, where CDMOs' presence in a specific region provides them with access to a vast distribution network as well as knowledge of existing regulatory guidelines.

GMP Testing Regional Insights

By region, the study provides the market insights into North America, Europe, Asia-Pacific and the Rest of the World. North America dominated the GMP testing service market in 2023 and is likely to continue to do so during the forecast period. This was linked to the presence of large biotech and pharmaceutical companies in countries like the United States. Furthermore, the increased frequency of major pharmaceutical businesses and their R&D activities will fuel demand for GMP testing in the region throughout the projection period.

Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: GMP TESTING MARKET SHARE BY REGION 2023 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe GMP Testing Market accounts for the second-largest market share. The growing burden of chronic diseases is predicted to drive up demand for innovative pharmaceuticals, resulting in greater drug manufacturing activity and market growth. Further, the German GMP Testing Market held the largest market share, and the UK GMP Testing Market was the fastest-growing market in the European region.

The Asia-Pacific GMP Testing Market is expected to grow at the fastest CAGR from 2024 to 2032. This is primarily due to an increase in the import and selling of pharmaceuticals prepared in accordance with internationally recognized GMP standards. Moreover, China’s GMP Testing Market held the largest market share, and the Indian GMP Testing Market was the fastest growing market in the Asia-Pacific region.

GMP Testing Key Market Players & Competitive Insights

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the GMP Testing Market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, GMP Testing industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global GMP Testing industry to benefit clients and increase the market sector. In recent years, the GMP Testing industry has offered some of the most significant advantages to medicine. Major players in the GMP Testing Market, including Eurofins Scientific, PPD Inc., Microchem Laboratory, Sartorius AG, North American Science Associates Inc. and others, are attempting to increase market demand by investing in research and development operations.

Eurofins Scientific SE is a French laboratory organization with headquarters in Luxembourg that provides testing and support services to the pharmaceutical, food, environmental, agriscience, and consumer products industries, as well as governments. Eurofins Group offers an international network of over 900 laboratories in 62 countries, as well as a portfolio of more than 200,000 certified analytical procedures for determining the safety, identification, purity, composition, authenticity, and provenance of goods and biological substances. Eurofins also offers clinical diagnostic testing services and in vitro diagnostic products. In December 2021, Eurofins announced that the Biopharma product testing network of laboratories has expanded its footprint of GMP testing laboratories with the recent acquisition of Astellas Analytical Science Laboratories, Inc. With this acquisition, ASL developed Eurofins, Japan's first good manufacturing practice (GMP) testing center.

Charles River Laboratories International, Inc. is an American pharmaceutical firm that provides a wide range of preclinical and clinical laboratory, gene therapy, and cell therapy services to the pharmaceutical, medical device, and biotechnology sectors. It also provides a variety of biomedical products, outsourcing services, and animals for pharmaceutical research and development (such as contract research organization services), as well as assistance in the fields of basic research, drug discovery, safety and efficacy, clinical support, and manufacturing. In August 2023, Charles River Laboratories International Inc. partnered with Fondazione Telethon to produce high-quality (HQ) plasmids.

Key Companies in the GMP Testing Market include

• Eurofins Scientific


• PPD Inc.


• Microchem Laboratory


• Sartorius AG


• North American Science Associates Inc.


• Laboratory Corporation of America Holdings (Covance Inc.)


• Sotera Health (Nelson Laboratories LLC)


• Almac Group


• Pace Analytical


• Wuxi AppTec


• Intertek Group PLC


• Charles River Laboratories

GMP Testing Industry Developments

In March 2022, Thermo Fisher Scientific, the world leader in science service, announced the extension of its capabilities from development to commercial manufacturing in France. The early development hub features a 430-square-meter (4,600-square-foot) research and development facility for preclinical non-GMP operations, as well as expanded good manufacturing practices (GMP) capabilities.

In April 2021, PPD Inc., a renowned global contract research organization, announced plans to expand its Good Manufacturing Practice facility in Ireland to improve biopharmaceutical testing capabilities.

In September 2020, Almac Group expanded its analytical services portfolio to include biologics testing solutions. To aid customers' drug substance and drug product programs for new biologics and biosimilars, the company announced that its services would now include GMP lot release and stability services.

GMP Testing Market Segmentation

GMP Testing By Service Type Outlook

• Product Validation Testing


• Bioanalytical Services


• Packaging and Shelf-Life Testing


• Other Service Types

 GMP Testing By End-use Outlook

• Pharmaceutical and Biopharmaceutical Companies


• Medical Devices Companies

GMP Testing Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America