GMP Testing Service Market Share, Size | Global Trends 2028

The GMP testing service market is valued US$ 1,830.57 million in 2021; it is estimated to grow at a CAGR of 6.7% from 2022 to 2028.

The market growth is attributed to the continuous proliferation of the pharmaceutical and medical industries.

The GMP testing service market comprises major competitive players adopting strategies such as product launches, geographic expansion, and technological advancements. A few recent developments in the market are listed below:

• In February 2022, Eurofins Clinical Testing Lux Sarl, a subsidiary of Eurofins Scientific, acquired Genetic Testing Service JSC (Gentis), a pioneer in genetic testing in Vietnam. Through this acquisition, Eurofins intends to expand its presence in Asia, which would complement its global network of clinical diagnostics laboratories focused on specialized and advanced genetic testing.
• In December 2021, oncology researchers at the University of Arkansas for Medical Sciences (US) and Queen’s University Belfast (UK) used a unique software-driven solution for gene expression data analysis—claraT—offered by Almac Diagnostic Services, a member of the Almac Group, in the study of brain and breast cancers. The study was recently published in the MDPI Cancer Journal and the British Journal of Cancer, have the potential to lead to better therapeutic outcomes for patients. 
• In December 2021, WuXi AppTec acquired OXGENE. This acquisition enables WuXi AppTec to offer its customers end-to-end support in the creation and development of cutting-edge cell and gene therapies.

Such product innovations and developments by major market players, along with regulatory approvals, are fueling the growth of the GMP testing service market.

The regulatory compliance criteria for GMP testing services depend on the location of pharmaceutical and biotechnology companies, and the geographic reach of their distribution channels. In North America, FDA regulates the GMP testing services market, whereas, in Europe, European Medicines Agency (EMA) regulates the GMP testing services market. The Association of South-East Asian Nations (ASEAN) and the Pharmaceutical Inspection Convention are among the other agencies that regulate GMP testing services. These regulatory agencies need to ensure appropriate compliance depending on where the product is manufactured, distributed, and marketed by the pharmaceutical companies. The regulatory agencies evaluate all sites involved in the manufacturing of a drug. This evaluation includes all the steps ranging from the initial steps of the raw materials/API manufacturing to the final packaging facilities. Moreover, regulations may change depending on the steps involved in a particular manufacturing process. If a company fail to comply with the specifications of a regulatory body in a particular country or region, its products are considered adulterated under the law, and the FDA advises patients not to take such medications, which could have serious consequences on their health. Thus, stringent regulatory frameworks for GMP testing services in different regions are hampering the growth of the GMP testing services market.

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GMP Testing Service Market: Strategic Insights

Market Size Value in	US$ 1,830.57 Million in 2021
Market Size Value by	US$ 2,863.42 Million by 2028
Growth rate	CAGR of 6.7% from 2022 to 2028
Forecast Period	2022-2028
Base Year	2021

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Regional Overview

Asia Pacific is expected to register the highest CAGR in the GMP testing service market during the forecast period. Regulation and rising awareness boost the demand for GMP testing services. The GMP testing services market in China is expected to flourish during the forecast period owing to the increase in the number of pharmaceutical companies and their R&D activities, and the ongoing development projects of medical devices, biosimilars, and combination products, which need GMP testing at both clinical and preclinical drug development stages.

The regulatory bodies keep on making amendments to their existing regulations or introducing new regulations for GMP testing. In April 2020, the National Medical Products Administration (NMPA) announced its newly implemented random inspection regimens for manufacturing, distribution, and management of medical devices marketed in China. Under the new regulation, the NMPA and its regional branches would conduct random inspections in the first quarter of each year. The heavily targeted medical devices are considered high-risk and of questionable quality. Foreign medical device manufacturers must designate a local representative based in China to cooperate with the health authorities for random inspections of their products.

The GMP testing market players are adopting inorganic and organic growth strategies for business development in China.

• In April 2020, WuXi Biologics (Suzhou) Co., Ltd. passed its first GMP inspection conducted by the EMA without any critical findings.
• In June 2020, the Suzhou facility of WuXi Biologics received the EMA GMP certificate, following that it also received certification from China Inspection Body and Laboratory Mandatory Approval (CMA) and China National Accreditation Service for Conformity Assessment (CNAS). This enables the company to be one of the few third-party biosafety testing providers certified by EMA GMP standards in China and Asia Pacific.
• In May 2020, Porton Pharma Solutions Ltd. opened integrated cGMP Laboratories at its Chongqing Process Technology Center in China.

Japan's quality control and quality assurance requirements are often more stringent than those in the West, and many Japanese quality standards and regulations have different names and content from equivalent Western regulations. In July 2021, the Government of Japan announced they would start conducting surprise inspections at drug, pharmaceutical, and medical device manufacturing facilities. The Pharmaceuticals and Medical Devices Agency (PMDA) started its surprise inspections in August 2021. In Japan, GMP for drugs is referred to as Japanese GMP, or J-GMP. Further, the Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP) are a few more Japan-specific pharmaceutical/drug quality standards.

Lucrative Regions for GMP Testing Service Market

Service Type Insights

Based on service type, the GMP testing service market is segmented into product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. The product validation testing segment held the largest market share in 2021. Moreover, this segment is expected to register the highest CAGR of 7.3% during the forecast period.

Product validation testing is documented evidence that ascertains the quality of manufactured pharmaceutical and medical products. The validation follows a set of guidelines to ensure that the manufactured products meet all the needs and requirements the product was intended to serve. Rising healthcare expenditure in various developed countries encourages new drug discoveries and the evaluation of various medical products for potential medical treatments. In addition to the continuous growth of the pharmaceuticals and biopharmaceuticals industries, the rising number of development and commercialization of pharmaceutical and biopharmaceutical products due to government support in countries such as the US, Germany, the UK, and Japan propels the need for product validation testing, thereby fueling the GMP testing service market.

GMP Testing Service Market, by Service Type – 2021 and 2028

Access Data

Companies operating in the GMP testing service market primarily focus on the product innovation strategy to meet the evolving customer demands worldwide, which also allows them to maintain their brand name in the market.

GMP Testing Service Market – Segmentation

The GMP testing service market is analyzed on the basis of service type, end user, and geography. Based on service type, the market is segmented into product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. Based on end user, the GMP testing service market is segmented into pharmaceutical and biopharmaceutical companies, and medical devices companies. On the basis of geography, the GMP testing service market is segmented into North America (US, Canada, and Mexico), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (UAE, Saudi Arabia, Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

Company Profiles

• Eurofins Scientific
• North American Sciences Associates, LLC
• Almac Group
• PPD, Inc
• Intertek Group Plc
• Nelson Laboratories
• Wuxi Apptec
• Sartorius AG
• Boston Analyticals
• Pace Analyticals