Publication Month: Sep 2022 | Report Code: TIPRE00029684 | No. of Pages: 166 | Category: Medical Device | Status: Published
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:
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.
|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|
|No. of Pages||166|
|No. of Tables||57|
|No. of Charts & Figures||71|
|Historical data available||Yes|
|Segments covered||Service Type, and End User|
|Regional scope||North America, Europe, Asia Pacific, Middle East & Africa, South & Central America|
|Country scope||US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina|
|Report coverage||Revenue forecast, company ranking, competitive landscape, growth factors, and trends|
|Free Sample Copy Available|
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.
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.
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.
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.
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).