The GMP testing service market is expected to grow from US$ 1,830.57 million in 2021 to US$ 2,863.42 million by 2028; it is estimated to grow at a CAGR of 6.7% from 2022 to 2028.

The report highlights trends prevailing in the market and factors driving its growth. The market growth is attributed to the proliferation of pharmaceuticals and medical device manufacturing industries. Additionally, advancements related to GMP testing services are likely to emerge as a significant trend in the market during the forecast period. However, the lack of a uniform regulatory framework related to GMP testing services hampers the growth of the market.

The medical device industry is a prime enabler of the development of medical technologies that help diagnose and treat various illnesses. This industry produces products ranging from common supplies such as surgical masks to high-tech imaging equipment. Medical devices such as insulin delivery systems, glucose monitors, oxygen concentrators, and nebulizers are increasingly being used for the at-home diagnosis and treatment of a few medical disorders. These devices are integrated with the patient's EMR, wearables, cellphones, and telehealth platforms to provide critical insights for enhanced clinical and operational decision-making. According to the data provided by PRODSMART, the medical devices manufacturing industry was valued at ~US$ 4.2 billion in 2020. A rise in the incidence of chronic diseases and the growth of the geriatric population are the major factors that are expected to influence the progress of the medical device industry in the coming years. The integration of medical devices with Internet of Medical Things (IoMT) systems involve smart gadgets, smart sensors, and other lightweight communication devices. Such innovations assist healthcare providers in improving patient outcomes, lowering costs, and increasing efficiency.

GMPs are enormously important in the manufacturing of medical devices because they ensure a level of quality, safety, purity, and strength in any products that are released to the public. Adhering to these practices helps manufacturers in preventing adverse effects, product recalls, and defects, which may lead to costly liability lawsuits in the future. As quality control and consistent testing environments are pivotal for a successful manufacturing cycle, the focus on GMPs is increasing for avoiding product contamination, failure, and quality deviation.

The lack of a uniform regulatory framework related to GMP testing service hinders the overall GMP testing service market growth. 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.

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. The market for this segment is expected to grow at the fastest CAGR during the forecast period. Based on end user, the GMP testing service market is segmented into pharmaceutical and biopharmaceutical companies, and medical devices companies. The pharmaceutical and biopharmaceutical companies segment held a larger market share in 2021. Moreover, it is expected to register a higher CAGR during the forecast period.

Various organic and inorganic strategies are adopted by companies in the GMP testing service market. The organic strategies mainly include product launches and product approvals, whereas the inorganic growth strategies include acquisitions, collaborations, and partnerships. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall market growth. Further, acquisition and partnership strategies help the market players strengthen their customer base and expand their product portfolios. A few of the significant developments by key players in the GMP testing service market are listed below.

- In June 2022, Almac Diagnostic Services, a member of the Almac Group, signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialize multiple companion diagnostic (CDx) products. Almac will support AstraZeneca in bringing new therapies to patients residing in areas of high unmet medical needs.

The Centers for Disease Control and Prevention (CDC), European Medical Agency (EMA), World Health Organization (WHO), and International Diabetes Federation (IDF) are a few of the major primary and secondary sources referred to while preparing the report on the GMP testing service market.