GMP Testing Service Market Research Report and Outlook by 2028

The GMP testing service market is projected to expand significantly, increasing from approximately US$ 1,830.57 million in 2021 to around US$ 2,863.42 million by 2028. This growth represents a compound annual growth rate (CAGR) of 6.7% from 2022 to 2028.

This report outlines the prevailing trends within the market and identifies key factors contributing to its expansion. The growth of the market is primarily driven by the rapid development of the pharmaceuticals and medical device manufacturing sectors. Furthermore, innovations in GMP testing services are anticipated to become a prominent trend throughout the forecast period. Nevertheless, the absence of a standardized regulatory framework for GMP testing services poses a challenge to market growth.

The medical device sector plays a crucial role in advancing medical technologies that facilitate the diagnosis and treatment of various health conditions. This sector encompasses a wide range of products, from everyday items like surgical masks to sophisticated imaging devices. Medical devices such as insulin delivery systems, glucose monitors, oxygen concentrators, and nebulizers are increasingly utilized for at-home diagnosis and management of certain medical conditions. These devices are often integrated with patients' electronic medical records (EMR), wearable technology, smartphones, and telehealth platforms, providing essential insights that enhance clinical and operational decision-making. According to PRODSMART, the medical device manufacturing industry was valued at approximately US$ 4.2 billion in 2020. The rising prevalence of chronic diseases and the growing elderly population are significant factors expected to drive the medical device industry forward in the coming years. The integration of medical devices with Internet of Medical Things (IoMT) systems, which includes smart gadgets, sensors, and lightweight communication devices, is also noteworthy. These advancements enable healthcare providers to improve patient outcomes, reduce costs, and enhance operational efficiency.

Good Manufacturing Practices (GMP) are vital in the production of medical devices, ensuring that products released to the market meet high standards of quality, safety, purity, and strength. Compliance with GMP helps manufacturers avoid adverse effects, product recalls, and defects, which can lead to expensive liability lawsuits. As maintaining quality control and consistent testing environments is essential for a successful manufacturing process, there is an increasing emphasis on GMP adherence to prevent product contamination, failures, and deviations in quality.

However, the lack of a cohesive regulatory framework for GMP testing services significantly impedes the overall growth of the market. The compliance requirements for GMP testing services vary based on the geographical location of pharmaceutical and biotechnology companies and the extent of their distribution networks. In North America, the FDA oversees the GMP testing services market, while in Europe, the European Medicines Agency (EMA) is responsible for regulation. Other regulatory bodies, such as the Association of South-East Asian Nations (ASEAN) and the Pharmaceutical Inspection Convention, also play a role in overseeing GMP testing services. These agencies must ensure compliance based on the manufacturing, distribution, and marketing locations of pharmaceutical products. Regulatory evaluations encompass all manufacturing sites involved in drug production, from the initial stages of raw material and active pharmaceutical ingredient (API) manufacturing to final packaging. Additionally, regulations may vary depending on specific manufacturing processes. Non-compliance with regulatory standards can result in products being deemed adulterated, leading to serious health risks and advisories against their use by the FDA. Thus, the stringent regulatory frameworks across different regions are a significant barrier to the growth of the GMP testing services market.

The GMP testing service market is categorized by service type into product validation testing, bioanalytical services, packaging and shelf-life testing, among others. The product validation testing segment accounted for the largest market share in 2021 and is expected to experience the highest growth rate during the forecast period. In terms of end users, the market is divided into pharmaceutical and biopharmaceutical companies, as well as medical device manufacturers. The pharmaceutical and biopharmaceutical segment held a larger share in 2021 and is projected to grow at a faster rate in the coming years.

Companies in the GMP testing service market employ various organic and inorganic strategies to foster growth. Organic strategies primarily involve product launches and approvals, while inorganic strategies include acquisitions, collaborations, and partnerships. These strategies enable market players to expand their operations and enhance their geographical reach, thereby contributing to overall market growth. Additionally, acquisition and partnership strategies help companies strengthen their customer base and broaden their product offerings. Notable developments in the GMP testing service market include:

• In June 2022, Almac Diagnostic Services, part of the Almac Group, entered into a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialize multiple companion diagnostic (CDx) products. Almac aims to assist AstraZeneca in delivering new therapies to patients in regions with significant unmet medical needs.

Key sources referenced in the preparation of this report on the GMP testing service market include the Centers for Disease Control and Prevention (CDC), the European Medicines Agency (EMA), the World Health Organization (WHO), and the International Diabetes Federation (IDF).