According to Bayer, the global number of elderly people, aged 65 or above, is projected to double from 2021 to 2050, reaching ~1.5 billion by 2050. A rise in the population of this demographic group is contributing to a surge in the prevalence of chronic diseases, such as cardiovascular diseases, cancer, hypertension, osteoarthritis, and diabetes mellitus. The elderly population is more susceptible to such diseases. Over the years, these chronic diseases have been a major area of focus for pharmaceutical companies. Thus, the proliferation of the pharmaceuticals industry will increase the implementation of GMP testing in drug development which will fuel the growth of the GMP testing services market.
Eurofins Scientific; Almac Group; Intertek Group Plc; WuXi AppTec; Sartorius AG; North American Science Associates, Inc.; Nelson Laboratories LLC; Boston Analytical; Pace Analytical Services; and Thermo Fisher Scientific Inc. (PPD Inc.) are among the leading companies operating in the global GMP testing service industry.
Various organic and inorganic strategies are adopted by companies operating in the GMP testing service market. Organic strategies mainly include product launches and product approvals. On the other hand, acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the market. 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 them 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 April 2022, the Tübingen analytics group of Berghof Analytik und Umwelt Engineering GmbH is now part of the Eurofins network of companies. A new GMP analytics site has been established under the name Eurofins Food Testing Süd GmbH, which focuses on residue analysis of herbal raw materials and extracts, along with pharmacopeia analysis.
- In December 2021, Thermo Fisher Scientific Inc. acquired PPD, Inc., a globally leading global provider of clinical research services to the biopharma and biotech industry, for the value of US$ 17.4 billion.
- In August 2020, Almac Clinical Services launched a virtual auditing solution to ensure continued quality and regulatory compliance during the COVID-19 pandemic, maintain GMP standards, and deliver products on the terms of quality and technical agreements, all while protecting employees and upholding social corporate responsibility to partners and suppliers.
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.
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 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.