Report : North America GMP Testing Service Market Forecast to 2028 - COVID-19 Impact and Regional Analysis by Service Type (Product Validation Testing, Bioanalytical Services, Packaging & Shelf Life Testing, and Other Services) and End User (Pharmaceutical and Biopharmaceutical Companies, and Medical Device Companies)

At 6.9% CAGR, the North America GMP Testing Service Market is speculated to be worth US$ 1,260.96 million by 2028, says Business Market Insights

According to Business Market Insights’ research, the North America GMP testing service market was valued at US$ 846.02 million in 2022 and is expected to reach US$ 1,260.96 million by 2028, registering a CAGR of 6.9% from 2022 to 2028. Continuous proliferation of pharmaceuticals industry and flourishment of medical device industry are the critical factors attributed to the North America GMP testing service market expansion.

The research, development, production, and distribution of medicinal drugs and other pharmaceutical products are the major areas of the pharmaceuticals industry. According to an article by Torreya, in 2017, the pharmaceutical expenditure was US$ 1,042 billion, and it is expected to reach US$ 1,671 billion by 2030. 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, as elderly population is susceptible to such diseases. Thus, these chronic diseases have been a major area of focus for pharmaceutical companies. New drug development is a resource-, cost-, and time-intensive process, where later clinical stages result in significant costs. It takes over 10–15 years and costs on average over US$ 1–2 billion to discover a drug and obtain regulatory approval. Therefore, to lower the attrition rate in drug research & development, pharmaceutical companies are focusing on following the good manufacturing practices (GMP) set by the US Food and Drug Administration (FDA) and other major regulatory organizations. Several pharmaceutical companies are opting for bioanalytical GMP testing services for drug development and validation of assays at both clinical and preclinical stages. Generic & branded drug compounds are mostly small molecules. Generic manufacturers conduct and submit bioanalytical GMP testing results to overcome the issue of patent expiration. Thus, with the proliferation of the pharmaceuticals industry, the implementation of GMP testing in drug development is fueling the growth of the North America GMP testing service market..

On the contrary, lack of uniform regulatory framework related to GMP testing services hurdles the growth of North America GMP testing service market. 

Based on service type, the North America GMP testing service market is categorized into product validation testing, bioanalytical services, packaging & shelf-life testing, and other services type. The product validation testing segment held 37.4% market share in 2022, amassing US$ 316.53 million. It is projected to garner US$ 485.41 million by 2028 to expand at 7.4% CAGR during 2022–2028.

Based on end user, the North America GMP testing service market is bifurcated into pharmaceutical and biopharmaceutical companies and medical device companies. The pharmaceutical and biopharmaceutical companies segment held 75.2% of the North America GMP testing service market share in 2022, amassing US$ 635.88 million. It is projected to garner US$ 957.28 million by 2028 to expand at 7.1% CAGR during 2022–2028.

Based on country, the North America GMP testing service market has been categorized into the US, Canada, and Mexico.  Our regional analysis states that US captured 79.5% of the North America GMP testing service market share in 2022. It was assessed at US$ 672.48 million in 2022 and is likely to hit US$ 1,014.75 million by 2028, exhibiting a CAGR of 7.1% during the forecast period.            

Key players dominating the North America GMP testing service market are 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.) among others.

  • In April 2022, Expansion of the analysis portfolio in the area of herbal raw materials, herbal extracts and foodstuffs.
  • In Aug 2020, Almac Clinical Services Launched Virtual Auditing Solution for Clients.

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