Market Trends of Pharmaceutical Analytical Testing Industry
Stability Testing Segment is Expected to Exhibit a Significant Market Growth Over the Forecast Period
Stability testing is done to evaluate the capability of the drug to retain its properties throughout its shelf-life. The stability studies of pharmaceutical products are one of the most important parameters for developing new drugs and formulations. The stability testing is done based on five parameters: chemical, physical, microbiological, therapeutic, and toxicity. The degradation of any of these parameters can lead to health hazards.
Factors such as the growing government initiatives and guidelines to support stability testing, advantages of stability testing, and key strategies adopted by the market players are expected to boost the growth of the studied segment over the forecast period.
The regulatory bodies are involved in developing guidelines to ensure the stability of the testing of pharmaceutical products. For instance, in July 2023, the European Medicines Agency published guidelines on stability testing for active ingredients and pharmaceutical products to ensure their safety. These guidelines mandate pharmaceutical companies to conduct stability testing, which is expected to drive segment growth over the forecast period.
Additionally, various studies were conducted to perform stability testing with different analytical techniques for determining drug quality, efficacy, and safety. For instance, in March 2023, a study published in the Turkish Journal of Pharmaceutical Sciences reported that stability testing was conducted for the biosimilar monoclonal antibodies candidate (TUR01) with advanced analytical techniques such as isoelectric focussing on capillary electrophoresis, capillary electrophoresis-sodium dodecyl sulfate, and others.
In addition to the above context, the study showed drug stability at ≤-65°C and 5 ± 3°C at least 18 months. Thus, analytical stability testing ensures that the drugs are highly stable, which in turn is expected to propel the adoption of such techniques across drug manufacturing companies, as it provides the safety and quality of biosimilars, hence contributing to segment growth.
Key players' strategic initiatives, such as product launches, approvals, and partnerships, are expected to fuel the segment's growth. For instance, in November 2023, CatSci Ltd established a partnership with Reach Separations in which the company can leverage CatSci's expertise in analytical science covering various services, including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability testing.
Additionally, in July 2023, ten23 Health launched quality control services in Switzerland for product release and stability testing of clinical and commercial drugs as per the international current good manufacturing practice (cGMP) standards. Such developments are estimated to boost the segment growth during the forecast period.
Therefore, the aforementioned factors, such as government initiatives, market players' strategies, and the effectiveness of pharmaceutical product stability testing, are anticipated to drive the segment growth over the forecast period.
North America Holds a Significant Share in the Market and Expected to do Same During The Forecast Period
North America is expected to occupy a significant market share in the pharmaceutical analytical testing market owing to the increasing number of R&D activities, investments, and strategic initiatives taken by the market players in the region.
The region's need for pharmaceutical analytical services is growing due to increased clinical research activities and drug approvals. For instance, in January 2024, the United States Food and Drug Administration's Center for Drug and Evaluation approved 55 new drugs in 2023, which are indicated for treating various infectious diseases. Also, as of February 2024, about 146,311 clinical trials were registered in the United States, contributing 30% of the total registered clinical trials. Thus, the significant number of drug approvals and clinical trials in the region is anticipated to boost the market growth in the area during the forecast period.
Furthermore, growing investments in clinical research fuel the demand for pharmaceutical analytical services to develop safe and high-quality pharmaceutical products and drive market growth in the region. For instance, the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group represents the leading biopharmaceutical research companies in the United States. In 2022, its member companies' research and development (R&D) expenditure reached about USD 101 billion worldwide, in which the United States accounted for 21% of R&D investment. Therefore, significant research and development expenditures for conducting clinical trials will likely employ pharmaceutical analytical services to ensure safety at each drug development stage and are expected to propel the market growth.
The strategic initiatives, including product launches, approvals, acquisition and partnerships, not only enhance the capabilities and service offerings of key market players but also drive the broader adoption of pharmaceutical analytical services. For instance, in January 2024, Alcami Corporation acquired Pacific Pharmaceutical Services, Inc. to improve its pharma storage and services capabilities in Nevada, ensuring the stability and security of storing pre-clinical and clinical materials. Additionally, in December 2022, Pharmacopeia opened its advanced manufacturing technology lab in Richmond, Virginia, with the launch of analytical services to boost drug manufacturing activities and medication supply chain resilience. Such developments are estimated to propel market growth in the region.
Therefore, the increasing number of clinical trials, increase in research and development expenditures, and product launches are expected to boost the demand for pharmaceutical analytical testing market growth in the North American region, ensuring high-quality and safe drug development.
