Pharmaceutical Analytical Testing Outsourcing Market Analysis
Based on the services, the global market is categorized into bioanalytical testing, method development & validation, stability testing, and other services. The stability testing segment dominated the market in 2023 and is expected to sustain its leading position, forecasted to yield revenue of USD 6.6 billion by 2032.
- Stability testing remains critically important in ensuring the quality, safety, and efficacy of pharmaceutical products. The testing involves subjecting pharmaceutical formulations to various environmental conditions over time to assess their stability and shelf-life.
- Furthermore, the bioanalytical testing services sector is projected to experience rapid expansion in the coming years, driven by rise in clinical trial registrations. Also, small-size companies often outsource analytical services to CRO, to expedite their process, thereby fueling the market growth.
Based on product type, the pharmaceutical analytical testing outsourcing market is classified into active pharmaceutical ingredients (API), additives, and finished products. API segment held the largest market share of 41.5% in 2023.
- API testing involves a wide range of analytical procedures aimed at assessing the quality, purity, potency, and stability testing. Outsourcing API testing is common due to its cost-effectiveness which provides specialized expertise and advanced analytical techniques. This streamline operations pace up the development process and ensures regulatory compliance and product quality.
- Additionally, outsourcing testing services ensure adherence to regulatory standards while enabling companies to concentrate on their primary strengths. Thus, the escalating complexity and diversity of APIs, coupled with the rising demand for both generic and specialty drugs, have further bolstered the prominence of API testing within the pharmaceutical analytical testing outsourcing sector.
Based on the end-user, the market is classified into pharmaceutical companies, biopharmaceutical companies, and academics & research institutes. The pharmaceutical companies segment is expected to exhibit CAGR of 7.8% during the forecast period.
- Several pharmaceutical companies lack internal analytical testing capabilities, prompting collaborations with CROs, and CMOs for outsourcing services. This enables pharmaceutical companies to concentrate on their core strengths while tapping into external resources and capabilities for different aspects of drug development and manufacturing. Such aforementioned factor is expected to spur the segmental growth over the coming years.
North America region is expected to maintain its dominance throughout the forecast period, reaching the market revenue of USD 8.3 billion by 2032.
- The factors driving this region's dominance include technological advancements, the presence of key market players, increasing chronic disease cases, and rising pharmaceutical research, development, and funding.
- In addition, expanding strategic alliances among key players, aimed at broadening service offerings, are fueling market expansion in North America. For instance, in October 2021, Pace Analytical Services, LLC acquired Velesco Pharmaceutical Services, Inc., enhancing its capabilities in developing liquid, semi-solid, and oral solid dose products for pre-clinical and clinical use. This strategic move enables Pace to better serve clients across the drug development continuum. Such initiative is expected to spur the regional market growth.