PUBLISHER: Grand View Research | PRODUCT CODE: 1842131
PUBLISHER: Grand View Research | PRODUCT CODE: 1842131
The U.S. pharmaceutical dissolution testing services market size was estimated at USD 224.36 million in 2024 and is projected to reach USD 423.71 million by 2033, growing at a CAGR of 7.41% from 2025 to 2033.Rising demand for generic drugs and bioequivalence studies, constant regulatory emphasis on consistent drug release profiles and quality control, and growing outsourcing activities are driving the market growth.
The U.S. pharmaceutical dissolution testing services industry's growth is driven by the increasing regulatory stringency surrounding drug quality, safety, and bioavailability. Health authorities such as the U.S. FDA, EMA, and CDSCO mandate dissolution testing as a core requirement in the approval process for both branded and generic pharmaceuticals. This has led to a growing need for advanced, reliable, and standardized dissolution testing to ensure consistent drug release profiles. The rising volume of generic drug approvals globally has intensified the demand for comparative dissolution testing in bioequivalence studies, making it essential for companies to outsource these services for faster and cost-effective regulatory compliance. Moreover, the complexity of modern drug formulations, such as sustained-release and poorly soluble drugs, necessitates customized and high-precision testing protocols, prompting pharma firms to rely on specialized contract service providers with technical expertise and instrumentation capabilities.
Furthermore, the rapid expansion of pharmaceutical R&D pipelines, especially in emerging markets, is creating heightened demand for dissolution testing across early- and late-phase development. Small and mid-sized pharmaceutical and biotech firms, often operating with limited in-house infrastructure, are increasingly turning to third-party service providers for dissolution testing to accelerate timelines and reduce operational burdens. Furthermore, the rise in personalized medicine and novel drug delivery systems, including nanotechnology and 3D-printed tablets, is reshaping dissolution testing needs.Advances in automation, real-time analytics, and integration of dissolution testing with other quality control technologies are also streamlining workflows and improving data accuracy, further incentivizing outsourcing.
U.S. Pharmaceutical Dissolution Testing Services Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. pharmaceutical dissolution testing services market report based on method, dosage form, and dissolution apparatus: