Pharmaceutical Dissolution Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Services Method (In vitro, In vivo), By Dissolution Apparatus (Basket, Paddle, Others), By Dosage Form (Capsule, Tablets, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 761.39 Million
CAGR (2026-2031)	8.72%
Fastest Growing Segment	Capsule
Largest Market	North America
Market Size (2031)	USD 1257.37 Million

Market Overview

The Global Pharmaceutical Dissolution Testing Services Market is projected to grow from USD 761.39 Million in 2025 to USD 1257.37 Million by 2031 at a 8.72% CAGR. Pharmaceutical dissolution testing services involve the outsourced analytical evaluation of the rate at which an active drug substance releases from its dosage form under simulated physiological conditions. The expansion of this market is fundamentally supported by the escalating demand for rigorous bioequivalence studies and the stringent quality control mandates enforced by global health authorities. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, North America accounted for 54.8% of estimated world pharmaceutical sales, underscoring the immense volume of products requiring comprehensive quality verification and compliance testing.

However, the industry faces a notable constraint regarding the scarcity of specialized personnel capable of managing complex method development and validation processes. This shortage of skilled analysts creates operational bottlenecks that can delay product timelines and increase costs for service providers. Consequently, the difficulty in recruiting and retaining technical talent presents a substantial barrier to the seamless scalability of these testing operations.

Key Market Drivers

Rising Pharmaceutical R&D Investments and Pipeline Expansion directly propel the market by increasing the volume of compounds requiring solubility and release-rate profiling. As drug candidates become more structurally complex, manufacturers must conduct rigorous dissolution testing throughout the development lifecycle to ensure bioavailability and regulatory compliance. This surge in development activity is evident in the industry's financial commitment; according to the Pharmaceutical Research and Manufacturers of America, July 2025, in the '2025 PhRMA Annual Membership Survey', member companies invested approximately $100 billion in research and development during 2024. This massive capital injection correlates with high productivity in drug output, which fuels the service market. Illustrating this pipeline momentum, according to the U.S. Food and Drug Administration, January 2025, in the 'Novel Drug Approvals for 2024' report, the agency approved 50 novel drugs, each necessitating extensive dissolution data for quality assurance.

The Proliferation of Generic Drugs and Bioequivalence Requirements further cements the necessity for outsourced dissolution services. For generic manufacturers, dissolution testing is the critical surrogate for in vivo bioequivalence studies, serving as the primary metric to demonstrate that a generic formulation performs identically to the innovator product. This reliance is intensifying as healthcare systems globally prioritize cost-effective medications. According to the Association for Accessible Medicines, September 2025, in the '2025 U.S. Generic & Biosimilar Medicines Savings Report', generic and biosimilar medicines accounted for 90% of all prescriptions filled in the United States. This dominance necessitates a vast, continuous volume of comparative dissolution testing to support Abbreviated New Drug Applications and post-market batch consistency, thereby driving sustained demand for specialized laboratory services.

Download Free Sample Report

Key Market Challenges

The primary challenge hampering the growth of the Global Pharmaceutical Dissolution Testing Services Market is the acute scarcity of specialized personnel capable of executing complex analytical procedures. Dissolution testing is not merely a mechanical process; it requires highly trained analysts to design, validate, and interpret method development protocols that mimic variable physiological conditions. When service providers face a shortage of these skilled experts, they encounter an immediate ceiling on their production capacity. This talent gap creates severe operational bottlenecks, as testing laboratories cannot simply automate these high-level interpretative tasks. Consequently, even with rising demand for bioequivalence studies, service providers are forced to extend project timelines or decline new contracts, directly stalling market expansion and revenue realization.

The impact of this workforce deficit is quantified by recent industry data highlighting the severity of the labor crunch in scientific sectors. According to the Pistoia Alliance, in 2025, 34% of life sciences organizations identified the lack of skilled personnel as a significant barrier to laboratory operations and the adoption of advanced methodologies, marking a notable increase from the previous year. This metric illustrates a widening gap between the industry's technical requirements and the available talent pool. As laboratories struggle to recruit qualified analysts, the competition for limited human capital intensifies, driving up operational costs and diminishing the profit margins necessary for reinvestment and scalability.

Key Market Trends

The widespread adoption of automated and robotic testing systems is rapidly emerging as a primary trend in the dissolution testing market, fundamentally altering laboratory workflows to mitigate human error and improve throughput. As service providers face increasing pressure to handle higher sample volumes with greater precision, they are integrating fully automated dissolution apparatuses that manage tasks ranging from media preparation to sample analysis. This shift is not only a response to the need for reproducibility but also a strategic move to optimize operational efficiency amidst workforce constraints. The momentum behind this technological integration is substantial; according to Rockwell Automation, June 2025, in the 'State of Smart Manufacturing Report 2025: Life Sciences Edition', 50% of life sciences manufacturers intend to increase automation within their facilities in the coming years, reflecting a decisive sector-wide commitment to modernizing production and quality control environments.

Simultaneously, the application of Artificial Intelligence (AI) and Machine Learning (ML) for predictive modeling is revolutionizing how dissolution data is utilized for in vivo correlation and formulation development. Rather than relying solely on empirical wet-lab testing, laboratories are increasingly employing AI algorithms to analyze historical datasets and predict release profiles, thereby accelerating the method development phase and reducing the number of required physical tests. This digital evolution allows for more accurate simulation of physiological conditions and faster decision-making during the drug development lifecycle. The industry's confidence in these digital tools is growing rapidly; according to the Pistoia Alliance, September 2025, in the 'Lab of the Future Survey', 77% of life sciences professionals expect to utilize artificial intelligence technologies within their laboratories over the next two years, signaling a major paradigm shift toward data-driven testing strategies.

Segmental Insights

Based on current market intelligence, the Capsule segment is recognized as the fastest-growing category within the Global Pharmaceutical Dissolution Testing Services Market. This rapid expansion is primarily driven by the increasing prevalence of poorly water-soluble drug candidates and the rising demand for bioavailability enhancement in new chemical entities (NCEs). Pharmaceutical developers are frequently selecting advanced capsule technologies, such as liquid-filled hard capsules and softgels, to overcome solubility challenges and ensure optimal drug delivery. Consequently, these complex formulations require specialized, rigorous dissolution testing protocols to establish in vitro-in vivo correlations (IVIVC) and meet stringent regulatory standards, thereby fueling the accelerated demand for testing services in this segment.

Regional Insights

North America maintains a dominant position in the global pharmaceutical dissolution testing services market due to the high concentration of established pharmaceutical companies and extensive research activities. The region benefits from a rigorous regulatory framework enforced by the United States Food and Drug Administration, which mandates comprehensive dissolution studies for product approval and quality control. Furthermore, the widespread adherence to standards established by the United States Pharmacopeia drives the demand for compliant testing services. This strong emphasis on regulatory compliance and continuous drug development secures North America’s leading status in the industry.

Recent Developments

• In November 2025, Pharma Test announced the upcoming release of its next-generation tablet dissolution testing instruments, including the PTWS 830, PTWS 1230, and PTWS D630 models. These systems featured a modern graphical user interface, advanced user management options, and a fully integrated audit trail to ensure compliance with 21 CFR Part 11 regulations. The instruments were designed with mechanical enhancements to improve reliability and simplify maintenance for laboratory operators. This launch marked a significant milestone for the company, reflecting a focus on delivering user-oriented and sustainable testing solutions that meet the evolving regulatory and operational demands of the global pharmaceutical industry.
• In May 2025, Agilent Technologies announced the release of the Dissolution Workflow Manager for its OpenLab Chromatography Data System. This innovative software solution was engineered to streamline and enhance dissolution testing workflows by integrating data management within a unified platform. The system offered features such as automated dosage delivery, real-time monitoring of test progress, and comprehensive reporting capabilities. By facilitating seamless connectivity between dissolution apparatus and analytical systems, the software aimed to improve efficiency, accuracy, and regulatory compliance in pharmaceutical and biopharmaceutical laboratories, directly addressing the industry's need for data integrity and operational excellence.
• In May 2025, Pion Inc. launched the DissoSpec QC Dissolution Monitoring System, a fully integrated instrument designed to transform dissolution analysis. The system incorporated in situ fiber optic probes directly into the dissolution vessels, which eliminated the need for traditional sampling and sample transfer processes. This approach significantly reduced analyst variability and the risks associated with offline sample degradation or filtration errors. By enabling real-time, direct measurement of drug release profiles, the technology provided scientists with stable and reliable data, thereby accelerating method development and ensuring consistent quality control in drug manufacturing.
• In November 2024, the Sotax Group expanded its Xtend dissolution platform with the launch of the SAM-SR sample manager and the CP-SR piston pump. These new modules were designed to elevate dissolution workflows by saving valuable bench space while delivering enhanced precision and versatility to laboratories. The introduction of these components allowed for flexible automation configurations, ranging from manual baths to semi- and fully automated systems. This development underscored the company's commitment to providing robust and scalable solutions for pharmaceutical quality control and research and development environments, facilitating the efficient handling of increasing workloads.

Key Market Players

• Intertek Group Plc
• Avivia BV
• Almac Group
• Agilent Technologies, Inc.
• Catalent, Inc.
• Thermofisher Scientific Inc
• Charles River Laboratories International Inc.
• Cambrex Corp.
• Boston Analytical
• Pace Life Sciences LLC

By Services Method	By Dissolution Apparatus	By Dosage Form	By Region
In vitro In vivo	Basket Paddle Others	Capsule Tablets Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Pharmaceutical Dissolution Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Pharmaceutical Dissolution Testing Services Market, By Services Method:

• In vitro
• In vivo

• Pharmaceutical Dissolution Testing Services Market, By Dissolution Apparatus:

• Basket
• Paddle
• Others

• Pharmaceutical Dissolution Testing Services Market, By Dosage Form:

• Capsule
• Tablets
• Others

• Pharmaceutical Dissolution Testing Services Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE