Pharmaceutical Dissolution Testing Services Market By Dosage Form (Tablets, Capsules, Others), By Service Type (Routine Testing, Stability Testing, Bioequivalence & Pharmacokinetic Studies), By Method (In Vitro Testing, In Vivo Testing), By Dissolution Apparatus (Basket Apparatus, Paddle Apparatus, Others), By End-User (Pharmaceutical & Biopharmaceutical Companies, Contract Research Organizations (CROs), Academic & Research Institutes, Others), Global Market Size, Segmental Analysis, Regional Overview, Company Share Analysis, Leading Company Profiles and Market Forecast, 2025 – 2035.

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What trends will shape the Pharmaceutical Dissolution Testing Services Market in the coming years?

The Pharmaceutical Dissolution Testing Services Market accounted for USD 485.02 Million in 2024 and USD 528.43 Million in 2025 is expected to reach USD 1245.26 Million by 2035, growing at a CAGR of around 8.95% between 2025 and 2035. A range of key trends in the next few years will likely influence the pharmaceutical dissolution testing services market. Outsourcing of dissolution testing will continue to increase due to the increasing demand for generic drugs and bioequivalence studies. Automation and the introduction of AI will increase the efficiency of tests, their accuracy, and data analysis. Predictive drug performance will be enhanced with the adoption of advanced in vitro-in vivo correlation (IVIVC) models.

Specialized testing on complex dose forms like sustained-release dosage and transdermal dosage formulations will also be of interest. The stringency of regulation will persist with the standardizing and high-capacity testing measures. The growth of contract research organizations (CROs) will facilitate the development of pharmaceuticals worldwide. The market will continue to grow as more attention is paid to inexpensive and high-throughput testing. In general, innovation, compliance, and outsourcing will be the most critical trends that will define the market.

What do industry experts say about the Pharmaceutical Dissolution Testing Services market trends?

“Our expert can create a market testing requirements report, known as an Access Passport, specific to a company’s requirements. This service streamlines diverse regulatory requirements into a single process for accessing multiple markets.”

• André Lacroix, CEO, Intertek Group plc.

“We are committed to providing chemistry, manufacturing, and controls-based product development services to the global pharmaceutical, biotechnology, and consumer health industries.”

• Alessandro Maselli, CEO, Catalent, Inc.

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Pharmaceutical Dissolution Testing Services market?

How does increasing generic pharmaceutical production accelerate demand for dissolution testing services globally?

One major factor affecting the pharmaceutical dissolution testing services market is the rising number of generic pharmaceuticals being produced globally. Being among the largest manufacturers of generic drugs, India contributes a big percentage of the global supply of generic drugs; hence, the need to carry out stringent quality tests. Generic drugs must undergo high-level regulation to guarantee both bioequivalence and therapeutic equivalence between generic drugs and branded drugs, and to increase the demand for dissolution test services. These services determine the rate and amount of active pharmaceutical compounds that are released following dosage forms that are critical to regulatory approvals and marketability.

Special testing protocols are required due to the increased complexity of modern drug formulations, e.g., sustained-release drugs and drugs with poor solubility. To satisfy these needs, pharmaceutical companies are increasingly outsourcing to a contract service provider that has sophisticated instrumentation and technical capabilities. During the development stage, the need for dissolution testing is further intensified because of the expansion of pharmaceutical R&D pipelines, especially in emerging markets. Small- and middle-scale companies tend to outsource testing to minimise the operational load and speed up the timeline. New methods of drug delivery, including nanotechnology-based and 3D-printed pills, generate new specialised testing requirements. Automation, real-time analytics, and integrated technologies are enhancing the efficiency and accuracy of dissolution testing services, thus prompting a greater adoption of dissolution testing.

Can regulatory authorities’ stringent guidelines boost quality control and compliance in drug development?

The presence of strict regulatory requirements highly affects the pharmaceutical dissolution testing services market by improving quality controls and providing compliance during the development of drugs. In India, pharmaceutical products must follow stringent safety, efficacy and quality standards as enforced by the Department of Pharmaceuticals through the Drugs and Cosmetics Act. Such regulations require comprehensive testing, such as dissolution testing, to determine the release properties of the active pharmaceutical components of dose forms. Such instructions force pharmaceutical companies to follow strict quality control, and this is why special dissolution tests are necessary.

Compliance with regulatory standards can also make the process of approving new drugs easier, since adherence is a decisive factor when it comes to evaluation. Strict controls are useful in patient safety assurance, instill confidence in pharmaceutical products and encourage market expansion. To address these needs, pharmaceutical firms are making more investments in modern testing facilities and human resources. Contract Research Organisations (CROs) also participate in the provision of expertise and infrastructure pertaining to compliance-based testing. The changing pharmaceutical environment focuses on regulatory compliance as one of the primary elements of developing drugs. On the whole, stringent regulations have been increasing demand, accuracy of testing, and the market of dissolution testing services.

Does the high cost of sophisticated dissolution testing equipment restrict adoption among small-scale manufacturers?

The Pharmaceutical Dissolution Testing Services Market is highly restrained, as the cost of advanced dissolution testing equipment is very high. Modern equipment, such as automated dissolution systems or built-in analysis equipment, demands a large amount of capital. Small pharmaceutical manufacturers tend to have smaller budgets, and it is difficult to acquire and maintain such equipment. The high costs of operation and maintenance also act as a limiting factor, especially to firms that produce at reduced volumes. This can be a limiting factor on in-house testing, as smaller firms may have to turn to third-party service providers. Moreover, advanced equipment is difficult to use, and only qualified staff can correctly operate it and interpret the data.

Compliance with regulations requires regular and accurate testing, and this puts a strain on small manufacturers to purchase expensive systems. The option of outsourcing to Contract Research Organisations (CROs) may be more appealing, though this would result in a higher overall cost of operation. This means that the entry into the market by new players may be slowed due to expensive equipment. In general, affordability and availability continue to be major issues affecting small-scale adoption in the market.

Will partnerships with CROs expand access to specialized dissolution testing services internationally?

Partnering with Contract Research Organisations (CROs) has had a positive influence on the Pharmaceutical Dissolution Testing Services Market, expanding access to regional specialised dissolution testing services. The role of CROs in aiding the drug development process, including advanced dissolution testing, has been indicated to increase by the Department of Pharmaceuticals in India. Such alliances can allow small and medium-sized pharmaceutical companies to access high-quality testing services without paying a huge capital cost to install a laboratory within the company. The CROs are the ones who give information about the compliance problems faced in the regulatory affairs and ensure that the dissolution tests are performed to international standards so that the product can pass the test in the international market. The second positive partnership effect is that they will reduce the time in which drugs can be developed, and thus testing becomes efficient and cheaper.

Firms venturing into global markets attain a competitive advantage when they use CRO capabilities to address tough regulatory standards. Being able to access advanced equipment, expertise, and competencies in technical fields, as well as having competent personnel in place as a result of CROs, has a positive impact on testing accuracy and reliability. Special testing protocols in complex drug formulations like sustained-release and poorly soluble products are also supported under these collaborations. Outsourcing to CROs will enable pharmaceutical companies to concentrate on core R&D operations and also provide high-quality dissolution testing. In general, collaborations with CROs are essential to international growth and productivity within the pharmaceutical dissolution testing services market.

Can AI-driven predictive models optimize formulations and accelerate regulatory approval timelines efficiently?

AI-powered predictive models are progressively dominating the pharmaceutical dissolution testing services market, as they efficiently optimize formulations and help manufacturers shorten the regulatory approval timeline. The Central Drugs Standard Control Organisation (CDSCO) in India is embracing AI to improve regulatory efficiency, which will also shorten the processing time to license drug tests and export certifications. Using AI, one can simulate the dissolution profiles, determine how drugs will release active ingredients over time, and so reduce the physical tests. This ability to predict enables formulation optimization during early development, reducing the time spent in experimentation and cost.

AI also forecasts the most promising formulations, analyses big data, and helps in making more accurate decisions. Clinical trial design. It may also be utilised as a component of a clinical study to forecast patient behaviour and may be utilised to derive ideal dosing regimens. Applications of this kind have a reduced development cycle and an increased likelihood of passing through regulators. AI and dissolution testing combination can enhance the quality of data and efficiency of the working process and reproducibility. The pharmaceutical companies exploiting AI are in a better position to respond to market and regulatory needs. Overall, predictive models based on AI play a crucial role in enhancing efficiency, innovation, and competitiveness in the pharmaceutical dissolution testing services market worldwide.

What are the key market segments in the Pharmaceutical Dissolution Testing Services industry?

Based on the dosage form, the Pharmaceutical Dissolution Testing Services Market is classified into Tablets, Capsules, and Others. Tablets lead the market because they are widely used, easy to produce, and easily administered by patients. Capsules are on the rise due to the ease of swallowing, and they can also help to conceal the bad tastes. Formulations in the category of Others, like suspensions, emulsions, and dermal patches, should be tested by special methods.

The different dosage forms should be tested in terms of proper dissolution, so there is conformity in the release and control of the drugs. The rising demand for generic drugs and bioequivalence studies leads to the growth of the market. All dosage forms are becoming more efficient with new technologies in testing, including automation and AI. In general, dosage form classification plays an important role in quality control, formulation development, and market strategy planning.

Based on the service type, the Pharmaceutical Dissolution Testing Services Market is classified into Routine Testing, Stability Testing, and Bioequivalence & Pharmacokinetic Studies. Testing is conducted regularly to support consistency in quality and compliance for each production batch. Stability testing measures the ability of drugs to remain potent, safe, and effective over time under different environmental conditions. The comparison of generic formulations with their reference products, in which the absorption and therapeutic effect are comparable, is performed by bioequivalence and pharmacokinetic investigations.

These are important services to access the market and regulatory approvals. Complex formulations and increased demand for generics are providing opportunities to demand specialized testing services. Increases in technological efficiency and accuracy of tests through automation and predictive modeling are raising test accuracy and efficiency. In general, the classification of the type of service is used to enable the pharmaceutical companies to test most efficiently and preserve the reliability of the product.

Which regions are leading the Pharmaceutical Dissolution Testing Services market, and why?

The North America Pharmaceutical Dissolution Testing Services Market is leading due to the advantage of strict regulatory frameworks implemented by agencies such as the FDA, which guarantees high standards of drug development and testing. Advanced dissolution testing services are requested by the increasing demand for generic drugs and compound formulations. High investment in research and development and implementation of automation and AI technologies also contribute to the high efficiency and accuracy of the tests.

CROs and laboratories specialized in specific tests have a great role to play in the provision of outsourced testing. The rising trends of pharmaceutical firms teaming up with service providers to speed up the drug approval process are also being witnessed in North America. The high-throughput testing is backed by the strong infrastructure and qualified labor in the region. On the whole, North America is still leading in the market by integrating regulatory compliance with technological innovation and industry experience.

The Asia Pacific Pharmaceutical Dissolution Testing Services Market is growing due to the rapid growth of the pharmaceutical and biotechnology industries in some countries, such as China, India, and Japan. The market is growing due to the rising demand for generic drugs and low-cost testing solutions. The area is also enjoying increased research and development, and the construction of current testing labs. An increase in outsourcing to Contract Research Organizations (CROs) leads to increased availability of special dissolution testing services.

Some regulatory systems are slowly gaining strictness, pushing towards the use of standard testing procedures. Efficiency and performance are being highly enhanced through technological applications, such as automation and the introduction of AI. Availability of qualified professionals and the positive government policy favor the growth of the market. All in all, the Asian Pacific comes with a lot of growth potential because of its manufacturing capacity, low cost, and pharmaceutical production that is on the rise.

What does the competitive landscape of the Pharmaceutical Dissolution Testing Services market look like?

The Pharmaceutical Dissolution Testing Services Market is a highly competitive sector, and the key players in this industry are Intertek Group Plc, Agilent Technologies, Inc., Thermo Fisher Scientific Inc., SGS SA, Catalent, Inc., and Charles River Laboratories. These organisations are keen on applying the current technologies in testing to enhance the speed, accuracy, and management of data through automation and artificial intelligence. Mergers, acquisitions, and partnerships are some of the strategic efforts to market portfolios of services and establish a strong presence globally. The requirement to offer cost-effective and specialised solutions is pushing the dissolution tests to Contract Research Organisations (CROs). The competition in the market is mostly defined by adherence to the regulation, which ensures a high degree of quality offered by the FDA, just like the EMA.

The increasing popularity of generic medicine and problematic dosage form issues will demand increasingly accurate and dependable dissolution investigations. Companies are also investing in new innovative testing solutions to handle high-throughput and complex formulation demands. In March 2025, Agilent Technologies published a version of the automated dissolution system that better analyzes the data and enhances the pharmaceutical testing process. The necessity to pay much attention to quality assurance and the rapid development of drugs remains the characteristic feature of competing strategies. Generally, the market competitors are continually innovating and creating services to remain on top in a constantly changing and growing industry.

Pharmaceutical Dissolution Testing Services Market, Company Shares Analysis, 2024

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Which recent mergers, acquisitions, or product launches are shaping the Pharmaceutical Dissolution Testing Services industry?

• In March 2025, Agilent Technologies launched an advanced automated dissolution system featuring enhanced data analysis capabilities. This innovation aims to streamline dissolution testing processes, ensuring compliance with stringent regulatory standards and improving efficiency in pharmaceutical quality control.
• In February 2025, Sotax introduced a miniaturized dissolution system designed for high-throughput screening. This system is tailored to meet the growing demand for rapid and efficient dissolution testing in the pharmaceutical industry, facilitating the development of new drug formulations.

Report Coverage:

By Dosage Form

• Tablets
• Capsules
• Others

By Service Type

• Routine Testing
• Stability Testing
• Bioequivalence & Pharmacokinetic Studies

By Method

• In Vitro Testing
• In Vivo Testing

By Dissolution Apparatus

• Basket Apparatus
• Paddle Apparatus
• Others

By End-User

• Pharmaceutical & Biopharmaceutical Companies
• Contract Research Organizations (CROs)
• Academic & Research Institutes
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Intertek Group plc
• Almac Group Ltd
• Agilent Technologies, Inc.
• Catalent, Inc.
• Thermo Fisher Scientific Inc.
• SOTAX AG
• Charles River Laboratories International, Inc.
• Boston Analytical, Inc.
• Pace Analytical Life Sciences, LLC
• Albany Molecular Research Inc.
• SGS SA
• Eurofins Scientific SE
• WuXi AppTec Co., Ltd.
• Parexel International Corporation
• Covance Inc.

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