The pharmaceutical dissolution testing market size is estimated to be USD 645.85 million in 2022 and is expected to witness a CAGR of 8.37% during the forecast period 2023-2033. Rising prevalence of chronic and infectious diseases and the expansion of R&D efforts are some of the factors contributing to the market growth. Furthermore, increasing importance of oral solid dose forms and rise in awareness for self-care are other factors supporting the market growth. However, shortage of skilled professional is expected to hinder the growth.

Expansion of R&D efforts is expected to propel the market growth during the projected period. The demand for pharmaceutical dissolution testing services has expanded as a result of pharmaceutical companies investing in R&D and as more innovative drugs enter the preclinical stage of development. The pandemic first disrupted the dissolution testing services. Various pharmaceutical businesses experienced an increase in workload and a decrease in their capacity for internal lab testing as a result.

Increasing importance of oral solid dose forms is predicted to fuel the market growth during the forecast period. Its significance is growing as a result of the fact that before a medicine can be effectively absorbed into the blood vessels, it must be released from the product and dissolved in gastrointestinal fluids. There are 1444 drug products in the Food and Drug Administration Dissolution Database that are available in oral solid dosage form as of July 2022. It is easy to distinguish one oral solid dose product from another and to provide the oral solid dose.

Segmentation

By Method

The market is categorized into in vivo and in vitro. In 2022, the in vitro segment accounted for the highest revenue share due to the expansion of the preclinical pipeline and rising public knowledge of dissolution testing. The market for in-vitro pharmaceutical dissolution testing is also predicted to grow due to the typical increases in the price of animal testing and their socio-ethical issues. The in-vitro dissolution testing assays, which are used to assess the safety of medicines and their possible effects on cells and tissues are expected to make substantial advancements, which will boost market expansion. Businesses are expanding their product lines as the market for in-vitro pharmaceutical dissolution testing rises to meet the growing demand for these tests.

By Dosage Form

The market is categorized into tablets, capsules, and others. In the global market, the tablets segment accounted for the largest revenue share in 2022 owing to their ease of mass production, favorable chemical and physical stability, and ability to be personalized for the body’s dosage requirements. Throughout the projection period, the segment is expected to continue to lead the industry and achieve the quickest CAGR. The capsules segment is anticipated to post the second-fastest CAGR during the projected period. A solid dose form is a capsule. The stability, easy accessibility of storage conditions, and simplicity of capsule formulation and development are a few of the key factors driving this market segment.

By Dissolution Apparatus

The market is segmented into paddle, basket, and others. In 2022, the paddle segment accounted for the largest revenue share owing to the fact that it can easily be automated for a routine checkup, changes pH, and is simple to use. A motor with variable and controlled speed is mounted vertically to the paddle. A flask with a circular bottom is used to dissolve the tablet or capsule, and the apparatus is maintained at a constant temperature. This is frequently utilised for oral solid dose forms. The market for basket dissolution apparatus is anticipated to have the second-fastest CAGR over the forecast period. When employing the basket dissolution method, new equipment is placed at the end of the rotating shaft. In order to prevent any accidental chemical interactions that can alter the outcome, it is composed of non-reactive mesh and has a cylindrical shape. The fact that this method’s pH can fluctuate during the test is led to its widespread adoption.

Regional Markets

In 2022, North America region accounted for the highest revenue in the pharmaceutical dissolution testing market and is expected to maintain its dominance during the forecast period. This is attributed to the presence of large firms that offer pharmaceutical dissolution testing services and the increasing R&D expenditures by them for the development of novel therapies for chronic diseases. A growth in the burden of disease and expansion of the healthcare system have also boosted the demand for laboratory dissolution testing and the need for innovative medicines. The Asia Pacific area is anticipated to grow at the fastest CAGR during the projection period due to the increasing expenditures made in improving regional healthcare by companies from developed economies. In order to expand the reach of their services to different regions in the area, service providers are also building new facilities and forming collaborations.

Competitor Insights

Some of the key players operating in the pharmaceutical dissolution testing market AMRI, Pace Analytical Life Sciences, SOTAX, Almac Group, Agilent Technologies, Inc., Boston Analytical, Catalent, Inc., Thermofisher Scientific Inc., Cambrex Corp, Charles River Laboratories, Avivia BV, Intertek Group Plc., and SGS SA.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

• For instance, Agilent Technologies, Inc. announced the Dissolution Center of Excellence (CoE) facility would open in Craven Arms, United Kingdom, in October 2022. Agilent will be able to bring all of its dissolution-related processes under one roof due to this investment, making cross-business collaboration easier and advancing the development of the upcoming dissolution products and services.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including method, dosage form, and dissolution apparatus from 2023 to 2033.

Report Scope:

Segmentation: Pharmaceutical Dissolution Testing Market Report 2022 – 2033

Method (Revenue, USD Million), 2022 – 2033

• In vivo
• In vitro

Dosage Form (Revenue, USD Million), 2022 – 2033

• Tablets
• Capsules
• Others

Dissolution Apparatus (Revenue, USD Million), 2022 – 2033

• Paddle
• Basket
• Others

By Region (Revenue, USD Million), 2022 – 2033

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA