Challenges to clinical trial growth in Thailand

Thailand has potential to become an increasingly attractive location for pharmaceutical companies to conduct clinical trials. The total number of clinical trials conducted in 2024 was 527, an increase of 1.9% from 2023, BMI research has found.

Thailand is increasingly being recognised by drugmakers for its capacity to conduct clinical trials, supported by experienced investigators, well-established infrastructure and a regulatory framework prioritising patient safety. In June 2025, the Public Health Systems Research Institute (PHRI) and Novo Nordisk Thailand signed an agreement to raise the standard of clinical research and support the expansion of clinical research opportunities in the country.

Additionally, in December 2024 AstraZeneca Thailand, in collaboration with the Faculty of Medicine of Siriraj Hospital, Mahidol University, signed an agreement to jointly advance clinical research in Thailand. The initiative aims to enhance the capabilities of researchers in Thailand and broaden the scope of study for developing medicines and treatments in the market.

The rise in clinical trial activity in Thailand will support the growth of the pharmaceutical market. In 2024, Thailand’s pharmaceutical market was valued at 214 billion baht ($6.1 billion). Over the forecast period to 2029, we anticipate that the pharmaceutical market will reach 275 billion baht, with a compound annual growth rate of 5.3% in local currency terms and 6.5% in US dollar terms. The continued emphasis on clinical research will play a critical role in facilitating market access for medicines.

Thailand will continue to enact regulatory reforms to support overall pharmaceutical sector competitiveness. On March 1, 2024, new regulations governing drugs imported into Thailand for clinical studies came into effect, transforming the clinical trial landscape. These regulations introduce a detailed framework for the importation of drugs for clinical studies.

Notably, while there were no specific requirements governing clinical trial applications (CTAs) before, the new rules mandate the submission of a CTA, which must be approved by the Thai Food and Drug Administration (FDA) before any clinical study begins. This permit will have a five-year validity and can be renewed. Another critical change is enhanced oversight and post-approval obligations.

The Thai FDA will now actively inspect and oversee clinical studies throughout different phases, including the authority to modify, suspend or cancel studies. Furthermore, the new rules specify detailed reporting requirements, including the submission of progress reports and adverse event reports.

This level of detailed oversight and reporting is designed to align Thailand’s clinical practices with international standards, such as those set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. These requirements were already a part of the old rules but are now being reinforced.

While the clinical trial environment has shown improvement in recent years, the sector in Thailand lags regionally due to structural and political shortcomings.

Unlike Malaysia with its dedicated Clinical Research Malaysia entity, and Indonesia with its Clinical Research Center (INA-CRC), Thailand has failed to establish comparable institutional support or articulate comprehensive industry strategies. The result has been a fragmented ecosystem that struggles to attract multinational pharmaceutical investment.

This institutional gap is further exacerbated by political instability, which has disrupted policy continuity, complicated international negotiations and delayed implementation of pharmaceutical sector reforms.

Governmental instability along with heightened concerns regarding regulatory inconsistency, has fostered an environment substantially less conducive to pharmaceutical investment relative to Thailand’s regional counterparts.

This commentary is published by BMI, a Fitch Solutions Company, and is not a comment on Fitch Ratings’ Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent sources.

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