Clinical Trials in Indonesia: Challenges and Opportunities for Industry Sponsors

The increasing focus on diversity in clinical trials by regulatory authorities worldwide, combined with the ongoing need to expand pools of eligible patient participants, is leading many sponsors to explore opportunities for research in developing countries that have not historically participated in large-scale, industry-sponsored clinical trials.

Consider Indonesia, a country with 275.5 million people and the fourth most populated country in the world.1 Indonesia’s pharmaceutical market is the largest among the Association of Southeast Asian Nations (ASEAN) countries, with a total value of around USD 3.3 billion and a 10%-14% annual growth rate.2 In the last two decades, Indonesia has also experienced significant growth in healthcare infrastructure.2

However, Indonesia has hosted fewer clinical trials—including fewer industry-sponsored clinical trials—than other ASEAN countries.2 Recent commitments by Indonesia’s Ministry of Health (MOH) to boost the country’s clinical research industry suggest Indonesia has significant potential for becoming a regional and possibly a global leader in clinical research, opening significant opportunities for both Indonesia and its people as well as industry sponsors.

Strengthening research capabilities

• For example, in 2023, the MOH signed a decree establishing a national clinical research center, INA-CRC to facilitate clinical trials across all hospitals and be a catalyst for accelerating health research in Indonesia. The government has mandated that each hospital establish a Clinical Research Unit and engage in capacity-building initiatives. Accredited ethics committees have been established by national and teaching hospitals.
• Indonesia’s National Biomedical and Genome Science Initiative (NBGSi) is collecting baseline genomics data from nine hospitals to form a crucial foundation for personalized medicines tailored to Indonesia’s diverse genetic landscape. Initial areas of focus include tuberculosis, cancer, brain and neurodegenerative diseases (stroke), metabolic diseases (diabetes mellitus), psoriasis, rare diseases (Duchenne Muscular Dystrophy, pulmonary arterial hypertension), maternal and pediatric health and cardiovascular disease.

Streamlined approval processes, greater transparency

• In September 2009 the MOH mandated a Material Transfer Agreement (MTA) before samples can be sent out of the country (e.g., to central laboratories commonly used in multi-regional clinical trials). Experience since then suggests the MTA requirement may be a lower hurdle than perceived and can be achieved in 1-2 months, on average. The MOH is currently revising the MTA decree to make its requirements and approval process simpler and more transparent, which in turn should help to increase confidence among industry sponsors and accelerate timelines.

Building site capacity

Facilitating study start-up, accelerating timelines, increasing predictability in clinical trial delivery and promoting diversity and inclusion in clinical trials depend on the existence of well-established research sites with experienced staff, which are not yet widely available in Indonesia.

• To help address this challenge, Syneos Health has been working to develop sites within Indonesia that are new to clinical research through its global Catalyst Site Network. The very first Syneos Health global and regional “New to Clinical Research” Catalyst Site was established on 19 March 2024 at Mayapada Hospital Jakarta Selatan.

Regional collaborations

• A collaboration between Clinical Research Malaysia (CRM) and Indonesia is under active discussion. CRM launched in 2012, spurring significant growth in clinical research in Malaysia.2 As such, it’s a role model for the national-level management Indonesia needs to support an environment conducive to high-quality clinical research.
• The Singapore Clinical Research Institute (SCRI) is the national academic clinical research organization established to enhance the standards of clinical research in Singapore. SCRI signed a Memorandum of Understanding (MOU) with ONWARD Health Research in March 2024 to open doors for collaboration to nurture Clinical Research Coordinator (CRC) talent in Indonesia.

Looking ahead

Thanks to these and other regulatory and capacity-building and collaborative initiatives, the future looks bright for Indonesia as a center of research excellence. This is good news for the people of Indonesia, who stand to benefit from greater access to new therapies addressing national health issues and from further development of the country’s healthcare system.

This is also good news for sponsors. Indonesia is an ideal market for many kinds of studies, including urgently needed vaccine and pediatric nutrition clinical trials and for medical products and devices utilizing cutting edge technologies, particularly for products that will be marketed in the country.

Because this is a dynamic period of growth and change, navigating Indonesia’s clinical research landscape requires practical local insights gained through on-the-ground experience in Indonesia as well as insights gained from work in other countries in the region. Just as importantly, it requires the ability to build relationships and the desire to collaborate and help build Indonesia’s research capacity to benefit the people of Indonesia and global health.

Download our recent white paper, Clinical Trials in Indonesia: Challenges and Opportunities for Industry Sponsors | Syneos Health, to learn more about the clinical trial landscape in Indonesia (including types and phases of clinical trials, therapeutic areas of interest and patient populations) and additional information.

Contributors

Lena Low, Executive Director, Clinical Operations APAC, Syneos Health

Martin Lim, Co-founder & CEO of Onward Health Research

Terttu Haring, President, Site & Patients, Syneos Health

Serena Chan, Vice President, Clinical Operations APAC, Syneos Health

David Gebbo, Director, Clinical Operations APAC, Syneos Health

Lucia Rizka Andalucia, Director General of Pharmaceuticals and Medical Devices, Indonesian Ministry of Health and Acting Head, Indonesia National Agency of Drug and Food Control (BPOM)

Roy Himawan, Director of Pharmaceuticals and Medical Devices Resilience, Indonesian Ministry of Health

Indri Rooslamiati, Acting Director for the National Biomedical and Genome Science Institute (NBGSi)

Dona Arlinda, Team Leader, INA-CRC, and the team from Indonesian MOH and INA-CRC

Acknowledgements

The authors wish to thank the following for their thoughtful perspective and input to this paper:

• The extended team at Indonesia Ministry of Health
• Anna Ching, Associate Director, Clinical Operations APAC, Syneos Health
• Marlinang Diarta Siburian, Department of International Trial, National Center for Global Health and Medicine, Indonesia

References

1. World Bank Open Data. https://data.worldbank.org/indicator/SP.POP.TOTL?locations=ID

2. Siburian MD, Muchanga SMJ, Villanueva AFDR, Setiabudy R, Tatsuo I. The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases. Global Health Journal.2020;(4):87-95. doi.org/10.1016/j.glohj.2020.08.003

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