With a population of more than 670 million across hundreds of different ethnic groups living in the Association of Southeast Asian Nations (ASEAN), the total number of patients experiencing rare diseases and conditions is high. According to a 2016 academic paper published in the Orphanet Journal of Rare Diseases by Asrul Akmal Shafie and colleagues, more than 45 million patients have a rare disease in ASEAN. Despite the extremely low incident rate of each disease, the collective prevalence of all rare diseases and conditions would reach 9% of the total population in ASEAN. Rare diseases can affect the quality of life of patients and their family members, and most patients require funding from the public and private sectors to access the expensive treatments targeting those conditions. However, most ASEAN members lack the legislation or national policy necessary to steadily support rare disease patients and accelerate new orphan drug entry into the markets.
Singapore, the Philippines, and Thailand are the pioneers in promoting rare disease awareness among ASEAN. As early as 1991, Singapore passed the Orphan Drug Act to create a legal framework for orphan drugs. However, due to budget concerns at that time, Singapore did not provide regulatory or reimbursement incentives to award orphan drugs. In 2019, the Rare Disease Fund (RDF) was established to reimburse treatments with high costs that target life-threatening genetic diseases. The budget allocated to the RDF to support Singaporean patients with rare diseases has grown in past few years.
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In the Philippines, the Rare Diseases Act (Republic Act No. 10747) was enacted in 2016 with the goal to create a comprehensive system covering the early diagnosis, medical treatment, and management of rare diseases. The Philippines’ Government also provides dedicated funding under the Rare Diseases Act to support patients, but the budget for this purpose has been insufficient since common diseases remain the country’s key healthcare focus. This is further reflected in the fact that funding delivered under the Rare Diseases Act was cut in 2023. In general, the expansion of universal healthcare insurance coverage, whether for rare or common diseases, has not met a satisfactory level for the public.
Thailand has not adopted a rare disease policy, although the government has acknowledged the importance of supporting the diagnosis and treatment of rare diseases. In 2020, the National Health Security Office designated 24 rare, inherited metabolic disorders or inborn errors of metabolism into a new benefit package under Thailand’s Universal Coverage Scheme. Patients with these conditions can receive free treatments under universal healthcare insurance. There are currently no other specific funds for rare disease treatments in Thailand. Research published by Suwattanapreeda and colleagues on the Orphanet Journal of Rare Diseases in 2025 has showed that treatments targeting rare diseases may be eligible for higher willingness-to-pay (WTP) thresholds when seeking reimbursement.
Malaysia has recently vowed to support patients with rare diseases. The first Malaysian rare disease policy was published in August 2025. The 2025 national policy outlines seven major challenges for patients to access rare disease treatments, including a lack of registries for rare diseases, a designated accelerated regulatory pathway for orphan drugs, insufficient funding, and limited healthcare insurance coverage. Before the release of the national policy, the government had made several attempts to promote rare disease accessibility, including the establishment of the Malaysia Rare Disease Trust Fund in 2022. However, the Fund has faced slow fund accumulation. The Rare Disease Trust Fund was mentioned in the 2025 national policy as a part of funding policy to support rare disease patients, but it was not highlighted in the budget proposal for 2026. Instead, the Ministry of Finance (MoF) promised to increase funding to strengthen the overall healthcare system in order to provide comprehensive services for genetic disease patients, including early diagnosis. Although the 2025 national policy on rare diseases marks a milestone that formalizes the government’s promise on supporting rare disease patients, more actions will need to be taken to achieve that goal.
Similar to the progression of rare disease support in Malaysia, Vietnam released the first National Action Plan for Rare Disease Management (2025–2026) this year. The first national action plan aims to explore solutions to improve the quality of life among the six million rare disease patients living in Vietnam, highlighting the need for a stable orphan drug supply and accessibility to diagnosis. By the end of 2026, the government is scheduled to release an official national list of rare diseases. In mid-2025, the Steering Committee for Strengthening Rare Disease Management was set up. Following the establishment of the Steering Committee, the Health Insurance Department of the Ministry of Health expressed hope to include orphan drugs as a key component when forming the national health insurance reimbursement package. Several reimbursement incentives may be introduced, such as waivers for cost-effectiveness assessments and higher prices. However, no clear schedule was provided for the expansion of reimbursement coverage on orphan drugs. The Vietnamese government already delayed the update of its national reimbursement drug list. The country’s Ministry of Health released a new guideline (Circular 37/2024/TT-BYT) clarifying the reimbursement requirements for drugs, and scheduled to release the new list in early 2025. However, the update of the reimbursement list has been delayed. According to the government’s latest announcement, a draft of the new reimbursement drug list was made in late November 2025.
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By GlobalDataRecent development in the five ASEAN nations demonstrates that the region is aware of patient needs regarding rare disease diagnosis and orphan drugs. Although there is no official joint drug regulatory system specific for orphan drugs in ASEAN, the member states have increased cross-broader communication in terms of rare disease management. Currently, Singapore is the leading country in ASEAN, providing stable funding dedicated for rare disease treatments. Allocating funding for new orphan drugs and promoting the strong public healthcare system could ensure that rare disease diagnosis rates remain the main issues to promote orphan drug accessibility.
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