Accelerating Global Access to Gene Therapies: Case Studies from Low- and Middle-Income Countries

The report argues that while gene therapies offer potential one-time cures for high-burden diseases, access is currently concentrated in high-income countries. It identifies seven essential capacity pillars—R&D, health facilities, manufacturing, workforce, community engagement, policy/regulation, and finance—necessary for sustainable delivery in LMICs. Through case studies of Uganda, Tanzania, South Africa, Thailand, and India, the document highlights the transition from basic facility equipping to advanced self-reliance and the critical need for 'place-of-care' manufacturing to reduce costs. It concludes that proactive capacity building and international partnerships are essential to prevent a widening global health divide.

• There is a significant global disparity in gene therapy access; as of 2022, only three of the 20 approved gene therapies worldwide were approved in LMICs: China, Brazil, and the Philippines.
• LMICs bear nearly 90% of the global disease burden, yet fewer than 5% of approximately 1,000 open gene therapy clinical trials globally were recruiting in LMICs (excluding China), with only four trials in Africa.
• The report identifies seven 'capacity pillars' essential for sustainable gene therapy delivery: R&D ecosystems, equipped health facilities, localized manufacturing, a multidisciplinary workforce, community engagement, converged policy and regulation, and public-private financing.
• To achieve cost-effectiveness in LMICs, 'place-of-care' manufacturing is critical as it could reduce the required trained personnel by approximately fivefold and shorten the procedure by several weeks compared to centralized manufacturing.
• A 'hub-and-spoke' model is proposed to coordinate care, where tertiary 'hubs' handle research and administration while primary and secondary 'spokes' manage community education, screening, and long-term follow-up.
• Significant funding gaps exist for LMIC affordability; while industry innovation may reduce in vivo HIV cure costs to $10,000–$50,000 in high-income countries, a price point of $1,000–$2,000 is estimated as necessary for cost-effectiveness in LMICs.
• Case studies reveal varying levels of readiness: Uganda and Tanzania are focused on equipping facilities and regulatory frameworks, while South Africa, Thailand, and India are prioritizing self-reliance and private sector growth.
• Workforce shortages are a critical barrier, particularly for specialists; for example, the WHO recommends one clinical haematologist per 100,000 people, but South Africa has fewer than one per 2 million.
• Regulatory challenges include the need for 'work-sharing' and 'reliance' between national authorities to expedite access, as most LMICs currently repurpose existing medicinal product regulations for gene therapies.

APA

World Economic Forum (2022). Accelerating Global Access to Gene Therapies: Case Studies from Low- and Middle-Income Countries. https://www3.weforum.org/docs/WEF_Accelerating_Global_Access_to_Gene_Therapies_2022.pdf

Chicago

World Economic Forum. Accelerating Global Access to Gene Therapies: Case Studies from Low- and Middle-Income Countries. 2022. https://www3.weforum.org/docs/WEF_Accelerating_Global_Access_to_Gene_Therapies_2022.pdf.

Wikipedia

{{cite report |author=World Economic Forum |title=Accelerating Global Access to Gene Therapies: Case Studies from Low- and Middle-Income Countries |date=October 2022 |url=https://www3.weforum.org/docs/WEF_Accelerating_Global_Access_to_Gene_Therapies_2022.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{worldeconomicforum2022accelerating, author = {{World Economic Forum}}, title = {{Accelerating Global Access to Gene Therapies: Case Studies from Low- and Middle-Income Countries}}, institution = {World Economic Forum}, year = {2022}, month = oct, url = {https://www3.weforum.org/docs/WEF_Accelerating_Global_Access_to_Gene_Therapies_2022.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }