The pharmaceutical launch landscape witnessed significant shifts in 2024, with Asia-Pacific markets emerging as increasingly attractive early-launch destinations alongside traditional Western markets. Analysis of 33 innovative drugs that received both approval and pricing reveals evolving market priorities and changing dynamics in global pharmaceutical launches.
Shifting Geographic Launch Patterns
While the United States maintains its position as a critical first-launch market, South Korea and Japan have made notable strides in securing early-launch status for select products. A prime example is Onconic Therapeutics's Jaqbo, On Cab, Q Zetas (zastaprazan), an anti-ulcer agent for erosive gastroesophageal reflux disease (GERD), which launched first in South Korea. Similarly, AstraZeneca's Voydeya (danicopan) chose Japan as its second launch market after the US, before expanding to Germany.
Market Reform Impacts
South Korea's enhanced position in launch sequences can be attributed to its reformed reimbursement system, designed to foster drug innovation. The reforms included higher initial pricing for innovative medicines, expanded risk-sharing agreements, and improved reimbursement process transparency.
Japan similarly implemented favorable changes for branded medicines in 2024, introducing the "pioneer premium" for early-launch products and expanding eligibility criteria for price maintenance premiums. These reforms have directly influenced pricing dynamics, as evidenced by Voydeya's launch pricing, where Japan commanded a slightly higher price ($0.25/unit/mg) compared to the US ($0.23/unit/mg).
Therapeutic Focus and Market Assessment
The analysis reveals a continued strong focus on oncology, representing 47% of new drug launches, followed by neurological disorders. Health Technology Assessment (HTA) outcomes across seven markets showed predominantly positive results, with Japan, the UK, Canada, France, and Germany all delivering favorable assessments for evaluated drugs.
Orphan Drug Trends
A significant 53% of launched brands carried orphan drug designation, reflecting sustained investment in specialty drugs for rare diseases. However, this high percentage might indicate a plateau in the orphan drug sector, facing challenges from cost containment policies like US Medicare price negotiations and growing investment in diabetes treatments.
Market Access Considerations
The landscape for market access is evolving, with health technology assessments playing a crucial role in launch strategies. Of the 16 HTA decisions across seven markets in 2024, most resulted in positive outcomes, leading to reimbursement list inclusion or favorable pricing procedures. Only Finland recorded a negative outcome, declining reimbursement for Vyloy (zolbetuximab).
Future Outlook
While the US and Germany maintain their prominence as early-launch markets, the emergence of South Korea and Japan as innovation-friendly destinations signals a potential shift in global launch strategies. The rare disease space, while still robust, faces new challenges from cost containment measures and competing therapeutic areas like diabetes.
These trends suggest a more complex and nuanced approach to global drug launches, where pharmaceutical companies must balance traditional market priorities with emerging opportunities in reformed APAC markets.
