Cell and gene therapies in the Asia-Pacific region: evolving reimbursement pathways

The demand for cell and gene therapies is increasing within the Asia-Pacific region

APAC markets include some of the most populous countries in the world, have fast-growing and aging populations, are faced with high disease burdens, and have a relatively high biopharmaceutical expenditure—China and Japan rank among the five largest global pharmaceutical markets.

The demand for innovative therapies, including CGTs, is increasing; for CAR-T therapies alone, APAC is estimated to have a compound annual growth rate of 56% over a 5 year-period until 2026, compared with a global rate of 39%.

As these markets undoubtedly represent the next big growth opportunity for CGTs, it is beneficial to consider how global lessons from this field can be applied to overcome hurdles in the APAC region.

 

The evolving national regulatory and reimbursement pathways for cell and gene therapies in Asia-Pacific markets

The figure below shows the average regulatory and reimbursement evaluation timelines for global CGTs in key APAC markets relative to US FDA registration. It indicates that APAC markets are lagging behind in access to global CGT products.

 

 

Dedicated pathways for CGTs specific to regenerative medicines or advanced therapies have been set up in most major markets in the APAC region. Global CGTs have been launched in Japan and Australia first, followed by later launches in other markets such as South Korea, Taiwan, and Singapore. China and India typically see global products launching much later, but the resulting gap is being filled by innovators from the region offering locally developed CGTs.

From the timelines alone, it is evident that it is difficult for manufacturers to secure simultaneous approvals for CGTs across these diverse markets.

Compounding the regulatory challenge is the absence of formalized financing mechanisms for CGTs in most markets in the region. Other than in major markets such as Australia, Japan, South Korea, and Taiwan, public payers are CGTs.

Some active efforts to harmonize regulatory approaches are under way, such as the ACCESS Consortium’s working group for advanced therapy medicinal products (ATMPs), but today, this regional divergence requires manufacturers to strike a balance between meeting individual evidence requirements and ensuring timely access for patients across borders. The limited reimbursement opportunities necessitate alternative business models and financing mechanisms, requiring innovative approaches to secure funding for these transformative therapies.

 

Supporting your Policy, Access, Value, and Evidence in the Asia-Pacific region

The expert APAC team at Avalere Health will help you bring out the best in your asset, using our extensive market access and disease area experience.

The APAC region is characterized by its dynamic nature and rapidly evolving markets. These are critical to the future growth plans of our biopharmaceutical clients and we are leading many groundbreaking market access projects in the region.

We’re based in Singapore, experienced, easy to talk to, and we love a challenge. Let us show you why our clients come back to work with us time and again. Contact us.