MarketingMedicalPolicy,Access,Value, andEvidenceConsultingData,Technology,and Media
murmuration of birds

thought leadership

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

Sudha Sundaram, Associate Director | 1/10/2024

In the Asia-Pacific (APAC) region, the demand for cell and gene therapies (CGTs) is increasing but the reimbursement environment for these therapies is still nascent. This update and excerpt from our on-demand webinar summarizes the evolving national regulatory and reimbursement pathways for CGTs in the APAC region.

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.


The evolving national regulatory and reimbursement pathways for CGTs in APAC markets


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.


Expert insight: “Cell and gene therapy market access in the Asia-Pacific region”

Watch the on-demand webinar

Watch now

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.

How we use cookies

Cookies are files saved on your phone, tablet or computer when you visit a website.

We use cookies to store information about how you use the Fishawack Health website, such as the pages you visit.

For more information, check the cookie statement


Cookie settings

We use 4 types of cookies. You can choose which cookies you're happy for us to use.

Cookies that measure website use.

We use Google Analytics to measure how you use the website so we can improve it based on user needs. We do not allow Google to use or share the data about how you use this site.

  • how you got to the site
  • the pages you visit on, and how long you spend on each page
  • what you click on while you're visiting the site

Cookies that help with our communications and marketing

These cookies may be set by third party websites and do things like measure how you view Vimeo videos that are on

Cookies that remember your settings

These cookies do things like remember your preferences and the choices you make, to personalize your experience of using the site.

Strictly necessary cookies

These essential cookies do things like remember your progress through a form (eg. Registering for new content alerts).

These cookies always need to be on.