The emerging markets of the APAC region offer tremendous potential for clinical research. Best practices for cardiovascular medical device development in Asian countries can offer insights on navigating the regulatory and clinical landscape of this region.
Widely recognized as one of the most important growth frontiers for medical devices, the Asia Pacific (APAC) region comprises a complex mix of people, regulations, and payment models. According to one forecast, the APAC surgical and medical device market is expected to grow at a compound annual growth rate (CAGR) of 6.5 percent from 2017 to 2026, reaching $167 billion by the end of the forecast period. For device manufacturers who hope to tap into the potential of this burgeoning market, it is critical to understand the regulatory and clinical nuances of this diverse region.
Medical device development is distinct from pharmaceutical development and requires different clinical development strategies and regulatory pathways depending upon device classification in the U.S. and EU. In contrast, APAC markets have evolving and developing regulatory environments. To succeed in APAC markets, device manufacturers have used various approaches to approval, from integrating regulatory activities with global clinical trials to establishing local infrastructures through mergers and acquisitions of local players.
In this white paper, we explore best practices for cardiovascular medical device development in Asian countries and offer insight on navigating the regulatory and clinical landscape of this region.
APAC cardiovascular disease overview
As the worldwide population ages, cardiovascular disease (CVD) has become a leading global health issue. By 2050, one in four people in the APAC region will be over age 60, representing 1.3 billion people. Given that the majority of the world’s population resides in the APAC region, it is expected that at least half of the world’s cardiovascular (CV) burden will be concentrated in that region. In China alone, an estimated 4.2 million people are living with heart failure. It is not surprising, then, that CV clinical trial activity in the APAC region is robust, accounting for 14 percent of all studies in India and 55 percent of all studies in Japan.