By Ames Gross
Introduction
Cardiovascular disease is one of the leading causes of death in Asia. According to the WHO, more than 57% of the 16.5 million people who die annually from cardiovascular diseases are from Asia. Cardiovascular disease is prevalent in Japan, China, India and Southeast Asia. This disease will increase all over Asia as rising incomes continue to change the lifestyles of Asians who now consume more Western fast food, smoke more and exercise less.
The rising focus on diagnosis, treatment and prevention of cardiovascular diseases has also led to a rising demand for cardiovascular medical devices in Asia. The cardiovascular medical device market in Asia is currently worth about $11.5 billion with 11% annual growth. Eventually, the Asian cardiovascular device market is expected to increase from the current 29% of the global market to 38% in 9 years.
In general, there are several major groups of cardiovascular devices in Asia – cardiovascular monitoring and diagnostic equipment and cardiac rhythm management devices. Examples of cardiac rhythm management devices include implantable cardioverter defibrillators (ICDs) and pacemakers.
Most of the sophisticated cardiovascular devices in Asia are imported from the US and Europe. Overall, foreign firms control more than 75% of the sophisticated medical device market in Asia. Examples of companies exporting these products are Boston Scientific, St. Jude and Medtronic. These companies have been selling their products in China since the 1990s.
Increasingly, there are also more foreign companies that have set up their own factories, R&D and technology centers in Asia. For instance, St. Jude recently went ahead to establish a Technology Center for Physicians in Beijing to educate and train local physicians to use the company’s cardiovascular medical devices.
Market Potential for Cardiovascular Devices in Asia
In countries with large populations like India and China, the demand for cardiovascular devices is growing rapidly. With a population of 1.38 billion, China’s rapidly aging population requires more cardiovascular devices. More than 19.8 million patients currently have coronary artery disease in China. Increasingly, more sophisticated interventional cardiovascular devices are being used in lieu of heart surgeries to treat cardiac diseases in China. Besides foreign firms, many local Chinese competitors have also begun to manufacture Class III cardiology products. Some local firms even have their own R&D facilities, or have teamed up with Western firms for technological joint ventures. The Chinese medical devices firms which are noteworthy include the Lepu and MicroPort.
In comparison, the Indian cardiovascular devices market is much smaller than China. This is largely due to the lower standard of healthcare and the lack of government facilities for cardiovascular disease treatment. Nonetheless, despite the low government healthcare spending, there are still growth opportunities in the private sector, which is a large part of India’s $3.5 billion medical device market. Cardiovascular devices account for almost a third of the total medical device market. The demand for cardiovascular devices will continue growing because of technological improvements for cardiovascular monitoring and treatment systems available in hospitals. There are also good opportunities for cardiovascular medical devices which treat rheumatic heart disease, and congenital heart diseases among infants.
Outside of China and India, there are also opportunities for cardiovascular devices companies in Japan. The rapidly aging population, coupled with the rising number of people with diabetes and young smokers have all led to the rise of cardiovascular diseases. Unlike India, Japan has government healthcare allocation for retirees and high government healthcare standards which have been fundamental to the growth of the interventional cardiology device market. Another device which is increasing in demand is the diagnostic catheters, as more senior citizens are opting for diagnostic angiography procedures.
Asian Cardiovascular Devices Regulation
Every Asian country has different regulations for cardiovascular devices. Like all medical devices, there are different classifications for cardiovascular devices as well, corresponding to the risk level that the device poses to the patient.
A good example of a regulatory difference can be pointed out in the case study of China and Hong Kong. Although Hong Kong is officially part of China, the two countries have very different medical device regulations. In China, all medical devices are categorized into three classes – Class I, Class II and Class III, with Class I being low risk and Class III being high risk. Class III devices are those which are “implanted into human [bodies], or used for life support or sustenance”. Examples of devices in this class include implantable cardiac pacemakers and cardiovascular endoscopy devices. In contrast, medical devices in Hong Kong are categorized into four classes, with Class IV being the highest risk. Devices that have “direct contact with [the patient’s] heart of central circulatory system” are classified as Class IV devices. Hence, the implantable cardiac pacemakers which are Class III devices in China are Class IV devices in Hong Kong.
Conversely, in developing markets such as India, more comprehensive guidelines are slowly beginning to be implemented. India does not have specific definitions for most medical devices yet, but there is a Medical Device Regulation Bill which might be implemented soon. Currently, many cardiovascular devices in India, including heart valves, cardiac patches, cardiac stents and occluders are classified as drugs under the 1940 Drugs and Cosmetic Act.
Conclusion
The market for cardiovascular devices in Asia is rapidly expanding. More Asian governments are also implementing national healthcare policies and programs to improve cardiovascular health. Some international cardiovascular device companies also realizing the market’s potential, and have established their own factories in Asia to lower manufacturing costs. Some Asian countries, such as Singapore, have even provided incentives such as tax breaks to attract foreign investments in manufacturing high end cardiovascular devices. A company which has taken advantage of Singapore’s comprehensive infrastructure and skilled work force is Medtronic, which launched a new manufacturing plant for cardiac devices in January 2011. The Medtronic office in Singapore will also serve as their regional distribution center for their Cardiac Rhythm Diseases Management business as well as their Asian headquarters. Similarly, the Swedish manufacturing company Sandvik AB has also started to manufacture pacemaker lead used in medical devices in India to lower their manufacturing cost.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at info@pacificbridgemedical.com.
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