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Huge Needs for Cardiovascular Intervention Device in China


According to the statistics cited in the 2015 China Cardiovascular Diseases (CVD) report, the number of cardiovascular patients in China has reached 290 million.  That number is expected to continue to grow rapidly in the future, and the death rate of CVD is also in a rising trend.  In 2009, the mortality rate of CVD in rural areas exceeded that of cities for the first time. At present, cardiovascular deaths account for the top cause of total deaths among urban and rural residents. For every 5 deaths, 2 were caused by CVD. The mortality rate of cardiovascular disease still ranks first in death by disease, making it higher than the death rate caused by tumors and other diseases.

China’s growing market demand for cardiovascular interventional devices

In this context, the market demand for cardiovascular interventional devices is huge, and development prospects for the industry are good.  In 2014, the size of the cardiovascular intervention device market in China was approximately 4.21 billion US dollar, an increase of 25.07% from 3.35 billion US dollar in 2013.  In 2015, the market size of cardiovascular intervention devices in China was approximately 5.09 billion US dollar.

The size of China’s cardiovascular intervention device market in the most recent years is shown in the following figure:

At present, China is the second largest coronary artery stent market in the Asia-Pacific region. In 2010, the coronary stent market in China was approximately 1.18 billion USD. In 2011, China’s coronary stent market reached approximately 1.48 billion USD. In 2012, the coronary stent market in China was approximately 1.79 billion USD. In 2014, the market scale reached 2.86 billion USD, and in 2015 it was approximately 3.47 billion USD.

Market size of the coronary stent in China in recent years is as follows:

2009-2015 China’s Market Size for Coronary Stent

The interventional treatment for CVD was introduced to China in the 1980s; the clinical application for coronary interventional treatment is developing at an unprecedented rate with the continuous improvement of interventional equipment and the accumulation of experience of interventional therapies. The number of cases of Percutaneous Coronary Intervention (PCI) has been increasing at a rate of 20% to 30% per year and has reached more than 500,000 cases by 2012.  

2000-2012 A Rapid Upward Trend of PCI Surgeries in China

H2: Pacemaker implants in China increasing annually by 10%

From 1995 to 2015, the number of pacemaker implants in China increased year by year. In 2015, the total number of pacemaker implants in mainland China was 65,697, an increase of about 10% compared to 2014.    

1995-2015 Pacemaker Implants in China

CVD medtech wanted: Accelerated pathways for innovation, review and approval in China

The innovation of cardiovascular devices continues to accelerate in China, as a result, stents, made with fully degradable and magnesium alloy material, have stepped into clinical trials. Moreover, the innovation is trending more and more towards to independent rather than imitation, meanwhile, the concept to production transition speed is rising as well.

The review process timing for cardiovascular innovative devices by CFDA has been shorten.  By now, China has approved 55 innovative products for special applications:  19 cardiovascular approved products accounted for 35%, which shown a “leadership” situation. In the first five months of 2016, six innovative cardiovascular stent intervention products that have been specifically approved by the National Food and Drug Administration to review the application process. In terms of market size, the sales volume of cardiovascular intervention devices is second only to the In vitro diagnostic market, ranking second, and the compound growth rate has grown rapidly in recent years. With the inevitable trend of aging and the high incidence of chronic diseases such as cardiovascular and cerebrovascular diseases, the market demand for cardiovascular interventional devices is huge, and the industry has good prospects for development.


About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.

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