China's heart stent industry development report: domestic stents occupy 80% of the country, and the growth rate is expected to return to more than 20%

According to the annual reports of relevant companies and the information of the Cinda Securities Research and Development Center, in 2013, 454,505 people in China underwent percutaneous coronary intervention (PCI), with an average of 1.51 stents placed. That is, in this year alone, China alone used 686 303 brackets. If calculated at an average of 20 mm per bracket, the brackets are nearly 14 kilometers together.

Domestic stents have occupied 80% of the country

This 14-kilometer row of brackets also means a huge bracket market. Due to the safety and effectiveness of domestic stents, 80% of this "cake" has been occupied by domestic companies, while foreign companies have shrunk, and even Johnson & Johnson has withdrawn (Figures 1-2).

Figure 1 Market share of domestic coronary stent-related companies (source: annual reports of related companies; organized by Cinda R&D Center)

Figure 2 Some domestic products of coronary drug-eluting stents

China's stent market expansion has slowed down

Judging from the data from 2009 to 2013, the use of domestic stents is still increasing year by year, and this "cake" is still fermenting and expanding, but the expansion rate has slowed down (Figure 3).

The reason for the slowdown in the growth rate is mainly due to three reasons: first, the bidding of high-value consumables has brought about a trend of price reduction; second, because patients flock to tertiary hospitals, the operation volume of tertiary hospitals is basically saturated, and it is basically in a balanced and small growth. The third is that the majority of county-level areas are limited by local medical resource limitations and the reimbursement ratio of the new rural cooperative medical system, and the growth is slow.

Figure 3 Growth of the number of domestic stents

The threshold for stents has become higher: listing needs to cost at least 50 million

Since the "big cake" of the stent market is still growing, new manufacturers will want to squeeze in, but with the change of policies, the threshold has become higher.

According to the "Guidelines for Clinical Trials of Coronary Drug-Eluting Stents" issued by the Medical Device Technology Review Center of the State Food and Drug Administration (CFDA) in September 2011, the regulations on the sample size of clinical trials have been changed.

Previously, the sample size was around 300 cases, but now the total sample size is required to be no less than 1,000 cases (200 cases in the randomized control group test and 800 cases in the single-group target value test), and this will cost 50 million to 100 million yuan. After that, no less than 2000 cases should be followed up for at least 5 years after surgery. It can be seen that for new entrants, the preliminary approval will cost all the money, and the time and money that need to be invested are not cheap.

In addition, since the "cake" is divided, it means that the industry structure is stable, and new entrants and new products have no obvious price advantage on the one hand, and more importantly, the safety is not as convincing as the existing products. cake" is difficult.

Potentially huge number of patients needing stents in China

However, it is worth noting that the Chinese cardiac stent market still has great potential for development. According to the current data, there are 600,000 cases of PCI in the United States every year, while in China there were only 450,000 cases in 2013, and the population base in China is so large. In addition, the prevalence of hypertension, diabetes, and obesity is surprisingly high. These all indicate that the patient population or potential patient population in need of treatment is large.

In addition, the reimbursement ratio of medical insurance and the new rural cooperative medical system is gradually increasing, so the covered population will benefit relatively more, and it will also encourage them to accept higher-quality medical services.

For example, in 2014, a "Notice on Doing a Good Job in Several Key Works of New Rural Cooperative Medical Care" required that all localities should adjust and optimize the overall compensation plan, and maintain the reimbursement ratio of hospitalization expenses within the policy scope to more than 75%.

In the same year, another document, "Notice on Doing a Good Job in the Implementation of the Pilot Work of Comprehensive Reform of County-level Public Hospitals in 2014", requires that the pilot work of serious illness insurance for urban and rural residents be launched before the end of June, and the pilot work will be fully rolled out before the end of the year.

Some secondary hospitals can carry out PCI, which will further promote the demand

With the deepening of medical reform, the improvement of the medical quality of county-level hospitals and secondary hospitals has also become the focus of attention, and the government will also increase investment for this. With the increase of investment and the maturity of software and hardware, there is no doubt that the demand for coronary intervention in these hospitals will be stronger.

The "Technical Management Specification for Interventional Diagnosis and Treatment of Cardiovascular Diseases (2011 Edition)" promulgated in August 2011 allows secondary hospitals that meet the hard conditions and relevant regulations of the specification to carry out cardiovascular interventional surgery. Facts also show that in 2013, in hospitals with 1 to 99 cases, the annual growth rate of PCI operations reached 48.08%, far exceeding the national average growth rate (Figure 4).

Figure 4 Growth of cases in hospitals with different surgical volumes in 2012 in 2013

Treatment of STEMI: Only 5% of patients in China receive emergency PCI

As far as ST-segment elevation myocardial infarction (STEMI) patients are most in need of interventional therapy, it currently only accounts for 25% of all PCIs, and there are 500,000 to 600,000 patients in China every year. Among STEMI patients treated with PCI, only 5% can receive early effective reperfusion therapy, and with the improvement of coronary intervention technology in county-level and some secondary hospitals, the proportion of STEMI patients treated with PCI will be higher.

Fully degradable stent: a new round of product substitution will start

In addition to the improvement and improvement of medical services, the advancement of stent technology will also promote the application of PCI. It is reported that fully degradable stents can be approved for marketing in 3 to 5 years, which means the beginning of a new round of product substitution.

In short, the demand for PCI surgery will be greatly released in the next two years, and the industry growth rate will return to more than 20%.