Original title: The current status and pattern of transcatheter aortic valve replacement (TAVR) globally and China in 2021, with 6,630 surgeries already reached "Picture"
1. Transcatheter aortic valve replacement (TAVR) industry overview
Transcatheter aortic valve replacement (TAVR) was first used in clinical treatment of aortic valve narrowing in 2002. The technical principle is to implant artificial aortic valve through the use of a catheter.
1, classification status
Due to the irreversible mechanical damage of the valve, the drug treatment effect for valve heart disease is limited. Drugs usually can only temporarily relieve symptoms, but cannot provide a continuous solution. Surgery is the best choice for treating heart valve diseases. Currently, the treatment of valvular heart disease is generally divided into three categories: traditional open chest valve replacement and repair surgery, minimally invasive valve surgery and transcatheter valve treatment. Aortic valve stenosis refers to aortic valve narrowing, which blocks blood flow from the left ventricle into the ascending aorta during the systolic period of the heart. Currently, the mainstream treatment methods are transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
compared with TAVR and SAVR, the clinical efficacy shows that the efficacy of TAVA is not as good as SAVR. It is treated through percutaneous interventional method of minor trauma. The complexity and resource occupancy of surgery are lower than that of SAVR (the special care cycle after surgery is long and the cost is high), the postoperative recovery is faster, and the hospital stay is short, but the current surgical cost and valve cost are relatively high.
Comparison between catheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR)
Source: Public information compilation
2, treatment process
When performing TAVR surgery, the prosthetic valve enters the catheter through completely folding, and the catheter enters the heart through the major artery. First, through the imaging and delivery system, the doctor positioned the catheter within the lesion valve; after completing the positioning, the doctor gradually released the valve; when the valve is fully released, the biological valve fully unfolds within the lesion valve and replaces the function of the native valve in the patient's body.
TAVR treatment process diagram
Source: Minimally Invasive Xintong Medical Official Website, Huajing Industry
2. Number of patients with aortic valve stenosis
Aortic valve stenosis is often associated with other valve heart diseases, or to a certain extent is confused with aortic valve regurgitation , and brings physiological and clinical impacts. The mortality rate of patients who progress to the symptomatic stage within two years after diagnosis is higher than 50%. The number of patients with aortic valve stenosis worldwide in 2017 was 19 million, while it reached 20.4 million in 2021, and is predicted to reach 23.9 million in 2030.
In China, the number of patients with aortic valve stenosis in China has reached 4.5 million in 2021, and is estimated to reach 5.2 million in 2030. About 75% of patients with initial diagnosis of aortic valve stenosis also suffer from aortic valve regurgitation. The mortality rate of patients who progress to the symptomatic stage within two years after diagnosis is higher than 50%, so surgical treatments such as TAVR and SAVR are crucial.
2017-2021 Trend chart of the number of patients with aortic valve stenosis in China
Source: Frost Sullivan, compiled by Huajing Industry Research Institute
In 2011, the FDA approved the use of TAVR surgery for patients who cannot undergo SAVR surgery for the first time. Subsequently, the indications continued to expand. Until August 2019, the FDA approved the implementation of TAVR surgery for patients with medium and low surgical risks. Currently, TAVR surgery is only suitable for patients with high-risk SAVR surgery and SAVR in China. Referring to the development process of TAVR in the United States, China is expected to expand the TAVR adaptation population in the future.
FDA's approval process for TAVR
Source: FDA, compiled by Huajing Industry Research Institute
Patients who are eligible for TAVR surgery in 2019 Classification of patients who are eligible for TAVR surgery
Source: Public information sorting
3. Current status of global transcatheter aortic valve replacement (TAVR)
1, TAVR market size
The global market size of transcatheter aortic valve replacement (TAVR) increased from US$3.474 billion in 2017 to US$6.085 billion in 2021, with an annual compound annual growth rate of 15%. It is expected that as the market gradually matures and the overall number of surgical cases continues to grow, the global TAVR market size will continue to expand, reaching US$15.89 billion by 2030.
2017-2030 Global Transcatheter Aortic Valve Replacement Market Size
Source: Frost Sullivan, compiled by Huajing Industry Research Institute
2, TAVR surgery cases
Data shows 2 In 21, the number of TAVR surgery cases worldwide increased to 195,000, an increase of 19.8% year-on-year in 2020. It is expected that, driven by the aging population, the increased acceptance of transcatheter aortic valve replacement surgery by patients, and the increase in the number of qualified doctors in qualified hospitals, the number of transcatheter aortic valve replacement surgery worldwide will grow at a compound annual growth rate of 14.9% and 12.0% from 2022 to 2025 and 2026 to 2030, respectively, and the number of surgical cases will be close to 600,000 as of 2030.
2017-2030 Global cases of transcatheter aortic valve replacement surgery
Source: Frost Sullivan, compiled by Huajing Industry Research Institute
IV. Current status of transcatheter aortic valve replacement (TAVR) in China
1, TAVR market size
1, TAVR market size
1, TAVR market size html ml6
Regarding the current situation of my country's transcatheter aortic valve replacement (TAVR) market, the overall domestic scale is still relatively small, and the penetration rate of is relatively low. Data shows that in 2021, my country's TAVR market size was only about US$910 million, accounting for 14.98% of the global market. As one of the global medical markets, it is expected that as the domestic technology level gradually approaches the world's leading level, the global market share is expected to continue to increase. It is expected that the market size will reach US$11.36 billion by 2030, accounting for 71.5% of the global market.
2017-2030 China's transcatheter aortic valve replacement market size
Source: Frost Sullivan, compiled by Huajing Industry Research Institute
2, TAVR surgery cases
In terms of the number of domestic TAVR surgery cases, about 6,630 TAVR surgery were performed in China in 2021, accounting for 3.4% of the world. As the acceptance of transcatheter aortic valve replacement surgery continues to increase, the number of eligible hospitals continues to increase, and patients with medium- and low-risk surgical aortic valve replacement are expected to be included in the indications. It is estimated that about 109,500 transcatheter aortic valve replacement surgery will be performed in China in 2030, accounting for 18.27% of the global number of surgeries.
2017-2030 China's transcatheter aortic valve replacement surgery number
Source: Frost Sullivan, compiled by Huajing Industry Research Institute
3, penetration rate
In 2019, a total of 148,500 TAVR surgeries were performed worldwide. If the differences in approved indications in different places are not considered, the average penetration rate is 4%. After removing China's data, there were 2.927 million patients eligible for TAVR surgery in other regions around the world, with a TAVR penetration rate of nearly 5%. China completed 2,400 TAVR surgery in 2019, corresponding to a 290,000 patient population, with a penetration rate of only 0.83%. There is huge room for improvement in the future.
2019 Global and China TAVR penetration rate
Source: Frost Sullivan, compiled by Huajing Industry Research Institute
5. China TAVR competitive landscape
1. Major enterprises and products
A significant proportion of patients with aortic valve stenosis also suffer from aortic valve regurgitation. Most approved TAVR products in the world have not included aortic valve regurgitation as indication, resulting in a huge unmet patient needs.Currently, there are 25 major transcatheter aortic valve replacement products approved for commercialization around the world, and 9 TAVR products approved for commercialization in China, of which only J-Valve includes main vein valve regurgitation as the indication. In terms of competitive landscape, Qiming Medical, Peijia Medical and Micro-Invasive Xintong account for nearly 60% of the domestic market share, of which Qiming Medical accounts for nearly 60%.
Comparison of major TAVR product companies and related products in China
Note: Aortic valve regurgitation combined with aortic valve stenosis
Source: Public information sorting
2, Qiming Medical
In terms of Qiming Medical's TAVR product business, as the overall penetration rate of domestic TAVR continues to rise, the domestic TAVR surgery volume continues to grow. Qiming Medical's TAVR surgery volume from 2020 to 2021 was about 2,200 and 3,600 respectively, with a fast overall growth rate. The revenue of TAVR products also increased by 49% to 405 million yuan, accounting for 97.4% of the total revenue, and the market share (calculated by Sullivan's surgery volume) dropped slightly to 54.3%.
2020-2021 Qiming Medical TAVR surgery volume, revenue and market share
Source: Company Gazette, compiled by Huajing Industry Research Institute
VI. TAVR development trend
1. The market development is very difficult
①: There are fewer hospitals available at the terminal. Because the technical threshold for TAVR surgery is high, the doctor's learning cycle is long, and an operation requires the coordination of relevant departments such as the hospital's cardiology, anesthesia room, cardiac color ultrasound room, and respiratory medicine. At present, Grade A hospitals are still concentrated in first- and second-tier cities, and the number of hospitals can be implemented as a whole is small. ②: The price is high, TAVR has not been included in medical insurance, the overall price of a single operation exceeds 300,000 yuan, and mainly the elderly, the overall funds come from savings or offspring, and there are fewer patients with the ability to pay. It is expected that as medical services decline in the future, it may drive the increase of market penetration rate .
2. The potential market size is large
TAVR surgery is becoming the mainstream way to treat aortic valve stenosis in the future. The potential domestic market size is vast and the market penetration rate is low, which can fully accommodate multiple companies to develop together; and the industry is still in the early stage of development, and the overall progress is slow due to the limited cost of products. The leader Qiming Medical has grown rapidly in 2021. Peijia Medical and Micro-Invasive Xintong have continued to expand the market as a whole after they were listed respectively, but there is still a broad market waiting for major companies to promote and discover.
Original title: The current status and pattern of transcatheter aortic valve replacement (TAVR) globally and China in 2021 have reached 6,630 surgeries. "Picture"
Huajing Industry Research Institute conducted an in-depth analysis of the development status of China's transcatheter aortic valve replacement industry, upstream and downstream industrial chains, competitive landscape and key enterprises, to minimize corporate investment risks and operating costs and improve corporate competitiveness; and use a variety of data analysis technologies to predict the industry development trends so that enterprises can seize the market initiative in a timely manner; for more detailed content, please pay attention to the "2022-2027 China Transcatheter Aortic Valve Replacement Market Panoramic Evaluation and Investment Planning Recommended Report" published by Huajing Industry Research Institute.
