Under the support of China's medical device industry policies and the promotion of healthcare system reform, the overall operating environment of China's healthcare industry has significantly improved. In recent years, with the steady increase in the treatment rate of cardiovascular diseases such as arrhythmia in China, the ability of residents to pay for healthcare has improved, and health awareness has enhanced, leading to continuous growth in the market for cardiac electrophysiological interventional treatment in China.
Although China has become the world's second-largest medical device market, there are still multiple sub-sectors dominated by imported products, such as large medical imaging equipment, laparoscopic surgical robots, cardiac electrophysiological interventional instruments, and so on. The fields of devices where domestic substitution has not been completed have attracted a large number of companies to enter, and capital has also flowed in accordingly.
Electrophysiological technology refers to the technology that measures, records, and analyzes electrical phenomena occurring in organisms and their electrical properties. Cardiac electrophysiological interventional technology can help doctors understand the electrophysiological characteristics of the heart conduction system, clarify the mechanism of arrhythmia, and thus select appropriate clinical treatment plans. Benefiting from the progress of positioning navigation technology and the maturity of minimally invasive interventional technology, the detection rate of heart diseases has increased significantly, and cardiac electrophysiological interventional technology has developed rapidly in the diagnosis and treatment of arrhythmia, becoming one of the hotspots in the field of cardiac electrophysiology. Cardiac electrophysiological technology is mainly used to treat rapid arrhythmias.
Arrhythmia refers to abnormalities in the origin of cardiac impulses, heart rate and rhythm, or any link in impulse conduction. The main classification criteria for arrhythmias include heart rate (rapid or slow) during the abnormality and the origin location (supraventricular or ventricular). Rapid and slow arrhythmias refer to situations where the heart rate is greater than 100 beats per minute and less than 60 beats per minute respectively. Among rapid arrhythmias, common types include atrial fibrillation and supraventricular tachycardia.
Data from the "China Cardiovascular Health and Disease Report 2019" show that arrhythmia is a common condition among cardiovascular diseases, with about 30 million patients. Atrial fibrillation (also known as "AF") is a common rapid arrhythmia disease in clinical practice. The standardized prevalence rate of AF among the standardized population of China and by gender is about 0.77%. In 2020, the number of AF patients in China reached 11.596 million. Affected by population aging, the number of AF patients is expected to further increase in the future. Supraventricular tachycardia (hereinafter referred to as "SVT") is also one of the common rapid arrhythmia diseases in clinical practice. In the general population, the prevalence rate of SVT is about 0.23%. In 2020, the number of SVT patients in China reached 327.3 million.
Treatment methods for rapid arrhythmias include drug therapy and non-drug therapy. Drug therapy can be divided into sodium channel blockers, β-blockers, drugs that prolong action potential duration, and calcium channel blockers according to their mechanism of action; non-drug therapy includes interventional treatment, electrical cardioversion and defibrillation, surgical treatment, etc.
In the early days, drug therapy was the preferred treatment method due to its economy and convenience, and it had good effects in the treatment of acute arrhythmias. Sequential or combined use of anti-arrhythmic drugs is generally the first choice for treatment. However, drug therapy can only control heart rhythm to a certain extent, requires long-term medication, and is accompanied by side effects.Since the medical community applied catheter ablation surgery (i.e., cardiac electrophysiological surgery) to treat rapid arrhythmias in 1987, it has been rapidly promoted and applied worldwide due to its minimal trauma, safety, and effectiveness.
Although drug therapy is the preferred treatment method, it requires long-term medication, and most cases cannot be treated with drugs; surgical treatment generally uses maze surgery, but the operation process is complex and the operation time is long, and it is currently rarely used clinically. Catheter ablation treatment is a common treatment method for patients with tachycardia who do not respond to drug therapy.
Cardiac signal mapping is an important part of cardiac electrophysiological surgery, mainly achieved by the mapping system and mapping catheter. According to different mapping technologies, cardiac electrophysiological surgery can be divided into two-dimensional cardiac electrophysiological surgery and three-dimensional cardiac electrophysiological surgery. Two-dimensional cardiac electrophysiological surgery mainly uses traditional X-ray-assisted positioning, while three-dimensional cardiac electrophysiological surgery is a major improvement based on two-dimensional cardiac electrophysiological surgery. It uses magnetic and/or electric fields for positioning to construct a three-dimensional anatomical structure of the heart cavity, more accurately showing the condition of the diseased area.
Ablation is another important part of cardiac electrophysiological surgery. During the ablation treatment process, doctors will release different energies into smaller areas of the internal tissues of the heart through catheters to destroy the origin point or abnormal conduction of arrhythmia and thus re-establish normal heart rhythm. According to different ablation technologies, the commonly used ablation technologies in clinical practice in the field of cardiac electrophysiology can be divided into radiofrequency ablation and cryoablation.In addition, technologies such as pulsed ablation are under clinical development. In the future, with increased R & D investment by enterprises and changes in clinical needs, electrophysiological technology will continue to iterate and upgrade.
As the advantages of cardiac electrophysiological surgical treatment are gradually verified clinically, the number of surgeries using electrophysiological surgery for patients with rapid arrhythmias in China continues to grow, from 118,000 cases in 2015 to 212,000 cases in 2020;It is expected that by 2024, the number of cardiac electrophysiological surgeries will reach 489,000 cases, with a compound annual growth rate of 23.3%.
Among rapid arrhythmias, the pathogenesis of AF is relatively complex, and ablation surgery is more difficult. Therefore, in the treatment of AF, a three-dimensional mapping system is usually required for more accurate heart modeling to facilitate precise treatment by doctors. According to the "China Cardiovascular Health and Disease Report 2019", the proportion of AF radiofrequency ablation surgeries has been increasing year by year. From 2015 to 2018, the proportion of AF radiofrequency ablation surgeries in total radiofrequency ablation surgeries increased from 21.0% to 31.9%.Driven by a series of factors such as the development of three-dimensional mapping technology and the promotion of AF centers, it is expected that by 2024, the number of AF catheter ablation surgeries will reach 252,000 cases.
The domestic market scale of cardiac electrophysiological devices increased from 1.48 billion yuan in 2015 to 5.15 billion yuan in 2020, with a compound annual growth rate of 28.3%.China has a large base of patients with rapid arrhythmias. With the gradual penetration of electrophysiological surgical treatment, it is expected that by 2024, the market scale of electrophysiological devices will reach 211.1 billion yuan, with a compound annual growth rate of 42.3%.
The electrophysiology industry is characterized by high technical levels and interdisciplinary integration. The development of the electrophysiological medical device industry is closely related to biomedical technology, material technology, electronic information engineering, precision automation manufacturing and processing, etc.
Based on the current market situation of China's electrophysiological medical device industry and the development level of global electrophysiological technology, the development situation and future trends of China's electrophysiological industry mainly include the following aspects:
1) Three-dimensional cardiac electrophysiological surgery has become an important development trend, achieving high-definition visualization of the mapping process;
2) Multifunctional high-precision catheters achieve precise and efficient treatment processes;
3) Rapid ablation technology effectively reduces surgical complexity and shortens surgical time.
At present, the major foreign-funded manufacturers in the domestic electrophysiology market are Johnson & Johnson, Abbott Laboratories, Medtronic, and Boston Scientific. The major domestic manufacturers in the domestic electrophysiology market are Huitai Medical, Xinuo Pu Medical, Jinjiang Electronics, and Minimally Invasive Electrophysiology.There is still a large gap between domestic and foreign enterprises. It is not easy for domestic enterprises to overtake on a curve, mainly reflected in the following three aspects:
1) From the perspective of product registrationExcept for radiofrequency ablation catheters, the number of registrations of cardiac electrophysiological products by foreign-funded enterprises is much larger than that of domestic ones. Especially for electrophysiological devices with high technical difficulty such as three-dimensional ablation catheters, imported products still dominate;
2) From the perspective of technical levelDomestic enterprises started relatively late in the field of electrophysiology, and their overall level lags behind foreign-funded enterprises such as Johnson & Johnson, Medtronic, and Abbott. From the currently listed three-dimensional electrophysiological devices, the technical level difference between domestic and imported products is nearly a generation. Moreover, the technical barriers of electrophysiological devices are relatively high, involving multiple interdisciplinary fields such as medicine, material science, biology, mechanical manufacturing, and physical chemistry. To make technological breakthroughs, it is necessary to vigorously increase R & D investment and reserve multidisciplinary talents;
3) From the perspective of market cultivationForeign brands have cultivated the usage habits of clinical doctors to a certain extent through years of market cultivation and training for clinical doctors. Moreover, when choosing, doctors and patients usually tend to prefer imported products.
