50 Billion Big Market! Interventional Medical Devices Products, Companies, and Prospect Analysis

Interventional radiology (also known as interventional radiology) refers to a series of techniques that utilize puncture needles, catheters and other interventional devices under the guidance and monitoring of digital subtraction angiography, CT, ultrasound and magnetic resonance imaging equipment to introduce specific devices into the diseased parts of the human body for minimally invasive treatments through the body’s natural apertures or tiny incisions.

In recent years, interventional radiology has made rapid development in many clinical fields with its remarkable advantages of minimally invasive, rapid, safe and effective, especially in the fields of cardiovascular, cerebrovascular, peripheral vascular, and oncology, and has become one of the three mainstays of clinical disciplines alongside traditional internal medicine and surgery.

Interventional radiology has been developing rapidly and has now developed into many different subdisciplines. Since interventional radiology diagnostic and treatment techniques are widely used in various specialties such as basic medicine and clinical medicine, the classification criteria of interventional radiology are numerous and complicated, and there is also intersectionality among them.

Currently more commonly used classification standards include:

1, according to the diagnosis and treatment system for classification: can be divided into cardiac intervention, neurological intervention, tumor intervention, gastrointestinal or general intervention.

2, according to the diagnosis and treatment purpose of classification: can be divided into diagnostic interventional radiology technology and therapeutic interventional radiology technology.

3、Categorized according to the operation mode: it can be divided into vascular interventional therapy technology and non-vascular interventional therapy technology.

Generic devices for interventional therapy mainly include stents, catheters, guidewires, etc. The general devices involved in interventional therapy include the following:

1, stents: the main purpose is to provide support for narrowed or occluded blood vessels or lumens to prevent retraction and remodeling, including vascular stents and luminal (non-vascular) stents.

2、Puncture Needle: It consists of needle sleeve and needle core, some with occluder. Requirements: sharp needle, smooth cutting edge, moderate thickness.

Dilator: used to dilate the puncture hole and subcutaneous tissue of the puncture site to reduce the damage of blood vessels.

4, guide wire: also known as guide wire, used to guide the insertion of the catheter, through, strengthen the hardness of the catheter in order to facilitate the manipulation of the catheter, if necessary, for the exchange of catheters.

5, catheter: is the key equipment, mostly made of plastic. The catheter should have the appropriate hardness, elasticity, flexibility, torque, molding memory, the wall should be smooth. The thickness of the conduit using legal standards (F number) that 1F = 0.355 (0.013 inches), commonly used 5-8F.

6, connection switch: commonly used two-way and three-way beginning, used to connect the end of the catheter, easy to flush the catheter and high-pressure syringe connection.

7, catheter insertion sheath: used to guide the catheter into the blood vessel smoothly, but also mainly used for catheter exchange. Through the guide sheath exchange catheter, can reduce the operation of guidewire exchange. Commonly, there are arterial sheaths, venous sheaths and tearing sheaths.

Interventional therapy in China started late but developed rapidly, and has penetrated deeply into the cardiovascular and cerebrovascular diseases and other fields, and the increase in the incidence of major diseases to further promote the demand for interventional therapy, a rough estimate, including cardiac, neurological and oncological fields, the total market size is conservatively estimated at more than 50 billion yuan.

Interventional therapy is highly dependent on medical devices, and it can be said that interventional devices are the key link of interventional therapy. The vast majority of interventional procedures need to be completed with high-tech pathway interventional devices, and in the cost of interventional procedures, the part of the device accounts for a relatively high proportion. Taking coronary stent implantation surgery as an example, assuming that two stents need to be implanted at once, the average cost of stents, catheters and other auxiliary devices is 30,000 RMB, together with the total cost of 35,000-40,000 RMB for imaging and surgery, and the cost of the device part can account for more than 80% of the total cost. Therefore, the rapid development of interventional therapy also opens up growth space for related medical devices.

Interventional devices are mostly class III medical devices, with high technical barriers. At present, in addition to the more mature development of coronary stents, which have basically completed the import substitution (80% of China’s production), most of the products are still in the pattern of foreign monopoly, and it is expected that import substitution can be achieved gradually under the accelerated localization process of the devices in the future.

In China’s interventional device market, foreign-funded giants include Medtronic, Cook, Abbott, Poco, etc., while domestic companies include Wicresoft, CCTC, etc.

In recent years, the high morbidity and mortality of cardiovascular diseases have promoted the concentration of high-frequency research in the field of cardiovascular interventions, especially in the field of interventional devices for coronary artery diseases, and the localization rate of coronary stents, which are the most mature in application, has reached 80%, with the basic completion of import substitution, and the competition pattern in the domestic market is relatively stable, and the research in the field of stents is mainly focused on the fourth-generation fully degradable stents; in the implantation of coronary stents, there is still much room for technological improvement. The balloon dilatation catheter used in conjunction with stents in coronary stent implantation surgery still has more room for technical improvement. In the field of neuro-intervention, carotid stents, distal protection devices and intracranial vascular stents and other interventional devices have been developed for ischemic stroke, and the proportion of imports in the domestic market is more than 70%, and there are no domestic manufacturers of carotid stents and other products, and there is a wide space for import substitution in the future. China’s annual new tumor patients about 4 million people, tumor treatment has been the focus of attention of the medical community. At present, interventional therapy has penetrated into the field of tumor treatment. At present, there are 60-70 million people undergoing tumor interventional therapy every year in China, and with the development of minimally invasive interventional technology, the therapeutic scope and population of tumor interventional therapy are also expanding. At present, the mainstream tumor interventional therapy in China mainly includes vascular intervention based on arterial perfusion/embolization therapy and non-vascular interventions such as tumor ablation therapy and luminal stent implantation.

Main instruments and consumables for tumor interventional therapy. In addition to large and medium-sized ultrasound imaging equipment required for imaging, the main necessary equipment for tumor interventional therapy includes puncture needles, catheters and guide wires, etc. In the treatment pathway of vascular interventions, chemotherapeutic drugs and embolization equipment are the special needs in addition to the general equipment; in the non-vascular interventions, it is also necessary to include radiofrequency ablation-related equipment and non-vascular stents, etc. Among them, embolization microspheres and non-vascular stent implantation are the most common.

Among them, embolization microspheres and non-vascular stents are two major types of interventional devices with good application prospects and high technical barriers.

1, non-vascular stents: non-vascular stents are stents relative to vascular stents such as coronary stents, which are used for implantation into non-vascular lumen of the human body, mainly including biliary stents, pancreatic stents, esophageal stents, tracheal stents, urethral stents, intestinal stents, etc., which are mainly applicable to various luminal stenosis caused by tumors.

The foreign giants in the field of stents, American Cook and Boston Scientific, still have absolute advantages in luminal stents, while domestic non-vascular stents have a certain share, such as Changzhou Jiasen (the birthplace of China’s first non-vascular stent and China’s first non-vascular stent exporter), Nanjing Wicresoft (a subsidiary of Wicresoft, partly an OEM for Cook), and so on.

In the interventional therapy of tumor stents, clinical medical personnel have also studied the application of stents carrying radioactive particles (particle stents) in luminal tumors such as esophageal cancer, which can quickly restore the smoothness of the pipeline and at the same time effectively control the growth of cancer cells, greatly enhancing the therapeutic effect.

Embolization microspheres: they are mainly used as embolizing agents in vascular embolization intervention, through injecting the microspheres into the blood supplying vessels of the target organs to achieve the therapeutic effect of interrupting the blood supply of the diseased organs. Traditional embolic products include gelatin sponges, iodized oil + chemotherapeutic drug suspension, biogel, spring coils, etc. Drug-carrying eluting embolic microspheres overcame the shortcomings of traditional embolic products in terms of drug delivery and embolization effect, and have become the most desirable embolization agent nowadays. In recent years, there have been a lot of researches on drug-carrying microspheres, but the successful products are very rare. The technical problems behind need to be solved mainly include the biocompatibility of the microspheres, easy maneuverability, as well as suitable stretchability and recovery in order to achieve complete embolization effect.

Currently, there are DC bead embolization microspheres from Biocompatibles and Hepasphere embolization microspheres from BioSphere.

Domestically, only Hengrui’s subsidiary, Calisen, has obtained registration approval for drug-carrying microspheres, including CalliSpheres drug-carrying embolization microspheres and 8Spheres conformal embolization microspheres, both of which are polyvinyl alcohol embolization microspheres. Carotid chemoembolization for the treatment of non-surgically resectable tumors is widely used around the world and is considered to be the treatment of choice for middle and advanced hepatocellular carcinoma. From the perspective of technology path, drug-carrying embolization microspheres have good application prospects, and Hengrui Jialisheng has walked in the forefront of the technology, and its products have significant advantages, and are expected to compete with foreign products in the future.

Peripheral vascular disease is increasing in the population, but due to the lack of widespread attention before, the development of related technology is lagging behind, peripheral vascular intervention is still in the early stages of development in the country, which involves the aortic membrane stent, peripheral stents and other products in the foreign dominated the pattern!