Endoscope market analysis-a gold mine in the field of medical devices
一、Introduction to the background of endoscopes
An endoscope is a commonly used medical device that enters the human body through the natural orifice of the human body or through a small incision made by surgery. When in use, the endoscope is introduced into the organ for pre-examination, and the changes in the relevant part can be directly observed.
The composition of the endoscope system
The endoscope is mainly composed of three major systems, namely the endoscope system, the image display system, and the illumination system. Take the currently more commonly used electronic endoscope as an example. The endoscope system includes an operating handle and a scope. The scope extends into the patient's body. There are multiple pipes in the scope, including illumination fibers and image transmission fibers (in electronic endoscopes). It is a CCD video cable), air transmission channel, water transmission channel, instrument channel, etc. The endoscope is extremely precise and requires the cooperation of multiple professional fields.
From the historical timeline, through the continuous progress of the principle of the imaging system and the two standards of softness and hardness, the development of endoscopes has experienced rigid tube endoscopes, semi-flexible endoscopes, and fiber endoscopes. , Four stages of electronic endoscope. Generally speaking, rigid tube endoscopes and semi-flexible endoscopes are defined as rigid endoscopes. Fiber endoscopes and electronic endoscopes are called soft endoscopes because they can bend freely, and their clinical applications are also expanding.
At present, the clinical application of electronic endoscopes is divided into two aspects: diagnosis and treatment. The diagnosis function is mainly that the clinician obtains real-time dynamic internal images through the endoscope, and obtains tissues for in vitro detection through appropriate equipment; while the treatment function needs to be equipped Professional minimally invasive surgical instruments for specific surgical treatments. The main application scenarios of endoscopes include ENT, oral cavity, digestive tract, urethra, bladder, kidney, joints, abdominal cavity and other organs or parts.
At present, the clinical application of electronic endoscopes is divided into two aspects: diagnosis and treatment. The diagnosis function is mainly that the clinician obtains real-time dynamic internal images through the endoscope, and obtains tissues for in vitro detection through appropriate equipment; while the treatment function needs to be equipped Professional minimally invasive surgical instruments for specific surgical treatments. The main application scenarios of endoscopes include ENT, oral cavity, digestive tract, urethra, bladder, kidney, joints, abdominal cavity and other organs or parts.
二、 Development status of endoscope market
1. Current status of the global endoscope market
In 2015, the global endoscopy market has reached 30.2 billion U.S. dollars, with a compound growth rate of 7.17% from 2011 to 2015. In the future, with the improvement of medical awareness and the expansion of application scenarios, the compound annual growth rate is expected to increase to 7.72 from 2016 to 2019. %. The continuous introduction of new endoscope accessories further promoted the market growth, accounting for 26.0%.
2. Current status of domestic endoscope market
The domestic speculum market in China reached 15.6 billion yuan in 2015 and is expected to reach about 20 billion yuan in 2017. The scale of China's soft mirror market has maintained a steady growth, from 1.65 billion yuan in 2010 to 2.65 billion yuan in 2015. High-end is a market that domestic production has not been able to cover in the past.
三、 Analysis of barriers to entry into the endoscopy industry
1. Entry barriers
Endoscope minimally invasive medical device products cover Class I, Class II and Class III medical devices, and the State Drug Administration implements a strict medical device manufacturer license and product registration system. Companies that are new to this industry need to pass the review of the provincial drug regulatory authority, and can only operate after obtaining the "Medical Device Manufacturing Enterprise License" and the "Medical Device Operating Enterprise License"; in addition, the manufacturing companies in the industry must obtain the product after obtaining the "Medical Device Manufacturing Enterprise License" and "Medical Device Operating Enterprise License" Only after the registration certificate can the production and sales of corresponding medical device products be carried out.
Enterprises can only engage in the production of endoscopic minimally invasive medical devices under the premise of meeting the requirements of the production environment, personnel quality, equipment configuration, etc., and the sales of various products need to complete a series of testing, analysis, clinical trials, and pass Product registration is carried out under the premise of high barriers for new entrants.
2. Market channel barriers
The sales of endoscopic minimally invasive medical devices have the characteristics of wide coverage, high professionalism, scattered customers, etc., and companies in the industry generally adopt the "distribution + direct sales" business model to sell to end users. Distributors need to pass the approval of the drug regulatory authority and obtain a medical device operating company license before they can engage in distribution business. Secondly, in addition to certain financial strength and marketing capabilities, distributors also need to be able to provide professional services to end users , To help physicians coordinate and solve the problems encountered in the use of the equipment, and these distributors have basically carried out long-term and stable cooperation with the companies that have entered early, and it is difficult for new companies to find a suitable distributor in a short time. Business team.
3. Brand barriers
Endoscope minimally invasive medical devices are used for clinical diagnosis and minimally invasive treatment, which are directly related to the life and health of patients. Medical institutions pay special attention to brand and product quality. Customers are usually subjected to rigorous investigation and verification before accepting new brands. , Even the brand effect of high-quality products needs to be accumulated for a long time, which has become an insurmountable obstacle for new entrants in the short term.
In addition, due to the differences in the field of view, edge light effect, angular resolution and field quality of different brands of medical endoscopes, the matching performance, corrosion resistance, surface roughness of minimally invasive surgical instruments, and the medical materials used All are different. Endoscopists will develop specific product preferences during operation training and surgical implementation, and medical institutions will usually choose endoscopic minimally invasive medical devices that are used by endoscopists from the perspective of patient safety. The brand thus constitutes a brand barrier for new entry into the industry.
4. Technology and talent barriers
The endoscopy minimally invasive medical device industry is a multi-disciplinary and knowledge-intensive high-tech industry. Its products integrate multiple disciplines such as medicine, bioengineering, optics, precision manufacturing, image processing, medical materials, and optomechanical information. High technical barriers. Enterprises in the industry need to develop and produce products of different series, specifications and models for different departments, different diseases and different diagnosis and treatment methods, in order to meet the diagnosis and treatment requirements of medical institutions, and the proprietary technology of endoscopic minimally invasive medical device products The accumulation of research and development capabilities is a long-term process, and general enterprises cannot be formed quickly in a short period of time.
In addition, the technological innovation and production and processing of endoscopic minimally invasive medical devices must be supported by a stable technical team. The lack of talents in the field of endoscopic minimally invasive medical devices in my country is also a major factor in the slow development of industrial technology; at the same time, R&D personnel It is necessary to communicate with medical institutions, scientific research institutes, institutions of higher learning and other units, be familiar with the use requirements of hospitals, and combine technical theories with their own experience. Therefore, qualified high-end talents are difficult to train on a large scale in a short period of time, which constitutes entry An important barrier in this industry.
五、 Analysis of the status quo of the endoscope market
With the continuous development of endoscopy technology, nowadays, endoscopy has become an indispensable diagnostic and surgical equipment in general surgery, ENT, urology, orthopedics, gynecology and other departments, and it is also the most growing medical device industry in the world. One of the quickest products. In the future, my country's domestic speculum market will continue to maintain rapid growth. The specific development trends can be summarized in the following four aspects:
1. The proportion of imported substitute products continues to increase
At present, most of my country's minimally invasive medical device products rely on imports, and the prices of equipment and equipment are high, coupled with the late start of domestic endoscope production, and the slower improvement in product quality. This has become some of the reasons why the popularization of minimally invasive technology in my country is relatively slow. . As the government actively encourages the research and development of domestically-made minimally invasive medical devices, product quality continues to rise, and basic functions are close to imported products. Domestic-made devices with better cost performance can reduce hospital procurement costs and the medical burden of patients. As the country continues to promote the development of primary medical institutions, the gradual implementation of the new "graded" referral policy will promote the increase in equipment procurement of primary medical institutions, help increase the market share of domestic endoscope products, and gradually achieve product upgrades. , A breakthrough from the low-end market to the high-end market.
2. The export scale continues to expand
With the gradual development of my country's minimally invasive medical device industry, many companies have the technical strength to go abroad. A number of domestic leading minimally invasive medical device companies have set their sights on foreign countries and set out to open up the international market.
Compared with products from European and American countries, the basic performance of domestic minimally invasive medical devices is close to that of developed countries, but the price has obvious advantages. The export of domestic minimally invasive medical device products is no longer limited to developing countries and regions such as Southeast Asia and Africa, and has now entered developed countries such as the United States and Germany.
3. Medical care reform drives the investment of medical endoscopes in primary medical institutions
The continuous development of my country's medical market, the continuous expansion of consumer groups, and policy promotion have enabled my country's medical device industry to develop rapidly. Especially during the "Twelfth Five-Year Plan" period, the increase in medical insurance coverage, the improvement of the medical and health system, and the development of primary medical institutions have promoted the popularization of minimally invasive endoscopic surgery technology in primary medical institutions, and thus promoted the primary medical device market. Especially the development of demand for endoscope products. However, compared with developed countries, the per capita share of medical institutions in my country is low. In the future, as the scale of medical institutions continues to grow, the demand for annual updates and new purchases of medical endoscopes and supporting surgical instruments will also increase.
4. Technology, intelligence, and standardization are the future market
Technologicalization is a major trend in the development of the medical device industry in the future. Many endoscope companies are sparing no effort to give full play to their technological advantages, increase R&D investment, and accelerate the pace of commercialization of R&D results. The main trends in the development of international endoscope technology are: high-definition images and greater viewing angles; multi-functionalization, for example, Stanford University has developed an endoscope system with MRI function; endoscopes are non-contact and reduce the contact zone Cross-infection and human error have come; more miniaturization.