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Healthy China strategy to promote the medical device industry bloom
Release time: 2016/11/01
Healthy China strategy to promote the medical device industry bloom
China Securities Journal reporter learned that the National Health and Family Planning Commission has fully launched the "Healthy China Construction Plan (2016-2020)" preparation work, and recently began to solicit public opinions。The plan will become a programmatic document for promoting the construction of healthy China in the next five years, and related industries and companies in the medical and health field may usher in rapid development opportunities。The comprehensive judgment of China Securities Journal reporters interviewed by industry associations, listed companies, and securities brokerage researchers is that the medical device industry will be the obvious beneficiaries of the healthy China strategy。
  Policy leads domestic equipment "counterattack"
  2015 is a policy year for China's medical device industry, and support policies have been intensively introduced。In addition to the healthy China strategic plan, the China Securities Journal reporter found that in 2015, for the transformation and upgrading of domestic medical equipment, the policy side issued a total of 18 documents。Such a huge level of policy support shows good intentions。This has also greatly increased the status and importance of the medical device industry, and import substitution has become the main trend of the development of the industry。This trend will continue in 2016, and the state's support for the medical device industry will not change。
  These policies include: "Opinions on Reforming the Review and Approval System for Pharmaceutical medical devices", which will include innovative medical device registration applications with product core technology invention patents and great clinical value in the scope of special review and approval, and give priority to handling。"Made in China 2025 Key areas Technology Roadmap (2015 edition)", the key development objects in the field of medical devices are mainly concentrated in high-performance diagnosis and treatment equipment, such as imaging equipment, medical robots, etc., high-value medical consumables, such as fully degraded blood vessel stents。
  At present, the policy of the medical device industry mainly focuses on the following aspects:
  The first is to enhance the status and importance of the medical device industry。Whether it is the key special project of digital diagnosis and treatment equipment issued by the Health and Family Planning Commission and the Food and Drug Administration, the "Made in China 2025",It is also the national "13th Five-Year" strategic plan,High-performance medical devices are clearly listed as a key development industry,To the national strategic height,High performance medical devices have received unprecedented attention and expectations,Was given the privilege of priority development。
  The second is to explicitly encourage import substitution。At present, a series of policies such as public hospital reform and graded diagnosis and treatment are mentioned that domestic medical equipment should be prioritized。In addition, the reform of the approval and evaluation system has opened up a special approval channel for domestic innovative medical devices, simplified the approval process, improved the approval efficiency, and encouraged the research and development and innovation of medical devices。The state has also launched the selection of domestic excellent medical equipment in order to promote the development and application of domestic medical equipment。
  Moreover, the industry is increasingly regulated。Various regulatory departments have issued various regulatory policies,Further standardize the supervision of the medical device market,In accordance with the regulations of the world,The supervision ensures that domestic medical devices get rid of shoddy production and low quality,It has played a positive role in ensuring the safety and effectiveness of medical device products and promoting the healthy development of the industry,It is conducive to the development of large-scale enterprises。
  This support will continue in 2016, the general trend of the state to vigorously support the development of the medical device industry will not change, and the huge domestic market released by the policy will provide guarantee support for the rise of domestic medical devices。Among a series of encouraging policies, import substitution has received much attention。At present, domestic medical devices are used more in basic hospitals, and imported devices are still the main ones in tertiary hospitals。The government encourages public hospitals to purchase domestic devices, and the relevant specific implementation policies for public hospitals to purchase domestic medical devices are expected to be gradually introduced in 2016。In the "13th Five-Year Plan" proposal, it is proposed to build a new system for the biomedical and high-performance medical device industry, and it is expected that high-performance medical devices such as large-scale imaging equipment and high-value medical consumables will become the focus of future policy support。Compared with high-end medical devices, China's middle and low-end medical devices have experienced slow growth in recent years due to fierce competition。
  "Small and beautiful" IVD or sudden rise
  The emerging IVD(in vitro diagnosis) industry in China should be given enough attention as a new form of business。
  In vitro diagnostic industry refers to products that obtain clinical diagnostic information by testing human samples, such as blood, body fluids, tissues, etc., outside the human body。In vitro diagnosis is fast, convenient, highly penetrating and highly effective, which can be called the "doctor's eyes", and more than 80% of clinical disease diagnosis is completed by in vitro diagnosis。
  The in vitro diagnostic industry has developed with the development of biochemistry, immunology, molecular biology and other fields, and can be divided into three stages of development。The first stage,Embryonic period before the 20th century,Using some traditional medical diagnostic techniques;The second stage,Early 20th century,With the development of modern medicine and the discovery of enzyme-catalyzed reaction and antigen-antibody reaction,In vitro diagnosis gradually emerging;The third stage,1953年后,The application of DNA double helix structure, monoclonal antibody technology, macromolecular marker technology and so on,Promote the leapfrog development of the entire in vitro diagnostic industry。
  China's IVD industry is still in the early stage of industrial development, showing a small base, fast growth and other characteristics。In 2013, the market size of China's in vitro diagnosis was nearly 20 billion yuan, an increase of 20% year-on-year, and the growth rate was much higher than that of the international market in the same period。Hospital market demand accounts for more than 90% of the total demand for in vitro diagnosis, the future of China's in vitro diagnosis industry will benefit from the increase in the number of patients and per capita inspection costs, is expected to maintain a high growth rate of 16% ~ 18%。According to this average growth rate, by 2015, the scale of China's in vitro diagnosis industry will be about 31.6 billion yuan。
  Growing in the context of the Internet, China's "scattered, small, chaotic" IVD industry is expected to take off first with the wind of the Internet, and the birth of leading enterprises and even overlords in the field of segmentation。
  In vitro diagnosis is an important emerging industry in China, in the "Twelfth Five-Year" period has been strongly supported by the policy, in this context, more enterprises began to get involved in in vitro diagnosis industry。In the first half of 2015, nearly 20 traditional pharmaceutical companies entered the in vitro diagnostic industry through or about to enter the joint venture through acquisition。The increasingly fierce competition will prompt enterprises to continuously improve their competitiveness, thereby improving the level of domestic in vitro diagnosis on the whole。Since the release of the "Special Notice on the Organization and Implementation of the high-tech Industrialization of biological Vaccines and diagnostic reagents" in December 2005, the state has been encouraging and supporting biological high-tech, including in vitro diagnosis, and has promulgated more than 10 relevant supporting documents in 9 years。
  With the improvement of technical level, the domestic in vitro diagnosis market has gradually shifted from biochemical diagnosis to immune diagnosis and molecular diagnosis。According to statistics, from 2010 to 2014, the market share of biochemical diagnostics decreased from 27% to 19%, the market share of immunochemistry increased from 33% to 38%, and the market share of molecular diagnostics increased from 5% to 15%. POCT developed rapidly and approached the share of molecular diagnostics in 2014。
  In the field of biochemical diagnostic reagents, domestic enterprises have occupied about 2/3 of the market share, mature technology, serious homogenization, and the reduction of product localization space have led to a slowdown in growth, and the compound annual growth rate has been maintained at about 7%。The focus of development in the field of biochemical diagnostics will shift to the cost, channels, marketing means and quality control competition, on this basis, self-produced raw materials, reagent and instrument linkage sales and biochemical enterprises with channel advantages will be more advantageous。
  Chemiluminescence is the current mainstream direction of immunodiagnostic products, with high sensitivity, strong specificity, high degree of automation, fast detection speed and other advantages, gradually replace the domestic enzyme-linked immunodiagnostic products。At present, China's chemiluminescence products are mainly imported, and the detection cost is high。The environment of medical insurance control costs and the independent research and development of chemiluminescence products will usher in explosive growth of immune diagnostics, and domestic enterprises with technological advantages and price advantages will be the first to benefit。
  The home medical device industry will flourish
  When it comes to medical equipment, most people think of X-ray machines, MRI machines, or scalpels and bandages in hospitals。In fact, with the expansion of chronic diseases year by year, many fresh home medical devices will enter the people's homes in the future。
  Household medical devices are not yet popular in China, but they are commonplace in developed countries abroad。The global market size grew from $17.9 billion in 2010 to $22.9 billion in 2014, a compound annual growth rate of 6.7%, higher than the overall growth rate of the medical device industry in the same period.12% and 3% of the drug market.81%。In 2010, China's home medical market size was 137.6.5 billion yuan, the market size in 2014 was 376.4.2 billion yuan, the compound annual growth rate of the past five years is 29.8%, higher than the pharmaceutical industry in the same period of 7.26% and 11% of the medical device industry.70%, in a period of vigorous growth。
  Due to the increasing aging, the number of patients with chronic diseases in China is rising。At the same time, China's consumer spending at an annual growth rate of more than 15%, the improvement of consumption level, the change of consumption structure and the progress of consumption awareness, will stimulate the increase in the penetration rate of household medical devices。From the path of medical system construction in developed areas, family health care, rehabilitation and prevention have become an important part of the medical system。China's medical system is currently in the transition period from the second stage to the third stage, and family prevention, medical treatment and rehabilitation will become the mainstream in the future。China's home medical device industry will benefit from the construction and improvement of the medical system。
  Blood glucose monitoring systems, massage devices, blood pressure monitors and hearing AIDS are the four main subcategories of home medical devices。Blood sugar monitoring system benefits from the rigid demand of 100 million diabetes patients, the industry growth rate reached 20%, the current relative penetration rate is only 20%, far lower than 90% in developed countries, and the theoretical room for rise is large。Massage equipment and blood pressure monitor industry development potential is second。Hearing AIDS because of the lack of domestic fitting points and lack of professional service awareness, and short-term difficult to solve, the current development is more limited。
  Specifically, the market size of blood glucose monitoring systems is expected to reach 102 by 2020.700 million yuan, the prospect of cooperation between China's leading enterprises and international giants is promising。Based on the current level of domestic consumption and medical insurance coverage, it is expected that the penetration rate of China's blood sugar monitoring system will reach 55% in 2020, and the market size is about 102.7亿元。The production of blood glucose test strips in the blood glucose monitoring system has a strong scale effect, and the sales volume is positively correlated with the gross profit rate of enterprises, and the enterprises with high scale level have obvious advantages。There is little difference between domestic blood sugar monitoring products at the same price, and the core competitiveness of each manufacturer in the OTC side is mainly reflected in the layout of channels。From the sale of Bayer's blood sugar business, it can be seen that the downward pressure on the price of blood sugar test bars caused by the strong bargaining power of US medical insurance makes Chinese enterprises expected to share a part of the market share in the low-end field by cooperating with international giants。
  Massage equipment market size is expected to reach 241 in 2020.700 million yuan, in the domestic market export to domestic sales trend, brand building for the success of the enterprise gene。With the increasing demand for massage health care, the penetration rate of massage equipment in the Chinese market is expected to reach 25% in 2020, and the corresponding market size is 241.7亿元。Under the trend that domestic sales demand is greater than exports, the domestic market layout and brand power are the wind vane of successful enterprises。
  The market size of blood pressure monitors is expected to reach 241 in 2020.700 million yuan, the industry competition is fierce, the differentiation advantage is highlighted。At present, Omron ranks first in brand influence with 60% market share. With its advanced operation and research and development capabilities, Omron has achieved a leap in its business in China through differentiated layout of products, services and personnel。Differentiation is an important advantage in this fully competitive industry。
  At present, there are no listed companies involved in hearing AIDS, only the subsidiaries of Hainan Sea medicine produce cochlear implants, and medical device companies have the advantage of intervention。Driven by multiple factors such as economic development, the improvement of residents' income level, and the change of consumption concepts, it is expected that by 2020, the market size of China's hearing aid industry will reach 5 billion yuan。Compared with foreign capital and Sino-foreign joint ventures, domestic enterprises are not yet able to compete in scale。Patients' choice of hearing aid products will follow the advice and recommendation of doctors, and enterprises' involvement in this field requires the advantages of hospital channels。
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