In recent years, growing together with global IVD industry, China IVD industry is increasing at a speed of around 20% every year. According to Evaluat emedtech’s report, at the end of 2018, global IVD market will reach 58.8 billion USD.
In Asia-Pacific, China IVD industry is growing at the highest speed and has become the second largest IVD producing country. But we also should see that the consumption per person for IVD in China is only 2 USD, but in the West is 28 USD (market size/population), there’s still a huge gap between us. According to the statistics given by Clearststate in Singapore, in the next few years, the growing speed of China IVD industry will maintain at the top among Asia-Pacific countries and will rise by around 20% every year.
¢ñ. China IVD industry is still under a period of simple and low-tech growth.
Judging from the whole industry, though we have a grow speed of 20%, most of the growth comes from routine test reagents and instruments which contains high repeatability, most of all routine biochemical tests and immunochemiluminescence. This phenomenon is due to the high demand for outpatient clinic, increase of health consciousness and huge population base. On one hand, this kind of growth lead to the fast grow of some corporate champions, on the other hand it further widen the gap between corporations. For now, we seldom have products that contains high technologies and world-class innovations.
1. The IVD market, new technologies and methods in China is led and greatly affected by famous international corporations like Roche, Siemens, Abbott, BD and SYSMEX. Though some Chinese companies have got a certain share of the market and their competitive power is getting stronger, the number of our companies with an annual output value of more than 500 million is less than 10.
2. Because of favorable factors such as the aging of population and medical insurance from Chinese government, the market of biochemical reagent is expanding. However, the increasing cost and fierce competition makes the price going down rather than going up. Company’s profits is shrinking and the gap between big companies and small companies is further widened.
3. Generally speaking, immunoreagents captured 35%-40% clinical share in the whole IVD market. In the past few years, domestic immunoreagents have got a dominating share of the market. However, since the Chinese government canceled the mandatory testing for hepatitis and issued several charge policies, imported products have captured most of the market again, especially in chemiluminescence. Now domestic IVD companies are accelerating the research, development and producing of Chemical luminescence immune reagents and instruments. We believe in the next few years, the structure will change in these fields.
4. POCT is developing very fast and the global market has reached 19 billion USD in 2014. The heat of POCT in China is also increasing and by the end of 2014, the market of POCT has reached nearly 6 billion CNY.
5. Domestic routine biochemical and immune instruments takes up more share in small hospitals, especially in grassroots hospitals. 40% of the biochemistry analyzers come from government procurement, 40% come from self-procurement and the rest come from free delivery. However, in big hospitals especially tertiary referral centers, imported automatic enzyme immunoassay analyzers, full automatic analyzers and chemiluminescence analyzers captured a dominating share of the market.
¢ò. There is still a large development space for IVD products in China.
In recent years, many domestic real economies especially those related with health are getting into IVD industry, aiming to expand their market and increase their share in health industry. For instance, SHINVA, which was focusing on surgical instruments and disinfection products, acquired 4 IVD companies including Beijing Wetech and Changchun Bomai and thus start its business in IVD; Shandong Weigao Group was doing medical polymer, but now they’re turning to IVD and their IVD products have already entered the market.
1. Under the background of medical insurance cost control, the governmental charge for IVD projects is loose. Added with the huge population base, the aging of population and the increase of people’s health consciousness, China IVD industry is in a period of rapid growth.
2. The size of global IVD market has reached nearly 50 billion USD and the main driving forces come from developing countries. Large population, environmental pollution, aging of population, rise of chronic infectious diseases and increase of health consciousness are the main driving forces. Judging from the structure of the global market, the USA captures the largest share, European Union is the next. The size of China IVD market has reached 37 billion CNY, increased by 17% comparing to 31 billion in 2013.
3. By the end of 2014, the number of medical institutions in China has reached more than 980000, including 25000 hospitals, 920000 grassroots health care institutions, 32000 public health agencies and 3000 other institutions. Compared to 2013, the number increase by 20327, among which 1214 are new hospitals and 19440 are new public health agencies, the number of grassroots health care institutions reduced by nearly 1000. A sound medical system paved the way for the taking off of China IVD industry.
4. The total public health subsidies from the government in 2014 reached 37.8 billion. The government also offered 11 kinds of basic health care services to its people for free, most of which are related with the prevention of serious infectious diseases such as tuberculosis and AIDS and the screening of cervical carcinoma and mammary cancer. All these things that the government do plays a positive role in the development of China IVD industry.
5. The output of domestic IVD products is another driven force. Though in 2014, the increase of domestic medical apparatus and instruments output slowed down, it reached 18 billion USD during the whole year. Therapeutic goods and IVD products takes up 56% of the whole output, POCT products has a rapid increase because of their inexpensive prices.
¢ó. The present situation of China IVD in 2014.
The further developing diagnostic methods and increasing spending plays a positive role in the early prevention and treatment of diseases. More and more new technologies and applications are used in clinical diagnostics. In routine IVD field, since it doesn’t require high technologies and the price is rising with quality, the present situation of IVD industry is developing smoothly.
1. The popularization of POCT makes it more convenient for patients to see and keep their test results. In China, there are 160 to 170 million hypertension population, 92.4 million diabetes patients, 120 million people with hepatic adipose infiltration, 120 million hepatitis B carriers, 30 million chronic hepatitis B patients, 22.2 million drug addicts, 8.4 million AIDS carriers and 80000 AIDS patients. The large demand is a great driven force for POCT and the market of POCT devices increased dramatically in 2014.
2. Imported brands are still playing a dominating role in China IVD market, they’re leading the trend of development in IVD industry.
3. Besides real economies and corporations that are related with health care, network companies are trying to enter IVD industry. Google invested a huge amount of money and developed a kind of contact lens that can test blood sugar. Alibaba announced to cooperate with Chinasoft International and start their business in health care industry.
4. In the purchase of test instruments and reagents, most tertiary referral centers still prefer imported goods. For now, 99% of the biochemical, immune and clinical testing devices in tertiary referral centers are imported brands.
5. CFDA further slowed down the examination and approval speed of IVD products and issued several new policies that are related with IVD industry. There was not a single creative IVD product with proprietary intellectual property rights that comes into market in 2014. Because of the high cost and long processing time, even if it’s an innovative product, when it is approved by CFDA, it may fall behind. It greatly influenced companies’ enthusiasm for innovation.
IVD is an interdisciplinary and cross-industry field while it is apparently affected by policies and correlative factors and is different from civilian goods. Looking back at the opportunities and challenges we faced in 2014, favorable policies, larger population base and people’s increased health consciousness are pushing the industry forward. However, we should also see that China IVD industry is facing great challenges on the globe----with a huge population, the IVD consumption in China only ranks sixth in the world, even less than that of Italy, which has only a population of 61 million. In the future, if we continue developing according to the requires of automation, integration, miniaturization, clinical application and individuation, together with the support from the government, the IVD industry in China will surly have a brighter future.
All the related statistics mentioned above comes from our members and related units, thank you for all the information.
China Association of Clinical Laboratory Practice
April, 2015
