In-depth Analysis of China’s Rapidly Growing Point of Care Test Industry

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In-depth Analysis of China’s Rapidly Growing Point of Care Test Industry

China’s Point of Care Testing industry: A billion-dollar market and growing 20-30% annually

The rapid growth of the Point of Care Testing Industry and the obvious advantages of primary medical institutions are as follows: the POCT industry belongs to the subdivision industry of the in-vitro dialysis (IVD) industry and is one of the fastest growing subdivisions of IVD industry in recent years.

China’s Point of Care Testing industry annual growth rate remained at 20% -30%, which is higher than the international market growth rate of about 8%. In 2013, the domestic market size of POCT was close to $540 million; three years later, with an extremely rapid growth, the total market size almost reached $1 billion by the end of 2016. It is estimated that the market scale will approach $1.5 billion by 2018.

China's domestic POCT market 2013 to present

POCT has three significant advantages. First, it is quick, easy and has higher detection efficiency than traditional inspection equipment. Second, it can be field-tested conveniently. Lastly, and not least, it is easy to operate, especially for non-professionals and allows for a high degree of automation.

China markets offer bright prospects for widely used POCT in 13 categories

POCT technology is gradually upgraded to become more quantitative, smaller and more convenient. It has a wide range of clinical applications. From a technical point of view, early POCT was mainly characterized by qualitative detection, including colloidal gold, immunochromatography, and dry chemical techniques. With the gradual increase of testing requirements comes increasingly higher accuracy and accuracy of detection. Therefore, the POCT products with immunofluorescence, chemiluminescence, biochip and microfluidic technology as the core are gradually applied to clinical practice and have achieved rapid quantitative testing, and are developing very fast.

POCT China market opportunities: blood sugar testing, drug abuse screening, infections disease testing, and cardiovascular fields

POCT products are widely used, from the test items point of view, mainly in blood glucose testing, blood gas and electrolyte analysis, rapid blood coagulation test, rapid diagnosis of cardiac markers, drug abuse screening, urine analysis, dry biochemical tests, pregnancy tests, fecal occult blood analysis, food pathogen screening, hemoglobin testing, infectious disease testing, triglycerides and cholesterol and other lipid projects–totaling 13 major projects.

Therefore, at this stage, we think that the growth of domestic brands in the field of blood sugar, heart markers, and infectious agent testing is better, and has brighter prospects for future development.

Benefits of POCT: quantitative, smaller, convenient, more accurate tests

Compared with the clinical laboratory test corresponding to POCT, the POCT test procedure is simpler, the sample processing is convenient, and the operation requirements of the test instrument are not as high. Although there is a certain distance between the quality of the experimental result and clinical laboratory tests, due to its advantageous properties, it has good potential to be applied in a primary medical institution.

Also, POCT has distinct advantages in the field of home testing. The most typical use is for blood glucose testing. The sales pattern of glucose meters in China is divided into Over the Counter (OTC) channels and hospital channels, each accounting for 50% of the market. Therefore, glucose meter detection system has also been the largest POCT applications, the highest market share.

China’s a blue ocean market for POCT products needed for healthcare in cities and rural communities alike

POCT products in China are an immense blue ocean market with huge application space in the fields of hospital operation, emergency department, intensive care, chronic disease prevention and control, public health emergencies, construction of county-level medical institutions and new rural cooperative medical care.

From the point of view of the current Chinese domestic market capacity, blood gas/ electrolyte analyzer market size is about 900 million yuan, with an annual growth rate of 20% -25%. At present, the import brands occupied the absolute monopoly position.

From the current competitive landscape point of view, in 2016, the overall market size of China’s blood glucose meter monitoring system exceeded $600 million. Compared with the developed countries in Europe and the United States, the annual average test paper consumption of single glucose meter in China is low. The market growth of the industry is expected to remain at around 15% in the future, with a market capacity of nearly $770 million in 2017.

China’s growing POCT industry equals opportunities for U.S companies with cutting edge test products

For domestic blood glucose products, the main advantages of domestic brands are focused on price. Also, the Chinese government gradually tilts the bidding policy for hospitals to encourage the purchase of domestic brand products, and some provinces require bidding products include at least one domestic brand that is successful, which is conducive to the rapid development of domestic brands. Also, the agreement between blood glucose detection systems and industry regulations and the application of cloud platforms are the core competitiveness of Chinese domestic enterprises as well. The future of blood glucose monitoring will be more intelligent, and more efficient, which will help Chinese domestic products enter hospitals.

The cardiovascular field is also in a period of rapid growth, with many Chinese leading companies appearing in this market. The current domestic market size is about 1.2 billion, with the industry growth rate about 30%. Domestic products occupy the major markets in hospitals below the second level. The technical routes are mainly immunochromatography and colloidal gold, of which Nanjing Base Egg (603387.SH) and Shenzhen Lailai City take the lead.

POCT future trends: Improvements in speed, accuracy, integrated testing, detecting multiple results, and quantitative testing

In terms of future trends in development, the key application fields for POCT are in the emergency department, and the future screening of cardiovascular diseases (myocardial infarction, heart failure, etc.) will rapidly develop on the one hand toward gradually increasing detection speed and detection accuracy. On the other hand, there will be development of an integrated test combination, detecting multiple results at the same time, which is highly efficient and meets the needs of clinical applications. From a technical point of view, the future quantitative testing is still the general trend, and the main technical routes include small chemiluminescence, immunofluorescence quantitative and microfluidics.

Demand for POCT for infection factors and pregnancy testing grows as China’s national policies shift

Infection factor testing POCT market is significantly affected by national policies. In recent years, authorities began to promote the use of antibiotics vigorously. As a result, the demand for infectious agent testing has risen sharply. The current market size is between $12 million and $15 million (mainly CRP and PCT), with a growth rate of 25%. Furthermore, the Second Child Policy also opens the market for POCT in pregnancy testing.

 

China Med Device, LLC, provides turn-key solution for medtech/IVD companies to enter China in commercialization and regulatory & CRO services. Our commercialization services include: China market assessment and due diligence, distribution qualification and management, CFDA premarket approval and legal representation.