In recent years, with the continuous reform of China's medical care , people pay more attention to their own health, driving the demand of the in vitro diagnostic reagent market, coupled with the strong support of national policies, in vitro diagnostic (IVD) reagents will become a high-income industrial zone in the future.

In-Vitro Diagnostics (IVD) is the cornerstone of modern medical diagnosis, treatment, prevention and other clinical decisions. China's IVD industry started late, showing a small base and rapid growth. After more than 30 years of development, it now has the conditions for industrial scale development. The IVD reagent industry as a whole is in the high point of the cycle boom. In the future, China's in vitro diagnostic market will still maintain a growth rate of 15% to 20%. Medical enterprises can further invest in mergers and acquisitions related enterprises. Expand the market share of in vitro diagnostic reagents. This article will review the 2016 in vitro diagnostic reagents from five aspects: market, policy, investment M&A, approval status, and technology trends.

2016 in vitro diagnostic reagent market situation

EvaluateMedTech forecasts based on statistics from 120 companies in the industry: By 2018, global medical technology (including medical devices, diagnostic products) will reach $440 billion in sales, a growth rate of 4.4%. The segment with the largest market share is IVD, which is expected to account for 12.4% of the entire market in 2018, reaching $54.5 billion.

According to Marketresearchreports. The biz survey report "China's in vitro diagnostic (IVD) market - opportunity assessment, competition pattern and market forecast before 2021" data, China's in vitro diagnostic market will grow by 10% in five years, the scale will exceed 10 billion US dollars.

In the domestic IVD market, imported instruments and reagents account for more than 50%. As the market demand of the hospital accounts for more than 90% of the total in-vitro diagnostic needs, the in-vitro diagnostic industry in China will benefit from the increase in the number of medical practitioners and the cost of per capita inspection. It is expected that the growth rate will remain high at 16%-18%. Level.

Founder Securities Research Report pointed out that in the context of medical insurance control fees, medical in vitro diagnostic reagents are relatively loose. In addition, China's population accounts for 20% of the world's total, and the in vitro diagnostic market share is less than 15% of the global market share. At present, China has tens of thousands of hospitals, hundreds of blood stations, as well as a variety of physical examination centers, clinical laboratory independent medical laboratories, which provide a broad application space for IVD reagents.

At present, there are 1,199 in vitro diagnostic reagent manufacturers in China, and the larger companies include Kehua Bio, Daan Gene, Jiuqiang Bio, Lidman, Shenzhen Mindray, Sichuan Mike, Zhongsheng North Control, and Fosun Long March. Listed companies include Kehua Bio, Daan Gene, Lidman, and Yprecon. (Data from hsmap, as of December 21)

2016 in vitro diagnostic reagent policy

In recent years, the state has also strongly supported and rectified the development of the IVD industry from the policy level. It has been included in the National Medium- and Long-Term Science and Technology Development Plan, the 13th Five-Year National Key R&D Program, and the accelerated development of the bio-industry. Policy documents such as several policies, and a series of normative regulations have been issued for rectification and regulation, including the well-known "In vitro diagnostic reagent clinical trial technical guidelines" and "in vitro diagnostic reagent quality assessment and comprehensive treatment program."

2016 In vitro Diagnostic Reagent Policy Memorabilia:

On September 21, 2016, the State Food and Drug Administration intends to adjust the classification of three types of in vitro diagnostic reagents: 730 are classified into three categories, and 287 are not medical devices.

On August 5, 2016, the State Food and Drug Administration issued a textual change in the instructions for in vitro diagnostic reagents.

On February 3, 2016, the National Food and Drug Administration announced the notice of the national standard and reference catalogue for in vitro diagnostic reagents for registration.

From the perspective of the industry, the domestic industry supervision system and mechanism are still not perfect, and the IVD industry standard system is not sound enough. However, these policies have promoted the development of the IVD industry, and promoted the regulation and self-discipline of industry enterprises, which has a positive and far-reaching impact on the entire industry.

2016 in vitro diagnostic reagent investment mergers and acquisitions

With the adjustment of China's economic structure, industries related to medical and medical care are increasingly receiving capital attention. The aging population trend, the second-child policy, and the medical system reform that tilts medical resources to the grassroots level have provided significant opportunities for the development of the IVD industry. As the world's largest emerging market, China's IVD reagent industry has entered the development period from the introduction stage and gradually broke the market pattern dominated by imported products, and a number of strong local enterprises emerged. The opportunities on the demand side and the challenges on the supply side provide an opportunity for the integration of the domestic IVD industry. Investment mergers and acquisitions play an important role in industry integration. Listed companies are expected to take advantage of the financing advantages and leverage advantages of the capital market to accelerate the pace of industry consolidation.

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