Register for Upcoming Webinar on DEC. 8 @ 11AM

2024 China NMPA Bluebook is here:

China’s In Vitro Diagnosis (IVD) Market Overview


China’s In Vitro Diagnosis (IVD) Market is an opportunity for U.S. companies to take their product offering overseas. Here is a current overview of the current market.

  1. Introduction

In vitro diagnostic represents the products and services used to obtain clinical diagnostic information by conducting in vitro testing on human blood, body fluid, tissue samples.

Among all IVD products, Diagnostic reagents take up 80% of the total market share.

IVD includes immunological diagnosis, biochemical diagnosis, molecular diagnosis, blood diagnosis and others, consisting of 39%, 23%, 17%, 11% and 10% of the global market share respectively.

The global market of IVD is dominated by several big companies, including Abbott, Siemens, Roche, BD.

Roche dominates nearly 20% of the market in IVD industry. Backman, Siemens, and Abbott each have 10% of the market share respectively. As predicted by EvaluateMedTech, these big companies will take over more than 80% of the global market by 2018.

China’s IVD market is far from being highly concentrated. A great number of small-scale businesses compete in the industry, most of them with a single product line. Even the top players only have a competitive advantage in a sub-segment rather than the whole industry. By 2015, there are around 1000 companies marketing their IVD products in China. Only 20 of them received annual revenues over 2 billion CNY.

  1. Market Size
  2. Global IVD market size

In general, the downstream demand for IVD can be divided into two large categories; medical diagnosis and blood testing.

Recently, the major IVD markets located in North America, Europe, Japan, and other developing countries, controlled more than 70% of the entire market share. Although the market shares in China, India, and Brazil are smaller, IVD processes have big market potential in these countries due to their large populations, rapid economic growth, and the health problems of older adults.

According to Boston Biomedical Consultants, Inc, in 2014, the global IVD market was 55.8 billion USD with an 4% increase. By 2019, this number will reach to 68.9 billion USD followed by a 4% annual growth.

  1. China domestic IVD market size

As per the Blue Paper issued by the Center for China Medical Industry Information, in 2014, the entire medical device market size was 276 billion RMB, in which IVD reached 30.6 billion RMB as the second largest market. It is predicted that by 2019, the size of the IVD market will be 72.3 billion RMB, with a 18.8% annual growth rate.

  1. Market segment of IVD in China

In China’s IVD market, the top three products are immunological diagnosis, biochemical diagnosis, and molecular diagnosis, accounting for 38%, 19% and 15% of the entire market respectively.

  • Immunological diagnosis

o   Immunological diagnosis has been regarded as the fastest growing and the most diverse field in IVD. It’s growth rate is higher than 15% and the market share was around 35% in 2014. According to Kalorama & Huidian Research, the market size of immunological diagnosis was 6.6 billion in 2013, which became the biggest part in IVD.

o   At present, more than 60% of immunological diagnosis market is occupied by foreign products, including Roche, Siemens, and Abbott. Domestic products mainly focus on ELISA reagents. The Chemical luminescence diagnostic reagent is expected to become a mainstream product in the future.

  • Biochemical diagnosis

o   Although the biochemical-diagnosis technology is relatively mature in China, the most advanced automatic biochemical analyzer products are still dominated by foreign companies.

o   In 2014, the market capacity of Biochemical diagnosis was 9 billion RMB in China. Between 2012 and 2015, the market grew at a rate of 14%. The growth rate is expected to remain 6%-8% in the future.

  • Molecular diagnosis

o   The development of molecular diagnosis is still at an early stage in China, taking only 15% of the entire IVD market. Compared to other medtech markets, it is growing at the fastest speed. With the aging of populations, transformation of medical models, and support from the Chinese government, the market demand for molecular diagnosis will keep growing.

III. Development Trends

  1. Industry centralization
  • In the global market, the IVD industry is relatively centralized. Nearly 60% of the entire market share is controlled by Roche, Siemens, Abbott, J&J, Backman, and BD.
  • Chinese markets are less centralized compared to global markets. The centralization of the IVD industry relies mainly on two aspects: the consolidation of technological capitals, and the integration of device and reagent.
  1. Replace import products with domestic products
  • Domestic companies have made great progress in both technologies and services. Recently, in the low-end market, import products have gradually been replaced by domestic products. In the future, with policy preference and capital injection in China, the trend of product replacement from low-end market to high-end market will continue to be the trend.
  1. Technology upgrading
  • The entire market is going through a transformation from biochemical diagnosis to immunological diagnosis and molecular diagnosis. Chemical luminescence diagnosis will eventually take over ELISA as the mainstream technology because it offers high sensitivity and strong specificity.
  • In addition, precision medicine will be the new solution in cancer treatment, which allows the physician to design a personalized treatment plan based on patient’s genetic features.
  • Blood type molecular diagnosis is also a promising trend because it provides more accurate information for the disease diagnosis, prediction, and treatment.
  1. Industry Upstream and Downstream
  • In the IVD industry, the upstream is the provider of chemical and biological products. The middle stream includes manufacturing and sales. In China, most of the manufacturers are providers. Reagents and devices are usually bundled together to sell. Manufacturers sell their products via professional dealers, or by collaborating with major units in the sales chain.

China Med Device invites companies in this space with an interest in China Market Access to contact us for an evaluation and assessment of your IVD product offering. Contact us with your questions and to schedule a conversation.

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