IVD in China

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Published Apr 12, 2018 | 138 Pages | Pub ID: KLI15654332

What is the Size of the Market in China?

In 2017, the IVD market in China was estimated at $3,200million.  The fast pace of market growth is expected to continue.  Supporting growth will be a modernizing healthcare infrastructure andsteady migration from manual to automated processes.  

As an in vitro diagnostics (IVD) market, China trails only the populous, developed economy markets of the United States, western European countries, and Japan. The country and its healthcare system are confronted by challenges shared by less developed countries, but also burdens common among developed middle-income and affluent countries such as diabetes, cardiovascular disease, and diseases of aging. 

This report provides the following market data:
  • Market by Province (Guangdong, Shangdong, Henan, Sichuan, Jiangsu, Hebei, Hunan, Anhui, Zhejiang, Others)
  • Market by Rural/Urban
  • Regulatory Process for IVD Products in China
  • Companies Operating in China
  • Disease Statistics in China
  • Healthcare Spending in China
  • Economic Statistics
  • Market Drivers and Restrainers
  • Venues for IVD Test Usage

The report is designed to provide the reader with an overview of the Chinese laboratory market and its influences.  The focus is on the IVD discipline including reagents, consumables, calibrators and controls of the following sub-segments:

Clinical Chemistry: routine lab testing; substrates, enzymes, homogeneous immunoassays, proteins, ISE (non-POC), HBA1c (non-POC), includes urinalysis and blood chemistry testing.
Immunoassays: hormones and thyroid function, tumor markers, allergy, anemia, neonatal tests, prenatal tests, interleukins, PCT, toxicology and common infectious diseases (HIV, hepatitis, influenza)

Microbiology and Molecular Testing: manual and automated tests, culture media (to be prepared or ready to use), latex tests, transport media, blood culture, sensitivity discs, Gram and other stains, MTB culture, Mycoplasma, Ureaplasma, nucleic acid testing.  

Point-of-Care Testing: all POC tests for cardiology, toxicology, coagulation, diabetes, infectious diseases,  including POC and non-POC blood gas and electrolytes, and glucose self-monitoring tests.
Histology/Cytology: PAP, HE, IHC, ISH, FISH, primary and secondary antibodies.  

Included in the report are trends influencing the industry and country-level data including incidence of disease, life expectancy, population demographics, economic status, healthcare utilization and other market influences.

The information in the report was gathered using both primary and secondary research methods including more than 15 major interviews completed during the period of February 2018 and April 2018.  These interviews were with government officials, medical device regulators, domestic distributors, and leading market participants in the global market.  In some cases, the use of a third-party interpreter service was used to complete the interview.   Secondary data included the use of government databases, company literature, medical journals and reports.  
All market data pertains to the IVD market in China at the manufacturers' level.  Market data is presented for the 2017 year with forecast data provided for 2022.  Compound annual growth rates (CAGRs) are provided for the 2017-2022 period.  

Specific Market Data include the following segments:

  • China General Chemistries Market
  • China Blood Gases Testing Market
  • China Urinalysis Testing Market
  • China POC Glucose Market
  • China POC Infectious Disease Market
  • China POC Other Market
  • China Infectious Disease Immunoassay Market
  • China Blood Bank Immunoassay Market
  • China Other Diseases Immunoassay Market
  • China Molecular Microbiology Market
  • China Blood Bank Molecular Market
  • China HPV Molecular Market
  • China Cancer Molecular Market
  • China Other Molecular Market
  • China ID/AST Market
  • China Molecular Microbiology Market
  • China HPV Testing Market
  • China CTC Testing Market
  • China Other Histology/Cytology Market

As an in vitro diagnostics (IVD) market, China trails only the populous, developed economy markets of the United States, western European countries, and Japan. The country and its healthcare system are confronted by challenges shared by less developed countries, but also burdens common among developed middle-income and affluent countries such as diabetes, cardiovascular disease, and diseases of aging. China as an IVD market opportunity is defined by its standing next to other populous countries with demonstrated economic promise for over the past decade – Brazil, Russia and India; collectively with China referred to as one of the important, rapidly growing “BRIC” nations.

Companies Profiled in the Report include:

IVD Market in China

China offers a large market opportunity but much of this potential remains untapped. With one fifth of the world's population, it is the second largest clinical laboratory market in Asia and one of the world’s fastest growing. But by world standards, the healthcare system needs modernization and expansion to serve rural populations. Even in the major cities, most residents cannot afford healthcare.

In the last 30 years, the rate of Chinese economic growth has been impressive, averaging 8% - 10% growth in GDP per year. The economy has grown more than 10 times during that 30-year period, with China’s GDP now exceeding $9 trillion. Most analysts project that based on these GDP measures, China will become the largest economy in the world by mid 21st century. However, China's state spending on health has failed to keep up with its booming economy. In 2006, China's government health expenditure was less than 1% of GDP, ranking China 156th out of 196 countries surveyed by the WHO. While this has expanded in recent years, the amount is still minimal considering the size of the population and the huge gap to be filled. Furthermore, government spending has tended to favor urban populations; according to the WHO, only 25% of public-health money was devoted to rural areas, home to roughly 57% of the population.

China also suffers from a significant shortage of trained physicians. In 2017, the China Ministry of Health estimated that there were approximately 1.7 doctors per 1,000 people, a number that has not shown any significant change since the early 2000s. Nationwide, about 17% of public hospital medical staff members had a bachelor’s or graduate degree. In village and township hospitals, just 2.2% had a university education, according to health ministry exhibits. China has recently embarked on some reforms to start narrowing that gap. As part of the reforms, more independence was granted to hospitals, of which there are more than 65,000 throughout the country. This meant that healthcare officials at the local levels and hospital managers had more authority than before. There are currently about 1,200 private and public hospitals that serve the wealthy, mostly government employees and company insured. These state-of-the-art Class 1 hospitals are always looking to upgrade. Another 6,800 Class 2 private and public hospitals have engaged in slow modernization efforts as part of the reform plan. About 40,000 township health centers now offer very rudimentary diagnostics, which are also showing signs of improvements and upgrades as a result of the reforms. Still underserved are 150,000 privately-run village clinics that offer almost no services except those such as blood pressure, thermometer and pregnancy tests.

This hospital and clinic infrastructure is supported by at least 18,000 hospital-based labs. They help support hospital services that have been cut in order to help fund expansion into rural areas. There are very few private laboratories or reference labs in China. It is estimated that private labs account for 1% - 5% of the IVD testing in China, but they are very aggressive and offer sophisticated testing not generally available in hospital labs. Currently, only the top-tier of hospitals has the resources to buy the type of clinical laboratory equipment used in developed countries. 

In April 2009, the State Council, China's cabinet, announced $120-billion-plus initial phase of a 10-year plan to improve the country’s healthcare system. Included in the plan is the construction of a medical clinic in every village and at least one hospital in every county. China also pledged to expand medical insurance: government subsidies for insurance premiums aim to extend at least basic coverage to 90% or more of China's 1.4 billion people.

Since county-level hospitals cater to more than 900 million individuals, developing these hospitals will lead to a recognizable difference in the nation’s health. In 2017, the IVD market in China was estimated at $3,200 million and is expected to show annual growth of 13.2% to reach $5,955 million in 2022. Supporting growth will be a modernizing healthcare infrastructure and steady migration from manual to automated processes. 

IVD market growth in China will remain considerably higher than in the mature markets of U.S. and Western Europe, offering a significant opportunity to manufacturers able to work within the Chinese infrastructure. Through the foreseeable future, China will continue to offer one of the fastest growing markets for IVD products, even for western-style lab instrumentation and advanced tests outside of the scope of recent public healthcare network expansion.

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