China Non Invasive Prenatal Testing Market Size & Outlook
The non invasive prenatal testing market in China is expected to reach a projected revenue of US$ 406.4 million by 2030. A compound annual growth rate of 11% is expected of China non invasive prenatal testing market from 2024 to 2030.
In terms of revenue, China accounted for 4.7% of the global non invasive prenatal testing market in 2023.
Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
In Asia Pacific, China non invasive prenatal testing market is projected to lead the regional market in terms of revenue in 2030.
India is the fastest growing regional market in Asia Pacific and is projected to reach USD 247.6 million by 2030.
The China NMPA FDA (CFDA) is responsible for the IVD registration process. Most IVD products in China are regulated in the device group, with only a few defined as drugs. Mostly, they follow similar guidelines for review and registration as medical devices.
The Class I IVDs do not need registration; all required is filing for a notification application. In China, mostly all Class II and III IVDs are required to go through local clinical studies. The Class III IVDs must undergo a multicenter clinical survey with at least three sites.
In 2017, China's State Council issued new guidelines allowing some foreign clinical trial data for IVD registration. Clinical studies must be conducted at multiple locations and meet CFDA registration requirements. This new guideline can reduce the time needed for registration and lower the barriers to entry for foreign manufacturers.
China Non Invasive Prenatal Testing Market Outlook
The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to Non Invasive Prenatal Testing Market Outlook will help companies and investors design strategic landscapes.
13-24 Weeks was the largest segment with a revenue share of 57.16% in 2023.
Horizon Databook has segmented the China non invasive prenatal testing market based on 0-12 weeks, 13-24 weeks, 25-36 weeks covering the revenue growth of each sub-segment from 2018 to 2030.
The China NMPA FDA (CFDA) is responsible for the IVD registration process. Most IVD products in China are regulated in the device group, with only a few defined as drugs. Mostly, they follow similar guidelines for review and registration as medical devices.
The Class I IVDs do not need registration; all required is filing for a notification application. In China, mostly all Class II and III IVDs are required to go through local clinical studies. The Class III IVDs must undergo a multicenter clinical survey with at least three sites.
In 2017, China's State Council issued new guidelines allowing some foreign clinical trial data for IVD registration. Clinical studies must be conducted at multiple locations and meet CFDA registration requirements. This new guideline can reduce the time needed for registration and lower the barriers to entry for foreign manufacturers.
China Non Invasive Prenatal Testing Market Gestation Period Outlook (Revenue, USD Million , 2018-2030)
0-12 weeks
13-24 weeks
25-36 weeks
China Non Invasive Prenatal Testing Market Risk Outlook (Revenue, USD Million , 2018-2030)
High & Average Risk
Low Risk
China Non Invasive Prenatal Testing Market Method Outlook (Revenue, USD Million , 2018-2030)
Ultrasound Detection
Biochemical Screening Tests
Cell-Free DNA in Maternal Plasma Tests
China Non Invasive Prenatal Testing Market Technology Outlook (Revenue, USD Million , 2018-2030)
NGS
Array Technology
PCR
Others
China Non Invasive Prenatal Testing Market Product Outlook (Revenue, USD Million , 2018-2030)
Consumables & Reagents
Instruments
China Non Invasive Prenatal Testing Market Application Outlook (Revenue, USD Million , 2018-2030)
Trisomy
Microdeletion Syndrome
Other Applications
China Non Invasive Prenatal Testing Market End-use Outlook (Revenue, USD Million , 2018-2030)
Hospitals & Clinics
Diagnostic Laboratories
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Horizon Databook provides a detailed overview of country-level data and insights on the China Non Invasive Prenatal Testing Market Outlook, including forecasts for subscribers. This country databook contains high-level insights into China Non Invasive Prenatal Testing Market Outlook from 2018 to 2030, including revenue numbers, major trends, and company profiles.
China Non Invasive Prenatal Testing Market, 2018-2030 (US$M)