The $3.95 billion worldwide molecular diagnostic point-of-care (mPOC) testing market is seeing increasing international activity with China becoming a particularly intriguing part of the Asia Pacific (APAC) region according to a new report, The Market and Future Potential for Molecular Point of Care (mPOC), 2023, published by market research firm Kalorama Information, a sister brand of LabPulse.
As is true of other nations, COVID-19 has been a major driver of market growth for China, and COVID-19 tests represent the largest component of its mPOC market.
However, the potential for POC testing was already growing when the pandemic focused the attention of the country’s healthcare system on in vitro diagnostic (IVD) and imaging testing. APAC now accounts for approximately 10% of global sales in a worldwide mPOC testing market that is dominated by North America.
With one of the largest economies in the world and a gross domestic product that will soon surpass that of the U.S., China nonetheless remains largely a developing country, and point-of-care testing (POCT), until quite recently has played a relatively insignificant role.
For several reasons, the molecular point-of-care market is attractive to China and other nations. Molecular diagnostic technologies provide sensitivity and specificity improvements for current near-patient and rapid tests. These tests expand diagnostic capabilities at points of care, where they are used to assess conditions or admit patients. In the developing world, similar to wealthy nations, such points of care include hospital critical care units, physician offices, outpatient clinics, and community health posts.
Overall, molecular point-of-care testing combines the accessibility of POC testing with the accuracy of molecular technologies. The market includes sales of clinical IVD systems -- incorporating tests, consumables, and instruments -- used outside of central clinical laboratories such as hospital laboratories and reference or independent laboratories. The tests detect or interrogate nucleic acid analyte sequences using processes such as nucleic acid amplification, hybridization with oligonucleotide probes, and nucleic acid sequencing.
In China, the POC testing market is closely aligned with government hospital clinics. Government hospitals dominate the Chinese clinical laboratory landscape, and associated doctors and overall hospital operations depend heavily on testing fees from these settings. Additionally, pharmaceutical reform has limited profits from hospital pharmacies.
Private clinics and physician practices represent an ancillary channel for POC testing products, but there is currently low market penetration for analyzers among private clinics and physician practices in China. The development of a private practice industry in China would likely feed the fellow emergent industry of private lab testing. Otherwise, hospital labs will provide testing for primary-care settings, and the location of most private practices in cities will make sample collection and delivery relatively quick for physicians.
In developing countries generally, screening for some of the most burdensome emerging infectious diseases has grown because of global initiatives. These initiatives are supported by organizations such as the Clinton Foundation HIV/AIDS Initiative; Roll Back Malaria; UNAIDS; the United States President's Emergency Plan for Aids Relief (PEPFAR); the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund); and the World Health Organization (WHO).
Significant POC testing demand even in the least-developed countries and regions has been generated by the support of these international organizations.
Some of the programs use rapid tests while others use standard microscopic techniques, and they are performed in community clinics where no formal lab services are available.
Chinese central and provincial governments have also played a role in the expansion of POC testing. Screening campaigns have targeted diseases such as HPV, prenatal conditions, hepatitis, and emerging infectious diseases such as avian flu and drug-resistant tuberculosis. Additional studies have assessed the role of rapid POC tests in sexually transmitted infection (STI) control.
Overall, however, the Chinese IVD market is complex and continuously changing. In the future, we anticipate that government reforms will increase funding for public hospitals and decentralized care, and expand medical insurance. At the same time, the government will tighten the management and oversight of medical institutions, health insurers, and retailers.
These reforms, along with increasing incidence of cancer, diabetes, heart disease, and infectious diseases (such as HIV, hepatitis, and STIs), provide opportunities for point-of-care, advanced tests and molecular diagnostic technologies.
In China, IVD testing is concentrated in large laboratories affiliated with 2,418 top-tier (also known as class III) hospitals in the major cities. By 4 a.m. at almost all of China’s class III hospitals, people start to line up for care, which includes lab testing. It is normal for these facilities to conduct 20,000 or more tests per day using automated immunoassay and chemistry analyzers.
Although the more than 600,000 village clinics in China present a potential market, POC testing is more likely to grow among the community health centers that have emerged in cities nationwide since healthcare reform.
Before China committed to healthcare reform and improvements in medical infrastructure and health insurance system a decade ago, diagnostic testing in the countryside -- outside of rapid tests for pregnancy and ovulation -- mainly involved the use of stethoscopes, thermometers, and mercury manometers.
For integrated molecular analyzers that are now being marketed as solutions for low-resource countries and health facilities in the developing world, system cost is a major consideration. The Alere q (HIV) and Genedrive’s recently launched platforms are among the most notable molecular diagnostic systems for use in the resource-poor labs or for distributed use in the developing world; both platforms are CE-marked.