Already expanding for the past 5–10 years in Japan, Singapore, Taiwan, South Korea and other Asian countries whose rapidly aging populations are increasingly susceptible to chronic health conditions that require diagnostic products to diagnose disease, the 2020 IVD industry finds itself in the spotlight as never before.
Demand for IVD products of all kinds—reagents, instruments and systems used to diagnose and monitor COVID-19, heart disease, diabetes and other conditions—is surging. Prominent players including Sysmex Corp., Roche Diagnostics and Abbott Laboratories are expanding in the market very quickly. And they are meeting an increasingly supportive regulatory landscape for product development and commercialization.
The Pandemic Spurs Progress—and an Aging Population Presents Opportunities
Polymerase chain reaction (PCR) tests, a mainstay in the IVD market, are currently the primary detection method for COVID-19. The tests are used to directly detect the genetic information of the virus, the RNA. Patients get results from the tests relatively fast, and they are proving to be highly accurate compared to conventional techniques. PCR test producers around the world are moving to scale up production of the tests as rapidly as possible, to address supply chain bottlenecks, and to push the tests out to medical professionals.
Efforts to curb the spread of the virus is driving rapid development of diagnostics, fast-tracking regulatory clearances and spurring producers to ramp up distribution. PCR systems are also used for diagnosis and screening of a wide array of other infectious diseases as well as testing cancer patients and for hereditary diseases.
But in Asian countries where the number of elderly is rising very fast, where incomes are growing, personalized medicines are becoming more prominent, and new innovative techniques are growing in demand, the demand for IVD products is far broader.
The Asia-Pacific IVD market generated revenues of US$14.4 billion in 2016 and is expected to register a compound annual growth rate (CAGR) of 6.3% through 2021, according to a report from research firm Frost & Sullivan.
Leading the growth are PCR systems as well as hematology analyzers. Together they account for about 45% of the region’s IVD analyzers and reagents market. In Japan alone, the diagnostic market estimates could reach $5 billion by 2026, including immunochemistry, molecular diagnostics, self-monitoring blood glucose meter, point-of-care testing (POCT), hematology, tissue diagnostics, hemostatic, and clinical microbiology.
The IVD market is segmented into PCR, NGS, ELISA, rapid-tests, clinical chemistry, hematology, hemostasis, urinalysis, and microbiology testing, among others. In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These technologies can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
IVD Market Growing Fastest Where Incomes Are Too
The IVD market is showing particularly strong growth in Asian countries with advanced healthcare systems. And that growth has been on steep trajectories since several years before the pandemic hit.
Since 2018, when China’s Food and Drug Administration (CFDA), now called the NMPA, refined their IVD regulations, the medical diagnostics market has grown steadily, making China the fastest growing medical diagnostic market.
In China, the IVD market is growing quickly as a result of a number of factors, including Increased awareness of public health, an increase in the overall number of hospitals, more chronic Western diseases and an increased income in the middle class.
In Japan, the IVD market is growing due to an increase in chronic diseases that can be diagnosed and monitored more easily than in the past. Among the products showing the most growth are immunoassay and infectious disease IVDs, tumor markers, hematology, pathology and genetic testing.
The South Korean market for in-vitro diagnostics is projected to experience a CAGR of 5% until the end of 2025. IVD products used to diagnose infectious diseases account for the largest share, followed by oncology, which is the fastest growing segment owing to the increasing prevalence of cancer.
In Singapore, marked by an advanced healthcare system and high per capita spending, diagnostics has emerged as a way for earlier and better identification of diseases to control rising healthcare costs. Along with the country’s state-of-the-art infrastructure and high standards of medical practice, Singapore has become a natural choice for many global diagnostic companies to establish their regional business operations thanks to its strategic location and position as the most developed healthcare system in Southeast Asia.
The IVD market has been propelled by the COVID-19 pandemic for much of this year, and the global response to the crisis is expected to continue to drive diagnostics growth. But it is not the only driver.
Also pushing the market for IVDs will be a number of factors. First, as diagnostics laboratories increasingly use fully automated instruments, they will decrease hands-on time, reduce batch testing, and provide doctors with quicker tests compared to non-automated instruments. Second, the integration of biomarkers and the availability of biomolecular tools are predicted to help in the development of a new set of condition-specific tests, thus creating new opportunities for the growth of IVD market size. And last, the IVD market will be driven by the use of personalized medicine products in treating cancer and other chronic diseases, along with increasing technological advances related to artificial intelligence and machine learning, which makes it possible to achieve higher levels of diagnostic precision.