The global in-vitro diagnostics (IVD) market continued to flourish in 2016, with immunoassay, clinical molecular, and point-of-care/physician office laboratory (POC/POL) markets driving much of the sector’s overall growth trends, according to an industry review by consulting firm Enterprise Analysis Corp.
Total IVD manufacturer sales from 2015 to 2016 grew from $54.6 billion to $56.5 billion, a 3.6% overall increase. Taking the strength of the dollar into account in relation to other currencies, this actually represents a 5% increase ($57.3 billion, at constant exchange rates).
Looking at overall growth trends, immunoassays, whole blood glucose monitoring (WBGM), clinical chemistry, clinical molecular, and POC/POL represent the 5 largest IVD markets. However, EAC cited the 5 fastest growing markets in 2016 as some of the key drivers of overall growth in the IVD industry.
Clinical molecular sales, which exceeded $5 billion in 2016, took the top spot as the fastest growing segment of IVD over the past year, with a growth rate of 9.4%. Buoyed by new products and test menu expansions, POC/POL testing came in second at 6.6%, reaching overall sales of $6.1 billion. Immunoassays command the largest IVD segment and in 2016 grew by 6.3% to reach $14 billion in sales.
Microbiology also grew by 6.3% due to increased utilization in mass spectrometry and automation. This market is worth nearly $3 billion, as is anatomic pathology, with a sales growth rate of 5.8% in 2016.
Emerging markets in Asia Pacific countries—especially in China and India—also contributed to IVD growth on a global basis. “[They] continued to expand at double digit growth rates, which compensated for slower growth rates in the U.S. and in Europe,” according to the report.
Countering these upward trends, nations facing healthcare spending pressures have taken steps to tamp down on IVD usage, a factor that’s hindering growth.
Latin American spending on IVD for example has slowed due to Brazil’s ongoing recession, and health reform provisions in the United States have discouraged providers from ordering too many tests. And in Japan, flagging reimbursement has led to more conservative use of IVD testing.
Flat sales for diabetic WBGM due to significant price competition is another factor that’s negatively impacting growth. “The only positive note in the WBGM segment is the rapidly growing market for continuous glucose monitoring, especially in the U.S.,” the report’s authors observed.
EAC projects that IVD will continue to thrive up through 2021, negative factors aside. Pricing pressures will remain, but as Europe’s economy continues to improve, IVD testing volume will increase.
From a demographic standpoint, IVD sales will benefit from middle class populations in Brazil, Russia, India, China, and South Africa that can afford healthcare and subsequently these types of tests, in addition to older populations in major developed countries facing chronic disease and requiring more healthcare resources.
Advances in mass spectrometry and molecular techniques will aid in the rapid identification of infectious organisms and guide therapy. Additionally, next generation sequencing (NGS) tools in oncology, prenatal and genetic testing will emerge as a game changer in molecular diagnostics. EAC analysts expect that NGS will impact how cancer and genetic disease testing is carried out.
“Clearly, short-term growth is in oncology. But prenatal screening as an IVD kit has substantial potential if it becomes standard for pregnancies,” said EAC’s CEO Gerard Conti, in comments to CLN Stat.
Other future areas of interest include: the expansion of image analysis into the areas of hematology and anatomic pathology; new generations of integrated chemistry and IA platforms; wireless communication; and ID/AST (microbial identification/antimicrobial sensitivity testing), Conti noted.
All of these factors considered, this market’s worth has the potential to reach $74.7 billion in 2021.