Growth in global IVD markets is indicator of increasing demand for clinical laboratory and anatomic pathology testing
During the next 24 months, the global in vitro diagnostics (IVD) market is predicted to exceed $50-billion in revenues. However, this robust growth has an upside and a downside for the clinical laboratories and pathology groups that purchase IVD analyzers, reagents, and consumables.
In a recent story in about the IVD industry, Frost & Sullivan, a global consulting and research firm, made predictions in different segments of the IVD market. It won’t surprise pathologists and clinical laboratory managers that the two fastest-growing segments are molecular and tissue diagnostics.
A recent story on growth in IVD markets by Jonathan Witonsky, a principal analyst in the life sciences group at Frost & Sullivan, was published in Genetic Engineering News (GEN). Witonsky noted that IVD sales growth will be driven by two market factors during the coming years.
One market factor is increased demand for infectious disease testing. Wkitonsky wrote, “Infectious disease testing will always be a key driver for diagnostic testing because new pathogen strains develop each year, such as in seasonal influenza and H1N1. “Additionally, hospital acquired infections, like Methicillin-resistant Staphylococcus aureus (MRSA), necessitate increased testing.”
The second market factor is the aging demographics common to all developed nations. This trend is further intensified by the increased incidence of chronic disease across all age cohorts of the population.
Here is a short summary of Wkitonsky’s comments on the X IVD market segments:
• 12% Growth in Tissue Diagnostics Market Segment
The tissue diagnostics market, is predicted to grow by about 12% compound annual growth rate (CAGR), to $3.6 billion, by the end of 2014. Tissue diagnostics currently represents 7% of the IVD market and generates about $3 billion in revenues annually.
• 11% Boost in Molecular Diagnostics Market Segment
The molecular diagnostics market is expected to grow at about 11% CAGR through 2014. This will represent annual global sales of about $5.5 billion. Currently, the molecular diagnostics segment represents 11% of total global IVD sales. This IVD market segment involves products used to analyze nucleic acids to detect genetic disorders or infectious disease pathogens.
• 7% Growth in Immunochemistry Market Segment
Immunochemistry is a major segment, generating 36% of global IVD revenues. In 2014, sales are estimated to reach $16.9 billion, based on estimated 7% CAGR. IVD vendors are marketing integrated immunochemistry analyzers to medical laboratories in developed nations and standalone immunoassay and clinical chemistry analyzers to labs in emerging countries.
• 7% Growth in Point-of-Care Tests (POCT) Market Segment
Point-of-Care testing (POCT) is predicted to have a 7% CAGR and is on track to generate global IVD sales of $5.9 billion during 2014. POCT currently makes up 12% of the global IVD market. This IVD market segment includes test devices used by healthcare professionals in hospitals, physician offices, and health clinics.
• 6% Growth in Hemostasis Market Segment
With a 6% CAGR, sales are predicted to reach $1.6 billion at the end of the next 24 months in this market segment. The hemostasis test market includes products used in tests to monitor anticoagulation therapy dosage and represents about 3% of global IVD markets.
• 4% Growth in Microbiology Market Expected
There will be 4% CAGR growth in microbiology sales. This segment of the IVD market is expected to grow to more than $2.5 billion by 2014. Microbiology represents about 5% of the global IVD market. Microbiology involves products used to study disease microorganisms. Growth in this segment is a result of new solutions to streamline and automate workflow in the microbiology laboratory and reduce time required to produce results.
• 3% Growth Predicted for Blood-Glucose Self-Monitoring Products
Growth in the incidence of diabetes is one factor in the estimated 3% CAGR increase for this market segment. Sales in 2014 are predicted to be $8.4 billion. Self-monitoring Blood Glucose products now represents 19% of the IVD market. This market segment includes the sale of test meters, test strips and combination meter and insulin pump products used by individuals to monitor and treat their own blood-glucose levels.
• 2% Growth in Hematology Market
Hematology testing makes up 7% of the global IVD market. With a projected growth of 2% CAGR, the Hematology test market will reach annual global IVD sales of $3.2 billion in 2014. This IVD market involves instruments and test products used to examine various blood components.
Several favorable trends support the predictions of continued growth in sales of IVD products. For instance, a Frost & Sullivan study reported by Darkdaily.com, predicted that growing demand for diagnostic testing by Europe’s over-60 population will increase IVD sales 69.5% by 2018, to $22.2 billion annually.
Advances in DNA sequencing technologies are driving growth in this market. “As sequencing costs fall, the market will increasingly move away from screening panels to using personal genomes,” Witonsky pointed out, noting that this trend should help eliminate variability in testing by zeroing in on disease susceptibility and mutations in different populations.
High demand for automation is another driver of growth, particularly in the area of histology. Witonsky pointed out that histology technicians are essential, particularly in pre-analytical steps of the histology process, but there is a shortage of trained histologists. “Only 30% of the AP [anatomic pathology] laboratory is automated, compared to 80% of the clinical chemistry laboratory,” he said.
None of the predictions of Frost & Sullivan will be a surprise to clinical laboratory managers and pathologists. It is generally recognized that high volume, routine testing—[particularly chemistry and hematology—is growing at low single digits each year. It is other segments of the IVD testing menu that are growing at much faster rates.