In 2014, the global in vitro diagnostics (IVD) market is forecasted to surpass a major milestone: crossing the $50 billion mark. One of the most important market drivers promoting this achievement is the regular need for detecting infections. 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.
Another primary driver of the IVD market is the aging demographic, which drives demand for laboratory testing. The likelihood of chronic disease and cancer risk increases for individuals above the age of 65. Consequently, this population’s healthcare needs augment and drive the demand for more screening and diagnostic testing. This will create a positive impact on clinical laboratory test volumes. Chronic diseases like diabetes, asthma, and heart disease will have a high prevalence and require long-term patient management that will include clinical laboratory testing.
An analysis of each major segment of the global IVD market, along with key trends that are influencing market growth, is provided in this article.
The $15.8 billion immunochemistry market is forecasted to grow with a roughly 7% compound annual growth rate (CAGR) between 2012 and 2014. The immunochemistry market, which includes revenues from the sales of instruments, reagents, and automation for standalone immunoassay and clinical chemistry analyzers, as well as integrated immunochemistry analyzers, represents 36% of the global IVD market.
In the immunochemistry market, vendors are continually expanding their product lines to fit varying end-user needs. For example, manufacturers are developing analyzers to meet end-user budgets, test volumes, desired breadth of test panels, and levels of automation. Additionally, many analyzers are modular for expansion as desired. Integrated immunochemistry analyzers are marketed more to developed countries, while standalone immunoassay and clinical chemistry analyzers are marketed more toward emerging countries.
The $2.4 billion microbiology market is forecasted to grow with a roughly 4% CAGR between 2012 and 2014. The microbiology market, which includes revenues from the sales of products for the study of microorganisms as causative agents of disease, represents 5% of the global IVD market. Microorganisms are identified through direct examination and culture of clinical specimens.
In some cases, automated methods are used for the identification and determination of organism susceptibility to antibiotics. Antibiotic susceptibility testing determines the growth of a bacterium in the presence of antibiotics and classifies it as susceptible, resistant, or intermediate.
In the microbiology market, there is an increasing focus on lab efficiency: end-users are performing efficiency audits to optimize laboratory workflow. To address this market opportunity, manufacturers are offering assessments and processes to help streamline lab workflows, reduce time to results, and generate productivity gains for end-users.
The $5.5 billion point-of-care testing market is forecasted to grow with a roughly 7% CAGR between 2012 and 2014. The point-of-care testing market, which includes revenues from tests used by healthcare professionals in hospitals, physician office labs, and health clinics, represents 12% of the global IVD market.
There is a rising use of point-of-care tests as screening tools. Point-of-care tests enable the identification of high-risk patients during large awareness campaigns. Additionally, point-of-care testing for HIV is moving to standard practice in routine examinations. Point-of-care tests also provide a convenient and rapid way to diagnose disease. For example, point-of-care hemoglobin A1C testing allows clinicians to diagnose and screen for diabetes, and studies have identified it as a convenient alternative to fasting glucose plasma levels.
The $5.0 billion molecular diagnostics market is forecasted to grow with a roughly 11% CAGR between 2012 and 2014. The molecular diagnostics market, which includes products used to directly analyze nucleic acids for the detection of genetic disorders or infecting pathogens such as HIV or hepatitis viruses, represents 11% of the global IVD market. This market is composed of virology, bacteriology, molecular blood donor screening, and genetic testing.
The declining costs of genetic testing, specifically on next-generation sequencing technologies, promotes personalized testing. The cost of sequencing an entire individuals’ genome continues to drop. As sequencing costs fall, the market will increasingly move away from screening panels to using personal genomes. This trend should help eliminate the variability of testing, as different populations can vary widely as to susceptibility of diseases and mutations.
The $1.5 billion hemostasis market is forecasted to grow with a roughly 6% CAGR between 2012 and 2014. The hemostasis market, which includes tests to monitor anticoagulation therapy dosage, represents 3% of the global IVD market.
Self-Monitoring Blood Glucose
The $8.2 billion self-monitoring blood glucose market is forecasted to grow with a roughly 3% CAGR between 2012 and 2014. The self-monitoring blood glucose market, which includes revenues from testing outside of medical facilities from the sales of test meters, strips, and combination meter and insulin pump products, represents 19% of the global IVD market.
The $3.0 billion tissue diagnostics market is forecasted to grow with a roughly 12% CAGR between 2012 and 2014. The tissue diagnostics market, which includes products for anatomic pathology (AP), represents 7% of the global IVD market. AP is a medical specialty that provides disease diagnosis based on histology, or microscopic examination of a tissue specimen. The tissue diagnostics market includes products from the pre-analytical, routine staining, and advanced staining markets. Revenues are generated from the sales of instrumentation, consumables, and supporting products for manual and automated tissue diagnostic testing.
In this market, there is continued demand for automation due to the shortage of histology technicians, especially in pre-analytical steps. AP laboratories often fail in procedural standardization as every histotech employs self-optimized methods. Only 30% of the AP laboratory is automated, compared to 80% of the clinical chemistry laboratory. There is an enormous opportunity for vendors to continue to develop systems that address unmet needs in the histological preparation process.
The $3.0 billion hematology market is forecasted to grow with a 2% CAGR between 2012 and 2014. The hematology market, which includes revenues from hematology instruments and testing products, as well as revenues from flow cytometry instrumentation and testing products, represents 7% of the global IVD market. Hematology tests are used to examine different parts of the blood, including tests to determine white blood cell counts, red blood cell counts, complete blood cell (CBC) counts, platelet counts, the amount of hemoglobin in the blood, and other measurements.
Despite a high number of automated CBC analyzers in use, a significant percentage of samples require a manual cell differential count of blood specimens under a microscope. Frequently, a manual count is required due to the inability of automated CBC and differential analyzers to discriminate complex morphology, especially the shape of abnormal cells, such as immature white blood cells or the presence of diseased cells. It is important, though, to accurately detect the presence of immature white blood cells since they are often associated with conditions such as leukemia, infection, inflammation, or tissue injury.
Accordingly, manufacturers are working to decrease the number of manual reviews that are required through improvements in analyzer accuracy.