What Will IVD Test Procedure Volumes Be at in the Future?

Excluding glucose and other self-testing activity by diabetes patients, global volume of IVD tests   is projected to grow 2.5 percent annually through 2021 to 26.3 billion. .  The most current estimates and forecasts for the IVD Market can be found in Kalorama Information’s Global IVD Market Report.

Several trends and factors will account for this gain, including:

• advances in life science technologies, which will expand the number of disease markers that can be detected and characterized in blood, urine, and saliva samples;
• ongoing advances and improvements in reagents and automated instruments, which will broaden the range of diseases, disorders, and other medical conditions that can be tested accurately and efficiently through IVD techniques;
• expansion in private and public health insurance coverage for IVD procedures due to their cost saving and cost containment advantages related to early disease detection and treatment; and
• the increasing adoption of value-based patient care systems in the United States and other countries, which will encourage medical providers to expand the use of IVD procedures to improve the quality, effectiveness, cost efficiency, and overall outcomes of therapeutic decision-making.

Selection of IVD Tests

The selection of IVD tests by medical providers depends on a number of factors. Among the key influences are the nature of the healthcare activity involved, the presence or absence of obvious patient symptoms, patient characteristics and history, and, increasingly, cost and third-party reimbursement eligibility. Based on broad detection capabilities, core laboratories generate the largest share of global IVD procedure volume, or about 63 percent in 2016. These establishments apply clinical chemistry and immunoassays to the high throughput analysis of blood samples. Both techniques are able to detect or measure several target markers simultaneously. As a result, a single clinical chemistry or immunoassay test can involve multiple IVD procedures.

Increasing applications in the testing of hospital patients, patients undergoing physical examinations and periodic healthcare checkups, and patients suspected of ingesting toxic substances will boost the volume of core laboratory procedures implemented worldwide. However, growth in this activity will slow from historical levels as many countries see shorter hospital stays and tighter health insurance restrictions on outpatient testing. Moreover, increasing competition from point-of-care (POC), molecular, and histology/cytology diagnostics will eliminate the need for some core laboratory tests.

Through 2021, the fastest global growth in IVD procedure volume will emerge in molecular assays followed by histology/cytology processes, and non-glucose POC tests. Reflecting further advances in amplification technologies and the discovery of new genetic and protein markers, molecular assays will expand applications in cancer and infectious disease detection and characterization, transplant matching, donated blood screening, and pharmacodiagnostics. The increasing use of in situ hybridization in the diagnosis, analysis, and monitoring of hematopoietic neoplasms and solid tumors, along with the widening adaptation of immunohistochemistry techniques to the identification of cancerous cell- and tissue-based antigens, will underlie fast-paced growth in the combined worldwide volume of histology and cytology procedures. The continuing diversification of hospital ambulatory and emergency departments, outpatient clinics, and physicians’ offices into onsite patient testing will promote strong growth in the number of non-glucose POC procedures conducted on lower volume, desktop immunoassay systems.

Hematology tests will remain the second-largest group of IVD procedures based on worldwide volume, accounting for almost one-fourth of the total in 2021. This segment will see moderate growth over the long term based on continuing use in hospital testing and ambulatory physical examinations as well as in the diagnosis of blood cell disorders such as leukemia. Similar to clinical chemistry and immunoassay technologies, hematology detection capabilities have benefited from advances in automated systems, including the development of digital imaging configurations.

Expanding applications in the diagnosis and characterization of infectious and viral pathogens, along with widening uses in antibiotic sensitivity testing, will create slightly above average growth in the worldwide volume of IVD microbiology procedures. The developing countries will contribute the majority of gains as government health authorities and private philanthropic groups pursue improvements in disease control and prevention capabilities. Competition from molecular assays will hold down overall growth in the volume of microbiology procedures implemented in the developed world.

Advances in molecular assays will also weaken growth in the global volume of traditional blood grouping procedures implemented by blood banks. Lastly, the number of traditional coagulation tests conducted worldwide will expand at a below average pace due to advances in blood thinner therapies. Specifically, new-generation blood thinners such as rivaroxaban do not require regular prothrombin time procedures to check for bleeding problems.

As with other healthcare activity, a wide disparity exists in the relative volume of IVD tests performed in developed and developing countries. In 2016, the number of procedures in the United States, Canada, Western Europe, Australia, and Japan averaged 11.1 per capita compared to 2.0 per capita in the remainder of the world. This gap will remain intact over the long term. In spite of improvements in medical delivery systems, most developing countries will continue to lag well behind the developed countries in terms of IVD capabilities, technologies, and overall resident accessibility. Eastern Europe deviates from overall developing world trends. Based on surpluses of practicing physicians and high outpatient consultation rates in many countries, the average number of per capita IVD tests was equivalent to 7.6 in 2016.