The in vitro diagnostics market was $25.2 billion dollars in 2001. It now exceeds $117 billion, according to Kalorama Information’s new report on the in vitro diagnostics market. Not only has COVID-19 testing volumes persisted despite the presence of a vaccine, but other test markets have recovered. This has lead to a 12% increase in the market between 2020 and 2021, according to The Worldwide Market for In Vitro Diagnostics, now in its 14th Edition.

In vitro diagnostics are non-imaging tests utilized for a medical diagnosis, prognosis or therapy selection. The report said that as the world recovered from the most extreme emergency phase of the COVID-19 pandemic and relaxed lockdowns. As provider visits fuel the use of medical testing products, restored visits improved sales of cancer IVDs, glucose testing, immunoassays and bloodwork tests from the end of last year to the current time.

“While the market grew double digits between 2020 and 2021, that rate of growth can’t be sustained.” – Kalorama Information

“An early view of this year’s IVD market might have predicted that given pandemic testing levels—that associated sales would be reduced while traditional test sectors improved,” reports Kalorama Information. “That didn’t happen.”

Instead, the report says, both are increasing: COVID-19 volumes are brisk, while IVD sectors for chemistries, immunoassays, and diabetes testing are recovered or recovering. The result is a charged and growing market.

Kalorama said the results in this study exceed even Kalorama’s own projections of the market made last year by fifteen percent, due to the strength of COVID-19 test volumes.

Kalorama’s report says the market for in vitro diagnostic instruments, reagents and related supplies is estimated at $117 billion in 2021 and is projected to grow to $128 billion in 2026.  That means while the market grew double digits between 2020 and 2021, that rate of growth can’t be sustained in each year of our forecast. You’ll see a larger market, but with more status quo growth, says Kalorama Information’s analysts.

Kalorama’s report estimates the market for many sectors of in vitro diagnostic testing including: clinical chemistry, blood banking, point-of-care, histology, hematology, coagulation and other in vitro diagnostics markets. The report, published each year, can be found at:

Leading medical market research publisher Kalorama Information analyzes the IVD industry across multiple reports published in 2021, including the upcoming The Worldwide Market for In Vitro Diagnostic Tests, 14th Edition, a 1,500-plus page report that has provided reliable estimates and real-world forecasts for two decades. The report is scheduled to publish in August.

Previously published by Kalorama Information in 2021 were United States Market for In Vitro Diagnostic (IVD) Tests and The Market for In Vitro Diagnostic Tests in Latin America. Both reports are currently available for purchase.

Learn a bit about the IVD market in select regions of the Western Hemisphere through our infographic below.


By Daniel Granderson

The IVD market’s growth in key segments in the U.S. has been accelerated due to COVID-19 and the need for testing.


The IVD market’s growth in key segments in the U.S. has been accelerated due to the COVID-19 pandemic and the need for testing for the coronavirus.

The United States is the largest healthcare market in the world with high privatization of payments relative to other major developed countries. The U.S. healthcare market serves as an incubator for medical technologies and treatments that are often subsequently marketed in the rest of the world. Unsurprisingly, the United States is also the world’s largest in vitro diagnostics (IVD) market at $41.3 billion—approximately 40%-45% of the global IVD market.

The findings are according to data published in the recently released report United States Market for In Vitro Diagnostic (IVD) Tests by leading medical market research publisher Kalorama Information. A companion report, The Market for In Vitro Diagnostic Tests in Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru, Venezuela and other nations) is also available for sale from Kalorama Information.

The U.S. IVD market is projected by Kalorama Information to grow to an estimated $53.2 billion in 2025. Projected growth for the U.S. IVD market – 5.2% on average annually through 2025 – does not match the growth of developing and emerging markets abroad in Asia and Latin America but is projected to outpace other IVD markets in the developed world such as Western Europe and Japan.

Kalorama Information’s research reveals that the IVD market to some extent is in a state of flux, yet the market’s growth in various key segments in the United States has been accelerated due to the COVID-19 pandemic and the need for testing for the coronavirus. COVID-19 had a profound effect on the IVD diagnostic industry – some segments exploded and others languished. Looking ahead, COVID-19’s impact on future growth will result from the coronavirus remaining a component of the IVD market due to the likely continued prevalence of the virus and the evolving variants that are expected to persist.

COVID-19 related growth aside, the U.S. IVD market can expect moderate growth through the following market factors and trends:

  • demographic aging that increases demand for clinical testing paid for through the country’s leading vehicle for lab payments (Medicare);
  • relatively optimistic macroeconomic indicators vis-à-vis the domestic outlook five years ago or other developed markets in the world;
  • and continued product innovation and industry responsiveness to clients’ needs in the world’s largest IVD market.