In Vitro Diagnostics
In vitro diagnostics (IVDs) are diagnostic tests that that can detect diseases, conditions, or infections. In vitro diagnostics test a sample of tissue or bodily fluids, as opposed to testing inside the body, such as:
- Microbiological culture, which determines the presence or absence of microbes in a sample from the body, usually targeted at detecting pathogenic bacteria
- Genetic testing
- Blood glucose
- Liver function tests
- Calcium
- Electrolytes in the blood, such as sodium, potassium, creatinine and urea
In vitro tests can be classified according to the location of the sample being tested, including blood and urine tests.
Some tests are used health professional settings such as clinical laboratories, and other tests are for consumers to use at home. The expression in vitro comes from Latin, literally meaning “within the glass.” The name reflects the fact that historically such tests were conducted in glass vessels, such as test tubes.
Unlike other forms of medical technology, IVDs never interact directly with the human body. Their value stems from the information they provide. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique among health technologies.
In the U.S., in vitro diagnostics products are medical devices as defined in section 210(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.
The IVD industry is growing steadily due to a number factors, such as increased demand for infectious disease testing as new pathogen strains develop each year, such as in seasonal influenza and H1N1, and increased incidences of hospital-acquired infections. Other factors include aging demographics common to all developed nations and the accompanying increased incidence of chronic disease across all age cohorts of the population; advances in DNA sequencing; and growing demand from emerging markets, which are only now becoming able to pay for diagnostic devices.
For IVD Companies, Tariff Refunds May Be a Long Haul
Following the US Supreme Court’s decision declaring certain tariffs illegal, the diagnostics industry has entered a murky period regarding potential refunds. For in vitro diagnostics (IVD) manufacturers who paid these tariffs under policies f…
Global IVD Woes in China Should Resonate with US Labs
In vitro diagnostics (IVD) companies reported a mix of overall growth, with many noting continuing challenges in their diagnostics divisions for recent quarterly financial results. Thermo Fisher Scientific, QuidelOrtho, and Danaher reported the…
Abbott Bets Hard on Cancer Diagnostics with New Deal
Abbott Laboratories’ deal to acquire Exact Sciences for $23 billion emphasizes the value that the in vitro diagnostics (IVD) manufacturer puts on cancer testing. Clinical laboratories involved with oncology should monitor the progres…
Reforms in China Affect IVD Companies’ Q3 2025 Earnings
Most of the in vitro diagnostics (IVD) manufacturers that serve clinical laboratories worldwide reported facing financial “headwinds” in the China IVD market that affected their third-quarter performance. This was due to policy changes in the country…
What Private Equity Sees in Diagnostics
CEO SUMMARY: Hologic’s acquisition by private equity firms Blackstone and TPG marks one of the year’s largest in vitro diagnostics transactions and a clear vote of confidence in the sector’s resilience. Industry analyst Bruce Carlson unpacks what the buyout …
FDA Has Future Avenues to LDT Oversight
CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in mode…
2025 Ranking of the World’s Top 13 IVD Corporations
BASED ON PUBLICLY-REPORTED 2024 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) companies continue to dominate the global market, as they have for the last two years: Thermo Fisher Scientific, Roche, Danaher, and Abbott Laboratories. The top 13 companies …
Despite Trade Tariffs, IVD Firms Report Upbeat Earnings
LEADING IN VITRO DIAGNOSTICS (IVD) COMPANIES RECENTLY REPORTED POSITIVE QUARTERLY FINANCIALS despite swirling concerns about trade tariffs and cuts to US federal research grants. It’s not yet clear what the long-term effect of tariffs’ will be on IVD manu…
Fast, $17.5B Deal Lands Waters Corp. in IVD Market
WHEN BECTON DICKINSON (BD) ANNOUNCED ITS INTENT to spin off its in vitro diagnostics (IVD) and life sciences units in February, few observers expected a deal to close just five months later. But now that such an agreement has occurred as of July 14, the buy…
BD Will Sell Diagnostics Arm but Retain Vacutainer Brand
LESS THAN TWO MONTHS AFTER ANNOUNCI…
CURRENT ISSUE
Volume XXXIII, No. 6 – May 04, 2026
Speakers at the 2026 Executive War College have re-imagined the diagnostic laboratory’s role from back-office utility to a primary driver of system-wide strategy and clinical excellence. Also, it is apparent that direct-to-consumer lab testing is booming.
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