$65 Billion Market in Medical Laboratory Tests

Press Release
Sep 4, 2018
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Rockville (MD), September 4, 2018 — In vitro diagnostic tests, or non-imaging laboratory tests that doctors use to make critical health decisions, represent a $65 billion-dollar and growing healthcare market. Hundreds of companies participate, though key firms such as Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers and Danaher dominate. This according to market research firm Kalorama Information, a New York City-based research firm that focuses on biotechnology and in vitro diagnostics, or IVD. Kalorama just released its 1800+ page market study, The Worldwide Market for In Vitro Diagnostics, 11th Edition.

Why is this market growing? Kalorama says threats to human health continue - obesity, diabetes, cancer, cardiac disease and infectious diseases, worldwide. These situations have created demand for highly specific, sensitive and sometimes expensive tests. IVD companies spend a lot more than other industries on research, and this fuels new testing products. Is there any limit to growth? Kalorama says that there are limits because testing is regulated by governments worldwide, and test reimbursements in developing countries are often reduced.

“It’s a paradox of sorts. As great technologies come out, as new genomics, microfluidics and IT appear, the appetite of world healthcare systems to pay for tests decreases,” said Bruce Carlson. “What’s the way around it? Even more innovation, and public pressure for test funding, for starters. But even without any action on the industry’s part, demand is fueled by aging world populations and disease trends.”

These specialized tests have come under scrutiny from payers and regulatory authorities. The study balances out regulations and payor information with new product innovations, disease statistics and clinical practice to arrive at market estimates. Kalorama surveys vendors and reviews published facts and medical journals in making assessments. The firm thinks in vitro diagnostics grow at 4% overall – but that average is brought down by mature industries within IVD. There are biomarker segments that will double in 5-7 years, according to the report.

“Cancer and infectious disease lead growth,” said Bruce Carlson, Publisher of Kalorama Information. “But we are closely watching the infectious disease categories in the wake of PAMA cuts and European lab consolidation and payment slowdowns.”

Nevertheless, the market for IVD products is in good shape overall, according to the report. The market improved generally since the last edition of Kalorama's worldwide in vitro diagnostics report.

  • Discovery and proof of biomarkers continue to drive new test development.
  • Diagnostics that can save long-term costs of treatment, limit infection or reduce hospital stays are popular.
  • Reimbursement continues to be favorable for some testing, though not all. Tests that can prove their value thrive.
  • There is no shortage of innovation and industry spending on R&D has been robust.
  • Increased private insurance and growth of middle class in emerging countries.

The next five to ten years or so will see moderate and gradual change in IVD product markets. IVD manufacturers can expect:

  • Modest IVD growth in developed countries, much faster growth in developing countries.
  • In developing countries, a simultaneous shift from preoccupation with infectious diseases to chronic conditions, worldwide. The prevalence of cancer, cardiac, and autoimmune diseases has increased.
  • Increased privatization of healthcare services throughout the world, developed and emerging economies included and thus increased pricing pressure on all devices including IVDs.
  • Increased demand from an increasing middle class in Brazil, India and China that is supported by the availability of healthcare insurance programs.

International initiatives such as the Clinton Foundation and the Gates Foundation have begun to develop testing and treatment programs for infectious diseases—TB, HIV, malaria, and sexually transmissible diseases. This has created a market for test devices to diagnose and monitor treatment efficacy of these diseases and other infectious diseases.

Infectious diseases are a category to watch in IVD, said Carlson. “Chagas, dengue, chikungunya and other emerging infectious diseases, along with the well-known Ebola and Zika virus have brought a reality that tropical infectious diseases know no borders.”

But these aren’t the only areas where testing is set to grow.

“Every time you hear about a significant health issue in the United States or worldwide, it’s likely that testing has a role,” Carlson said. “Substance abuse and opioids? Testing is helping there. Over prescription of antibiotics? Testing is helping there. Reducing hospital stays? There again, testing can aid.”

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.

Please link any media or news references to our reports or data to https://www.kaloramainformation.com/.

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