ROCKVILLE, Md., Nov. 29, 2016 /PRNewswire/ -- The recent election could make the next few years uncertain for funding of services that drive in vitro diagnostic sales, Kalorama Information says, but might also remove anticipated increases in regulation on some test products. The healthcare market research firm with a specialty in biotech and IVD said that dismantling the Affordable Care Act (ACA) will be a legislative priority of the new regime, but since which provisions will be kept is not known, the impact on the industry is an open question. The impact of the incoming administration's policies on the newly insured is the scope and priorities of government-funded research will determine how the prevention-focused IVD industry will fare. Kalorama Information's report on the domestic in vitro diagnostics industry, The United States Market for In Vitro Diagnostic Tests, can be found at: https://www.kaloramainformation.com/United-States-Vitro-10133262/
The most fundamental concern for IVD companies and other healthcare suppliers would be the decline of healthcare utilization in the United States if there are coverage losses. Spending on core lab systems and consumables demonstrably rose among clinical laboratories between 2013 and 2015 in anticipation of ACA implementation. Positive effects on core lab test demand or the volume of tests ordered as part of routine care and treatment episodes would dissipate or disappear if substantial numbers of Americans lose insurance.
"Shedding all or the majority of over 20 million Americans newly insured through the ACA is unlikely, but providers and industry suppliers should be prepared for reduced healthcare utilization if national coverage dips," said Emil Salazar, analyst for Kalorama Information, in a recent blog post. "Slashing of medical research budgets is likewise doubtful, but high-profile initiatives such as the Cancer Moonshot remain vulnerable amid possible reductions or freezing in discretionary federal spending."
The new administration's steps are far from decided at this stage. President elect-Trump has voiced opposition to the individual mandate but has publicly voiced support for provisions that guarantee eligibility to patients with pre-existing conditions and allow children under 26 years old to remain on their parents' insurance. The fate of preventative care service provisions of the ACA, including the obligation of insurers to pay for USPSTF-recommended services without copay, is uncertain at this time. The inclusion of services has been a boon to certain in vitro diagnostic (IVD) markets and suppliers as higher patient volumes and more routine care boosted demand for select screening tests.
Kalorama Information notes that the implications of a Trump presidency also relate to product regulation. Deregulation has been promised broadly by President-elect Trump, but where and to what extent it materializes is not yet clear. There have been indications that he could loosen or streamline approval processes under the Food and Drug Administration (FDA) for new drugs and devices. In a Trump Presidency, the FDA may also be inhibited from its current track in seeking oversight over laboratory developed tests (LDTs).
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.
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