The FDA approvals of Roche Holdings’ RHHBY Hemlibra or Cobas Cdiff Nucleic acid test and Thermo Fisher Scientific’s TMO slew of advancements in next-generation sequencing (the latest one being the FDA approved Oncomine Dx Target Test) clearly point toward the rapid emergence of in vitro diagnostics (IVD) in the MedTech space.
The recent EvaluateMedTech World Preview indicates that while worldwide MedTech sales are expected to witness CAGR of 5.1% to $522 billion by 2022, steering ahead of cardiology, IVD will rake in annual sales of $69.6 billion at a CAGR of 5.9%.
The above data is just a small indicator of the vast scope for growth of the IVD market. For investors keen on MedTech, the most important fact is that IVD’s benefits are not limited to any particular country or geographic territory. With the emergence of complex and transmittable diseases worldwide, this part of the MedTech space is currently in the spotlight.
IVD in a Nutshell
If we go by FDA’s definition, in vitro diagnostics are, “tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.”
Rapid occurrence of infectious diseases worldwide, increasing burden of killer bugs like cancer, cardiovascular diseases, stroke and other heart diseases, and diabetes in developing and developed nations as well as growing cognizance of early cancer screening, detection, and prevention have made IVD indispensable in the healthcare space.
Growing investment from both government and private players in the form of reimbursement coverage and speedy patent approvals are also driving demand.
These apart, per a report by Research and Markets, increasing geriatric population, rising per capita GDP and per capita healthcare expenditure are acting as major growth catalysts. Per the report, owing to suitable demographical changes and rising disposable income coupled with improving basic infrastructure, developing regions are gradually becoming happy hunting grounds for this business.
So far, North America has the lead in the in vitro diagnostic market. Per Coherent Markets Insights’ data, it is the highest contributing region with projected market share of 46.7% by 2024 (at CAGR of 5.4% between 2016 and 2024). Favorable demography and regulatory policies along with increasing healthcare spending have aided growth of the IVD business in this geography.
However, increasing instances of lifestyle oriented diseases, improving government funding and growing awareness of new technologies have fueled demand for IVD in emerging economies.
According to a recent report by Research and Market, China is the fastest growing among the top 10 IVD country markets. It is likely to expand more than threefold by 2022 from 2016.
On the other hand, the revenue of the Indian IVD market has grown at a CAGR of 20% having increased from $0.64 billion in 2012 to $1.6 billion in 2017 (data by Goldstein Research).
Per a MedGadget report, apart from geographic distribution, the global in vitro diagnostic market has been segmented on the basis of application, type, end user and usability. Application wise, diabetes, infectious diseases, oncology, nephrology, autoimmune diseases and cardiology are generating huge revenues across the globe.
From the point of view of end user, hospitals, laboratory, point of care testing are the leading users. In terms of usability, disposable IVD devices and re-usable IVD devices are widely used across the globe.
Roche remains the top player in the IVD market with expected sales of $12.8 billion in 2022. Key IVD developments at Roche include the Cobas range of tests, the latest one being Cobas Zika (the first commercially available test for the detection of the Zika virus RNA in samples of human plasma).
On the other hand, Abbott’s ABT recent acquisition of Alere should establish the company as the global leader in point-of-care testing, the fastest-growing segment of in vitro diagnostics market. In this regard, the company noted that, point-of-care testing is a $7 billion segment of the in vitro diagnostics market and is growing rapidly.
Among the other bigwigs, Becton Dickinson & Company BDX deserves a mention. The company is striving to get approval for the commercialization of its innovative products in the fast-growing infectious diseases testing market. Its BD Diagnostics provides products for the safe collection and transport of diagnostics specimens, as well as instruments and reagent systems to detect a broad range of infectious diseases, healthcare-associated infections and cancer.
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