In Vitro Diagnostics
The process of testing and analyzing human samples, such as blood or tissue to diagnose infections and health conditions is called in vitro diagnostics (IVDs). The purpose of IVD tests is to assess the health status of a patient. These tests are performed outside of the body. Checking blood for signs of infections, tests for infectious disease, such as HIV or hepatitis, cholesterol, anaemia and for various genetic diseases or conditions are common uses of IVDs.
Federal agencies involved in the regulation of IVDs in the USA include the Food and Drug Administration and the Centers for Medicare & Medicaid Services. Roche Diagnostics Limited, Abbott Laboratories, Inc. and Siemens Healthcare are some of the major players in the in vitro market.
Key Market Segments
IVDs of the types mentioned below are used in health care in numerous ways and at various points.
Clinical laboratory testing: These tests are generally prescribed by the physician. The information obtained assists in the evaluation of overall health, in disease diagnosis and in the establishment of appropriate treatment. Clinical laboratory tests influence approximately 70% of healthcare decisions.
Point-of-care diagnostics: This kind of test is carried out by healthcare professionals, such as doctors, nurses or paramedics. These tests do not require specialist laboratory facilities and can normally deliver results very quickly. This type of testing is used for providing insights for a preliminary diagnosis or for managing patient conditions.
Self-testing: These tests are designed for patients or individuals to use themselves. They do not require any specialist facilities, and the user can usually interpret the information. The most familiar are bloodsugar tests for managing diabetes and home pregnancy tests, but a variety of other tests is becoming widely available. HIV self-testing is increasingly being sought and offered globally.
Regional Market Shares
Increasing emphasis on the early detection of diseases and infections is likely to drive the global demand for IVDs to about $75 billion by 2020. The USA, Europe and Asia account for the largest share of the IVD market.
The USA is one of the largest markets for IVDs in the world, with a market value of more than $24 billion. Professional point-of-care diagnostics is the largest segment in the USA. Population aging and expansion of the insured population resulting from the Affordable Care Act are likely to drive growth of the US IVD market to more than $28 billion in the near future.
The healthcare system in most of Europe depends on government funding. As a result the IVD market in Europe has recently witnessed slow growth as governments have cut costs. Increasing incidence of serious diseases has, however, driven up the market; the European market for cancer IVD, for instance, was worth more than $1.5 billion in 2015.
Asia’s IVD market is estimated to be worth more than $17 billion. Corporate firms offering annual health checks for their employees and insurance companies conducting pre-insurance policy checks are fuelling the industry. Increasing levels of chronic diseases, patient awareness, patient self testing and significant urban populations are driving the uptake of various IVD tests and creating opportunities for market expansion.
Some of the key trends driving the global IVDs business include:
Molecular diagnostics (MD) are growing in the advanced economies and are addressing critical unmet needs in healthcare, enabling early disease detection. MD is a technique that analyses bio markers such as specific cells, molecules, or genes, gene products, enzymes or hormones in blood or tissue that indicate the state of a body’s organs. Molecular tests used for oncology and critical care infectious diseases are seeing robust growth at present.
Growing interest in personalized medicine that uses genetic profiling to adapt medical care to an individual’s needs is also driving this market. All these factors are paving the way for the substitution of high-value molecular tests for the conventional low cost tests. As these tests provide critical information more quickly and accurately, they are already significant markets in the USA and Europe but in the next five years this industry is expected to spread in the emerging countries driving the global market to over $8 billion by 2020.
Lab-on-a-chip (LOC), a niche technology, is changing the field of diagnostics. LOC devices integrate and reduce laboratory functions and processes to a miniaturized chip format. They are being used primarily for point-of-care in-vitro diagnostic testing. Much of this health technology is rapidly becoming available through health-tracking platforms such as Google Fit and HealthKit, allowing connected devices to track health status such as blood pressure and heart rate.
List of Associations
- British In Vitro Diagnostics Association
- European Diagnostic Manufacturers Association
- Association of Medical Diagnostics Manufacturers
- Society of Diagnostic Medical Sonography
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