In-vitro diagnostics is a type of medical test to help detect and diagnose diseases or infections and determine a course of treatment, under a controlled environment such as a laboratory. The tests may be conducted on either urine, blood or a human body tissue. Patients undergoing these tests may either receive or decline further medical care, thus making the reliability of these tests extremely crucial.
The speed of results generated plays a significant role in selecting a diagnostic tool/technique. Rapid diagnostic tests such as cartridge based molecular technology helps deliver TB diagnosis results in less than two hours and thereby help in early detection, better control and limit the prevalence of a disease in a region or country. Innovations in the market have seen the technology being moved to Point-of-Care settings. In today’s technology-driven world, use of MEMS and micro-fluidics has resulted in LoC (lab-on-chip) designs, which are fully automated and miniaturized.
The global In-Vitro Diagnostics market is expected to grow based on the following factors:
There is an increase in demand for non-invasive medical procedures and high prevalence of chronic and infectious diseases such as tuberculosis (TB), cardiovascular diseases, cancer and diabetes.
Rise in number of patients who succumb to infectious diseases such as sexually transmitted diseases (STD), respiratory and gastrointestinal diseases, etc. has made early diagnosis and regular monitoring for these patients essential, to help identify, treat and control their spread. This is expected to serve as one of the drivers to the market.
In-Vitro Diagnostics plays a significant role in diagnosis of other infectious disease such as HIV which has a high global prevalence, and thus is expected to drive the market.
Increase in number of patients affected by non-communicable diseases including cardiovascular disease and diabetes is also expected to have a positive impact on the market growth.
The In-Vitro Diagnostics market in Western Europe is expected to grow on account of rise of disease such as cancer.
Key products include tissue diagnostics, professional diagnostics, molecular diagnostics, and diabetes monitoring. Growth in professional diagnostics segment including immunoassays, coagulation test, clinical chemistry etc. is spurred by factors such as the ability to get speedy and reliable diagnostic results and unmet medical needs. Increased number of people suffering from diabetes is expected to serve as a market opportunity for diabetes diagnostic tests. In light of lab automation and increased rate of cancer patients, demand for tissue diagnostics is expected to continue increasing over the forecast period.
North America dominates the market and the ubiquity of chronic disorders in this region has accentuated the need for more accurate and cost-effective diagnostic techniques. Europe is a close second, with the UK, Germany, Spain, France and Italy being the major markets. The health care system in most of the European regions, especially Western Europe takes assistance of government funds.
As a result of budgetary pressure, there has been a cut in healthcare per capita expenditure. Furthermore, prevalence of chronic disorders and aging population are two significant reasons that will impact demand of IVD products and technology in Europe. Also, manufacturing of disposable LoC cartridges must be done at a high volume, which creates unique challenges for the manufacturers.
The In-Vitro Diagnostics market comprises various small and large industry players that provide In-Vitro Diagnostics solutions. A few major market players include:
Johnson and Johnson
Beckman Coulter Inc.
Some of the recent developments that the In-Vitro Diagnostics market has seen include:
In March 2019, Luxia Scientific, a biotech organization from France, announced its exclusive distribution agreement with Life Genomics to commercialize ‘1test1™’ in the Nordic region. The test had been launched earlier in France in October 2018 and in Luxembourg in November 2018. The ‘1test1™’ is an In-Vitro Diagnostics test, which analyses bacterial content of gut microbiome. Life Genomics will be exclusively distributing this test in its home country of Sweden, as well as in Finland, Norway, Iceland and Denmark.
In September 2018, OptraSCAN, the California-based end-to-end digital pathology solution provider announced that their whole-slide scanners have been the recipients of the CE mark approval for European standards applicable to the “In-Vitro Diagnostics Directive (IVDD)” 98/79/EC for use in IVD. This will allow OptraSCAN’s scanners to be sold in EU affiliated countries that recognize the CE mark. The development would help European pathologists adopt Digital Pathology for their needs.
In January 2018, Roche announced its partnership with GE regarding the development of an integrated digital diagnostics platform aimed at improving oncology and critical care treatment. The partnership allows convenient analysis of data, both in-vivo and in-vitro, as well as patient records, real time monitoring, as well as the latest research outcomes, which will enable clinicians to provide the best possible treatment and care for the patients.
In October 2017, the US FDA approved the Roche’s ‘cobas Zika test’ as the first commercially available donor screening test for the Zika virus. The test would be used on the cobas 6800/8800 Systems. The test expands Roche’s donor screening portfolio for blood-borne diseases further. The test had first been deployed in Puerto Rico in April 2016 to screen the collected blood donations.
In-depth report on global in-vitro diagnostics (IVD) market by Grand View Research:
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