In-Vitro Diagnostics Tests Overview
According to WHO, In-Vitro Diagnostic tests are used for in vitro examination of specimens procured from the human body so as to provide information for medical screening, detection, or treatment supervision procedures. IVDs are important to boost health outcomes and are crucial tools both in everyday medical procedures and in case of an emergency.
The COVID-19 pandemic is one of the biggest challenges ever faced by humanity and is officially declared as a global health emergency by WHO on January 30, 2020. After it’s origination in Wuhan, China by the end of December 2019, the virus has spread across the globe like a catastrophe. The virus is anticipated to severely impact the political, economic, and socio-economic landscape of countries.
The health care sector is deeply stressed owing to the extensive need to escalate the number of tests daily as per the recommendation by regulatory bodies such as the U.S. FDA and WHO.
Market Size and Forecast
The in-vitro diagnostics test market is expected to attain a notable CAGR during the forecast period, i.e., 2020-2028. The market is segmented by product type, technique, application, usability, end-user, and region. The global need for in-vitro diagnostics testing kits to contain the COVID 19 pandemic has generated significant growth opportunities in the global market owing to the rise in confirmed cases that are going beyond the control and increasing supply chain bottlenecks as there is a major shortage of these test kits all across the globe.
Rising cases of novel coronavirus around the world to boost market growth
With large scale transmission of the virus around the globe, the novel coronavirus has shined a spotlight on the diagnostics market especially Point-Of-Care (POC) Diagnostics market and Molecular Diagnostics market. Various pharmaceutical and biotechnology companies are collaborating to escalate the production of coronavirus testing kits all around the globe to ease the testing shortages.
The presently utilized Molecular Diagnostic reference tests are built upon real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) technology which is known for high sensitivity and specificity. However, other technologies such as Antibody Detection and CRISPR, cutting-edge technology are also observing remarkable breakthrough developments in the diagnosis of this life-threatening virus. These factors attributed to the global rise in the in-vitro diagnostics test kits which is significantly boosting the overall market growth.
GenMark Diagnostics, a leading market player in this industry, preannounced its first-quarter revenue of about $38.7 million, showcasing an increase of around 80% over the first quarter of 2019. The FDA, on March 18, 2020, granted an Emergency Use Authorization for GenMark's ePlex SARS-CoV-2 test.
Additionally, rapidly improving healthcare facilities, an increase in government initiatives, and rising incidence of infections such as HIV, HPV, and hepatitis, and rising cases of chronic diseases have driven the demand for in-vitro diagnostics tests globally. CLICK TO DOWNLOAD FREE SAMPLE REPORT
Likelihood of inaccuracy in results
There have been many cases where the results were false-negative and false-positive which could be fatal for someone’s mental and physical health.
On April 27, 2020, The Indian Council of Medical Research (ICMR), commanded states to stop the usage of rapid antibody test kits that were purchased from China-based Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics after they revealed broad variations in results.
Additionally, strict & time-consuming approval policies by government and low awareness about in-vitro diagnostics tests are anticipated to restrain the market growth.
Our-in depth analysis of the global in-vitro diagnostics market includes the following segments:
By Product Type
Geographically, the in-vitro diagnostics tests market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region.
North America is anticipated to dominate the overall market during the forecast period owing to ongoing commercialization of inventive diagnostic products, helpful government policies and their stress on novel product development, the presence of key players in the region, increasing prevalence of chronic diseases, well established diagnostic infrastructure, and technological advancements in the area of in-vitro diagnostics.
Currently, owing to the dreadful outbreak of COVID 19 pandemic across Europe, the in-vitro diagnostics test market is expected to rise exponentially over the next few years. Furthermore, growth in cancer disease patients, technological advancements, and a rapidly aging population are some of the other key factors contributing towards the market growth in European regions.
The number of positive cases for COVID-19 is very high in North America and Europe. According to the WHO, Europe remains at the center of the pandemic. There’s a continuous escalation in new confirmed cases in the European Region. Further, Europe was the first region to develop RT-PCR based coronavirus testing kits.
The Asia-Pacific region provides lucrative opportunities for the key players operating in the market owing to a rise in disposable incomes, increasing investment by the government, and a large patient pool. On account of these factors, the Asia-Pacific region is expected to witness the fastest growth in the forecast period.
Furthermore, a huge pool of patients with unmet medical needs and soaring investments in research and development of healthcare industry in the developing economies such as India, China, and Brazil, support the growth of the in-vitro diagnostics test market.
Changing medical management in the Latin American and African economies will boost the future market growth of the in-vitro diagnostics test. The current situation of the COVID-19 pandemic has helped in raising awareness around these tests.
Health Policy Watch: In South Africa, testing for COVID 19 is still low as against the rest of the globe. In Latin America, Chile has enhanced its testing five-fold for a cumulative total of 1209 tests per million; followed by Costa Rica, which has doubled its testing range to 600 tests per million.
The in-vitro diagnostics test market is further classified based on region as follows:
Top Featured Companies Dominating the Market
Some of the affluent industry leaders in the global in-vitro diagnostics test market are Abbott Laboratories, Mylab Discovery Solutions Pvt. Ltd. Becton, Dickinson and Company, Quidel Corp, BioMérieux SA, Bio-Rad Laboratories, Inc.; F. Hoffmann-La Roche Ltd., QIAGEN, Hologic, Inc., Sysmex Corporation, and Thermo Fisher Scientific, Inc.
Major players such as Thermo Fisher Scientific, Abbott Laboratories, Hologic, Quidel Corp, and Roche Diagnostics have now all granted Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for their COVID-19 diagnostic assays. Henceforth, they are in the process of bolstering their production to help ease testing shortages.
Roche was the first commercial test maker company to receive the FDA’s Emergency Use Authorization and it has started shipping around 400K testing kits to the US weekly.
Thermo Fisher Scientific began shipping their COVID-19 testing kits in mid of March and are seeking to produce five million tests per week by April.
Abbott Laboratories, in March 2020, launched a small and movable COVID-19 test kit, which can detect the virus in just five minutes and can be used in almost any health-care setting.
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