According to our new research study on “Laboratory Developed Test Market Forecast to 2028 – COVID-19 Impact and Global Analysis – by Type and Application,” the market is expected to reach US$ 7,269.3 million by 2028 from US$ 4,524.75 million in 2021; it is expected to grow at a CAGR of 7.0% during 2021–2028. The report highlights trends prevailing in the market and factors driving its growth. The market growth is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, and large number of product launches. However, changing regulatory landscape is hindering the market growth. For example, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry, which is a great concern for the market players.
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Top Companies Synopsis- Quest Diagnostics Incorporated; F. HOFFMANN-LA ROCHE LTD; QIAGEN; Illumina, Inc; Eurofins Scientific; Biodesix; Adaptive Biotechnologies; Biotheranostics; Rosetta Genomics Ltd and Guardant Health are among the leading companies in the laboratory developed test market.
LDTs are developed and used within laboratories and are not distributed or sold to other laboratories or healthcare facilities. These tests are developed to overcome the challenge of the unavailability of commercial tests. Many LDTs are genetic tests developed for rare diseases. Thus, the frequency of development and introduction of new LDTs is high. In November 2020, Aditx Therapeutics, Inc received a CLIA certification for AditxtScore laboratory operations for immune monitoring, which allowed it to launch AditxtScore test for the diagnosis of COVID-19. The increasing emergence of SARS-CoV-2 variants has highlighted the need to identify, trace, and track mutations across the complete viral genome. In January 2021, Eurofins launched the NovaType test for detecting and monitoring new variants of SARS-CoV-2. This RT-PCR assay is clinically validated for identifying B.1.1.7 and B.1.351 variants with a short turnaround time. NovaType is already available as an LDT in Germany, and it will be made available in over 50 Eurofins laboratories worldwide for testing patients for COVID-19.
Further, increasing research on the development of LDTs to detect cancer and autoimmune diseases is driving the market growth. In August 2021, Immunovia AB received final approval to use the IMMray PanCan-d test on patients; it is an LDT that will be the first blood test dedicated to the early detection of pancreatic cancer. The company received a CLIA Certificate of Registration in June 2021. As a result, Immunovia, Inc. can begin selling the IMMrayTM in the US, exclusively through its laboratories.
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Asia Pacific held the largest share of the laboratory developed test market in 2021, while India is the largest shareholder in the regional market. The market growth in Asia Pacific is mainly attributed to factors such the advancements in medical industry led to the development of advanced methods in diagnosis systems with the highest accuracy and safety, low energy consumption and cost derive the demand for laboratory developed test market. However, changing regulatory landscape is a great concern to hinder the market growth in Asia-Pacific.
The laboratory developed test market, by type, is segmented into clinical biochemistry, critical care, hematology, microbiology, molecular diagnostics, immunology, and others. Based on Application, the laboratory developed test market is segmented into academic institutes, clinical research organizations, hospitals laboratory, specialty diagnostic centers, and others. On the basis of geography, the laboratory developed test market is segmented into North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (the UAE, Saudi Arabia, South Africa, and Rest of the Middle East & Africa), and South and Central America (Brazil, Argentina, and the Rest of South and Central America).
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