Publication Month: Aug 2021 | Report Code: TIPRE00019603 | No. of Pages: 183 | Category: Medical Device | Status: Published
A laboratory developed test (LDT) is a type of in vitro diagnostic test designed and used within a single laboratory. These tests can be used to estimate or distinguish an analytes such as proteins, biomolecules/compounds (glucose, cholesterol, etc.), and DNA extracted from specimens collected from human subjects. The expansion of automated in vitro diagnostics (IVD) methods for laboratories and dispensaries to render precise and error-free analysis is fueling the laboratory developed test market growth.
The growth of the laboratory developed test market 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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LDTs play a vital role in the development of personalized medicines that are likely to prove as promising means of tackling diseases through far eluded effective treatments or cures. As per the Personalized Medicine Coalition, personalized medicines accounted for only 5% of the new FDA-approved molecular entities in 2005; however, in 2016, this number rose to more than 25%. Additionally, 42% of all compounds and 73% of oncology compounds in the pipeline have the potential to serve as personalized medicines. Biopharmaceutical companies have nearly doubled their R&D investments in personalized drugs in the last five years, and they are further expected to increase their investments by 33% in the next five years. Biopharmaceutical researchers also predict a 69% increase in the development of personalized medicines in the next five years. Laboratory tests are used to diagnose illness and predict and monitor drug response as well as to obtain informatics data needed for complex predictive algorithms.
Personalized medicines are becoming the trademark of cancer treatment; it is a constantly evolving approach that is based on the customization of treatments as per the individual genetic makeup. In 2019, the FDA approved 12 personalized medications to investigate and address the root causes of disease, thus combining precision medicine in clinical care. The rising demand for personalized medicine is offering significant growth opportunities for the growth of the players operating in the laboratory developed test market.
The laboratory developed test market, by type, is segmented into clinical biochemistry, critical care, hematology, microbiology, molecular diagnostics, immunology, and others. The molecular diagnostics segment is expected to hold the largest share of the market in 2021. However, the hematology segment is anticipated to register the highest CAGR in the market during the forecast period.
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By application, the laboratory developed test market application into academic institutes, clinical research organizations, hospitals laboratory, specialty diagnostic centers, and others. The hospitals laboratory segment is estimated to account for the largest market share in 2021. However, the specialty diagnostic centers segment is anticipated to register the highest CAGR in the market during the forecast period.
|Market Size Value in||US$ 4,524.75 Million in 2021|
|Market Size Value by||US$ 7,269.3 Million by 2028|
|Growth rate||CAGR of 7.0% from 2021-2028|
|No. of Pages||183|
|No. of Tables||86|
|No. of Charts & Figures||77|
|Historical data available||Yes|
|Segments covered||Type and Application|
|Regional scope||North America, Europe, Asia Pacific, Middle East & Africa, South & Central America|
|Country scope||US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina|
|Report coverage||Revenue forecast, company ranking, competitive landscape, growth factors, and trends|
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Product launches and approvals are commonly adopted strategies by companies to expand their global footprints and product portfolios. Moreover, the laboratory developed test market players focus on the partnership strategy to enlarge their clientele, which, in turn, permits them to maintain their brand name globally.
Based on type, the laboratory developed test market 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).
The List of Companies - Laboratory Developed Test Market