Laboratory Developed Test Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Clinical Biochemistry, Critical Care, Hematology, Microbiology, Molecular Diagnostics, Immunology, and Others) and Application (Academic Institutes, Clinical Research Organizations, Hospitals Laboratory, Specialty Diagnostic Centers, and Others)
Publication Month: Aug 2021 |
Report Code: TIPRE00019603
| No. of Pages: 183
| Category: Medical Device
| Status: Published
The laboratory developed test 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.
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.
Lucrative Regions in Laboratory Developed Test Market
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Market Insights
Continuous Research on Personalized Medicines Provides Growth Opportunities to Laboratory Developed Test Market Players
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.
Type-Based Insights
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.
Laboratory Developed Test Market by Type – 2021 and 2028
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Application-Based Insights
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.
Strategic Insights
Report Coverage - Laboratory Developed Test Market
Report Coverage
Details
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
Forecast Period
2021-2028
Base Year
2021
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
Free Sample Copy Available
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.
The report segments laboratory developed test market as follows
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).
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.
The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, large number of product launches. However, changing regulatory landscape for instance, 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 is a great concern to hinder the market growth. In August 2021, eMed, a telehealth company democratizing healthcare through digital-point-of-care solutions, and Quest Diagnostics the world's leading provider of diagnostic information services, are collaborated to bring clinician-guided rapid antigen testing for COVID-19 to employers seeking to foster safer environments by decreasing the risk of COVID-19 exposure in their workplaces which is contributing to the growth of the target market. Such strategic steps are also projected to drive the market growth.
The growth of the region is attributed to factors such as rising public–private partnerships, and increasing funding activities are widely enhancing the performance of medical devices. Moreover, presence of well-developed healthcare infrastructure and government support are some of the prominent factors propelling the market growth in Asia Pacific. In Asia Pacific, India is the largest market for laboratory developed test. The market growth in Asia Pacific is mainly attributed to factors such as the growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, large number of product launches. However concerns high capital investment for setting up advanced labs hinders the market growth in Asia Pacific.
The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under huge pressure to manage increasing test volumes and conduct more complex diagnostic assays, which further underlines the need for flexible automation systems. Many MedTech companies are offering automation solutions to help streamline clinical laboratory processes. For instance, Roche Cobas Omni–Utility Channel is beneficial for both IVD assays and high-volume LDTs. It is designed to meet the growing needs of efficient workflows in laboratories, as it can assist in different stages ranging from sample processing to quick data interpretation. It can run up to 96 results in about 3 hours and up to 864 results in 8 hours, thereby boosting the efficiency of laboratories.
The laboratory developed test market is led by type molecular diagnostics segment is growing significantly due to the increasing attention to the development of genetic therapeutics. The growing research in human genomics is playing a vital role in developing laboratory developed tests. The technological advantages of molecular tests make them compelling diagnostic tools, and they have become valuable for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS).
The List of Companies - Laboratory Developed Test Market
Quest Diagnostics Incorporated
F. HOFFMANN-LA ROCHE LTD.,
QIAGEN
Illumina, Inc.,
Eurofins Scientific
Biodesix
Adaptive Biotechnologies
Biotheranostics
Rosetta Genomics Ltd.,
Guardant Health
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