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.
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.
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Some of the Prominent/Emerging Players in Laboratory Developed Test Market:
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.
Key Questions regarding Current Laboratory Developed Test Market Landscape
- What are the current options for Laboratory Developed Test Market?
- How many companies are developing for the Laboratory Developed Test Market?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Laboratory Developed Test market?
- Which are the dormant and discontinued products and the reasons for the same?
- What is the unmet need for current Laboratory Developed Test Market?
- What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Laboratory Developed Test?
- What are the critical designations that have been granted for Laboratory Developed Test Market?
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.
Based on type, the laboratory developed test market is segmented into clinical biochemistry, critical care, hematology, microbiology, molecular diagnostics, immunology, and others. The molecular diagnostics segment is expected to held 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. The rapid growth of the market for molecular diagnostics is ascribed to the increasing attention toward the development of genetic therapeutics and growing research in human genomics. Technological advantages in molecular tests make them valuable diagnostic tools for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS). It is designed to enable clinical laboratories to develop sequencing-based laboratory developed tests in a quick, simple, and efficient manner.
Impact of COVID-19 Pandemic on Laboratory Developed Test Market:
The COVID-19 pandemic is adversely affecting industries worldwide. The outbreak led to significant disruptions in primary industries such as manufacturing, healthcare, energy & power, electronics & semiconductor, aerospace & defense, and construction in 2020. However, it provided a vital growth opportunity to the laboratory developed test market players. The market experienced exponential growth in demand for PCR-based COVID-19 test kits. The government of many countries is working towards scaling up testing capacity, which is further driving the laboratory developed test market. Many market players have launched products to meet the growing demand. For instance, in August 2020, to address the COVID-19 testing shortage, the US Department of Health and Human Services (HHS) made a statement that effectively rescinded the FDA guidance requiring clinical labs to seek an emergency use authorization (EUA) or submit data to the FDA in conjunction with offering laboratory-developed tests (LDTs).
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