The laboratory developed test market is expected to grow from US$ 4,524.75 million in 2021 at a CAGR of 7.0% during the forecast period 2021 - 2028, to reach US$ 7,269.3 million by 2028.

The growth of the laboratory developed test market is mainly attributed to factors such 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.

Laboratory developed tests (LDTs) are designed for the early and precise diagnosis of diseases and monitoring the progress of patient treatment. These tests further assist healthcare providers to provide accurate guidance. They can be developed quickly and modified to meet the unique needs of patients. Cancer is one of the leading causes of death worldwide. As per the WHO estimates, cancer was a cause of ~9.6 million deaths in 2018. Clinical diagnostics helps in detecting early signs and risk factors, paving way for early intervention. The LDTs have a decisive impact on each step of diagnosis, from screening to the prevention of certain diseases and early diagnosis at the onset of illness. For instance, the Oncotype DX lab test is used to determine if chemotherapy would benefit patients with early-stage breast cancer. It also helps evaluate the likelihood of disease recurrence; for this, the test is performed on a small tissue sample removed during breast cancer surgery. In addition, the increasing incidence of genetic disorders is also driving the demand for LDTs. According to the March of Dimes report, globally, ~7.9 million births occur with severe birth defects every year. A large number of LDTs are available for genetic testing owing to a lack of availability of genetic tests in the market. As per the Association for Molecular Pathology 2018 assessment, ~70,000 genetic tests are available in the medical market, and most of these are LDTs. Therefore, the rising incidence of cancer and growing awareness regarding the importance of early diagnostics are boosting the adoption of LDTs.

The laboratory developed test market is segmented into type and application. 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. Based on application, the laboratory developed test market is segmented into academic institutes, clinical research organizations, hospitals laboratories, specialty diagnostic centers, and others. The hospitals laboratories segment is expected 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.

A few of the major primary and secondary sources referred to while preparing the report on laboratory developed test market are the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and the US Food and Drug Administration (USFDA), and Laboratory Information Management Systems (LIMS).