The global laboratory-developed tests market is projected to generate USD 16,539.9 million revenue by 2030, advancing at a CAGR of 7.2% during 2024–2030. The growth is attributed to the rising incidence of cancer and genetic disorders and large number of product launches. Additionally, the rising awareness about the early and precise diagnosis of diseases and monitoring the progress of patients undergoing treatment drive the market. Moreover, the growth in the healthcare infrastructure and penetration of new technology are other significant factors behind market growth.
At the root of all, the rising prevalence of chronic disease and growing adoption of laboratory-developed tests for their detection drives the market. According to a report of the WHO published in September 2022, non-communicable diseases kill 41 million people each year, equivalent to 74% of all deaths globally. LDTs have a decisive impact on each step of diagnosis, from screening to the prevention of certain diseases, as well as early diagnosis at the onset of the illness.
On the basis of end user, the specialty diagnostic centers category accounted for the largest market share, of 45%, in 2023, and it is expected to maintain its dominance in the future. This is owing to the rising prevalence of chronic disease and a surging volume of their diagnoses. Additionally, the availability of expansive infrastructure and facilities for carrying out laboratory investigations utilizing advanced technologies in most countries propels this category.
Moreover, the presence of adequate and skilled personnel and cutting-edge instruments for the detection of such diseases at specialty diagnostic centers makes this category the strongest in this market. The use of laboratory-developed tests in specialty diagnostic centers provides high-quality healthcare to patients by offering accurate, specific, and reliable information about their health or disease condition.
The clinical research organizations category is expected to witness considerable growth during the forecast time frame due to the growing trend of outsourcing the tests. The expansion of the CRO industry is also being fueled by outsourcing firms’ use of innovative strategies to reduce healthcare expenses and the improvement in the quality of service offered by them.
Laboratory-developed tests are extensively used by clinical research organizations for the detection and identification of biomarkers associated with diseases. This helps identify new drug targets and improve the understanding of disease pathology. Moreover, it supports in the assessment of the safety and efficacy of new molecules before marketing approvals for them are applied for with regulatory authorities.
Moreover, in academic institutes laboratories, LDTs are routinely established as samples are obtained from clinics and medical facilities are spread over large geographic areas or networks. Moreover, with the high expenses of gaining premarket approvals and the limited financial motivation for IVD procedures to create tests for rare diseases, these laboratories design their own tests, which may be administered there itself, to address unmet clinical needs.
In APAC, the laboratory-developed tests market is expected to witness lucrative growth in the coming years owing to the increasing scientific research, unmet medical needs, and economic growth. Moreover, the region has a high prevalence of cancer and other genetic diseases, for which early diagnosis is required. This, in turn, propels the demand for novel products for early and effective diagnoses. Moreover, the region has an enhancing healthcare infrastructure and a reimbursement policy that provides a better coverage for LDT.
Some of the major market players are Quest Diagnostics Incorporated, Abbott Laboratories, Illumina Inc., F. Hoffmann-La Roche Ltd., Siemens AG, Bio-Rad Laboratories Inc., NeoGenomics Laboratories Inc., Guardant Health Inc., Becton, Dickinson and Company, and QIAGEN N.V.