Clinical Diagnostic

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Increasing patient awareness and rising demand for high quality care have made it imperative for healthcare providers to develop targeted therapies through specific and sensitive diagnostic tests. Clinical diagnostic tests are used to diagnose a medical condition, provide information about the patient’s health, or monitor a course of disease and assess the patient’s response to treatments. Various techniques of clinical diagnostic testing include blood gas testing, clinical chemistry, immunoassay, coagulation testing, hematology, polymerase chain reaction (PCR), and staining method.

Typically, clinical diagnostic tests involve use of antibody-based techniques for recognizing proteins or disease markers. However, these immunoassays cannot identify all biomarkers in one test and are prone to false-positive and false-negative results. Therefore, there is growing demand for more accurate, efficient, and reliable technologies. This has led to development of alternative testing methods such as LC-MS and GC-MS. However, high initial capital investment and lack of skilled labor is deterring adoption of advance testing devices. Major instruments used in clinical diagnostics include immunoassay analyzer, HPLC system, chemical analyzer, mass spectrometer (MS), LC-MS, and GC-MS. The use of reagents has simplified the testing practice and workflow for personnel in diagnostic laboratories.

New Techniques in Use

Molecular diagnostics is driving growth of the personalized medicine market which involves co-development of drugs/devices and specialized diagnostic tests. The technique is also referred to as companion diagnostic and can be used for toxicity studies, dose selection, monitoring patient response, and patient stratification.

Rapid diagnostic tests are performed at the physician office laboratory (POL), hospitals, health centers and home care. Demand for these tests is increasing rapidly owing to faster and accurate results. Tests have been developed for HbA1c testing, drug abuse, pregnancy testing, micro albumin, creatinine, blood gases, RSV, etc.

Demand for In-vitro diagnostics (IVD) is increasing in emerging markets such as India, China, Brazil, and South Korea. In-vitro diagnostic techniques have transformed the diagnostics industry by eliminating the complex in-vivo testing methods. The IVD techniques include the advance PCR technique, assays and hematology testing, helps diagnose and monitor patient’s health condition using samples of blood, cells or tissues.

Immunoassay diagnostics is expected to be driven by technological advancements such as novel biomarkers, ultrasensitive detection system and assays.

Fragmented Market

The diagnostic landscape, especially in the emerging countries, is highly fragmented and marked by the strong presence of unorganized diagnostic labs. Global players are now building global networks by investing in foreign markets. Moreover, in terms of manufacturers, the market is fragmented in a similar manner with many small players dominating local markets. Owing to the increasing demand for home care, manufacturers and diagnostic laboratories need to work in collaboration to provide quality care at patient convenience.


Increasing healthcare costs is deterring patients from undergoing regular health tests that can be improved with a wider insurance coverage. Inadequate insurance coverage in emerging economies is restricting patients from undergoing expensive health tests, thus fueling the market growth. Moreover, centralization of testing laboratories is projected to drive demand for high volume instrumentation and automation equipment. Demand for IVD tests from Asia Pacific, Latin America and the Middle East markets is also increasing rapidly.

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