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Unfavourable reimbursement scenario
Inadequate reimbursement is a major factor restraining the growth of the immunoassay market. In the US, Medicare revised its reimbursement mechanism for some IVD tests, including immunoassays and molecular tests, in 2012. Some of these molecular pathology tests do not have their own Healthcare Common Procedure Coding System (HCPCS) codes and are instead billed using unlisted codes. In such cases, Medicare Administrative Contractors (MACs) establish a payment amount for their local jurisdictions. According to the CMS, ~75% of tests showed reductions in reimbursement rates from January 2017. Some of these tests include molecular tests, targeted NGS analysis panels of five to 50 genes, and cancer tests. These developments are expected to adversely affect the US molecular and genetic testing market, which, in turn, will restrain the growth of the immunoassay market.
According to MedPAC (Medicare Payment Advisory Commission), medical testing has seen a 40% decline in reimbursement over the last 40 years. This, along with budgetary considerations among healthcare systems, will act as a major obstacle for the implementation of novel diagnostic techniques in clinical laboratories, as the reimbursements for these tests are low.
Increasing importance of companion diagnostics in the immunoassay market
Companion diagnostics include tests or assays intended to assist healthcare providers in making treatment decisions for patients based on the best response to therapy. The co-development of companion diagnostics with therapeutic products has the potential to significantly alter the drug development process and commercialize drug candidates by yielding safer drugs with enhanced therapeutic efficacy quickly and cost-effectively. With an increase in the demand for high-priced specialist therapies and safer drugs, the market for companion diagnostics is expected to showcase a high growth potential.
Key players in the immunoassays market include Roche (Switzerland), Abbott Laboratories (US), Siemens (Germany), Danaher Corporation (US), Sysmex Corporation (Japan), bioMérieux (France), Ortho Clinical Diagnostics (US), DiaSorin (Italy), QIAGEN (Netherlands), Thermo Fisher Scientific (US), Becton, Dickinson and Company (US), Merck (Germany), Bio-Rad Laboratories (US), Agilent Technologies (US), PerkinElmer (US), Quidel Corporation (US), Bio-Techne Corporation (US), and Mindray (China).
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North America held the largest share of the market in 2017
Based on region, the immunoassay market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the market in 2017. The large share of this regional segment is attributed to the increasing incidence of chronic diseases and improved healthcare infrastructure.