Vendors compete fiercely based on multiplexing and data analytics platform features, finds Frost & Sullivan’s Transformational Health team
London – December 19, 2016 – Molecular diagnostics is one of the fastest growing segments in the in vitro diagnostics (IVD) industry and a game changer in the patient care continuum. Compared to other platforms with overlapping disease portfolios, it offers superior test precision, ability to miniaturize, and quick turnaround times. As a result, molecular diagnostics will replace low-cost microbiology and other gold-standard tests in the US, at least partially, despite higher costs and strict FDA guidelines for laboratory-developed tests (LDTs).
“With the right strategies, molecular diagnostics companies will see high adoption of their technologies in hospitals and clinical settings, especially in point-of-care testing for rapid diagnosis of multiple infectious diseases,” said Transformational Health Research Analyst Aish Vivekanadan. “Increasing clinical validations will also go a long way with the FDA and user bases, eventually spurring collaborations for pharmacogenomics and enabling personalized medicine.”
Frost & Sullivan’s Life Sciences Growth Partnership Service (GPS) program recently released The US Molecular Diagnostics Market, Forecast to 2021, with upcoming installments that will detail the European and Asia-Pacific markets. This deliverable finds that the US molecular diagnostics market will reach $6.55 billion by 2021. Polymerase chain reaction (PCR), next-generation sequencing (NGS), microarray, and fluorescent in situ-hybridization (FISH) are the dominant technologies in the space.
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Roche, Cepheid, Qiagen, Abbott and Thermo Fisher dominate the market and are strengthening their positions through mergers and acquisition of smaller start-ups. Illumina currently monopolizes the NGS segment. Other notable players include GenMark, Nanostring, and Provista Diagnostics.
The pressing issues the market faces include automation and reimbursement.
“Companies need to adhere to FDA guidelines early in their product development to ensure consistent growth,” noted Vivekanandan. “Further, they must pursue differentiating features such as multiplexing, sample preparation and data analytics. Companion Diagnostics with the objective to advance precision medicine will find its immediate growth opportunities for product developments in oncology however, medium term opportunities will stretch across the cardiovascular space and long term opportunity areas include infectious disease and central nervous system.”
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The US Molecular Diagnostics Market, Forecast to 2021
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