Automation to drive molecular diagnostics market

The global molecular diagnostics market size was valued at USD 9.2 billion in 2019 and is anticipated to register a CAGR of 9 percent over the next 7 years. Advancements in molecular diagnostics have facilitated the detection of numerous diseases and are particularly effective when faced with challenging differential diagnosis. Technological advancements in molecular diagnostics are anticipated to substantially drive the market growth as they facilitate cost-effectiveness, accuracy, and portability. The commercialization of MinION, an affordable and portable sequencer by Nanopore Technologies, is suitable for use in small laboratories and point-of-care facilities, which is projected to boost the market for molecular diagnostics.

Molecular diagnostics play an essential role in the testing of infectious diseases as they offer quick and effective results. Thus, the growing prevalence of hospital-acquired infections and infectious diseases are further estimated to drive the demand for molecular diagnostics in coming years.

The regulatory framework for approvals has always posed major restrictive factors on pharmaceutical, biotechnology, and medical technology industries. Faulty diagnostic kits could provide inaccurate results. Hence, the possibility of causing harm to the patients has driven the FDA to ensure compliance with premarketing regulations. The regulatory environment is already complicated, and the FDA is becoming increasingly careful owing to the growing dependency on molecular diagnostics for making critical medical decisions. The US FDA also conducts post-market investigation of IVD products to ensure parity between performance and claims. For instance, a heavy penalty was imposed on Nichols Institute, a subsidiary of Quest Diagnostics, as its test kits produced results that were inaccurate and unreliable. Hence, the stringency of regulations associated with the approval process for molecular diagnostics is limiting market growth.

In 2019, reagents dominated the overall market for molecular diagnostics. High usage of reagents in molecular diagnostic testing, increased demand for over-the-counter diagnostic tests, and rise in adoption of these tests in nonmedical facilities such as self-testing at home are some of the key growth drivers for the segment. Furthermore, advantages such as standardized results, improved efficiency, and cost-effectiveness are anticipated to support the segment growth.

North America was the largest revenue generating region for molecular diagnostics in 2019 and this trend is expected to continue over the next 7 years. North America dominated the market owing to the presence of a well-established diagnostic infrastructure, technological advancements, patient awareness, and presence of advanced products in the field of molecular diagnostics.

Increasing government initiatives in Asia Pacific, particularly in economies such as China and India, to improve healthcare infrastructure are expected to drive the demand for molecular diagnostics in the region. Asia Pacific is projected to witness the fastest growth owing to unaddressed clinical needs and the rising demand for improved diagnostic technologies such as molecular testing.

Some of the key players in the global market include Roche Diagnostics; Abbott; Bio-Rad Laboratories, Inc.; Siemens Healthcare GmbH; Alere, Inc.; Bayer AG; Dako; Hologic, Inc. (Gen probe); Sysmex Corporation; Danaher; Johnson & Johnson; Novartis AG; Qiagen N.V.; Becton, Dickinson and Company; Cepheid; and bioMerieux SA.