The global molecular diagnostics market size was valued at USD 9.2 billion in 2019 and is anticipated to register a CAGR of 9.0% over the forecast period. 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.
According to the WHO, the average prevalence rate of hospital-acquired infections in 2019 was 4.5% and 7.1% in U.S. and Europe, respectively. 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 over the forecast period.
Growing funding by governments and numerous organizations for R&D in molecular diagnostics is anticipated to drive the demand for molecular testing. Funding plays a significant role in product development process. For instance, Accelerate Diagnostics received USD 19.5 million from various entities, such as Oracle Partners, Oracle Institutional Partners, and the Schuler Family Foundation, to enhance the development and sales of infectious disease in vitro diagnostics tests and tools.
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 U.S. FDA also conducts post-market investigation of in vitro diagnostic device (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.
The key players offering reagents are Roche Diagnostics; Illumina Inc.; and Abbott. Reagents is also projected to be the fastest-growing segment over the forecast period. This can be attributed to the growing demand for advanced cancer diagnostic tests and genetic testing in countries with unmet medical needs, such as South Africa and India.
Central laboratories dominated the market for molecular diagnostics in 2019 due to high procedure volume and significant presence of ancillary support in terms of infrastructure and manpower.
Point-of-Care (PoC) is estimated to be the fastest-growing segment over the forecast period. Rising demand for bedside patient care with the booming home healthcare market and increasing market penetration are among the major factors driving the segment growth. Furthermore, rising adoption of self-testing or OTC products, increased awareness of molecular testing among patients, and development in healthcare infrastructure are projected to drive the growth of the segment.
PCR dominated the overall market for molecular diagnostics in 2019. PCR is the most widely used technology in molecular diagnostics. Increased usage and advancements in PCR techniques, e.g., multiplex PCR, are some of the highest impact rendering drivers of this segment.
Sequencing is projected to witness the highest growth rate over the forecast period. This is attributed to factors such as possible decrease in cost and rise in the portability of DNA sequencers combined with the development of NGS techniques, providing high throughput analysis and sequencing of genomic data.
Furthermore, in situ hybridization (ISH) is projected to witness a substantial growth rate during the forecast period. Increasing prevalence of cancer and need for early cancer diagnosis are some of the drivers of this segment.
Infectious disease testing dominated the molecular diagnostics market in 2019, given the relapse of infectious diseases, including new strains of multidrug-resistant TB, H1N1, and HIV. Most molecular diagnostic tests are designed for detecting infectious diseases; however, molecular testing is becoming increasingly popular in other spaces, mainly in oncology.
Oncology is expected to be the fastest-growing segment over the forecast period owing to factors such as increasing prevalence of cancer and development of advanced diagnostic tests such as companion diagnostics. Companion diagnostics are based on the concept of personalized medicine and involve the identification of biomarker response in a population of patients with the same type of cancer. Moreover, the introduction of such advanced molecular diagnostic technologies will prove to be cost-effective, subsequently driving the growth of the oncology segment.
North America was the largest revenue generating region for molecular diagnostics in 2019 and this trend is expected to continue over the forecast period. 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 over the forecast period owing to unaddressed clinical needs and the rising demand for improved diagnostic technologies such as molecular testing.
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.
Key players are adopting various strategies such as mergers and acquisitions to increase their market share. For instance, Qiagen acquired STAT-Dx, a Spanish firm developing next-generation multiplex diagnostics using a novel system based on real-time PCR and Qiagen chemistries. Players are also focusing on expanding their product portfolio. For instance, in 2019, Roche launched the first IVD ROS1 IHC assay-VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody-for the detection of ROS1 protein in cancers.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million and CAGR from 2019 to 2027
North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA)
Revenue forecast, company share, competitive landscape, growth factors and trends
U.S., Canada, Germany, U.K., France, Italy, Spain, Belgium, Switzerland, Netherlands, Poland, Austria, Greece, Sweden, Turkey, Finland, China, Japan, India, Sri Lanka, Malaysia, Australia, New Zealand, Thailand, Vietnam, Singapore, Brazil, Mexico, Chile, Peru, Colombia, Argentina, South Africa, Saudi Arabia, Jordan, UAE, Qatar, Nigeria, Egypt
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global molecular diagnostics market report on the basis of product, test location, technology, application, and region:
Product Outlook (Revenue, USD Million, 2016 - 2027)
Test Location Outlook (Revenue, USD Million, 2016 - 2027)
Self-Test or Over the Counter
Technology Outlook (Revenue, USD Million, 2016 - 2027)
Polymerase chain reaction (PCR)
PCR, by Type
PCR, by Product
In Situ Hybridization
Isothermal Nucleic Acid Amplification Technology (INAAT)
Chips and Microarrays
Transcription Mediated Amplification
Application Outlook (Revenue, USD Million, 2016 - 2027)
Methicillin-resistant Staphylococcus Aureus (MRSA)
Vancomycin-resistant Enterococci (VRE)
Respiratory Syncytial Virus (RSV)
Tuberculosis and Drug-resistant TBA
Gastrointestinal Panel Testing
Other Infectious Disease
Predictive and Presymptomatic Testing
Other Genetic Testing
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East & Africa
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