The North American molecular diagnostics market size was USD 3.66 billion in 2017 and is expected to register a CAGR of 10.4% over the forecast period. Increased adoption of molecular diagnostics (MDx) for infectious diseases, coupled with advent of new cancer diagnostic solutions, is driving the market.
Furthermore, molecular diagnostic has made its place in regular medical practice and has expanded to all the levels of healthcare, from laboratories to the physician’s office and clinics. Though, it has occupied routine spaces, its growth is driven by clinical next-generation sequencing and platform innovation in lower-cost nucleic acid amplification tests.
According to The Centers for Disease Control and Prevention (CDC), hospital-acquired infections in the U.S. account for a projected 1.7 million infections and 99,000 related deaths every year. Molecular diagnostics is important in the field of infectious disease testing by yielding fast and effective results. Hence, growing prevalence of infectious diseases and hospital-acquired infections is expected to fuel the market expansion.
Regulatory framework is one of the major restraining factors for the market. The likelihood of possible harm to patients has driven the U.S. FDA premarketing guidelines. The regulatory atmosphere is already complex and the FDA is becoming increasingly careful as dependency on molecular diagnostics is increasing for making serious medical decisions.
However, technological advancements are also projected to substantially drive the growth of the market, as they provide portability, greater accuracy, and cost-effectiveness. Advent of MinION, an affordable and portable sequencer, which caters to the users in small peripheral laboratories and Point-of-Care (PoC) facilities, is likely to drive the market.
On the basis of products, the North American MDx market is categorized into instruments, reagents, and other services. Reagents led the market in 2017 owing to their wide use in molecular diagnostics tests. Increased adoption of these tests in non-medical facilities will drive the segment further.
Moreover, high demand for Over-the-Counter (OTC) diagnostics is expected to help accelerate the market growth in this space. The reagent segment is anticipated to witness the fastest growth over the next few years. This growth can be attributed to the factors, such as rise in demand for genetic testing and advanced cancer diagnostic tests.
On the basis of test location, the North America molecular diagnostics market is segmented into PoC, self-test or OTC, and central laboratories. Central laboratories held the largest market share in 2017 owing to high procedure volume. In addition, the presence of ancillary support, in terms of manpower and infrastructure, in these healthcare facilities will contribute toward the segment growth.
The PoC segment is expected to witness the fastest growth during the forecast period due to the factors, such as lower cost of development and technology. Moreover, need for easy and quick access to molecular diagnostics for attaining faster results will also drive the segment.
On the basis of technology, the market can be categorized into Polymerase Chain Reaction (PCR), In-situ hybridization, sequencing, chips and microarrays, INAAT, mass spectrometry, transcription mediated amplification, and others. The PCR segment was the largest technology segment, in terms of revenue, in 2017 and is likely to expand further. This growth can be attributed to the wide utilization of PCR techniques, such as multiplex PCR.
Technological advancements in PCR techniques will also propel segment growth. In Situ Hybridization (ISH) segment is projected to be the fastest-growing segment during the forecast period owing to an estimated rise in number of patients affected by cancer and need for early diagnosis of cancer.
On the basis of application, the North America MDx market is segmented into oncology, pharmacogenomics, infectious disease testing, genetic testing, neurological disease, Cardiovascular Disease (CVD), microbiology, and others. Infectious disease testing segment holds the largest share of the market as a result of the recurrence of diseases, such as new strains of HIV, H1N1, and multidrug-resistant TB.
On the other hand, oncology is likely to be the fastest-growing application segment during the forecast period. This growth can be credited to the rising cases of cancer and the development of advanced diagnostic tests, such as companion diagnostics.
The U.S. held the largest revenue share in 2017 as it makes up most of the existing market and is the most advanced market, in terms of the adoption of molecular diagnostics. In addition, increasing focus on market strategies, such as partnerships between diagnostic companies to develop companion diagnostics has further accelerated the growth of this market.
The regulatory and reimbursement landscape in the country is continually evolving to adapt to fast-paced research progress in this sector. Moreover, the FDA is developing new regulatory strategies for NGS tests, which has fostered innovation in test development, while ensuring that data produced by these tests is accurate and reliable. These factors are further expected to accelerate the U.S. market.
Canada is expected to witness the fastest growth over the forecast period with rising usage of molecular diagnostics in the region. Furthermore, increasing prevalence of target diseases, coupled with growing presence of health-conscious and more aware individuals, is expected to drive the market.
Some of the key companies in the market are Roche Diagnostics; Qiagen N.V.; Danaher; Hologic, Inc.; Johnson & Johnson; Becton, Dickinson and Company; Abbott laboratories; bioMérieux SA; Illumina, Inc.; Novartis AG; and Cepheid, Inc.
These companies have undertaken strategies, such as mergers and acquisitions, to gain a higher market share. For instance, in April 2017, Abbott acquired Alere with an aim to create the world’s premier PoC testing business and strengthen its position in diagnostics space.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2018 - 2025
Revenue in USD Million & CAGR from 2018 to 2025
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue and volume growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the North America molecular diagnostics market report on the basis of product, test location, technology, application, and region:
Product Outlook (Revenue, USD Million, 2014 - 2025)
Test Location Outlook (Revenue, USD Million, 2014 - 2025)
Self-test or Over the Counter (OTC)
Technology Outlook (Revenue, USD Million, 2014 - 2025)
Polymerase Chain Reaction (PCR)
In Situ Hybridization
Isothermal Nucleic Acid Amplification Technology (INAAT)
Chips and Microarrays
Transcription Mediated Amplification
Application Outlook (Revenue, USD Million, 2014 - 2025)
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, 2014 - 2025)
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The most common concern for the governments of all Covid-19 hit nations is the excruciating need to screen for and test large numbers of patients for possible Sars-Cov-2 infection. As a result, most of them are facing major shortages in the supply for diagnostic kits to test for the virus. Diagnostics virology entities are under immense pressure to provide reliable testing kits, and there is a surge in demand for in-vitro or point-of-care testing capacities by labs across a large number of countries. The report will account for Covid19 as a key market contributor.