North American Molecular Diagnostics Market, Sector / Industry Report & Analysis, 2025 (Includes Business Impact of COVID-19)

                                          
Abstract, Snapshot, Market Analysis & Market Definition: North American Molecular Diagnostics Market


The North American Molecular Diagnostics market size is projected to reach US$ 8.92 billion by 2026, from US$ 4.92 billion in 2020, at a CAGR of 10.4% during 2021-2026. 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 physicians 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 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.

Market Segmentation, Outlook & Viewpoint: North American Molecular Diagnostics Market

Product Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)

  
Instruments
  
Reagents

Test Location Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)

  
Point-of-Care (PoC)
  
Self-test or Over the Counter (OTC)
  
Central Laboratories

Technology Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)

Polymerase Chain Reaction (PCR)

  
Multiplex PCR
  
Other PCR

In Situ Hybridization

Isothermal Nucleic Acid Amplification Technology (INAAT)

Chips and Microarrays

  
Mass Spectrometry

Sequencing

Transcription Mediated Amplification

  
Others

Application Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)

Oncology

  
Breast Cancer
  
Prostate Cancer
  
Colorectal Cancer
  
Cervical Cancer
  
Kidney Cancer
  
Liver Cancer
  
Blood Cancer
  
Lung Cancer
  
Other Cancer

Pharmacogenomics

Infectious Diseases

  
Methicillin-resistant Staphylococcus Aureus (MRSA)
  
Clostridium Difficile
  
Vancomycin-resistant Enterococci (VRE)
  
Carbapenem-resistant Bacteria
  
Flu
  
Respiratory Syncytial Virus (RSV)
  
Candida
  
Tuberculosis and drug-resistant TBA
  
Meningitis
  
Gastrointestinal Panel Testing
  
Chlamydia
  
Gonorrhea
  
HIV
  
Hepatitis C
  
Hepatitis B
  
Other Infectious Disease

Genetic Testing

  
Newborn Screening
  
Predictive and Presymptomatic Testing
  
Other Genetic Testing

Neurological Disease

Cardiovascular Disease

Microbiology

Others

Key Players, Recent Developments & Regional Insights: North American Molecular Diagnostics 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.

Test Location Insights

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 man power 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.

Technology Insights

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 the segment development. In Situ Hybridization (ISH) segment is projected to be the fastest-growing segment during the forecast period owing to estimated rise in number of patients affected by cancer and need for early diagnosis of cancer.

Application Insights

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.

Regional Insights

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.

North America Molecular Diagnostics Market Share Insights

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; bioMerieux 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 worlds premier PoC testing business and strengthen its position in diagnostics space.

Key Insights Covered: North American Molecular Diagnostics Market

1. North America, Europe, Asia Pacific, Middle East & Africa, Latin America market size (sales, revenue and growth rate) of North American Molecular Diagnostics industry.
2. Global major manufacturers" operating situation (sales, revenue, growth rate and gross margin) of North American Molecular Diagnostics industry.
3. Global major countries (United States, Canada, Germany, France, UK, Italy, Russia, Spain, China, Japan, Korea, India, Australia, New Zealand, Southeast Asia, Middle East, Africa, Mexico, Brazil, C. America, Chile, Peru, Colombia) market size (sales, revenue and growth rate) of North American Molecular Diagnostics industry.
4. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of North American Molecular Diagnostics industry.
5. Global market size (sales, revenue) forecast by regions and countries from 2019 to 2024 of North American Molecular Diagnostics industry.

Research Methodology: North American Molecular Diagnostics Market

  
Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more please Request a Sample Report.
  
Demand Side Primary Contributors: OEMs, Industrial Professionals, Researches, Suppliers and Distributors, Group Purchasing Organizations, Associations, Insurers, Universities, Technological Writers, Scientists, Promoters, Investors among others.
  
Supply Side Primary Contributors: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, Regulatory Affairs Managers among other