North American Molecular Diagnostics Market

North American Molecular Diagnostics Market Outlook 2031

The North American molecular diagnostics market size was USD 9.50 Billion in 2022 and is projected to reach USD 16.93 Billion by 2031 expand at a high CAGR 6.63% during the forecast period, 2023 – 2031. The growth of the market is attributed to the increasing funding for research and development, growing presence of infectious diseases and several types of cancer, rising Point-of-Care (PoC) testing devices, and advanced technologies.

Molecular diagnostics refers to laboratory-based testing that is widely used to characterize and identify microorganism. It is a rapid test and able to find exact cause and measures of infectious burden. In regular medical practice, molecular diagnostic is extensively used from the range of healthcare sector, laboratories to the clinics and physician’s office. The growth of molecular diagnostic is driven by rising development of sequencing clinical next generation and introduction of platform innovation in less cost nucleic acid amplification tests.

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As per a report published by the Centers for Disease Control and Prevention (CDC), around 1.8 million of Americans were admitted to hospital due to infections-related cases and 99,000 related deaths were anticipated in every year in the US. For infectious disease testing, molecular diagnostics plays a vital role that offers fast and effective results.

However, the US Food and Drug Administration (FDA) is getting progressively careful for molecular diagnostics as it is aware of certain risks involved in the testing. Meanwhile, technological development and introduction of cost-effective diagnostics process from key players are key aspects for the market expansion. For instance, MinION has launched an affordable and portable sequencer, which aimed to provide PoC facilities and small peripheral laboratories to enhance the diagnostics.

North American Molecular Diagnostics Market Trends, Drivers, Restraints, and Opportunities

• Growing adoption of molecular diagnostics and new cancer diagnostics solutions are factors responsible for the market growth.
• Rising occurrence of cancer and infectious diseases are major drivers influencing the market growth.
• Increasing development of advanced and efficient companion diagnostic devices and testing kits are anticipated to grow the market during the forecast period.
• High cost of the molecular diagnostic instruments and strict regulations imposed by FDA to restrict the approval of certain instruments are key challenges that can retrain the market growth.
• Ongoing R&D activities and technological advancement of PoC facilities are projected to create immense opportunities for the market expansion.

Scope of Molecular Diagnostics Market Report

The report on the North American molecular diagnostics market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

North American Molecular Diagnostics Market Segment Insights

Polymerase chain reaction segment to account for a key share

Based on technology, the North American molecular diagnostics market is divided into polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips and microarrays, mass spectrometry, sequencing, transcription mediated amplification, and others.

The PCR segment accounted for a large revenue market share in 2020 and is anticipated to expand significantly during the forecast period. The growth of the market is because of extensive utilization of PCR techniques such as multiplex PCR. The PCR segment is further subdivided into multiplex PCR and other PCR.

Technological advancements in polymerase chain reaction technique is a key factor boosting the segment growth in the market. The in situ hybridization segment, however, is anticipated to grow at a fast pace during the forecast period due to growing number of cancer patients and requirement of early diagnosis of cancer.

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Oncology is expected to grow at a rapid pace

On the basis of applications, the market is divided into oncology, pharmacogenomics, infectious diseases, genetic testing, neurological disease, microbiology, cardiovascular disease, and others. The oncology segment is further divided into breast cancer, prostate cancer, colorectal cancer, cervical cancer, kidney cancer, liver cancer, blood cancer, lung cancer, and others.

The genetic testing is subdivided into newborn screening, predictive and presymptomatic testing, and others. The infectious disease segment is further subdivided into 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, and others.

The oncology segment is projected to grow at a rapid pace during the forecast period owing to increasing cases of cancer and developing advanced diagnostic tests. Meanwhile, the infectious disease testing segment is projected to hold a large market share in the coming years owing to result of reappearance of diseases such as multidrug-resistant TB, new strains of HIV and H1N.

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PoC segment is expected to grow at a rapid pace

Based on test locations, the North American molecular diagnostics market is segmented into PoC, OTC or self-tests, and central laboratories. The central laboratories is anticipated to account for a considerable market share during the forecast period owing to high procedure volume. Moreover, the existence of ancillary support with respect to infrastructure and manpower are contributing to segment growth.

On the other hand, the PoC segment is projected to grow at a rapid pace during the forecast period owing to requirement of easy and quick access for molecular diagnostics and cheaper development and technological cost.

Reagents segment to hold a major market share

On the basis of products, the market is bifurcated into instruments and reagents. The reagents segment is anticipated to hold a major market share in the coming years due to extensive use of molecular diagnostics tests. In non-medical facilities, the use of reagents are increasing, which is anticipated to expand the segment growth. However, the instruments segment is expected to expand at a significant growth rate due to rapid development of advanced cancer diagnostic instruments and devices.

The US is projected to hold a dominant share

In terms of regions, the North American molecular diagnostics market is segmented into Canada and the US. The U.S. accounted for a large revenue share in 2020 and the trend is expected to continue in the coming years due to the wide adoption of molecular diagnostic to early detection of chronic illness among a large health-conscious people of the country.

Moreover, the presence of key global players and favorable reimbursement policies of the government agencies in the country present another driver for the market growth in the US. On the other hand, the market in Canada is anticipated to register a high CAGR during the forecast period by increasing use of molecular diagnostics in the country. Additionally, rising presence of health-conscious people and increasing occurrence of target diseases are projected to drive the market growth in Canada.

Segments

The North American molecular diagnostics market has been segmented on the basis of

Technology

• 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

Applications

• Oncology
  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Kidney Cancer
  • Liver Cancer
  • Blood Cancer
  • Lung Cancer
  • Others
• 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
• Genetic Testing
  • Newborn Screening
  • Predictive and Presymptomatic Testing
  • Others
• Neurological Disease
• Cardiovascular Disease
• Microbiology
• Others

Test Locations

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

Products

• Instruments
• Reagents

Geography

• Canada
• The US

Key Players

• Roche Diagnostics
• Hologic, Inc.
• Qiagen N.V.
• Danaher
• Johnson & Johnson
• Becton, Dickinson and Company
• Abbott laboratories
• bioMérieux SA
• Illumina, Inc.
• Novartis AG
• Cepheid, Inc.

Competitive Landscape

Some of the key players competing in the North American molecular diagnostics 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 key players are actively engaged in implementing and focusing on strategies such as mergers and acquisitions to increase their market share. For instance, Abbott acquired Alere, in April 2017, with an aim to create effective PoC testing business around the world and reinforce its position in diagnostics space.