Molecular Diagnostics Market Size, Share & Trends Analysis Report By Technology, By Test Location, By Product (Instruments, Reagents), By Application (Oncology, Infectious Diseases), And Segment Forecasts, 2019 - 2026

Industry Insights

The global molecular diagnostics market size was valued at USD 9.9 billion in 2018 and is anticipated to expand at a CAGR of 9.1% over the forecast period. Advancements in molecular diagnostics have enabled detection of various diseases that could possibly reduce social and economic burden in a country.

Technological advancements in molecular diagnostics are expected to significantly drive the market as they enable greater accuracy, portability, and cost-effectiveness. Introduction of MinION, a portable and affordable sequencer by Nanopore Technologies catering to users in point-of-care facilities and small peripheral laboratories, is expected to boost market growth.

According to WHO, in 2019, the average prevalence rate of hospital-acquired infections in Europe and U.S. was 7.1% and 4.5%, respectively. Molecular diagnostics play an important role in infectious disease testing as they provide effective and fast results. Hence, rising prevalence of infectious diseases and hospital-acquired infections is expected to drive the market over the forecast period.

Increase in funding by governments and different organizations for clinical studies in the molecular diagnosis space is expected to boost the market growth. These initiatives play a vital role in the process of new product development. For instance, Accelerate Diagnostics received a funding of USD 19.5 million from different organizations, such as the Schuler Family Foundation, Oracle Institutional Partners, and Oracle Partners, for the development and sale of infectious disease IVD tests and tools.

Regulatory framework pertaining to approval process has always been the most critical factor restraining the pharmaceutical, biotechnology, and medical technology markets. Developing countries such as India and China lack well-defined regulatory framework and guidelines for the diagnostic sector, which negatively impacts the growth in Asia Pacific, irrespective of the presence of a large population.

Regulatory ambiguities in approval process for molecular diagnostics creates uncertainties and confusion among manufacturers regarding product commercialization. In addition, lack of a robust reimbursement framework for personalized and genomic medicine in mature markets, such as U.S., is expected to restrain the market growth due to limited purchasing power of buyers.

Product Insights

Reagents dominated the overall molecular diagnostics market in terms of revenue in 2018. Increased use of reagents in molecular diagnostic testing, rise in adoption of these tests in nonmedical facilities, such as home, and high demand for over-the-counter diagnostic tests are some of the drivers of this segment.

Key market players offering reagents are Abbott; Illumina Inc.; and Roche Diagnostics. In addition, this segment is expected to witness the fastest growth over the forecast period. This can be attributed to rise in demand for genetic testing and advanced cancer diagnostic tests in countries with high unmet medical needs, such as South Africa and Belgium.

Instruments, such as PCR and next generation sequencing platforms, are being widely preferred by central laboratories and diagnostic institutes due to the rapid nature of these tests in delivering quick and reliable results and the high volume of diagnostic procedures in this segment.

Test Location Insights

Central laboratories dominated the market in terms of revenue share in 2018 owing to high procedure volume and extensive presence of ancillary support in terms of man power and infrastructure.

The point-of-care (PoC) segment is projected to exhibit the fastest CAGR during the forecast period. Growing demand for bedside patient care owing to a flourishing home healthcare market coupled with rising market penetration of decentralized healthcare establishments is one of the major factors that can be attributed to its rapid growth. Moreover, growing popularity of self-test or OTC products with constantly improving healthcare infrastructure and patient awareness levels is expected to aid in growth of the segment.

Technology Insights

PCR dominated the overall molecular diagnostics market in 2018. PCR is the most widely used technology in molecular diagnostics. Increased usage and advancements in PCR techniques, such as multiplex PCR, are some of the highest impact rendering drivers of this segment.

Sequencing is expected to show the fastest growth over the forecast period owing to the 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 substantial growth rate during the forecast period. Increase in the size of cancer affected population and need for early cancer diagnosis are some of the drivers of this segment.

Application Insights

Infectious disease testing holds a large share of the current market, given the recurrence of infectious diseases, including new strains of H1N1, HIV, and multidrug-resistant TB. Most of the molecular diagnostic tests are for infectious diseases but there is a growing number in other spaces, mainly in oncology.

Increase in incidence of cancer and development of advanced cancer diagnostic tests, such as companion diagnostics, are some of the factors estimated to attribute to the high CAGR of the oncology segment over the forecast period.

Companion diagnostics is based on the concept of personalized medicine and involves the identification of biomarker response in a population of patients with the same type of cancer. Moreover, the introduction of such advanced diagnostic technologies will prove to be cost-effective and will further boost the growth of the oncology segment.

Regional Insights

North America was the largest revenue generating region for molecular diagnostics in 2018 and is expected to show the same trend over the forecast period. North America is the industry leader 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.

Presence of a huge target population and high unmet clinical needs is expected to drive the market in Asia Pacific. Rising government initiatives in economies, such as China and India, to improve the healthcare infrastructure are expected to fuel the market growth.

Molecular Diagnostics Market Share Insights

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

Key players are adopting different strategies such as mergers and acquisitions to increase their market share. For instance, in July 2012, Hologic acquired Gen-Probe to expand the portfolio with a focus on cancer diagnostics. Players are also focusing on expanding their product portfolio. For instance, in 2015, Cepheid launched GeneXpert Omni, the world's most portable molecular diagnostics system.

Report Scope

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on the latest industry trends in each of the sub-segments from 2014 to 2026. 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, 2014 - 2026)

  • Instruments

  • Reagents

  • Others

• Test Location Outlook (Revenue, USD Million, 2014 - 2026)

  • Point-of-Care

  • Self-Test or Over the Counter

  • Central Laboratories

• Technology Outlook (Revenue, USD Million, 2014 - 2026)

  • Polymerase Chain Reaction (PCR)

    • PCR, by Type

      • Multiplex PCR

      • Other PCR

    • PCR, by Product

      • Instruments

      • Reagents

      • Others

  • In Situ Hybridization

    • Instruments

    • Reagents

    • Others

  • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Instruments

    • Reagents

    • Others

  • Chips and Microarrays

    • Instruments

    • Reagents

    • Others

  • Mass Spectrometry

    • Instruments

    • Reagents

    • Others

  • Sequencing

    • Instruments

    • Reagents

    • Others

  • Transcription Mediated Amplification

    • Instruments

    • Reagents

    • Others

  • Others

    • Instruments

    • Reagents

    • Others

• Application Outlook (Revenue, USD Million, 2014 - 2026)

  • 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

• Regional Outlook (Revenue, USD Million, 2014 - 2026)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Belgium

    • Switzerland

    • Netherlands

    • Poland

    • Austria

    • Greece

    • Sweden

    • Turkey

    • Finland

  • Asia Pacific

    • Japan

    • China

    • India

    • Sri Lanka

    • Malaysia

    • Australia

    • New Zealand

    • Thailand

    • Vietnam

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Chile

    • Peru

    • Colombia

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • Jordan

    • UAE

    • Qatar

    • Nigeria

    • Egypt