Molecular Diagnostics Market Size, Share & Trend Analysis Report By Technology (PCR, ISH, INNAT, Chips & Microarrays, Mass spectrometry, Sequencing, TMA), And Segment Forecasts, 2018 - 2024

Industry Insights

The global molecular diagnostics market size was valued at USD 6,451.5 million in 2015 and is anticipated to grow at a CAGR of 12.1% over the forecast period. Advancements in molecular diagnostics have enabled detection of various diseases that could possibly result in severe social and economic burden.

Technological advancements in molecular diagnostics are expected to significantly drive the market as they enable greater accuracy, portability, and cost-effectiveness. The 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 the growth of global molecular diagnostics market.

According to WHO, the average prevalence rate of hospital-acquired infections in Europe and the U.S. was valued at 7.1% and 4.5%, respectively, in 2010. Molecular diagnostics play an important role in infectious disease testing as they provide effective and fast results. Hence, the rising prevalence of infectious diseases and hospital-acquired infections are expected to drive the market growth over the forecast period. In addition, rise in incidence rates of cardiovascular, neurological, and genetic disorders is also expected to fuel the market growth.

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 funding of USD 19.5 million different organizations, such as the Schuler Family Foundation, Oracle Institutional Partners, Oracle Partners, & others, for the development and sale of infectious disease IVD tests and tools. Moreover, in April 2014, Merck’s venture capital arm financed AdvanDx with USD 12 million for research and development of pathogen screening for major hospital-acquired infections.

Regulatory framework pertaining to approval process has always been the most critical restraining factor for the pharmaceutical, biotechnology, and medical technology market. Developing countries, such as India and China, lack well-defined regulatory framework and guidelines for the diagnostic sector, which negatively impacts the growth in this region 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, the lack of a robust reimbursement framework for personalized and genomic medicine in mature markets, such as the U.S., is expected to restrain the market growth due to limited purchasing power of buyers.

Product Insights

Reagents dominated the overall market in terms of revenue in 2015. 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 market.

In addition, this segment is expected to show the fastest growth rate over the forecast period. This can be attributed to the rise in demand for genetic testing and advanced cancer diagnostic tests in countries with high unmet medical needs, such as South Africa and Belgium.

Test Location Insights

Central laboratories dominated the market in terms of revenue share in 2015 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 grow at 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.

Application Insights

Increase in incidence of cancer and development of advanced cancer diagnostic tests, such as companion diagnostics, are some of the factors attributing to the high CAGR of oncology market 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.

Technology & Regional Insights

PCR dominated the overall market in 2015. PCR is the most widely used technology in molecular diagnostics. Increased usage and advancements in PCR technique, e.g., multiplex PCR, are some of the highest impact rendering drivers of this segment. In Situ Hybridization is expected to witness the fastest growth over the forecast period owing to the factors such as increase in the size of cancer affected population and need for early cancer diagnosis.

In terms of region, North America was the largest region for molecular diagnostics in 2015 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 and technological advancements in the field of molecular diagnostics

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

Molecular Diagnostics Market Share Insights

Some of the key players in the global molecular diagnostics market include 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, Hologic acquired Gen-Probe in July 2012 to expand the portfolio with focus on cancer diagnostics. Players are also focusing on expanding their product portfolio. For instance, Cepheid launched GeneXpert Omni, the world's most portable molecular diagnostics system in 2015.

Report Scope

Segments covered in the report 

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the industry trends in each of the sub segments from 2013 to 2024. For the purpose of this study, Grand View Research has segmented the global molecular diagnostics market report based on product, test location, technology, application, and region:

• Product Outlook (Revenue, USD Million, 2013 - 2024)

  • Instruments

  • Reagents

  • Others

• Test Location Outlook (Revenue, USD Million, 2013 - 2024)

  • Point-of-Care

  • Self-test or Over the Counter

  • Central Laboratories

• Technology Outlook (Revenue, USD Million, 2013 - 2024)

  • 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 Outlook (Revenue, USD Million, 2013 - 2024)

  • 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, 2013 - 2024)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • 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