Molecular Diagnostics Market Size, Share & Trends Analysis Report By Technology (PCR, INAAT, Sequencing, Mass Spectrometry, TMA), By Product, By Test Location, By Application, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global molecular diagnostics market size was valued at USD 36.2 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 3.9% from 2021 to 2028. The growth can be attributed to technological advancements, rising elderly population, and external funding for R&D. Rising demand for Point-of-Care (PoC) testing is attributable to government support, demand for self-testing diagnostics, and rising consumer awareness about faster diagnostics. A surge in the prevalence of infectious diseases is also boosting the demand for molecular diagnostics.

The global geriatric population is increasing. According to 2017 UN estimates, there were around 962 million people aged 60 years and above globally. In addition, the number of individuals aged 80 years and above is projected to increase threefold, from 137 million in 2017 to 425 million by 2050. Aging increases the risk of getting numerous diseases including cancer, cardiovascular diseases, neurological disorders, obesity, and diabetes. Therefore, the fact that the global geriatric population is expected to grow over the forecast period is anticipated to be a high-impact rendering driver of the market for molecular diagnostics.

In addition, the geriatric population is more likely to suffer from COVID-19 due to decreased immune function, multimorbidity, and physiological changes associated with aging. According to the WHO Regional Director for Europe, till April 2020, around 95% of the deaths were reported among patients 60 years or above. Furthermore, more than 50% of deaths occurred in patients aged 80 years or older.

Rapid technological advancements leading to accurate results, portability, and cost-effectiveness are expected to be a high-impact rendering driver of the market for molecular diagnostics. Companies are upgrading their products by implementing new techniques to gain specific and accurate results. Sigma Aldrich Corporation and QIAGEN are developing new technologies, such as Transcription-Mediated Amplification (TMA) and Loop-Mediated Isothermal Amplification (LAMP), for the diagnosis of tumors.

In addition, the growing incidence of infectious diseases is expected to propel the market growth over the forecast period. According to WHO estimates, 38.0 million individuals across the globe were living with HIV infection in 2019. Moreover, rising initiatives by market players to improve access to cost-effective resources are anticipated to drive the market for molecular diagnostics. For instance, in July 2019, F. Hoffmann-La Roche Ltd expanded its Global Access Program beyond HIV and included HPV and other infectious diseases to enhance access to early detection and diagnostics for low and middle-income countries.

Product Insights

The reagents segment accounted for the largest revenue share of 65.6% in 2020. It is anticipated to grow at a significant rate in upcoming years owing to its wide adoption in research and clinical settings. Standard reagents help achieve efficient and accurate results. Standardized results, improved efficiency, and cost-effectiveness are anticipated to support market growth.

Furthermore, the growing use of instruments to detect coronavirus, which were earlier developed for other infectious diseases, is anticipated to boost the growth of the market for molecular diagnostics. For instance, in March 2020, Abbott received Emergency Use Authorization (EUA) for RealTime SARS-CoV-2 EUA tests to be used on the m2000 RealTime System.

Increasing adoption of molecular diagnostics with analyzer software at diagnostic centers is anticipated to fuel the market growth. For instance, in July 2019, Mobidiag Ltd. entered into an agreement with Pro Med Diagnostics for Novodiag solution and Amplidiag solution distribution in African countries. Amplidiag solution consists of Amplidiag Analyzer software that automates the complete process of detection of Helicobacter pylori infection, C. difficile infection, and other infectious diseases.

Test Location Insights

The central laboratories segment dominated the market for molecular diagnostics and accounted for the largest revenue share of 85.7% in 2020. This growth is attributable to high market penetration and procedure volumes. An increase in the number of initiatives undertaken by the government to provide various services, such as reimbursement for diagnostic tests, is another major factor anticipated to drive the market. Many healthcare institutions are working with laboratories to integrate different tests, such as microbiology testing.

There is an increasing interest in the development of molecular diagnostic platforms that can also be used in PoC settings. Therefore, various companies are designing assays and molecular diagnostic platforms for POC or near-patient testing. In addition, the growing development of new assays that offer quick PoC results is anticipated to boost the market growth. For instance, in October 2018, the U.S. FDA cleared Abbott’s Influenza A & B2 and Strep A2 assay for PoC testing, which can be used on the ID NOW platform.

PoC is gaining popularity in the molecular diagnostics space. PoC includes tests that provide rapid results and are portable. Molecular tests that identify the genetic material of an infectious agent are one of the fastest-growing PoC test types. Since many tests are fast, portable, and inexpensive, they are being adopted in as well as away from hospital settings. Companies such as Alere, Roche Diagnostics, and Cepheid have already marked their presence in this space.

Application Insights

The infectious disease segment dominated the market for molecular diagnostics and accounted for the largest revenue share of 86.3% in 2020, owing to molecular diagnostics forming the basis of medical diagnosis for COVID-19. The drawbacks of traditional testing, such as long turnaround time, difficulty in growing organisms in manually prepared culture media, poor in vitro kinetic development, and the lack of sensitivity have been offset with technological advancements, such as PCR and ISH.

Molecular diagnostics find applications in neurological disorders, such as neurodegenerative diseases, brain tumors, chronic depression, and more due to rapid and precise diagnosis. With the growing incidence of diseases of the nervous system, such as chronic depression and neuroblastoma, this application segment is expected to witness moderate growth during the forecast period.

The application of molecular diagnostic techniques in the field of pharmacogenomics involves high throughput testing of NCE that are viable for novel drug development specific to a certain genetic profile. Analysis of individual drug responses helps gain insights into the correlation between nucleotide polymorphism and drug metabolism. This enables the formulation of medication specific to a population subset suffering from a particular disease, which paves way for the development of personalized medicine.

Oncology research and cancer drug discovery have significant advantages in performing molecular diagnosis using specific biomarkers with regard to major cancer-causing genes and their manifestations. Early identification of predictive biomarkers in molecular diagnosis provides opportunities for early diagnosis of cancer-affected patients, which helps develop specifically tailored medication for treatment. As a result, the application of molecular diagnostics in oncology holds high growth potential; thus, the segment is expected to witness the highest CAGR during the forecast period.

Technology Insights

The Polymerase Chain Reaction (PCR) segment dominated the market for molecular diagnostics and accounted for the largest revenue share of 83.3% in 2020. This is attributed to its use in the detection of infectious microorganisms such as viruses and bacteria. The significant share held by the PCR segment is due to the associated benefits and varied applications of multiplex PCR over conventional PCR methodologies. Increasing use of high-throughput PCR technology to detect coronavirus is expected to drive the market. For instance, in April 2020, Mobidiag Ltd. received EUA for Amplidiag COVID-19 for use in clinical laboratories in Finland.

Sequencing technologies for the molecular diagnostics market include DNA sequencing processes and emerging NGS technologies, such as sequencing platforms and RNA sequencing. DNA sequencing technologies are integrally linked to drug discovery, novel drug development, and personalized medicine. It is expected that the sequencing technology segment will witness the highest growth throughout the forecast period owing to an increase in the number of genome profiling initiatives & R&D for novel drugs and a decrease in prices and sizes of DNA sequencers.

The sequence specificity of the ISH technique is the major application that helps in understanding pathogenic processes and performing molecular testing for diagnosis, monitoring, and treatment of cancer. Key applications of ISH technology include identifying and investigating mRNA expression in preserved tissue samples, using probes that are complementary to the concerned sequence, and molecular diagnosis of chromosomal integrity using Fluorescence ISH (FISH). Owing to the increasing use of the ISH technology for the detection of cancer and a rise in the aging population that is more prone to cancer, this technology segment is expected to witness significant growth over the forecast period.

Regional Insights

North America dominated the market for molecular diagnostics and accounted for the largest revenue share of 36.2% in 2020. This growth is attributed to rising consumer awareness, technological advancements, the growing prevalence of diseases, and better healthcare infrastructure. Europe accounted for a significant revenue share of 27.5% in 2020 and is expected to grow at a lucrative rate over the forecast period. This is attributed to the rising epidemiology of infectious as well as chronic diseases, thus encouraging the R&D activities, thereby boosting the market growth. High standard of living and consumer awareness about the early diagnosis, as well as the well-established healthcare system, acts as key drivers for growth.

In Asia Pacific, the market for molecular diagnostics is anticipated to exhibit the fastest CAGR of 5.7% during the forecast period, owing to increased market penetration and high unmet needs of the market, which are collectively driving the growth in this region. Constantly expanding patient pool, early prevention & diagnosis, and more targeted therapies are expected to boost the market in the region.

Key Companies & Market Share Insights

Players such as Roche are using a partnership strategy to enhance product capabilities and promote their product offerings. Roche Diagnostics Middle East (RDME) has entered into partnerships with several laboratories to achieve improved performance in terms of product safety, efficacy, and sustainability. In the COVID-19 pandemic, manufacturers are entering into partnerships to increase the supply of test kits. For instance, Novacyt partnered with the U.K. Department of Health and Social Care (DHSC) to supply COVID-19 tests. Under the agreement, Novacyt committed to supplying 288,000 tests per week to DHSC for six months from May 2020.

The market is competitive in nature. Manufacturers are required to update their products in terms of specificity, accuracy, and other parameters in order to gain a competitive edge. Some of the prominent players in the molecular diagnostics market include:

• BD

• bioMérieux SA

• Bio-Rad Laboratories, Inc.

• Abbott

• Agilent Technologies, Inc.

• Danaher

• Hologic Inc. (Gen-Probe)

• Illumina, Inc.

• Johnson & Johnson Services, Inc.

• Grifols, S.A.

• QIAGEN

• F. Hoffmann-La Roche, Ltd.

• Siemens Healthineers AG

• Sysmex Corporation

Molecular Diagnostics Market Report Scope 

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. 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, 2017 - 2028)

  • Instruments

  • Reagents

  • Others

• Test Location Outlook (Revenue, USD Million, 2017 - 2028)

  • Point-of-Care

  • Self-test or Over the Counter

  • Central Laboratories

• Technology Outlook (Revenue, USD Million, 2017 - 2028)

  • Polymerase Chain Reaction (PCR)

    • PCR, by Type

      • Multiplex PCR

      • Other PCR

    • PCR, by Product

      • Instruments

      • Reagents

      • Others

    • PCR, by Procedure

      • Nucleic Acid Extraction & Purification

      • Others

  • In Situ Hybridization (ISH)

    • 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 (TMA)

    • Instruments

    • Reagents

    • Others

  • Others

    • Instruments

    • Reagents

    • Others

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • 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 TB

    • 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, 2017 - 2028)

  • 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