Molecular Diagnostics Market Size & Share, Market Research and Industry Forecast Report, 2020-2027 (Includes Business Impact of COVID-19)

                                          
Industry Insights, Market Size, CAGR, High-Level Analysis: Molecular Diagnostics Market


The global molecular diagnostics market size was valued at USD 9.2 billion in 2019 and is anticipated to register a CAGR of 9.0% over the forecast period. Advancements in molecular diagnostics have facilitated the detection of numerous diseases and are particularly effective when faced with challenging differential diagnosis.
Technological advancements in molecular diagnostics are anticipated to substantially drive the market growth as they facilitate cost-effectiveness, accuracy, and portability. The commercialization of MinION, an affordable and portable sequencer by Nanopore Technologies, is suitable for use in small laboratories and point-of-care facilities, which is projected to boost the market for molecular diagnostics.

According to the WHO, the average prevalence rate of hospital-acquired infections in 2019 was 4.5% and 7.1% in U.S. and Europe, respectively. Molecular diagnostics play an essential role in the testing of infectious diseases as they offer quick and effective results. Thus, the growing prevalence of hospital-acquired infections and infectious diseases are further estimated to drive the demand for molecular diagnostics over the forecast period.

Growing funding by governments and numerous organizations for R&D in molecular diagnostics is anticipated to drive the demand for molecular testing. Funding plays a significant role in product development process. For instance, Accelerate Diagnostics received USD 19.5 million from various entities, such as Oracle Partners, Oracle Institutional Partners, and the Schuler Family Foundation, to enhance the development and sales of infectious disease in vitro diagnostics tests and tools.

The regulatory framework for approvals has always posed major restrictive factors on pharmaceutical, biotechnology, and medical technology industries. Faulty diagnostic kits could provide inaccurate results. Hence, the possibility of causing harm to the patients has driven the FDA to ensure compliance with premarketing regulations. The regulatory environment is already complicated, and the FDA is becoming increasingly careful owing to the growing dependency on molecular diagnostics for making critical medical decisions.

The U.S. FDA also conducts post-market investigation of in vitro diagnostic device (IVD) products to ensure parity between performance and claims. For instance, a heavy penalty was imposed on Nichols Institute, a subsidiary of Quest Diagnostics, as its test kits produced results that were inaccurate and unreliable. Hence, the stringency of regulations associated with the approval process for molecular diagnostics is limiting market growth.

Product Insights of Molecular Diagnostics Market

In 2019, reagents dominated the overall market for molecular diagnostics. High usage of reagents in molecular diagnostic testing, increased demand for over-the-counter diagnostic tests, and rise in adoption of these tests in nonmedical facilities such as self-testing at home are some of the key growth drivers for the segment. Furthermore, advantages such as standardized results, improved efficiency, and cost-effectiveness are anticipated to support the segment growth.

The key players offering reagents are Roche Diagnostics; Illumina Inc.; and Abbott. Reagents is also projected to be the fastest-growing segment over the forecast period. This can be attributed to the growing demand for advanced cancer diagnostic tests and genetic testing in countries with unmet medical needs, such as South Africa and India.

Test Location Insights

Central laboratories dominated the market for molecular diagnostics in 2019 due to high procedure volume and significant presence of ancillary support in terms of infrastructure and manpower.
Point-of-Care (PoC) is estimated to be the fastest-growing segment over the forecast period. Rising demand for bedside patient care with the booming home healthcare market and increasing market penetration are among the major factors driving the segment growth. Furthermore, rising adoption of self-testing or OTC products, increased awareness of molecular testing among patients, and development in healthcare infrastructure are projected to drive the growth of the segment.

Technology Insights of Molecular Diagnostics Market

PCR dominated the overall market for molecular diagnostics in 2019. PCR is the most widely used technology in molecular diagnostics. Increased usage and advancements in PCR techniques, e.g., multiplex PCR, are some of the highest impact rendering drivers of this segment.

Sequencing is projected to witness the highest growth rate over the forecast period. This is attributed to 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 a substantial growth rate during the forecast period. Increasing prevalence of cancer and need for early cancer diagnosis are some of the drivers of this segment.

Application Insights of Molecular Diagnostics Market

Infectious disease testing dominated the molecular diagnostics market in 2019, given the relapse of infectious diseases, including new strains of multidrug-resistant TB, H1N1, and HIV. Most molecular diagnostic tests are designed for detecting infectious diseases; however, molecular testing is becoming increasingly popular in other spaces, mainly in oncology.

Oncology is expected to be the fastest-growing segment over the forecast period owing to factors such as increasing prevalence of cancer and development of advanced diagnostic tests such as companion diagnostics. Companion diagnostics are based on the concept of personalized medicine and involve the identification of biomarker response in a population of patients with the same type of cancer. Moreover, the introduction of such advanced molecular diagnostic technologies will prove to be cost-effective, subsequently driving the growth of the oncology segment.

Regional Insights of Molecular Diagnostics Market

North America was the largest revenue generating region for molecular diagnostics in 2019 and this trend is expected to continue over the forecast period. North America dominated the market 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.

Increasing government initiatives in Asia Pacific, particularly in economies such as China and India, to improve healthcare infrastructure are expected to drive the demand for molecular diagnostics in the region. Asia Pacific is projected to witness the fastest growth over the forecast period owing to unaddressed clinical needs and the rising demand for improved diagnostic technologies such as molecular testing.

Market Share Insights of Molecular Diagnostics Market

Key players in the global market include Roche Diagnostics; Abbott; Bio-Rad Laboratories, Inc.; Siemens Healthcare GmbH; Alere, Inc.; Bayer AG; Dako; Hologic, Inc. (Gen probe); Sysmex Corporation; Danaher; Johnson & Johnson; Novartis AG; Qiagen N.V.; Becton, Dickinson and Company; Cepheid; and bioMerieux SA.
Key players are adopting various strategies such as mergers and acquisitions to increase their market share. For instance, Qiagen acquired STAT-Dx, a Spanish firm developing next-generation multiplex diagnostics using a novel system based on real-time PCR and Qiagen chemistries. Players are also focusing on expanding their product portfolio. For instance, in 2019, Roche launched the first IVD ROS1 IHC assay-VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody-for the detection of ROS1 protein in cancers.

Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Molecular Diagnostics Market Research Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2019 to 2030. For the purpose of this study, this market research report has segmented the global molecular diagnostics market report on the basis of product, test location, technology, application, and region:

Product Outlook (Revenue, USD Million, 2019 - 2030)

  
Instruments
  
Reagents
  
Others

Test Location Outlook (Revenue, USD Million, 2019 - 2030)

  
Point-of-Care
  
Self-Test or Over the Counter
  
Central Laboratories

Technology Outlook (Revenue, USD Million, 2019 - 2030)

  
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, 2019 - 2030)

  
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