Molecular Diagnostics Market Size to Reach Around US$ 59.3 Billion by 2030

The global molecular diagnostics market size is expected to reach around US$ 59.3 billion by 2030, according to a new report by Vision Research Reports.

The global molecular diagnostics market size was valued at US$ 46.2 billion in 2020 and is anticipated to grow at a CAGR of 4.9% during forecast period 2021 to 2030.

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Growth Factors

This growth is owing to factors such as an increasing geriatric population, the outbreak of COVID-19, and the growing demand for point-of-care facilities.

Molecular diagnostics play an important role in infectious disease testing as they can yield effective and fast results. Hence, the increasing prevalence of hospital-acquired infections and infectious diseases is projected to drive the market over the forecast period. Increasing incidence of cardiovascular, neurological, and genetic disorders is further anticipated to accelerate market growth.

Companies expanding their regional presence owing to approval of COVID-19 IVD tests are expected to boost the market growth. For instance, Vela Diagnostics received the CE-IVD mark for ViroKey SARS-CoV-2 RT-PCR Test. It is a probe-based RT-PCR test used on Applied Biosystems 7500 Fast Dx instrument to detect SARS-CoV-2. The CE-IVD mark has enabled Vela diagnostics to expand its COVID-19 test in Europe.

Key players are enhancing their range of testing options for real-time PCR instruments by increasing R&D activities for the development of kits that target emerging diseases, or by entering into agreements with other kit manufacturing companies. These include the introduction of Cobas HPV test assay in Cobas 4800 by Roche Diagnostics. The introduction of tuberculosis testing Xpert assay on GeneXpert platform by Cepheid is an example of such advancement. Such advances are anticipated to drive the market. 

Scope of The Report

Report Highlights

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.

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.

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.

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 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.

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.

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Opportunities

Growing R&D Investments to Drive the Market Growth

The demand for molecular testing is expected to drive growing funding by governments and numerous organisations for R&D in molecular diagnostics. The availability of R&D funds and increasing government support for the life sciences sector are expected to boost molecular diagnostics market growth in this region.

Restraints

Stringency Of Molecular Diagnostics Regulations Likely to Impede Market Growth

In the pharmaceutical, biotechnology, and medical technology sectors, the regulatory framework for approvals has always been a major restrictive factor. Inaccurate results could be provided by faulty diagnostic kits. Therefore the strictness of regulations associated with the approval process for molecular diagnostics limits molecular diagnostics market growth.

Key Market Trends

Instruments Segment is Expected to Hold Significant Market Share Over the Forecast Period

Molecular diagnostics plays a vital role in the assessment of disease prognosis and therapy response, as well as in the detection of minimal residual disease. In the past decade, molecular diagnostics has grown, due to advances in chemistries and instrumentation, including automation, integration, throughput, and the ability to use the instrumentation in a random-access mode.

The impact of COVID-19 on molecular diagnostics instruments is positive because during the pandemic US FDA has been approved many instruments in the diagnosis of COVID-19. For instance, in July 2020, FDA granted an amendment, to add the Promega Maxwell RSC 48 as an authorized extraction instrument for use with the CDC 2019-nCoV rRT-PCR Diagnostic Panel.

Additionally, in July 2020, Roche Diagnostics India launched the Cobas 8800 instrument at the National Institute of Cholera and Enteric Diseases, Kolkata, and Cobas 6800 at the National Institute for Research in Reproductive Health, Mumbai, to aid with SARS CoV-2 diagnostic testing. Roche’s Cobas 6800/8800 systems provide test results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-time results.

Some of the sophisticated instruments used in this market are high-performance liquid chromatography (HPLC), mass spectrometry (MS), and nuclear magnetic resonance (NMR), along with real-time PCR, enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), lateral flow devices, patient safety syringes, and point-of-care testing devices, among others.

Furthermore, with the tremendous opportunity in in vitro diagnostics, many market players are adopting various strategies, such as collaborations, acquisitions, new products launches, and expansions, into the Asia Pacific Market.

For instance, in January 2020, Illumina received product approval from Pharmaceuticals and Medical Devices Agency (PMDA), Japan for MiSeqDx instrument. This approval allows for the distribution of the MiSeqDx as a Class I medical device in Japan, which shows a positive impact on the market.

Thus, owing to the factors mentioned above, it is expected to drive market growth over the forecast period.

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Key Players

• 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

Market Segmentation

• Product Outlook
• Instruments
  • Reagents
  • Others
• Test Location Outlook
  • Point-of-Care
  • Self-test or Over the Counter
  • Central Laboratories
• Technology Outlook
  • 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
  • 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
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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