Molecular Diagnostics Market

The global molecular diagnostics market size was valued at 43.89 billion in 2020 and is projected to register a substantial CAGR during the forecast period, 2021–2028. The growth of the market is attributed to the growing elderly population, technological advancements, and rising external funding for R&D.

The molecular diagnostics refers to the process of analyzing biological markers that are involved in a wide range of human ailments by using several testing techniques. These tests are a significant part of a successful healthcare system. Additionally, molecular diagnostics provides critical information that can help the patients and healthcare workers to make the appropriate medical decisions for a better outcome of a medical procedure.

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Molecular diagnostics also offers accurate measurements that are helpful in providing every stage of care and enable for successful management of the health conditions. Molecular diagnostic tools have favored the clinical setting, which further ensures to provide rapid and sensitive approaches for the detection of various infectious diseases, cancer, and other chronic diseases. Increasing demand for self-testing diagnostic and rising consumer awareness about quick diagnostics are some major aspects for rising demand for Point-of-Care (PoC) testing.

Increasing the geriatric population across the globe presents another key factor for rising cases of chronic illness, which in turn, boosting the demand for molecular diagnosis. For instance, in 2017, the UN estimated that there were around 962 million people aged 60 years and above worldwide. According to the WHO Regional Director for Europe, till April 2020, nearly 95% of the deaths of the region were reported among patients 60 years or older. Furthermore, more than 50% of deaths were reported to be occurred to patients, who were aged 80 years or above. Moreover, the number of individuals aged 80 years and above is anticipated to increase three times, from 137 million in 2017 to 425 million by 2050. Aging increases the risk of getting numerous diseases such as cancer, cardiovascular diseases, neurological disorders, obesity, and diabetes.

Market Drivers, Restraints, Trends, and Opportunities

• Rising prevalence of infectious diseases and chronic illness is expected to propel the demand for molecular diagnostics during the forecast period.
• Rapid technological advancements leading to accurate results, portability, and cost-effectiveness of the diagnosis are projected to boost the market growth during the forecast period.
• The emergence of COVID-19 pandemic has positively impacted the molecular diagnostic market. However, diagnostics virology entities are facing immense pressure to provide reliable testing kits, thereby, increasing the demand for in-vitro or point-of-care testing capacities by labs across various countries.
• Lack of expert technicians handling the diagnosis and lack of advanced healthcare facilities especially in developing regions act as major challenges that can hinder the market expansion.
• Massive ongoing R&D activities with a series of substantial investment from key players to develop innovative testing techniques are offering lucrative opportunities for the market development.

Scope of Molecular Diagnostics Market Report

The report on the global molecular diagnostics market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Global Molecular Diagnostic Market Segment Insights

Reagents segment projected to constitute a large market share

On the basis of products, the global molecular diagnostics market is divided into instruments, reagents, and others. The reagents segment is projected to constitute a large market share during the forecast period owing to the growing adoption of reagents in research and clinical settings. Standards reagents helps to achieve efficient and accurate results besides offering enhanced efficiency, cost-effectiveness, and standardized results. Moreover, the increasing adoption 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. Additonally, the growing adoption of molecular diagnostics with analyzer software at diagnostic centers is projected to spur the market growth. For instance, in July 2019, Mobidiag Ltd. merged into an agreement with Pro Med Diagnostics for Novodiag solution and Amplidiag solution distribution in African countries. Amplidiag solution is equipped with Amplidiag Analyzer software that automates the process of detection of Helicobacter pylori infection, C. difficile infection, and other infectious diseases.

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Central laboratories segment anticipated to represent a considerable market share

Based on test locations, the market is segmented into point-of-care (PoC), self-test or over the counter, and central laboratories. The central laboratories segment is anticipated to represent a considerable market share during the forecast period owing to various government initiatives encouraging a vast number of laboratory testing services and other benefits such as reimbursement for diagnostic tests. Emerging affiliation and partnership between various healthcare institutions towards working with laboratories to initiate several laboratory tests such a microbiology testing is another key aspect for the segment growth.

Meanwhile, the PoC segment is expected to expand at a healthy CAGR during the forecast period due to growing preference of the PoC settings in the development of molecular diagnostic platforms. Additionally, rapid development of new assays and platforms offering quick PoC results is projected to spur the market growth. For instance, in October 2018, the US FDA cleared Abbott’s Influenza A & B2 and Strep A2 assay for PoC testing, that are to be used on the ID NOW platform.

Polymerase Chain Reaction (PCR) segment anticipated to constitute a large share

Based on technology, the market is bifurcated into polymerase chain reaction (PCR), INAAT, sequencing, mass spectrometry, and TMA. The PCR segment is anticipated to constitute a large market share during the forecast period owing to its increasing use in the detection of infectious microorganisms such as viruses and bacteria. Multiplex PCR offer various benefits and applications over conventional PCR methodologies and growing use of high-throughput PCR technology to detect coronavirus are anticipated to spur the market growth. For instance, in April 2020, Mobidiag Ltd. received approval for emergency use for Amplidiag COVID-19 for clinical laboratories usage in Finland.

Meanwhile, the sequencing segment is anticipated to exhibit an impressive CAGR during the forecast period. Sequencing technologies consists of DNA sequencing processes and emerging NGS technologies, such as sequencing platforms and RNA sequencing. DNA sequencing technologies are linked to drug discovery, personalized medicine, and novel drug development. A substantial rise in the number of genome profiling initiatives & R&D for novel drugs and a decline in prices and sizes of DNA sequencers are projected to spur the molecular diagnostics market growth during the forecast period.

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Infectious disease segment projected to account for a significant market share

In terms of applications, the global molecular diagnostics market is classified as oncology, pharmacogenomics, infectious diseases, genetic testing, neurological disease, cardiovascular disease, microbiology, and others. The infectious disease segment is projected to account for a significant market share during the forecast period owing to molecular diagnostics forming the basis of medical diagnosis for COVID-19. Traditional testing methods have drawback such as long turnaround time, difficulty to grow organisms in manually prepared culture media, poor in vitro kinetic development, and the absence of sensitivity have been in the offset with recent technological advancements such as PCR and ISH.

The pharmacogenomics segment, however, is anticipated to expand at an impressive CAGR during the forecast period. In the pharmacogenomics sector, the application of molecular diagnostic techniques involves high testing of NCE that are required for novel drug development especially to a certain genetic profile. Individual drug response analysis helps to gain correlational insights between nucleotide polymorphism and drug metabolism.

Meanwhile, the oncology segment is anticipated to register a high CAGR during the forecast period owing to the massive investment in the field of oncology research and cancer drug discovery. Oncology offers various advantages in the molecular diagnosis performance by using specific biomarkers regarding to major cancer-causing genes and their manifestations. Early diagnosis of cancer-affected patients is possible by early identification of predictive biomarkers in molecular diagnosis and helps in the development of tailored medication for treatment.

North America anticipated to account for a large market share

In terms of regions, the global molecular diagnostics market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is anticipated to account for a large market share during the forecast period. The growing prevalence of diseases, rising consumer awareness, technological advancements, and improved healthcare infrastructure are the major factors driving the regional market growth. Additionally, improved standard of living and consumer awareness about the early diagnosis as well as introduction of well-established healthcare system are further boosting the market growth.

Meanwhile, the market in Asia Pacific is projected to expand at a substantial CAGR during the forecast period due to the increasing market penetration and high unmet needs of the market in the region. Continuously growing patient pool, early prevention & diagnosis, and growing awareness of diagnosis benefits are projected to fuel the market growth in this region.

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Segments

The global molecular diagnosis has been segmented on the basis of

Products

• Instruments
• Reagents
• Others

Test Locations

• Point-of-Care
• Self-test or Over the Counter
• Central Laboratories

Technology

• Polymerase Chain Reaction (PCR)
• INAAT
• Sequencing
• Mass Spectrometry
• TMA

Applications

• Oncology
• Pharmacogenomics
• Infectious Diseases
• Genetic Testing
• Neurological Disease
• Cardiovascular Disease
• Microbiology
• Others

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

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

Competitive Landscape

Some of the key players in the global molecular diagnosis market include 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, and Sysmex Corporation.

Major companies are using partnership strategy to improve product capabilities and enhance their product offerings. Roche Diagnostics Middle East (RDME) has entered into partnerships with several laboratories to achieve improved performance such as product safety, efficacy, and sustainability. Owing the COVID-19 pandemic, manufacturers are consistently adopting to forge partnerships agreement to increase the supply of test kits.

For instance, Novacyt merged with the U.K. Department of Health and Social Care (DHSC) to supply COVID-19 tests. Under this agreement, Novacyt committed to supplying 288,000 tests per week to DHSC for six months from May 2020.

Companies are also focusing on product upgrade by implementing innovative techniques to acquire specific and accurate results. For instance, Sigma Aldrich Corporation and QIAGEN are focusing on diagnosis of tumors by developing new technologies, such as Transcription-Mediated Amplification (TMA) and Loop-Mediated Isothermal Amplification (LAMP).

Further, in July 2019, F. Hoffmann-La Roche Ltd. announced the expansion of its Global Access Program beyond HIV and included HPV and other infectious diseases to improve access to early detection and diagnostics for low and middle-income countries.