According to Delvens, the Global Molecular Diagnostics Market is expected to reach USD 18,542 million by 2030 from USD 9,892 million in 2022, registering impressive expansion at a compound annual growth rate (CAGR) of 10.2%. Molecular Diagnostics Market by Product & Service (Reagents, Kits, Instruments), Test Type (Lab, PoC), Technology (PCR, INAAT, NGS, ISH), Application (Infectious, Oncology, Genetic Testing), End User (Diagnostic Labs, Hospitals) & Region, Supply & Demand Side Analysis, and Segment Forecasts, 2023-2030

Chicago, June 02, 2023 (GLOBE NEWSWIRE) -- The global market for molecular diagnostics is expected to reach USD 18,542 million by 2030 from USD 9,892 million in 2022, registering impressive expansion at a compound annual growth rate (CAGR) of 10.2%. Some of the major players are 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, and Sysmex Corporation among others.

Due to lowered immune function, multimorbidity, and physiological changes brought on by ageing, the geriatric population is more likely to contract COVID-19. Up to April 2020, around 95% of recorded fatalities among patients 60 years of age or older were reported, according to the WHO Regional Director for Europe. Furthermore, patients 80 years of age or older accounted for more than 50% of deaths.

Additionally, it is anticipated that throughout the projected period, the prevalence of infectious disorders will fuel market expansion. Additionally, it is anticipated that the target population would increase due to the rising prevalence of STIs like HIV and HPV, which will accelerate the market's expansion. Globally, HIV prevalence and incidence were estimated by the WHO to be about 37.7 million and 1.5 million, respectively, in 2020. Additionally, HIV-positive individuals are extremely vulnerable to other illnesses including TB, which is the primary killer of HIV-positive individuals.

The increasing efforts being made by industry participants to increase access to affordable resources are projected to fuel the expansion of the molecular diagnostics market. The use of molecular diagnostics in disease diagnosis is essential since it produces accurate and efficient results. However, one of the main barriers to this sector is the high cost of molecular testing.

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Molecular Diagnostics Market research report deals with many parameters in depth to satisfy the requirements of business or clients. Moreover, it also displays all the information including market definition, classifications, key developments, applications, and engagements along with the detailed actions of key players with respect to product launches, joint ventures, developments, mergers and acquisitions and effects of the same in terms of sales, import, export, revenue and CAGR values. A team of experienced and consummate market research professionals persistently track key industries to spot key developments, unmet needs and possible growth opportunities.

Molecular Diagnostics Market Report Scope

Molecular Diagnostics Market Overview

Infectious diseases like HIV are becoming more prevalent on a global scale. For instance, about 38.4 million individuals worldwide had HIV in 2021, according to the UNAIDS estimate from August 2022. There were 1.7 million kids and 36.7 million adults among them. As a result, the rising use of molecular diagnostics for HIV is expected to spur market expansion due to the increased incidence of infectious diseases like HIV.

The most effective way to recognise and describe a bacterium is thought to be molecular diagnostics. A successful test must be accurate, quick, and able to quantify the infectious load. Improved testing swiftly detects the strain of the organism and its drug susceptibility, shortening the time it takes to discover the best antibiotic. The discovery of antibiotic resistance genes and the provision of public health information, such as strain characterization by genotyping, have both been made possible by technological breakthroughs such as the polymerase chain reaction (PCR). Therefore, based on the aforementioned considerations, it is anticipated that the market would experience considerable expansion throughout the forecast period.

But it's anticipated that the lack of funding for R&D, the slowing economy, and the demand for facilities for complex testing would impede market expansion.

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Key Companies & Market Share Insights

Some of the key players operating in the global Molecular Diagnostics market are 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, and Sysmex Corporation among others.

Recent Developments

• F. Hoffmann-La Roche Ltd. (Switzerland) announced in September 2021 that it had acquired TIB Molbiol (Germany) to expand the range of infectious disease assays that were accessible in its portfolio of PCR testing.
• In June 2021, QIAGEN N.V. (Netherlands) joined up with Verogen (US) to diversify its NGS technology portfolio.
• In June 2021, Mobidiag Oy (Finland), a leader in acute care molecular diagnostic testing, was acquired by Hologic, Inc. (US), a pioneer in the field. This acquisition will expand Hologic's product line for molecular diagnostics.
• In November 2020, the FDA granted Hologic, Inc. (US) further approval for the use of the AptimaHIV-1 Quant Dx Assay as a tool for HIV infection detection.

Molecular Diagnostics Market Segmentation Analysis

Product Insights

With a revenue share of 66.1% in the molecular diagnostics market in 2022, the reagents sector had the greatest revenue share. Due to its widespread use in research and clinical settings, it is anticipated to maintain its supremacy in the next years. Standard reagents aid in obtaining reliable and timely results. It is envisaged that standardised outcomes, increased effectiveness, and cost-effectiveness will support market expansion. The market growth is also predicted to be boosted by the expanding usage of coronavirus detection tools, which were created for other infectious disorders. For instance, in countries that obtained the CE mark approval, Roche Diagnostics expanded its Covid RT-PCR assays offering to the new cobas 5800 system in February 2022.

Test Location Insights

Due to the significant number of Covid testing procedures performed in central laboratories, central laboratories represented the greatest revenue share of the market in 2022, accounting for 81.7% of total revenues. Another significant factor projected to drive the market is an increase in the number of efforts done by the government to provide various services, such as payment for diagnostic tests. The creation of molecular diagnostic platforms that can be applied in PoC situations is becoming more and more popular. For POC or near-patient testing, different businesses are developing assays and molecular diagnostic platforms. Additionally, market growth is predicted to be boosted by the expanding development of new assays that provide speedy PoC findings. For instance, in March 2020, Abbott introduced the ID NOW COVID-19 test, a molecular point-of-care test for the rapid identification of COVID-19.

Application Insights

The infectious disease had the greatest revenue share in the molecular diagnostics market in 2022, at 82.4%. The primary factor driving this market's domination is the rising prevalence of molecular diagnostics, particularly PCR tests, for the diagnosis of COVID-19. With the introduction of new technologies like PCR and ISH, the shortcomings of conventional testing have been mitigated, including their lack of sensitivity, lengthy turnaround times, poor in vitro kinetic development, difficulties in cultivating organisms in manually created culture conditions, and difficulty in growing organisms.

Regional Insights

European revenue contributed 28.1% of worldwide revenue in 2022. This is associated with the rise in infectious and chronic illness prevalence, which has fueled R&D initiatives and accelerated market growth. High standards of living, consumer knowledge of early diagnosis, and an established healthcare system are important determinants of expansion. Asia Pacific is expected to experience a CAGR of -0.4% over the anticipated year due to growing market penetration and huge unmet demand. Because of the region's expanding patient base, early identification, targeted treatment, and early prevention, the Asia Pacific market is expected to expand.

The use of molecular diagnostics has dramatically increased in India in recent years. This growth is the result of several factors, including the expanding use of Next-Generation Sequencing (NGS), the rise in the testing of infectious diseases like cancer, COVID-19, TB, and STDs, the demand for individualised medicine, and the development of artificial intelligence and machine learning. Due to how quickly and easily these technologies can be used to comprehend complex genetic data and improve the accuracy of diagnoses, the use of AI and machine learning for molecular diagnostics has gained great popularity in India.

Molecular Diagnostics Market Outlook

Drivers: increasing R&D emphasis and increasing funding for molecular diagnostics

The molecular diagnostics industry may grow as a result of government initiatives, financial efforts, and other activities to support and promote research and development. For instance, the Rapid Acceleration of Diagnostics (RADx) initiative of the NIH, which was launched in August 2020 and has $200 million in funding, is one example. The objective of this effort was to hasten the creation, adoption, and commercialization of technologies for COVID-19 testing. Additionally, the Collaborative Influenza Vaccine Innovation Centres (CIVICs) programme was introduced in 2019 by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the US National Institutes of Health (NIH), to support a wide range of influenza research activities, including the development of vaccines, diagnostics, and therapeutics against seasonal and pandemic influenza. 51 million USD in funding for CIVICs was announced by NIAID.

Opportunities: Opportunities for growth in emerging nations

The majority of players are turning their attention to emerging regions as the US and European markets mature. Upgrading laboratory facilities in emerging markets is crucial due to the significant investments made in healthcare and life science research in these nations. In turn, this encourages the installation of diagnostic equipment in labs and promotes the expanding use of molecular diagnostics.

Restraints: Unfavourable scenario for reimbursement

Over the past 40 years, medical testing has suffered a 40% decrease in reimbursement, according to MedPAC (Medicare Payment Advisory Commission). The use of novel diagnostic procedures in clinical laboratories will be significantly hampered by this drop and extra-budgetary worries among healthcare organisations.

The Medicare reimbursement rate for COVID-19 tests based on high-throughput technology has been decreased by the Centres for Medicare & Medicaid Services (CMS) to USD 75 unless labs can process results in less than two days. For people without a personal history of cancer, Medicare does not currently fund genetic testing (Source: American Society of Clinical Oncology). These elements are anticipated to harm the US molecular testing business.

Challenges: Operational Roadblocks

Clinical laboratories are still developing in all major markets; technicians must overcome practical obstacles to ensure efficient sample collection, storage, and transportation, particularly as they incorporate cutting-edge technology like NGS and lab-on-a-chip PCR machines. To prevent cross-contamination and maintain effective time management, laboratory premises also need to be modified to conduct particular molecular diagnostic tests needed for pathogen detection. This causes the maintenance and operation of modern molecular diagnostic instruments, particularly those able to handle a single sample type, to significantly increase in cost.

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Global Molecular Diagnostics Market Table of Contents

Product & Service Outlook

• Reagents & Kits
• Instruments
• Services & Software

Test Type Outlook

• Lab Tests
• PoC Tests

Technology Outlook

• Polymerase Chain Reaction (PCR)
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• DNA Sequencing & Next-generation Sequencing (NGS)
• In Situ Hybridization (ISH)
• DNA Microarrays
• Other Technologies

Regional Outlook 

• Europe
  • • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Sweden
    • Austria
    • Finland
    • Belgium
    • Turkey
    • Russia
    • Poland
    • Hungary
    • Czech Republic
    • Switzerland
    • Netherlands
    • Rest of Europe
• North America
  • • U.S.
    • Canada
    • Mexico
• Asia-Pacific
  • • Japan
    • China
    • India
    • Australia
    • South Korea
    • Vietnam
    • New Zealand
    • Philippines
    • Thailand
    • Malaysia
    • Hong Kong
    • Taiwan
    • Singapore
    • Indonesia
    • Sri Lanka
    • Rest of Asia-Pacific
• South America
  • • Brazil
    • Argentina
    • Chile
    • Colombia
    • Rest of South America
• Middle East And Africa
  • • South Africa
    • U.A.E.
    • Saudi Arabia
    • Oman
    • Qatar
    • Iran
    • Egypt
    • Rest of Middle East and Africa

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