Molecular Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents), By Test Location, By Technology (PCR, Sequencing, INAAT, TMA), By Application, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global molecular diagnostics market size was valued at USD 30.89 billion in 2022 and is expected to decline at a compounded annual rate of -0.4% from 2023 to 2030. The decrease in the market size can be attributed to the reduced demand for molecular COVID-19 testing throughout the forecast period. However, factors such as technological advancements, the rising elderly population, and increasing demand for genetic testing are boosting the growth of the market. In addition, rising demand for Point of Care (PoC) testing can be attributed to increasing demand for self-testing diagnostics, and patient awareness about faster diagnostics.

The outbreak of COVID-19 impelled the diagnostics industry into action, with a race to develop novel and rapid diagnostics kits for the detection of coronavirus. The pandemic led to a spike in the revenue of companies operating in the infectious diseases segment. For instance, in April 2021, a 59% rise in revenue was reported by Thermo Fisher Scientific, owing to the diagnostics division that delivered 150% growth. However, with the rising number of vaccinations globally, the demand for diagnostics for COVID-19 testing is likely to decline during the forecast period.

The rising geriatric population globally is increasing the risk of getting numerous diseases including cancer, cardiovascular diseases, obesity, neurological disorders, and diabetes. According to a UN report, in 2020, there were about 727 million people aged 65 years & above globally. In addition, the number of individuals aged 80 and above is projected to double by 2050, that is, to cross more than 1.5 billion. 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.

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 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.

In addition, the growing incidence of infectious diseases is expected to propel market growth over the forecast period. Moreover, the growing incidence of STIs, such as HIV and HPV, is expected to expand the target population, thereby boosting the market growth. According to WHO, globally, in 2020, the prevalence and incidence of HIV were approximately 37.7 million and 1.5 million, respectively. Furthermore, people suffering from HIV are highly susceptible to other infections such as tuberculosis, which is the leading cause of death among HIV-affected people.

The rising initiatives by market players to improve access to cost-effective resources are anticipated to drive the molecular diagnostics market growth. Molecular diagnostics render accurate & effective results and has indispensable applications in disease diagnostics. However, high prices associated with molecular tests are one of the major factors impeding this market.

Product Insights

The reagents segment accounted for the largest revenue share the molecular diagnostics market with a revenue share of 65.1% in 2022. It is expected to maintain its dominance 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 the market growth.

Furthermore, the growing use of instruments to detect coronavirus, which was earlier developed for other infectious diseases, is anticipated to boost the market growth. For instance, in February 2022, Roche Diagnostics extended its Covid RT-PCR tests portfolio to the new cobas 5800 system in countries that accepted the CE mark approval.

Test Location Insights

Central laboratories held the largest share of the market revenue share of 80.9% in 2022, attributable to high procedure volumes for Covid testing in central laboratories. 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.

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 & 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 market growth. For instance, in March 2020, Abbott launched a molecular point of care test, ID NOW COVID-19 test for the diagnosis of COVID-19 in less than 5 minutes.

Application Insights

The infectious disease segment accounted for the largest revenue share of 80.7% of the molecular diagnostics market in 2022. The increased usage of molecular, particularly PCR tests, for the diagnosis of COVID-19 is the major reason for the dominance of this segment. The drawbacks of traditional testing, such as long turnaround time, poor in vitro kinetic development, difficulty in growing organisms in manually prepared culture media, and the lack of sensitivity have been offset with technological advancements, such as PCR and ISH.

Oncology segment is expected to grow at a high CAGR during the forecast period. According to WHO, in 2020, an estimated 19.3 million new cancer cases were diagnosed globally; and about 10.0 million cancer deaths occurred in 2020. Cancer is estimated to be the second most common cause of death in the U.S. Furthermore, in January 2021, the British In Vitro Diagnostics Association has made efforts by calling out NHS England for the development of a commissioning framework for molecular diagnostics in oncology. This is aimed at improving the adoption as well as access to oncology molecular diagnostics. 

Technology Insights

The polymerase chain reaction (PCR) segment accounted for the largest revenue share of 71.8% in 2022. This is attributed to its use in the detection of COVID-19 and other infectious diseases. The increasing use of high-throughput PCR technology to detect infectious diseases and genetic diseases is expected to drive market growth. For instance, in Jan 2022, Seegene announced the launch of its upcoming Allplex SARS-CoV-2 Fast PCR Assay. The test has a turnaround time of 60 minutes and thus is suitable for mass testing.

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. Companies are launching new NGS-based tests for early disease diagnosis. For instance, in Jan 2022, Biodesix announced the launch of its GeneStrat NGS™ Test, a blood-based tumor profiling test, to guide physicians in treating advanced lung cancer based on mutations.

The sequence specificity of the ISH technique is a 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 usage of ISH technology for the detection of cancer and the rise in the aging population that is more prone to cancer, and the launch of new products, this technology segment is expected to witness market growth over the forecast period. For instance, in April 2019, Roche Diagnostics launched a new companion diagnostic test, VENTANA HER2 Dual ISH for breast cancer.

Regional Insights

Europe accounted for a revenue share of 27.4% in 2022. 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. 

Asia Pacific is anticipated to exhibit a CAGR of -0.6% during the forecast period, owing to increased market penetration and high unmet needs of the market. Constantly expanding patient pool, early prevention, diagnosis, and more targeted therapies are expected to boost the Asia Pacific market.

Over the past few years, there has been a significant surge in the field of molecular diagnostics in India. This growth can be attributed to several factors such as the increasing adoption of Next-Generation Sequencing (NGS), rise in infectious disease testing such as cancer, COVID-19, Tuberculosis (TB), and STDs, growing demand for personalized medicine, and increasing use of artificial intelligence and machine learning. In particular, the use of AI and machine learning in molecular diagnostics has gained considerable popularity in India as these technologies facilitate the interpretation of complex genomic data and improve the accuracy of diagnoses.

Key Companies & Market Share Insights

Players such as Roche are using mergers and acquisitions strategy to enhance product capabilities and promote their product offerings. For instance, in May 2021, Roche acquired GenMark Diagnostics for USD 1.8 billion. This acquisition will help Roche expand its molecular diagnostics portfolio. Furthermore, in December 2021, the company also completed the acquisition of TIB Molbiol Group. TIB Molbiol Group has around 45 CE-IVD approved assays for the diagnosis of infectious diseases, inherited genetic testing, transplant medicine, and hematology testing. Some prominent players in the global 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

Recent Developments

• In March 2023, BD announced that it had received FDA clearance for the BD Vaginal Panel on the BD COR System, which leverages BD's high-throughput molecular diagnostic platform to detect the 3 most common causes for infectious vaginitis.

• In April 2023, bioMérieux SA announced a partnership with Oxford Nanopore Technologies plc to bring the latter’s nanopore-based molecular sensing technology in the infectious diseases space. This sequencing technology monitors electrical current changes as nucleic acids pass through protein nanopore, with the signal then decoded to provide a specific RNA or DNA sequence.

• In April 2023, Bio-Rad Laboratories announced an acceleration to measurable residual disease (MRD) research through multiple collaborations with companies and institutions that are leveraging the company’s QX600 Droplet Digital PCR System.

• In December 2022, Fluid Management Systems and Agilent Technologies announced a co-marketing agreement for creating and marketing workflows for testing various persistent organic pollutants and contaminants in the food and environmental segments.

• In May 2023, Hologic announced that its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay had received clearance from the US FDA. The assay helps in the detection and differentiation of 4 of the highly prevalent respiratory virus, which may exhibit common clinical symptoms – influenza A, influenza B, (SARS-CoV-2), and respiratory syncytial virus.

• In March 2023, Illumina announced that the company’s first ‘Illumina Complete Long Read’ technology-based product became available to order. The ‘Illumina Complete Long Read Prep, Human’ assay is compatible with the Illumina NovaSeq X, the NovaSeq X Plus, and the NovaSeq 6000 Sequencing systems.

• In April 2023, QIAGEN announced the imminent availability of its QIAstat-Dx syndromic testing solution for use with a SARS-CoV-2 Respiratory Panel in Japan. This would be the company’s latest entry in what is currently over 100 markets globally.

• In June 2023, Roche announced that it had WHO prequalification for its cobas HPV test that is used on the cobas 6800/8800 Systems. This would allow for a wider availability of the HPV screening tools in nations that depend on WHO’s list for making purchase and implementation decisions.

• In February 2023, Siemens Healthineers announced a multi-year partnership with Unilabs, a notable provider of diagnostic services, for improving patient care by investing in its laboratory infrastructure. As part of the agreement, the initial years will see the installation of various analyzers and automation solutions by Siemens.

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 and opportunities in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global molecular diagnostics market report based on the product, test location, technology, application, and region: 

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Reagents

  • Others

• Test Location Outlook (Revenue, USD Million, 2018 - 2030)

  • Point-of-Care

  • Self-test or Over the Counter

  • Central Laboratories

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Polymerase chain reaction (PCR)

    • PCR, by Type

      • Multiplex PCR

      • Other PCR

    • PCR, by Product

      • Instruments

      • Reagents

      • 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, 2018 - 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

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Belgium

    • Switzerland

    • Netherlands

    • Poland

    • Austria

    • Denmark

    • Sweden

    • Turkey

    • Norway

  • 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

    • Kuwait

    • Egypt