Molecular Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents), By Test Location (Point of Care, Self-Test), By Technology, By Application, By Region, And Segment Forecasts, 2025 - 2030

Molecular Diagnostics Market Summary

Furthermore, the rising popularity of Point-of-Care (POC) testing is fueled by the growing need for self-diagnostic tools and increased patient awareness of the advantages of quicker diagnostic results. This trend is motivating companies to innovate and launch new testing products. For instance, in February 2023, Huwel Lifesciences developed a portable RT PCR machine capable of testing various viruses, including respiratory diseases and STDs, in about 30 minutes. Designed for use in clinics and corporate settings, it offers high accuracy similar to traditional PCR tests without needing specialized training or environments.

The increase in the global elderly population is a major factor driving the market growth. According to the World Population Prospects 2022, the global elderly population aged 65 years and above is expected to increase from approximately 10% in 2022 to around 16% in 2050. The older population is more vulnerable to chronic and infectious diseases, such as cancer, cardiovascular ailments, diabetes, and neurodegenerative disorders, which create a demand for advanced diagnostic technologies. Molecular diagnostics, recognized for their accuracy and capability to identify diseases at an early stage, are becoming increasingly essential for addressing the healthcare requirements of the aging demographic. 

As the demand for point-of-care testing (POCT) continues to rise, various trends are transforming the market and promoting its integration within the molecular diagnostics field. Recently, there has been a notable shift towards increased specialization in clinical departments, with tailored designs emerging to address specific diagnostic requirements across a range of medical applications. This development aligns with the rising trend towards healthcare decentralization, where larger diagnostic devices become available in smaller facilities, and POCT products are designed for enhanced precision, speed, and cost-effectiveness.

Market participants are significantly involved in creating innovative point-of-care (POC) testing products to grab emerging market opportunities. For instance, in November 2024, an innovative pilot program for self-collected HPV screening was initiated in Texas, aimed at enhancing access to cervical cancer screening in underserved communities. This initiative, conducted at Su Clinica Federally Qualified Health Center (FQHC) in partnership with The University of Texas MD Anderson Cancer Center, is designed to assess the effectiveness of self-collection testing in practical healthcare environments. By employing the FDA-approved BD Onclarity HPV Assay, the study tackles significant obstacles to cervical cancer screening, such as geographic and socioeconomic disparities, while exploring effective strategies to enhance healthcare delivery. In addition, the program promotes the adoption of POC testing by showcasing its feasibility and effectiveness in addressing public health issues. By validating the use of self-collection methods in resource-limited settings, this initiative aims to increase confidence among healthcare providers and policymakers regarding the implementation of similar technologies for wider applications.

Market Concentration & Characteristics

The market growth stage is low, and the pace is accelerating. The molecular diagnostics industry is characterized by a low degree of growth due to the rising geriatric population base, increasing demand for point-of-care testing, increasing R&D funding, and the increasing introduction of technologically advanced products.

The molecular diagnostics industry is characterized by a high degree of innovation owing to increasing efforts by market players to develop innovative solutions to increase their market presence. For instance, in March 2023, Sysmex Life Science launched the Sentifitr 800 analyzer, a fully automated and high-throughput device designed for fecal immunochemical testing. This new product enhances diagnostic efficiency, supporting laboratories in delivering rapid and accurate results while expanding Sysmex's product offerings in the life sciences sector.

The regulatory landscape significantly influences the molecular diagnostics industry, presenting both challenges and opportunities, as a streamlined regulatory framework can enhance product approval processes, enhance innovation, and ensure high-quality testing. However, stringent regulations may delay product development and increase costs, limiting access to advanced diagnostics. For instance, according to an article published by Yale School of Medicine in February 2024, Yale experts are concerned over the FDA's proposed ruling to regulate laboratory-developed tests (LDTs), fearing it may limit access to crucial diagnostics, particularly for rare diseases. The ruling could hinder rapid responses to pandemics and increase costs, ultimately compromising patient care and safety despite intentions to enhance regulation.

The molecular diagnostics industry is witnessing significant mergers and acquisitions (M&A) activity as strategic M&A activities allow companies to enhance their product portfolios and expand their market presence, positioning themselves competitively in the market. For instance, in January 2023, Thermo Fisher Scientific completed its acquisition of The Binding Site Group, enhancing its specialty diagnostics segment, particularly in oncology testing for multiple myeloma. This acquisition is expected to improve patient outcomes through advanced diagnostic technologies.

The threat of substitutes in the molecular diagnostics industry is significant due to the presence of alternative testing methods, such as immunoassays and traditional microbiology tests. However, this threat is not high because molecular diagnostics offer enhanced accuracy and specificity, which are crucial for early disease detection and personalized medicine. In addition, advancements in technology and the growing demand for point-of-care testing further enhance the demand for molecular diagnostics over substitutes.

The molecular diagnostics industry has a significant end-user concentration, primarily among hospitals, diagnostic laboratories, research institutions, and others. Hospitals are among the key players, benefiting from increased patient hospitalizations and government support for advanced diagnostic technologies. This concentration highlights the crucial role these facilities play in the adoption and utilization of molecular diagnostics.

Product Insights

The reagents segment led the market with the largest revenue share of 65.44% in 2024, and is expected to witness at the fastest CAGR of 4.18% over the forecast period. This can be attributed to the increasing demand for accurate and efficient diagnostic tools across various healthcare sectors, including oncology, infectious diseases, and genetic disorders. Reagents, which include enzymes, probes, primers, and buffers, are critical components in molecular diagnostic tests such as PCR, NGS, and digital PCR. Moreover, the continuous innovation and launch of novel products by key industry players are further contributing to the segment growth. For instance, in April 2023, Cepheid, a subsidiary of Danaher, revealed plans to introduce new tests for infectious diseases, including respiratory illnesses and tuberculosis. These advancements are expected to improve efficiency, standardize results, and reduce costs, supporting the overall market expansion.

The instruments segment is expected to witness at a significant CAGR during the forecast period, owing to the increasing demand for early disease detection, particularly in oncology, infectious diseases, and genetic disorders. Technologies such as PCR, NGS, and microarrays are crucial for diagnosing conditions such as cancer, HIV, and genetic diseases. With the global cancer burden expected to rise to 30 million new cases by 2040 and cancer diagnoses in the Americas predicted to reach 6.23 million, a 57% increase, the need for accurate diagnostics is also anticipated to increase significantly.

Test Location Insights

Based on test location, the central laboratories segment led the market with the largest revenue share of 78.8% in 2024, owing to advancements in laboratory technology, including automation and integration, which significantly enhance testing efficiency and throughput. Central laboratories are capable of managing a large volume of tests, ensuring faster and more precise diagnoses, and their role in disease detection, monitoring, and personalized medicine continues to drive the market forward. Moreover, key market players are continuously developing and offering laboratory-based molecular diagnostic solutions. For instance, in September 2024, QIAGEN released the QIAcuityDx Digital PCR System, a significant innovation in molecular diagnostics. This system, designed for clinical testing in oncology, provides precise quantification of DNA and RNA, supporting applications such as cancer monitoring through liquid biopsies. With integrated partitioning, thermocycling, and imaging, the QIAcuityDx system reduces laboratory space and costs while offering increased throughput, precision, and faster processing times.

The self-test or OTC segment is expected to witness at the fastest CAGR over the forecast period. This can be attributed to the increasing consumer demand for at-home health monitoring solutions. This segment enables individuals to perform diagnostic tests in the comfort of their homes without the need for clinical intervention. The rising focus on convenience, privacy, and cost-effective healthcare solutions has accelerated the adoption of self-test kits for conditions such as infectious diseases, genetic testing, and wellness monitoring. Technological advancements in test accuracy and ease of use are further enhancing the segment's growth, positioning it as a key player in personalized healthcare.

Technology Insights

Based on technology, the PCR segment led the market with the largest revenue share of 68.0% in 2024. PCR technologies encompass several methods, such as quantitative PCR, reverse transcription PCR, inverse PCR, and multiplex PCR, with multiplex PCR emerging as a preferred method for its ability to detect multiple targets simultaneously. Real-time PCR has become particularly important for cancer marker analysis, contributing to the growing use of high-throughput PCR techniques for cancer detection. The development of digital PCR systems has further fueled segment growth. For instance, Thermo Fisher Scientific's 2023 release of the QuantStudio Absolute Q AutoRun dPCR Suite automates lab processes, improving efficiency and reducing costs, while Roche’s Digital LightCycler System launched significantly advanced cancer detection methods in 2022.

The ISH segment is expected to witness at the fastest CAGR during the forecast period, owing to recent launches, including RNAscope ISH probes for B-cell lymphoma and HPV detection, enhance diagnostic precision, support clinical applications, and cater to the rising demand for advanced cancer diagnostic tools. For instance, in May 2023, Bio-Techne launched Kappa and Lambda RNAscope ISH Probes as ASRs for detecting immunoglobulin kappa and lambda light chain mRNA in B-cells. These probes aid in assessing B-cell clonality, which is crucial for diagnosing B-cell lymphomas. Unlike traditional methods, RNAscope probes offer high sensitivity, especially for FFPE tissues. The new probes support laboratory-developed tests (LDTs) and are compliant with GMP standards, enhancing accuracy in clinical diagnostics and research.

Application Insights

Based on application, the infectious disease segment led the market with the largest revenue share of 63.1% in 2024. This can be attributed to the rising demand for rapid and accurate detection of pathogens. Molecular diagnostic techniques, such as polymerase chain reaction (PCR) and next-generation sequencing, have revolutionized the identification of infectious agents, enabling healthcare providers to diagnose conditions such as tuberculosis, HIV, and various viral infections more efficiently than traditional culture methods. Moreover, key market players contribute to the growth of the infectious disease by developing innovative, rapid, and accurate diagnostic technologies. For instance, in May 2022, BD launched the fully automated BD COR MX system in the U.S., which processes up to 1,700 specimens with minimal staff interaction. The system first detects three common STIs: Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. This system improves efficiency and enables labs to handle higher volumes of tests, particularly for women’s health and STI testing.

The oncology segment is expected to witness at a significant CAGR during the forecast period, owing to the increasing demand for early detection, personalized treatment, and monitoring of cancer therapies. Molecular diagnostic technologies are essential for identifying genetic mutations, cancer biomarkers, and tumor-specific variations that guide treatment decisions. Moreover, the increasing global prevalence of cancer is a key factor driving segment growth. As per American Cancer Society estimates, in 2022, around 1,918,030 new cases of cancer were reported in the U.S., and around 609,360 individuals in the U.S. died due to cancer. Hence, oncology holds one of the largest shares in the applications segment.

Regional Insights

North America dominated the molecular diagnostic market with the largest revenue share of 40.95% in 2024, owing to the growing adoption of molecular diagnostics, which are valued for their superior accuracy, sensitivity, and specificity. The rising demand for genetic testing, particularly for personalized healthcare in conditions such as diabetes and cancer, is anticipated to fuel market expansion. Moreover, the increasing regulatory support for advanced solutions further contributes to market growth. For instance, in 2022, Myriad Genetics, Inc. received U.S. FDA approval for its BRACAnalysis CDx test as a companion diagnostic. This test identifies patients with germline BRCA mutations (gRBCAm) in HER2-negative, high-risk early-stage breast cancer who may benefit from treatment with Lynparza (olaparib).

U.S. Molecular Diagnostics Market Trends

The molecular diagnostics market in the U.S. is driven by the presence of key market players, favorable reimbursement policies, developed R&D infrastructure, and the rising prevalence of various health conditions in the country. For instance, according to the American Cancer Society, over 2 million new cancer cases are projected to be diagnosed in the U.S. in 2024. This figure excludes basal and squamous cell skin cancers, which are not mandatory for reporting to cancer registries, as well as noninvasive carcinoma in situ, with the exception of urinary bladder cases. These factors are expected to contribute to the market growth in the U.S.

The Canada molecular diagnostics market is expected to witness at a significant CAGR over the forecast period. The rising number of cancer cases highlights an increasing need for advanced molecular diagnostics to enable early detection and personalized treatment are driving market growth. According to the Canadian Cancer Society, an estimated 247,100 Canadians are expected to be diagnosed with cancer in 2024, up from 239,100 new cases in 2023. This increase is largely attributed to Canada's growing and aging population. In addition, cancer-related deaths are projected to rise from 86,700 in 2023 to 88,100 in 2024. Such a rise in the prevalence of cancer in the country is expected to fuel the market growth in the country.

Europe Molecular Diagnostics Market Trends

The molecular diagnostics market in Europe is anticipated to witness at a significant growth, driven by the increasing prevalence of genetic and cardiovascular disorders and growing investments in proteomics & genomic research initiatives. According to WHO data from 2024, cardiovascular diseases (CVDs) are the leading cause of disability and premature death in the European Region, responsible for over 42.5% of all deaths annually. This equates to approximately 10,000 deaths per day. Thus, the rising CVD population is expected to boost demand for molecular tests during the forecast period.

The UK molecular diagnostics market is experiencing significant growth, driven by the presence of developed healthcare infrastructure, high disposable income, and growing awareness about the benefits of early diagnosis. In April 2024, the rollout of community diagnostic centers (CDCs) across England is set to address long waiting lists, provide better value for taxpayers, and contribute to decarbonizing the NHS. Such efforts to enhance the efficiency of the country’s healthcare sector and services are further expected to fuel the market growth over the forecast period.

The molecular diagnostics market in Germany is driven by the increasing demand for faster, more accurate diagnostic solutions across various therapeutic areas, particularly infectious diseases, oncology, and genetic disorders. Moreover, the country’s growing geriatric population base further contributes to market growth. According to the UN’s population data, one in every 20 people in Germany is over 80 years old, which is expected to increase to one in every six individuals by 2050. This population has a higher risk of chronic diseases, such as diabetes, cardiovascular diseases, and neurovascular disorders, due to the onset of senescence & decreased immunity levels.

Asia Pacific Molecular Diagnostics Market Trends

The molecular diagnostics market in the Asia Pacific region is driven by a high burden of various conditions such as TB, drug-resistant TB, multi-drug-resistant (MDR-TB), and rifampicin-resistant (RR-TB) TB cases. For instance, according to the WHO Global TB Report 2023, the WHO South-East Asia (SEA) Region, which was home to approximately one-fourth of the global population, carries a significant burden of tuberculosis (TB), accounting for over 45% of the annual TB incidence. In 2022, more than 4.8 million people in this region fell ill with TB, and over 600,000 people died from the disease, excluding HIV-related TB mortality. This represents more than half of all global TB-related deaths. Moreover, the developing healthcare infrastructure and growing geriatric population further contribute to this growth in the region.

The China molecular diagnostics market is anticipated to witness at a significant CAGR during the forecast period, driven by the rising geriatric population, increasing R&D initiatives, and increasing demand for effective diagnostics solutions in the country. For instance, in December 2020, Genetron Health announced the launch of a novel cancer screening kit worth USD 765, facilitating the assessment of risk for eight types of cancer. Similarly, AnchorDx received funding of USD 40 million to develop screening and diagnostic tests. Such initiatives are expected to fuel the market growth in the country.

Latin America Molecular Diagnostics Market Trends

The molecular diagnostics market in Latin America is experiencing significant growth, primarily driven by the rising R&D initiatives in the country, the rising prevalence of chronic diseases, and the growing geriatric population. Furthermore, key players and organizations are adopting strategic initiatives to increase their regional presence, fueling market growth during the forecast period. For instance, In September 2023, the Pan American Health Organization (PAHO) partnered with FIND to enhance the availability of essential diagnostic tests across Latin America and the Caribbean.

Middle East and Africa Molecular Diagnostics Market Trends

The molecular diagnostics market in the Middle East and Africa (MEA) is experiencing significant growth, driven by the increasing prevalence of chronic conditions, such as cancer, cardiovascular diseases, and other diseases is expected to accelerate market growth. According to WHO estimates, in 2020, cancer incidence in the Middle East is expected to double by 2030. Around 9 out of 22, countries in the MEA did not have optimal operational facilities to deal with cancer. Economic development and the presence of high unmet healthcare needs-witnessed in emerging markets such as South Africa are also contributing to the market growth.

The Saudi Arabia molecular diagnostics market is experiencing significant growth, driven by various factors, such as the rising prevalence of non-communicable diseases, including cardiovascular diseases (CVDs) and diabetes. According to ScienceDirect, the prevalence of CVDs is estimated to reach 479,500 by 2035. Similarly, according to the International Diabetes Atlas, in 2021, over 4.27 million people in the country had diabetes. In 2023, the nation is anticipated to witness a diagnosis of over 31,000 new cancer cases. Chronic diseases need constant support from diagnostics and immunoassays to make treatment possible. Hence, the growing prevalence is expected to create growth opportunities. 

Key Molecular Diagnostics Company Insights

Key market players are adopting various strategic initiatives such as launches, partnerships, collaborations, mergers & acquisitions, approvals, expansion, and others to increase their presence in the global molecular diagnostics market. These advancements in the molecular diagnostics industry are anticipated to boost market growth over the forecast period.

Recent Developments

• In August 2024, Sysmex Corporation expanded its strategic alliance with QIAGEN to enhance genetic testing, focusing on research, development, production, clinical trials, and global sales marketing.

• In January 2023, QIAGEN announced the launch of its EZ2 Connect MDx platform, aimed at enhancing its automation capabilities for sample processing. The platform will be compatible with dPCR, PCR, and other downstream applications.

• In February 2023, BD received FDA Emergency Use Authorization for a molecular diagnostic test that detects COVID-19, influenza A/B, and RSV. The test, for use with the BD MAX System, provides results in under two hours from a single nasal or nasopharyngeal swab, improving testing efficiency during respiratory virus seasons.

• In April 2023, Quest Diagnostics Incorporated acquired the MRD Platform of Haystack Oncology. It is an early-stage business specializing in testing for Minimal Residual Disease (MRD). 

Molecular Diagnostics Market Report Scope

Global Molecular Diagnostics Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends 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

  • Regards

  • Others

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

  • Point of care

  • Self-test or OTC

  • Central laboratories

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

  • Polymerase chain reaction (PCR)

    • PCR, by Procedure

      • Nucleic Acid Extraction

      • Others

    • 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

  • 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

    • Kidney

    • Liver

    • Blood

    • Lung

    • Other

  • Pharmacogenomics

  • Infectious disease

    • MRSA

    • Clostridium difficile

    • Vancomycin-resistant enterococci

    • Carbapenem-resistant bacteria testing

    • Flu

    • Respiratory syncytial virus (RSV)

    • Candida

    • Tuberculosis and drug-resistant TB

    • Meningitis

    • Gastro-intestinal panel testing

    • Chlamydia

    • Gonorrhea

    • HIV

    • Hepatitis C

    • Hepatitis B

    • Other Infectious Diseases

  • Genetic testing

    • Newborn screening

    • Predictive and presymptomatic testing

    • Others

  • Neurological disease

  • Cardiovascular disease

  • Microbiology

  • Others

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

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait