According to Precedence Research, the worldwide molecular diagnostics market revenue was valued at $43.68 billion in 2024. The increasing prevalence of infectious diseases and advancements in molecular diagnostic technologies are driving the growth of the molecular diagnostics market.
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Molecular Diagnostics Market Key Highlights:
• North America dominated the market by holding more than 40% of market share in 2024.
• Asia Pacific is expected to grow at a CAGR of 4.9% during the forecast period.
• The reagent segment held a major market share of 66% in 2024.
• The infectious disease segment contributed the biggest market share of 78% in 2024.
• The hospitals segment led the global market in 2024.
Molecular diagnostics involves the analysis of genetic material, proteins, and other molecules to diagnose diseases, monitor health conditions, and guide treatment decisions. The analysis of genetic material together with proteins and various molecules serves as the basis for detecting diseases while also providing information for condition status monitoring and treatment choices. The U.S. Food and Drug Administration (FDA) delivered marketing authorization in November 2023 for an at-home sample collection diagnostic test specific to chlamydia and gonorrhea disease recognition as a breakthrough achievement in diagnostic inspection alignment with patient needs.
Molecular diagnosis benefits from next-generation sequencing (NGS) technology which delivers faster accuracy in patient assessments. The molecular diagnostic field experiences transformative development due to CRISPR techniques which lead to improved disease detection practices and enhanced disease monitoring capabilities. Additionally, the integration of artificial intelligence and digital PCR technologies is enhancing accuracy and efficiency, promoting the adoption of advanced molecular diagnostic systems.
Molecular diagnostics technology under artificial intelligence revolution transformed genetic mutation and infectious agent and molecular biomarker detection and analysis. Complex genomic data processes through AI algorithms deliver both swift and highly precise diagnostic results. The new technology enables swift disease identification so doctors prescribe personalized medical treatments. The implementation of AI in digital PCR systems promotes more accurate nucleic acid quantification as a result of improved measurement precision.
Molecular Diagnostics Market Report Coverage
|
Report Coverage |
Key Statistics |
|
Market Size in 2024 |
USD 43.68 Billion |
|
Market Size in 2025 |
USD 45.11 Billion |
|
Market Size by 2034 |
USD 63.86 Billion |
|
CAGR 2025 to 2034 |
3.87% |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Product, Test Location, Technology, Application, End User, and Regions |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Molecular Diagnostics Market Emerging Trends in the
Advancements in NGS and Digital PCR
Continuous innovations in next-generation sequencing (NGS) and digital PCR technologies are revolutionizing disease detection and personalized treatment. These advancements are expected to drive the growth of molecular diagnostic products. NGS technologies have led to complete genomic profile scanning that finds treatable gene alterations within different cancer types to direct targeted treatments.
Minimal residual disease detection through integrated technologies has produced superior results for clinical practice which helps healthcare professionals achieve better patient stratification and treatment effectiveness. The decreased prices together with NGS's enhanced operational speed have made personalized medicine available to a wider range of patients.
Rising Adoption of Companion Diagnostics
The growing trend of personalized medicine is driving the demand for companion diagnostics, which enable targeted therapies by identifying specific genetic markers and biomarkers. Patients experience enhanced personalized treatment when companion diagnostics are adopted because these tools help medical professionals apply targeted therapies while identifying biomarkers along with genetic markers.
FDA approved the FoundationOne Liquid CDx test in 2022 for discovering EGFR mutations in non-small cell lung cancer patients which improves the process of selecting appropriate tyrosine kinase inhibitors. Companion diagnostics demonstrate essential functions in precision medicine for improved patient results through recent technological advancements.
Growing Focus on Liquid Biopsy
Liquid biopsy is emerging as a non-invasive molecular diagnostic tool for cancer detection, monitoring, and personalized treatment. The technique of liquid biopsy serves today as a novel non-invasive method for molecular diagnosis of cancer along with its detection and monitoring of treatment response.
The worldwide cancer statistics showed rising numbers in 2023, as the United States documented 1.95 million new cases together with 600,000 fatal cancer diagnoses. Early detection methods become necessary because more than half of all patients receive their cancer diagnosis when the disease has already progressed significantly.
The implementation of multi-omics approaches which combine mutation and DNA methylation analysis and other molecular changes has improved the sensitivity of liquid biopsy tests so they monitor disease progression in real-time along with treatment responses. These novel developments create opportunities to establish better individualized treatments for cancer medical management.
Molecular Diagnostics Market Key Regional Analysis:
🔸 North America molecular diagnostics market was valued at USD 16.85 billion in 2023, and it is expected to reach around USD 23.3 billion by 2033.
🔸 Europe molecular diagnostics market size was estimated at USD 11.7 billion in 2023, and it is predicted to hit around USD 16.34 billion by 2033.
🔸 Asia Pacific molecular diagnostics market size was reached at USD 10.59 billion in 2023, and it is projected to surpass around USD 16.92 billion by 2033.
🔸 Latin America molecular diagnostics market accounted for USD 1.76 billion in 2023, and it is expanding to around USD 2.54 billion by 2033.
🔸 MEA molecular diagnostics market was valued at USD 1.4 billion in 2023, and it is expanding by around USD 2.18 billion by 2033.
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U.S. Molecular Diagnostics Market Size to Worth $19 Billion by 2034
The U.S. molecular diagnostics market size was estimated at USD 14.09 billion in 2024 and is expected to be worth around USD 19 billion by 2034, growing at a CAGR of 3.03% from 2025 to 2034.
North America dominated the global molecular diagnostics market due to the presence of advanced healthcare infrastructure, high adoption of innovative diagnostic technologies, and favorable reimbursement policies. The region continues its domination, as chronic and infectious diseases are spreading more frequently. The financial results of major industry operators demonstrate a strong interest in diagnostic solutions among end-users.
The second quarter sales performance for Labcorp's diagnostics unit during 2024 brought USD 2.52 billion in revenue as their diagnostic division reported 7.9% growth over previously reported figures. Molecular diagnostics in North America maintain their market leadership, as various technological advancements, disease rates along substantial healthcare spending.
Asia Pacific is anticipated to witness substantial growth during the forecast period, driven by rising healthcare investments, improving healthcare infrastructure, and increasing awareness about early disease detection. Countries, including China and India, with large populations and high disease burden, are contributing significantly to regional market growth. Molecular diagnostic technologies are set for substantial growth within the Asia Pacific market with expanding healthcare funding improving infrastructure and rising sensitivities about early disease diagnosis.
China and India represent significant forces behind the regional growth, as they have both large population sizes and heavy disease prevalence. The public healthcare expenditure of India reached more than 2% of GDP in 2022 which demonstrates its dedication toward improving healthcare service delivery. The Asia Pacific region continues to prioritize healthcare system improvements through disease detection programs that lead to the expansion of molecular diagnostics in the region.
Molecular Diagnostics Market Segmentation Insight:
Product Insights
The reagent segment is anticipated to grow at the fastest rate in the market during the forecast period, due to the molecular diagnostic tests depending heavily on these components. Standardized results coupled with cost-effectiveness together with improved efficiency processes make reagents dominant in the market sector.
Organizations across the healthcare field require accurate diagnostic solutions which drives the requirement for reagents. The market gain support from the reagent segment, as the ongoing innovations in the molecular assay development process
Location Insights
The central laboratories size segment accounted for a considerable share of the market in 2023, owing to the high testing volume combined with advanced infrastructure of central laboratories made them the dominant market segment throughout recent years.
People seek their diagnostic results from these labs since they provide standardized precise measurements which appeals to healthcare providers. The testing of complex molecular tests strengthens their position in the market. The market keeps expanding because of rising requirements for high-throughput testing thus maintaining its present dominance.
Application Insights
The infectious diseases segment held a dominant presence in the market, as infectious diseases are becoming increasingly widespread globally. Rapid pathogen detection through molecular diagnostic testing leads to precise disease management due to its accurate detection capabilities. The need for timely diagnostics during outbreaks, such as COVID-19, drives this segment's growth. PCR and NGS technologies show continuous growth at present which reinforces their leadership position in the market.
The mild segment is expected to grow at the fastest rate in the market during the forecast period, owing to the rising requirements for customized cancer diagnosis services. The early-stage cancer detection, mutation identification and therapy customization functions of molecular diagnostic methods help medical practitioners. Global cancer rates continue to rise which emphasizes how important it is to develop precise diagnostic methods.
End-user Insights
The polymerase chain reaction segment is projected to expand rapidly in the market in the coming years, due to the PCR technology provides highly precise results for detecting infectious diseases along with genetic diseases.
The testing method proves fundamental for identifying both novel and traditional viral and bacterial infections. Digital PCR implementations improve the precision of measurements and accuracy standards. This technology's versatility and cost-effectiveness support its widespread adoption in molecular diagnostics.
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Molecular Diagnostics Market Companies
• Abbott Laboratories
• Agilent Technologies, Inc.
• Becton
• bioMérieux SA
• Danaher Corporation, Illumina, Inc.
• Dickinson and Company
• F. Hoffmann-La Roche Ltd.
• geneOmbio Technologies Pvt. Ltd.
• Grifols, S.A.
• Hologic, Inc.
• Myriad Genetics, Inc.
• PerkinElmer, Inc.
• QIAGEN N.V.
• Quidel Corporation
• Siemens Healthineers AG
• Thermo Fisher Scientific, Inc.
Recent Development
• In August 2024, MP Biomedicals launched new rapid tests for infectious diseases, enabling accurate detection of Helicobacter pylori, Salmonella typhi, and Vibrio cholerae serogroups. These diagnostic kits aim to improve early detection and enhance patient outcomes.
• In October 2024, the World Health Organization (WHO) approved the first in vitro diagnostic test for mpox for emergency use. The Alinity m MPXV assay, produced by Abbott Molecular Inc., is designed to enhance diagnostic capacity in countries facing outbreaks of this disease.
• In November 2024, Augurex Life Sciences Corp. introduced the Anti-14-3-3eta Multiplex Analyte Specific Reagents (ASRs) for a diagnostic test for axial spondyloarthritis (axSpA). This test, developed by New Day Diagnostics in Knoxville, TN, aims to help clinicians identify axSpA earlier, potentially improving patient outcomes.
• In December 2024, BD and Babson Diagnostics announced an expansion of fingertip blood collection and testing technologies for health systems in the U.S., including urgent care facilities and doctor’s offices.
• In January 2025, Co-Diagnostics, Inc. participated in Nasdaq’s "Live from MarketSite" broadcast during the Silicon Slopes Summit 2025. CEO Dwight Egan discussed the Co-Dx PCR platform and its tests for COVID-19, tuberculosis, HPV, and other infectious diseases, emphasizing the company’s preparedness for future health crises.
Segments Covered in the Report
By Product
• Instruments
• Reagents
• Services & Software
By Test Location
• Central laboratories
• Point of care
• Over the counter or self-test kits
By Technology
• Polymerase Chain Reaction (PCR)
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• DNA Sequencing & Next- generation Sequencing (NGS)
• In Situ Hybridization (ISH)
• DNA Microarrays
• Others
By Application
• Infectious diseases
o COVID-19
o Hepatitis
o HIV
o CT/NG
o HAI
o HPV
o Tuberculosis
o Influenza
o Other Infectious Diseases
• Oncology
o Breast Cancer
o Colorectal Cancer
o Lung Cancer
o Prostate Cancer
o Other
• Genetic testing
• Neurological disease
• Microbiology
By End User
• Diagnostic Laboratories
• Hospitals & Clinics
• Others
By Geography
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
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