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Molecular Diagnostics Market Size Worth $45.24B by 2034

08-13-2025 07:31 AM CET | Health & Medicine

Press release from: Expert Market Research

What is driving the growth of the molecular diagnostics market?

The global molecular diagnostics market reached a value of USD 20.57 billion in 2024, propelled by continuous innovations in molecular diagnostic technologies and their expanding applications in healthcare. The demand is fueled by the growing prevalence of infectious diseases, cancer, and genetic disorders, along with an increased focus on personalized medicine.

Over the forecast period 2025-2034, the market is projected to grow at a CAGR of 8.20%, reaching USD 45.24 billion by 2034. This growth is further supported by advancements in genomic research, increasing adoption of point-of-care testing, and rising awareness about early disease detection.

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Molecular Diagnostics Market Size and Forecast

The market has witnessed substantial growth due to its ability to offer accurate, rapid, and sensitive diagnostic solutions. The shift from traditional laboratory methods to advanced molecular platforms such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and isothermal amplification has transformed disease diagnosis and monitoring.

The rising investment in R&D for oncology, infectious diseases, and pharmacogenomics applications will continue to shape the market outlook, especially in emerging economies where diagnostic infrastructure is improving.

Molecular Diagnostics Market Segmentation

By Product & Service

Instruments - Advanced molecular diagnostic instruments, such as automated PCR systems, are enabling high-throughput testing and faster turnaround times.

Reagents & Kits - Represent the largest revenue share due to their recurring demand in laboratories and healthcare facilities.

Services & Software - Includes bioinformatics tools and diagnostic data management systems that support clinical decision-making.

By Test Location

Point-of-Care (POC) - Rapid testing at patient care sites, critical for timely treatment in infectious diseases and emergency care.

Self-test or Over the Counter - At-home testing kits are growing in popularity, especially for infectious diseases and genetic risk screening.

Central Laboratories - Continue to serve as the primary hubs for complex and high-volume diagnostic testing.

By Technology

Polymerase Chain Reaction (PCR) - The gold standard for detecting genetic material of pathogens.

In Situ Hybridization - Used in cancer diagnostics for identifying specific DNA or RNA sequences in cells.

Isothermal Nucleic Acid Amplification Technology (INAAT) - Enables rapid amplification without thermal cycling, ideal for POC testing.

Chips and Microarrays - Allow parallel analysis of thousands of genes.

Mass Spectrometry - Used for biomarker detection and molecular profiling.

Sequencing - Next-generation sequencing (NGS) drives precision medicine initiatives.

Transcription Mediated Amplification (TMA) - Applied in infectious disease testing.

Others - Emerging molecular technologies and hybrid platforms.

By Application

Oncology - Molecular diagnostics play a vital role in early cancer detection, prognosis, and therapy selection.

Breast Cancer

Colorectal Cancer

Lung Cancer

Prostate Cancer

Other Cancers

Pharmacogenomics - Enables tailoring treatments based on an individual's genetic makeup.

Infectious Diseases - Represents the largest segment, including:

Hepatitis

HIV

CT/NG

Hospital-Acquired Infections (HAI)

HPV

Tuberculosis

Influenza

Other Infectious Diseases

Genetic Testing - For inherited disorders, carrier screening, and prenatal testing.

Neurological Diseases - Identification of molecular biomarkers for early detection.

Cardiovascular Diseases - Genetic risk profiling and biomarker analysis.

Microbiology & Others - Covering pathogen identification in various clinical settings.

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By End User

Diagnostic Laboratories - Major consumers due to the need for high-throughput capabilities.

Hospitals & Clinics - Growing adoption of in-house molecular testing facilities.

Other End Users - Includes research institutes and academic centers.

By Region

North America - Leads the market due to advanced healthcare infrastructure, strong R&D investment, and high adoption rates.

Europe - Significant market driven by public health initiatives and genetic testing programs.

Asia Pacific - Fastest-growing region, fueled by expanding healthcare access, government support, and medical tourism.

Latin America - Increasing adoption of molecular diagnostics for infectious disease control.

Middle East and Africa - Gradual market expansion due to improved diagnostic infrastructure.

Competitive Landscape

Key players in the molecular diagnostics market are investing heavily in R&D, strategic partnerships, and product innovation to strengthen their market presence:

BioMérieux SA

BD

Bio-Rad Laboratories, Inc.

Abbott

Agilent Technologies, Inc.

Hologic Inc.

Danaher Corporation

DiaSorin

Illumina, Inc.

Johnson & Johnson Services, Inc.

QIAGEN N.V.

F. Hoffmann-La Roche, Ltd.

PerkinElmer, Inc.

Siemens Healthineers

Thermo Fisher Scientific Inc.

These companies are actively developing advanced molecular platforms, automation solutions, and integrated bioinformatics systems to enhance diagnostic accuracy and speed.

Market Trends and Opportunities

Rise of Personalized Medicine - Molecular diagnostics is central to tailoring treatments for individual patients based on genetic profiles.

Expansion of Point-of-Care Testing - Increasing demand for portable, rapid, and accurate diagnostic tools in both developed and emerging markets.

Integration with AI and Data Analytics - Advanced algorithms are enhancing test interpretation and predictive diagnostics.

Shift Toward Preventive Healthcare - Growing emphasis on early detection to reduce healthcare costs and improve patient outcomes.

Adoption of Self-Testing Kits - Driven by consumer demand for privacy, convenience, and faster results.

Challenges in the Molecular Diagnostics Market

High Costs - Advanced molecular tests can be expensive, limiting access in low-income regions.

Regulatory Complexities - Stringent approval processes for diagnostic products.

Skilled Workforce Shortage - Need for trained professionals in molecular laboratory techniques.

Future Outlook

With continuous innovation, wider accessibility, and integration into routine healthcare, the molecular diagnostics market is expected to see strong double-digit growth in specific subsegments such as oncology testing, pharmacogenomics, and infectious disease detection. The market's evolution will be heavily influenced by digital health integration, AI-powered diagnostics, and decentralized testing models.

FAQs

What is the current size of the molecular diagnostics market?

The global molecular diagnostics market was valued at USD 20.57 billion in 2024 and is projected to reach USD 45.24 billion by 2034 at a CAGR of 8.20%.

What factors are driving the molecular diagnostics market growth?

Key drivers include rising prevalence of chronic and infectious diseases, technological advancements such as NGS and PCR, increased demand for personalized medicine, and expanding point-of-care testing.

Which technology dominates the molecular diagnostics market?

Polymerase Chain Reaction (PCR) remains the most widely used technology due to its high accuracy, speed, and versatility. However, sequencing technologies are rapidly gaining share.

Which region is expected to witness the fastest growth in the molecular diagnostics market?

The Asia Pacific region is anticipated to experience the fastest growth, driven by expanding healthcare infrastructure and increased investment in diagnostics.

Who are the leading players in the molecular diagnostics market?

Major players include Abbott, Roche, QIAGEN, Bio-Rad Laboratories, and Thermo Fisher Scientific, among others.

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