Global Molecular Diagnostics Market to Reach US$ 43.4 Billion by 2035 | Transparency Market Research

The global molecular diagnostics market is set for a transformative decade, expanding rapidly as precision medicine, infectious disease management, and advanced genomic testing redefine the healthcare landscape. According to the latest market analysis, the global molecular diagnostics industry was valued at US$ 16.6 billion in 2024 and is projected to reach US$ 43.4 billion by 2035, growing at a robust CAGR of 9.1% from 2025 to 2035.

The molecular diagnostics industry has emerged as one of the most dynamic sectors in modern healthcare, bridging biotechnology, genomics, and clinical medicine. As the world continues to witness rising rates of infectious and chronic diseases, the demand for faster, more accurate, and cost-efficient diagnostic solutions has never been greater. This market's evolution is being powered by groundbreaking technological advances in polymerase chain reaction (PCR), next-generation sequencing (NGS), liquid biopsy, and artificial intelligence (AI), paving the way for more personalized, predictive, and preventative healthcare.

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Market Overview: The global molecular diagnostics market encompasses a range of products, technologies, and applications that enable the detection and monitoring of genetic material (DNA or RNA) associated with diseases. These technologies are integral to diagnosing infectious diseases, cancer, and genetic disorders, and they are becoming increasingly critical in drug development and clinical decision-making.

In 2024, the market stood at US$ 16.6 billion, with reagents dominating the product category due to their repetitive use and essential role in ensuring test accuracy. The industry is expected to maintain strong momentum, supported by the rising adoption of molecular testing in hospitals, diagnostic laboratories, and research institutes across North America, Europe, and Asia Pacific.

Key Drivers of Market Growth

1. Rising Prevalence of Infectious and Chronic Diseases
The increasing burden of diseases such as COVID-19, HIV, Hepatitis, and respiratory infections continues to fuel the need for precise and early diagnostics. According to the Centers for Disease Control and Prevention (CDC, 2024), six in ten Americans suffer from at least one chronic disease, while sexually transmitted infections exceeded 2.5 million cases in 2022. The demand for rapid, reliable, and scalable molecular testing methods is accelerating market expansion globally.

2. Technological Advances in PCR, NGS, Liquid Biopsy, and AI
The integration of advanced molecular techniques is a cornerstone of market growth. PCR and NGS technologies are now indispensable for identifying genetic mutations and microbial agents. Liquid biopsy, a minimally invasive testing method, enables real-time tumor DNA analysis through blood samples, reducing the need for surgical biopsies. Meanwhile, AI-driven diagnostics enhance data interpretation, reduce error rates, and improve turnaround time in both centralized laboratories and point-of-care settings.

3. Expansion of Point-of-Care (POC) Testing
The rise of decentralized healthcare models has pushed molecular testing closer to the patient. Portable, user-friendly molecular diagnostic systems are enabling rapid on-site testing in clinics, pharmacies, and even home environments. This shift supports faster decision-making and early intervention, especially in infectious disease outbreaks and remote healthcare delivery.

Latest Market Trends

The molecular diagnostics sector is witnessing significant innovation and diversification. The shift toward personalized medicine is one of the most notable trends, driven by precision oncology and companion diagnostics that help match patients with targeted therapies. The increasing use of digital PCR and AI-powered algorithms is further refining diagnostic accuracy and enabling real-time disease monitoring.

Liquid biopsy continues to revolutionize cancer diagnostics by detecting circulating tumor DNA (ctDNA) and RNA, offering a non-invasive alternative to traditional biopsies. Similarly, home-based testing kits and telehealth-integrated molecular diagnostics are gaining traction, reflecting a broader move toward accessible and patient-centric care.

Key Players and Industry Leaders

The molecular diagnostics landscape is led by globally recognized companies that continue to shape the market through innovation, acquisitions, and strategic collaborations. Major players include:

F. Hoffmann-La Roche AG, Abbott, Illumina, Inc., Thermo Fisher Scientific Inc., Becton, Dickinson and Company (BD), bioMérieux, DiaSorin S.p.A., Hologic, Inc., SD Biosensor, Inc., QIAGEN N.V., QuidelOrtho, and Siemens Healthineers AG.
These companies are continuously expanding their product portfolios and investing in automation, digitalization, and next-gen molecular platforms to enhance clinical accuracy and scalability.

Recent Developments

Recent years have seen a surge in product innovation and regulatory approvals in molecular diagnostics:

• April 2025 - Abbott launched its CE-marked HR HPV assay in Europe, supporting self-collection of vaginal samples via the simpli-COLLECT HPV Kit. This test enables high-risk HPV genotype detection and enhances accessibility for women's health diagnostics.

• September 2024 - QIAGEN introduced the QIAcuityDx Digital PCR System, offering precise DNA and RNA quantification for clinical diagnostics. FDA-exempt in the U.S. and IVDR-certified in Europe, the system is designed for oncology and infectious disease monitoring.

• Illumina continues to advance its sequencing platforms for clinical genomics, partnering with pharmaceutical companies to integrate NGS-based companion diagnostics into therapeutic pipelines.
These developments underscore the industry's move toward precision-driven, patient-centric diagnostic solutions that bridge genomics, AI, and clinical care.

Market New Opportunities and Challenges

While the molecular diagnostics market offers enormous potential, it also faces a set of unique challenges and opportunities:

Opportunities
• Companion diagnostics for oncology and targeted therapies represent one of the fastest-growing segments.

• Minimal residual disease (MRD) testing is emerging as a key tool for cancer recurrence monitoring.

• AI and cloud-based molecular data management platforms are opening new avenues for real-time diagnostics and global data sharing.

• Emerging markets in Asia Pacific, Latin America, and the Middle East offer untapped growth potential due to expanding healthcare infrastructure and increasing adoption of advanced diagnostics.

Challenges

• High equipment and reagent costs, particularly in developing regions, remain barriers to widespread adoption.

• Regulatory complexities and variable reimbursement frameworks hinder the global harmonization of diagnostic practices.

• Shortage of skilled professionals in molecular biology and bioinformatics poses operational challenges in scaling testing capacity.

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Future Outlook

The outlook for the molecular diagnostics market remains overwhelmingly positive. Analysts anticipate strong growth driven by increasing test volumes, regulatory support for companion diagnostics, and the integration of multi-omics data into clinical decision-making. By 2035, molecular diagnostics will likely be at the heart of precision medicine, transforming how diseases are detected, monitored, and treated.

Emerging technologies such as AI-guided interpretation, wearable biosensors, and real-time sequencing will enable faster diagnostics at lower costs. Furthermore, strategic collaborations between diagnostic companies, pharmaceutical firms, and digital health innovators will create new ecosystems for data-driven healthcare.

North America will continue to lead the global market, followed by Europe and the rapidly growing Asia Pacific region. The latter's growth will be powered by healthcare modernization, government initiatives, and increasing investments in genomic research and laboratory infrastructure.

Market Segmentation

The molecular diagnostics market is segmented as follows:
By Product Type:
• Instruments
• Reagents
• Software & Services

By Technology:
• Polymerase Chain Reaction (PCR)
• In Situ Hybridization (ISH)
• Isothermal Nucleic Acid Amplification
• Sequencing
• DNA Microarrays
• Others (Mass Spectrometry, Liquid Biopsy, etc.)

By Application:
• Infectious Diseases
• Oncology & Genetic Testing (including Breast, Prostate, Colorectal, Lung, and Bladder Cancer)
• Women's Health
• Neurological Diseases
• Cardiovascular and Others

By End User:
• Hospitals & Clinics
• Diagnostic Laboratories
• Research Institutes and Others

By Region:
• North America (U.S., Canada)
• Europe (Germany, U.K., France, Italy, Spain, The Netherlands)
• Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN)
• Latin America (Brazil, Mexico, Argentina)
• Middle East & Africa (GCC Countries, South Africa)

Why Buy This Report?

This comprehensive report on the Global Molecular Diagnostics Market Outlook 2035 offers:

• Detailed quantitative and qualitative analysis covering market trends, drivers, restraints, and opportunities.

• Insights into key product innovations, regulatory shifts, and regional market dynamics.

• Competitive benchmarking of major players with profiles, financial overviews, and strategic developments.

• An in-depth examination of emerging technologies like AI, NGS, and liquid biopsy.

• Exclusive coverage of companion diagnostics, MRD testing, and point-of-care expansion trends.

• Forward-looking projections to support strategic decision-making, investment planning, and market entry strategies.

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