Viral Molecular Diagnostic Market Forecasted to Hit US$ 7.3 Bn by 2032 | Persistence Market Research

Market Overview

The global viral molecular diagnostic market is experiencing remarkable expansion, fueled by rising prevalence of viral infections, technological innovations, and increased awareness of early disease detection. Valued at US$ 4.0 Bn in 2025, the market is projected to reach US$ 7.3 Bn by 2032, expanding at a CAGR of 9.0% during the forecast period. The rapid adoption of polymerase chain reaction (PCR) and nucleic acid amplification tests (NAATs) has been pivotal in diagnosing infectious diseases such as COVID-19, influenza, hepatitis B and C, and HIV. In addition, the emergence of CRISPR-based molecular diagnostics and next-generation sequencing (NGS) is reshaping the diagnostic landscape by offering more rapid, precise, and scalable solutions.

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Among the market segments, Reagents and Kits dominate with a 55% share, driven by consistent demand for PCR-based pathogen detection. Hospitals remain the leading end-use segment, holding a 40% share, while Point-of-Care (POC) settings emerge as the fastest-growing category due to their portability and real-time results. Geographically, North America leads with a 35% share in 2025, benefiting from advanced healthcare infrastructure and regulatory approvals for CE-IVD and FDA-approved assays. However, Asia Pacific is anticipated to witness the fastest growth, propelled by government healthcare investments and the rising incidence of viral diseases in China and India.

Key Highlights from the Report

✦ Global viral molecular diagnostic market expected to reach US$ 7.3 Bn by 2032, expanding at a 9.0% CAGR.
✦ North America leads with a 35% market share, while Asia Pacific is the fastest-growing region.
✦ Reagents and Kits dominate (55% share in 2025) due to recurring demand in PCR-based pathogen detection.
✦ PCR technology holds 60% market share, supported by wide adoption in hepatitis and COVID-19 testing.
✦ Infectious diseases diagnosis leads with a 45% market share, driven by pathogen surveillance initiatives.
✦ Emerging technologies such as CRISPR-based diagnostics and INAAT projected to capture 10% share by 2032.

Market Segmentation

By Product Type:
The market is categorized into Instruments, Reagents & Kits, and Software & Services. Reagents & Kits remain the largest segment, reflecting recurring demand across laboratory workflows. Software & Services, though smaller, are growing rapidly, supported by AI-driven analytics, automated interpretation, and cloud-enabled reporting tools that enhance diagnostic efficiency.

By Technology:
PCR and RT-PCR dominate with 60% share, sustaining their gold standard status for accuracy and reliability. Meanwhile, NGS is rising swiftly due to its ability to decode viral genomes, track mutations, and support precision medicine. Emerging platforms like isothermal amplification and CRISPR diagnostics offer cost-effective and faster alternatives, particularly for decentralized testing.

By Application:
Infectious disease diagnosis leads with a 45% share, primarily in COVID-19, influenza, HIV, and hepatitis testing. Oncology applications are accelerating, with NGS technologies uncovering viral links to cancers such as HPV-related cervical cancer, supporting personalized treatment strategies.

By End-Use:
Hospitals remain dominant, accounting for 40% of the market, as they house centralized labs and high-throughput instruments. However, POC testing environments are rapidly expanding, driven by demand for near-patient testing solutions that require minimal infrastructure.

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Regional Insights

North America: With a 35% share, the U.S. leads adoption of FDA-approved viral assays and CE-IVD-compliant tests. Government investments and widespread use of decentralized PCR platforms, like Cepheid's GeneXpert, support continued dominance.

Europe: Holding 30% of the market, the region benefits from collaborative healthcare initiatives, robust funding, and strict regulatory standards. Germany and the UK are investing heavily in genome sequencing for outbreak monitoring.

Asia Pacific: The fastest-growing region with 25% market share. China's focus on pathogen surveillance and India's expanding healthcare infrastructure are key drivers. Increasing diagnostic investments and pandemic preparedness strategies are accelerating demand.

Latin America & Middle East/Africa: These regions show growing adoption due to increasing infectious disease burden. Government-backed diagnostic programs in Brazil, South Africa, and GCC countries are creating new growth avenues.

Market Drivers

The viral molecular diagnostic market is driven by the rising burden of viral infections such as COVID-19, influenza, hepatitis B and C, and HIV. The World Health Organization (WHO) estimates 1.5 million new hepatitis C cases annually, underscoring the need for reliable viral RNA testing. Advancements in PCR, NGS, and isothermal amplification have transformed molecular diagnostics, enabling faster and more accurate results. Moreover, government investments, like the U.S. allocation of US$ 10 billion for COVID-19 testing, further bolster demand for NAATs and surveillance assays.

Market Restraints

Despite rapid growth, the market faces barriers such as high costs of PCR and NGS platforms, with some instruments exceeding US$ 500,000. These costs limit adoption in resource-constrained healthcare systems. Additionally, stringent regulatory approval processes (FDA and CE-IVD compliance) extend product timelines and increase operational costs. The shortage of skilled professionals capable of managing advanced sequencing technologies further slows market penetration in developing regions.

Market Opportunities

Significant opportunities lie in emerging diagnostic technologies such as CRISPR-based tools and isothermal amplification, expected to capture a 10% share by 2032. Expansion of healthcare infrastructure in Asia Pacific and Latin America presents vast untapped potential. Furthermore, the integration of artificial intelligence into diagnostic workflows enhances speed and accuracy, reducing human error. These innovations, coupled with a growing emphasis on pandemic preparedness, are expected to reshape the market in the coming decade.

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Reasons to Buy the Report

✔ Gain in-depth insights into current and projected market size and growth trends through 2032.
✔ Understand detailed segmentation by product, technology, application, and end-use.
✔ Access comprehensive regional insights and competitive landscape analysis.
✔ Identify emerging technologies and innovation opportunities for future investment.
✔ Benefit from strategic recommendations for navigating regulatory challenges and market entry.

Company Insights

• Abbott
• Roche
• Thermo Fisher Scientific
• Qiagen
• Bio-Rad Laboratories
• Cepheid
• Gen-Probe
• Becton, Dickinson and Company

Recent Developments:

In September 2024, Roche launched the cobas® Respiratory flex test featuring its novel TAGS technology, capable of identifying up to 15 pathogens in a single PCR test.

Thermo Fisher Scientific introduced a new NGS platform for viral genome sequencing, enhancing oncology-focused molecular diagnostics.

Conclusion

The viral molecular diagnostic market is undergoing a transformative phase, driven by PCR, NGS, and CRISPR-based innovations, with applications extending beyond infectious diseases to oncology and personalized medicine. With a projected growth from US$ 4.0 Bn in 2025 to US$ 7.3 Bn by 2032, the industry is poised for robust expansion. North America will maintain leadership, while Asia Pacific will emerge as the fastest-growing region. Despite challenges of high costs and regulatory hurdles, opportunities in emerging technologies and AI integration are expected to redefine the future of viral diagnostics, making the sector one of the most dynamic in the global healthcare landscape.

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