Point-of-Care Molecular Diagnostics Market to Surge Across USA, Europe, APAC and Saudi Arabia Through 2035

Point-of-care Molecular Diagnostics Market

The PoC molecular diagnostics market is set to grow from USD 5.29B in 2025 to USD 13.73B by 2035, driven by rapid testing demand and decentralized healthcare.

The market reflects a major shift toward faster, patient-centric diagnostics supported by AI and connected care models that reshape global disease management.”

— Sabyasachi Ghosh

DE, UNITED STATES, November 10, 2025 /EINPresswire.com/ -- The global Point-of-Care (PoC) molecular diagnostics market is set for significant expansion, projected to grow from USD 5,295 million in 2025 to USD 13,733.8 million by 2035, registering a CAGR of approximately 10% over the forecast period. This growth is fueled by rising chronic disease prevalence, increased demand for rapid near-patient testing, and government support for decentralized healthcare systems across major regions, including North America, Europe, Asia-Pacific (APAC), and the Middle East, particularly Saudi Arabia.

PoC molecular diagnostics enable immediate disease detection at or near the patient’s location, reducing turnaround time and improving treatment outcomes. As healthcare ecosystems prioritize speed, accessibility, and accuracy, PoC technologies are becoming central to care delivery in hospitals, clinics, emergency care units, and home healthcare environments.

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Key Market Drivers

Three primary factors are advancing global market growth:

Rise in Chronic and Infectious Diseases
Persistent increases in respiratory infections, sexually transmitted infections, and antimicrobial resistance have heightened the need for faster diagnostic solutions. Early detection is now a cornerstone of clinical decision-making, fueling adoption of on-site testing platforms.
Expansion of Home-Based and Remote Testing
Telemedicine integration accelerated during and after the COVID-19 pandemic. Today, home-compatible PoC molecular diagnostic devices support decentralized care models, particularly in the United States and Europe.
Technological Advancements
Progress in microfluidics, CRISPR-based diagnostics, and AI-driven interpretation tools has significantly improved test accuracy and processing speed. Laboratory-quality results are becoming available in minutes rather than hours.
Regional Outlook

North America
The United States leads global adoption due to its advanced healthcare infrastructure, growing personalized medicine initiatives, and strong innovation pipelines. Favorable regulatory pathways and expanding home-testing approvals contribute to sustained market leadership.

Europe
European healthcare systems continue to emphasize decentralized diagnostic testing. Countries such as Germany, the United Kingdom, France, and Italy are integrating PoC systems into primary care networks to enhance disease surveillance and early intervention capabilities.

Asia-Pacific (APAC)
APAC remains the fastest-growing region, with China, India, Japan, and South Korea increasing investment in modern diagnostics. Rapid urbanization, expanding clinical laboratory networks, and government-led affordability programs are key contributors.

Saudi Arabia and the Middle East
Saudi Arabia is actively modernizing its healthcare system under Vision 2030, supporting diagnostic technology localization and public health readiness. Strategic partnerships between global medical device manufacturers and regional companies are accelerating market penetration.

Product & Technology Trends

Assays & Kits Lead Market Demand
Assays and test kits are expected to hold approximately 52.7% market share by 2025. Ease of deployment and widespread applicability in respiratory disease detection, oncology screening, and infection monitoring drive their dominance.

RT-PCR Continues as the Core Technology
RT-PCR is projected to represent nearly 64.2% of the market in 2025, attributed to its high diagnostic sensitivity and reliability. New miniaturized RT-PCR platforms allow portable, field-ready testing.

Challenges Limiting Wider Adoption

Despite rapid growth, cost remains a major barrier—particularly for resource-limited clinical settings. In addition, regulatory complexity and interoperability challenges between diagnostic platforms and digital health systems can slow deployment. Data privacy and security concerns continue to shape AI-integrated diagnostics adoption.

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Future Opportunities (2025–2035)

The next decade will witness a shift toward:

AI-enabled automated result interpretation
Lab-on-a-chip integrated portable diagnostics
Cloud-connected home-based disease monitoring
Multiplex assays capable of screening multiple pathogens simultaneously
Increased OEM collaboration for localized manufacturing to strengthen supply chain resilience
As healthcare systems worldwide move toward personalized, prevention-oriented care, PoC molecular diagnostics are positioned to become indispensable components of routine medical workflows.

Competitive Landscape

Leading players include Abbott Laboratories, Cepheid (Danaher Corporation), bioMérieux SA, Roche Diagnostics, and QuidelOrtho Corporation. Industry strategies emphasize real-time data connectivity, workflow automation, and expansion into remote testing markets. Emerging biotech innovators continue to introduce compact, cost-efficient diagnostic systems further expanding market accessibility.

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