Infectious Disease Rapid Diagnostics Devices Market Growth Outlook, Opportunities and Forecast 2035

The gap between infection and intervention is closing at a historic rate. Valued at US$ 9.7 Billion in 2024, the Global Infectious Disease Rapid Diagnostics Devices Market is projected to grow to US$ 20.2 Billion by 2035, expanding at a CAGR of 6.9%.

As of February 2026, the market has fully transitioned into the "Post-Pandemic Infrastructure" phase. Rapid diagnostic tests (RDTs) are no longer temporary emergency tools but have become permanent fixtures in both clinical workflows and home medicine cabinets. In 2026, the market is defined by Decentralized Intelligence—a shift where high-accuracy molecular results, once exclusive to central labs, are now available via handheld devices in pharmacies, rural clinics, and private residences.

Strategic Growth Drivers: The 6.9% Momentum

The march toward US$ 20.2 Billion is driven by the need for speed in a globalized world:

• Rise of "Multiplex" Respiratory Testing: In 2026, the "single-test" era is fading. Consumers and clinicians are driving demand for Triple-Threat Panels—single swabs that can simultaneously differentiate between COVID-19, Influenza A/B, and RSV in under 20 minutes.


• Global AMR (Antimicrobial Resistance) Crisis: By early 2026, the urgent need to curb antibiotic overprescription has made rapid bacterial-vs-viral differentiation a mandate. RDTs are the primary tool used in primary care to ensure antibiotics are only given for confirmed bacterial infections.


• Decentralization of Specialized Care: In 2026, rapid tests for Hepatitis C (HCV), HIV, and Syphilis are moving out of hospitals and into community centers. This "test-and-treat" model allows patients to receive results and start therapy in a single visit, significantly improving public health outcomes in underserved regions.

Technological Frontier: The 2035 Roadmap

The next decade focuses on Molecular Sensitivity and Smartphone Synergy:

• Portable Isothermal Amplification: In 2026, technology like LAMP (Loop-mediated Isothermal Amplification) has made molecular-grade testing portable. These devices offer the sensitivity of a lab-based PCR but without the need for complex thermal cyclers, allowing for "gold-standard" accuracy at the point of care.


• Smartphone-Integrated Readers: By early 2026, the use of AI-enhanced smartphone apps to interpret lateral flow test results has solved the problem of "user error." These apps use computer vision to read faint lines on tests, quantify the results, and automatically upload them to secure public health databases.


• CRISPR-Based Diagnostics: For the 2035 horizon, CRISPR is moving into the field. In 2026, we are seeing the first widespread commercial use of CRISPR-powered paper strips that can detect specific viral RNA sequences with near-perfect accuracy and zero lab equipment.

Regional & Segment Insights

North America: The Innovation Anchor

Holding approximately 37% of the market share in 2026, North America leads due to a highly developed regulatory pathway (FDA De Novo clearances) and a massive shift toward telehealth-integrated testing, where home-test results are verified by doctors via video call.

Asia-Pacific: The Fastest Growth Engine

APAC is the fastest-growing region through 2035. In 2026, China and India are scaling domestic production of low-cost microfluidic chips. The region is the global leader in Mass Screening Programs for Tuberculosis (TB) and Malaria, leveraging rapid diagnostics to manage disease burden in high-density urban and remote rural areas alike.

Segment Focus: POC vs. Home-Based

• Point-of-Care (POC) (Largest): Remains the dominant segment in 2026, as clinics and emergency rooms replace traditional "send-out" lab tests with immediate in-house diagnostics.


• Homecare/At-Home Testing (Fastest Growth): Seeing a surge in 2026 as "proactive consumers" use RDTs for routine monitoring of chronic infections and seasonal illnesses.

Conclusion: The Era of Real-Time Epidemiology

By 2035, Infectious Disease Rapid Diagnostics will be the first line of defense against global health threats. The growth to US$ 20.2 Billion reflects a world where diagnosis is a precursor to—not a delay of—treatment. The winners of 2035 will be those who, in 2026, successfully integrated lab-grade accuracy into user-friendly, connected hardware.