Healthcare Diagnostics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product (Instrument, Reagent), By Application (Infectious Disease, Oncology), By End Use (Hospitals & Clinics, Diagnostic Laboratory, Home Care Settings) and Region Forecast 2020-2031

Healthcare Diagnostics Market size was valued at US$ 84.0 billion in 2024 and is projected to reach US$ 122.2 billion by 2031 at a CAGR of 5.5% from 2025-2031. Moreover, the U.S. Healthcare Diagnostics Market is projected to grow at a CAGR of 5.4% over the forecast period.

The diagnostic market for healthcare sits at the nexus of precision medicine, global health awareness, and technology. No longer relegated to back-end central laboratories and lagging cycles of reporting delays, diagnostic testing is being transformed by AI-powered imaging, point-of-care molecular diagnostics, and consumer-focused point-of-care technology. With increasing numbers of aging populations and chronic disease burdens, fast, reliable, and economical testing has become steadily more attractive in the clinical and extended settings. Governments, payers, and investors are looking at diagnostics increasingly not just as a service business but as a strategic driver of preventive care, early intervention, and system-wide excellence. The result is a market place that is repositioning its role from passive observer to active health consciousness.

This revolution is breaking out unprecedented commercial and clinical value in fields such as liquid biopsy and digital pathology, AI-driven imaging, and home diagnosis. Traditional test models are being supplemented, or replaced, by decentralized, data-facilitated platforms with real-time decision support and patient-specific care pathways. Established players and new entrants are vying to marry diagnostics with wearable devices, telehealth platforms, and predictive analysis, enabling a volume-based testing to value-based diagnostics transition. Innovation cycles lagging and regulation paradigms evolving to stay ahead of the pack, the space of healthcare diagnostics is not only expanding, it's creating how health is being measured, monitored, and managed at scale.

Facts & Figures

• Over 70% of clinical decisions are based on the results of diagnostic testing, so diagnostics are pivotal in determining the precision of care, treatment regimen, and patient outcome within global health systems.
• Decentralized diagnostics are rapidly revolutionizing access to diagnostics among low-resource communities and rural communities as point-of-care testing kits, artificial intelligence-powered mobile diagnostics, and telepathology platforms fill infrastructural gaps within underpenetrated markets
• Oncology remains the fastest-growing diagnostics segment, with liquid biopsy and MRD testing enabling ultra-early diagnosis and relapse tracking, leading oncologists to reconsider conventional treatment protocols.
• Diagnostic firms increasingly combine cloud-based AI platforms and installed lab infrastructure, enabling real-time data analysis, remote operation, and predictive modeling of diagnostic networks and hospitals.

Key Developments

• In May 2025, Danaher Company partnered with AstraZeneca to co-develop innovative diagnostic products capable of potentially identifying patients who are likely to benefit from precision medicine, promoting use of companion diagnostics to personalize therapy.
• In August 2024, MP Biomedicals expanded its infectious disease diagnostic product line with the release of rapid immunochromatographic test kits for Helicobacter pylori, Salmonella typhi, and Vibrio cholerae, to allow for faster, more precise gastrointestinal diagnostics at the point of care.
• In April 2024, GE HealthCare unveiled over 40 artificial intelligence-enabled innovations at RSNA 2024, including combined imaging platforms designed to enhance clinical decision-making and operational efficiency for radiology and oncology treatment pathways. GE HealthCare's latest AI-enabled equipment is all part of a broader shift toward data-driven, precision diagnosis, with artificial intelligence infused throughout the continuum of care to allow more rapid, more tailored interventions.

Healthcare Diagnostics Market Segmentation

Based on the product

• Instrument
• Reagent

Reagents are the basis of diagnostic quality, and in the product business, they are the highest and most stable source of income. They are at the crossroads of molecular, immunoassay, and hematology testing, which puts them right at the center of the diagnostic process. Highly sensitive reagent use in ready-to-use form has grown exponentially as laboratories try to meet rapid turnaround with as little variation as possible. Most prominently in infectious disease and cancer testing, reagent innovation has been stimulated by the development of high-throughput reagent sets and multiplexed tests. The reproducibility-enhancing quality, standard performance, and automated platform amenability of reagents render them a vital commodity while dictating a high-priority investment and innovation segment in both central and point-of-care laboratories.

Based on the application

• Infectious Disease
• Oncology
• Others

Infectious disease diagnosis remains in the highest areas of application due to growing global pressure of bacterial and viral pathogens as well as a heightened emphasis on pandemic preparedness. Molecular testing is the sought-after sub-segment due to its sensitivity, quickness, and detection rates of broad variations of pathogens from a single sample. Techniques like real-time PCR and isothermal amplification became the norm, and particularly the early infection diagnosis of the likes of tuberculosis, HIV, and most recently, COVID-19. They are not only being used clinically but also preclinically, which makes surveillance, outbreak detection, and quick public health response all possible, all the pillars of today's global health policy.

Based on the end user

• Hospitals & Clinics
• Diagnostic Laboratory
• Home care Setting

Diagnostic labs are the working nucleus of healthcare diagnostics, conducting most of the volumes of tests with clinical accuracy and logistical economy. These are still the dominant segment due to their capacity to house sophisticated instrumentation and trained manpower in a single location. Central labs are especially critical for high-complexity tests like genetic profiling, liquid biopsy, and AI-assisted imaging interpretation. As test menu expansion grows and laboratory information systems are integrated into them, they are being framed as health data hubs. Beyond diagnosis, their role is that of population screening and epidemiologic tracking, and thus one of central importance to the continuum of care between public and private health networks.