United States Predictive Diagnostics Market 2031 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The Global Predictive Diagnostics Market reached US$ 48.67 billion in 2023 and is expected to reach US$ 139.18 billion by 2031, growing at a CAGR of 14.70% during the forecast period 2024-2031.

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Key Development:

United States: Recent Industry Developments

✅ In November 2025, CapsoVision said it submitted its AI module for FDA review targeting non‐invasive pancreatic cancer risk screening, advancing its predictive diagnostics platform under a planned 6‐month review and strengthening plans for next‐gen diagnostic tools.

✅ In November 2025, CapsoVision reported progress on its AI‐enhanced colon imaging and diagnostic programs, with pivotal enrollment underway and collaboration agreements to deliver advanced sensor tech for future predictive diagnostics devices.

Japan: Recent Industry Developments

✅ In January 2026, MedDevice industry news highlighted ongoing AI support projects in Japan for predictive and precision medicine applications under PMDA and Ministry of Health initiatives, aligning with broader regulatory and innovation push for AI diagnostic technologies.

✅ In January 2026, NTTドコモ and partners began a Ministry‐supported AI pilot integrating smartphone, voice recognition, and electronic health records to streamline medical documentation and predictive clinical insights, representing a foundational step toward AI‐augmented predictive diagnostics workflows.

✅ In December 2025, a Japanese AI‐powered imaging analysis system showed performance matching or exceeding clinical readers for early pancreatic cancer detection at UEGW 2025, demonstrating enhanced predictive diagnostic performance in real‐world research settings.

✅ In December 2025, at CES 2026 Dassault Systèmes showcased next‐generation AI solutions combining virtual twin tech for predictive and personalized healthcare applications, reflecting how AI diagnostic and predictive tools are moving into broader applied technology showcases.

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Key Players:

=>Abbott Laboratories, Certis Oncology Solutions, Inc., Proteomics International Laboratories Ltd, QIAGEN N.V., Prometheus Laboratories Inc., F. Hoffmann-La Roche Ltd., Illumina Inc., Myriad Genetics, Exact Sciences Corporation, and Reliance Life Sciences. among others.

Key Segments:

By Type

Presymptomatic Testing leads with 55% share, driven by early disease detection, preventive healthcare adoption, and rising awareness among at-risk populations. Predispositional Testing accounts for 45%, supported by genetic risk assessment, personalized medicine initiatives, and growing interest in predictive healthcare for chronic and hereditary conditions.

By Application

Cardiovascular Diseases dominate with 25% share, fueled by early detection of heart disease risk, preventive interventions, and integration with personalized healthcare programs. Neurological Diseases account for 20%, supported by growing demand for early diagnosis of Alzheimer's, Parkinson's, and other neurodegenerative disorders. Genetic Diseases hold 20%, driven by hereditary disorder screening and newborn genetic testing programs. Oncology represents 25%, fueled by genetic testing for cancer risk, early detection, and precision oncology initiatives. Others make up 10%, including metabolic disorders, autoimmune diseases, and rare hereditary conditions.

By End-User

Diagnostic Centers lead with 40% share, driven by their wide accessibility, patient volume, and integration of genetic testing services into routine diagnostics. Genetic Laboratories and Clinics account for 35%, supported by specialized testing, counseling services, and personalized risk assessment offerings. Research and Academic Institutes hold 25%, fueled by ongoing studies, clinical trials, and development of novel genetic diagnostics.

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By Region

North America - 40% Share
North America leads with 40%, driven by advanced healthcare infrastructure, early adoption of genetic testing, and high awareness of presymptomatic and predispositional diagnostics in the U.S. and Canada.

Europe - 25% Share
Europe holds 25%, supported by precision medicine initiatives, robust healthcare systems, and genetic testing programs across Germany, France, U.K., Italy, Spain, and neighboring countries.

Asia Pacific - 20% Share
Asia Pacific accounts for 20%, fueled by rising healthcare investments, increasing genetic testing awareness, and expanding laboratory infrastructure in China, India, Japan, South Korea, and Southeast Asia.

Middle East & Africa - 10% Share
The Middle East & Africa represent 10%, driven by growing healthcare modernization, public health initiatives, and adoption of predictive diagnostics in GCC countries and South Africa.

South America - 5% Share
South America holds 5%, supported by gradual adoption of genetic diagnostics, emerging healthcare facilities, and research-driven initiatives in Brazil, Mexico, and neighboring regions.

FAQ

What is the current size of the Predictive Diagnostics Market?

A: In 2023, the Predictive Diagnostics Market was valued at US$ 48.67 billion, reflecting its strong industry presence.

Q2: How large is the Predictive Diagnostics Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Predictive Diagnostics Market will grow to around US$ 139.18 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Predictive Diagnostics Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 14.70% during the forecast period from 2024 to 2031.

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