Report Highlights

Cancer Diagnostics in the United States: Market Overview

The U.S. cancer diagnostics market was valued at USD 31.6 billion in 2024 and is forecast to reach USD 52.0 billion by 2032. Laboratory assays, imaging systems, and pathology services form its core, with Quest Diagnostics and LabCorp processing a large share of routine oncology testing. Guardant Health, Natera, and Exact Sciences have led commercialisation of liquid biopsy and blood-based screening platforms.

Government has been the dominant force in shaping the market's structure, while the private sector has driven technology. The National Cancer Institute, funded at approximately USD 7.2 billion in fiscal 2024, underwrites early assay validation through its Division of Cancer Prevention and Division of Cancer Control and Population Sciences. Medicare coverage decisions made by the Centers for Medicare and Medicaid Services determine which tests reach volume, and FDA premarket review determines which tests can be sold at all.

Policy-Driven Growth in U.S. Cancer Diagnostics

Three federal mechanisms drive demand. National Coverage Determination 210.3 requires Medicare to pay for FDA-approved blood-based colorectal screening tests meeting 74 percent sensitivity and 90 percent specificity thresholds. Section 2713 of the Public Health Service Act, implemented through the Affordable Care Act, requires first-dollar private coverage of USPSTF A and B screenings, expanding commercial volumes. Guardant Health's Shield test, approved by FDA in 2024, illustrates the mechanism. The mechanism converts reimbursement certainty into laboratory volume.

Third, Section 11403 of the Inflation Reduction Act of 2022 eliminated Medicare cost-sharing for follow-on colonoscopies after a positive stool-based test, effective 2023. This removes patient financial barriers at the point where stool-based screening generates referrals, shifting demand toward colonoscopy and diagnostic pathology. Together, these mechanisms convert statutory coverage into predictable test volume, which underwrites capital investment by manufacturers and laboratories across the sector.

Regulatory Barriers and Compliance Costs

Laboratory-developed tests face a shifting oversight regime. The FDA's 2024 final rule extending premarket review to laboratory-developed tests was vacated by the U.S. District Court for the Eastern District of Texas in March 2025, leaving the Clinical Laboratory Improvement Amendments of 1988 as the operative framework. Under CLIA, the Centers for Medicare and Medicaid Services issues certificates, while the Centers for Disease Control and Prevention sets analytical standards. Laboratories bear inspection, proficiency testing, and personnel compliance costs.

Premarket and reimbursement barriers are more costly. Original Premarket Approval applications require FDA review under MDUFA performance goals, with the standard original PMA user fee exceeding USD 500,000 for fiscal 2025. Payment for laboratory services is set through the Clinical Laboratory Fee Schedule under PAMA, which requires applicable laboratories to report private-payer rates. Reporting failures trigger payment reductions for Medicare-billed tests.

Policy-Created Opportunities in U.S. Cancer Diagnostics

Medicare coverage for lung screening represents a policy-created opportunity. CMS National Coverage Determination 210.14 covers annual low-dose CT for adults aged 50 to 77 with a 20 pack-year smoking history, aligning federal reimbursement with the USPSTF 2021 recommendation. Providers deploying AI-enabled imaging readers and nodule management software can capture this volume where health systems lack radiologist capacity.

Multi-cancer early detection is the next policy frontier. The proposed Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, under active congressional consideration, would establish a Medicare coverage pathway for MCED tests that currently lack USPSTF endorsement. Manufacturers holding FDA Breakthrough Device designation under Section 515B of the Federal Food, Drug, and Cosmetic Act can position for early reimbursement and adoption.

Market at a Glance

Leading Market Participants

• Roche Diagnostics
• Abbott Laboratories
• Danaher
• Thermo Fisher Scientific
• Hologic
• Qiagen
• Guardant Health
• Exact Sciences
• Natera
• Myriad Genetics

Regulatory and Policy Environment

The primary framework is the Federal Food, Drug, and Cosmetic Act, administered by the Food and Drug Administration's Center for Devices and Radiological Health, which governs in vitro diagnostics through 510(k), De Novo, and Premarket Approval pathways. CLIA 1988 governs laboratory testing and is administered by CMS with the CDC. Manufacturers must comply with the Quality Management System Regulation at 21 CFR Part 820, which takes effect in February 2026 and aligns with ISO 13485:2016.

Regulatory change is accelerating. The LDT vacatur leaves a gap that congressional proposals such as the VALID Act have sought to fill with risk-based premarket oversight, while CMS continues to revise PAMA-based fee schedule reporting. Compared with regional peers, the U.S. remains more permissive than the European Union, where Regulation (EU) 2017/746 requires notified-body certification for most cancer assays, with transition deadlines running from 2027 to 2029. China's NMPA requires in-country clinical data for many imported assays.

Long-Term Policy Outlook for U.S. Cancer Diagnostics

By 2032, Congress will have resolved the LDT question through statute, because the vacatur means FDA oversight of laboratory-developed tests requires legislative authority. CMS will also reset PAMA-based payment rates, shifting laboratory reimbursement toward value-based pricing for multi-marker panels. These changes will reward laboratories with robust clinical validation data.

MCED coverage and risk-stratified screening will reshape volume. Expansion of blood-based screening beyond colorectal cancer, under FDA's PMA pathway and CMS coverage decisions, will move screening revenue from colonoscopy and imaging toward laboratory channels. Manufacturers that complete PMA submissions and secure NCD-compliant evidence packages before 2028 will hold reimbursable positions, while laggards face shrinking addressable volume.