Report Highlights

Mild Cognitive Impairment in the U.S.: Market Overview

The U.S. mild cognitive impairment market spans diagnostic testing, disease-modifying therapies and cognitive assessment services, valued at USD 2.1 billion in 2024. Private actors have led clinical delivery, with Quest Diagnostics, Labcorp and academic memory centres performing most cognitive testing, biomarker analysis and imaging. Government has shaped the market's form mainly through Medicare, which covers most older patients and sets the coverage rules that determine which diagnostics and drugs reach commercial scale.

The Centers for Medicare and Medicaid Services (CMS) set coverage for anti-amyloid antibodies through National Coverage Determination 200.3, finalised in 2022, which requires enrolment in a CMS-approved registry. The National Institute on Aging, part of the National Institutes of Health, funds the Alzheimer's Disease Research Centers that generate the biomarker science underpinning commercial diagnostic products. Private developers therefore lead on product innovation, while federal payers determine how quickly those products reach patients.

Policy-Driven Growth in U.S. Mild Cognitive Impairment

CMS removed the coverage limitation on amyloid PET imaging under National Coverage Determination 220.6.17 in October 2023, allowing Medicare to pay for scans previously restricted to narrow clinical settings. Each scan now feeds directly into treatment eligibility for anti-amyloid therapy, so imaging volume at PET centres rises with the number of Medicare beneficiaries screened. Under NCD 200.3, the registry requirement links every treated patient to outcome data, which keeps prescribing concentrated in certified sites and drives referrals to diagnostic centres.

The Medicare Annual Wellness Visit and the cognitive assessment and care planning service, billed under CPT 99483, reimburse structured cognitive evaluation in primary care. The Centers for Medicare and Medicaid Innovation launched the GUIDE Model in July 2024 as an eight-year programme that pays participating practices for dementia care navigation and caregiver support. Each reimbursed assessment converts primary-care screening into diagnostic demand, moving MCI detection from specialist clinics toward routine office visits.

Regulatory Barriers and Compliance Costs in U.S. Mild Cognitive Impairment

Diagnostic laboratories must hold a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate issued by CMS, and high-complexity assays such as plasma pTau217 require qualified personnel and ongoing proficiency testing. The FDA regulates the assay kits under its in vitro diagnostic rules, with 510(k) or De Novo review often taking six to twelve months. Smaller entrants must absorb these regulatory and validation costs before generating any reimbursed revenue.

Anti-amyloid therapies carry compliance overheads from FDA labelling and CMS coverage conditions. The lecanemab label requires MRI monitoring for amyloid-related imaging abnormalities before the fifth, seventh and fourteenth infusions, and prescribers must submit data to the CMS registry for each treated patient. Lecanemab and donanemab sit outside Inflation Reduction Act negotiation for now, leaving list prices exposed to Medicare Part B inflation rebate calculations.

Policy-Created Opportunities in U.S. Mild Cognitive Impairment

The GUIDE Model creates demand for care-management software and primary-care cognitive screening tools that generate the documentation participating practices need for CMMI reporting. Vendors offering CPT 99483-compliant digital assessments can capture reimbursed volume in practices that previously lacked dedicated memory-care staff. Dementia care navigation payments under the model also fund community health workers, widening the customer base beyond academic centres.

The FDA's May 2025 clearance of the Lumipulse blood test creates a lower-cost alternative to amyloid PET and cerebrospinal fluid testing. Developers that secure CLIA-validated laboratory capacity and Medicare payment codes will capture referral flows from primary care, where screening volume is highest. Reference laboratories such as Quest Diagnostics and Labcorp are positioned to scale these assays across their national networks.

Market at a Glance

Leading Market Participants

• Eisai
• Biogen
• Eli Lilly
• Roche Diagnostics
• Fujirebio
• C2N Diagnostics
• Quanterix
• Quest Diagnostics
• Labcorp
• Linus Health

Regulatory and Policy Environment

The primary legislative framework combines the Federal Food, Drug, and Cosmetic Act, administered by the FDA, with Title XVIII of the Social Security Act, which governs Medicare coverage through CMS National Coverage Determinations. The Clinical Laboratory Improvement Amendments of 1988 set laboratory certification standards, and the Inflation Reduction Act of 2022 (Public Law 117-169) introduced Medicare drug price negotiation and Part B inflation rebates. CMS publishes its next selected-drug list by 1 February 2026, and the CY2027 Physician Fee Schedule proposed rule is expected in mid-2026 with new diagnostic payment provisions.

Compared with regional peers, the U.S. framework offers broader Medicare coverage than most markets, but its registry-based conditions add administrative burden. The European Medicines Agency issued a negative opinion on lecanemab in 2024, and the UK's National Institute for Health and Care Excellence declined NHS funding for anti-amyloid therapies in 2025. Japan's Ministry of Health, Labour and Welfare approved lecanemab in 2023 and later applied price reductions, placing the U.S. between restrictive European access and Japan's price-controlled model.

Long-Term Policy Outlook for U.S. Mild Cognitive Impairment

By 2032, CMS will reassess the registry conditions in NCD 200.3 against real-world safety and outcome data, and the agency's decision will determine whether anti-amyloid therapy access broadens to primary-care prescribing. The GUIDE Model's eight-year term will end in 2032, and its outcome evaluation will shape whether dementia care navigation payments become permanent Medicare benefits. These decisions will move the market from a therapy-led model toward a diagnostic-led one.

Inflation Reduction Act negotiation will reach lecanemab and donanemab later this decade, compressing net prices and pushing manufacturers toward outcomes-based contracts with CMS. Blood-based biomarker tests will become the first-line screening step as CLIA-certified laboratories and Medicare payment codes mature. Market growth to USD 4.6 billion by 2032 will therefore rely on diagnostic reimbursement rather than therapy volume alone.