On April 1, 2026, China’s national unified outpatient chronic and special disease catalog management policy officially came into effect, with Alzheimer’s disease (AD) included within it. Beyond that, the new policy abolished the previous requirement that patients must be hospitalized to qualify for recognition — meaning that AD patients now have a stable medical insurance reimbursement channel for outpatient medications, examinations, and tests. For pharmaceutical companies, diagnostics firms, and the entire supply chain, this amounts to a starting pistol being fired.
Patient Scale and Hidden Impact: A Trillion-Yuan Burden Behind Tens of Millions of Patients
Consider a set of figures first. Statistics from Alzheimer’s Disease International show that a new case of dementia emerges somewhere in the world every three seconds, of which 60% to 70% are Alzheimer’s disease. Even more noteworthy is the population with mild cognitive impairment (MCI) — with a prevalence rate of approximately 15% to 20%. China’s population aged 60 and above has already surpassed 310 million. According to Eisai’s estimates, in 2024 the number of Chinese patients with MCI or mild dementia caused by AD reached 17 million.
The social impact extends far beyond the scope of healthcare. The direct medical costs and family caregiving losses attributable to AD in China reach a trillion-yuan scale annually. Large numbers of caregivers are forced to leave their jobs or experience physical and mental health problems. “One person loses their mind, the whole family loses its balance” is becoming one of the heaviest hidden burdens of an aging society. AD has been upgraded from an “elderly disease” to a systemic social risk — and the core of risk management lies precisely in early identification and effective intervention.
The Three Major Obstacles in Traditional Diagnosis and Treatment: Low Diagnosis Rates, High Barriers, No Effective Drugs
Before lecanemab came to market, AD diagnosis and treatment had long been in an “awkward” state.
Low diagnosis rates: In the past, early screening relied almost entirely on the clock drawing test and simple questionnaires — highly subjective, with a high rate of missed diagnoses. For a precise diagnosis, PET scans cost more than RMB 8,000 (≈ USD 1,111.11) out of pocket per session, with insufficient device coverage; cerebrospinal fluid testing requires a lumbar puncture, resulting in poor patient compliance. The result was that China’s AD diagnosis rate remains below 30%, with the proportion receiving an early diagnosis in the single digits.
Limited treatment options: For nearly two decades from 2003 to 2021, there were no genuinely effective drugs for AD available anywhere in the world. The donepezil and memantine used clinically could only delay the worsening of symptoms and could not arrest disease progression. The standard clinical script — “stay social, read the newspaper” — was in essence an admission that there were no fundamental solutions at hand.
Broken intervention pathways: With no effective early detection tools or targeted drugs, large numbers of patients were “sorted by category”: mild cases assigned to community care, moderate cases to nursing homes, severe cases transferred to palliative care. The golden window for intervention was wasted entirely.
It is precisely for this reason that the market approval of lecanemab in 2024 and the policy implementation in 2026 together constitute the true starting point of a closed loop spanning diagnosis, treatment, and payment.
A Drug Surge: “Treatable” Moves From Ideal to Reality
The history of Alzheimer’s disease drug development reads like a catalogue of failures, but the page is now turning.
In January 2024, lecanemab was approved in China, making it the third country to approve the drug after the United States and Japan. As the world’s first disease-modifying treatment for AD, it works by targeting and clearing amyloid-beta (Aβ) protein to slow disease progression. Four-year follow-up data from the global Phase III Clarity AD trial show that among patients on continuous treatment, 81.4% were still able to maintain mild cognitive status at the four-year mark, with a 56% reduction in the risk of progression.
On the commercial side, according to Minet data, lecanemab’s sales at terminal hospitals nationwide in the first half of 2025 reached RMB 127 million (≈ USD 17.64 million). CSPC Pharmaceutical Group’s biosimilar has also received clinical approval — the entry of a domestically produced version means that price competition is about to intensify. The drug has not yet been included in the national medical insurance catalog; the unit price per bottle is RMB 2,508 (≈ USD 348.33) for 200 milligrams, with an annual treatment cost of approximately RMB 180,000 (≈ USD 25,000). However, the first edition of the Commercial Health Insurance Innovative Drug Catalog, published in December 2025, has already included it, with more than ten Huimin Bao (inclusive insurance) products providing coverage ahead of the public system; Beijing’s Puhui Health Insurance reimburses at a rate of 65% for the general healthy population. The payment puzzle of “treatable and sustainably affordable” is being completed.
The Early Screening Track: The “Three Kingdoms” Contest Between PET, Cerebrospinal Fluid, and Blood Testing
No matter how good a drug is, it means nothing if patients cannot be found. Early screening is a critical link in the AD diagnostic and treatment closed loop, and it is also the field where technological iteration is currently most active.
PET imaging and cerebrospinal fluid (CSF) testing are the diagnostic “dual gold standards.” But PET costs more than RMB 8,000 (≈ USD 1,111.11) per session, the number of devices is limited, and the penetration rate is less than 1%; CSF testing requires a lumbar puncture, with low patient acceptance. In the context of “large-scale screening,” both approaches are willing but unable.
Blood testing has therefore become the focus. A single tube of venous blood — non-invasive, repeatable, and low-cost. Current blood tests have achieved 80% to 90% concordance with the gold standards and perform reliably in distinguishing AD from other types of dementia. However, single biomarkers still have limitations. Research shows that plasma p-Tau217 is an effective biomarker for identifying Aβ-positive status in cognitively unimpaired individuals, capable of achieving 80% accuracy when used alone, but its sensitivity is poor — according to the reference standard, it only identified 46% of all Aβ-positive cases. A two-step screening approach (plasma p-Tau217 initial screening plus PET/CSF confirmation) can significantly improve predictive performance, reducing testing demand by 40% compared with PET screening alone.
Commercial progress is equally rapid. To date, dozens of AD blood testing reagent kits have received approval from national and provincial drug regulatory authorities domestically. In March 2026, Berger Medical obtained the registration certificate for its Aβ42/Aβ40 reagent kit; in April, Kemai Diagnostics’ p-tau217 reagent kit was approved in Shanghai. “Blood screening, multi-dimensional biomarker combinations, automated high-throughput testing” — AD early screening is expected to move from “high-end and niche” toward “accessible at the primary care level.”
Market Estimation: From Hundreds of Millions to Billions, With Impressive Compound Growth
Drug market: Lecanemab is currently still primarily funded through out-of-pocket and commercial insurance payments, with penetration rates in a growth phase. However, the price competition introduced by CSPC’s entry is expected to significantly improve patient access to innovative drugs over the next two to three years.
Diagnostics market: According to Grand View Research data, China’s Alzheimer’s disease diagnostics market was valued at approximately USD 319.6 million in 2024 and is expected to reach USD 617.8 million by 2030, representing a CAGR of 11.7% from 2025 to 2030. The blood biomarker subsegment is expected to grow significantly faster than the overall market, with a projected CAGR of approximately 18%.
Payment side: The unified outpatient chronic and special disease catalog management provides a basic safety net for AD patients, with commercial innovative drug catalogs and Huimin Bao serving as supplements. It is expected that over the next three years, more local governments will incorporate AD early screening into the free physical examination packages for elderly residents. The diversification of the payment system will directly stimulate the expansion of both the diagnostics and treatment markets.
From the “official entry ticket” of the 2026 outpatient chronic and special disease catalog, to lecanemab securing a place in the commercial insurance drug catalog, to the dense wave of blood testing reagent kit approvals — the AD market is undergoing a substantive transition from “policy ice-breaking” to “commercial starting gun.”
A clearly visible trend is emerging: the fragments of policy, drugs, diagnostics, and insurance are being pieced together into a complete picture. The product matrix for early screening is growing increasingly rich; the payment system is extending from basic medical insurance toward multi-channel payment; and the clinical pathway is evolving from “nothing to treat with” into a complete closed loop of “early screening → precise diagnosis → targeted intervention.” A clinical demand market that has been overlooked for too long will ultimately not be forgotten by the commercial world — and the years ahead may move faster than anyone imagines.
[Disclaimer]: The above content reflects analysis of publicly available information, expert insights, and BCC research. It does not constitute investment advice. BCC is not responsible for any losses resulting from reliance on the views expressed herein. Investors should exercise caution.