Breakthroughs in Alzheimer's diagnosis and treatment portend multibillion-dollar industry

Investors and business leaders are closely watching sales figures as Japanese and US breakthrough drugs for the diagnosis and treatment of Alzheimer's go head to head this year in China, which has the world's largest incidence of the disease.

The rivalry pits US-based Eli Lilly, which obtained Chinese regulatory for its Kisunla drug late last year, against Eisai's Leqembi, approved a year earlier. Kisunla is a treatment for early symptoms of the disease; Lequmbi is the world's first approved "disease-modifying drug" for Alzheimer's.

China has an aging population, with an estimated 9.8 million people 60 years or older who are afflicted with Alzheimer's. That number is expected to reach 28 million by 2050.

The disease not only diminishes the mental capacity of patients but also causes great sorrow and a sense of helplessness among family members.

At the moment, Leqembi is priced at 2,508 yuan (US$456) per vial, and roughly 200,000 yuan for a full-year treatment. Kisunla is expected to be similarly priced when it hits the market this month.

If the market penetration of these drugs reaches 3 percent of Alzheimer's patients, it would position China's market for the disease therapeutics at 60 billion yuan a year. And that doesn't even include the more lucrative market of "mild-cognitive impairment" drugs, which treat Alzheimer's at stage when people who retain independent living capabilities start to show symptoms of near-term memory loss.

Population at risk

China is estimated to have some 39 million people in the mild-cognitive-impairment category, according to the nation's last dementia epidemiological survey in 2020.

To differentiate Alzheimer's from other forms of dementia, caused, say by Parkinson's or cardiovascular diseases, patients must be given a biomarker test of amyloid-beta or tau – the two hallmark biomarkers.

What does the arrival of Leqembi and Kisunla portend for the market in advanced therapeutics?

Typically, the approval of innovative medicines with new treatment pathways triggers growth in diagnostic demand.

For example, the launch of Keytruda, the world's best-selling prescription cancer treatment, fueled the growth of testing with a protein called PD-1, creating a new testing market globally.

The approval of Leqembi and Kisunla, along with other disease-modifying drugs, will inevitably boost the adoption of Alzheimer's biomarker testing.

Last year was a turning point for blood-based biomarker development.

Significant clinical guidelines for biomarkers have been released by leading physician groups, and a number of leading international and domestic players in the industry are using different business models to gain a foothold in what promises to be a lucrative market.

Updated progress report

A leading organization called Alzheimer's Association Workgroup had its "Revised Criteria for Diagnosis and Staging of Alzheimer's Disease" published in the industry journal Alzheimer's & Dementia in April 2024.

This group said three major developments prompted the update.

First, treatments that target core disease pathology have, for the first time, received regulatory approval, with the prospect of these therapies entering clinical practice.

Second, the most significant advance in recent year in diagnostics for the disease has been the development of blood-based biomarkers, with some, but not all, showing accurate diagnosis.

They are another tool to integrate with traditional biomarkers such as "positron emission tomography" and "cerebrospinal fluid assays."

And finally, the group noted important research showing that imaging, assays and blood-based biomarkers are interchangeable in some, though not all, cases.

This revised criteria for Alzheimer's diagnosis seems to remove some of the roadblocks for physicians hesitant to use blood-based biomarkers. That potentially reduces cost and hospital stays for diagnosis.

"Positron emission tomography," or PET scans, are priced at about US$10,000 in the US and US$1,000 in China, while "cerebrospinal fluid assays" require a 4-5 hour hospital procedure that can have side effects.

On the commercial side, the market for Alzheimer's blood-based biomarkers is swiftly gathering steam, with a series of major research results released in leading publications and leading players jumping on the bandwagon.

Flurry of global industry moves

In January 2024, ALZpath published research results of "pTau217" in JAMA Neurology, a medical journal published by the American Medical Association. It claimed its blood-based biomarker performed on the Simoa platform on a par with the golden standard of "cerebrospinal fluid assays."

Quanterix, a leading US-based diagnostic technology company, partnered with Chinese startup UltraDx in 2023 to commercialize its Simoa-technology testing solutions in China.

In 2020, US-based C2N Diagnostics launched its first "amyloid-beta" test with a price of US$1,250. Last year, Japan's Eisai invested US$15 million into C2N to streamline its early diagnosis process.

Roche Diagnostics partnered with Eli Lilly to develop the Elecsys Amyloid Plasma Panel to test biomarker pTau181 and ApoE4, a specific gene associated with a specific group of Alzheimer's patients.

Last July, ALZpath signed a licensing agreement with Beckman Coulter Diagnostics to integrate its proprietary antibody into a blood-based diagnostic for Alzheimer's, and in December, Eisai entered into a memorandum of understanding with Tokyo-based Fujirebio Holdings Inc. for the joint research on novel blood-based biomarkers.

But these international players clearly haven't yet found a feasible path forward in China.

High standards

To succeed in China's diagnostic market requires clinically acceptable quality of more than 90 percent sensitivity and specificity, access with either in-hospital testing or out-of-hospital laboratory development testing, and affordability for patients.

The standards may be high but the potential is vast. The market for Alzheimer's blood-based biomarkers is estimated to reach 33.2 billion yuan by 2030, according to a report by Founder Securities published in May.

The market is currently fraught with products of less than 90 percent optimal sensitivity and specificity. Out of the more than 50 China-approved projects, only a few met that requirement, meaning that physicians will not risk patient health or their own professional reputations by using a diagnosis product that doesn't meet standards.

Access is a make-it-or-break-it factor. If a company boasting a premium technology platform can't install its machines in hospital's testing centers, it won't generate projected sales targets.

Quanterix's Simoa-based, blood-based biomarker product is one example. Its tests show very high sensitivity and specificity, and the company is well-respected in the research community. However, one testing machine is priced at about 3 million yuan, coming up against Chinese public hospitals under pressure to control costs.

With Alzheimer's blood-based biomarkers not included in the country's national pharmaceutical reimbursement list, the cost remains high for patients.

All these factors don't at the moment bode well for the commercial outlook of advanced therapeutics.

Search for cheaper costs

Astrabio, a Suzhou-based biotech company, and Nanjing-based Vazyme, which went public in 2021 on the Shanghai stock market, are pursuing ways to ease commercialization of diagnostic solutions.

Astrabio has produced China's first proprietary, single-molecule immune detection platform, claiming it matches the performance of systems developed by players such as Quanterix, but at more reasonable prices.

The company has successfully installed its testing machines in Shanghai Huashan Hospital and Beijing Xuanwu Hospital, two of the top three national neuroscience medical centers in China. The company also has aggressive plans to its machines in more than 100 hospitals this year.

Astrabio is also actively expanding its footprint in overseas markets, with a recent partnership deal signed in Thailand.

Blood-based biomarker development has become a leading area of research and bio investment funding the past two years.

However, for an uncharted market like Alzheimer's to really take off, pure scientific advancement is not enough. A sound ecosystem must be established to increase disease awareness and testing at early stages.

All too often, patients beginning to show signs of mental deterioration simply write memory loss off as a normal part of aging and don't seek medical advice.

Encouraging news came in January, when 15 central government ministries, led by National Health Commission, enacted the 2024-30 National Action Plan for Coping with Dementia. It urges that public awareness of dementia be elevated to 80 percent of the population and that cognitive screening of the at-risk population reach four of five people. Treatment rates are recommended to reach a minimum 50 percent by 2030.

It's obvious that the China market for a multibillion-dollar market in Alzheimer's diagnosis is at a tipping point, and more accessible, affordable solutions are just around the corner.

(The author has more than 20 years' experience in China's pharmaceutical and meditech realms and held senior executive positions in industries spanning oncology, neuroscience, corporate strategy, commercial operations and public affairs in China and the US. She was CEO of a Hong Kong-based biotech startup before founding her own business consulting firm.)