Alzheimer's Disease Biomarkers Market to Surpass US$ 1.7 Bn by 2031, Driven by Rising Dementia Prevalence and Advancements in Early Diagnostic Technologies | Latest Report TMR

The global Alzheimer's Disease biomarkers market was valued at US$ 825.2 Mn in 2021 and is projected to exceed US$ 1.7 Bn by the end of 2031, expanding at a compound annual growth rate (CAGR) of 7.3% from 2022 to 2031. The growth trajectory of the market is largely attributed to the rising global burden of neurodegenerative disorders and increasing emphasis on early disease detection through advanced diagnostic biomarkers.

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As healthcare systems worldwide prioritize early diagnosis and personalized treatment strategies for neurological conditions, the demand for reliable biomarkers capable of detecting disease progression at early stages is increasing rapidly.

Market Overview

Alzheimer's Disease is a progressive and irreversible neurodegenerative disorder characterized by gradual deterioration of neurons in the brain. This degeneration affects cognitive functions such as memory, reasoning, language, and decision-making. The condition is widely recognized as the leading cause of senile dementia worldwide.

Biomarkers are measurable biological indicators that help identify physiological or pathological processes occurring within the body. In the context of Alzheimer's disease, biomarkers are detected in blood, cerebrospinal fluid (CSF), tissues, or through digital monitoring tools. These markers assist clinicians and researchers in diagnosing the disease, predicting progression, monitoring therapeutic responses, and assessing disease risk in individuals.

Key Market Growth Drivers

Increase in Geriatric Population

Aging remains the most significant risk factor associated with dementia. As individuals grow older, their probability of developing neurodegenerative conditions such as Alzheimer's disease increases substantially.

According to the Harvard T.H. Chan School of Public Health, nearly 47 million people worldwide were living with dementia in 2020, and the number is expected to triple over the next three decades due to the rapidly aging global population. Similarly, data from the Alzheimer's Society indicates that around two out of every 100 people aged between 65 and 69 suffer from dementia, with the risk doubling approximately every five years.

Changing Lifestyle and Rising Neurological Risk Factors

Lifestyle factors are also contributing to the increasing incidence of Alzheimer's disease. Traumatic brain injuries (TBI), sedentary lifestyle patterns, smoking, alcohol consumption, and poor dietary habits are among the factors associated with cognitive decline.

According to the Centers for Disease Control and Prevention, the United States reported 223,135 TBI-related hospitalizations and 64,362 TBI-related deaths between 2019 and 2020. Studies have shown that traumatic brain injuries can increase the risk of developing Alzheimer's disease years after the initial injury.

Market Challenges & Opportunities

Despite strong growth prospects, the Alzheimer's disease biomarkers market faces several challenges. One major obstacle is the complexity involved in validating biomarkers for clinical use, which requires extensive research and regulatory approvals. Additionally, the high costs associated with advanced diagnostic technologies can limit accessibility in certain healthcare systems.

However, the market also presents numerous opportunities. Advances in molecular diagnostics, artificial intelligence, and digital health technologies are enabling the development of next-generation biomarkers capable of detecting Alzheimer's disease earlier than ever before. The emergence of blood-based biomarkers and digital biomarkers is expected to transform the diagnostic landscape, making testing more accessible and scalable across healthcare settings.

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Analysis of Key Players

• Enzo Life Sciences, Inc.
• Thermo Fisher Scientific, Inc.
• AnaSpec, Inc.
• Merck KGaA
• Cell Signaling Technology, Inc.
• Fujirebio
• Imagilys
• NanoSomiX
• QIAGEN
• 23andMe, Inc.
• Quanterix
• C2N Diagnostics
• Quest Diagnostics

Market Segmentation

By Type of Biomarker
• CSF (Cerebrospinal Fluid) Biomarkers
• Blood-Based Biomarkers
• Genetic Biomarkers
• Imaging Biomarkers

Among these, the CSF biomarkers segment held a major share of the global market in 2021. Cerebrospinal fluid biomarkers play an important role in predicting disease progression and guiding outcome assessments in disease-modifying therapy clinical trials. Since CSF maintains direct contact with the brain, it serves as a reliable biological source for detecting proteins and peptides associated with Alzheimer's pathology.

By Detection Technique
• Immunoassays
• Mass Spectrometry
• Polymerase Chain Reaction (PCR)
• Imaging Techniques

The immunoassays segment is expected to account for a significant share of market growth during the forecast period. Immunoassays are widely preferred due to their simplicity, affordability, and ability to analyze biological samples efficiently.

Regional Outlook

North America accounted for the largest share of approximately 35% in 2021. The region's dominance is attributed to the high prevalence of neurological disorders, strong healthcare infrastructure, and the presence of major diagnostic companies. The United States leads the regional market due to extensive research and development activities and increased adoption of advanced diagnostic technologies.

Meanwhile, Asia Pacific is expected to be the fastest-growing region during the forecast period. The region's rapid growth can be attributed to the increasing incidence of Alzheimer's disease, dementia, and other neurodegenerative disorders, coupled with improving healthcare infrastructure and rising investments in biomedical research.

Recent Developments

• On July 27, 2022, Quanterix Corporation announced the validation of a laboratory developed test (LDT) to quantitatively measure phospho-Tau 181 (pTau-181) in plasma as an aid in Alzheimer's disease diagnostic evaluation (AD). Quanterix' LDT, the first pTau-181 plasma test approved for clinical use in the U.S., is a quantitative immunoassay designed to measure pTau-181 concentrations in human plasma. The test results are intended to be used in adults with cognitive impairment who are being evaluated for Alzheimer's disease and must be interpreted in conjunction with other diagnostic tools.

• In March 2022, Fujirebio introduced Lumipulse G-Amyloid 1-42 Plasma and Lumipulse G-Amyloid 1-40 Plasma assays for the fully automated LUMIPULSE G immunoassay systems. These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative measurement of amyloid1-42 and amyloid1-40 in human plasma in just 35 minutes. Furthermore, blood-based testing can become an even simpler, more accessible, and scalable approach to assist in the diagnosis of Alzheimer's disease.

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• Gain comprehensive insights into the global Alzheimer's disease biomarkers market and forecast trends through 2031
• Understand the key drivers, challenges, and emerging opportunities shaping the industry
• Analyze competitive strategies adopted by leading market players
• Access detailed regional and segment-wise market intelligence
• Support strategic planning and investment decisions in the rapidly evolving diagnostics sector

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FAQs

1. What is the projected size of the Alzheimer's disease biomarkers market by 2031?
The market is expected to exceed US$ 1.7 Bn by 2031.

2. What is the expected CAGR of the market during the forecast period?
The industry is projected to grow at a CAGR of 7.3% from 2022 to 2031.

3. Which region dominates the Alzheimer's disease biomarkers market?
North America held the largest market share of about 35% in 2021.

4. Which biomarker type leads the market?
The CSF biomarkers segment accounted for a major share due to its reliability in predicting disease progression.

5. Who are the major players in the Alzheimer's disease biomarkers market?
Key companies include Thermo Fisher Scientific, Fujirebio, Quanterix, QIAGEN, Merck KGaA, Quest Diagnostics, and others.

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