Neurological Biomarkers Market

Market Overview

The global neurological biomarkers market size was valued at USD 7,823.39 million in 2022. It is estimated to reach USD 23,332.71 million by 2031, growing at a CAGR of 12.91% during the forecast period (2023–2031). Factors such as increasing prevalence of neurological diseases and increased funding for R&D in biomarkers, significantly drives the neurological biomarkers market demand by 2031.

Neurological biomarkers are molecules found in the blood or cerebral spinal fluid (CSF) that aid in diagnosing neurological conditions and tracking disease development. Neurological illnesses are becoming more manageable due to recent advancements in detection and the comprehensive power of cluster biomarkers or biomarker signatures. Genetic mutations, metabolite levels, brain imaging, changes in protein expression, and post-translational alterations are the main sources of these biomarkers.

Neurological biomarkers are frequently utilized in clinical practice during drug development because they can identify biological reactions to experimental medications and help identify novel targets for therapeutic intervention. Researchers evaluate biomarker concentrations for non-invasive testing, earlier diagnosis, and individualized treatment. With the recent development of neurological biomarkers found in blood, diagnosing and treating neurological disorders—such as chronic traumatic encephalopathy (CTE), Alzheimer's disease, Parkinson's disease, autism, and major depressive disorder—should become simpler.

Market Dynamics

Neurological Biomarkers Market Drivers

Increasing Prevalence of Neurological Diseases

The rising incidence of neurological disorders such as migraine, dementia, Alzheimer's disease, brain tumors, epilepsy, and others is expected to boost the market growth. For instance, according to WHO, epilepsy accounts for around 13 million disability-adjusted life years and is accountable for more than 0.5% of the global disease burden.

In addition, increasing cases of Alzheimer's disease in older people are expected to fuel market growth. For instance, according to WHO, globally, approximately 50 million people have dementia, and about 10 million new cases are reported every year. The development of therapeutics for neurological diseases has been difficult mainly due to the blood–brain barrier. Moreover, the rising prevalence of neurological diseases presents significant unmet needs. Therefore, there is an increased need for biomarkers for use in neurological disease drug development, diagnosis, and the study of disease progression.

Increased Funding for R&D in Biomarkers

Increased funding for the R&D of neurological biomarkers to boost the development of new drugs is expected to accelerate market growth. The National Institute of Neurological Disorders and Stroke provides funding opportunities such as development grants and cooperative agreements for researchers conducting studies related to biomarker discovery, analytical validation, and clinical validation. In addition, the presence of organizations offering funds at various stages of research is anticipated to drive market growth. For instance, the University of North Texas Health Science Center (HSC) was awarded around USD 45.5 million in funds from the National Institutes of Health to support research regarding health disparities in Alzheimer's and brain aging.

Similarly, increasing funding for new companies developing advanced technologies and biomarkers is anticipated to boost market growth. For instance, in June 2018, Mindstrong Health received USD 15 million in series B funding from One Mind Brain Health Impact Fund, Optum Ventures, Decheng Capital, Bezos Expeditions, Berggruen Holdings, Foresite Capital, and ARCH Venture Partners.

Neurological Biomarkers Market Restraint

Reimbursement Policies

Medicare and other health insurance programs currently only cover a few restricted types of biomarker tests for dementia symptoms, and their application must be supported by the patient's symptoms and unique needs. In addition, the reimbursement for Alzheimer's disease is not covered by most insurance providers like Blue Cross and Blue Shield Association. Reimbursement for assessing cerebrospinal fluid biomarkers of patients with Alzheimer's disease, including amyloid beta peptides, tau protein, neural thread proteins, or alpha-synuclein, is not authorized. The lack of reimbursement policies for the population in developed countries constrains Neurological Biomarkers Market growth.

Neurological Biomarkers Market Opportunities

Technological Advancements

Innovative treatments that combine biomarkers with new or existing medicines are continuously being launched. Recent biomarker advancements, such as biomarker signatures, make neurological diseases more treatable. This has resulted in non-invasive testing, faster drug development, and early diagnosis. Similarly, digital biomarkers provide pharmaceutical companies contextual and supplemental information to conclude clinical trial decisions. For instance, IXICO plc—a digital technology-based company with expertise in neurosciences—is collaborating with biopharmaceutical companies to validate clinically digital biomarkers and use them in clinical trials.

Furthermore, the development and introduction of blood-based biomarker tests for diagnosing indications such as Alzheimer's disease and mild traumatic brain injury, among others, are contributing to market growth. For instance, in March 2020, NIH-funded researchers developed a blood-based test for detecting phosphorylated-tau-181 (ptau181), which indicates the presence of Alzheimer's disease. This approach is less costly and invasive than the existing brain imaging and spinal fluid tests. Such technological advancements are further expected to create opportunities for market growth.

Regional Analysis

Based on region, the global neurological biomarkers market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global neurological biomarkers market shareholder and is anticipated to exhibit a CAGR of 12.9% during the forecast period. The neurological biomarker market in North America is expected to grow due to various factors, such as the burden of neurological disorders and an increase in favorable government initiatives. Moreover, increasing product launches and demand for biomarkers will positively impact the North American neurological biomarkers market growth. Funding for the R&D of novel biomarkers is high in the region.

Some of the major players operating in this market are Abbott, Merck & Co., Inc., General Electric Company, and Thermo Fisher Scientific, Inc., which collectively hold the majority share in the market. In addition, the local presence of leading companies is expected to increase the availability of biomarkers in the region. The local presence of regulatory entities in North American countries is expected to foster the growth of biomarker-based drug development soon. This is mainly because these entities play a vital role in creating awareness among people about the potential of biomarker-based therapies in disease management.

Europe is estimated to exhibit a CAGR of 12.6% over the forecast period. The high prevalence of neurological disorders, such as Multiple Sclerosis (MS), Alzheimer's Disease (AD), Motor Neuron Disease (MND), Parkinson's Disease (PD), and Huntington's Disease (HD), is a major concern for healthcare agencies and governments across Europe. Public and private stakeholders are working together to speed up the development of novel biomarkers, digital diagnostic capabilities, new drugs, and personalized medicine to manage the public health crisis brought on by the rising burden of neurological diseases. For instance, HEALIOS LLC introduced a new digital tool, dreaMS, which can help improve the development of biomarkers using consumer data, devices, and data science. The company received funding from the EC and aims to commercialize the product by 2022. The usage of novel neurological biomarkers is anticipated to grow over the coming years due to the increasing prevalence of brain and CNS cancers across the region.

The Asia-Pacific region's market is anticipated to rise due to increased clinical trials in developing nations like China and India, a rising disease burden, and a growing demand for medications that target the central nervous system. Increasing disposable income, improving healthcare infrastructure, and rising consumer awareness will likely be key market drivers in the Asia-Pacific region. Economic development in this region is enabling a broader market penetration of biomarkers. In addition, developing technologically advanced products to reduce treatment costs and mortality rates is expected to fuel market demand in the Asia-Pacific. The need for early diagnosis of neurodegenerative disorders or PoC diagnostics and personalized medicines is expected to drive the Asia-Pacific market, supported by the regional presence of key manufacturers and market demand for cost-effective test and diagnostic options.

The LATAM countries are following a demographic shift in terms of aging population similar to developed regions in North America and Europe. The neurological disease prevalence estimates for LATAM are not well-documented due to differences in access to healthcare and diagnostics and a lack of accurate data reporting mechanisms. Among the several neurological conditions, dementia and epilepsy are commonly observed among the LATAM population. As per data published by Alzheimer's Disease International and WHO, the prevalence of dementia is higher in low- and middle-income economies, with several cases undiagnosed. However, with continuous investment to improve public access to healthcare facilities and diagnostics, the usage of neurological biomarkers is expected to grow rapidly over the forecast period.

In the Middle East and Africa, the growing demand for neurological biomarkers in this region is one of the major factors expected to contribute to market growth. The increasing need for enhanced healthcare infrastructure and the high burden of various diseases, such as multiple sclerosis, Alzheimer's disease, and Parkinson's disease, are expected to increase the demand for neurological biomarkers. Growing economic development and unmet healthcare needs fuel the Middle East and Africa's neurological biomarkers market share. In addition, the rate of diagnosis of neurological disorders is low in the region. Delays in treatment and diagnoses can lead to lower treatment and survival rates. This has created major unmet needs for low-cost and efficient tests and therapeutics in the region, which is expected to fuel the market over the coming years.

Segmental Analysis

The global market for neurological biomarkers is segmented by type, application, and end-user.

Based on type, the global market is bifurcated into genomic, proteomic, metabolomic, imaging, and others. 

The proteomic segment dominates the global market and is projected to exhibit a CAGR of 9.8% over the forecast period. Proteomic biomarkers are useful as high functional implications of several post-translational modifications cannot be concluded from mRNA expression. In that case, proteomic biomarkers are required to accurately diagnose disease onset and progression due to the careful detection of protein signatures and post-translational modifications. These biomarkers have been very useful for the identification of underlying cellular changes involved in multifactorial and idiopathic diseases such as AD. The commonly used proteomic biomarkers for AD include glial fibrillary acidic protein (GFAP), copper-zinc superoxide dismutase (SOD1), Aβ42, tau, and Aβ peptides. Increasing product launches is expected to drive market growth.

Metabolomic biomarkers identify specific metabolic pathways modified by disease progression or treatment. These biomarkers represent the downstream products of ongoing biological processes in cells, tissues, and organs. These biomarkers include choline, creatine, lactate, and NAAG, which are used in the diagnosis of epilepsy; glutamate and glutamine are used for the detection of cerebral stroke, prolonged seizures, mitochondrial encephalopathy, and neurodegenerative disorders. In addition, myoinositol is being used for the diagnosis of AD. Research initiatives for developing effective diagnosis and understanding of the pathology of diseases like amyotrophic lateral sclerosis (ALS) may help market growth.

Based on application, the global market is segmented into Alzheimer's disease, Parkinson's disease, multiple sclerosis, autism spectrum disorders, and others. 

The Alzheimer's disease segment owns the market and is estimated to exhibit a CAGR of 13.3% during the forecast period. Alzheimer's disease mostly occurs in people above 65 years of age. According to the Alzheimer's Association, around 5.8 million people were estimated to be affected by the disease in the U.S. alone. Similarly, according to Alzheimer's Disease International, as of 2019, around 50 million people are living with some form of dementia globally, and the institute estimates that this number is expected to reach around 152 million by 2050. A rise in the prevalence of the disease coupled with disease awareness is expected to drive the market. Likewise, the government and nonprofit organizations provide many research opportunities that fuel market growth.

Multiple sclerosis is considered one of the most common causes of disability. The estimated base of the target population in 2020 was around 2,500,000 worldwide and 131,720 in the U.K. Organizations like the Multiple Sclerosis Association of America (MSAA) and the National MS Society are actively involved in educating people and raising awareness about the associated symptoms of multiple sclerosis, such as unusual sensations and tingling or pain. The different types of biomarkers for multiple sclerosis diagnosis include Oligoclonal bands, IgG index, Anti-aquaporin-4 antibodies, Anti-MOG antibodies, and Antinuclear antibodies.

Based on end-user, the global market is divided into hospitals and hospital laboratories, independent clinical diagnostic centers, and research organizations and others. 

The hospitals and hospital laboratories segment is the largest contributor to the neurological biomarkers market share and is expected to grow at a CAGR of 13.11% during the forecast period. Hospital laboratories are anticipated to witness significant growth during the forecast period owing to increased hospitalization. Diagnostic centers often collaborate with hospitals; hence, hospitals have their diagnostic setup. In addition, it is anticipated that the ongoing development of healthcare infrastructure will improve the extant hospital facilities. Most blood-based biomarker assays are purchased by hospitals and utilized in significant volumes. Research initiatives and clinical studies are being conducted in hospitals for developing biomarker tests, which are anticipated to fuel market growth.

An increase in initiatives undertaken by the government to provide various facilities, such as reimbursement for diagnostic tests, are major factors anticipated to drive the market. In addition, many healthcare institutions are working with laboratories to integrate different tests. Increased awareness about blood-based biomarker tests, a rise in the demand for affordable services, and technological advancements are some of the significant factors expected to expedite the growth of the laboratory segment.

Recent Developments

• February 2023- Ad Scientiam, a leader in digital biomarkers, launched two ambitious initiatives on Rare Disease Day to develop and validate novel digital biomarkers for the self-assessment of patients with generalized Chronic Neurological Diseases such as myasthenia gravis (gMG) and neuromyelitis optica spectrum disorders (NMOSD).
• July 2022- NeuroSense Therapeutics Ltd., a company that develops treatments for severe neurodegenerative diseases, and NeuraLight, a company that develops objective and sensitive biomarkers for neurological disorders, announced a partnership to advance the science of digital biomarkers in the detection and monitoring of neurological diseases, such as amyotrophic lateral sclerosis (ALS).