세계의 신경 바이오마커 시장 규모는 2024년에 100억 달러에 달했습니다. 앞으로 IMARC Group은 이 시장이 2033년에는 251억 달러에 달하고, 2025년부터 2033년까지 10.8%의 연평균 복합 성장률(CAGR)을 보일 것으로 예측했습니다. 2024년 신경 바이오마커 시장 점유율은 현재 북미가 41.6% 이상을 차지했고 신경질환 증가, 견고한 헬스케어 시스템, 가속하는 고액 연구 투자가 그 원동력이 되고 있습니다. 게다가 조기진단을 위한 바이오마커 채용 증가, 임상시험 확대, 혁신적인 신경학적 치료법 개발을 위한 바이오테크놀러지 기업과 연구개발기관과의 공동연구의 진전이 시장 성장을 가속하고 있습니다.
뇌졸중, 운동 뉴런증(MND), 알츠하이머병(AD), 파킨슨병(PD), 헌팅턴병(HD) 등 신경질환의 발생이 증가하여 보다 신속한 의약품 개발의 필요성이 높아지고 있습니다. 바이오마커는 신약 및 치료 전략의 효능을 측정하는 데 도움이 되기 때문에 시장 성장을 가속하는 주요 요인 중 하나가 되었습니다. 또한 저침습 수술과 맞춤형 의료의 채용이 증가하고 있는 것도 성장을 가속하는 큰 요인이 되고 있습니다. 이와는 별도로, 다양한 신경질환이 표준 특징을 공유하기 때문에 특정 질병과 그 하위유형을 구별하기 위한 여러 바이오마커 수요가 증가하고 있습니다. 게다가 질량분석과 영상진단의 진보로 대량의 생화학 마커와 뇌의 구조 변화를 신속하게 평가할 수 있게 되었습니다. 이는 디지털 바이오마커의 도입과 임상시험 증가와 함께 향후 수년간 시장 성장을 가속할 것으로 예측됩니다.
미국은 첨단 의료 인프라와 의료 연구에 대한 강한 주력으로 세계 시장 점유율에서 돌출한 지위를 차지하고 있습니다. 알츠하이머병이나 파킨슨병 등 신경질환의 유병률이 높기 때문에 혁신적인 진단 도구에 대한 수요가 높아지고 있습니다. 예를 들어, 업계 보고서에 따르면 미국에서는 약 100만 명이 파킨슨병을 앓고 있으며, 이 수는 2030년까지 120만 명으로 증가할 것으로 예측됩니다. 게다가 미국은 생명공학과 제약산업에 대한 많은 투자를 통해 신경 바이오마커의 개발과 상업화를 촉진하고 있습니다. 또한 규제 당국의 지원과 최첨단 기술을 갖춘 병원 검사실의 대규모 기반이 시장 성장을 더욱 강화하고 있습니다. 미국은 맞춤형 의료를 추진하고 질병의 조기 발견과 관리를 개선하는데 여전히 중요한 역할을 하고 있습니다.
신경질환 발생률 상승
WHO가 2024년에 발표한 보고서에서도 강조된 바와 같이, 신경질환은 건강에 해로움과 신체장애의 원인의 1위를 차지하고 있습니다. 보고에 따르면 1990년 신경장애의 결과, 장애, 나쁜 건강, 또는 조기 사망으로 인한 전반적인 부담의 DALY는 일반적으로 18% 증가했다고 합니다. 이들은 모두 알츠하이머병, 파킨슨병, 다발성 경화증(MS) 증가 때문입니다. 이에 더해 세계적인 노화로 인해 질병의 검출 및 모니터링에 있어서 바이오마커를 이용한 진단 툴 수요가 증가하고 있으며, 신경 바이오마커 시장의 세계 성장을 추진하고 있습니다.
생명공학과 유전체 연구의 진보
유전체학, 단백질체학, 분자 생물학의 개발은 신경 질환의 보다 정확하고 정밀한 바이오마커의 개발에 크게 기여하고 있습니다. 사실, 이러한 진보로 진단 정확도가 향상되고 질병의 조기 발견과 치료 효과 모니터링이 용이해졌습니다. WHO가 2023년 2월에 발표한 기사에 의하면, 세계에서 매년 500만명 가까이가 새롭게 간질로 진단되고 있어 정확한 진단 기술이 요구되고 있습니다. 또한, 노인 인구의 알츠하이머병 증가는 조기 발견, 모니터링 및 지향성 치료의 지속적인 성장으로 시장을 더욱 확대할 것으로 예측됩니다.
맞춤형 의료에 대한 수요 증가
맞춤형 의료는 환자의 유전적 체질과 다양한 질환의 바이오마커에 근거해, 개개의 환자의 요구에 따라 개입이나 치료 방법을 커스터마이즈 해 처방하는 것으로, 다른 의약품을 능가하는 기세입니다. 신경 바이오마커는 이러한 맞춤형 치료를 현저하게 촉진하는 중요한 요소이며, 이에 의해 질병 특이적인 분자 시그니처의 동정과 다양한 치료법의 개량을 적극적으로 지원하고 있습니다. 그 결과, 개인화된 의료는 신경 바이오마커 시장 예측을 세계적으로 확대할 것으로 예측됩니다. 알츠하이머병 협회에 따르면 현재 세계 5,500만 명이 치매를 앓고 있으며, 이 수치는 2030년까지 7,800만명, 2050년까지 1억 3,900만명 가까이까지 증가할 것으로 예측되고 있습니다. 이러한 증상의 현저한 증가는 진단 도구뿐만 아니라 보다 정확한 표적 치료에 필요한 필수 요건을 부각시키고 신경 질환 관리 및 치료에서 신경 바이오 마커의 필요성을 더욱 높여줍니다.
The global neurological biomarkers market size was valued at USD 10.0 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 25.1 Billion by 2033, exhibiting a CAGR of 10.8% during 2025-2033. North America currently dominates the neurological biomarkers market share, of over 41.6% in 2024, driven by escalating incidents of neurological conditions, robust healthcare systems, and accelerated high research investments. The growth of the market is further fueled by an increase in biomarkers adoption for early diagnosis, expanded clinical trials, and growing collaborations between biotech companies and research organizations to develop innovative neurological treatments.
The rising occurrence of neurological disorders, such as stroke, motor neuron disease (MND), Alzheimer's disease (AD), Parkinson's disease (PD) and Huntington's disease (HD), is escalating the need for faster drug development. This represents one of the primary factors impelling the market growth as biomarkers help measure the efficacy of new drugs and therapeutic strategies. The increasing adoption of minimally invasive procedures and personalized medicines are acting as another major growth-inducing factor. Apart from this, as various neurological disorders share standard features, there is an increase in the demand for multiple biomarkers to differentiate specific diseases and their sub-types. Moreover, advancements in mass spectrometry and imaging procedures enable faster evaluation of large numbers of biochemical markers and structural changes in the brain. This, along with the introduction of digital biomarkers and the rising number of clinical trials, is anticipated to propel the growth of the market in the coming years.
The United States holds a prominent position in the global neurological biomarkers market share, driven by its advanced healthcare infrastructure and strong focus on medical research. With a high prevalence of neurological disorders, including Alzheimer's and Parkinson's disease, there is a growing demand for innovative diagnostic tools. For instance, as per industry reports, around 1 million U.S. population is affected with Parkinson's disease, and this count is anticipated to elevate to 1.2 million by the year 2030. Furthermore, the U.S. benefits from significant investments in biotechnology and pharmaceutical industries, fostering the development and commercialization of neurological biomarkers. Additionally, regulatory support and a large base of hospital laboratories equipped with cutting-edge technologies further enhance market growth. The U.S. remains a key player in advancing personalized medicine and improving early disease detection and management.
Rising Incidence of Neurological Disorders
As highlighted by a report from WHO in 2024, neurological disorders have become the number one cause of ill health and disability. According to reports, DALYs of overall burden due to disability, ill health, or early death as a result of neurological disorders in 1990 has been stated to be the 18-percentage increase in general. These all are attributed with the growth incidence of Alzheimer, Parkinson's as well as multiple sclerosis (MS). In addition to this, the aging population in the world increases the demand for diagnostic tools with biomarkers in the detection and monitoring of diseases, thereby propelling the neurological biomarkers market growth globally.
Advancements in Biotechnology and Genomic Research
Advances in genomics, proteomics, and molecular biology have contributed much towards developing far more accurate and precise biomarkers for neurologic disorders. Actually, these advances have enhanced diagnostic precision as well as facilitated early detection of diseases and better monitoring of responses to treatment. According to an article from the WHO released in February 2023, almost 5 million people worldwide are newly diagnosed each year with epilepsy, with the call for precise diagnostic techniques. In addition, the elderly population's increase in Alzheimer's disease is predicted to further expand the market due to the continuing growth in early detection, monitoring, and directed treatments.
Increasing Demand for Personalized Medicine
Personalized medicine is rapidly surpassing other pharmaceutical components, in which interventions and treatment methods are customized and formulated as per the individual needs of a patient, based on their genetic makeup and biomarkers of various disease. Neurological biomarkers are the crucial components that significantly facilitate this kind of personalized treatment, thereby actively supporting the identification of disease-specific molecular signatures and refinement of varied therapeutic methods. As a result, personalized medicine is anticipated to bolster the expansion of the neurological biomarkers market forecast globally. According to the Alzheimer's Association, currently 55 million people worldwide are suffering from dementia; this number is suspected to elevate to 78 million by the year 2030 and to almost 139 million by 2050. The notable increase in cases of such conditions highlights the indispensable requirement for more precise targeted therapies as well as diagnostic tools, further escalating the need for neurological biomarkers in both the management and treatment of neurological disorders.
Based on the neurological biomarkers market forecast, proteomic biomarkers lead the market with around 31.2% of market share in 2024, chiefly because of their excellent capability to locate disease-associated proteins and their role in comprehending complicated neurological conditions. Such biomarkers are critical in identifying particular protein alterations in the brain that can play the role of early indicators for neurodegenerative disorders, mainly including Parkinson's and Alzheimer's disease. Besides, the growing emphasis on personalized therapies as well as precision medicine has significantly bolstered the requirement for proteomic biomarkers, mainly because they foster targeted treatment methodologies. In addition, active innovations in protein analysis methods and mass spectrometry have facilitated more dependable and precise biomarker discovery. Furthermore, the amplifying acknowledgement of proteomic biomarkers' potential to substantially improve diagnostic accuracy, combined with their feasibility in disease assessment and prognosis, guarantees that this type continues to dominate the market. The incorporation of proteomic biomarkers with several other diagnostic technologies further fortifies their position as a crucial driver propelling the neurological biomarkers market demand.
Alzheimer's disease holds the largest market share by application in the global neurological biomarkers market, mainly influenced by its accelerated prevalence and the urgent demand for efficient management and early diagnosis. As the most prevalent type of dementia, Alzheimer's exhibits notable healthcare challenges worldwide, with a rapid increase in geriatric population fueling its escalating incidence. Early detection of Alzheimer's disease enables for timely interventions, likely reducing disease progression and enhancing patient outcomes. Moreover, biomarkers, including tau proteins and amyloid-beta, coupled with rising blood-based markers, are crucial in diagnosing Alzheimer's at its early phases. In addition, the requirement for non-invasive, precise biomarkers for Alzheimer's diagnosis has resulted in a constant innovation and research initiatives. Furthermore, biomarkers are requisite in assessing treatment effectiveness, aiding in tailoring personalized therapeutic tactics. Given the profound economic as well as social impacts of Alzheimer's disease, its management via biomarkers remains a leading priority in neurological healthcare and research, straightening its leading market share and contributing to a positive neurological biomarkers market outlook.
Hospital laboratories represent the largest segment by end use in the global neurological biomarkers market, as they play a central role in the diagnosis and monitoring of neurological conditions. These laboratories are equipped with advanced diagnostic technologies, enabling the efficient testing and analysis of neurological biomarkers, which are essential for disease detection and prognosis. With the rising incidence of neurological disorders such as Alzheimer's, Parkinson's, and multiple sclerosis, hospital laboratories are increasingly relied upon for early diagnosis and treatment decision-making. Their ability to provide accurate, timely results supports improved patient outcomes and aids in the development of personalized treatment plans. Furthermore, hospital laboratories benefit from regulatory approvals and the integration of new biomarker assays, which enhance their diagnostic capabilities. Moreover, as healthcare systems evolve, hospital laboratories remain at the forefront of leveraging neurological biomarkers to address the growing burden of neurological diseases, thus driving their significant share in the market.
In 2024, North America accounted for the largest market share of over 41.6%, driven by magnifying cases prevalence of neurological conditions, well-established healthcare infrastructure, and innovative research abilities. For instance, as per industry reports, by 2030, in Canada, around 1 million people are expected to be living with dementia, an umbrella term for memory-related neurological disorder encompassing Alzheimer's, with projections exceeding 1.7 million by 2050. Moreover, the region notably profits from heavy investments in pharmaceuticals and biotechnology sectors, facilitating advancements in diagnostic technologies as well as biomarker discovery. In additionally, North America's amplifying need for early detection and customized treatment options for neurological conditions, mainly encompassing Parkinson's and Alzheimer's, further boosts market growth. The beneficial regulatory ecosystem and presence of leading players in Canada and the U.S. also fuel the region's domination in the neurological biomarkers industry.
United States Neurological Biomarkers Market Analysis
In 2024, United States accounted for the 91.00% of the market share in North America. The neurological disorders market in the United States is being heavily driven by an increase in the prevalence of neurological disorders. Stroke has been estimated to be the third cause of death in the country, and Parkinson's disease has been documented to have around 1 million affected individuals, as per reports. The increasing cases for other neurological diseases, such as Alzheimer's and epilepsy, also look at the rising demand for accurate diagnostics and biomarkers. All of these requirements-the need for early detection, the use of individualized treatment plans, and ongoing monitoring of the disease process-propel the implementation of neurological biomarkers. Since the field of genomics, proteomics, and molecular biology is continuously progressing, new and more specific biomarkers are found, thus better diagnostic accuracy and treatment monitoring. Increasing number of the geriatric population along with an ever-growing awareness toward neurological conditions, in turn, are anticipated to continue propelling demand for biomarkers in the United States-ensuring it a critical role in patient outcome enhancement and disease management.
Europe Neurological Biomarkers Market Analysis
The neurological conditions are increasingly developing in Europe and are the greatest driver for this market. Alzheimer's Society recently reported that around 850,000 people living in the UK were suffering from dementia in 2019. This is how the incidence of neurological disorders increases in the region. This means, on average, 1 of every 14 individuals above 65 years suffer from dementia- a statistic underlining the growing need for highly advanced diagnostic tools. With aging populations on the rise, more neurological biomarkers that can help to detect diseases earlier, diagnose it, and then monitor it including Alzheimer's disease, Parkinson's disease, or multiple sclerosis is expected to continue rising. Advances in molecular biology, genomics, and proteomics are enabling the discovery of more specific and reliable biomarkers, further fueling the adoption of these diagnostic tools. In the coming years, the increasing burden of neurological diseases in Europe is expected to drive the market for neurological biomarkers.
Asia Pacific Neurological Biomarkers Market Analysis
The Asia Pacific neurological biomarkers market is booming because of the increased incidence and prevalence of neurological disorders such as Parkinson's Disease (PD). The NIH estimated that from 1990 to 2021, the incidence of PD in Asia increased by 198.01%, while its prevalence rose by 284.35%, mortality by 111.27%, and disability-adjusted life years (DALY) by 144.45%. These disturbing statistics draw attention to an ever-increasing burden of neurological conditions in the region. Additionally, the statistics point to a significant growing gender gap where males constantly demonstrate a more significant burden than females. Due to the rise in the number of aging individuals in Asia Pacific, the requirements for early diagnosis and monitoring of neurological diseases will continue to increase over time. This trend drives the need for advanced biomarkers to aid in the detection and tracking of conditions like PD, Alzheimer's, and other neurodegenerative diseases, further propelling the market for neurological biomarkers in the region.
Latin America Neurological Biomarkers Market Analysis
The Latin America neurological biomarkers market is expected to undergo a significant boost with the surging prevalence of dementia in this region. Within the last ten years, many Latin American nations have reported an increase in prevalence rates of dementia from 6.2% to 12.1% among the older population aged 65 and more. The NIH estimates that dementia will affect the region most within the decade ahead, with data for the year 2022. The burden of healthcare is expected to increase manifolds with dementia patient count increasing close to four fold by 2050. Such an alarming rise of dementia further brings forth the demand for advanced diagnostic tools that include neurological biomarkers in the detection and monitoring of such conditions. The growth of the aging population and the increasing prevalence of neurodegenerative diseases have fueled the growth of the neurological biomarkers market in Latin America, as the need for efficient biomarkers for early diagnosis and personalized treatment continues to grow.
Middle East and Africa Neurological Biomarkers Market Analysis
The neurological biomarkers market in the Middle East and Africa is experiencing an increase due to the increasing dementia burden, mainly in low and middle-income countries. Dementia prevalence in this region ranges between 2.3% and 20.0%, and the incidence rates are at 13.3 per 1000 person-years, as NIH data shows for 2023. As the continent of Africa accelerates its population's urbanization and aging population, the statistics of dementia increases, leading to higher mortality counts, especially for regions that transform rapidly. There is a trend of increased occurrence of dementia patients, which demands more healthcare systems worldwide, thus presenting a growing interest in effective solutions for diagnosis in the form of neurological biomarkers. These biomarkers play a significant role in the early detection and follow-up of neurodegenerative diseases like dementia. This is, therefore, fueling the need for advanced diagnostic tools in the Middle East and Africa. Other factors driving the growth of this market in this region include rising healthcare burden and an aging population.
The market is extensively competitive, exhibiting a fusion of diagnostic solution providers, established pharmaceutical firms, and biotechnology companies. Leading players are currently emphasizing on tactical acquisition, partnerships, and research investments to proliferate their product portfolios. Moreover, industry giants, including Abbott Laboratories and Siemens Healthineers, utilize leading-edge technologies such as neuroimaging, genomic sequencing, and proteomics to offer upgraded products. For instance, in October 2024, Siemens Healthineers announced becoming the fisrt company to recieve Health Canada Licensing for its blood-based biomarker Neurofilament Light Chain (NfL), which is developed particularly for diagnosing and managing Multiple Sclerosis, a severe neurological condition. The company announced the commercial availability of this biomarker in Canada market. In addition, smaller, innovative firms are also establishing themselves gradually with customized medicine solutions and specialized biomarker assays. Furthermore, competitive tactics gravitate on designing novel biomarkers for various neurological disorders, including Parkinson's and Alzheimer's diseases, improving diagnostic precision, and enhancing patient outcomes.