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시장보고서

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세계의 중추신경계 바이오마커 시장(2023-2030년)

Global Central Nervous System Biomarkers Market - 2023-2030

발행일: 2023년 06월 | 리서치사:

DataM Intelligence | 페이지 정보: 영문 195 Pages | 배송안내 : 1-2일 (영업일 기준)

■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

시장 개요

세계의 중추신경계 바이오마커 시장 규모는 2022년 47억 9,080만 달러에 달하며, 2030년에는 최대 98억 5,270만 달러에 달할 것으로 예상됩니다. 예측 기간(2023-2030년)의 CAGR은 9.7%입니다.

바이오마커는 생물학적 과정, 질병 상태 및 치료에 대한 반응에 대한 정보를 제공하는 정량적 측정값입니다. 바이오마커는 질병의 병인과 병태를 더 깊이 이해할 수 있는 잠재력을 가지고 있으며, 연구자와 임상의에게 많은 쇠약해진 질병과 질환의 진단, 치료 및 예후에 대한 귀중한 지식을 제공합니다.

중추신경계 바이오마커 시장은 중추신경계 조직, 수액, 혈액의 프로테오믹스, 유전체학, 대사체 분석, 이미징 기술의 조합, 새로운 바이오마커 개발 등의 요인에 의해 주도되고 있습니다.

시장 역학

신규 바이오마커에 대한 수요 증가

중추신경계 질환의 새로운 바이오마커로 타우 단백질, 뉴로필라멘트 경쇄(NFL), 신경섬유성 산성 단백질(GFAP), 유비퀴틴 C말단 하이드롤라제 L1(UCH-L1) 등이 거론되고 있습니다. 타우 단백질은 주로 중추신경계 백질에 존재하는 신경축삭 마커로 허혈성 뇌졸중이나 심정지 시 증가하는 것으로 보고되고 있으며, NFL은 심정지 후 예후 예측에 높은 정확도를 보이지만 알츠하이머병과 같은 신경퇴행성 질환에서도 증가하는 것으로 보고되고 있습니다.

GFAP는 신경 보호 메커니즘의 일부로 생산되는 천체 세포 마커로 두부 외상, 뇌내 출혈, 허혈성 뇌졸중, 심정지 후 예후와 관련이 있으며, UCH-L1은 신경 세포체 마커로 뇌 손상 후 신경 축삭의 안정화 및 복구에 중요합니다.

기술의 발전으로 바이오마커의 발견 속도는 빨라지고 있지만, 아직 검증되지 않은 바이오마커가 대부분입니다. 바이오마커를 임상시험과 진료에 도입하면 시험의 효율성이 향상되고 개인화된 신경학이 발전할 수 있습니다.

중추신경계 바이오마커 검사 및 진단에 드는 고비용

검체 수집 및 보관 등 검증 과정에 드는 비용이 높아 표준 치료로 간주되지 않는 바이오마커를 통한 치료에는 보험이 적용되지 않는 등 정부의 규정과 정책이 바뀌고 있습니다.

바이오마커가 검사에 큰 부가가치를 제공하지만, 환급은 제한적입니다. 예를 들어 5,000만 명 이상의 수혜자를 보유한 미국 최대 의료 보험사인 메디케어는 실험용 의약품과 대부분의 선별 검사 및 바이오마커 검사에 자금을 지원하지 않습니다. 따라서 위의 요인들이 예측 기간 중 시장 성장을 저해할 것으로 예상됩니다.

COVID-19의 영향 분석

COVID-19 팬데믹은 인지 장애 및 신경 퇴행성 변화를 포함한 다양한 신경학적 합병증과 관련이 있습니다. 예를 들어 웨스트버지니아의 마샬 대학교는 COVID-19와 관련된 다양한 신경 퇴행성 변화를 검토하여 질병의 진행 및 중증도와 관련된 주요 순환 바이오마커의 중요성을 강조했습니다.

그들의 문헌 조사에서 GFAP, NfL, pT181-tau와 같은 중요한 CNS 단백질과 다양한 염증성 사이토카인이 COVID-19 환자에서 현저하게 변화하는 것을 보여주었습니다. 중증화 위험에 처한 환자를 식별하기 위한 바이오마커의 활용 가능성에 대한 이해는 현재로서는 제한적입니다.

러시아·우크라이나 분쟁 분석

전쟁이 세계 과학계에 미치는 장기적인 영향과 러시아·우크라이나 전쟁 중 우크라이나의 학술, 의학 및 과학 분야의 연구 기회를 놓친 위험, FDA의 임상시험 데이터베이스에 따르면 우크라이나는 251개의 의약품과 장비를 시험했습니다.

임상시험 데이터베이스에 따르면 2022년 우크라이나에서 1,000개 이상의 의약품에 대한 임상시험이 진행 중이거나 계획되어 있으며, 그 중 종양 분야만 786개에 달할 전망입니다. 전쟁으로 인해 러시아 임상시험 실시기관은 자원과 인력이 우선순위에 따라 배분되지 않아 중추신경계 치료가 악화되는 등 부정적인 영향을 받고 있습니다.

Market Overview

The Global Central Nervous System Biomarkers Market size reached US$ 4,790.8 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 9,852.7 million by 2030. The market is exhibiting at a CAGR of 9.7% during the forecast period (2023-2030).

Biomarkers or biological markers are quantitative measurements that provide information about biological processes, a disease state, or a response to treatment. They have the potential to better understand the etiology and pathogenesis of a given disorder, providing researchers and clinicians with valuable insight into diagnosis, treatment, and prognosis for many debilitating disorders and diseases.

The central nervous system biomarkers market is driven by factors such as combining proteomics, genomics, and metabolomic interrogation of CNS tissues, CSF, or blood, and imaging technologies and the development of novel biomarkers.

Market Dynamics

Increasing Demand For Novel Biomarkers

Novel potential biomarkers for CNS disorders include the tau protein, neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), and ubiquitin C-terminal hydrolase-L1 (UCH-L1). The tau protein is a neuroaxonal marker located mainly in the white matter of the central nervous system and is reported to be increased in ischemic stroke and cardiac arrest. The NFL is highly accurate in prognostication after cardiac arrest, but it has also been reported to increase in neurodegenerative disorders such as Alzheimer's disease.

GFAP is an astrocytic marker that is produced as part of a neuroprotective mechanism and has been associated with prognosis after head trauma, intracerebral hemorrhage, ischemic stroke, and cardiac arrest. UCH-L1 is a neuronal cell body marker that is crucial for neuroaxonal stability and repair after brain injury.

Technological advances have increased the pace of biomarker discovery, but most are yet to be validated. Incorporating biomarkers into clinical trials and practice will help improve study efficiency and inform advancements in personalized neurology.

High Cost of CNS Biomarker Testing and Diagnostics

With the high cost of the validation process, such as sample collection & storage, government rules and policies are changing since reimbursements do not cover biomarker-mediated therapies that are not considered standard of care.

Even though biomarkers add significant value to tests, refunds are limited. For instance, Medicare, the nation's largest healthcare insurer with more than 50 million beneficiaries, does not fund experimental medicines or most screening and biomarker tests. Therefore, the above factors are expected to hamper the market growth over the forecast period.

COVID-19 Impact Analysis

The COVID-19 pandemic has been linked to a range of neurological complications, including cognitive impairment and neurodegenerative changes. For instance, Marshall University, West Virginia, reviewed the diverse neurodegenerative changes associated with COVID-19 and highlighted the importance of major circulating biomarkers, associated with disease progression and severity.

Their literature survey indicated that important CNS proteins, such as GFAP, NfL, and pT181-tau, and various inflammatory cytokines, are altered significantly in COVID-19 patients. The current understanding of the neuropathological changes associated with COVID-19 and the potential use of biomarkers in identifying patients at risk for developing severe forms of the disease is limited.

Russia-Ukraine Conflict Analysis

Risk about the war's long-term impact on the scientific community worldwide and the missed opportunities for research in Ukraine's academic, medical, and scientific disciplines during Russia Ukraine war. Ukraine was testing 251 medicines and devices, according to the FDA's clinical trials database.

According to the clinical trials database, in 2022, over 1,000 medication clinical trials were underway or planned in Ukraine, including 786 in the field of oncology alone. The war has had a negative impact on Russian clinical trial sites, as resources and manpower are not allocated according to priority, leading to worsening CNS care.

Segment Analysis

The global central nervous system biomarkers market is segmented by type, application, disease, end-user, and by region.

Based on Type, Safety Biomarkers Segment Is Expected To Drive The Market Growth

The safety biomarkers segment accounted for the highest market stake accounting for approximately 35.5% of the central nervous system biomarkers market in 2022. Safety biomarkers are expected to dominate the market growth due to increased awareness of health issues such as depression, Parkinson's, and multiple sclerosis. They play a crucial role in preclinical and clinical research trials, with rapid changes in growth measurement, computation, and analysis leading to the explosive growth of the translational research field. For Instance, Donanemab improved cognition and ability to perform activities of daily living in patients with early Alzheimer's disease at 76 weeks.

Geographical Analysis

The Rising CNS Cancer Cases And Increasing R&D Expenditure

North America is estimated to hold around 42.7% of the total market share throughout the forecast period due to rising CNS cancer cases and increased R&D expenditure. According to the American Cancer Society, brain malignancy is the second most common cancer in children and adolescents, where CNS biomarkers are commonly used.

Competitive Landscape

The major global players in the market include: Acumen Pharmaceuticals, Biogen, Alseres Pharmaceuticals, Aposense, Avacta Life Sciences Ltd., Banyan Biomarkers Inc., Bio-Rad Laboratories Inc., DiaGenic ASA, G-Biosciences, and Thermo Fisher Scientific.

Why Purchase the Report?

To visualize the global central nervous system biomarkers market segmentation based on type, application, disease, end-user, and region and understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of central nervous system biomarkers market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as Excel consisting of key products of all the major players.

The global central nervous system biomarkers market report would provide approximately 54 tables, 46 figures, and 195 pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Type
3.2. Snippet by Application
3.3. Snippet by Disease
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing demand for Novel Biomarkers
- 4.1.2. Restraints
  - 4.1.2.1. High Cost of CNS Biomarker Testing and Diagnostics
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID-19
- 6.1.2. Scenario During COVID-19
- 6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturer's Strategic Initiatives
6.6. Conclusion

7. By Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 7.1.2. Market Attractiveness Index, By Type
7.2. Safety Biomarkers*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Efficacy Biomarkers
7.4. Validation Biomarkers
7.5. Others

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Drug Discovery & Development*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Personalized Medicines
8.4. Disease Risk Assessment
8.5. Diagnostics
8.6. Others

9. By Disease

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
- 9.1.2. Market Attractiveness Index, By Disease
9.2. Multiple Sclerosis*
9.3. Alzheimer's Disease
9.4. Parkinson's Disease
9.5. Traumatic Brain Injury
9.6. Others

10. By End-User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.1.2. Market Attractiveness Index, By End-User
10.2. Diagnostic Labs
10.3. Clinics
10.4. Hospitals
10.5. Research Centers
10.6. Others

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.2.7.1. The U.S.
  - 11.2.7.2. Canada
  - 11.2.7.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.3.7.1. Germany
  - 11.3.7.2. The U.K.
  - 11.3.7.3. France
  - 11.3.7.4. Italy
  - 11.3.7.5. Spain
  - 11.3.7.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.4.7.1. Brazil
  - 11.4.7.2. Argentina
  - 11.4.7.3. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 11.5.8. China
- 11.5.9. India
- 11.5.10. Japan
- 11.5.11. Australia
- 11.5.12. Rest of Asia-Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease
- 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

13.1. Acumen Pharmaceuticals Inc.*
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. Biogen Inc.
13.3. Alseres Pharmaceuticals Inc.
13.4. Aposense Ltd.
13.5. Avacta Life Sciences Ltd.
13.6. Banyan Biomarkers Inc.
13.7. Bio-Rad Laboratories Inc.
13.8. DiaGenic ASA
13.9. G-Biosciences
13.10. Thermo Fisher Scientific Inc.

LIST NOT EXHAUSTIVE

14. Appendix

14.1. About Us and Services
14.2. Contact Us

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