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生物標記

市場調查報告書

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1289774

全球中樞神經系統生物標記市場 - 2023-2030年

Global Central Nervous System Biomarkers Market - 2023-2030

出版日期: 2023年06月12日 | 出版商:

DataM Intelligence | 英文 195 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

市場概況

全球中樞神經系統生物標記市場規模在2022年達到47.908億美元，預計到2030年將出現有利可圖的成長，達到98.527億美元。在預測期間（2023-2030年），該市場的年復合成長率為9.7%。

生物標記或生物標記物是定量測量，提供有關生物過程、疾病狀態或對治療的反應的資訊。它們有可能更好地了解某一特定疾病的病因和發病機制，為研究人員和臨床醫生提供對許多衰弱性疾病的診斷、治療和預後的寶貴見解。

中樞神經系統生物標記市場受到一些因素的推動，如結合蛋白質組學、基因組學和中樞神經系統組織、CSF或血液的代謝組學詢問，以及成像技術和新型生物標記的開發。

市場動態

對新型生物標記的需求不斷增加

中樞神經系統疾病的新型潛在生物標記包括tau蛋白、神經絲輕鏈（NFL）、膠質纖維酸性蛋白（GFAP）和泛素C端水解物-L1（UCH-L1）。 tau蛋白是一種神經軸突標誌物，主要位於中樞神經系統的白質中，據報導在缺血性中風和心臟驟停中會增加。 NFL在心臟驟停後的預後中具有很高的準確性，但也有報導說它在神經退行性疾病（如阿滋海默症）中會增加。

GFAP是一種星形細胞標誌物，作為神經保護機制的一部分而產生，並與頭部創傷、腦內出血、缺血性中風和心臟驟停後的預後有關。 UCH-L1是一種神經元細胞體標記，對腦損傷後的神經軸突穩定性和修復至關重要。

技術的進步加快了生物標記的發現速度，但大多數生物標記還沒有得到驗證。將生物標記物涵蓋臨床試驗和實踐將有助於提高研究效率，並為個性化神經病學的發展提供資訊。

中樞神經系統生物標記測試和診斷的高成本

隨著驗證過程的高成本，如樣本收集和儲存，政府的規則和政策正在改變，因為報銷不包括不被認為是標準護理的生物標記介導的治療。

即使生物標記為測試增加了重要的價值，但退款是有限的。例如，擁有5000多萬受益人的美國最大的醫療保健保險公司Medicare不資助實驗性藥品或大多數篩查和生物標記測試。因此，上述因素預計將在預測期內阻礙市場的成長。

COVID-19影響分析

COVID-19大流行病與一系列神經系統併發症有關，包括認知障礙和神經退行性變化。例如，西弗吉尼亞州的馬歇爾大學回顧了與COVID-19有關的各種神經退行性變化，並強調了主要循環生物標記的重要性，與疾病的進展和嚴重程度有關。

他們的文獻調查表明，重要的中樞神經系統蛋白，如GFAP、NfL和pT181-tau，以及各種炎症細胞因子，在COVID-19患者中都有明顯改變。目前對與COVID-19有關的神經病理變化以及生物標記在識別有可能發展為嚴重疾病的病人方面的潛在用途的理解是有限的。

俄羅斯-烏克蘭衝突分析

關於戰爭對全球科學界的長期影響以及俄羅斯烏克蘭戰爭期間烏克蘭學術、醫學和科學學科研究機會的錯過的風險。根據FDA的臨床試驗數據庫，烏克蘭正在測試251種藥品和設備。

根據臨床試驗數據庫，2022年，烏克蘭正在進行或計劃進行1000多項藥物臨床試驗，其中僅在腫瘤學領域就有786項。戰爭對俄羅斯的臨床試驗基地產生了負面影響，因為資源和人力沒有按照優先次序分配，促使中樞神經系統護理惡化。

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