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市場調查報告書
商品編碼
1790231
美國帕金森氏症血液生物標記市場規模、佔有率及趨勢分析報告(按生物標記類型、技術、最終用途及細分市場預測,2025-2033)U.S. Blood-based Biomarker For Parkinson's Disease Market Size, Share & Trends Analysis Report By Biomarker Type, By Technology, By End Use, And Segment Forecasts, 2025 - 2033 |
預計 2024 年美國帕金森氏症血液生物標記市場規模將達到 4,575 萬美元,2025 年至 2033 年的複合年成長率將達到 18.33%。
美國帕金森氏症 (PD) 血液生物標記市場的發展受到患者人數不斷成長的驅動,每年新增 9 萬例確診病例,且對早期非侵入性診斷工具的需求日益成長。不斷擴展的研究活動,尤其是來自學術機構和製藥公司的研究活動,正在加速生物標記的發現和檢驗。多重檢測和基於人工智慧的平台的技術進步進一步推動了生物標記的採用。此外,美國國立衛生研究院 (NIH)、MJFF 和 Verily 之間的合作正在幫助標準化生物標記的使用。隨著 α-突觸核蛋白和 NfL 等檢測方法獲得監管部門核准,將其整合到臨床實踐中變得越來越可行。
美國帕金森氏症血液生物標記市場正蓬勃發展,這得益於對早期診斷、更精準的疾病監測以及更精準的臨床檢測患者分層的需求。據估計,目前美國有超過110萬帕金森氏症患者,每年新增確診病例9萬例。
迄今為止,帕金森氏症的診斷嚴重依賴運動症狀的存在與否,導致誤診頻傳和治療延誤。血液生物標記提供了一種非侵入性且便捷的替代方法,能夠在症狀出現前數年識別疾病的發生。目前正在研究的關鍵生物標記包括錯誤折疊的α-突觸核蛋白、神經絲輕鏈 (NfL)、DJ-1、 Tau、發炎細胞激素(如IL-6和CRP)以及氧化壓力標記。這些生物標記正在多個技術平台上開發,包括ELISA、多重蛋白質組學、基於外泌體的檢測以及整合AI的體學。
美國診斷公司Amplion正在推進其SynRT™血液檢測方法,用於檢測錯誤折疊的α-突觸核蛋白,這是帕金森氏症(PD)病理學的一個標誌。目前,此檢測方法僅核准用於腦脊髓液(CSF),但正在進行血液檢驗的臨床試驗。以阿茲海默症PrecivityAD™檢測方法而聞名的C2N Diagnostics正在將其平台擴展到帕金森氏症領域,利用質譜技術進行NfL和Tau的靶向檢測。
製藥公司也在將生物標記納入治療開發中。 Denali Therapeutics 和 Biogen 正在使用磷酸化 Rab10 作為 LRRK2 抑制劑臨床試驗中的動態學生物標記。羅氏/基因泰克正在與 AC Immune 合作,共同開發基於抗體的療法,同時檢驗相關的 α-突觸核蛋白生物標記。這些生物標記不僅對於確定治療反應至關重要,而且對於選擇合適的患者亞群(尤其是攜帶 LRRK2 或 GBA 突變的患者)也至關重要。
在技術方面,Olympus Proteomics 正在與邁克爾·J·福克斯基金會 (MJFF) 合作部署其鄰近延伸分析 (PEA) 平台,以識別一組與 PD 相關的蛋白質,而 Verily Life Sciences(Alphabet 的子公司)正在構建一個基於 AI 的多組體學平台,以分析血液、腦腦脊髓液和帕金森腦標記舉措的一部分 MJFFMI 的一部分 MJFFMI 標記。
賓州大學、梅奧診所和麻省總醫院等學術機構也是生物標記生態系統的核心參與者。這些機構正在進行由美國國立衛生研究院 (NIH) 和麻省總醫院 (MJFF) 資助的研究,以縱向隊列研究的形式檢驗外泌體 α-突觸核蛋白、miRNA 組和基於血液的神經纖維連接蛋白 (NfL)。這些努力對於推動生物標記候選物獲得 CLIA 認證、FDA 驗證以及最終獲得 CMS 報銷至關重要。隨著市場向臨床效用邁進,未來 5 到 10 年,隨著醫院和神經科專科診所採用基於生物標記的血液檢測進行診斷、治療選擇和疾病監測,生物標記檢測可能會從研究階段過渡到常規實踐階段。
美國帕金森氏症血液生物標記市場細分
該報告預測了2021年至2033年各國各國的收益成長,並分析了每個細分領域的最新行業趨勢。在本研究中,Grand View Research, Inc. 根據生物標記類型、技術和最終用途,對美國帕金森氏症血液生物標記市場報告進行了細分。
The U.S. blood-based biomarker for parkinson's disease market size was estimated at USD 45.75 million in 2024, and is projected to grow at a CAGR of 18.33% from 2025 to 2033. The U.S. Parkinson's disease (PD) blood-based biomarkers market is driven by a growing patient population, with 90,000 new diagnoses annually, and increasing demand for early, non-invasive diagnostic tools. Expanding research efforts, especially in academic and pharmaceutical settings, are accelerating biomarker discovery and validation. Technological advancements in multiplex assays and AI-based platforms are further supporting adoption. In addition, collaborations involving the NIH, MJFF, and Verily are helping standardize biomarker use. As assays such as a-synuclein and NfL progress toward regulatory approval, their integration into clinical practice is becoming increasingly viable.
The U.S. blood-based biomarker for parkinson's disease market is gaining significant momentum, fueled by the need for earlier diagnosis, improved disease monitoring, and more precise patient stratification in clinical trials. With over 1.1 million Americans currently living with Parkinson's disease and an estimated 90,000 new diagnoses each year-a 50% increase over prior estimates-there is growing urgency for scalable, non-invasive diagnostic tools that go beyond traditional clinical evaluation and imaging.
Historically, PD diagnosis has relied heavily on the presence of motor symptoms, leading to frequent misdiagnoses and delayed treatment. Blood-based biomarkers offer a non-invasive, accessible alternative that can identify disease onset years before symptoms emerge. Key biomarkers under investigation include misfolded a-synuclein, neurofilament light chain (NfL), DJ-1, tau, inflammatory cytokines (e.g., IL-6, CRP), and oxidative stress markers. These are being developed across multiple technological platforms, including ELISA, multiplex proteomics, exosome-based assays, and AI-integrated multi-omics.
Amprion, a U.S.-based diagnostics company, is advancing a blood-based version of its SynRT(TM) test, which detects misfolded a-synuclein-a hallmark of PD pathology. Although currently approved only for cerebrospinal fluid (CSF), this test is undergoing clinical studies for blood validation. C2N Diagnostics, known for its Alzheimer's PrecivityAD(TM) test, is extending its platform to PD with targeted assays for NfL and tau using mass spectrometry.
Pharmaceutical companies are also integrating biomarkers into therapeutic development. Denali Therapeutics and Biogen are utilizing phosphorylated Rab10 as a pharmacodynamic biomarker in trials for their LRRK2 inhibitors. Roche/Genentech is partnering with AC Immune to co-develop antibody-based therapies, while simultaneously validating associated a-synuclein biomarkers. These biomarkers are essential not only for determining therapeutic response but also for selecting appropriate patient subgroups-particularly those with LRRK2 or GBA mutations.
On the technology front, Olink Proteomics has deployed its Proximity Extension Assay (PEA) platform to identify PD-relevant protein panels, in partnership with the Michael J. Fox Foundation (MJFF). Meanwhile, Verily Life Sciences (an Alphabet subsidiary) is building AI-based multi-omic platforms to analyze blood, cerebrospinal fluid, and digital biomarkers as part of the MJFF-funded Parkinson's Progression Markers Initiative (PPMI).
Academic institutions such as the University of Pennsylvania, Mayo Clinic, and Massachusetts General Hospital are also central to the biomarker ecosystem. They are running NIH- and MJFF-funded studies to validate exosomal a-synuclein, miRNA panels, and blood-based NfL as part of longitudinal cohorts. These efforts are critical for advancing biomarker candidates toward CLIA certification, FDA validation, and eventual CMS reimbursement. As the market moves toward clinical utility, the next 5-10 years will likely witness a transition from research to routine care, with hospitals and specialty neurology clinics beginning to incorporate biomarker-based blood tests for diagnosis, treatment selection, and disease monitoring.
U.S. Blood-based Biomarker For Parkinson's Disease Market Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented U.S. blood-based biomarker for Parkinson's disease market report on the basis of biomarker type, technology, and end use: