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市场调查报告书
商品编码
1867492
PD-L1 和 PIK3CA 检测:全球市场份额和排名、总收入和需求预测(2025-2031 年)PD-L1 and PIK3CA Testing - Global Market Share and Ranking, Overall Sales and Demand Forecast 2025-2031 |
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全球 PD-L1 和 PIK3CA 检测市场预计在 2024 年达到 8.7 亿美元,预计到 2031 年将达到 26.5 亿美元,在预测期(2025-2031 年)以 16.9% 的复合年增长率成长。
PD-L1生物标记检测测量癌细胞上PD-L1的含量。 PD-L1是一种蛋白质,它能阻止免疫细胞攻击体内无害细胞。正常情况下,免疫系统会攻击病毒和细菌等外来物质,而不会攻击自身健康的细胞。一些癌细胞具有高水平的PD-L1,这使它们能够「欺骗」免疫系统,避免被当作外来物攻击。目前的PD-L1检测是基于免疫组织化学(IHC)技术,该技术利用抗体检测组织切片(例如肝臟、胰臟、心臟等)中细胞表面存在的蛋白质(抗原)。 PD-L1是一种配体,它与PD-1(程序性死亡受体1)结合,PD-1表达于活化的T细胞上,并在肿瘤细胞逃避免疫反应中发挥作用。 PD-L1抑制T细胞的活化和增殖,因此作为癌症治疗的重要标靶而备受关注。免疫组化(IHC)检测PD-L1蛋白被广泛用作抗PD-1/PD-L1疗法的预测性生物标记检测。 PIK3CA基因编码一种脂质激酶,参与多种讯息传递路径。这些通路影响细胞增生、凋亡和生长等功能。 PIK3CA突变会活化PI3K-PTEN-AKT通路,该通路位于EGFR和RAS-RAF-MAPK通路的下游。 PIK3CA突变可导致致癌性,且此过程独立于RAS或RAF突变。 PIK3CA突变在约15%至30%的乳癌、子宫内膜癌和大肠癌中发现,在肺癌和其他癌症类型中发生率较低。 PIK3CA突变与乳癌、子宫内膜癌和大肠直肠癌患者预后不良和对特定治疗反应不佳有关。
全球PD-L1和PIK3CA检测市场正经历强劲增长,这主要得益于精准肿瘤学的日益普及以及标靶治疗在包括非小细胞肺癌(NSCLC)、乳癌和子宫颈癌在内的多种癌症类型中的核准。伴随诊断(CDx)与免疫疗法和PI3K抑制剂联合应用的需求不断增长,加速了PD-L1免疫组化(IHC)和PIK3CA突变检测的普及。此外,政府主导的癌症筛检政策、次世代定序(NGS)平台的进步以及生物标记在临床决策中日益广泛的应用,也推动了临床对这些检测的依赖性增强。大型製药公司也在大力投资需要基于生物标记进行患者分层的临床试验,进一步推动了市场渗透。
儘管PD-L1和PIK3CA检测市场呈现成长态势,但仍面临许多挑战。检测结果解读的差异、检测方法缺乏标准化以及肿瘤异质性的复杂性,常常导致临床结果不一致,并削弱人们对检测结果的信心。伴随诊断方面的监管障碍(尤其是在新兴市场)以及基于次世代定序(NGS)平台的高成本,都阻碍了其普及应用。此外,健保报销的不确定性以及医疗基础设施的差异,限制了中低收入地区获得检测服务的机会。癌症诊断领域的不断演变也对该市场产生影响,新型生物标记和多基因检测组合的出现,可能会使临床关注点从PD-L1和PIK3CA等单一分析物检测转移开来。
本报告旨在按地区/国家、类型和应用对全球 PD-L1 和 PIK3CA 检测市场进行全面分析,重点关注总收入、市场份额和主要企业的排名。
PD-L1 和 PIK3CA 检测市场规模、估算和预测均以销售收入为指标,以 2024 年为基准年,并包含 2020 年至 2031 年的历史资料和预测资料。定量和定性分析将帮助读者制定 PD-L1 和 PIK3CA 检测的业务和成长策略,评估市场竞争,分析自身在当前市场中的地位,并做出明智的商业决策。
市场区隔
公司
按类型分類的细分市场
应用领域
按地区
The global market for PD-L1 and PIK3CA Testing was estimated to be worth US$ 870 million in 2024 and is forecast to a readjusted size of US$ 2650 million by 2031 with a CAGR of 16.9% during the forecast period 2025-2031.
PD-L1 Biomarker Testing measures the amount of PDL1 on cancer cells. PDL1 is a protein that helps keep immune cells from attacking nonharmful cells in the body. Normally, the immune system fights foreign substances like viruses and bacteria, and not your own healthy cells. Some cancer cells have high amounts of PDL1. This allows the cancer cells to "trick" the immune system, and avoid being attacked as foreign, harmful substances. Current PD-L1 testing is based on immunohistochemistry (IHC) methods. Immunohistochemistry (IHC) is the process whereby antibodies are used to detect proteins (antigens) in cells within a tissue section (for instance liver, pancreas or the heart). PD-L1 is a ligand that binds to PD-1 (programmed cell death-1), expressed on activated T cells, to evade anti-tumor responses. PD-L1 plays a role in inhibiting T cell activation and proliferation and has emerged as an important target in cancer treatment. PD-L1 protein detection by immunohistochemistry (IHC) testing is widely used as a predictive biomarker assay for anti-PD-1/PD-L1 therapies. PIK3CA is a gene that encodes a lipid kinase involved in multiple signaling pathways. These pathways influence cellular functions such as growth, death, and proliferation. PIK3CA mutations activate the PI3K-PTEN-AKT pathway, which is downstream from both the EGFR and the RAS-RAF-MAPK pathways. PIK3CA mutations may cause oncogenic transformation independent of RAS or RAF mutations. PIK3CA mutations occur in about 15% to 30% of breast, endometrial, and colon cancers. They occur less frequently in lung cancer and other types of cancer. Presence of PIK3CA mutations is associated with poor prognosis and lack of response to specific therapies in patients with breast, endometrial, or colon cancer.
The global PD-L1 and PIK3CA testing market is experiencing robust growth, driven by the expanding use of precision oncology and the approval of targeted therapies across various cancer types, including NSCLC, breast, and cervical cancers. The increasing demand for companion diagnostics (CDx) in tandem with immunotherapies and PI3K inhibitors is accelerating the adoption of PD-L1 IHC assays and PIK3CA mutation tests. Additionally, government-backed initiatives for cancer screening, advancements in next-generation sequencing (NGS) platforms, and the growing integration of biomarkers into clinical decision-making are fostering greater clinical reliance on these tests. Leading pharmaceutical companies are also investing heavily in clinical trials that necessitate biomarker-based patient stratification, further boosting market penetration.
Despite the growth, the PD-L1 and PIK3CA testing market faces several challenges. Variability in test interpretation, lack of assay standardization, and the complexity of tumor heterogeneity often lead to inconsistent clinical outcomes, hampering trust in testing results. Regulatory hurdles for companion diagnostics, especially in emerging markets, and the high cost of NGS-based platforms pose barriers to adoption. Moreover, reimbursement uncertainty and disparities in healthcare infrastructure limit access in low-to-middle-income regions. The market is also affected by the evolving landscape of oncology diagnostics, where novel biomarkers and multi-gene panels may shift clinical focus away from single-analyte tests like PD-L1 or PIK3CA.
This report aims to provide a comprehensive presentation of the global market for PD-L1 and PIK3CA Testing, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of PD-L1 and PIK3CA Testing by region & country, by Type, and by Application.
The PD-L1 and PIK3CA Testing market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. With both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding PD-L1 and PIK3CA Testing.
Market Segmentation
By Company
Segment by Type
Segment by Application
By Region
Chapter Outline
Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 2: Detailed analysis of PD-L1 and PIK3CA Testing company competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 3: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 4: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 5: Revenue of PD-L1 and PIK3CA Testing in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world.
Chapter 6: Revenue of PD-L1 and PIK3CA Testing in country level. It provides sigmate data by Type, and by Application for each country/region.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Conclusion.