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市場調查報告書
商品編碼
1867492
PD-L1 和 PIK3CA 檢測:全球市場佔有率和排名、總收入和需求預測(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 檢測市場預計在 2024 年達到 8.7 億美元,預計到 2031 年將達到 26.5 億美元,在預測期(2025-2031 年)以 16.9% 的複合年成長率成長。
PD-L1生物標記檢測測量癌細胞上PD-L1的含量。 PD-L1是一種蛋白質,它能阻止免疫細胞攻擊體內無害細胞。正常情況下,免疫系統會攻擊病毒和細菌等外來物質,而不會攻擊自身健康的細胞。一些癌細胞具有高水平的PD-L1,這使它們能夠「欺騙」免疫系統,避免被當作外來物攻擊。目前的PD-L1檢測是基於免疫組織化學(IHC)技術,該技術利用抗體檢測組織切片(例如肝臟、胰臟、心臟等)中細胞表面存在的蛋白質(抗原)。 PD-L1是一種配體,它與PD-1(程序性死亡受體1)結合,PD-1表達於活化的T細胞上,並在腫瘤細胞逃避免疫反應中發揮作用。 PD-L1抑制T細胞的活化和增殖,因此作為癌症治療的重要標靶而備受關注。免疫組化(IHC)檢測PD-L1蛋白被廣泛用作抗PD-1/PD-L1療法的預測性生物標記檢測。 PIK3CA基因編碼一種脂質激酶,參與多種訊息傳遞路徑。這些通路影響細胞增生、凋亡和生長等功能。 PIK3CA突變會活化PI3K-PTEN-AKT通路,該通路位於EGFR和RAS-RAF-MAPK通路的下游。 PIK3CA突變可導致致癌性,且此過程獨立於RAS或RAF突變。 PIK3CA突變在約15%至30%的乳癌、子宮內膜癌和大腸癌中發現,在肺癌和其他癌症類型中發生率較低。 PIK3CA突變與乳癌、子宮內膜癌和大腸直腸癌患者預後不良和對特定治療反應不佳有關。
全球PD-L1和PIK3CA檢測市場正經歷強勁成長,這主要得益於精準腫瘤學的日益普及以及標靶治療在包括非小細胞肺癌(NSCLC)、乳癌和子宮頸癌在內的多種癌症類型中的核准。伴隨診斷(CDx)與免疫療法和PI3K抑制劑聯合應用的需求不斷成長,加速了PD-L1免疫組化(IHC)和PIK3CA突變檢測的普及。此外,政府主導的癌症篩檢政策、次世代定序(NGS)平台的進步以及生物標記在臨床決策中日益廣泛的應用,也推動了臨床對這些檢測的依賴性增強。大型製藥公司也在大力投資需要基於生物標記進行患者分層的臨床試驗,進一步推動了市場滲透。
儘管PD-L1和PIK3CA檢測市場呈現成長態勢,但仍面臨許多挑戰。檢測結果解讀的差異、檢測方法缺乏標準化以及腫瘤異質性的複雜性,常常導致臨床結果不一致,並削弱人們對檢測結果的信心。伴隨診斷方面的監管障礙(尤其是在新興市場)以及基於次世代定序(NGS)平台的高成本,都阻礙了其普及應用。此外,健保報銷的不確定性以及醫療基礎設施的差異,限制了中低收入地區獲得檢測服務的機會。癌症診斷領域的不斷演變也對該市場產生影響,新型生物標記和多基因檢測組合的出現,可能會使臨床關注點從PD-L1和PIK3CA等單一分析物檢測轉移開來。
本報告旨在按地區/國家、類型和應用對全球 PD-L1 和 PIK3CA 檢測市場進行全面分析,重點關注總收入、市場佔有率和主要企業的排名。
PD-L1 和 PIK3CA 檢測市場規模、估算和預測均以銷售收入為指標,以 2024 年為基準年,並包含 2020 年至 2031 年的歷史資料和預測資料。定量和定性分析將幫助讀者制定 PD-L1 和 PIK3CA 檢測的業務和成長策略,評估市場競爭,分析自身在當前市場中的地位,並做出明智的商業決策。
市場區隔
公司
按類型分類的細分市場
應用領域
按地區
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.