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市場調查報告書
商品編碼
1961111
PD-L1生物標記檢測市場-全球產業規模、佔有率、趨勢、機會、預測:按癌症類型、檢測試劑盒類型、最終用途、地區和競爭格局分類,2021-2031年PD-L1 Biomarker Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Cancer Type, By Assay Kit Type, By End Use, By Region & Competition, 2021-2031F |
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全球 PD-L1 生物標記檢測市場預計將從 2025 年的 7.7102 億美元成長到 2031 年的 12.1808 億美元,複合年成長率為 7.92%。
此診斷領域專注於量化癌細胞上程序性死亡配體1 (PD-L1) 蛋白的表達水平,這是確定患者是否適合接受免疫查核點抑制劑治療的關鍵步驟。市場成長的主要促進因素是全球非小細胞肺癌發生率的上升,以及越來越多的伴隨診斷產品獲得監管機構核准,這些產品需要在治療開始前進行特定的通訊協定。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 771,020,000 美元 |
| 市場規模:2031年 | 1,218,080,000 美元 |
| 複合年成長率:2026-2031年 | 7.92% |
| 成長最快的細分市場 | 研究與開發 |
| 最大的市場 | 北美洲 |
儘管市場呈現上升趨勢,但由於在各種醫療基礎設施中實施先進診斷測試需要大量資金,市場發展仍受到阻礙。資金限制和不同的報銷機制常常阻礙這些技術的廣泛應用,尤其是在檢測設施尚不完善的資源匱乏地區。根據2024年國際肺癌研究協會(IASLC)的數據,成本是最佳生物標記檢測的最大障礙,27%的全球受訪者都提到了這一點。這項經濟挑戰可能導致檢測率波動、市場滲透緩慢,並阻礙精準癌症治療的公平取得。
全球非小細胞肺癌 (NSCLC) 發生率的上升是 PD-L1 生物標記檢測市場的主要促進因素,顯著增加了需要診斷的患者數量。隨著惡性腫瘤發生率的上升,用於確認患者合格免疫查核點抑制劑治療條件的診斷程序需求也相應增加,尤其是在一些重點醫療市場,這些市場正透過加強篩檢來識別未確診病例。美國肺臟協會於 2024 年 11 月發布的《2024 年肺癌現狀》報告預測,當年美國將新增約 23.5 萬例肺癌病例,這凸顯了建立可擴展的常規生物標記檢測基礎設施對於應對日益成長的疾病負擔的重要性。
此外,臨床上對PD-1和PD-L1免疫查核點抑制劑的依賴性日益增強,這加強了治療處方與診斷需求之間的聯繫,加速了市場擴張。由於這些高價值的免疫療法通常需要伴隨診斷來篩選可能從治療中受益的患者,這些藥物的商業性成功正在推動PD-L1檢測的同步應用。例如,默克在其2024年10月的公佈財報中報告稱,Keytruda的全球銷售額達到74億美元,年增17%,這表明這些治療方法已深度融入標準治療方案。此外,國際肺癌研究協會(IASLC)在2024年9月指出,67%的全球調查受訪者表示,其國家的大多數患者都接受了生物標記檢測,這反映出生物標記檢測的普及率顯著提高。
全球PD-L1生物標記檢測市場正面臨許多挑戰,主要原因是先進診斷檢測成本高且缺乏統一的報銷機制。儘管臨床指南日益要求進行此類檢測,但設備和耗材所需的巨額資金限制了其普及,尤其是在小規模實驗室和公共醫療網路中。因此,當報銷率不足以抵消營運成本時,醫療機構往往不願意進行這些關鍵診斷,導致檢測數量直接下降,並阻礙了市場參與企業的產生收入。
這種經濟差距導致已開發國家和發展中國家在市場滲透率方面有顯著差異。根據國際肺癌研究協會(IASLC)2024年的數據,僅有18.6%的中低收入國家受訪者表示其醫療系統支持生物標記檢測,這表明市場限制更多是由於缺乏金融基礎設施,而非缺乏臨床需求。因此,資金籌措不足和保險覆蓋範圍有限使得全球許多患者無法獲得檢測,阻礙了精準醫療的公平普及。
PD-L1評分的自動化透過將人工智慧(AI)整合到診斷工作流程中,正在變革這一領域,從而解決人工病理檢查中固有的觀察者間差異問題。透過標準化腫瘤百分比評分(TPS)和複合陽性評分(CPS)的解讀,演算法提高了免疫療法患者篩選的準確性,能夠識別出傳統視覺方法可能遺漏的合格候選者。為了凸顯這項能力,Lunit在2025年5月舉行的ASCO 2025新聞發布會上宣布,其人工智慧分析儀在231例經病理學家判定為陰性的非小細胞肺癌患者中發現了較高的PD-L1表達。這表明該技術具有顯著擴大符合治療條件的患者群體的巨大潛力。
同時,在監管標準的不斷完善和伴隨診斷新核准下,市場正策略性地拓展其診斷應用,包括肺癌以外的新型固態腫瘤適應症。製造商正積極尋求消化器官系統和婦科惡性腫瘤的認證,以滿足不斷擴大的免疫療法適應症範圍,生物標記檢測有望成為腫瘤學更廣泛領域的標準要求。根據Firstword Pharma報道,2025年4月,安捷倫科技公司(Agilent Technologies)的PD-L1 IHC 22C3 pharmDx檢測獲得歐洲體外診斷醫療器材法規(IVDR)認證,可作為胃癌或胃食道交界處腺癌的伴隨診斷,這進一步強化了上述趨勢。此次認證正式擴大了此檢測的監管批准範圍,有助於確定這種高死亡率癌症患者的治療合格。
The Global PD-L1 Biomarker Testing Market is projected to expand from USD 771.02 Million in 2025 to USD 1218.08 Million by 2031, reflecting a compound annual growth rate of 7.92%. This diagnostic sector focuses on quantifying Programmed Death-Ligand 1 protein expression on tumor cells, a vital step in determining patient suitability for immune checkpoint inhibitor therapies. Market growth is largely fueled by the rising global prevalence of non-small cell lung cancer alongside an increase in regulatory approvals for companion diagnostics, which necessitate specific testing protocols before treatment can commence.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 771.02 Million |
| Market Size 2031 | USD 1218.08 Million |
| CAGR 2026-2031 | 7.92% |
| Fastest Growing Segment | Research and Development |
| Largest Market | North America |
Despite this upward trajectory, market progress is hindered by the substantial financial requirements for deploying advanced diagnostic assays across various healthcare infrastructures. Financial limitations and varied reimbursement structures frequently curb widespread usage, specifically in resource-constrained environments where laboratory facilities are still maturing. Data from the International Association for the Study of Lung Cancer in 2024 indicates that cost remains the leading obstacle to optimal biomarker testing, noted by 27% of respondents globally; this economic challenge causes fluctuations in testing rates, potentially slowing market penetration and obstructing the equitable implementation of precision oncology.
Market Driver
The escalating global incidence of Non-Small Cell Lung Cancer (NSCLC) acts as a major engine for the PD-L1 biomarker testing market by significantly enlarging the patient population requiring diagnosis. As malignancy rates rise, there is a proportional increase in the demand for diagnostic procedures necessary to verify eligibility for immune checkpoint inhibitor treatments, particularly in leading healthcare markets where enhanced screening efforts are identifying previously undiagnosed cases. The American Lung Association's 'State of Lung Cancer 2024' report from November 2024 projected nearly 235,000 new lung cancer diagnoses in the United States for that year, highlighting the critical need for scalable, routine biomarker testing infrastructure to manage the increasing disease burden.
Additionally, the growing clinical reliance on PD-1 and PD-L1 immune checkpoint inhibitors is accelerating market expansion by solidifying the relationship between therapeutic prescriptions and diagnostic requirements. Because these high-value immunotherapies frequently depend on companion diagnostics to select likely responders, the commercial success of these drugs drives the parallel use of PD-L1 assays. For instance, Merck & Co., Inc. reported in their October 2024 earnings release that global sales of Keytruda rose 17% to $7.4 billion year-over-year, illustrating the heavy integration of these regimens into standard care; furthermore, the International Association for the Study of Lung Cancer noted in September 2024 that 67% of global survey respondents indicated most patients in their nations now receive biomarker testing, reflecting a substantial increase in adoption.
Market Challenge
The expansion of the Global PD-L1 Biomarker Testing Market faces significant obstacles due to the high expense of implementing advanced diagnostic assays and the absence of uniform reimbursement frameworks. While clinical guidelines increasingly require these tests, the heavy financial outlay needed for instrumentation and consumables restricts their adoption, especially within smaller laboratories and public healthcare networks. Consequently, when reimbursement rates do not adequately offset operational costs, healthcare providers are often discouraged from conducting these critical diagnostics, which directly lowers testing volumes and impedes revenue generation for market participants.
This economic divide creates a marked disparity in market penetration between developed nations and developing regions. According to 2024 data from the International Association for the Study of Lung Cancer, only 18.6% of respondents in low- and middle-income countries reported having healthcare system support for biomarker testing, suggesting that the market is limited more by financial infrastructure deficiencies than by a lack of clinical necessity. As a result, the inability to secure sufficient funding and insurance coverage excludes a large segment of the global patient population from testing access, thereby hindering the equitable distribution of precision medicine.
Market Trends
The incorporation of Artificial Intelligence (AI) into diagnostic workflows is transforming the sector by automating PD-L1 scoring to resolve the persistent issue of inter-observer variability found in manual pathology. By standardizing the interpretation of Tumor Proportion Score (TPS) and Combined Positive Score (CPS), algorithms improve the accuracy of patient selection for immunotherapy and detect eligible candidates who might otherwise be overlooked by conventional visual methods. Highlighting this capability, Lunit announced in a May 2025 press release regarding ASCO 2025 that their AI-powered analyzer identified higher PD-L1 expression in 231 non-small cell lung cancer patients who had been previously classified as negative by pathologists, demonstrating the technology's potential to significantly widen the treatable patient pool.
Simultaneously, the market is undergoing a strategic broadening of testing applications to include novel solid tumor indications beyond lung cancer, propelled by evolving regulatory standards and new approvals for companion diagnostics. Manufacturers are actively pursuing certifications for gastrointestinal and gynecological malignancies to match expanding immunotherapy labels, ensuring biomarker testing becomes a standard requirement across a wider range of oncology fields. This trend was reinforced in April 2025, as reported by FirstWord Pharma, when Agilent Technologies secured European IVDR certification for its PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic for gastric or gastroesophageal junction adenocarcinoma, officially extending the assay's regulatory clearance to support treatment eligibility in this high-mortality cancer.
Report Scope
In this report, the Global PD-L1 Biomarker Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global PD-L1 Biomarker Testing Market.
Global PD-L1 Biomarker Testing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: