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市场调查报告书
商品编码
1961111
PD-L1生物标记检测市场-全球产业规模、份额、趋势、机会、预测:按癌症类型、检测试剂盒类型、最终用途、地区和竞争格局划分,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 生物标记检测市场预计将从 2025 年的 7.7102 亿美元成长到 2031 年的 12.1808 亿美元,复合年增长率为 7.92%。
此诊断领域专注于量化癌细胞上程序性死亡配体1 (PD-L1) 蛋白的表达水平,这是确定患者是否适合接受免疫查核点抑制剂治疗的关键步骤。市场成长的主要驱动因素是全球非小细胞肺癌发生率的上升,以及越来越多的伴随诊断产品获得监管机构核准,这些产品需要在治疗开始前进行特定的通讯协定。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 771,020,000 美元 |
| 市场规模:2031年 | 1,218,080,000 美元 |
| 复合年增长率:2026-2031年 | 7.92% |
| 成长最快的细分市场 | 研究与开发 |
| 最大的市场 | 北美洲 |
儘管市场呈现上升趋势,但由于在各种医疗基础设施中实施先进诊断测试需要大量资金,市场发展仍受到阻碍。资金限制和不同的报销机制常常阻碍这些技术的广泛应用,尤其是在检测设施尚不完善的资源匮乏地区。根据2024年国际肺癌研究协会(IASLC)的数据,成本是最佳生物标记检测的最大障碍,27%的全球受访者都提到了这一点。这项经济挑战可能导致检测率波动、市场渗透缓慢,并阻碍精准癌症治疗的公平取得。
全球非小细胞肺癌 (NSCLC) 发生率的上升是 PD-L1 生物标记检测市场的主要驱动因素,显着增加了需要诊断的患者数量。随着恶性肿瘤发生率的上升,用于确认患者合格免疫查核点抑制剂治疗条件的诊断程序需求也相应增加,尤其是在一些重点医疗市场,这些市场正透过加强筛检来识别未确诊病例。美国肺臟协会于 2024 年 11 月发布的《2024 年肺癌现状》报告预测,当年美国将新增约 23.5 万例肺癌病例,这凸显了建立可扩展的常规生物标誌物检测基础设施对于应对日益增长的疾病负担的重要性。
此外,临床上对PD-1和PD-L1免疫查核点抑制剂的依赖性日益增强,这加强了治疗处方与诊断需求之间的联繫,加速了市场扩张。由于这些高价值的免疫疗法通常需要伴随诊断来筛选可能从治疗中受益的患者,这些药物的商业性成功正在推动PD-L1检测的同步应用。例如,默克在其2024年10月的公布财报中报告称,Keytruda的全球销售额达到74亿美元,年增17%,这表明这些治疗方法已深度融入标准治疗方案。此外,国际肺癌研究协会(IASLC)在2024年9月指出,67%的全球调查受访者表示,其国家的大多数患者都接受了生物标记检测,这反映出生物标记检测的普及率显着提高。
全球PD-L1生物标记检测市场正面临许多挑战,主要原因是先进诊断检测成本高且缺乏统一的报销机制。儘管临床指南日益要求进行此类检测,但设备和耗材所需的巨额资金限制了其普及,尤其是在小规模实验室和公共医疗网路中。因此,当报销率不足以抵消营运成本时,医疗机构往往不愿意进行这些关键诊断,导致检测数量直接下降,并阻碍了市场参与企业的产生收入。
这种经济差距导致已开发国家和发展中国家在市场渗透率方面有显着差异。根据国际肺癌研究协会(IASLC)2024年的数据,仅有18.6%的中低收入国家受访者表示其医疗系统支持生物标记检测,这表明市场限制更多是由于缺乏金融基础设施,而非缺乏临床需求。因此,资金筹措不足和保险覆盖范围有限使得全球许多患者无法获得检测,阻碍了精准医疗的公平普及。
PD-L1评分的自动化透过将人工智慧(AI)整合到诊断工作流程中,正在变革这一领域,从而解决人工病理检查中固有的观察者间差异问题。透过标准化肿瘤百分比评分(TPS)和复合阳性评分(CPS)的解读,演算法提高了免疫疗法患者筛选的准确性,能够识别出传统视觉方法可能遗漏的合格候选者。为了凸显这项能力,Lunit在2025年5月举行的ASCO 2025新闻发布会上宣布,其人工智慧分析仪在231例经病理学家判定为阴性的非小细胞肺癌患者中发现了较高的PD-L1表达。这表明该技术具有显着扩大符合治疗条件的患者群体的巨大潜力。
同时,在监管标准的不断完善和伴随诊断新核准下,市场正策略性地拓展其诊断应用,包括肺癌以外的新型固态肿瘤适应症。製造商正积极寻求消化器官系统和妇科恶性肿瘤的认证,以满足不断扩大的免疫疗法适应症范围,生物标记检测有望成为肿瘤学更广泛领域的标准要求。根据Firstword Pharma报道,2025年4月,安捷伦科技公司(Agilent Technologies)的PD-L1 IHC 22C3 pharmDx检测获得欧洲体外诊断医疗器材法规(IVDR)认证,可作为胃癌或胃食道交界处腺癌的伴随诊断,这进一步强化了上述趋势。此次认证正式扩大了此检测的监管批准范围,有助于确定这种高死亡率癌症患者的治疗合格。
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: