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PD-L1生物標記檢測市場報告:趨勢、預測和競爭分析(至2035年)

PD-L1 Biomarker Testing Market Report: Trends, Forecast and Competitive Analysis to 2035

出版日期: | 出版商: Lucintel | 英文 150 Pages | 商品交期: 3個工作天內

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PD-L1生物標記檢測市場

受醫院和診斷中心市場機會的推動,全球PD-L1生物標記檢測市場前景廣闊。預計到2035年,全球PD-L1生物標記檢測市場規模將從2027年的9.083億美元成長至16.901億美元,2027年至2035年的年複合成長率(CAGR)為12.5%。推動市場成長的關鍵因素包括個人化癌症治療的日益普及、標靶治療需求的成長以及人們對癌症生物標記檢測認知的不斷提高。

  • 根據 Lucintel 的預測,由於 PD-L1 (22C3) 類型在臨床應用和接受度方面不斷提高,預計 PD-L1 (22C3) 在預測期內將呈現最高的成長率。
  • 從應用角度來看,鑑於病理學和實驗室環境中對伴隨診斷的預期需求,診斷中心產業預計在預測期內將經歷更高的成長。
  • 從區域來看,亞太地區預計將在預測期內呈現最高的成長率,這主要得益於癌症患者數量的增加和診斷能力的提高。

PD-L1生物標記檢測市場的新趨勢

預計到2027年,PD-L1生物標記檢測市場將從單一標記檢測轉向更全面、更全面的腫瘤特異性診斷。同時,免疫療法的發展有望擴大其適用範圍。據Lucintel公司稱,該領域正在進行和即將取得的進展將推動對自動化和檢驗的生物標記檢測的需求。此外,生物標記檢測有望整合到數位化和流式細胞技術平台,使其能夠在大型大學醫院以外的場所進行。

  • 體外檢測:從 2025 年開始,PD-L1 檢測預計將與其他生物標記(例如 HER2、MSI、TMB、RAS 和其他基因組標記)結合,以實現對腫瘤的全面表徵和選擇最佳癌症治療方案。
  • 數位病理學:人工分析病理學論文是評估 PD-L1 表達的標準方法,但許多公司正在開發用於 PD-L1 和其他病理生物標記的自動化分析產品。
  • 液態生物檢體:PD-L1 預計將繼續作為組織生物標記物,但從 2025 年到 2027 年,研究可能會集中在使用液態生物檢體評估 PD-L1,其適應症與組織切片檢查相同。
  • 伴隨診斷的擴展:隨著查核點抑制劑的持續推廣應用,多種診斷測試也新增了適應症。實驗室機構需要檢驗更多測試並規範評估標準。適應症的擴展涵蓋多種腫瘤類型,包括肺癌、乳癌和胃癌。
  • 診斷模式轉向分散式:小規模醫院和參考實驗室正在加強其免疫組化能力,而大規模實驗室則提供異地PD-L1檢測。 PD-L1檢測對於確定初始(第一線)治療方案至關重要,在其他分子檢測方法無法進行的地區也同樣重要。

由於PD-L1檢測技術已成熟且標準化,預計未來將有進一步的改進,從而提高其與其他臨床檢測的整合性和互通性。數位病理學的持續發展和投資將使整合這些技術的公司受益。

PD-L1生物標記檢測市場近期趨勢

PD-L1生物標記檢測市場正從單一病理檢測轉向整合式、非腫瘤依賴性和/或風險降低型診斷檢測。 Lucintel預測,在自動化和醫療保險公司報銷政策調整的推動下,2025年至2027年間PD-L1檢測量將出現激增。展望未來,由於免疫療法適應症數量的預期成長,Lucintel預計PD-L1檢測市場競爭將加劇。

  • 擴大適應症和伴隨診斷:2025 年 1 月,美國食品藥物管理局(FDA) 批准了 PD-L1 伴隨診斷,將其用途從肺癌擴展到包括其他類型免疫療法的若干決策。
  • 數位病理學:2025 年 3 月,全球最大的檢測實驗室之一宣布,其病理部門已使用輔助 PD-L1 診斷的演算法對超過一百萬個病理病例進行了數位化和分析。
  • 檢測標準化:到2025年,已進行多項PD-L1抗體克隆的比較研究。未來幾年,我們預計將有證據支持這些抗體的檢查室比對。此類證據可能會對體外診斷產業產生影響,包括刺激對分散式檢查的投資。
  • 與生物製藥公司的合作:2025年,一家生物製藥公司與一家伴隨診斷公司宣佈建立合作關係,目標是兩種免疫療法。未來幾年,我們預計伴隨診斷開發領域的合作將會增加。這些合作可能會影響伴隨診斷的開發流程,該流程涉及與生物製藥公司共同開發診斷測試。
  • 臨床實驗室自動化:預計未來幾年對臨床實驗室自動化的投資將會增加。例如,一家診斷公司宣布,到2025年,將增加對基於免疫組化技術的臨床檢測套組生產的投資。自動化技術的進步預計將對診斷公司之間的競爭產生積極影響。

未來幾年,進行PD-L1檢測的機構數量預計將會增加,但檢測本身可能會變得更加靈活和獨立。病理學領域數位化工具的引入有望促進不同檢查室間檢測結果的比較。隨著癌症免疫療法市場的成長,這些檢測的普及程度也會提高。

目錄

第1章:執行摘要

第2章 市場概覽

  • 背景與分類
  • 供應鏈

第3章 市場趨勢與預測分析

  • 宏觀經濟趨勢與預測
  • 產業促進因素與挑戰
  • PESTLE分析
  • 專利分析
  • 法規環境

第4章 全球PD-L1生物標記檢測市場:按類型分類

  • 吸引力分析:按類型
  • PD-L1(22C3)
  • PD-L1(28-8)
  • PD-L1(SP142)
  • PD-L1(SP263)
  • 其他

第5章 全球PD-L1生物標記檢測市場:依應用分類

  • 吸引力分析:依目的
  • 醫院
  • 診斷中心
  • 其他

第6章 區域分析

第7章:北美PD-L1生物標記檢測市場

  • 北美PD-L1生物標記檢測市場:按類型分類
  • 北美PD-L1生物標記檢測市場:按應用分類
  • 美國PD-L1生物標記檢測市場
  • 加拿大PD-L1生物標記檢測市場
  • 墨西哥PD-L1生物標記檢測市場

第8章:歐洲PD-L1生物標記檢測市場

  • 歐洲PD-L1生物標記檢測市場:按類型分類
  • 歐洲PD-L1生物標記檢測市場:按應用分類
  • 德國PD-L1生物標記檢測市場
  • 法國PD-L1生物標記檢測市場。
  • 義大利PD-L1生物標記檢測市場
  • 西班牙PD-L1生物標記檢測市場
  • 英國PD-L1生物標記檢測市場

第9章:亞太地區PD-L1生物標記檢測市場

  • 亞太地區PD-L1生物標記檢測市場:按類型分類
  • 亞太地區PD-L1生物標記檢測市場:依應用分類
  • 中國PD-L1生物標記檢測市場
  • 印度PD-L1生物標記檢測市場
  • 日本PD-L1生物標記檢測市場
  • 韓國PD-L1生物標記檢測市場
  • 印尼PD-L1生物標記檢測市場

第10章:世界其他地區PD-L1生物標記檢測市場

  • 其他地區PD-L1生物標記檢測市場:按類型分類
  • 其他地區PD-L1生物標記檢測市場:按應用分類
  • 中東PD-L1生物標記檢測市場
  • 南美洲PD-L1生物標記檢測市場
  • 非洲PD-L1生物標記檢測市場

第11章 競爭分析

  • 產品系列分析
  • 業務整合
  • 波特五力分析
  • 市佔率分析

第12章 機會與策略分析

  • 價值鏈分析
  • 成長機會分析
  • 新趨勢:全球PD-L1生物標記檢測市場
  • 戰略分析

第13章:價值鏈中關鍵企業的公司概況

  • 競爭分析概述
  • Agilent Technologies
  • Roche
  • Merck
  • Bristol-Myers Squibb
  • AstraZeneca
  • Ono Pharmaceutical
  • Regeneron
  • Innovent
  • Hengrui Medicine
  • Junshi Biosciences

第14章附錄

PD-L1 Biomarker Testing Market

The future of the global pd-l1 biomarker testing market looks promising with opportunities in the hospital and diagnostic center markets. The global pd-l1 biomarker testing market is expected to reach an estimated $1690.1 million by 2035 from $908.3 million in 2027 with a CAGR of 12.5% from 2027 to 2035. The major drivers for this market are the increasing adoption of personalized cancer treatments, the rising demand for targeted therapies, and the growing awareness of cancer biomarker testing.

  • Lucintel forecasts that, within the type category, PD-L1 (22C3) is expected to witness the highest growth over the forecast period due to increased acceptance and clinical use of PD-L1 (22C3).
  • Within the application category, diagnostic center is expected to witness higher growth over the forecast period due to anticipated need for companion diagnostics at pathology and laboratory settings.
  • In terms of regions, APAC is expected to witness the highest growth over the forecast period due to rising cancer cases and improvements in diagnostic capabilities.

Emerging Trends in PD-L1 Biomarker Testing Market

The market for PD-L1 biomarker testing is expected to shift by 2027, from single-marker tests to more comprehensive, integrated, tumor-notation diagnostics. Simultaneously, immunotherapy drug development will lead to expansion of target indications. According to Lucintel, ongoing and upcoming advances in the field will boost the need for automated, validated biomarker assays. Further, it is anticipated that biomarker tests will be integrated in digital and flow formats, enabling biomarker tests to be conducted in locations other than major academic medical centers.

  • in Vitro Testing: In 2025 and beyond, it is expected that PD-L1 testing will be combined with other biomarkers (e.g. HER2, MSI, TMB, RAS, and other genomic markers) to allow for comprehensive tumor characterization and selection of optimal cancer therapies.
  • Digital Pathology: Although manual analysis of pathologic specimens is the standard for assessing PD-L1 expression, numerous companies have developed products for automated analysis of PD-L1 and other pathologic biomarkers.
  • Liquid Biopsy: PD-L1 will remain a tissue biomarker; however, in 2025-2027, research will focus on the use of liquid biopsy to assess PD-L1 for the same indications as tissue biopsy.
  • Expansion of Companion Diagnostics: Continued expansion of checkpoint inhibitors has led to additional labels for multiple assays. Laboratories will need to validate more assays and standardize scoring. The expanded indications cut across multiple tumor types, including lung, breast and gastric.
  • Shift To Decentralized Diagnostics: Smaller hospitals and reference laboratories are strengthening their immunohistochemistry capabilities, and larger laboratories are providing off-site PD-L1 testing. PD-L1 testing is particularly important to direct initial (first-line) therapy, and in locations where other molecular testing is not available.

PD-L1 testing is established and standardized, and therefore, will likely continue to improve, integrate and interoperate with other clinical tests. Continued evolution and investment in digital pathology will benefit companies integrating these technologies.

Recent Developments in the PD-L1 Biomarker Testing Market

In the pd-l1 biomarker testing market, there is a shift from single assay pathology to integrated, tumor agnostic, and/or mitigated diagnostic tests. Between 2025 and 2027, Lucintel anticipates a surge in completion of PD-L1 tests due to, among other things, automation of laboratory tests and adjustment of reimbursement policies by health insurance providers. Going forward, Lucintel expects the PD-L1 testing market to be competitive due to the anticipated increase in the number of indications for immunotherapies.

  • Expanded Indication and Companion Diagnostic: In January 2025, the U.S. Food and Drug Administration (FDA) granted PD-L1 companion diagnostic status to extend the use of the test to make several decisions about other types of immunotherapies beyond those made for lung cancers.
  • Digital Pathology: In March 2025, one of the largest reference laboratories in the world, announced that its pathology group had digitized and Interpreted more than 1 million pathology cases using algorithms to assist PD-L1 interpretation.
  • Standardization of Assays: In 2025, multiple studies comparing PD-L1 antibody clones were performed. In the coming years, evidence supporting the inter-laboratory comparison of these antibodies is expected. Such evidence is likely to influence the in-vitro diagnosis industry, including incentivizing investment in decentralized testing.
  • Biopharmaceutical Partnerships: In 2025, a collaboration between a biopharmaceutical company and a companion diagnostic company, for two immunotherapies, was announced. It is expected that in the coming years, collaboration for the development of companion diagnostics will increase. Such collaborations are likely to affect the companion diagnostic development process, whereby an assay is co-developed with the biopharmaceutical product.
  • Automation of Laboratory Tests: Investments in automating laboratory tests are likely to increase in the coming years. For example, in 2025, a diagnostics company announced an increase in its investment for manufacturing laboratory tests based on immunohistochemistry. Increased automation is expected to positively influence competition between diagnostics companies.

Centers performing PD-L1 tests are expected to increase in the coming years; however, the tests are likely to be more flexible and independent. The integration of digital tools in pathology is expected to facilitate test comparison across different laboratories. The availability of such tests is likely to increase with the market growth of cancer immunotherapy.

Strategic Growth Opportunities in the PD-L1 Biomarker Testing Market

The pd-l1 biomarker testing market is anticipated to grow as immunotherapy becomes an option for the treatment of earlier stages of cancer and as it expands to other cancer types. Through 2026, the market will be favorable because of the requirement for companion diagnostics, the development of multiplex assays, and the need to reduce the use of unnecessary expensive therapies. Lucintel is of the view that market trend will be for integrated, clinically relevant tests and away from individual tests.

  • Pd-l1 Assays for Solid Tumors: The completion of pivotal trials for checkpoint inhibitors for several solid cancers will lead to an increase in PD-L1 testing for cancers of the GI, Gynecologic, and Urothelial systems. During the first half of the 2020s, it is anticipated that numerous pivotal trials for checkpoint inhibitors will be initiated and/or completed.
  • Standardized High-sensitivity Assays: As Laboratories gain the ability to more consistently and reliably standardize assays, PD-L1 testing will become more widely available. Guidance from CAP and other Organizations will also facilitate the more uniform adoption and interpretation of PD-L1 testing.
  • Digital Pathology and AI Scoring: A combination of centralized PD-L1 staining, image analysis, and review will be offered with centralized quality control. The FDA database showed over 1,000 AI-based medical devices in April 2025. Digital pathology will be rapidly adopted to help increase oncology pathway innovation.
  • Centralized Testing Services: A shortage of qualified pathologists will force smaller hospitals to outsource PD-L1 testing to central laboratories. There were over 6,000 community hospitals in the U.S. in June 2025. Smaller hospitals will provide tests and other procedures that require specialized pathology. Centralization of pathology will provide smaller hospitals the means to quickly access services that they are not able to provide.
  • Expansion of Companion Diagnostics: The PD-L1 test will be used with other companion diagnostics to help determine the eligibility of patients for specific cancer treatments. The FDA has approved over 100 companion diagnostics for use in oncology.

ThepdL1 assay is one of several innovative pathology stains that will help bridge the gap for reimbursement of advanced oncology pathway tests. The first mover advantage will help supplier consolidate their position in the marketplace. The ability to provide reliability and decisions in an efficient manner will help suppliers succeed. There will always be a market for innovative pathology stains.

PD-L1 Biomarker Testing Market Drivers and Challenges

Lucintel analysts noted that the PD-L1 testing market has been rapidly developing due to advances in related technology and the rising incidence of cancer. The expanding use of PD-L1 testing to inform and justify the use of cancer immunotherapy has created a demand for PD-L1 testing. Challenges such as variations in the methodology of PD-L1 testing, equivocal clinical cut-off values, and uneven access to and cost of PD-L1 testing, have affected the market negatively. Lucintel analysts feel the market will be positively impacted by the introduction of new tests, standardization of PD-L1 and other oncology tests and innovations in the field of oncology. Other positive influences on the market will be integration of PD-L1 testing with other omics and pathology testing, and increasing evidence of the clinical relevance of PD-L1 testing.

The factors responsible for driving this market include :

  • The Increased Usage of Immunotherapies: With time, the use of immunotherapies and immune checkpoint blockade therapies gained momentum for the treatment of various types of cancers. Due to this, PD-L1 testing also gained importance. As of January 2025, the U.S. Food and Drug Administration (FDA) approved PD-1 and PD-L1 pathway inhibitors for more than 100 oncology indications. However, for a large number of indications, PD-L1 testing is not mandatory.
  • Demand for Precision Oncology: The WHO reports that in 2022, about 20 million people were diagnosed with cancer. With a greater appreciation for the types of molecular and immune biomarkers beyond the location of the tumor, more targeted treatment options can be prescribed. The next 3-5 years may bring heightened focus on PD-L1, along with other genomic and tumor mutation analyses, to help address the need for personalized cancer treatment.
  • Advances in Technology: Improvements in lab automation, digital pathology and image analysis along with the development of artificial intelligence and other stem cell and biotechnology innovations allow for more reliable evaluation of biomarkers. In the next 3-5 years, continuous improvements in these and other ancillary technologies will help standardize and improve the practice of pathology, especially in places where oncology pathologists are in short supply.
  • Positive Regulatory and Clinical Environment: Positive changes in the regulatory and clinical landscapes, along with updated professional guidelines and the requirement for companion diagnostics have and will continue to facilitate the use of PD-L1 assays. The next 3-5 years may bring similar positive changes for other lab developed tests for other cancer treatment innovations.
  • Investment in Healthcare Infrastructure: Investments in various healthcare facilities (e.g. cancer centers, reference laboratories, biobanks, and digital pathology) enhance the availability of advanced biomarkers. The International Agency for Research on Cancer (IARC) projected in June 2025 that the annual number of cancer cases would reach 35 million by 2050. The projection highlights the need to increase the capacity to diagnose cancer. The next 3-5 years will see further investments in healthcare, especially in high-growth and high-potential markets. These investments will increase the ability to perform diagnostic tests, ensure the timely processing of samples, and establish regional and interconnected networks of laboratories.

The challenges facing this market include:

  • Variability in Assays and Scoring: The variability occurs due to several factors including the platform used, the staining protocol, the quality of the specimen, and the scoring system. As a result, laboratories can obtain different PD-L1 results using the same specimen. In 2025, several scoring systems, such as the tumor proportion score and the combined positive score, were approved for different cancers. In the next 3-5 years, it is expected that the variability in PD-L1 assays will affect the selection of appropriate therapy for cancer patients, increase the need for re-biopsies, and limit the comparability of the results of clinical studies.
  • High Costs, Inequity in Cancer Diagnostics: PD-L1 testing is expensive due to several reasons, including the cost of reagents, consumables, and equipment. The World Health Organization has documented that several high-income countries have adequate cancer diagnostic services while several low-income countries do not. It is expected that in the next 3-5 years, smaller hospitals would not be able to afford PD-L1 testing. Centralized testing would increase the average wait time for the results and the overall costs incurred by the patients and the health care system.
  • Biological and Clinical Uncertainty: PD-L1 levels can change between different samples from the same person and can also vary based on the stage of the disease. Low or no PD-L1 expression has been reported in patients who responded to immunotherapy. As of September 2025, research focused on improving prediction of patients likely to benefit from immunotherapy by using other sample types (e.g., blood) and integrating multiple biomarkers. In the following years, it is expected that PD-L1 will not be sufficiently reliable to make predictive oncology-related decisions; therefore, other marker combinations will be used. This could also affect the company's decision regarding reimbursement. PD-L1 will most likely maintain its relevance as a biomarker for tumor classification in oncology.

Although PD-L1 test demand will increase due to the expansion of immunotherapy and other oncology-related services, the validation of PD-L1 tests by regulatory agencies and the establishment of PD-L1 testing in clinical oncology by different associations will enhance the PD-L1 testing market. However, biological limits and variability of PD-L1 will impede the expansion of the PD-L1 testing market. The same is expected for other molecular diagnostic tests. The PD-L1 testing market will largely depend on the availability of integrated digital pathology and other precision oncology-related diagnostic platforms and services.

List of PD-L1 Biomarker Testing Market Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies pd-l1 biomarker testing market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the pd-l1 biomarker testing market companies profiled in this report include-

  • Agilent Technologies
  • Roche
  • Merck
  • Bristol-Myers Squibb
  • AstraZeneca

PD-L1 Biomarker Testing Market by Segment

The study includes a forecast for the global pd-l1 biomarker testing market by type, application, and region.

PD-L1 Biomarker Testing Market by Type [Value ($M) from 2019 to 2035]:

  • PD-L1 (22C3)
  • PD-L1(28-8)
  • PD-L1 (SP142)
  • PD-L1 (SP263)
  • Others

PD-L1 Biomarker Testing Market by Application [Value ($M) from 2019 to 2035]:

  • Hospital
  • Diagnostic Center
  • Others

PD-L1 Biomarker Testing Market by Region [Value ($M) from 2019 to 2035]:

  • North America
  • Europe
  • Asia Pacific
  • The Rest of the World

Country Wise Outlook for the PD-L1 Biomarker Testing Market

According to Lucintel, companion diagnostics for tumor agnostix PD-L1 will continue to drive growth in the pd-l1 biomarker testing market, and changes to the PD-L1 CDRHregulatory framework and test comparability will become increasingly important from 2025 to 2027. During this time, decentralized, or 'at-site' testing will also gain focus. Lucintel predicts that after 2022, pd-l1 biomarker testing market disruptive innovations will occur at a slower pace and market players will remain focused on established geographies.

  • United States: In February 2025, the FDA granted approval to VENTANA PD-L1 (SP263) assay to be used as a companion diagnostic for a subset of non-small cell lung cancers. The approval set the foundation for regulated companion diagnostics in PD-L1 testing. Other indications for the PD-L1 assay were and will be approved in the following years. - China: China's National Medical Products Administration approved the Clinical Impact PD-L1 Assay in June 2025. The PD-L1 assay, developed by Amoy Diagnostics, will increase local testing of PD-L1, and decrease the reliance on imported PD-L1 companion diagnostics.
  • Germany: Complying with the EU IVDR in 2025 accelerated the sunset of certain IVDs by 2027. Digital pathology initiatives by Roche and other regional laboratories continued. PD-L1 testing, like other IVDs, will require completed quality systems. This could incentivize a shift to centralized testing laboratories.
  • India: In 2025, the collaboration to establish oncology diagnostics and standardize biomarker testing by Thermo Fisher Scientific and the National Cancer Grid of India continued. As the number of participating hospitals and laboratories expands, the increased volume will facilitate the establishment of channeled pathways for PD-L1 and PD-L1 companion diagnostics.
  • Japan: PD-L1 testing remained covered by national reimbursement in 2025. The review process of the Pharmaceuticals and Medical Devices Agency on pharmaceutical companion-and diagnostic-device applications also continued in 2025. The alignment of reimbursement and coverage with the review process signals an interest in establish routes for PD-L1 testing to facilitate access to the covered pharmaceuticals.

Features of the Global PD-L1 Biomarker Testing Market

  • Market Size Estimates: pd-l1 biomarker testing market size estimation in terms of value ($B).
  • Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
  • Segmentation Analysis: pd-l1 biomarker testing market size by type, application, and region in terms of value ($B).
  • Regional Analysis: pd-l1 biomarker testing market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
  • Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the pd-l1 biomarker testing market.
  • Strategic Analysis: This includes M&A, new product development, and competitive landscape of the pd-l1 biomarker testing market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

If you are looking to expand your business in this or adjacent markets, then contact us. We have done hundreds of strategic consulting projects in market entry, opportunity screening, due diligence, supply chain analysis, M & A, and more.

This report answers following 11 key questions:

  • Q.1. What are some of the most promising, high-growth opportunities for the pd-l1 biomarker testing market by type (PD-L1 (22C3), PD-L1(28-8), PD-L1 (SP142), PD-L1 (SP263), and others), application (hospital, diagnostic center, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
  • Q.2. Which segments will grow at a faster pace and why?
  • Q.3. Which region will grow at a faster pace and why?
  • Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
  • Q.5. What are the business risks and competitive threats in this market?
  • Q.6. What are the emerging trends in this market and the reasons behind them?
  • Q.7. What are some of the changing demands of customers in the market?
  • Q.8. What are the new developments in the market? Which companies are leading these developments?
  • Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
  • Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
  • Q.11. What M&A activity has occurred in the last 8 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

  • 2.1 Background and Classifications
  • 2.2 Supply Chain

3. Market Trends & Forecast Analysis

  • 3.1 Macroeconomic Trends and Forecasts
  • 3.2 Industry Drivers and Challenges
  • 3.3 PESTLE Analysis
  • 3.4 Patent Analysis
  • 3.5 Regulatory Environment

4. Global PD-L1 Biomarker Testing Market by Type

  • 4.1 Overview
  • 4.2 Attractiveness Analysis by Type
  • 4.3 PD-L1 (22C3) : Trends and Forecast 2019 to 2035
  • 4.4 PD-L1(28-8) : Trends and Forecast 2019 to 2035
  • 4.5 PD-L1 (SP142) : Trends and Forecast 2019 to 2035
  • 4.6 PD-L1 (SP263) : Trends and Forecast 2019 to 2035
  • 4.7 Others : Trends and Forecast 2019 to 2035

5. Global PD-L1 Biomarker Testing Market by Application

  • 5.1 Overview
  • 5.2 Attractiveness Analysis by Application
  • 5.3 Hospital : Trends and Forecast 2019 to 2035
  • 5.4 Diagnostic Center : Trends and Forecast 2019 to 2035
  • 5.5 Others : Trends and Forecast 2019 to 2035

6. Regional Analysis

  • 6.1 Overview
  • 6.2 Global PD-L1 Biomarker Testing Market by Region

7. North American PD-L1 Biomarker Testing Market

  • 7.1 Overview
  • 7.2 North American PD-L1 Biomarker Testing Market by Type
  • 7.3 North American PD-L1 Biomarker Testing Market by Application
  • 7.4 The United States PD-L1 Biomarker Testing Market
  • 7.5 Canadian PD-L1 Biomarker Testing Market
  • 7.6 Mexican PD-L1 Biomarker Testing Market

8. European PD-L1 Biomarker Testing Market

  • 8.1 Overview
  • 8.2 European PD-L1 Biomarker Testing Market by Type
  • 8.3 European PD-L1 Biomarker Testing Market by Application
  • 8.4 German PD-L1 Biomarker Testing Market
  • 8.5 French PD-L1 Biomarker Testing Market
  • 8.6 Italian PD-L1 Biomarker Testing Market
  • 8.7 Spanish PD-L1 Biomarker Testing Market
  • 8.8 The United Kingdom PD-L1 Biomarker Testing Market

9. APAC PD-L1 Biomarker Testing Market

  • 9.1 Overview
  • 9.2 APAC PD-L1 Biomarker Testing Market by Type
  • 9.3 APAC PD-L1 Biomarker Testing Market by Application
  • 9.4 Chinese PD-L1 Biomarker Testing Market
  • 9.5 Indian PD-L1 Biomarker Testing Market
  • 9.6 Japanese PD-L1 Biomarker Testing Market
  • 9.7 South Korean PD-L1 Biomarker Testing Market
  • 9.8 Indonesian PD-L1 Biomarker Testing Market

10. ROW PD-L1 Biomarker Testing Market

  • 10.1 Overview
  • 10.2 ROW PD-L1 Biomarker Testing Market by Type
  • 10.3 ROW PD-L1 Biomarker Testing Market by Application
  • 10.4 Middle Eastern PD-L1 Biomarker Testing Market
  • 10.5 South American PD-L1 Biomarker Testing Market
  • 10.6 African PD-L1 Biomarker Testing Market

11. Competitor Analysis

  • 11.1 Product Portfolio Analysis
  • 11.2 Operational Integration
  • 11.3 Porter's Five Forces Analysis
    • Competitive Rivalry
    • Bargaining Power of Buyers
    • Bargaining Power of Suppliers
    • Threat of Substitutes
    • Threat of New Entrants
  • 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

  • 12.1 Value Chain Analysis
  • 12.2 Growth Opportunity Analysis
    • 12.2.1 Growth Opportunity by Type
    • 12.2.2 Growth Opportunity by Application
  • 12.3 Emerging Trends in the Global PD-L1 Biomarker Testing Market
  • 12.4 Strategic Analysis
    • 12.4.1 New Product Development
    • 12.4.2 Certification and Licensing
    • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

  • 13.1 Competitive Analysis Overview
  • 13.2 Agilent Technologies
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.3 Roche
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.4 Merck
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.5 Bristol-Myers Squibb
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.6 AstraZeneca
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.7 Ono Pharmaceutical
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.8 Regeneron
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.9 Innovent
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.10 Hengrui Medicine
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.11 Junshi Biosciences
    • Company Overview
    • PD-L1 Biomarker Testing Market Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing

14. Appendix

  • 14.1 List of Figures
  • 14.2 List of Tables
  • 14.3 Research Methodology
  • 14.4 Disclaimer
  • 14.5 Copyright
  • 14.6 Abbreviations and Technical Units
  • 14.7 About Us
  • 14.8 Contact Us

List of Figures

  • Figure 1.1: Trends and Forecast for the Global PD-L1 Biomarker Testing Market
  • Figure 2.1: Usage of PD-L1 Biomarker Testing Market
  • Figure 2.2: Classification of the Global PD-L1 Biomarker Testing Market
  • Figure 2.3: Supply Chain of the Global PD-L1 Biomarker Testing Market
  • Figure 3.1: Trends of the Global GDP Growth Rate
  • Figure 3.2: Trends of the Global Population Growth Rate
  • Figure 3.3: Trends of the Global Inflation Rate
  • Figure 3.4: Trends of the Global Unemployment Rate
  • Figure 3.5: Trends of the Regional GDP Growth Rate
  • Figure 3.6: Trends of the Regional Population Growth Rate
  • Figure 3.7: Trends of the Regional Inflation Rate
  • Figure 3.8: Trends of the Regional Unemployment Rate
  • Figure 3.9: Trends of Regional Per Capita Income
  • Figure 3.10: Forecast for the Global GDP Growth Rate
  • Figure 3.11: Forecast for the Global Population Growth Rate
  • Figure 3.12: Forecast for the Global Inflation Rate
  • Figure 3.13: Forecast for the Global Unemployment Rate
  • Figure 3.14: Forecast for the Regional GDP Growth Rate
  • Figure 3.15: Forecast for the Regional Population Growth Rate
  • Figure 3.16: Forecast for the Regional Inflation Rate
  • Figure 3.17: Forecast for the Regional Unemployment Rate
  • Figure 3.18: Forecast for Regional Per Capita Income
  • Figure 3.19: Driver and Challenges of the PD-L1 Biomarker Testing Market
  • Figure 4.1: Global PD-L1 Biomarker Testing Market by Type in 2019, 2026, and 2035
  • Figure 4.2: Trends of the Global PD-L1 Biomarker Testing Market ($B) by Type
  • Figure 4.3: Forecast for the Global PD-L1 Biomarker Testing Market ($B) by Type
  • Figure 4.4: Trends and Forecast for PD-L1 (22C3) in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 4.5: Trends and Forecast for PD-L1(28-8) in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 4.6: Trends and Forecast for PD-L1 (SP142) in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 4.7: Trends and Forecast for PD-L1 (SP263) in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 4.8: Trends and Forecast for Others in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 5.1: Global PD-L1 Biomarker Testing Market by Application in 2019, 2026, and 2035
  • Figure 5.2: Trends of the Global PD-L1 Biomarker Testing Market ($B) by Application
  • Figure 5.3: Forecast for the Global PD-L1 Biomarker Testing Market ($B) by Application
  • Figure 5.4: Trends and Forecast for Hospital in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 5.5: Trends and Forecast for Diagnostic Center in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 5.6: Trends and Forecast for Others in the Global PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 6.1: Trends of the Global PD-L1 Biomarker Testing Market ($B) by Region (2019-2026)
  • Figure 6.2: Forecast for the Global PD-L1 Biomarker Testing Market ($B) by Region (2027-2035)
  • Figure 7.1: Trends and Forecast for the North American PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 7.2: North American PD-L1 Biomarker Testing Market by Type in 2019, 2026, and 2035
  • Figure 7.3: Trends of the North American PD-L1 Biomarker Testing Market ($B) by Type (2019-2026)
  • Figure 7.4: Forecast for the North American PD-L1 Biomarker Testing Market ($B) by Type (2027-2035)
  • Figure 7.5: North American PD-L1 Biomarker Testing Market by Application in 2019, 2026, and 2035
  • Figure 7.6: Trends of the North American PD-L1 Biomarker Testing Market ($B) by Application (2019-2026)
  • Figure 7.7: Forecast for the North American PD-L1 Biomarker Testing Market ($B) by Application (2027-2035)
  • Figure 7.8: Trends and Forecast for the United States PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 7.9: Trends and Forecast for the Mexican PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 7.10: Trends and Forecast for the Canadian PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 8.1: Trends and Forecast for the European PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 8.2: European PD-L1 Biomarker Testing Market by Type in 2019, 2026, and 2035
  • Figure 8.3: Trends of the European PD-L1 Biomarker Testing Market ($B) by Type (2019-2026)
  • Figure 8.4: Forecast for the European PD-L1 Biomarker Testing Market ($B) by Type (2027-2035)
  • Figure 8.5: European PD-L1 Biomarker Testing Market by Application in 2019, 2026, and 2035
  • Figure 8.6: Trends of the European PD-L1 Biomarker Testing Market ($B) by Application (2019-2026)
  • Figure 8.7: Forecast for the European PD-L1 Biomarker Testing Market ($B) by Application (2027-2035)
  • Figure 8.8: Trends and Forecast for the German PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 8.9: Trends and Forecast for the French PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 8.10: Trends and Forecast for the Spanish PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 8.11: Trends and Forecast for the Italian PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 8.12: Trends and Forecast for the United Kingdom PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 9.1: Trends and Forecast for the APAC PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 9.2: APAC PD-L1 Biomarker Testing Market by Type in 2019, 2026, and 2035
  • Figure 9.3: Trends of the APAC PD-L1 Biomarker Testing Market ($B) by Type (2019-2026)
  • Figure 9.4: Forecast for the APAC PD-L1 Biomarker Testing Market ($B) by Type (2027-2035)
  • Figure 9.5: APAC PD-L1 Biomarker Testing Market by Application in 2019, 2026, and 2035
  • Figure 9.6: Trends of the APAC PD-L1 Biomarker Testing Market ($B) by Application (2019-2026)
  • Figure 9.7: Forecast for the APAC PD-L1 Biomarker Testing Market ($B) by Application (2027-2035)
  • Figure 9.8: Trends and Forecast for the Japanese PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 9.9: Trends and Forecast for the Indian PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 9.10: Trends and Forecast for the Chinese PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 9.11: Trends and Forecast for the South Korean PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 9.12: Trends and Forecast for the Indonesian PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 10.1: Trends and Forecast for the ROW PD-L1 Biomarker Testing Market (2019-2035)
  • Figure 10.2: ROW PD-L1 Biomarker Testing Market by Type in 2019, 2026, and 2035
  • Figure 10.3: Trends of the ROW PD-L1 Biomarker Testing Market ($B) by Type (2019-2026)
  • Figure 10.4: Forecast for the ROW PD-L1 Biomarker Testing Market ($B) by Type (2027-2035)
  • Figure 10.5: ROW PD-L1 Biomarker Testing Market by Application in 2019, 2026, and 2035
  • Figure 10.6: Trends of the ROW PD-L1 Biomarker Testing Market ($B) by Application (2019-2026)
  • Figure 10.7: Forecast for the ROW PD-L1 Biomarker Testing Market ($B) by Application (2027-2035)
  • Figure 10.8: Trends and Forecast for the Middle Eastern PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 10.9: Trends and Forecast for the South American PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 10.10: Trends and Forecast for the African PD-L1 Biomarker Testing Market ($B) (2019-2035)
  • Figure 11.1: Porter's Five Forces Analysis of the Global PD-L1 Biomarker Testing Market
  • Figure 11.2: Market Share (%) of Top Players in the Global PD-L1 Biomarker Testing Market (2026)
  • Figure 12.1: Growth Opportunities for the Global PD-L1 Biomarker Testing Market by Type
  • Figure 12.2: Growth Opportunities for the Global PD-L1 Biomarker Testing Market by Application
  • Figure 12.3: Growth Opportunities for the Global PD-L1 Biomarker Testing Market by Region
  • Figure 12.4: Emerging Trends in the Global PD-L1 Biomarker Testing Market

List of Tables

  • Table 1.1: Growth Rate (%, 2025-2026) and CAGR (%, 2027-2035) of the PD-L1 Biomarker Testing Market by Type and Application
  • Table 1.2: Attractiveness Analysis for the PD-L1 Biomarker Testing Market by Region
  • Table 1.3: Global PD-L1 Biomarker Testing Market Parameters and Attributes
  • Table 3.1: Trends of the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 3.2: Forecast for the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 4.1: Attractiveness Analysis for the Global PD-L1 Biomarker Testing Market by Type
  • Table 4.2: Market Size and CAGR of Various Type in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 4.3: Market Size and CAGR of Various Type in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 4.4: Trends of PD-L1 (22C3) in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 4.5: Forecast for PD-L1 (22C3) in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 4.6: Trends of PD-L1(28-8) in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 4.7: Forecast for PD-L1(28-8) in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 4.8: Trends of PD-L1 (SP142) in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 4.9: Forecast for PD-L1 (SP142) in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 4.10: Trends of PD-L1 (SP263) in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 4.11: Forecast for PD-L1 (SP263) in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 4.12: Trends of Others in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 4.13: Forecast for Others in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 5.1: Attractiveness Analysis for the Global PD-L1 Biomarker Testing Market by Application
  • Table 5.2: Market Size and CAGR of Various Application in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 5.3: Market Size and CAGR of Various Application in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 5.4: Trends of Hospital in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 5.5: Forecast for Hospital in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 5.6: Trends of Diagnostic Center in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 5.7: Forecast for Diagnostic Center in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 5.8: Trends of Others in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 5.9: Forecast for Others in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 6.1: Market Size and CAGR of Various Regions in the Global PD-L1 Biomarker Testing Market (2019-2026)
  • Table 6.2: Market Size and CAGR of Various Regions in the Global PD-L1 Biomarker Testing Market (2027-2035)
  • Table 7.1: Trends of the North American PD-L1 Biomarker Testing Market (2019-2026)
  • Table 7.2: Forecast for the North American PD-L1 Biomarker Testing Market (2027-2035)
  • Table 7.3: Market Size and CAGR of Various Type in the North American PD-L1 Biomarker Testing Market (2019-2026)
  • Table 7.4: Market Size and CAGR of Various Type in the North American PD-L1 Biomarker Testing Market (2027-2035)
  • Table 7.5: Market Size and CAGR of Various Application in the North American PD-L1 Biomarker Testing Market (2019-2026)
  • Table 7.6: Market Size and CAGR of Various Application in the North American PD-L1 Biomarker Testing Market (2027-2035)
  • Table 7.7: Trends and Forecast for the United States PD-L1 Biomarker Testing Market (2019-2035)
  • Table 7.8: Trends and Forecast for the Mexican PD-L1 Biomarker Testing Market (2019-2035)
  • Table 7.9: Trends and Forecast for the Canadian PD-L1 Biomarker Testing Market (2019-2035)
  • Table 8.1: Trends of the European PD-L1 Biomarker Testing Market (2019-2026)
  • Table 8.2: Forecast for the European PD-L1 Biomarker Testing Market (2027-2035)
  • Table 8.3: Market Size and CAGR of Various Type in the European PD-L1 Biomarker Testing Market (2019-2026)
  • Table 8.4: Market Size and CAGR of Various Type in the European PD-L1 Biomarker Testing Market (2027-2035)
  • Table 8.5: Market Size and CAGR of Various Application in the European PD-L1 Biomarker Testing Market (2019-2026)
  • Table 8.6: Market Size and CAGR of Various Application in the European PD-L1 Biomarker Testing Market (2027-2035)
  • Table 8.7: Trends and Forecast for the German PD-L1 Biomarker Testing Market (2019-2035)
  • Table 8.8: Trends and Forecast for the French PD-L1 Biomarker Testing Market (2019-2035)
  • Table 8.9: Trends and Forecast for the Spanish PD-L1 Biomarker Testing Market (2019-2035)
  • Table 8.10: Trends and Forecast for the Italian PD-L1 Biomarker Testing Market (2019-2035)
  • Table 8.11: Trends and Forecast for the United Kingdom PD-L1 Biomarker Testing Market (2019-2035)
  • Table 9.1: Trends of the APAC PD-L1 Biomarker Testing Market (2019-2026)
  • Table 9.2: Forecast for the APAC PD-L1 Biomarker Testing Market (2027-2035)
  • Table 9.3: Market Size and CAGR of Various Type in the APAC PD-L1 Biomarker Testing Market (2019-2026)
  • Table 9.4: Market Size and CAGR of Various Type in the APAC PD-L1 Biomarker Testing Market (2027-2035)
  • Table 9.5: Market Size and CAGR of Various Application in the APAC PD-L1 Biomarker Testing Market (2019-2026)
  • Table 9.6: Market Size and CAGR of Various Application in the APAC PD-L1 Biomarker Testing Market (2027-2035)
  • Table 9.7: Trends and Forecast for the Japanese PD-L1 Biomarker Testing Market (2019-2035)
  • Table 9.8: Trends and Forecast for the Indian PD-L1 Biomarker Testing Market (2019-2035)
  • Table 9.9: Trends and Forecast for the Chinese PD-L1 Biomarker Testing Market (2019-2035)
  • Table 9.10: Trends and Forecast for the South Korean PD-L1 Biomarker Testing Market (2019-2035)
  • Table 9.11: Trends and Forecast for the Indonesian PD-L1 Biomarker Testing Market (2019-2035)
  • Table 10.1: Trends of the ROW PD-L1 Biomarker Testing Market (2019-2026)
  • Table 10.2: Forecast for the ROW PD-L1 Biomarker Testing Market (2027-2035)
  • Table 10.3: Market Size and CAGR of Various Type in the ROW PD-L1 Biomarker Testing Market (2019-2026)
  • Table 10.4: Market Size and CAGR of Various Type in the ROW PD-L1 Biomarker Testing Market (2027-2035)
  • Table 10.5: Market Size and CAGR of Various Application in the ROW PD-L1 Biomarker Testing Market (2019-2026)
  • Table 10.6: Market Size and CAGR of Various Application in the ROW PD-L1 Biomarker Testing Market (2027-2035)
  • Table 10.7: Trends and Forecast for the Middle Eastern PD-L1 Biomarker Testing Market (2019-2035)
  • Table 10.8: Trends and Forecast for the South American PD-L1 Biomarker Testing Market (2019-2035)
  • Table 10.9: Trends and Forecast for the African PD-L1 Biomarker Testing Market (2019-2035)
  • Table 11.1: Product Mapping of PD-L1 Biomarker Testing Suppliers Based on Segments
  • Table 11.2: Operational Integration of PD-L1 Biomarker Testing Manufacturers
  • Table 11.3: Rankings of Suppliers Based on PD-L1 Biomarker Testing Revenue
  • Table 12.1: New Product Launches by Major PD-L1 Biomarker Testing Producers (2019-2026)
  • Table 12.2: Certification Acquired by Major Competitor in the Global PD-L1 Biomarker Testing Market