한글목차

세계의 PD-L1 바이오마커 검사 시장 규모는 2024년에 28억 1,500만 달러로 추정되며, 2025-2031년의 예측 기간에 CAGR 38.7%로 성장하여 2031년까지 270억 2,000만 달러로 확대될 것으로 예측됩니다.

PD-L1 바이오마커 검사는 암세포의 PD-L1 양을 측정합니다. PD-L1은 면역세포가 체내의 무해한 세포를 공격하는 것을 막는 역할을 하는 단백질입니다. 일반적으로 면역계는 바이러스나 세균과 같은 이물질을 공격하지만, 자신의 건강한 세포를 공격하지는 않습니다. 일부 암세포는 고농도의 PD-L1을 보유하고 있습니다. 이를 통해 암세포는 면역체계를 '속여' 이물질로 인식되어 공격당하는 것을 피할 수 있습니다. 현재 PD-L1 검사는 면역조직화학(IHC) 방법을 기반으로 합니다. 면역조직화학(IHC)은 조직절편(예: 간, 췌장, 심장 등) 내 세포에 존재하는 단백질(항원)을 항체를 이용하여 검출하는 방법입니다. PD-L1은 활성화된 T세포에 발현하는 PD-1(프로그램 세포사멸 수용체-1)에 결합하는 리간드이며, 항종양 반응을 회피하는 역할을 합니다. PD-L1은 T세포의 활성화와 증식을 억제하는 역할을 하며, 암 치료의 중요한 표적으로 주목받고 있습니다. 면역조직화학(IHC) 검사를 통한 PD-L1 단백질 검출은 항 PD-1/PD-L1 치료의 예측 바이오마커 검사로 널리 사용되고 있습니다. PD-L1 검사는 면역치료의 혜택을 받을 수 있는 암이 있는지 여부를 확인하는 데 사용됩니다.

PD-L1 바이오마커 검사 시장은 면역관문억제제 치료, 특히 PD-1/PD-L1 축을 표적으로 하는 치료법의 급속한 확장에 힘입어 성장하고 있습니다. 이러한 치료법은 다양한 진행성 암 치료에서 임상적 성공을 거두면서 PD-L1 발현을 기반으로 한 환자 계층화에 대한 광범위한 수요를 불러일으키고 있으며, 치료 결과를 최적화하기 위해 PD-L1 발현을 기반으로 한 환자 계층화에 대한 수요가 증가하고 있습니다. 또한, 정밀의료로의 전환으로 분자진단의 중요성이 커지고 있습니다. 임상의와 제약 개발자들은 PD-L1 검사를 활용한 개별화 접근법을 치료 결정의 지침과 동반 진단을 가능하게 하는 수단으로 점점 더 중요하게 여기고 있습니다. 특히 자동화 IHC 시스템, NGS 플랫폼, AI 강화 분석 기술 등 진단 기술의 발전에 따라 그 중요성이 커지고 있습니다.

이러한 긍정적인 추세에도 불구하고, PD-L1 검사는 프로토콜, 분석 클론, 채점 시스템, 컷오프 값의 표준화 부족으로 인해 심각한 장벽에 직면해 있습니다. 이러한 불일치는 결과의 불일치(분석법마다 19-32%의 변동성이 보고됨)로 나타나 진단의 신뢰성을 떨어뜨리고 임상적 판단을 복잡하게 만듭니다. 또한, 첨단 검사 기술(IHC, NGS)에 따른 고가의 비용과 불균등한 상환제도는 특히 개발도상국에서 경제적 장벽을 만들어 광범위한 접근성을 저해하고 의료 격차를 확대시키고 있습니다.

PD-L1 바이오마커 검사의 분류에는 PD-L1(22C3), PD-L1(28-8), PD-L1(SP142), PD-L1(SP263), 기타가 포함되며, 2024년 PD-L1(22C3)의 매출 비중은 약 21.68%를 보일 것으로 예측됩니다. PD-L1 바이오마커 검사는 병원 및 진단실험실에서 널리 사용되고 있습니다. PD-L1 바이오마커 검사의 가장 큰 비중을 차지하는 곳은 병원이며, 2024년 그 비중은 약 52.7%를 보일 것입니다.

이 보고서는 PD-L1 바이오마커 검사 세계 시장에 대해 총 매출액, 주요 기업의 시장 점유율 및 순위를 중심으로 지역별, 국가별, 유형별, 용도별 분석을 종합적으로 제시하는 것을 목적으로 합니다.

PD-L1 바이오마커 검사 시장 규모, 추정 및 예측은 2024년을 기준 연도로 하여 2020년부터 2031년까지의 과거 데이터와 예측 데이터를 포함하는 매출액으로 제시되었습니다. 정량적, 정성적 분석을 통해 독자들이 PD-L1 바이오마커 검사에 대한 사업 전략 및 성장 전략 수립, 시장 경쟁 평가, 현재 시장에서의 자사 위치 분석, 그리고 정보에 입각한 비즈니스 의사결정을 할 수 있도록 도와드립니다.

시장 세분화

기업별

• Agilent Technologies
• Roche
• Merck
• Bristol-Myers Squibb
• AstraZeneca
• Ono Pharmaceutical
• Regeneron
• Innovent
• Hengrui Medicine
• Junshi Biosciences

유형별 부문

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

용도별 부문

• 병원
• 진단센터
• 기타

지역별

• 북미
  • 미국
  • 캐나다
• 아시아태평양
  • 중국
  • 일본
  • 한국
  • 동남아시아
  • 인도
  • 호주
  • 기타 아시아태평양
• 유럽
  • 독일
  • 프랑스
  • 영국
  • 이탈리아
  • 네덜란드
  • 북유럽 국가
  • 기타 유럽
• 라틴아메리카
  • 멕시코
  • 브라질
  • 기타 라틴아메리카
• 중동 및 아프리카
  • 튀르키예
  • 사우디아라비아
  • 아랍에미리트(UAE)
  • 기타 중동 및 아프리카

영문목차

The global market for PD-L1 Biomarker Testing was estimated to be worth US$ 2815 million in 2024 and is forecast to a readjusted size of US$ 27020 million by 2031 with a CAGR of 38.7% 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. PDL1 testing is used to find out if you have a cancer that may benefit from immunotherapy.

The PD-L1 biomarker testing market is being propelled by the rapid expansion of immune checkpoint inhibitor therapies, particularly those targeting the PD-1/PD-L1 axis, which have shown remarkable clinical success in treating various advanced cancers-spurring widespread demand for stratifying patients based on PD-L1 expression to optimize treatment outcomes. Additionally, the shift toward precision medicine has heightened the importance of molecular diagnostics. Clinicians and pharmaceutical developers are increasingly emphasizing personalized approaches, using PD-L1 testing to guide therapeutic decisions and enable companion diagnostics-especially as diagnostic technologies advance to include automated IHC systems, NGS platforms, and AI-enhanced analysis .

Despite these positive trends, the PD-L1 testing landscape faces significant obstacles due to a lack of standardization across protocols, assay clones, scoring systems, and cut-off thresholds. This inconsistency manifests in discordant results (with variability rates reported between 19-32% across different assays), undermining diagnostic reliability and complicating clinical decision-making. Moreover, high costs associated with advanced testing techniques (IHC, NGS) and uneven reimbursement frameworks create economic barriers, particularly in developing regions, impeding broad accessibility and exacerbating healthcare disparities.

The classification of PD-L1 Biomarker Testing includes PD-L1 (22C3), PD-L1 (28-8), PD-L1 (SP142), PD-L1 (SP263) and Other, and the revenue proportion of PD-L1 (22C3) in 2024 is about 21.68%. PD-L1 Biomarker Testing is widely used in Hospital and Diagnostic Laboratories. The most proportion of PD-L1 Biomarker Testing is Hospital, and the proportion in 2024 is about 52.7%.

This report aims to provide a comprehensive presentation of the global market for PD-L1 Biomarker Testing, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of PD-L1 Biomarker Testing by region & country, by Type, and by Application.

The PD-L1 Biomarker 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 Biomarker Testing.

Market Segmentation

By Company

• Agilent Technologies
• Roche
• Merck
• Bristol-Myers Squibb
• AstraZeneca
• Ono Pharmaceutical
• Regeneron
• Innovent
• Hengrui Medicine
• Junshi Biosciences

Segment by Type

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

Segment by Application

• Hospital
• Diagnostic Center
• Others

By Region

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • South Korea
  • Southeast Asia
  • India
  • Australia
  • Rest of Asia-Pacific
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Netherlands
  • Nordic Countries
  • Rest of Europe
• Latin America
  • Mexico
  • Brazil
  • Rest of Latin America
• Middle East & Africa
  • Turkey
  • Saudi Arabia
  • UAE
  • Rest of MEA

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 Biomarker 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 Biomarker 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 Biomarker 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.

Table of Contents

1 Market Overview

• 1.1 PD-L1 Biomarker Testing Product Introduction
• 1.2 Global PD-L1 Biomarker Testing Market Size Forecast (2020-2031)
• 1.3 PD-L1 Biomarker Testing Market Trends & Drivers
  • 1.3.1 PD-L1 Biomarker Testing Industry Trends
  • 1.3.2 PD-L1 Biomarker Testing Market Drivers & Opportunity
  • 1.3.3 PD-L1 Biomarker Testing Market Challenges
  • 1.3.4 PD-L1 Biomarker Testing Market Restraints
• 1.4 Assumptions and Limitations
• 1.5 Study Objectives
• 1.6 Years Considered

2 Competitive Analysis by Company

• 2.1 Global PD-L1 Biomarker Testing Players Revenue Ranking (2024)
• 2.2 Global PD-L1 Biomarker Testing Revenue by Company (2020-2025)
• 2.3 Key Companies PD-L1 Biomarker Testing Manufacturing Base Distribution and Headquarters
• 2.4 Key Companies PD-L1 Biomarker Testing Product Offered
• 2.5 Key Companies Time to Begin Mass Production of PD-L1 Biomarker Testing
• 2.6 PD-L1 Biomarker Testing Market Competitive Analysis
  • 2.6.1 PD-L1 Biomarker Testing Market Concentration Rate (2020-2025)
  • 2.6.2 Global 5 and 10 Largest Companies by PD-L1 Biomarker Testing Revenue in 2024
  • 2.6.3 Global Top Companies by Company Type (Tier 1, Tier 2, and Tier 3) & (based on the Revenue in PD-L1 Biomarker Testing as of 2024)
• 2.7 Mergers & Acquisitions, Expansion

3 Segmentation by Type

• 3.1 Introduction by Type
  • 3.1.1 PD-L1 (22C3)
  • 3.1.2 PD-L1(28-8)
  • 3.1.3 PD-L1 (SP142)
  • 3.1.4 PD-L1 (SP263)
  • 3.1.5 Other
• 3.2 Global PD-L1 Biomarker Testing Sales Value by Type
  • 3.2.1 Global PD-L1 Biomarker Testing Sales Value by Type (2020 VS 2024 VS 2031)
  • 3.2.2 Global PD-L1 Biomarker Testing Sales Value, by Type (2020-2031)
  • 3.2.3 Global PD-L1 Biomarker Testing Sales Value, by Type (%) (2020-2031)

4 Segmentation by Application

• 4.1 Introduction by Application
  • 4.1.1 Hospital
  • 4.1.2 Diagnostic Center
  • 4.1.3 Others
• 4.2 Global PD-L1 Biomarker Testing Sales Value by Application
  • 4.2.1 Global PD-L1 Biomarker Testing Sales Value by Application (2020 VS 2024 VS 2031)
  • 4.2.2 Global PD-L1 Biomarker Testing Sales Value, by Application (2020-2031)
  • 4.2.3 Global PD-L1 Biomarker Testing Sales Value, by Application (%) (2020-2031)

5 Segmentation by Region

• 5.1 Global PD-L1 Biomarker Testing Sales Value by Region
  • 5.1.1 Global PD-L1 Biomarker Testing Sales Value by Region: 2020 VS 2024 VS 2031
  • 5.1.2 Global PD-L1 Biomarker Testing Sales Value by Region (2020-2025)
  • 5.1.3 Global PD-L1 Biomarker Testing Sales Value by Region (2026-2031)
  • 5.1.4 Global PD-L1 Biomarker Testing Sales Value by Region (%), (2020-2031)
• 5.2 North America
  • 5.2.1 North America PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 5.2.2 North America PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
• 5.3 Europe
  • 5.3.1 Europe PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 5.3.2 Europe PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
• 5.4 Asia Pacific
  • 5.4.1 Asia Pacific PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 5.4.2 Asia Pacific PD-L1 Biomarker Testing Sales Value by Region (%), 2024 VS 2031
• 5.5 South America
  • 5.5.1 South America PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 5.5.2 South America PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031
• 5.6 Middle East & Africa
  • 5.6.1 Middle East & Africa PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 5.6.2 Middle East & Africa PD-L1 Biomarker Testing Sales Value by Country (%), 2024 VS 2031

6 Segmentation by Key Countries/Regions

• 6.1 Key Countries/Regions PD-L1 Biomarker Testing Sales Value Growth Trends, 2020 VS 2024 VS 2031
• 6.2 Key Countries/Regions PD-L1 Biomarker Testing Sales Value, 2020-2031
• 6.3 United States
  • 6.3.1 United States PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.3.2 United States PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.3.3 United States PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
• 6.4 Europe
  • 6.4.1 Europe PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.4.2 Europe PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.4.3 Europe PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
• 6.5 China
  • 6.5.1 China PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.5.2 China PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.5.3 China PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
• 6.6 Japan
  • 6.6.1 Japan PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.6.2 Japan PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.6.3 Japan PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
• 6.7 South Korea
  • 6.7.1 South Korea PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.7.2 South Korea PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.7.3 South Korea PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
• 6.8 Southeast Asia
  • 6.8.1 Southeast Asia PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.8.2 Southeast Asia PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.8.3 Southeast Asia PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031
• 6.9 India
  • 6.9.1 India PD-L1 Biomarker Testing Sales Value, 2020-2031
  • 6.9.2 India PD-L1 Biomarker Testing Sales Value by Type (%), 2024 VS 2031
  • 6.9.3 India PD-L1 Biomarker Testing Sales Value by Application, 2024 VS 2031

7 Company Profiles

• 7.1 Agilent Technologies
  • 7.1.1 Agilent Technologies Profile
  • 7.1.2 Agilent Technologies Main Business
  • 7.1.3 Agilent Technologies PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.1.4 Agilent Technologies PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.1.5 Agilent Technologies Recent Developments
• 7.2 Roche
  • 7.2.1 Roche Profile
  • 7.2.2 Roche Main Business
  • 7.2.3 Roche PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.2.4 Roche PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.2.5 Roche Recent Developments
• 7.3 Merck
  • 7.3.1 Merck Profile
  • 7.3.2 Merck Main Business
  • 7.3.3 Merck PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.3.4 Merck PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.3.5 Merck Recent Developments
• 7.4 Bristol-Myers Squibb
  • 7.4.1 Bristol-Myers Squibb Profile
  • 7.4.2 Bristol-Myers Squibb Main Business
  • 7.4.3 Bristol-Myers Squibb PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.4.4 Bristol-Myers Squibb PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.4.5 Bristol-Myers Squibb Recent Developments
• 7.5 AstraZeneca
  • 7.5.1 AstraZeneca Profile
  • 7.5.2 AstraZeneca Main Business
  • 7.5.3 AstraZeneca PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.5.4 AstraZeneca PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.5.5 AstraZeneca Recent Developments
• 7.6 Ono Pharmaceutical
  • 7.6.1 Ono Pharmaceutical Profile
  • 7.6.2 Ono Pharmaceutical Main Business
  • 7.6.3 Ono Pharmaceutical PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.6.4 Ono Pharmaceutical PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.6.5 Ono Pharmaceutical Recent Developments
• 7.7 Regeneron
  • 7.7.1 Regeneron Profile
  • 7.7.2 Regeneron Main Business
  • 7.7.3 Regeneron PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.7.4 Regeneron PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.7.5 Regeneron Recent Developments
• 7.8 Innovent
  • 7.8.1 Innovent Profile
  • 7.8.2 Innovent Main Business
  • 7.8.3 Innovent PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.8.4 Innovent PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.8.5 Innovent Recent Developments
• 7.9 Hengrui Medicine
  • 7.9.1 Hengrui Medicine Profile
  • 7.9.2 Hengrui Medicine Main Business
  • 7.9.3 Hengrui Medicine PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.9.4 Hengrui Medicine PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.9.5 Hengrui Medicine Recent Developments
• 7.10 Junshi Biosciences
  • 7.10.1 Junshi Biosciences Profile
  • 7.10.2 Junshi Biosciences Main Business
  • 7.10.3 Junshi Biosciences PD-L1 Biomarker Testing Products, Services and Solutions
  • 7.10.4 Junshi Biosciences PD-L1 Biomarker Testing Revenue (US$ Million) & (2020-2025)
  • 7.10.5 Junshi Biosciences Recent Developments

8 Industry Chain Analysis

• 8.1 PD-L1 Biomarker Testing Industrial Chain
• 8.2 PD-L1 Biomarker Testing Upstream Analysis
  • 8.2.1 Key Raw Materials
  • 8.2.2 Raw Materials Key Suppliers
  • 8.2.3 Manufacturing Cost Structure
• 8.3 Midstream Analysis
• 8.4 Downstream Analysis (Customers Analysis)
• 8.5 Sales Model and Sales Channels
  • 8.5.1 PD-L1 Biomarker Testing Sales Model
  • 8.5.2 Sales Channel
  • 8.5.3 PD-L1 Biomarker Testing Distributors

9 Research Findings and Conclusion

10 Appendix

• 10.1 Research Methodology
  • 10.1.1 Methodology/Research Approach
    • 10.1.1.1 Research Programs/Design
    • 10.1.1.2 Market Size Estimation
    • 10.1.1.3 Market Breakdown and Data Triangulation
  • 10.1.2 Data Source
    • 10.1.2.1 Secondary Sources
    • 10.1.2.2 Primary Sources
• 10.2 Author Details
• 10.3 Disclaimer