세계의 PD-L1 및 PIK3CA 검사 : 시장 점유율과 순위, 전체 판매량 및 수요 예측(2025-2031년)

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

• Agilent Technologies
• Roche
• QIAGEN
• EntroGen
• Amoy Diagnostics
• ACCB Biotech

Segment by Type

• PD-L1 Testing
• PIK3CA Testing

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 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.

Table of Contents

1 Market Overview

• 1.1 PD-L1 and PIK3CA Testing Product Introduction
• 1.2 Global PD-L1 and PIK3CA Testing Market Size Forecast (2020-2031)
• 1.3 PD-L1 and PIK3CA Testing Market Trends & Drivers
  • 1.3.1 PD-L1 and PIK3CA Testing Industry Trends
  • 1.3.2 PD-L1 and PIK3CA Testing Market Drivers & Opportunity
  • 1.3.3 PD-L1 and PIK3CA Testing Market Challenges
  • 1.3.4 PD-L1 and PIK3CA 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 and PIK3CA Testing Players Revenue Ranking (2024)
• 2.2 Global PD-L1 and PIK3CA Testing Revenue by Company (2020-2025)
• 2.3 Key Companies PD-L1 and PIK3CA Testing Manufacturing Base Distribution and Headquarters
• 2.4 Key Companies PD-L1 and PIK3CA Testing Product Offered
• 2.5 Key Companies Time to Begin Mass Production of PD-L1 and PIK3CA Testing
• 2.6 PD-L1 and PIK3CA Testing Market Competitive Analysis
  • 2.6.1 PD-L1 and PIK3CA Testing Market Concentration Rate (2020-2025)
  • 2.6.2 Global 5 and 10 Largest Companies by PD-L1 and PIK3CA 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 and PIK3CA Testing as of 2024)
• 2.7 Mergers & Acquisitions, Expansion

3 Segmentation by Type

• 3.1 Introduction by Type
  • 3.1.1 PD-L1 Testing
  • 3.1.2 PIK3CA Testing
• 3.2 Global PD-L1 and PIK3CA Testing Sales Value by Type
  • 3.2.1 Global PD-L1 and PIK3CA Testing Sales Value by Type (2020 VS 2024 VS 2031)
  • 3.2.2 Global PD-L1 and PIK3CA Testing Sales Value, by Type (2020-2031)
  • 3.2.3 Global PD-L1 and PIK3CA 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 and PIK3CA Testing Sales Value by Application
  • 4.2.1 Global PD-L1 and PIK3CA Testing Sales Value by Application (2020 VS 2024 VS 2031)
  • 4.2.2 Global PD-L1 and PIK3CA Testing Sales Value, by Application (2020-2031)
  • 4.2.3 Global PD-L1 and PIK3CA Testing Sales Value, by Application (%) (2020-2031)

5 Segmentation by Region

• 5.1 Global PD-L1 and PIK3CA Testing Sales Value by Region
  • 5.1.1 Global PD-L1 and PIK3CA Testing Sales Value by Region: 2020 VS 2024 VS 2031
  • 5.1.2 Global PD-L1 and PIK3CA Testing Sales Value by Region (2020-2025)
  • 5.1.3 Global PD-L1 and PIK3CA Testing Sales Value by Region (2026-2031)
  • 5.1.4 Global PD-L1 and PIK3CA Testing Sales Value by Region (%), (2020-2031)
• 5.2 North America
  • 5.2.1 North America PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 5.2.2 North America PD-L1 and PIK3CA Testing Sales Value by Country (%), 2024 VS 2031
• 5.3 Europe
  • 5.3.1 Europe PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 5.3.2 Europe PD-L1 and PIK3CA Testing Sales Value by Country (%), 2024 VS 2031
• 5.4 Asia Pacific
  • 5.4.1 Asia Pacific PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 5.4.2 Asia Pacific PD-L1 and PIK3CA Testing Sales Value by Region (%), 2024 VS 2031
• 5.5 South America
  • 5.5.1 South America PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 5.5.2 South America PD-L1 and PIK3CA Testing Sales Value by Country (%), 2024 VS 2031
• 5.6 Middle East & Africa
  • 5.6.1 Middle East & Africa PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 5.6.2 Middle East & Africa PD-L1 and PIK3CA Testing Sales Value by Country (%), 2024 VS 2031

6 Segmentation by Key Countries/Regions

• 6.1 Key Countries/Regions PD-L1 and PIK3CA Testing Sales Value Growth Trends, 2020 VS 2024 VS 2031
• 6.2 Key Countries/Regions PD-L1 and PIK3CA Testing Sales Value, 2020-2031
• 6.3 United States
  • 6.3.1 United States PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.3.2 United States PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.3.3 United States PD-L1 and PIK3CA Testing Sales Value by Application, 2024 VS 2031
• 6.4 Europe
  • 6.4.1 Europe PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.4.2 Europe PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.4.3 Europe PD-L1 and PIK3CA Testing Sales Value by Application, 2024 VS 2031
• 6.5 China
  • 6.5.1 China PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.5.2 China PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.5.3 China PD-L1 and PIK3CA Testing Sales Value by Application, 2024 VS 2031
• 6.6 Japan
  • 6.6.1 Japan PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.6.2 Japan PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.6.3 Japan PD-L1 and PIK3CA Testing Sales Value by Application, 2024 VS 2031
• 6.7 South Korea
  • 6.7.1 South Korea PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.7.2 South Korea PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.7.3 South Korea PD-L1 and PIK3CA Testing Sales Value by Application, 2024 VS 2031
• 6.8 Southeast Asia
  • 6.8.1 Southeast Asia PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.8.2 Southeast Asia PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.8.3 Southeast Asia PD-L1 and PIK3CA Testing Sales Value by Application, 2024 VS 2031
• 6.9 India
  • 6.9.1 India PD-L1 and PIK3CA Testing Sales Value, 2020-2031
  • 6.9.2 India PD-L1 and PIK3CA Testing Sales Value by Type (%), 2024 VS 2031
  • 6.9.3 India PD-L1 and PIK3CA 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 and PIK3CA Testing Products, Services and Solutions
  • 7.1.4 Agilent Technologies PD-L1 and PIK3CA 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 and PIK3CA Testing Products, Services and Solutions
  • 7.2.4 Roche PD-L1 and PIK3CA Testing Revenue (US$ Million) & (2020-2025)
  • 7.2.5 Roche Recent Developments
• 7.3 QIAGEN
  • 7.3.1 QIAGEN Profile
  • 7.3.2 QIAGEN Main Business
  • 7.3.3 QIAGEN PD-L1 and PIK3CA Testing Products, Services and Solutions
  • 7.3.4 QIAGEN PD-L1 and PIK3CA Testing Revenue (US$ Million) & (2020-2025)
  • 7.3.5 QIAGEN Recent Developments
• 7.4 EntroGen
  • 7.4.1 EntroGen Profile
  • 7.4.2 EntroGen Main Business
  • 7.4.3 EntroGen PD-L1 and PIK3CA Testing Products, Services and Solutions
  • 7.4.4 EntroGen PD-L1 and PIK3CA Testing Revenue (US$ Million) & (2020-2025)
  • 7.4.5 EntroGen Recent Developments
• 7.5 Amoy Diagnostics
  • 7.5.1 Amoy Diagnostics Profile
  • 7.5.2 Amoy Diagnostics Main Business
  • 7.5.3 Amoy Diagnostics PD-L1 and PIK3CA Testing Products, Services and Solutions
  • 7.5.4 Amoy Diagnostics PD-L1 and PIK3CA Testing Revenue (US$ Million) & (2020-2025)
  • 7.5.5 Amoy Diagnostics Recent Developments
• 7.6 ACCB Biotech
  • 7.6.1 ACCB Biotech Profile
  • 7.6.2 ACCB Biotech Main Business
  • 7.6.3 ACCB Biotech PD-L1 and PIK3CA Testing Products, Services and Solutions
  • 7.6.4 ACCB Biotech PD-L1 and PIK3CA Testing Revenue (US$ Million) & (2020-2025)
  • 7.6.5 ACCB Biotech Recent Developments

8 Industry Chain Analysis

• 8.1 PD-L1 and PIK3CA Testing Industrial Chain
• 8.2 PD-L1 and PIK3CA 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 and PIK3CA Testing Sales Model
  • 8.5.2 Sales Channel
  • 8.5.3 PD-L1 and PIK3CA 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