The global PD-L1 and PIK3CA Testing market size is expected to reach $ 3077 million by 2032, rising at a market growth of 16.5% CAGR during the forecast period (2026-2032).
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 studies the global PD-L1 and PIK3CA Testing demand, key companies, and key regions.
This report is a detailed and comprehensive analysis of the world market for PD-L1 and PIK3CA Testing, and provides market size (US$ million) and Year-over-Year (YoY) growth, considering 2025 as the base year. This report explores demand trends and competition, as well as details the characteristics of PD-L1 and PIK3CA Testing that contribute to its increasing demand across many markets.
Highlights and key features of the study
Global PD-L1 and PIK3CA Testing total market, 2021-2032, (USD Million)
Global PD-L1 and PIK3CA Testing total market by region & country, CAGR, 2021-2032, (USD Million)
U.S. VS China: PD-L1 and PIK3CA Testing total market, key domestic companies, and share, (USD Million)
Global PD-L1 and PIK3CA Testing revenue by player, revenue and market share 2021-2026, (USD Million)
Global PD-L1 and PIK3CA Testing total market by Type, CAGR, 2021-2032, (USD Million)
Global PD-L1 and PIK3CA Testing total market by Application, CAGR, 2021-2032, (USD Million)
This report profiles major players in the global PD-L1 and PIK3CA Testing market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Agilent Technologies, Roche, QIAGEN, EntroGen, Amoy Diagnostics, ACCB Biotech, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the world PD-L1 and PIK3CA Testing market
Detailed Segmentation:
Each section contains quantitative market data including market by value (US$ Millions), by player, by regions, by Type, and by Application. Data is given for the years 2021-2032 by year with 2025 as the base year, 2026 as the estimate year, and 2027-2032 as the forecast year.
Global PD-L1 and PIK3CA Testing Market, By Region:
United States
China
Europe
Japan
South Korea
ASEAN
India
Rest of World
Global PD-L1 and PIK3CA Testing Market, Segmentation by Type:
PD-L1 Testing
PIK3CA Testing
Global PD-L1 and PIK3CA Testing Market, Segmentation by Application:
Hospital
Diagnostic Center
Others
Companies Profiled:
Agilent Technologies
Roche
QIAGEN
EntroGen
Amoy Diagnostics
ACCB Biotech
Key Questions Answered
1. How big is the global PD-L1 and PIK3CA Testing market?
2. What is the demand of the global PD-L1 and PIK3CA Testing market?
3. What is the year over year growth of the global PD-L1 and PIK3CA Testing market?
4. What is the total value of the global PD-L1 and PIK3CA Testing market?
5. Who are the Major Players in the global PD-L1 and PIK3CA Testing market?
6. What are the growth factors driving the market demand?
Summary:
Get latest Market Research Reports on PD-L1 and PIK3CA Testing. Industry analysis & Market Report on PD-L1 and PIK3CA Testing is a syndicated market report, published as Global PD-L1 and PIK3CA Testing Supply, Demand and Key Producers, 2026-2032. It is complete Research Study and Industry Analysis of PD-L1 and PIK3CA Testing market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.