The Market Reports

Synopsis

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

Segment by Region

• North America: United States, Canada, and Mexico
• Europe: United Kingdom, Germany, France, Spain, Italy, and Rest of Europe
• Asia Pacific: China, India, Japan, Australia, South Korea, and Rest of Asia Pacific
• Middle East & Africa: Saudi Arabia, South Africa, and Rest of MEA
• Latin America: Brazil, Argentina, and Rest of Latin America

*If you need a regional or country-specific version, or customized segmentation, we can tailor the report to your requirements.