PD-L1 and PIK3CA Testing Product Market Grows with Rise in Precision Oncology & Targeted Cancer Therapies | CAGR of 18.45%

"The PD-L1 and PIK3CA Testing Product Market is estimated to reach at a high CAGR during the forecast period (2024-2031)." As per DataM intelligence research report

Market growth opportunities(2025-2031):

The testing market is expanding as demand for PD‐L1 and PIK3CA biomarkers grows in oncology diagnostics and companion diagnostics. Multiplex assay platforms integrating both markers are gaining traction in trials and clinical workflows. Point-of-care and decentralized diagnostics are emerging, offering faster turn-around and broader access. Expanded precision oncology and targeted therapy approvals are fueling uptake. Adoption in emerging markets is accelerating thanks to improving diagnostics infrastructure and greater cancer awareness

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PD-L1 and PIK3CA Testing Product Market: Recent Industry Developments

✅ In April 2025, Agilent PD L1 IHC 22C3 pharmDx assay received European IVDR certification as a companion diagnostic for identifying gastric/gastroesophageal junction adenocarcinoma patients eligible for pembrolizumab (Keytruda®). It is now certified for seven cancer indications across EU diagnostics laboratories

✅ In December 2024, Agilent's PD L1 IHC 28 8 pharmDx assay secured Class C IVDR certification in Europe, expanding its diagnostic use across nine cancer types including NSCLC, urothelial carcinoma, melanoma, esophageal and gastric cancers enhancing confidence in PD L1 guided immunotherapy selection

✅ Roche's VENTANA PD L1 (SP263) Assay was FDA approved in October 2021 as a companion diagnostic to identify NSCLC patients suitable for Tecentriq® (atezolizumab) adjuvant therapy Mbased on the IMpower010 study showing reduced recurrence risk

✅ For PIK3CA mutations, Roche offers the cobas® PIK3CA Mutation Test kit (RUO), enabling real time PCR detection of mutations in exons 1, 4, 7, 9, and 20 from FFPE samples with >95 % reliability primarily for research use

✅ In October 2024, FDA approved inavolisib (Itovebi®) for PIK3CA mutant breast cancer, using FoundationOne Liquid CDx as the companion diagnostic to identify eligible patients marking a significant therapeutic and diagnostic linkage for targeted PI3K inhibitor use

PD-L1 and PIK3CA Testing Product Market: Drivers

Rapid growth in immunotherapies targeting the PD‐1/PD‐L1 axis and PI3K inhibitors is driving demand for accurate testing. Precision medicine mandates biomarker stratification for targeted treatments. Companion diagnostics integration and regulatory trial requirements bolster market relevance. Advanced molecular platforms (IHC, NGS) and industry collaborations further support demand. Standardization and quality assurance remain key to clinical trust and broader adoption

Strategic Players Driving the PD-L1 and PIK3CA Testing Product Market Forward:

F. Hoffmann-La Roche Ltd, Agilent Technologies, QIAGEN, EntroGen, Inc., Amoy Diagnostics, ACCB Biotech, Myriad Genetic Laboratories, Inc. and FOUNDATION MEDICINE, INC.

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Segment Covered in the PD-L1 and PIK3CA Testing Product Market:

➥By Product Type: PD-L1, Cervical Cancer, Esophageal Cancer, NSCLC-Squamous, Squamous Cell Carcinoma of the Head and Neck, Triple-Negative Breast Cancer, Urothelial Carcinoma, PIK3CA
➥By End-User: Hospital, Diagnostic Center, Cancer Center, Others

Regional Analysis for PD-L1 and PIK3CA Testing Product Market:

North America currently dominates global market share, supported by mature oncology infrastructure and strong clinical research activity. Europe takes the second‐largest share with widespread diagnostic adoption and reimbursement support. Asia‐Pacific represents the fastest-growing region, fueled by rising cancer prevalence, improving healthcare access, and expanding precision oncology awareness

Why Purchase the Report for PD-L1 and PIK3CA Testing Product Market?:

➠ Technology & Innovation: Tracks clinical trials and upcoming pharmaceutical advancements to stay ahead in product development.
➠ Market Positioning & Competitive Strategy: Analyzes product performance, market share, and competitor tactics for strategic decision-making.
➠ Real-World Evidence & Physician Insights: Incorporates patient data and physician behavior to align products with actual healthcare needs.
➠ Pricing & Market Access: Reviews reimbursement trends and access models to optimize product pricing and launch strategies.
➠ Regulatory & Industry Shifts: Covers policy changes, health system dynamics, and technology trends impacting market opportunities.
➠ Regional Growth & Expansion: Identifies high-growth markets and investment opportunities for geographic expansion.

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Conclusion:

The PD‐L1 and PIK3CA testing product market is entering a period of robust growth as precision oncology expands. Multiplex biomarker panels and decentralized testing platforms will increase accessibility and ease integration into clinical workflows. North America and Europe are current leaders, while Asia‐Pacific is poised to deliver rapid growth. Market success will rely on innovations in assay standardization, reagent performance, regulatory alignment, and partnerships with pharma and diagnostics providers

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