United States PD-L1 and PIK3CA Testing Product Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Szie and Growth

PD-L1 and PIK3CA testing product market is growing at a CAGR of 18.45% during the forecast period (2023-2030).

Key Development:

United States: Recent Industry Developments

✅ In October 2025, Guardant Health launched Guardant360® Tissue, the first molecular profiling test for tumor tissue that incorporates comprehensive multiomics analysis-including DNA, RNA, AI-powered PD-L1, and genome-wide methylation data-to provide researchers and cancer care teams with a more comprehensive view of cancer.

✅ In September 2025, SOPHiA GENETICS expanded its collaboration with AstraZeneca to enhance detection of breast and prostate cancer, driving adoption of advanced PIK3CA/AKT1/PTEN testing in both tissue and liquid biopsy to expand patient access to precision therapies.

✅ In August 2025, the FDA granted fast track designation to ETX-636, a promising treatment for advanced breast cancer with PIK3CA mutations, aiming to improve patient outcomes.

Japan: Recent Industry Developments

✅ In July 2025, the European Commission approved Roche's Itovebi for PIK3CA-mutated, ER-positive advanced breast cancer, marking a significant advancement in targeted therapy.

✅ In May 2025, Foundation Medicine expanded its immunohistochemistry (IHC) testing portfolio to include PD-L1 IHC 22C3 pharmDx, Dako® PD-L1 IHC 28-8 pharmDx, Ventana® PD-L1 SP142, and Ventana® PD-L1 SP263, enhancing diagnostic capabilities in oncology.

✅ In April 2025, Guardant Health launched Guardant360® Tissue, the first molecular profiling test for tumor tissue that incorporates comprehensive multiomics analysis-including DNA, RNA, AI-powered PD-L1, and genome-wide methylation data-to provide researchers and cancer care teams with a more comprehensive view of cancer.

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PD-L1 and PIK3CA testing products are molecular diagnostic tools used to detect the expression of PD-L1 protein and mutations in the PIK3CA gene in cancer patients. They help guide personalized therapy decisions, predict response to immunotherapy or targeted treatments, and improve precision oncology outcomes.

Recent Mergers and acquisitions:

United States: Recent Mergers & Acquisitions

✅ In October 2025, Kazia Therapeutics announced an exclusive collaboration and in-licensing agreement with QIMR Berghofer for a first-in-class PD-L1 protein degrader program. The lead optimized compound, NDL2, is an advanced PD-L1 protein degrader currently in development and represents a new and innovative frontier of cancer immunotherapy.

✅ In July 2025, Bio/Pharma Industry Radar reported on top mergers and acquisitions closed or announced thus far in 2025, providing insights into the latest M&A activities in the pharmaceutical and biotechnology sectors.

✅ In July 2025, ApexOnco's M&A analysis highlighted signs of life emerging in the oncology sector, noting that the last truly big oncology deals were AbbVie's $10.1bn purchase of ImmunoGen and Pfizer's $43bn acquisition of Seagen, both of which were struck in 2023.

Japan: Recent Mergers & Acquisitions

✅ In July 2025, Bio/Pharma Industry Radar reported on top mergers and acquisitions closed or announced thus far in 2025, providing insights into the latest M&A activities in the pharmaceutical and biotechnology sectors.

✅ In July 2025, ApexOnco's M&A analysis highlighted signs of life emerging in the oncology sector, noting that the last truly big oncology deals were AbbVie's $10.1bn purchase of ImmunoGen and Pfizer's $43bn acquisition of Seagen, both of which were struck in 2023.

Key Players:

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

Growth Forecast Projected:

The Global PD-L1 and PIK3CA Testing Product Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global PD-L1 and PIK3CA Testing Product Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

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

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

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among PD-L1 and PIK3CA Testing Product producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze PD-L1 and PIK3CA Testing Product revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

Q: What is the growth rate of the PD-L1 and PIK3CA Testing Product Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 18.45% during the forecast period from 2023 to 2030.

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