PD-L1 and PIK3CA Testing Market Size and Share Analysis - Growth Trends and Forecasts (2025-2032)

Market Size and Trends

The PD-L1 and PIK3CA Testing market is estimated to be valued at USD 1.35 billion in 2025 and is expected to reach USD 2.47 billion by 2032, growing at a compound annual growth rate (CAGR) of 9.1% from 2024 to 2031. This considerable growth reflects increasing adoption of personalized medicine and targeted therapies in oncology, driving demand for these diagnostic tests. Enhanced awareness, advancements in molecular diagnostics, and expanding applications across various cancer types further contribute to the market expansion.

Emerging trends in the PD-L1 and PIK3CA testing market include the integration of next-generation sequencing (NGS) and companion diagnostics, which facilitate more precise and efficient patient stratification. Additionally, collaborations between biotech firms and diagnostic companies are accelerating innovation, while increasing investments in research and development are improving test accuracy and reducing costs. The rising prevalence of cancer globally and growing emphasis on immunotherapy adoption are also key factors shaping the market's trajectory toward more personalized treatment approaches.

Segmental Analysis:

By Test Type: Dominance of Immunohistochemistry (IHC) Driven by Established Clinical Utility and Cost-Effectiveness

In terms of By Test Type, Immunohistochemistry (IHC) contributes the highest share of the PD-L1 and PIK3CA testing market owing to its established clinical utility, broad accessibility, and relative cost-effectiveness compared to advanced molecular techniques. IHC has long been a gold standard in pathology labs for detecting protein expression levels, particularly for PD-L1, which is pivotal in determining patient eligibility for immunotherapy in cancer treatment. Its proficiency in visually localizing PD-L1 expression within tumor and immune cells enhances diagnostic accuracy, making it a preferred choice among clinicians. Furthermore, the relatively straightforward laboratory workflow and faster turnaround time of IHC assays appeal to hospital laboratories and diagnostic centers that require timely results to initiate targeted therapies.

While Next-Generation Sequencing (NGS) and PCR-based assays provide comprehensive genetic profiling, their complexity, higher costs, and infrastructural demands limit widespread adoption in certain healthcare settings, especially those with resource constraints. Digital PCR, although gaining traction for its sensitivity in detecting rare mutations, remains a niche application primarily due to its novelty and the need for specialized equipment. The ongoing advancements in IHC technology, such as automated staining platforms and improved antibody specificity, continue to reinforce its market dominance. Additionally, regulatory approvals and established reimbursement pathways for IHC tests further facilitate its adoption by healthcare providers globally. Consequently, the balance of precision and practicality inherent in IHC sustains its leading position in the PD-L1 and PIK3CA testing landscape.

By Application: Prevalence of Non-Small Cell Lung Cancer Amplifies Demand for PD-L1 and PIK3CA Testing

By Application, Non-Small Cell Lung Cancer (NSCLC) represents the largest segment in PD-L1 and PIK3CA testing, driven principally by the high incidence of NSCLC worldwide and the crucial role of molecular biomarkers in guiding personalized treatment regimens. PD-L1 expression is a key determinant for the use of immune checkpoint inhibitors, which have revolutionized NSCLC management by significantly improving patient outcomes. The necessity to accurately stratify patients who are likely to benefit from such immunotherapies fuels sustained demand for PD-L1 testing in this indication.

Similarly, PIK3CA mutations are increasingly recognized for their involvement in the oncogenic signaling pathways of various cancers, including subsets of NSCLC, making them targets for emerging PI3K inhibitors. The convergence of targeted therapies and immunotherapies in NSCLC underscores the importance of comprehensive molecular testing platforms. Aside from factors like rising tobacco consumption and environmental pollutants contributing to NSCLC prevalence, enhanced screening programs and greater clinician awareness about precision oncology intensify testing volume in this segment. Furthermore, evolving clinical guidelines now routinely recommend PD-L1 and PIK3CA testing as standard-of-care for NSCLC, solidifying its dominant position over other cancer applications such as breast, head and neck, and other solid tumors, which, while significant, have comparatively lower patient populations and therapeutic dependencies on these biomarkers.

By End User: Hospital Laboratories Lead Market Owing to Integration of Diagnostic and Clinical Services

By End User, hospital laboratories constitute the largest segment in the PD-L1 and PIK3CA testing domain, driven by their central role in integrating diagnostic services with therapeutic decision-making pathways within healthcare infrastructures. Hospitals typically handle a high volume of oncology patients requiring timely and precise biomarker testing to inform individualized treatment protocols. The in-house capacity of hospital labs to perform IHC and molecular assays reduces turnaround times, thereby accelerating patient management and improving clinical outcomes.

Moreover, the seamless coordination between oncology departments and hospital laboratories facilitates comprehensive patient profiling, ensuring that testing aligns closely with therapeutic advances and clinical trial opportunities. The consolidation of testing within hospitals also reflects the preference for maintaining regulatory compliance, quality control, and data confidentiality standards under one roof. Cancer research institutes and specialized diagnostic centers, while important contributors, often focus on targeted study populations or high-complexity assays, resulting in relatively limited throughput compared to hospital-based labs. The expanding prevalence of cancer, increased adoption of personalized medicine, and investments in hospital infrastructure collectively reinforce hospital laboratories' dominance as the key end-user segment for PD-L1 and PIK3CA testing.

Regional Insights:

Dominating Region: North America

In North America, the dominance in the PD-L1 and PIK3CA testing market is driven by a well-established healthcare infrastructure, advanced research ecosystems, and substantial investments in precision medicine. The region benefits from robust government support through agencies such as the National Institutes of Health (NIH) and favorable reimbursement policies that encourage adoption of molecular diagnostic technologies. A dense network of leading hospitals, academic research centers, and a strong presence of biopharmaceutical companies foster innovation and clinical adoption of these tests. Key industry players such as Roche Diagnostics, Thermo Fisher Scientific, and Abbott Laboratories have made significant contributions by developing high-sensitivity assays and expanding testing access. Moreover, collaborative efforts between pharmaceutical companies and diagnostic firms in North America fuel the integration of biomarker testing in treatment protocols, prominently in oncology.

Fastest-Growing Region: Asia Pacific

Meanwhile, the Asia Pacific exhibits the fastest growth in the PD-L1 and PIK3CA testing market, propelled by increasing awareness of precision oncology, growing cancer prevalence, and rising healthcare expenditures. Expanding healthcare infrastructure, rapid urbanization, and improving reimbursement frameworks in countries such as China, Japan, India, and South Korea create fertile ground for market expansion. Government initiatives to promote biotechnology innovation and public-private partnerships accelerate the availability and affordability of next-generation sequencing and immunohistochemistry-based diagnostics. The presence of global players like Illumina, Qiagen, and local companies such as BGI Genomics actively contributing to test development and localization of services also amplifies market growth. Additionally, increasing cross-border collaborations and regulatory convergence boost confidence among stakeholders, enabling faster product launches and wider clinical adoption.

PD-L1 and PIK3CA Testing Market Outlook for Key Countries

United States

The United States' market is the cornerstone of global development in PD-L1 and PIK3CA testing due to its cutting-edge research institutions and integrated healthcare providers. Diverse oncology clinical trials coupled with early adoption of companion diagnostics make it a hub for innovation. Major companies, including Foundation Medicine (a Roche company) and Guardant Health, lead in advancing liquid biopsy and tissue-based testing platforms, influencing global market trends. The presence of supportive regulatory mechanisms expedites the approval of novel assays, positioning the U.S. as a major influencer in clinical guidelines and adoption rates.

China

China's market has surged with growing government support for biotech innovation through programs like "Made in China 2025" and expansive healthcare reforms aiming to increase access to personalized medicine. Local incumbents such as Burning Rock Biotech and BGI Genomics drive innovation specifically tailored for local population genetics. Increase in cancer screening initiatives and investment in molecular diagnostics infrastructure bolsters testing adoption. Collaborations between multinational corporations and Chinese firms facilitate knowledge transfer and help navigate regulatory landscapes, spurring rapid market penetration.

Japan

Japan continues to lead in Asia with its advanced healthcare system and stringent regulatory framework that ensures high test accuracy and clinical relevance. Government subsidies and reimbursement policies favor incorporation of biomarker testing in oncology treatment regimens. Companies like Sysmex Corporation and SRL, Inc. are prominent in delivering high-quality diagnostics, supported by strong government-industry-academia collaborations. Japan's emphasis on precision medicine integration in cancer care makes it a critical market in the Asia-Pacific region.

Germany

Germany's market benefits from a strong diagnostics industry, notable for its high standards in clinical testing and supportive policy environment promoting innovation in molecular pathology. The German healthcare system facilitates efficient reimbursement mechanisms, fostering rapid adoption of PD-L1 and PIK3CA assays. Leading companies such as Qiagen and BioNTech have significant operations here, contributing to assay development and clinical validation. Industry partnerships with research institutions enhance translational research, keeping Germany at the forefront of personalized oncology diagnostics within Europe.

India

India's market is evolving rapidly due to growing cancer awareness, increasing healthcare investments, and expanding private healthcare infrastructure, especially in metropolitan areas. The government's push for affordable healthcare and diagnostic access has catalyzed growth in molecular testing services. Local companies like MedGenome and Strand Life Sciences are pivotal in providing cost-effective PD-L1 and PIK3CA testing solutions, tailored for local genetic diversity and healthcare needs. International collaborations and growing adoption of precision medicine are further accelerating market development.

Market Report Scope

Market Segmentation

Test Type Insights (Revenue, USD, 2020 - 2032)

• Immunohistochemistry (IHC)
• Next-Generation Sequencing (NGS)
• PCR-based Assays
• Digital PCR
• Others

Application Insights (Revenue, USD, 2020 - 2032)

• Non-Small Cell Lung Cancer
• Breast Cancer
• Head and Neck Cancer
• Other Solid Tumors
• Others

End User Insights (Revenue, USD, 2020 - 2032)

• Hospital Laboratories
• Diagnostic Centers
• Cancer Research Institutes
• Others

Regional Insights (Revenue, USD, 2020 - 2032)

• North America
• U.S.
• Canada
• Latin America
• Brazil
• Argentina
• Mexico
• Rest of Latin America
• Europe
• Germany
• U.K.
• Spain
• France
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East
• GCC Countries
• Israel
• Rest of Middle East
• Africa
• South Africa
• North Africa
• Central Africa

Key Players Insights

• Roche Diagnostics
• Thermo Fisher Scientific
• Qiagen
• Illumina Inc.
• Agilent Technologies
• bioMérieux
• Bio-Rad Laboratories
• Guardant Health
• Myriad Genetics
• Sysmex Corporation
• Hologic Inc.
• NeoGenomics Laboratories