PD-L1 and PIK3CA Testing Market Report 2025

The PD-L1 and PIK3CA testing market size has grown rapidly in recent years. It will grow from $1.45 billion in 2024 to $1.67 billion in 2025 at a compound annual growth rate (CAGR) of 15.6%. The growth during the historic period can be linked to the rise in clinical trials for regenerative medicine, increasing emphasis on personalized medicine, expansion of collaborations between academia and industry, greater awareness of the efficacy and safety of cell therapies, and rapid growth with the first approvals of CAR T and other autologous cell therapies.

The PD-L1 and PIK3CA testing market size is expected to see rapid growth in the next few years. It will grow to $2.96 billion in 2029 at a compound annual growth rate (CAGR) of 15.3%. The growth during the forecast period can be attributed to the wider adoption of personalized and precision medicine, expansion of the pipeline for cell and gene therapies, increase in clinical trials and commercial approvals, rising investment in regenerative medicine, and higher incidence of chronic and rare diseases. Key trends in the forecast period include the development of bioinformatics in cellular research, integration of cell therapy tracking with digital health platforms, advancement of artificial intelligence and machine learning applications, innovation in cloud based data management systems, and adoption of wearable biosensors.

The growing prevalence of cancer is expected to drive the expansion of the PD-L1 and PIK3CA testing market. Cancer, which is characterized by the uncontrolled growth and spread of abnormal cells, has become more common due to factors such as lifestyle-related risks and an aging population. These factors contribute to higher diagnosis rates and an increased demand for early detection and effective treatment solutions. PD-L1 and PIK3CA testing help manage cancer by providing accurate diagnoses and guiding targeted therapies, which allow treatments to be personalized to individual patients and improve clinical outcomes. For example, in September 2024, the American Cancer Society projected a significant increase in global cancer cases among men, estimating an 84% rise by 2029, from 10.3 million in 2022 to 19 million. This surge in cancer cases is driving the growth of the PD-L1 and PIK3CA testing market.

Key players in the PD-L1 and PIK3CA testing market are focusing on technological advancements, particularly the integration of companion diagnostics, to improve therapeutic targeting and enhance treatment efficacy in oncology. Companion diagnostic integration involves advanced testing systems designed alongside targeted medicines to identify patient groups most likely to benefit from specific treatments based on biomarker profiles. For instance, in October 2024, F. Hoffmann-La Roche AG, a Switzerland-based biotechnology and pharmaceutical company, introduced Itovebi (inavolisib) in combination with palbociclib and fulvestrant for patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced or metastatic breast cancer. The FDA approved this regimen based on the Phase III INAVO120 study, which showed more than double the progression-free survival compared to palbociclib and fulvestrant alone. This marks Roche’s first targeted therapy for HR-positive disease and incorporates a companion diagnostic to identify eligible patients, representing a major step forward in precision medicine for a patient population with limited treatment options.

In December 2022, Prenetics Global Limited, a Hong Kong-based health technology company, acquired ACT Genomics Co. Ltd. for an undisclosed amount. With this acquisition, Prenetics aims to strengthen its position in the precision oncology market by incorporating ACT Genomics’ advanced capabilities in next-generation sequencing (NGS), bioinformatics, and comprehensive genomic profiling. ACT Genomics, based in Taiwan, is a molecular diagnostics company that provides PD-L1 and PIK3CA biomarker testing to guide cancer treatment.

Major players in the PD-L1 and PIK3CA testing market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Laboratory Corporation of America Holdings (Labcorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Sonic Healthcare Limited, Illumina Inc., Bio-Rad Laboratories Inc., QIAGEN N.V., Myriad Genetics Inc., NeoGenomics Laboratories Inc., BGI Genomics Co. Ltd., Guardant Health Inc., Caris Life Sciences, Foundation Medicine Inc., Amoy Diagnostics Co. Ltd., ACCB Biotech Private Limited, EntroGen Inc.

North America was the largest region in the PD-L1 and PIK3CA testing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in PD-L1 and PIK3CA testing report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the PD-L1 and PIK3CA testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

PD-L1 and PIK3CA testing are molecular diagnostic methods used to identify specific biomarkers that support targeted cancer treatment decisions. PD-L1 testing measures the expression of the programmed death ligand 1 protein on tumor cells to evaluate the likelihood of response to immunotherapies. PIK3CA testing identifies mutations in the phosphatidylinositol 4,5 bisphosphate 3 kinase catalytic subunit alpha gene, which helps determine eligibility for therapies directed at the PI3K pathway.

The primary test types of PD-L1 and PIK3CA testing include immunohistochemistry, next generation sequencing, polymerase chain reaction, and others. Immunohistochemistry is a laboratory method that applies antibodies to detect specific proteins in tissue samples, making it possible to visualize their location and concentration under a microscope. The sample types used are tissue samples and liquid biopsy samples. The distribution channels include direct sales, distributors and resellers, and online sales platforms. The applications involve cancer diagnosis, drug development, research, and other uses, and they serve multiple end users such as hospitals and clinics, laboratories, and pharmaceutical companies.

The PD-L1 and PIK3CA testing market research report is one of a series of new reports that provides PD-L1 and PIK3CA testing market statistics, including the PD-L1 and PIK3CA testing industry global market size, regional shares, competitors with the PD-L1 and PIK3CA testing market share, detailed PD-L1 and PIK3CA testing market segments, market trends, and opportunities, and any further data you may need to thrive in the PD-L1 and PIK3CA testing industry. This PD-L1 and PIK3CA testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The PD-L1 and PIK3CA testing market includes revenues earned by entities through the biomarker testing, molecular diagnostics, genetic mutation detection, generation sequencing services, companion diagnostic testing, pathology interpretation, and clinical trial testing support. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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