Immuno Oncology Assay Market

Based on product, the global Immuno-oncology Assay market is segmented into reagents & kits, and instruments. The reagents & kits segment dominated the market in 2024, while the instruments segment is projected to be the fastest-growing segment during the forecast period, 2025–2035.

In order to precisely measure immune responses, find biomarkers, and gauge the effectiveness of therapeutic interventions, immuno-oncology tests depend on a wide variety of specialized reagents and kits. These tools include ELISA and multiplex platforms for cytokine measurement, gene expression assays for examining immune-related pathways, and flow cytometry antibodies and staining kits for immune cell profiling.

On the basis of assay type, the Global Immuno-oncology Assay market is segmented into Immune Cell Profiling Assays, Cytokine Release Assays, Tumor Mutation Burden Assays, Co-Culture Assays, Cytotoxicity Assays and Others. The immune cell profiling assays segment dominated the market in 2024, while the tumor mutation burden assays segment is projected to be the fastest-growing segment during the forecast period, 2025–2035.

Assays for immune cell profiling provide information on the composition, phenotype, and functional state of immune cells within the tumor microenvironment and peripheral circulation. By identifying important immune cell subsets and their activation state, these tests provide useful information to aid in the development of therapeutics, the search for biomarkers, and identification of patients approaches. A thorough understanding of the immunological responses to immunotherapies, including checkpoint inhibitors and cell-based therapies, is made possible by methods like flow cytometry, mass cytometry (CyTOF), immunohistochemistry, and single-cell RNA sequencing. By guiding treatment response evaluations, tracking immunological dynamics, and discovering resistance mechanisms, the integration of these tests into clinical and translational research pipelines improves decision-making. Immunocell profiling is therefore essential to the development of precision medicine techniques in oncology.

On the basis of technology, the global immuno-oncology assay market is segmented Enzyme-Linked Immunosorbent Assay, Flow Cytometry, PCR-based Techniques, Next-Generation Sequencing (NGS), Mass Cytometry, Others. The PCR-based techniques segment dominated the market in 2024, while the next-generation sequencing (NGS) segment is projected to be the fastest-growing segment during the forecast period, 2025–2035

The Enzyme-Linked Immunosorbent Assay (ELISA) is a prominent analytical approach in immuno-oncology for quantitative detection of cytokines, chemokines, growth factors, and other immune-related proteins in a variety of biological materials. It is critical for evaluating immune activation, monitoring tumor microenvironment alterations, and determining pharmacodynamic responses to immunotherapy. From a development and regulatory perspective, ELISA is a cost-effective, scalable, and reproducible assay that supports both early discovery and clinical biomarker programs. It is often used in conjunction with other immunoassays and cellular assays to build a comprehensive immune response profile. As immuno-oncology continues to advance, ELISA remains a core platform for biomarker validation and therapeutic monitoring, supporting data-driven decisions in both preclinical and clinical stages.

Based on Application, the Global immuno-oncology assay market has been segmented into Cancer Diagnosis, Therapeutic Monitoring, Patient Stratification, and Clinical Trials. The cancer diagnosis segment held the largest market share in 2024, and the clinical trials segment is the fastest-growing segment during the forecast period (2025 -2035).

Cancer diagnosis is a multifaceted process aimed at detecting and understanding the nature of cancer in a patient. It typically involves a combination of screening methods, imaging techniques (like CT scans or MRIs), tissue biopsies, and molecular testing to identify the type, stage, and genetic makeup of the tumor.

Based on Indication, the global immuno-oncology assay market has been segmented into Lung Cancer, Colorectal Cancer, Melanoma, Ovarian Cancer, Breast Cancer, and Others. The lung cancer segment held the largest market share in 2024, and the melanoma segment is the fastest-growing segment during the forecast period (2025 -2035).

As the most prevalent cancer worldwide, lung cancer affects approximately 2.1 billion individuals annually and is responsible for an estimated 1.7 billion deaths each year. It remains the leading cause of cancer-related mortality for both men and women globally. In the United States alone, 2023 saw an estimated 240,000 new cases of lung cancer and around 130,000 associated deaths, underscoring its substantial health burden. Lung cancer's lethality surpasses that of breast, prostate, and colon cancers combined. The disease is broadly classified into two main types: small cell lung cancer (SCLC), which accounts for approximately 10-15% of all lung cancer cases, and non-small cell lung cancer (NSCLC), representing about 85-90% of cases. Immuno-oncology assays play a crucial role in understanding and targeting these mechanisms by analyzing key immune biomarkers and cellular interactions within the tumor microenvironment. These assays evaluate factors such as PD-L1 expression levels, tumor mutational burden (TMB), microsatellite instability (MSI), and the presence of tumor-infiltrating lymphocytes (TILs). For Instance, in October 2024, China’s National Medical Products Administration (NMPA) has granted marketing approval for LungCure CDx, a next-generation sequencing (NGS)–based companion diagnostic designed to guide the use of sunvozertinib (DZD9008) in patients with EGFR exon 20 insertion mutation–positive non–small cell lung cancer (NSCLC). This approval is a significant milestone in the field of immuno-oncology and precision medicine, as it marks the first NGS-based companion diagnostic co-developed and approved under China’s updated companion diagnostic guidelines.

Based on End User, the Global immuno-oncology assay market has been segmented into Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), and Others. The hospitals & clinics segment held the largest market share in 2024, and the contract research organizations (CROs) segment is the fastest-growing segment during the forecast period (2025 -2035).

Hospitals and clinics represent important end-user sectors in the Immuno-oncology Assay Market, with each playing a crucial role in its continued expansion. Hospitals and clinics represent critical end-user sectors in the immuno-oncology assay market due to their central role in cancer diagnosis, treatment planning, and patient management. As the demand for precision oncology continues to grow, hospitals and clinics are increasingly investing in advanced diagnostic platforms, making them key drivers of market expansion.

On the basis of technology, the global immuno-oncology assay market is segmented Enzyme-Linked Immunosorbent Assay, Flow Cytometry, PCR-based Techniques, Next-Generation Sequencing (NGS), Mass Cytometry, Others. The PCR-based techniques segment dominated the market in 2024, while the next-generation sequencing (NGS) segment is projected to be the fastest-growing segment during the forecast period, 2025–2035

The Enzyme-Linked Immunosorbent Assay (ELISA) is a prominent analytical approach in immuno-oncology for quantitative detection of cytokines, chemokines, growth factors, and other immune-related proteins in a variety of biological materials. It is critical for evaluating immune activation, monitoring tumor microenvironment alterations, and determining pharmacodynamic responses to immunotherapy. From a development and regulatory perspective, ELISA is a cost-effective, scalable, and reproducible assay that supports both early discovery and clinical biomarker programs. It is often used in conjunction with other immunoassays and cellular assays to build a comprehensive immune response profile. As immuno-oncology continues to advance, ELISA remains a core platform for biomarker validation and therapeutic monitoring, supporting data-driven decisions in both preclinical and clinical stages.

Based on Application, the Global immuno-oncology assay market has been segmented into Cancer Diagnosis, Therapeutic Monitoring, Patient Stratification, and Clinical Trials. The cancer diagnosis segment held the largest market share in 2024, and the clinical trials segment is the fastest-growing segment during the forecast period (2025 -2035).

Cancer diagnosis is a multifaceted process aimed at detecting and understanding the nature of cancer in a patient. It typically involves a combination of screening methods, imaging techniques (like CT scans or MRIs), tissue biopsies, and molecular testing to identify the type, stage, and genetic makeup of the tumor.

Based on Indication, the global immuno-oncology assay market has been segmented into Lung Cancer, Colorectal Cancer, Melanoma, Ovarian Cancer, Breast Cancer, and Others. The lung cancer segment held the largest market share in 2024, and the melanoma segment is the fastest-growing segment during the forecast period (2025 -2035).

As the most prevalent cancer worldwide, lung cancer affects approximately 2.1 billion individuals annually and is responsible for an estimated 1.7 billion deaths each year. It remains the leading cause of cancer-related mortality for both men and women globally. In the United States alone, 2023 saw an estimated 240,000 new cases of lung cancer and around 130,000 associated deaths, underscoring its substantial health burden. Lung cancer's lethality surpasses that of breast, prostate, and colon cancers combined. The disease is broadly classified into two main types: small cell lung cancer (SCLC), which accounts for approximately 10-15% of all lung cancer cases, and non-small cell lung cancer (NSCLC), representing about 85-90% of cases. Immuno-oncology assays play a crucial role in understanding and targeting these mechanisms by analyzing key immune biomarkers and cellular interactions within the tumor microenvironment. These assays evaluate factors such as PD-L1 expression levels, tumor mutational burden (TMB), microsatellite instability (MSI), and the presence of tumor-infiltrating lymphocytes (TILs). For Instance, in October 2024, China’s National Medical Products Administration (NMPA) has granted marketing approval for LungCure CDx, a next-generation sequencing (NGS)–based companion diagnostic designed to guide the use of sunvozertinib (DZD9008) in patients with EGFR exon 20 insertion mutation–positive non–small cell lung cancer (NSCLC). This approval is a significant milestone in the field of immuno-oncology and precision medicine, as it marks the first NGS-based companion diagnostic co-developed and approved under China’s updated companion diagnostic guidelines.

Based on End User, the Global immuno-oncology assay market has been segmented into Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), and Others. The hospitals & clinics segment held the largest market share in 2024, and the contract research organizations (CROs) segment is the fastest-growing segment during the forecast period (2025 -2035).

Hospitals and clinics represent important end-user sectors in the Immuno-oncology Assay Market, with each playing a crucial role in its continued expansion. Hospitals and clinics represent critical end-user sectors in the immuno-oncology assay market due to their central role in cancer diagnosis, treatment planning, and patient management. As the demand for precision oncology continues to grow, hospitals and clinics are increasingly investing in advanced diagnostic platforms, making them key drivers of market expansion.