Immuno Oncology Assays Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication (Colorectal Cancer, Lung Cancer, Melanoma Cancer, Bladder Cancer, Others), By Technology (Immunoassays, Polymerase chain reaction (PCR), Next-generation sequencing (NGS), Flow Cytometry), By Region and Competition, 2019-2029F

Market Overview

Global Immuno Oncology Assays Market was valued at USD 4.76 Billion in 2023 and is anticipated to project steady growth in the forecast period with a CAGR of 6.25% through 2029. The global immuno-oncology assays market is witnessing substantial growth, driven by advancements in cancer immunotherapy and an increased focus on personalized medicine. Immuno-oncology assays play a crucial role in the development, monitoring, and optimization of immunotherapies by assessing the immune system’s response to cancer.

The growing incidence of cancer globally is a significant driver of the immuno-oncology assays market. According to the World Health Organization (WHO), cancer is the second leading cause of death worldwide, with millions of new cases reported each year. This increase in cancer cases has accelerated the demand for innovative treatment options, including immunotherapy, which harnesses the body's immune system to target and destroy cancer cells. Immuno-oncology assays are essential in evaluating the efficacy of these therapies, leading to market growth.

Immunotherapy has emerged as a transformative approach in cancer treatment, with therapies such as checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines showing significant promise. These treatments require precise and detailed assessments to optimize their effectiveness and monitor patient responses. Immuno-oncology assays, which include biomarkers and functional assays, are critical in this process. They help identify suitable patients for specific therapies, predict treatment responses, and monitor disease progression, thereby driving demand for these assays.

Technological advancements are playing a pivotal role in the expansion of the immuno-oncology assays market. Innovations such as next-generation sequencing (NGS), high-throughput screening, and multiplex assays have enhanced the ability to analyze complex biological samples with high precision and efficiency. These technologies facilitate the identification of novel biomarkers and provide insights into the immune landscape of tumors, supporting the development of targeted and personalized immunotherapies.

The global immuno-oncology assays market is poised for substantial growth, driven by rising cancer incidence, advancements in immunotherapy, and technological innovations. While challenges such as high costs and regulatory hurdles exist, opportunities in emerging markets and ongoing research and development present a promising future for the sector. As the demand for personalized and effective cancer treatments continues to rise, immuno-oncology assays will play a critical role in advancing cancer care and improving patient outcomes.

Key Market Drivers

Rising Incidence of Cancer

The global immuno-oncology assays market is experiencing significant growth, largely driven by the escalating incidence of cancer worldwide. As cancer remains a leading cause of morbidity and mortality, there is an increasing demand for advanced diagnostic and therapeutic tools to manage and treat this complex disease. Immuno-oncology assays, which are critical in evaluating the immune response to cancer, play a pivotal role in the development and optimization of immunotherapies.

The rising prevalence of cancer is attributed to factors such as aging populations, lifestyle changes, environmental exposures, and improved diagnostic capabilities. This surge in cancer cases has intensified the need for effective diagnostic and treatment solutions, including immuno-oncology assays.

According to the World Health Organization (WHO) statistics from 2022, cancer remains a leading cause of death globally, accounting for nearly 10 million fatalities in 2020, or roughly one in six deaths. The most prevalent types of cancer include breast, lung, colorectal, and prostate cancers. Approximately one-third of cancer deaths are attributed to risk factors such as tobacco use, high body mass index, alcohol consumption, inadequate fruit and vegetable intake, and insufficient physical activity. Additionally, air pollution is a significant risk factor for lung cancer. Infections that cause cancer, such as human papillomavirus (HPV) and hepatitis, contribute to around 30% of cancer cases in low- and lower-middle-income countries. Many cancers can be effectively treated and potentially cured if detected early and managed properly.

The increasing burden of cancer is placing substantial pressure on healthcare systems around the world. Governments and healthcare providers are seeking innovative approaches to improve cancer management and patient outcomes. Immuno-oncology assays are essential in this regard, as they help in the identification of biomarkers, assessment of immune responses, and monitoring of treatment efficacy, thereby supporting more personalized and effective cancer care.

Immunotherapy has emerged as a groundbreaking approach in cancer treatment, harnessing the body's immune system to target and destroy cancer cells. This modality includes various therapies such as checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines. The effectiveness of these treatments relies heavily on accurate and comprehensive assessments provided by immuno-oncology assays. These assays help in identifying suitable candidates for specific therapies, predicting treatment responses, and monitoring disease progression, thus driving the demand for advanced assay technologies.

Immuno-oncology assays are crucial in the discovery and validation of biomarkers that are predictive of treatment responses or disease progression. For example, assays that measure the expression of PD-L1, a protein associated with immune checkpoint inhibition, are used to identify patients who are likely to benefit from checkpoint inhibitor therapies. The increasing focus on personalized medicine and targeted therapies is driving the demand for assays that can accurately identify relevant biomarkers and guide treatment decisions.

Advancements in technologies such as next-generation sequencing (NGS) are enhancing the capabilities of immuno-oncology assays. NGS allows for comprehensive genomic profiling of tumors, identifying genetic mutations and alterations that can influence cancer progression and treatment responses. This technology provides valuable insights for developing targeted immunotherapies and optimizing patient management strategies.

Multiplex assays and high-throughput screening technologies enable the simultaneous measurement of multiple biomarkers and immune responses. These innovations improve the efficiency and accuracy of assessments, supporting the development of more effective immunotherapies and driving market growth.

The rising incidence of cancer is a significant driver of the global immuno-oncology assays market. As cancer prevalence continues to increase, the demand for advanced diagnostic and therapeutic tools, including immuno-oncology assays, is growing. These assays play a critical role in advancing immunotherapy, identifying biomarkers, and optimizing cancer treatment. While challenges such as high costs and regulatory hurdles exist, opportunities in emerging markets and ongoing technological innovations offer a promising outlook for the market. As the global fight against cancer intensifies, immuno-oncology assays will remain at the forefront of efforts to improve patient outcomes and advance cancer care.

Advancements in Immunotherapy

The global immuno-oncology assays market is experiencing robust growth, significantly driven by advancements in immunotherapy. As the field of immunotherapy evolves, the demand for sophisticated assays that can effectively support and optimize these treatments has surged.

Immunotherapy has revolutionized cancer treatment by harnessing the body's immune system to target and destroy cancer cells. Innovations such as checkpoint inhibitors, CAR-T cell therapies, and cancer vaccines have demonstrated remarkable efficacy in treating various types of cancer. These advancements have not only expanded the scope of immunotherapy but also underscored the need for advanced diagnostic tools to ensure the optimal use of these therapies.

In March 2024, Researchers at the Wyss Institute at Harvard University and Harvard’s John A. Paulson School of Engineering and Applied Sciences (SEAS) have made significant strides in neutrophil therapies. While neutrophils have been employed for over 40 years to bolster the immune systems of cancer patients undergoing chemotherapy, utilizing neutrophils to directly target cancer cells represents a novel approach. The research team has innovatively attached disc-shaped micropatches to neutrophils, allowing these cells to sustain their anti-tumor (N1) state. This technique has demonstrated promising results in preclinical studies involving mice.

Checkpoint inhibitors, such as pembrolizumab (Keytruda) and nivolumab (Opdivo), work by blocking proteins that inhibit the immune system’s ability to attack cancer cells. These therapies have shown substantial promise in treating cancers like melanoma, lung cancer, and bladder cancer. The success of checkpoint inhibitors has driven the need for assays that can identify patients most likely to benefit from these treatments by assessing biomarker expression levels, such as PD-L1.

Chimeric Antigen Receptor T-cell (CAR-T) therapy involves modifying a patient’s T-cells to recognize and attack cancer cells. This personalized approach has been effective in treating hematologic malignancies. However, CAR-T therapies require rigorous monitoring to manage potential side effects and assess treatment efficacy, driving demand for specialized assays that can track CAR-T cell activity and monitor patient responses.

Therapeutic cancer vaccines aim to stimulate the immune system to target cancer cells specifically. These vaccines are designed to enhance the immune response against tumor-associated antigens. The development of cancer vaccines necessitates assays that can evaluate immune responses and predict patient outcomes, supporting the ongoing advancement of these therapies.

Oncolytic virus therapy uses genetically modified viruses to selectively infect and kill cancer cells while sparing normal cells. This novel approach requires advanced assays to assess viral activity, immune response, and the impact on tumor progression, highlighting the need for innovative diagnostic tools.

As immunotherapy continues to advance, there is an increasing need for precise diagnostic tools to identify suitable candidates and monitor treatment responses. Immuno-oncology assays are crucial for evaluating biomarkers, assessing immune responses, and guiding treatment decisions. The integration of these assays into clinical practice is essential for maximizing the benefits of immunotherapy.

The success of immunotherapies has led to the development of companion diagnostics that help determine patient eligibility for specific treatments. These companion assays are designed to identify biomarkers associated with therapeutic response, ensuring that patients receive the most appropriate and effective therapies.

Regulatory agencies are increasingly supporting the use of immuno-oncology assays as integral components of immunotherapy treatments. Approvals and guidelines for these assays facilitate their adoption in clinical settings, further driving market growth.

The continuous advancements in immunotherapy create opportunities for ongoing research and development in assay technologies. Innovations in assay platforms, such as high-throughput screening and next-generation sequencing, are expanding the capabilities of immuno-oncology assays and supporting the development of new therapeutic approaches.

Key Market Challenges

High Development and Validation Costs

The global immuno-oncology assays market is experiencing significant growth, driven by the increasing adoption of immunotherapy and the need for precise diagnostic tools. However, one of the most pressing challenges facing this market is the high development and validation costs associated with these assays. These costs impact not only the pace of innovation but also the accessibility and affordability of advanced diagnostic solutions.

The development of immuno-oncology assays involves a multi-faceted process that is both intricate and resource-intensive. Immuno-oncology assays are designed to measure and interpret immune responses and tumor characteristics, which requires a deep understanding of immunology and oncology. This complexity necessitates substantial investment in research and development (R&D) to create assays that are both accurate and reliable.

The development process typically includes several stagesinitial research, assay design, prototype testing, and optimization. Each stage requires specialized equipment, skilled personnel, and extensive experimentation. For instance, designing assays to detect specific biomarkers or immune cell types involves sophisticated technology and methods such as flow cytometry, ELISA (enzyme-linked immunosorbent assay), and multiplex assays. These technologies are costly to acquire and maintain, adding to the overall development expenses.

Once an assay is developed, it must undergo rigorous validation to ensure its accuracy, reliability, and clinical utility. Validation involves conducting extensive preclinical and clinical trials, which are both time-consuming and expensive. These trials are essential for demonstrating that the assay performs consistently and provides clinically relevant information.

Validation costs can be particularly high due to the need for large patient cohorts and the complexity of conducting studies that meet regulatory standards. For example, clinical trials must be designed to evaluate the assay’s performance in real-world settings, including its ability to predict treatment outcomes and guide clinical decisions. Ensuring that these trials meet regulatory requirements, such as those set by the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency), further adds to the costs.

The high development and validation costs of immuno-oncology assays pose significant financial challenges for companies operating in this market. Smaller companies and startups, in particular, may struggle to secure the necessary funding to bring their products to market. This financial barrier can limit innovation and slow the introduction of new and potentially groundbreaking assays.

Moreover, the high costs can affect the pricing and accessibility of assays once they are found at. Companies may need to set higher prices to recoup their R&D investments, which can limit the adoption of these assays in clinical practice. This can have broader implications for patient care, as cost constraints may restrict access to advanced diagnostic tools that are crucial for personalized cancer treatment.

Addressing the challenge of high development and validation costs requires a multi-pronged approach. Collaboration between industry stakeholders, including research institutions, healthcare providers, and funding agencies, can help share the financial burden and accelerate the development process. Public-private partnerships and grants can also provide essential funding and support for R&D efforts.

Additionally, leveraging technological advancements such as high-throughput screening and computational modeling can streamline the development process and reduce costs. Innovations in assay design and production techniques can further enhance efficiency and cost-effectiveness.

Key Market Trends

Growing Adoption of Liquid Biopsies

The global immuno-oncology assays market is witnessing transformative growth, driven by several emerging trends that are reshaping cancer diagnostics and treatment. Among these, the growing adoption of liquid biopsies stands out as a pivotal development. Liquid biopsies, which involve the analysis of circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and other biomarkers in blood samples, are revolutionizing the landscape of cancer diagnostics and monitoring.

Liquid biopsies offer a non-invasive alternative to traditional tissue biopsies, providing a more accessible and less traumatic method for cancer diagnosis and monitoring. By analyzing blood samples, these assays enable the detection of tumor-related biomarkers and genetic mutations associated with cancer. This approach enhances diagnostic precision, allowing for the early detection of tumors, monitoring of disease progression, and assessment of treatment efficacy. As a result, liquid biopsies are becoming an integral component of immuno-oncology assays, driving demand for advanced testing solutions that improve patient outcomes.

One of the significant advantages of liquid biopsies is their ability to provide real-time insights into tumor dynamics and treatment responses. Unlike traditional biopsies, which may require invasive procedures and are often limited to specific time points, liquid biopsies offer continuous monitoring of tumor-related changes through regular blood draws. This real-time assessment enables oncologists to track how tumors respond to immunotherapy treatments, make timely adjustments to treatment plans, and tailor therapies to individual patient needs. The ability to monitor disease evolution and treatment response in real-time enhances the overall effectiveness of immuno-oncology therapies.

The shift towards personalized medicine is a central trend in oncology, and liquid biopsies play a crucial role in this evolution. By analyzing ctDNA and CTCs, liquid biopsies provide valuable information about the genetic and molecular characteristics of tumors, enabling the identification of specific biomarkers that can guide personalized treatment strategies. This targeted approach ensures that patients receive therapies tailored to their unique cancer profiles, improving treatment efficacy and minimizing adverse effects. The integration of liquid biopsies into immuno-oncology assays supports the broader trend of precision medicine, driving market growth and innovation.

Traditional tissue biopsies, while valuable, have limitations such as invasiveness, risk of complications, and the need for repeated procedures. Liquid biopsies address these limitations by offering a less invasive alternative that can be performed more frequently. This advantage is particularly important for patients with difficult-to-access tumors or those requiring regular monitoring. As the adoption of liquid biopsies grows, it complements traditional biopsy methods and enhances the overall diagnostic and monitoring capabilities of immuno-oncology assays.

The increasing adoption of liquid biopsies is creating new market opportunities within the immuno-oncology assays sector. As the technology advances and becomes more widely found at, the demand for liquid biopsy tests is expected to rise. This growth presents opportunities for companies specializing in assay development, technology platforms, and related services. Investments in research and development, partnerships, and collaborations will drive innovation and expand the range of liquid biopsy applications, further fueling market growth.

Regulatory support and clinical advancements are also contributing to the growing adoption of liquid biopsies. Regulatory agencies are providing guidelines and frameworks for the approval and use of liquid biopsy assays, facilitating their integration into clinical practice. Clinical trials and studies are continuously validating the effectiveness and utility of liquid biopsies, reinforcing their role in cancer management. As regulatory and clinical landscapes evolve, the adoption of liquid biopsies is expected to gain momentum, enhancing the global immuno-oncology assays market.

Segmental Insights

Indication Insights

Based on Indication, Colorectal Cancer have emerged as the fastest growing segment in the Global Immuno Oncology Assays Market in 2023. Colorectal cancer (CRC) is a major contributor to the global cancer burden, and its rising incidence is significantly influencing the global immuno-oncology assays market. The increasing prevalence of colorectal cancer is driving demand for advanced diagnostic and therapeutic tools, including immuno-oncology assays, which are essential for the development and optimization of immunotherapies.

The incidence of colorectal cancer varies across regions, with higher rates observed in developed countries. In the United States and Europe, colorectal cancer is among the most prevalent cancers, largely due to lifestyle factors such as diet, sedentary behavior, and obesity. However, rising awareness and screening programs are also identifying more cases in regions with traditionally lower incidence rates, further contributing to the global burden.

The growing incidence of colorectal cancer is driving the demand for advanced diagnostic tools, including immuno-oncology assays. These assays are crucial for identifying specific biomarkers associated with colorectal cancer and assessing the immune system's response to treatment. Biomarkers such as microsatellite instability (MSI) and programmed cell death ligand-1 (PD-L1) expression are key indicators used to tailor immunotherapy treatments and monitor patient responses.

Immunotherapy has emerged as a promising treatment modality for colorectal cancer, particularly for patients with mismatch repair-deficient (dMMR) tumors or MSI-high (MSI-H) status. These tumors are more likely to respond to immune checkpoint inhibitors, such as PD-1/PD-L1 inhibitors. Immuno-oncology assays play a vital role in identifying patients who are likely to benefit from these therapies and in guiding treatment decisions. The increasing use of immunotherapies for colorectal cancer is driving demand for assays that can accurately assess biomarkers and predict treatment outcomes.

Technological advancements in immuno-oncology assays are enhancing the ability to analyze complex tumor and immune system interactions. Innovations such as next-generation sequencing (NGS), multiplex assays, and high-throughput screening are improving the accuracy and efficiency of colorectal cancer diagnostics. These technologies enable comprehensive genomic profiling and the simultaneous measurement of multiple biomarkers, supporting the development of more targeted and effective immunotherapies.

Technology Insights

Based on Technology, Polymerase chain reaction (PCR) have emerged as the dominating segment in the Global Immuno Oncology Assays Market during the forecast period. Polymerase Chain Reaction (PCR) technology has become a cornerstone in the global immuno-oncology assays market, playing a dominant role due to its versatility, precision, and critical applications in cancer diagnostics and treatment.

PCR is renowned for its high sensitivity and specificity in detecting specific genetic sequences. In immuno-oncology, this precision is crucial for identifying cancer-related biomarkers and mutations that are critical for diagnosis, prognosis, and treatment decisions. PCR assays can detect low-abundance biomarkers that other methods might miss, providing detailed insights into tumor genetics and patient responses to therapies.

PCR technology is highly versatile and can be adapted for various applications in immuno-oncology. It is used for detecting tumor mutations, identifying pathogen-associated sequences, and assessing gene expression profiles. This flexibility makes PCR an essential tool for a wide range of assays, including those for personalized cancer treatment, biomarker identification, and monitoring therapeutic responses.

PCR offers a rapid turnaround time compared to traditional methods. The process of amplifying DNA and obtaining results can be completed within hours, which is critical for timely decision-making in cancer treatment. Fast results enable clinicians to quickly assess patient conditions and adapt treatment plans accordingly, enhancing the overall efficiency of cancer care.

PCR technology is often used in conjunction with next-generation sequencing (NGS) to provide comprehensive genetic profiling of tumors. PCR can target specific regions of interest, which are then sequenced for detailed genetic analysis. This integration allows for high-throughput, detailed examination of cancer genomes, supporting advanced research and clinical applications.

PCR is cost-effective compared to some other advanced diagnostic techniques. Its established protocols and widespread availability of reagents and equipment make it a practical choice for many laboratories and clinical settings. The cost-effectiveness of PCR contributes to its widespread adoption and use in routine cancer diagnostics and research.

The PCR technique has been extensively validated and standardized, ensuring reproducibility of results across different laboratories. This consistency is essential for reliable diagnostics and therapeutic monitoring, and it enhances the credibility of PCR-based assays in clinical practice.

PCR plays a crucial role in developing companion diagnostics that are used alongside targeted therapies. By identifying specific genetic mutations or biomarkers, PCR-based assays help determine patient eligibility for targeted treatments, ensuring that patients receive the most effective therapies based on their genetic profiles.

Continuous advancements in PCR technology, such as real-time PCR (qPCR) and digital PCR (dPCR), have further enhanced its capabilities. These innovations provide even greater sensitivity, quantification, and precision, making PCR an increasingly powerful tool in the evolving landscape of immuno-oncology.

Regional Insights

Based on Region, North America have emerged as the dominating region in the Global Immuno Oncology Assays Market in 2023. One of the primary reasons for North America's dominance in the immuno-oncology assays market is its highly developed healthcare infrastructure. The region boasts some of the world's most advanced medical facilities, research centers, and universities, which are integral to the development and application of cutting-edge immuno-oncology assays. Institutions such as the National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center, and MD Anderson Cancer Center are at the forefront of cancer research and play a crucial role in advancing diagnostic and therapeutic technologies.

This infrastructure supports the integration of innovative assays into clinical practice, facilitating early diagnosis and personalized treatment approaches. The availability of state-of-the-art laboratories and skilled professionals ensures that North American facilities are well-equipped to conduct the complex testing and validation required for immuno-oncology assays.

North America leads in investment in research and development (R&D) for immuno-oncology assays. Both public and private sectors are heavily invested in advancing cancer research and developing new diagnostic tools. Government funding, such as grants from the National Institutes of Health (NIH) and the Cancer Research UK, as well as substantial investments from pharmaceutical and biotechnology companies, contribute to this robust R&D environment.

This financial support enables the development of innovative assays and technologies that drive market growth. Additionally, the presence of numerous biotechnology firms and startups in North America accelerates the pace of innovation and commercialization, further solidifying the region’s market leadership.

The regulatory environment in North America, particularly in the United States, is a significant factor in the region's dominance. The FDA (U.S. Food and Drug Administration) provides a clear and structured pathway for the approval of new assays, which, while stringent, offers a well-defined process for market entry. This regulatory clarity fosters confidence among developers and investors, encouraging the development and adoption of new immuno-oncology assays.

Additionally, the FDA’s efforts to expedite the approval of breakthrough technologies and its initiatives to support personalized medicine play a critical role in facilitating market growth. The regulatory framework in Canada also supports the development and approval of advanced diagnostics, contributing to the overall market strength in North America.

North America faces a high prevalence of cancer, which drives the demand for advanced diagnostic tools and therapies. The region’s large patient population and increasing cancer incidence rates create a significant market for immuno-oncology assays. This demand drives investment in developing new assays and integrating them into clinical practice to improve patient outcomes.

Moreover, the region’s focus on personalized medicine and precision oncology aligns with the capabilities of immuno-oncology assays, which are designed to tailor treatments based on individual immune responses and tumor profiles.

North America’s dominance is also attributable to its role as a leader in market innovation. The region hosts many of the world’s leading biotechnology and pharmaceutical companies, which are at the forefront of developing and commercializing new immuno-oncology assays. This leadership not only drives technological advancements but also influences global market trends and standards.

Recent Development

• In July 2024, Tempus AI, Inc., a leader inartificial intelligence and precision medicine, announced the availability ofits multimodal immune profile score (IPS) algorithmic test for research useonly (RUO). The IPS is the inaugural product in Tempus's expandingimmunotherapy-based portfolio, which aims to introduce next-generationalgorithmic diagnostics to the immuno-oncology field. Additionally, Tempus iscollaborating with partners such as Cleveland Clinic to enhance this portfoliowith more immunotherapy-focused algorithmic tests. These efforts leverageclinical, laboratory, genomic, and transcriptomic data to identify patients whomay benefit from immunotherapy.
• In February 2024, researchers at UF Health CancerCenter introduced a groundbreaking compound that may pave the way for newimmunotherapy treatments for various cancers. Laboratory and mouse studiesusing skin and colorectal cancer models demonstrated that this compoundsignificantly slowed the growth of established tumors by harnessing the body'simmune system to target and destroy cancer cells. In some cases, the compoundeven led to the complete eradication of the tumors.
• In February 2023, Agilent Technologies announcedthe integration of its xCelligence RTCA HT (real-time cell analysishigh-throughput) platform with the BioTek BioSpa 8 Automated Incubator. Thisintegration enhances workflow automation by combining these technologies.According to Agilent, this development responds to market demands by offeringnew capabilities for creating label-free high-throughput potency assays in theimmuno-oncology field and high-throughput viral cytopathic effects (CPE) assaysfor the vaccine market.

Key Market Players

• Agilent Technologies, Inc.
• BIO-RADLABORATORIES, INC.
• CharlesRiver Laboratories, Inc.
• F.Hoffmann-La Roche