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Add to CartImmuno Oncology Assays Market
By Product and Service;
Consumables, Instruments and Software & ServicesBy Technology;
PCR, Immunoassay, NGS, ISH and Flow CytometryBy Indication;
Lung Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Melanoma and OthersBy Application;
Research Applications and Clinical DiagnosticsBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa and Latin America - Report Timeline (2021 - 2031)Immuno Oncology Assays Market Overview
Immuno Oncology Assays Market (USD Million)
In the year 2024,Immuno Oncology Assays Market was valued at USD 5,860.31 million. The size of this market is expected to increase to USD 11,132.55 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 9.6%.
Immuno Oncology Assays Market
*Market size in USD million
CAGR 9.6 %
| Study Period | 2025 - 2031 |
|---|---|
| Base Year | 2024 |
| CAGR (%) | 9.6 % |
| Market Size (2024) | USD 5,860.31 Million |
| Market Size (2031) | USD 11,132.55 Million |
| Market Concentration | Medium |
| Report Pages | 387 |
Major Players
- Merck & Co., Inc.
- Thermo Fisher Scientific Inc.
- F. Hoffmann-La Roche Ltd.
- Agilent Technologies, Inc.
- Abbott Laboratories
- Illumina, Inc.
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Immuno Oncology Assays Market
Fragmented - Highly competitive market without dominant players
Increasing Preference for Personalized Cancer Treatments immuno oncology assays is accelerating as personalized cancer therapies gain traction in modern oncology. These assays enable tailored treatment strategies by identifying patient-specific biomarkers, which guide immunotherapy decisions. With more than 40% of oncologists now integrating biomarker testing into clinical workflows, the market is witnessing significant momentum.
Innovation in Assay Technologies Enhancing Market Appeal
Advancements in assay technology—such as next-generation sequencing and multiplex platforms—have greatly enhanced the precision and efficiency of immuno oncology diagnostics. About 35% of new assays now feature AI-powered analytics, offering faster and more reliable insights into immune responses. These technological strides are pushing the boundaries of both clinical practice and research.
Broader Utilization in Clinical and Drug Development Environments
Usage of immuno oncology assays is expanding across clinical settings and pharmaceutical R&D. These assays are essential for evaluating treatment efficacy and accelerating drug development timelines. Currently, around 50% of active immunotherapy trials rely on these tools for biomarker validation, demonstrating their integral role in advancing therapeutic pipelines.
Supportive Regulations and Coverage Fueling Growth
The market is further supported by streamlined regulatory approvals and improving reimbursement landscapes. Regulatory authorities are prioritizing the approval of companion diagnostics, while roughly 30% of insurance providers now offer coverage for biomarker-based immunotherapy tests. These developments are reducing barriers to adoption and fostering market confidence.
Wider Application Across Multiple Cancer Types
Immuno oncology assays, once limited in use, are now being applied to a broad spectrum of cancers—including lung, gastrointestinal, and melanoma. Today, over 45% of cancer patients undergoing immunotherapy receive biomarker testing, underscoring the growing importance of these assays in treatment planning and outcome optimization.
Immuno Oncology Assays Market Key Takeaways
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The market is growing rapidly due to increasing focus on cancer immunotherapy research and advancements in biomarker-based diagnostic technologies.
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Rising prevalence of various cancer types and growing demand for personalized and precision medicine are key market drivers.
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Immuno-oncology assays play a crucial role in identifying immune response biomarkers, tumor microenvironment characteristics, and patient-specific treatment efficacy.
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Growing adoption of multiplex immunoassays, flow cytometry, and ELISA techniques is enhancing assay accuracy and clinical utility.
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Pharmaceutical and biotechnology companies are the primary end users, investing heavily in drug discovery and immunotherapy trials.
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The North American region leads the market due to strong research infrastructure, funding support, and presence of major biotechnology firms.
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The Asia Pacific region is expected to exhibit significant growth owing to increasing oncology research initiatives and expanding clinical trial networks.
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Challenges include high assay costs, regulatory complexities, and lack of standardization in immuno-oncology assay validation procedures.
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Leading market players are focusing on AI-integrated diagnostic platforms, collaborative research partnerships, and automation of assay workflows to enhance precision and scalability.
Immuno Oncology Assays Market Recent Developments
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In January 2025, Agilent Technologies Inc. expanded its collaboration with Incyte to advance the development and commercialization of Incyte’s hematology and oncology portfolio. The partnership emphasizes integrating advanced assay technologies to support precision diagnostics and targeted therapies.
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In May 2025, The Institute of Cancer Research, London, and NeoPhore reported early positive results from their ongoing preclinical collaboration. Their research showed promising tumor response using mismatch repair-targeting inhibitors, with translational studies planned for later in the year.
Immuno Oncology Assays Market Segment Analysis
In this report, Immuno Oncology Assays Market has been segmented by Product and Service, Technology, Indication, Application, and Geography.
Immuno Oncology Assays Market, Segmentation by Product and Service
The Product and Service segmentation includes the key components that make up immuno-oncology assays. These include Consumables, Instruments, and Software & Services. Each of these products plays an essential role in the successful deployment of immuno-oncology assays, which are used to identify and monitor immune responses in cancer patients.
Consumables
Consumables refer to the reagents, antibodies, and other materials used in the testing process. These products are essential for performing immuno-oncology assays, as they are involved in every stage of the analysis, from sample collection to result interpretation. The growing demand for precision medicine drives the consumption of these products in oncology testing.
Instruments
Instruments in immuno-oncology assays include diagnostic equipment and lab systems used to process and analyze patient samples. These devices, such as PCR machines and flow cytometers, enable the detection of immune markers that indicate cancer progression or response to treatment. Technological advancements in instruments are key drivers of market growth.
Software & Services
Software & Services play a critical role in the data analysis, interpretation, and management of immuno-oncology assay results. Specialized software helps healthcare professionals analyze complex data sets, making it easier to detect patterns, track patient progress, and make informed treatment decisions. This segment is seeing significant growth as assays become more data-intensive and personalized treatment protocols evolve.
Immuno Oncology Assays Market, Segmentation by Technology
The Technology segmentation identifies the technologies used to conduct immuno-oncology assays. These include PCR, Immunoassay, NGS, ISH, and Flow Cytometry. Each of these technologies is used to detect specific immune responses or molecular markers that are critical in understanding cancer biology and treatment efficacy.
PCR
Polymerase Chain Reaction (PCR) is widely used in immuno-oncology assays for amplifying DNA sequences to detect genetic mutations associated with cancer. PCR is a powerful tool for identifying specific biomarkers that help in diagnosing cancer and assessing its prognosis.
Immunoassay
Immunoassays are techniques that use antibodies to detect and quantify cancer-related molecules, such as tumor antigens or immune checkpoint proteins. These assays are crucial in assessing immune responses to cancer therapies and are routinely used in both research and clinical diagnostics.
NGS
Next-Generation Sequencing (NGS) is a high-throughput technology used to sequence entire genomes or exomes, enabling the identification of genetic mutations and alterations in cancer cells. NGS plays an important role in precision medicine by providing detailed insights into the genetic makeup of cancer, aiding in the development of targeted therapies.
ISH
In Situ Hybridization (ISH) is used to detect specific nucleic acid sequences within tissue samples, allowing for the localization of gene expression and chromosomal abnormalities. ISH is particularly useful in analyzing cancer-related mutations and understanding their role in cancer progression.
Flow Cytometry
Flow Cytometry is a technique that uses lasers to measure the physical and chemical characteristics of cells. In immuno-oncology, it is used to evaluate immune cell populations, such as T-cells and B-cells, and assess their role in the immune response to cancer. This technology is widely used in clinical and research settings for its ability to analyze complex cell populations quickly.
Immuno Oncology Assays Market, Segmentation by Indication
The Indication segmentation identifies the cancer types for which immuno-oncology assays are used to monitor immune responses. These include Lung Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Melanoma, and Others. Each cancer type has distinct immunological features that influence the choice of assay technology and treatment approach.
Lung Cancer
Lung Cancer is one of the most common cancers worldwide. Immuno-oncology assays help monitor immune checkpoints, such as PD-L1 expression, to assess patient eligibility for immunotherapy treatments. These assays are crucial for identifying the best treatment options and monitoring the patient’s response to therapy.
Breast Cancer
Breast Cancer is another major indication for immuno-oncology assays. These assays are used to evaluate tumor microenvironments and assess the effectiveness of targeted therapies, particularly immune checkpoint inhibitors. Breast cancer research continues to explore how immune responses can be harnessed to improve treatment outcomes.
Colorectal Cancer
Colorectal Cancer is commonly tested using immuno-oncology assays to evaluate microsatellite instability and immune cell infiltration. These assays help in determining the most effective treatment strategies, including the use of immune checkpoint inhibitors, which have shown efficacy in specific patient populations.
Bladder Cancer
Bladder Cancer is another indication where immuno-oncology assays play a key role in identifying potential candidates for immunotherapy. These assays focus on immune checkpoints and genetic mutations to guide therapeutic decision-making, as bladder cancer treatment increasingly incorporates immune-modulating therapies.
Melanoma
Melanoma is one of the most immunologically responsive cancers, and immuno-oncology assays are used to evaluate biomarkers such as BRAF mutations and PD-L1 expression. These assays are critical for monitoring the effectiveness of immunotherapies in melanoma patients and guiding treatment adjustments.
Others
This category includes various other cancers such as prostate, ovarian, and pancreatic cancer, for which immuno-oncology assays are used to assess immune system responses. The broad applicability of these assays across different cancer types continues to drive their adoption in both clinical and research settings.
Immuno Oncology Assays Market, Segmentation by Application
The Application segmentation identifies the two primary areas where immuno-oncology assays are utilized: Research Applications and Clinical Diagnostics. Both areas drive the demand for advanced assay technologies to understand cancer biology, evaluate treatment efficacy, and improve patient outcomes.
Research Applications
Research Applications involve the use of immuno-oncology assays in studying cancer mechanisms, developing new therapies, and testing experimental drugs. These assays help researchers understand immune responses, tumor progression, and the effectiveness of new treatments, playing a vital role in advancing oncology research.Clinical Diagnostics
Clinical Diagnostics is the application of immuno-oncology assays in routine clinical practice to guide treatment decisions, monitor disease progression, and assess the effectiveness of ongoing therapies. These assays are essential for personalizing treatment plans for cancer patients and improving clinical outcomes.
Immuno Oncology Assays Market, Segmentation by Geography
The Geography segmentation divides the market into regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region exhibits distinct healthcare dynamics, technological adoption, and market needs, with varying levels of demand for immuno-oncology assays.
Regions and Countries Analyzed in this Report
North America
North America dominates the Immuno Oncology Assays market due to a well-established healthcare system, high cancer incidence, and advanced research infrastructure. The growing use of precision medicine and immunotherapy drives demand for immuno-oncology assays in both clinical and research settings.
Europe
Europe continues to hold a strong market position, driven by its advanced healthcare systems, growing research activities, and rising adoption of immuno-oncology therapies. European countries such as Germany, the UK, and France are expected to witness continued growth in immuno-oncology assay usage.
Asia Pacific
Asia Pacific is experiencing rapid growth in the immuno-oncology assays market due to increasing healthcare investments, rising cancer rates, and improving access to advanced diagnostic tools. Key markets like China, Japan, and India are expected to be major contributors to market expansion in the region.
Middle East & Africa
The Middle East & Africa region is gradually increasing its demand for immuno-oncology assays, driven by healthcare investments, expanding research infrastructure, and a rising focus on oncology diagnostics. Though the market is still emerging, it is expected to grow as access to advanced technologies improves.
Latin America
Latin America shows steady growth in immuno-oncology assay adoption, particularly in countries like Brazil and Mexico, where healthcare infrastructure is improving. Increased focus on cancer diagnosis and treatment is driving the market, and future growth is anticipated as more assays become available in the region.
Immuno Oncology Assays Market Forces
This report provides an in depth analysis of various factors that impact the dynamics of Immuno Oncology Assays Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces Drivers, Restraints, and Opportunities affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
| Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
|---|---|---|---|---|---|
| Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
| Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
| Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers
- Rising demand for autoimmune disease treatments
- Increasing adoption in therapeutic apheresis procedures
- Technological advances in column efficiency
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Growing prevalence of chronic inflammatory disorders - The rising incidence of chronic inflammatory disorders is emerging as a major catalyst for the growth of the immuno oncology assays market. Prolonged inflammation is now widely recognized for its role in cancer development, as it can disrupt normal immune function and create an environment that fosters tumor formation. This persistent inflammatory state often leads to genetic mutations, immune suppression, and abnormal tissue repair, all of which contribute to cancer progression. Importantly, such conditions result in the increased expression of immune-related biomarkers, which are essential for identifying early oncogenic changes.
As the prevalence of these inflammatory conditions continues to grow, so does the demand for advanced diagnostic solutions capable of detecting and monitoring relevant biomarkers. Immuno oncology assays are at the forefront of this need, offering precision in identifying immune responses associated with both inflammation and malignancy. Healthcare professionals are increasingly relying on these assays for early cancer detection, treatment planning, and therapeutic monitoring in patients with chronic inflammation. This trend is driving significant market expansion, supported by the need for accurate, reliable, and clinically validated testing platforms that can link inflammation with cancer risk.
Restraints
- High cost of immunoadsorption procedures
- Limited awareness in developing healthcare systems
- Stringent regulatory requirements for product approval
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Inconsistent reimbursement across treatment markets - Inconsistent reimbursement policies across global healthcare systems pose a significant challenge to the expansion of the immuno oncology assays market. While these assays are becoming critical tools in the diagnosis and monitoring of cancer, their high cost and lack of uniform coverage hinder widespread adoption. In many regions, especially in low- and middle-income countries, these diagnostic tests are not fully reimbursed by insurance providers or public health programs. They are often viewed as non-essential or investigational tools, limiting access for patients and discouraging healthcare facilities from incorporating them into routine clinical practice.
The absence of a standardized global reimbursement framework not only impacts the affordability and availability of these assays but also slows down their integration into mainstream healthcare. Countries with strong healthcare funding and consistent reimbursement structures are seeing higher adoption rates, while others are lagging behind due to financial and policy-related constraints. This imbalance affects the overall market potential and restricts the delivery of personalized cancer care on a broader scale. Eliminating these disparities is essential to support equal access to advanced diagnostics and fully leverage the benefits of immuno oncology innovations.
Opportunities
- Expansion into emerging healthcare markets
- Development of disease-specific adsorption columns
- Strategic collaborations with biotech firms
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Rising focus on personalized treatment solutions - The growing emphasis on personalized treatment strategies in oncology is unlocking new growth opportunities for the immuno oncology assays market. As cancer care increasingly moves toward precision medicine, healthcare providers are prioritizing diagnostic tools that can tailor therapies to an individual’s unique immune response and tumor profile. Immuno oncology assays are vital in this shift, enabling the identification of specific biomarkers that help determine the most effective and targeted treatment options. This personalized approach improves treatment outcomes while minimizing side effects, aligning with the broader goal of enhancing patient care.
The integration of genomic, proteomic, and immunologic data into clinical decision-making is accelerating the adoption of advanced assay technologies. Research institutions, pharmaceutical companies, and diagnostics developers are increasingly investing in tools that support individualized therapeutic planning. Immuno oncology assays stand at the center of this transformation by delivering comprehensive insights into the interactions between cancer cells and the immune system. This rising demand is driving innovation in companion diagnostics, adaptive therapy solutions, and next-generation testing platforms, all of which are helping expand the market and redefine how cancer is managed at a personalized level.
Immuno Oncology Assays Market Competitive Landscape Analysis
Immuno Oncology Assays Market is highly competitive, with nearly 60% share controlled by leading biotechnology and diagnostic companies. Firms adopt diverse strategies including assay development, biomarker discovery, and clinical trial integration. Strong partnerships with pharmaceutical companies enhance adoption, while continuous innovation in assay platforms and personalized testing drives consistent growth across oncology research and therapeutic monitoring.
Market Structure and Concentration
The market reflects moderate concentration, where top brands account for about 55% of revenues. Regional companies secure nearly 25% share by applying specialized strategies in niche biomarker testing. Ongoing merger activity consolidates research and development capacity, while collaboration with academic institutions ensures balanced competition between global leaders and regional innovators.
Brand and Channel Strategies
Nearly 65% of sales are generated through direct hospital and laboratory contracts, highlighting targeted strategies. Partnerships with clinical research organizations and oncology centers expand product reach. Around 30% of growth stems from pharmaceutical collaboration in clinical trials, while continuous channel expansion into digital platforms strengthens visibility and reinforces brand positioning across oncology diagnostics.
Innovation Drivers and Technological Advancements
Approximately 45% of market competitiveness is shaped by innovation in multiplex assays, next-generation sequencing, and liquid biopsy technologies. Technological advancements in AI-enabled platforms and automated workflows enhance precision. Strategic collaboration with research organizations accelerates development, while growth is reinforced by new biomarker discoveries that expand the clinical utility of immuno oncology assays.
Regional Momentum and Expansion
North America accounts for nearly 40% share, supported by advanced strategies and strong clinical partnerships. Europe contributes around 30%, driven by regulatory-led innovation and collaborative research networks. Asia-Pacific demonstrates more than 25% growth, fueled by healthcare infrastructure expansion. Regional collaboration with cancer research institutes strengthens market adoption across diverse oncology landscapes.
Future Outlook
The future outlook indicates steady growth, with over 55% of companies expected to integrate AI-driven strategies and digital pathology platforms. Expanding partnerships with pharmaceutical firms and oncology networks will accelerate adoption. Continuous innovation in biomarker discovery and assay sensitivity ensures long-term expansion, positioning immuno oncology assays as essential tools in precision cancer care.
Key players in Immuno Oncology Assays Market include:
- Thermo Fisher Scientific
- F. Hoffmann-La Roche
- Illumina
- Danaher Corporation
- QIAGEN
- Agilent Technologies
- PerkinElmer
- Bio-Rad Laboratories
- Merck KGaA
- Becton, Dickinson & Company (BD)
- Sartorius
- NanoString Technologies
- Guardant Health
- Abbott Laboratories
- Charles River Laboratories
In this report, the profile of each market player provides following information:
- Market Share Analysis
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product and Service
- Market Snapshot, By Technology
- Market Snapshot, By Indication
- Market Snapshot, By Application
- Market Snapshot, By Region
- Immuno Oncology Assays Market Forces
- Drivers, Restraints and Opportunities
- Drivers
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Rising demand for autoimmune disease treatments
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Increasing adoption in therapeutic apheresis procedures
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Technological advances in column efficiency
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Growing prevalence of chronic inflammatory disorders
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- Restraints
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High cost of immunoadsorption procedures
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Limited awareness in developing healthcare systems
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Stringent regulatory requirements for product approval
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Inconsistent reimbursement across treatment markets
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- Opportunities
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Expansion into emerging healthcare markets
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Development of disease-specific adsorption columns
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Strategic collaborations with biotech firms
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Rising focus on personalized treatment solutions
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- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Immuno Oncology Assays Market, By Product and Service, 2021 - 2031 (USD Million)
- Consumables
- Instruments
- Software & Services
- Immuno Oncology Assays Market, By Technology, 2021 - 2031 (USD Million)
- PCR
- Immunoassay
- NGS
- ISH
- Flow Cytometry
- Immuno Oncology Assays Market, By Indication, 2021 - 2031 (USD Million)
- Lung Cancer
- Breast Cancer
- Colorectal Cancer
- Bladder Cancer
- Melanoma
- Others
- Immuno Oncology Assays Market, By Application, 2021 - 2031 (USD Million)
- Research Applications
- Clinical Diagnostics
- Immuno Oncology Assays Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN(Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Immuno Oncology Assays Market, By Product and Service, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Thermo Fisher Scientific
- F. Hoffmann-La Roche
- Illumina
- Danaher Corporation
- QIAGEN
- Agilent Technologies
- PerkinElmer
- Bio-Rad Laboratories
- Merck KGaA
- Becton, Dickinson & Company (BD)
- Sartorius
- NanoString Technologies
- Guardant Health
- Abbott Laboratories
- Charles River Laboratories
- Company Profiles
- Analyst Views
- Future Outlook of the Market