Global Immuno Oncology Assays Market Size study & Forecast, by Product & Service, Technology, Cancer Indications, Application and Regional Forecasts 2022-2032

Description

The Global Immuno Oncology Assays Market, valued at approximately USD 6.26 billion in 2024, is poised to expand at a remarkable CAGR of 12.50% during the forecast period from 2025 to 2035. Immuno-oncology assays, which serve as the backbone of precision cancer research and clinical diagnostics, are pivotal in evaluating immune responses, identifying predictive biomarkers, and guiding personalized therapy decisions. These assays enable clinicians and researchers to gain deeper insights into the complex interplay between the immune system and tumors, allowing for the development of targeted treatments that significantly enhance patient survival outcomes. Market growth is being accelerated by the rising global cancer burden, the rapid adoption of precision medicine, and continuous advancements in molecular diagnostic technologies. Additionally, the expanding application of next-generation sequencing (NGS) and highly sensitive immunoassays is unlocking new opportunities for biomarker discovery and companion diagnostics in oncology.

The upward trajectory of the market is further propelled by a surge in clinical trials evaluating novel immunotherapies, particularly immune checkpoint inhibitors and CAR-T cell therapies. As pharmaceutical companies and research institutions intensify their R&D investments, there is a parallel need for robust, reproducible, and high-throughput assay platforms to monitor therapeutic efficacy and detect resistance mechanisms. For instance, the integration of PCR and NGS into immuno-oncology workflows has enabled the detection of minute genetic alterations and immune signatures that inform treatment strategies with unprecedented accuracy. While these innovations are transforming cancer care, the high cost of advanced assay platforms and regulatory complexities surrounding biomarker validation may pose temporary hurdles, particularly in emerging markets. Nevertheless, ongoing collaborations between diagnostic developers, biotech firms, and healthcare providers are expected to mitigate these barriers and expand global accessibility.

Regionally, North America holds the lion's share of the market, fueled by a mature healthcare infrastructure, strong biotechnology presence, and an extensive network of oncology research centers. The United States, in particular, benefits from robust funding for cancer research, a high concentration of key industry players, and favorable regulatory frameworks that encourage innovation in diagnostics. Europe follows closely, driven by cross-border collaborations in cancer genomics, public health initiatives to improve early cancer detection, and the integration of molecular diagnostics into national healthcare systems. Meanwhile, Asia Pacific is anticipated to experience the fastest growth through 2035, owing to rapid advancements in healthcare infrastructure, rising cancer prevalence in countries like China and India, and increasing participation in global oncology research initiatives. Furthermore, expanding diagnostic capabilities in Latin America and the Middle East & Africa are creating emerging opportunities for assay adoption, particularly as these regions scale up their precision medicine programs.

Major market player included in this report are:

Thermo Fisher Scientific Inc.
Roche Diagnostics
Bio-Rad Laboratories, Inc.
Agilent Technologies, Inc.
Illumina, Inc.
Qiagen N.V.
BD (Becton, Dickinson and Company)
PerkinElmer, Inc.
Merck KGaA
Abbott Laboratories
Danaher Corporation (Cytiva & Beckman Coulter Life Sciences)
Guardant Health, Inc.
NanoString Technologies, Inc.
Adaptive Biotechnologies Corporation
Sysmex Corporation

Global Immuno Oncology Assays Market Report Scope:

Historical Data - 2023, 2024
Base Year for Estimation - 2024
Forecast period - 2025-2035
Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:

By Product & Service:

Consumables
Instruments
Software

By Technology:

PCR
NGS
Immunoassay

By Cancer Indications:

Lung
Breast
Colorectal
Bladder
Melanoma

By Application:

Research
Diagnostics

By Region:

North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
Rest of Europe (ROE)
Asia Pacific
China
India
Japan
Australia
South Korea
Rest of Asia Pacific (RoAPAC)
Latin America
Brazil
Mexico
Middle East & Africa
UAE
Saudi Arabia
South Africa
Rest of Middle East & Africa

Key Takeaways:

Market Estimates & Forecast for 10 years from 2025 to 2035.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market.

Chapter 1. Global Immuno Oncology Assays Market Report Scope & Methodology

1.1. Research Objective
1.2. Research Methodology
- 1.2.1. Forecast Model
- 1.2.2. Desk Research
- 1.2.3. Top Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
- 1.4.1. Market Definition
- 1.4.2. Market Segmentation
1.5. Research Assumption
- 1.5.1. Inclusion & Exclusion
- 1.5.2. Limitations
- 1.5.3. Years Considered for the Study

Chapter 2. Executive Summary

2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. Key Findings

Chapter 3. Global Immuno Oncology Assays Market Forces Analysis

3.1. Market Forces Shaping The Global Immuno Oncology Assays Market (2024-2035)
3.2. Drivers
- 3.2.1. Rising adoption of immunotherapies and biomarker-driven precision oncology.
- 3.2.2. Technological advancements in NGS, PCR, multiplex immunoassays and high-throughput automation.
3.3. Restraints
- 3.3.1. High cost of advanced assay platforms, reagents and associated consumables.
- 3.3.2. Regulatory complexity, long validation timelines and reimbursement challenges.
3.4. Opportunities
- 3.4.1. Expansion into emerging markets and proliferation of clinical trials & companion diagnostics.
- 3.4.2. Integration of AI, digital pathology and multi-omics data for enhanced biomarker discovery.

Chapter 4. Global Immuno Oncology Assays Industry Analysis

4.1. Porter's 5 Forces Model
- 4.1.1. Bargaining Power of Buyer
- 4.1.2. Bargaining Power of Supplier
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
4.2. Porter's 5 Force Forecast Model (2024-2035)
4.3. PESTEL Analysis
- 4.3.1. Political
- 4.3.2. Economical
- 4.3.3. Social
- 4.3.4. Technological
- 4.3.5. Environmental
- 4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis And Trends 2025
4.8. Analyst Recommendation & Conclusion

Chapter 5. Global Immuno Oncology Assays Market Size & Forecasts by Product & Service 2025-2035

5.1. Market Overview
5.2. Global Immuno Oncology Assays Market Performance - Potential Analysis (2025)
5.3. Consumables (Reagents, Kits)
- 5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.3.2. Market size analysis, by region, 2025-2035
5.4. Instruments (Sequencers, PCR Platforms, Analyzers)
- 5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.4.2. Market size analysis, by region, 2025-2035
5.5. Software (Data Analysis, Interpretation, LIMS Integration)
- 5.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.5.2. Market size analysis, by region, 2025-2035

Chapter 6. Global Immuno Oncology Assays Market Size & Forecasts by Technology & Application 2025-2035

6.1. Market Overview
6.2. Global Immuno Oncology Assays Market Performance - Potential Analysis (2025)
6.3. PCR
- 6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.3.2. Market size analysis, by region, 2025-2035
6.4. Next-Generation Sequencing (NGS)
- 6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.4.2. Market size analysis, by region, 2025-2035
6.5. Immunoassay & Multiplex Assays
- 6.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.5.2. Market size analysis, by region, 2025-2035
6.6. Application: Research
- 6.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.6.2. Market size analysis, by region, 2025-2035
6.7. Application: Diagnostics
- 6.7.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.7.2. Market size analysis, by region, 2025-2035

Chapter 7. Global Immuno Oncology Assays Market Size & Forecasts by Region 2025-2035

7.1. Immuno Oncology Assays Market, Regional Market Snapshot
7.2. Top Leading & Emerging Countries
7.3. North America Immuno Oncology Assays Market
- 7.3.1. U.S. Immuno Oncology Assays Market
  - 7.3.1.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.3.1.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.3.2. Canada Immuno Oncology Assays Market
  - 7.3.2.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.3.2.2. Application/Technology breakdown size & forecasts, 2025-2035
7.4. Europe Immuno Oncology Assays Market
- 7.4.1. UK Immuno Oncology Assays Market
  - 7.4.1.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.4.1.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.4.2. Germany Immuno Oncology Assays Market
  - 7.4.2.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.4.2.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.4.3. France Immuno Oncology Assays Market
  - 7.4.3.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.4.3.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.4.4. Spain Immuno Oncology Assays Market
  - 7.4.4.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.4.4.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.4.5. Italy Immuno Oncology Assays Market
  - 7.4.5.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.4.5.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.4.6. Rest of Europe Immuno Oncology Assays Market
  - 7.4.6.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.4.6.2. Application/Technology breakdown size & forecasts, 2025-2035
7.5. Asia Pacific Immuno Oncology Assays Market
- 7.5.1. China Immuno Oncology Assays Market
  - 7.5.1.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.5.1.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.5.2. India Immuno Oncology Assays Market
  - 7.5.2.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.5.2.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.5.3. Japan Immuno Oncology Assays Market
  - 7.5.3.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.5.3.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.5.4. Australia Immuno Oncology Assays Market
  - 7.5.4.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.5.4.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.5.5. South Korea Immuno Oncology Assays Market
  - 7.5.5.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.5.5.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.5.6. Rest of APAC Immuno Oncology Assays Market
  - 7.5.6.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.5.6.2. Application/Technology breakdown size & forecasts, 2025-2035
7.6. Latin America Immuno Oncology Assays Market
- 7.6.1. Brazil Immuno Oncology Assays Market
  - 7.6.1.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.6.1.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.6.2. Mexico Immuno Oncology Assays Market
  - 7.6.2.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.6.2.2. Application/Technology breakdown size & forecasts, 2025-2035
7.7. Middle East and Africa Immuno Oncology Assays Market
- 7.7.1. UAE Immuno Oncology Assays Market
  - 7.7.1.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.7.1.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.7.2. Saudi Arabia (KSA) Immuno Oncology Assays Market
  - 7.7.2.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.7.2.2. Application/Technology breakdown size & forecasts, 2025-2035
- 7.7.3. South Africa Immuno Oncology Assays Market
  - 7.7.3.1. Product & Service breakdown size & forecasts, 2025-2035
  - 7.7.3.2. Application/Technology breakdown size & forecasts, 2025-2035

Chapter 8. Competitive Intelligence

8.1. Top Market Strategies
8.2. Thermo Fisher Scientific Inc.
- 8.2.1. Company Overview
- 8.2.2. Key Executives
- 8.2.3. Company Snapshot
- 8.2.4. Financial Performance (Subject to Data Availability)
- 8.2.5. Product/Services Port
- 8.2.6. Recent Development
- 8.2.7. Market Strategies
- 8.2.8. SWOT Analysis
8.3. Roche Diagnostics
8.4. Bio-Rad Laboratories, Inc.
8.5. Agilent Technologies, Inc.
8.6. Illumina, Inc.
8.7. Qiagen N.V.
8.8. BD (Becton, Dickinson and Company)
8.9. PerkinElmer, Inc.
8.10. Merck KGaA
8.11. Abbott Laboratories
8.12. Danaher Corporation (Cytiva & Beckman Coulter Life Sciences)
8.13. Guardant Health, Inc.
8.14. NanoString Technologies, Inc.
8.15. Adaptive Biotechnologies Corporation
8.16. Sysmex Corporation