Immuno Oncology Assay Market Forecasts to 2030 – Global Analysis By Product (Software, Consumables, Instruments and Other Products), Indication (Bladder Cancer, Melanoma Cancer, Lung Cancer, Colorectal Cancer, Breast Cancer, Lymphoma and Other Indications

Immuno Oncology Assay Market Forecasts to 2030 – Global Analysis By Product (Software, Consumables, Instruments and Other Products), Indication (Bladder Cancer, Melanoma Cancer, Lung Cancer, Colorectal Cancer, Breast Cancer, Lymphoma and Other Indications), Technology (Polymerase Chain Reaction (PCR), Immunoassays, Flow Cytometry, Next-generation Sequencing (NGS), In Situ Hybridization and Other Technologies), Application and By Geography

According to Stratistics MRC, the Global Immuno Oncology Assay Market is accounted for $5.04 billion in 2023 and is expected to reach $11.71 billion by 2030 growing at a CAGR of 12.8% during the forecast period. The Immuno Oncology Assay Market refers to the sector within the healthcare industry focused on developing and commercializing assays that aid in the study and treatment of cancer by harnessing the body's immune system. These assays play a pivotal role in drug development by enabling the evaluation of novel immuno-oncology therapies, helping researchers identify promising candidates and assess their efficacy and safety profiles.

According to the ECIS, the European cancer burden is expected to reach 3.36 million new cases by 2040, compared to 2.94 million patients in 2025.

Market Dynamics:

Driver:

Growing interest in immunotherapy

Immunotherapy has emerged as a promising approach for cancer treatment, leveraging the body's immune system to combat tumors effectively. As traditional cancer treatments often encounter resistance and can have severe side effects, the appeal of immunotherapy lies in its potential for targeted and durable responses with fewer adverse effects. Immuno-oncology assays are integral to the development and evaluation of immunotherapeutic agents, allowing researchers and clinicians to assess their efficacy, safety, and mechanism of action.

Restraint:

High development costs

The research and development (R&D) process for immuno-oncology assays involves extensive validation studies, optimization of assay protocols, and clinical validation trials to ensure accuracy, reproducibility, and regulatory compliance. These activities require substantial financial investment, including expenditures on equipment, reagents, personnel, and regulatory submissions. For smaller companies with limited resources, the high upfront costs and long development timelines can be prohibitive, preventing them from entering the market or competing effectively with larger established players.

Opportunity:

Technological advancements

Innovations such as multiplex assays, next-generation sequencing (NGS), and high-throughput screening are revolutionizing the field of immuno-oncology by enabling researchers to analyze multiple parameters simultaneously with greater efficiency and precision. Multiplex assays allow the measurement of multiple analytes in a single sample, providing comprehensive insights into the complex interactions between the immune system and cancer cells. NGS technologies offer unprecedented opportunities for genomic and transcriptomic profiling, facilitating the identification of novel biomarkers and therapeutic targets.

Threat:

Competition from alternative technologies

Alternative technologies such as liquid biopsy assays or imaging modalities offer distinct advantages, such as non-invasiveness, real-time monitoring, and comprehensive molecular profiling. These alternatives may provide valuable insights into cancer progression, treatment response, and patient outcomes, often in ways that complement or surpass the capabilities of immuno-oncology assays. As a result, researchers and clinicians may opt for these alternative approaches, particularly in settings where immuno-oncology assays may be limited by sample availability, assay complexity, or cost.

Covid-19 Impact:

Initially, the outbreak led to disruptions in supply chains, laboratory operations, and clinical trials, causing delays in assay development, validation, and commercialization. Restrictions on non-essential medical procedures and laboratory activities also hindered the conduct of immuno-oncology research and the adoption of assay technologies in clinical settings. Furthermore, the redirection of healthcare resources and funding towards COVID-19 response efforts diverted attention and investment away from immuno-oncology research and development. However, as the pandemic progressed, there emerged a heightened recognition of the importance of immunology and infectious disease research, potentially stimulating interest and investment in immuno-oncology assays.

The consumables segment is expected to be the largest during the forecast period

Consumables segment dominated the largest share of the market during the forecast period due to its indispensable role in supporting the operation and scalability of immuno-oncology assays. As the demand for immuno-oncology assays continues to rise, fueled by increasing cancer prevalence and the growing adoption of immunotherapy, the need for consumables also escalates proportionally. Moreover, innovations in assay development often rely on specialized consumables designed to improve assay sensitivity, specificity, and throughput. This creates a continuous demand for consumables within the immuno-oncology assay market.

The flow cytometry segment is expected to have the highest CAGR during the forecast period

Flow Cytometry segment is expected to have the highest CAGR during the projection period due to its versatility and precision in analyzing immune cell populations and their interactions within the tumor microenvironment. This segment allows for the simultaneous measurement of multiple parameters at the single-cell level, providing valuable insights into immune cell phenotypes, activation states, and functional responses. Additionally, flow cytometry enables the assessment of immune checkpoint expression and cytokine production, facilitating the evaluation of immunotherapy efficacy and patient stratification.

Region with largest share:

Asia Pacific region commanded the largest share over the extrapolated period. With a rapidly expanding population, aging demographics, and changing lifestyles, countries across Asia Pacific are experiencing a surge in cancer incidence and mortality rates. Factors such as urbanization, tobacco consumption, pollution, and dietary habits contribute to the rising burden of cancer in the region. As a result, improvements in healthcare infrastructure, access to diagnostic services, and awareness of cancer screening programs are leading to earlier detection and diagnosis of cancer cases in the region thereby enhancing the market growth.

Region with highest CAGR:

Europe region is poised to witness profitable growth throughout the estimation period. The stringent regulatory framework established by European regulatory bodies, such as the European Medicines Agency (EMA) and the European Commission, ensures the safety, efficacy, and quality of immuno-oncology assays used in clinical research and patient care. The European regulatory environment emphasizes transparency, evidence-based decision-making, and ethical considerations, which contribute to building trust and confidence in immuno-oncology assays among stakeholders. As a result, regulatory compliance serves as a catalyst for market growth by facilitating timely market entry, encouraging innovation, and promoting the adoption of immuno-oncology assays for precision medicine and personalized cancer care throughout the European region.

Key players in the market

Some of the key players in Immuno Oncology Assay market include Agilent Technologies, Inc, Bio-Rad Laboratories, Inc, Charles River Laboratories, Inc, F. Hoffmann-La Roche Ltd, Guardant Health, Inc, HTG Molecular Diagnostics, Inc, llumina, Inc, NanoString Technologies, Inc, Novartis International AG, Perkinelmer, Inc, Qiagen Nv, Sartorius AG, Sysmex Corporation and Thermo Fisher Scientific, Inc.

Key Developments:

In January 2024, Thermo Fisher Scientific introduced Gibco™ Cell Therapy Systems (CTS™) Cellmation™ Software, a new automation solution. It integrates workflows across Thermo Fisher Scientific cell therapy instruments and ensures cGMP compliance for innovators in breakthrough cell therapies.

In March 2023, Mimetas, a company that models human diseases, formed a strategic alliance with Astellas Pharma Inc., a multinational pharmaceutical corporation. The partnership entails using MIMETAS' exhaustive tumor models to assist the next generation of immuno-oncological therapies.

In February 2023, Agilent Technologies, Inc. revealed that their xCELLigence RTCA HT (real-time cell analysis high-throughput) platform is compatible with the BioTek BioSpa 8 Automated Incubator. This combination, developed in response to market demands, enables a higher level of workflow automation and provides novel functionality for developing label-free high-throughput potency assays for the immuno-oncology market and high-throughput viral cytopathic effects (CPE) assays for the vaccine market.

Products Covered:
• Software
• Consumables
• Instruments
• Other Products

Indications Covered:
• Bladder Cancer
• Melanoma Cancer
• Lung Cancer
• Colorectal Cancer
• Breast Cancer
• Lymphoma
• Other Indications

Technologies Covered:
• Polymerase Chain Reaction (PCR)
• Immunoassays
• Flow Cytometry
• Next-generation Sequencing (NGS)
• In Situ Hybridization
• Other Technologies

Applications Covered:
• Clinical Diagnostics
• Research Applications
• Other Applications

Regions Covered:
• North America
US
Canada
Mexico
• Europe
Germany
UK
Italy
France
Spain
Rest of Europe
• Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
• South America
Argentina
Brazil
Chile
Rest of South America
• Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances