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Growth Opportunities in the Immuno-oncology Therapeutics Market, 2024-2030

  • Country Profile

  • August 2025
  • Region: Global
  • Frost & Sullivan
  • ID: 6168152

Advances in Next-Generation Immunotherapies, AI, and Biomarker-Driven Personalization are Driving Transformational Growth

Worldwide cancer incidence is expected to exceed 35 million new cases by 2050, a 77% rise from the 20 million cases in 2022. Alcohol intake, tobacco usage, obesity, and air pollution are the main causes of this increase. Cancer studies today emphasize cell and gene therapy, antibody-drug conjugates (ADCs), checkpoint inhibitors, and multi-specific antibodies. With clinical trials emphasizing combinations of radiation, chemotherapy, or many immunotherapy medicines, more than 5,000 immuno-oncology medications are under development.

Although immuno-oncology (I-O) has revolutionized cancer therapy, problems with clinical trials must be resolved to improve patient outcomes and speed approvals. Many I-O therapies show failure when evaluated across too-large or incompatible patient groups; human immune responses cannot always be deduced from animal models and two-dimensional in vitro systems. Conventional randomized controlled studies may not find signs or call for continuous changes should a medicine not be functioning as expected.

AI and biomarker-based patient selection, combination approaches to offset resistance, real-time safety monitoring for immune-related adverse events, distributed clinical trials to improve patient access, and adaptive, AI-driven trial designs are fundamental strategies to meet these challenges. With these approaches, stakeholders are strengthening I-O innovation and improving the effectiveness, accessibility, and safety criteria of cancer therapy.

Improved biomarker platforms help to increase tumor immunobiology’s depth of knowledge and accuracy. Fast-growing fields in biomarker research include multiplex IHC, NGS-based testing for gene mutations and expression profiles, epigenetic mapping for higher-order gene structures, and metabolic profiling for tumor energy status.

The analyst studied clinical and pipeline developments, technological innovation, and regional market dynamics to develop this research service, which provides an overview of the global I-O market and a revenue projection from 2025 to 2030. The geographical scope is North America, Europe, Asia-Pacific, the Middle East and North Africa, and Latin America.

With an eye on checkpoint inhibitors, ADC, bispecific antibodies, cancer vaccines, and adoptive cell treatments including CAR-T, TCR, and TILs, this report examines the main themes and technologies driving the evolution of I-O therapies. Along with strategic target areas including overcoming resistance to PD-1/PD-L1 inhibitors, it stresses next-generation drugs including allogeneic approaches and multi-specific modalities. In this fast-changing environment, the study also investigates growth drivers, restraints, and opportunities for stakeholders.

Revenue Forecast

The revenue estimate for the base year 2024 is projected at $110.69 billion, with a compound annual growth rate (CAGR) of 10.7% during the study period from 2021 to 2030.

The Impact of the Top 3 Strategic Imperatives on the I-O Therapeutics Industry

Customer Value Chain Compression

Why

Patient value chain compression in the immuno-oncology market entails optimizing and simplifying the patient’s journey, including the stages of diagnosis, treatment, and post-treatment care. This is accomplished by combining different healthcare services and using cutting-edge technology in immuno-oncology clinical trials market.

Comprehensive, integrated cancer care is important, especially in the context of the immuno-oncology biomarker platforms market. Integrated treatment facilities, coordinated care teams, and extensive aftercare plans are examples of this.

The Analyst's Perspective

Companies in the immuno-oncology market are providing direct-to-consumer services, such as cancer risk genetic testing kits that may be used at home thus expedite the diagnosing process.

Digital technology optimizes operations, improves patient engagement, and customizes treatment in the context of the adaptive AI-driven oncology trials market. This includes remote consultations, data-driven diagnostics, and treatment recommendations.

By tightly integrating racial, age, and socioeconomic considerations into their survival and clinical decision-making, the oncology value chain can significantly improve patients' experiences within the immuno-oncology biomarker platforms market.

Disruptive Technologies

Why

Recent technological advancements, including single-cell sequencing and spatial transcriptomics, have greatly enhanced our understanding of the immunobiology of the tumor microenvironment, influencing the adaptive AI-driven oncology trials market.

A new AI method uses treatment change predictions to identify clinical trial candidates, advancing the use of next-generation sequencing (NGS) data for patients' trial matching in the next-generation immuno-oncology therapies market. A machine learning algorithm predicts cancer acute care occurrences using patient-reported outcome variables.

Sanofi is collaborating with Owkin to boost biomarker identification and raise clinical trial success rates. GSK has teamed with Tempus to aid the effort in the immuno-oncology market.

The Analyst's Perspective

Multi-modality methods have improved our understanding of tumor-immune system interactions relevant to the immuno-oncology market. Digital tools help to organize data, uncover complicated patterns, and extract immunologically relevant information in a flexible way. Since few companies respond to innovations in immunotherapy, it is crucial to select.

AI and accelerated computing are revolutionizing medicine, and companies like NVIDIA are investing heavily in healthcare services, including IOVIA, Illumina, and Mayo Clinic, impacting the adaptive AI-driven oncology trials market.

Competitive Intensity

Why

The immuno-oncology market is competitive, with several companies aiming for similar clinical targets and big pharma teaming up with emerging biotech for novel assets in the immuno-oncology clinical trials market.

Clinical development and regulatory environments are complicated by the convergence of immunotherapy, radiation, targeted treatments, and new demands, such as microbiome regulation.

Cell treatments, oncologic viruses, mRNA vaccines, and AI-driven biomarker discovery are advancing in the immuno-oncology biomarker platforms market. These developments have driven many strategic alliances, joint ventures, mergers, and acquisitions.

The Analyst's Perspective

Despite recent breakthroughs, there are still obstacles in the field of cancer immunotherapy within the immuno-oncology clinical trials market. These include limited effectiveness, temporary duration, and unintended impacts. Under a general strategy, differentiating via precision targets medicines for certain patient groups or tumor types has become a focal point.

Factors: Human beings are asking companies to optimize label expansion strategies via RWE. Market RWE will facilitate escape from earlier stages of the small cell lung.

Growth Drivers

Growth Opportunities in the Immuno-oncology Therapeutics Market, 2024-2030

  • Technological developments in biomarker platforms provide the potential for more accurate and comprehensive knowledge of tumor immunobiology. Multiple IHC, NGS-based testing to detect gene mutations and gene expression profiles, epigenetic mapping to define higher-order gene structures, and metabolic profiling to assess the tumor’s energy status are among the quickly expanding fields of biomarker research in the immuno-oncology market. Combining these methods can offer a comprehensive depiction of the tumor from multiple perspectives. When multiple IHC and imaging are combined with NGS, for instance, the spatial distribution of gene expression in the context of cell-cell interactions inside the tumor may be revealed.
  • Anti-PD-(L)1 and anti-CTLA-4 immunotherapy has changed cancer treatment in the immuno-oncology market, although resistance and toxicity persist. New immunoregulatory targets and mechanisms are being discovered as I-O advances, promising to enhance therapeutic immunotherapy. As cancer immunobiology is better understood and antibody engineering advances, agents targeting additional inhibitory immune checkpoints, such as LAG-3, TIM-3, TIGIT, CD47, and B7 family members, are becoming important in cancer immunotherapy research.
  • Precision medicine methods such as immunotherapy and molecularly targeted treatment have changed cancer care within the immuno-oncology clinical trials market. However, few people benefit from these therapies. Most cancers develop resistance to conventional treatments. These issues are being addressed by clinical studies of various treatment combinations. These studies use immunotherapy, molecularly targeted therapy, and radiation to treat different malignancies. There is emerging evidence that combination treatment may prevent or delay resistance. When combined with other cancer treatments, immunotherapies, especially ICIs, are effective. Multiple FDA approvals of immunotherapy combinations for cancer therapy are indicative of their effectiveness in the next-generation immuno-oncology therapies market.
  • There is a need for wider adoption of innovative tools that can effectively measure and integrate the various host factors that influence tumor immunity and the response to immunotherapy in the immuno-oncology market. Wearable devices can track various physiologic variables, including heart rate, respiratory rate, oxygenation levels, sleep patterns, and stress and distress levels. Instruments for assessing systemic inflammation and metabolic fitness are either under development or commercially accessible. Tools are available to capture consumption of food and other metabolites to describe metabolic variables within the adaptive AI-driven oncology trials market. Technology is available to describe dietary patterns and examine associations with outcomes based on data.

Growth Restraints

  • Three significant challenges exist when it comes to understanding the mechanisms of antitumor response, immune-related toxicity, and therapeutic resistance: the ability to use tumor models that are relevant to clinical applications for both forward and reverse translation; the availability of biospecimens collected from patients undergoing immunotherapy treatment, allowing for longitudinal analysis at baseline, during treatment, and post-treatment; and the implementation of standardized definitions and frameworks for conducting studies in the immuno-oncology clinical trials market.
  • Genomic testing has the potential to provide valuable clinical information in the immuno-oncology market, but it can also have financial and psychological consequences for individuals and families. It may also lead to social stigma and affect one’s ability to obtain insurance. Testing can be challenging due to the need for fast testing and efficient data analysis. Another problem with clinical follow-up is the need for reevaluating the danger to a family and an individual when new germline pathogenic variations are identified, and their relative risk of illness is determined.
  • Identifying the most suitable antigens to target within the immuno-oncology biomarker platforms market continues to be a significant challenge. Tumors caused by viral infection or genetic mutations, whether inherited or acquired, may contain (neo)antigens that the immune system can easily identify. In other circumstances, common tumor antigens can provide a more widely applicable treatment. Examining premalignant lesions for new and powerful antigens to focus on is crucial in the context of the immuno-oncology market. Lesions that appear in the initial stages of tumorigenesis, such as hyperplasia and carcinoma in situ, are typically tiny and offer only a small amount of tissue for examination. Accessing these lesions can be challenging and may require specialized procedures, such as colony cytology or bronchoscopy, performed by skilled professionals to obtain tissue samples.
  • Preclinical models fall short in reproducing the effects of the interactions between the host environment and the onset, progression, and immune response of cancer in the adaptive AI-driven oncology trials market. This might partially account for their inadequacies in determining the mechanisms of immunotherapy response and resistance as well as immune-related toxicity. The community requires new models that can effectively capture the intricate interactions between the host and environment, which play a crucial role in shaping the dynamics between the tumor and immune system within the immuno-oncology market. For instance, breaking in the genetic smoke has been shown to enhance and change the developing tumors in cancers. In line with this, there is a definite correlation between the existence of a genomic smoking signature, particular smoking-related genetic alterations found by NGS and reflected by TMB, and the impact these have on immune cell behavior in the context of cancer in the immuno-oncology clinical trials market. There is still much to be discovered regarding the indirect environmental exposures on tumor immunity and the effectiveness of immunotherapy.

Competitive Environment

  • Number of Competitors: 12 with revenue greater than $1 billion in the immuno-oncology market
  • Competitive Factors: Cost, efficacy, technology, safety, resistance, line of treatment, immuno-toxicity in the immuno-oncology clinical trials market
  • Key End-user Industry Verticals: Healthcare and manufacturing in the adaptive AI-driven oncology trials market
  • Leading Competitors: Merck & Co., Roche, Bristol Myers Squibb, Johnson & Johnson, AstraZeneca, Daiichi Sankyo, Pfizer, Gilead Sciences, Amgen, Merck KGaA in the immuno-oncology market
  • Revenue Share of Top 10 Competitors (2024): 88.5%
  • Other Notable Competitors: Eli Lilly, Novartis, Regeneron, Incyte, BioNTech, BeiGene, Abbvie in the immuno-oncology clinical trials market
  • Distribution Structure: Retail sales and direct sales in the adaptive AI-driven oncology trials market
  • Notable Acquisitions and Mergers: Novartis acquired MorphoSys AG for $2.91 billion; Johnson & Johnson acquired Ambrx for $2.4 billion in the immuno-oncology market

Table of Contents

Research Scope
  • Market Definition, Scope, and Segmentation
  • Market Segmentation
Growth Environment: Transformation in the I-O Therapeutics Market
  • Why is it Increasingly Difficult to Grow?
  • The Strategic Imperative 8
  • The Impact of the Top 3 Strategic Imperatives on the I-O Therapeutics Industry
Ecosystem in the I-O Therapeutics Market
  • Cancer Cases and Deaths Worldwide
  • Predicted Number of New Cancer Cases Worldwide
  • Top Therapeutic Categories
  • Oncology Drug Development Trend
  • I-O Drug Development Trends
  • Clinical Trial Challenges and Strategies to Overcome
  • Technology Trends Across the Cancer Continuum
  • I-O Business Models
  • Strategic Partnerships and Collaborations - ICIs
  • Strategic Partnerships and Collaborations - ACT
  • Strategic Partnerships and Collaborations - Antibody-based Targeted Therapies
  • Strategic Partnerships and Collaborations - Cancer Vaccines
  • Key Strategies for Advancing Precision Oncology
  • M&A Assessment
  • Venture Financing Assessment
  • Competitive Environment
  • Key Competitors: I-O Value Chain and Stakeholder Ecosystem
Growth Generator in I-O Therapeutics Market
  • Growth Metrics
  • Growth Drivers
  • Growth Restraints
  • Research Process and Methodology
  • Forecast Considerations
  • Revenue Forecast
  • Revenue Forecast Analysis
  • Revenue Forecast by Modality
  • Revenue Forecast Analysis
  • Revenue Forecast by Indication
  • Revenue Forecast Analysis
  • Revenue Forecast by Region
  • Forecast Analysis by Region
  • Trends and Initiatives - North America
  • Trends and Initiatives - Europe
  • Trends and Initiatives - APAC
  • Trends and Initiatives - LATAM
  • Trends and Initiatives - MENA
  • I-O Pricing Trends and Potential Avenues for Cost Reduction
  • Cancer Immunotherapy Cost Reduction Strategies in LMICs
  • Revenue Share
  • Revenue Share Analysis
Growth Generator: ICI
  • Growth Metrics
  • Revenue Forecast
  • Forecast Analysis
Growth Generator: ACT
  • Growth Metrics
  • Revenue Forecast
  • Forecast Analysis
Growth Generator: Antibody-based Targeted Therapies
  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast - ADC
Growth Generator: Others
  • Growth Metrics
  • Revenue Forecast
  • Forecast Analysis
Growth Opportunity Universe
  • Growth Opportunity 1: Expanding the Use of Immune Checkpoint ICIs in Neoadjuvant and Pre-operative Settings for Early-Stage Cancer
  • Growth Opportunity 2: Advancing Multi-biomarker Approaches
  • Growth Opportunity 3: Preclinical Models That Precisely Mimic Tumor Immunobiology
  • Growth Opportunity 4: Generative AI-based In Silico Techniques
Next Steps
  • Benefits and Impacts of Growth Opportunities
  • Next Steps
  • Legal Disclaimer