Growth Opportunities In The Immuno-Oncology Therapeutics Market, 2024-2030: Advances In Next-Gen Immunotherapies, AI, And Biomarker-Driven Personalization Are Driving Transformational Growth
Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "Growth Opportunities in the Immuno-oncology Therapeutics Market, 2024-2030" report has been added to ResearchAndMarkets's offering.
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.
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.
Growth Drivers
- 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
Growth Opportunity Universe
- Expanding the Use of Immune Checkpoint ICIs in Neoadjuvant and Pre-operative Settings for Early-Stage Cancer Advancing Multi-biomarker Approaches Preclinical Models That Precisely Mimic Tumor Immunobiology Generative AI-based In Silico Techniques
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