Driven by a paradigm shift to curative early-stage interventions and surging ADC demand, the market offers massive upside. With 60+ regulatory approvals in 2024 and multi-billion dollar M&A activity, stakeholders are capitalizing on expanded patient populations and functional cure pathways.
Chicago, Jan. 07, 2026 (GLOBE NEWSWIRE) — The global immuno-oncology drugs market was valued at US$ 35.78 billion in 2025 and is expected to reach US$ 185.69 billion by 2035, growing at a CAGR of 17.9% during the forecast period 2026–2035.
Curative intent is aggressively reshaping the investment and operational landscape of the immuno-oncology drugs market. Clinical volume drives this shift, evidenced by 6,528 oncology trials projected to complete in 2024. Regulatory bodies such as FDA are amplifying this demand, issuing 60+ oncology approvals in 2024, including 11 first-in-class therapeutics. The transition from palliative care is fueling massive capital injections, such as Vertex’s USD 4.9 billion acquisition of Alpine and the USD 10.3 billion raised across 169 venture rounds in 2024.
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Commercial success in targeted therapies is validating these high stakes in the immuno-oncology drugs market. Enhertu alone generated USD 3.75 billion in 2024 sales, proving the profitability of “smart chemotherapy.” The industry is responding with deep pipelines, including 600+ bispecific antibodies in development and 25 registrational studies by Merck in early-stage settings. Bristol Myers Squibb’s USD 11.15 billion R&D spend further confirms that major players view this sector as their primary growth engine.
to accommodate this demand, Infrastructure around the world is expanding rapidly. For instance, Gilead is scaling to 24,000 annual CAR-T treatments, while Nucleus RadioPharma added 100,000 square feet of capacity. Administrative frameworks are also adapting, with 230 new CPT codes added in 2024 to facilitate reimbursement. With 44,000+ stakeholders attending ASCO 2024, the ecosystem is fully mobilized to support next-generation immuno-oncology delivery.
Key Findings
- In 2024, North America accounted for the largest portion of immuno-oncology drugs market revenue.
- Looking ahead, the Asia Pacific region is poised to witness the fastest growth in the coming years.
- Based on treatment type, the immune checkpoint inhibitors segment emerged as the leading category in the market in 2024.
- Considering disease type, the lung cancer segment took the lead in market share during the same year.
- Among distribution channels, hospital pharmacies captured the highest share of market revenue in 2024.
Immune Checkpoint Inhibitors Secure Market Supremacy via Broad Label Expansion
By treatment type, the Immune Checkpoint Inhibitors (ICIs) segment maintained an unassailable lead in immuno-oncology drugs market. This dominance is not static, it is actively evolving through aggressive label expansions into earlier lines of therapy. While CAR-T cell therapies grabbed headlines, PD-1 and PD-L1 inhibitors like Keytruda (pembrolizumab) and Opdivo (nivolumab) remained the financial bedrock of the industry, generating combined sales exceeding $40 billion.
The segment’s stronghold in 2024 was fortified by a paradigm shift: the move from treating metastatic disease to “adjuvant” and “perioperative” settings (treating before and after surgery). This strategy effectively tripled the duration of therapy for eligible patients, directly correlating to higher revenue per script. Furthermore, 2024 marked the rise of “next-gen” checkpoints, specifically bispecific antibodies. The disruptive success of Ivonescimab (PD-1/VEGF), which demonstrated superior efficacy over standard-of-care monotherapies in head-to-head trials during late 2024, signaled that the ICI segment is regenerating its own growth pipeline rather than ceding ground to other modalities.
By Disease Type, Lung Cancer Segment Leads Revenue with Perioperative Immunotherapy Adoption
By disease type, the Lung Cancer segment remained the undisputed market leader in immuno-oncology drugs market. This leadership is driven by the sheer scale of the patient population—lung cancer remains the leading cause of cancer-related mortality worldwide—combined with the near-universal adoption of immunotherapy for Non-Small Cell Lung Cancer (NSCLC). The 2024 revenue surge was specifically catalyzed by the widespread implementation of perioperative immunotherapy regimens. Following pivotal FDA approvals, oncologists began routinely administering chemo-immunotherapy combinations to patients with resectable stages II and III lung cancer, a patient pool that was previously treated with surgery alone. This clinical shift has entrenched immunotherapies as a non-negotiable standard of care across the entire disease continuum, not just late-stage palliative care.
Additionally, the Small Cell Lung Cancer (SCLC) sub-segment contributed new growth due to the uptake of tarlatamab, a DLL3-targeting bispecific T-cell engager approved in mid-2024, which offered the first major survival breakthrough for this aggressive subtype in decades, further expanding the segment’s financial footprint.
By Distribution, Hospital Pharmacies Command Distribution Through Specialized Handling and Infusion Protocols
By distribution channel, the Hospital Pharmacies segment held the major revenue share in immuno-oncology drugs market. This dominance is structural and unlikely to wane, primarily because the leading immuno-oncology agents are large-molecule biologics requiring intravenous (IV) infusion. The administration of these drugs involves complex logistics, including strictly monitored cold-chain storage (2°C to 8°C) and sterile compounding in USP <797> compliant cleanrooms, infrastructure that retail pharmacies generally lack. Furthermore, the economic model of oncology care in major markets like the U.S. relies heavily on the “buy-and-bill” reimbursement system.
Under this model, hospitals purchase these high-value drugs upfront—often treating the pharmacy as a significant revenue generator for the health system—before billing insurers. Beyond economics, the safety profile of these drugs necessitates hospital administration; the risk of immune-related adverse events (irAEs), such as cytokine release syndrome or pneumonitis, requires immediate access to emergency medical intervention, keeping the dispensing and administration loop tightly closed within the hospital environment.
6,528 Trials Signal Immuno-Oncology Pipeline Explosion
Global research activity currently underscores the robust expansion of the Immuno-oncology drugs market. Data indicates 6,528 oncology clinical trials were projected to complete in 2024, signaling massive throughput. Specific therapeutic focuses are emerging rapidly. Researchers planned 82 new clinical trials for solid tumor treatments to launch in 2024 alone. Stakeholders observe 65 trials targeting Non-Small Cell Lung Cancer (NSCLC) scheduled to commence in the same period. Developers also set 57 new breast cancer clinical trials to begin in 2024, highlighting diverse target indications. Such volume necessitates distinct operational strategies for market entrants.
Scientific dissemination channels reflect this surge in the Immuno-oncology drugs market. Organizers selected 3,000+ abstracts for presentation at the 2024 ASCO Annual Meeting, demonstrating high-yield research output. Merck is conducting 25 registrational studies in early-stage disease settings as of May 2024, pushing the boundaries of curative care. Furthermore, 600+ bispecific antibody candidates are currently in clinical development as of 2024, representing a significant technological shift. These metrics confirm that clinical pipelines are not just active but overflowing with next-generation candidates.
Regulatory Momentum Builds With 60+ Oncology Approvals Granted Within One Year
Regulatory bodies are processing applications at record speeds, acting as a catalyst for the Immuno-oncology drugs market. The FDA issued 60+ oncology drug approvals throughout 2024, validating new mechanisms of action. Activity peaked late in the year, with 15 oncology approvals occurring specifically in the final quarter of 2024. Innovation remains the primary driver of these decisions. Authorities granted approval to 11 first-in-class therapeutics in 2024, offering novel options to patients. October 2024 alone saw 4 new cancer therapies approved by the FDA.
Advanced modalities are receiving particular attention within the Immuno-oncology drugs market. Two first-in-class bispecific antibodies, Zanidatamab and Zenocutuzumab, received accelerated approval in Q4 2024. Earlier in May 2024, the FDA granted approval for the first T-cell engager, tarlatamab, for small cell lung cancer. Historical data supports this trend, as 129 agents were granted accelerated approval for cancer indications between 2013 and 2023, setting a precedent for the intense scrutiny seen in 2024.
Billion Dollar Acquisitions By Vertex and Novartis Drive Immuno-Oncology Drugs Market Consolidation Trends Forward
High-value transactions characterize the current landscape of the Immuno-oncology drugs market. Vertex Pharmaceuticals completed the acquisition of Alpine Immune Sciences for USD 4.9 billion in 2024, securing key assets. Novartis actively strengthened its portfolio through multiple high-profile deals. The pharmaceutical giant signed a licensing deal with Dren Bio potentially valued at USD 3.0 billion in July 2024. Furthermore, Novartis purchased MorphoSys for USD 2.9 billion in 2024 to acquire advanced pipeline candidates.
Consolidation extends beyond these giants in the Immuno-oncology drugs market. AstraZeneca acquired Fusion Pharmaceuticals for USD 2.4 billion in 2024, expanding its radiopharmaceutical capabilities. Similarly, ONO Pharmaceutical acquired Deciphera for USD 2.4 billion in 2024. Johnson & Johnson executed the acquisition of Ambrx Biopharma for USD 2.0 billion in January 2024. These multi-billion dollar capital deployments indicate that established players are aggressively buying innovation rather than solely relying on internal discovery.
Strategic Licensing Deals and High Value Funding Rounds Fuel Commercial Expansion Rapidly
Licensing agreements provide critical capital flow within the Immuno-oncology drugs market. PeptiDream and Novartis signed a peptide-drug conjugate agreement totaling USD 2.89 billion in April 2024. Roche collaborated with Moma Therapeutics in a deal valued at USD 2.07 billion signed in January 2024. Smaller biotech firms also commanded significant valuations. Genmab acquired ProfoundBio for a cash value of USD 1.8 billion in April 2024. Such liquidity ensures continuous development of promising assets.
Emerging players in the Immuno-oncology drugs market are securing substantial resources. Xaira Therapeutics raised USD 1.0 billion in one of the largest Series A financings of 2024. Ipsen entered a licensing agreement with Foreseen Biotechnology potentially valued at USD 1.03 billion in 2024. Additionally, Ipsen signed an exclusive global licensing deal with Sutro Biopharma worth USD 900 million in April 2024. Merck also contributed USD 588 million in an upfront payment to LaNova Medicines in November 2024.
Antibody Drug Conjugate Revenue Soars With Enhertu Leading Global Sales Performance Tables
Commercial performance in the Immuno-oncology drugs market is currently dominated by Antibody-Drug Conjugates (ADCs). Global regulators have approved 17 ADC drugs as of early 2025. Enhertu recorded massive sales revenue of USD 3.75 billion in FY 2024, leading the segment. Padcev followed with sales revenue of USD 1.58 billion in 2024. These figures demonstrate the high reimbursement potential for targeted cytotoxic delivery systems.
Sales data for other key agents confirms the health of the Immuno-oncology drugs market. Trodelvy generated revenue of USD 1.31 billion in 2024. Polivy achieved similar success with sales revenue of USD 1.30 billion in 2024. Even niche products like Elahere reported sales revenue of USD 479 million in 2024. Scientific interest parallels this commercial success, with 30+ distinct ADC abstracts presented at the ASCO 2024 annual meeting. Additionally, 1 new ADC, sacituzumab tirumotecan, received approval in China in 2024.
Pipeline Depth Increases With 600 Bispecific Candidates In Active Development Stages
R&D expenditure proves that stakeholders are betting heavily on the Immuno-oncology drugs market. Bristol Myers Squibb reported an annual R&D expense of USD 11.15 billion for 2024. Keytruda continues to dominate, holding 40 approved indications in the US as of Q2 2024. These indications now cover 17 different tumor types as of 2024. Such broad coverage necessitates continuous clinical evaluation.
Developers are refining their portfolios within the Immuno-oncology drugs market. Merck had 14 Phase 3 trials for Keytruda active in early-stage disease settings between 2022 and 2025. However, strategic discipline is evident; Merck discontinued 2 Phase 3 trials (KEYNOTE-867 and KEYNOTE-630) in August 2024. Emerging data supports continued investment. Immunocore reported 4 patients showed partial tumor responses in a dual-targeting antibody trial presented at ASCO 2024.
Investment Capital And Diagnostic Coding Updates Fortify The Oncology Infrastructure Base Firmly
Financial and administrative structures are evolving to support the Immuno-oncology drugs market. Venture capital remains robust, with 169 funding rounds completed for cancer startups in 2024. These rounds raised a total capital of USD 10.3 billion in 2024. Notable raises include Tubulis securing USD 140 million in Series B financing in March 2024. OnCusp Therapeutics raised USD 100 million in Series A financing in Jan 2024, and Alamar Biosciences raised USD 100 million in Series C financing in Feb 2024.
Reimbursement frameworks are adapting to the Immuno-oncology drugs market. The CPT 2024 code set added 230 new codes, impacting oncology billing. Revisions affected 70 existing codes, while 49 codes were deleted in the 2024 update. Specific advancements include 3 new CPT codes for HIPEC introduced in 2024 and 1 new code for uterine fibroid ablation. Diagnostic precision is improving, with Cleveland Diagnostics raising USD 75 million in Jan 2024 and 7 genes identified in a new methylation panel for lung cancer.
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Immuno-Oncology Drugs Market Major Players:
- AbbVie Inc.
- Amgen Inc.
- AstraZeneca
- Bayer AG
- Bluebird Bio, Inc.
- Bristol Myers Squibb Company
- Coloplast Corp
- Eli Lilly and Company
- F. Hoffmann-La Roche Ltd.
- Fresenius Kabi AG
- Genentech Inc.
- GSK Plc.
- Ipsen
- Johnson & Johnson
- Merck & Co., Inc.
- Merck KGaA
- Novartis AG
- Pfizer Inc.
- Regeneron Pharmaceuticals, Inc.
- Sanofi
- Other Prominent Players
Key Market Segmentation:
By Treatment Type
- Immune Checkpoint Inhibitors
- Immune System Modulators
- Cell therapy
- Cancer Vaccines
- Oncolytic Virus
- Others
By Disease Type
- Melanoma
- Lung Cancer
- Blood Cancer
- Renal Cell Carcinoma
- Prostate Cancer
- Bladder Cancer
- Others
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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