Cancer Biologics Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Monoclonal Antibodies, Cytokine-Based Immunotherapy, Cancer Vaccines, CAR-T Cell Therapy, Immune Checkpoint Inhibitors), By Application (Non-small Cell Lung Cancer, Prostate Cancer, Breast Cancer, Acute Myeloid Leukemia, Lymphoma, Others), By End User (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 100.86 Billion
CAGR (2026-2031)	7.17%
Fastest Growing Segment	Immune Checkpoint Inhibitors
Largest Market	North America
Market Size (2031)	USD 152.81 Billion

Market Overview

The Global Cancer Biologics Market will grow from USD 100.86 Billion in 2025 to USD 152.81 Billion by 2031 at a 7.17% CAGR. Cancer biologics are therapeutic agents derived from living organisms, including monoclonal antibodies and vaccines, engineered to treat malignancies by targeting specific immune pathways or tumor cells. The market is primarily supported by the rising global demand for precision medicine and substantial capital allocation toward oncology research, which ensures a steady pipeline of therapeutic innovations. These structural drivers differ from temporary market trends, as they represent a fundamental shift in clinical standards of care. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, the research-based pharmaceutical industry invested an estimated €55 billion in R&D in Europe, underscoring the sustained financial commitment fueling this sector.

Despite the strong growth trajectory, the market encounters a significant challenge regarding the prohibitive costs associated with biopharmaceutical manufacturing and development. This financial burden necessitates high pricing strategies that create complex reimbursement hurdles and restrict patient access, particularly in cost-sensitive healthcare systems. Such economic barriers effectively limit the addressable market in developing regions and pose a substantial impediment to the global expansion of these therapies.

Key Market Drivers

The rising global incidence of various cancer types acts as the primary catalyst for market expansion, necessitating the widespread adoption of advanced biological therapies. As the burden of oncological diseases intensifies due to aging populations and environmental factors, healthcare systems are increasingly relying on biologics for their target-specific mechanisms which differ significantly from systemic chemotherapy. This surge in patient volume directly correlates with a higher demand for monoclonal antibodies and immunotherapies, compelling providers to integrate these treatments into standard protocols. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024', the United States is projected to witness over 2 million new cancer cases in 2024 for the first time, a milestone that highlights the critical need for effective biological interventions.

Parallel to rising demand, the rapid advancement in biological drug development and the subsequent surge in regulatory approvals are structurally reshaping the sector. Biopharmaceutical developers are prioritizing the engineering of complex molecules that offer superior efficacy and safety profiles, leading to a prolific period of commercialization for novel agents. This regulatory momentum ensures that breakthroughs in research translate quickly into available treatments. According to the U.S. Food and Drug Administration, January 2024, in 'Novel Drug Approvals for 2023', the agency approved 55 novel therapeutics, marking a significant increase in approval rates that facilitates faster market entry for innovative cancer biologics. The substantial commercial viability of these approved therapies is evident in the financial performance of market leaders. According to Merck & Co., in 2024, worldwide sales for the oncology biologic Keytruda grew 19% to $25.0 billion in the full year of 2023.

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Key Market Challenges

The prohibitive costs associated with biopharmaceutical manufacturing and development constitute a primary impediment to the growth of the Global Cancer Biologics Market. Unlike traditional small-molecule drugs, cancer biologics require highly complex production processes involving living cell lines, which necessitates substantial upfront capital and sophisticated infrastructure. This intense financial burden forces manufacturers to implement high pricing strategies to recoup research and development investments. Consequently, these elevated price points create significant friction within healthcare systems, leading to rigorous reimbursement scrutiny and restricted formulary inclusion.

This economic pressure directly hampers market expansion by limiting patient access to these advanced therapies, particularly in cost-sensitive regions. The pricing dynamics are further complicated by systemic markups that exacerbate the affordability crisis. According to the Pharmaceutical Research and Manufacturers of America, in 2024, hospital outpatient facilities charged 1.3 to 4.3 times more than physician offices for cancer medicines. Such disparities in pricing structure intensify the reimbursement hurdles mentioned in the market overview, effectively shrinking the addressable market as payers and patients struggle to absorb the escalating costs of care.

Key Market Trends

The rapid expansion of Antibody-Drug Conjugate (ADC) pipelines represents a structural pivot in the sector, moving beyond standard monoclonal antibodies toward armed constructs that deliver cytotoxic payloads directly to tumor cells. This trend is characterized by intense investment in manufacturing capabilities to support the complex conjugation processes required for these therapeutics, which offer higher potency with reduced systemic toxicity compared to traditional chemotherapy. Major industry players are securing their supply chains to ensure the scalability of these targeted agents, anticipating a sustained increase in clinical utilization. According to AstraZeneca, May 2024, in the press release 'AstraZeneca plans $1.5 billion manufacturing facility in Singapore', the company announced a significant capital commitment to construct a facility specifically designed to enhance the global supply of its ADC portfolio, reflecting the high strategic priority placed on this modality.

Concurrently, the integration of artificial intelligence into biologic drug discovery is fundamentally altering the efficiency of protein engineering and target identification. Pharmaceutical developers are increasingly forming high-value partnerships with technology firms to utilize generative models that predict protein structures and optimize binding affinities, effectively compressing the timeline for bringing novel biologics to clinical trials. These collaborations enable the exploration of vast biological spaces that were previously inaccessible through conventional screening methods, allowing for the design of therapeutics with superior specificity. According to Isomorphic Labs, January 2024, in the announcement 'Isomorphic Labs announces strategic partnerships with Eli Lilly and Company and Novartis', the company established a multi-target collaboration with Eli Lilly valued at up to $1.7 billion to apply digital biology approaches for the discovery of new therapeutic agents.

Segmental Insights

The Immune Checkpoint Inhibitors segment is currently identified as the fastest-growing category within the Global Cancer Biologics Market. This significant upward trend is largely attributed to the distinct mechanism of action, which blocks specific proteins to enable the immune system to recognize and eliminate tumor cells effectively. Growth is further accelerated by frequent product approvals from regulatory bodies like the U.S. Food and Drug Administration for an expanding range of oncology indications. Consequently, the increasing clinical preference for targeted immunotherapy over traditional treatment methods continues to drive widespread adoption and market expansion.

Regional Insights

North America dominates the Global Cancer Biologics Market due to the strong presence of major pharmaceutical companies and substantial investment in research and development. The region benefits from established healthcare systems that support the wide adoption of biologic therapies. Furthermore, regulatory agencies such as the U.S. Food and Drug Administration facilitate market growth through efficient drug approval processes for new oncology treatments. Rising cancer prevalence and favorable reimbursement policies also contribute significantly to the sustained demand for biologic products in the United States and Canada.

Recent Developments

• In January 2025, AstraZeneca and Daiichi Sankyo received approval from the U.S. Food and Drug Administration for datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate. This biologic therapy was authorized for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who had received prior systemic therapy. The regulatory decision was based on clinical trial results showing a statistically significant improvement in progression-free survival compared to standard chemotherapy. This launch introduced a new targeted biologic mechanism for this patient population, further diversifying the portfolio of advanced antibody-drug conjugates available in the Global Cancer Biologics Market.
• In September 2024, AstraZeneca presented breakthrough research results from the Phase III NIAGARA trial at the European Society for Medical Oncology Congress. The data demonstrated that a perioperative regimen of durvalumab, a monoclonal antibody targeting PD-L1, combined with chemotherapy, significantly improved event-free and overall survival in patients with muscle-invasive bladder cancer compared to chemotherapy alone. This study established the first immunotherapy-based regimen to show extended survival benefits in this setting. These findings underscore the expanding clinical utility of immune checkpoint inhibitors, reinforcing their critical role in driving growth and treatment standards in the Global Cancer Biologics Market.
• In July 2024, Novartis entered into a strategic collaboration with Dren Bio to discover and develop bispecific antibodies for oncology indications. Under the agreement, Novartis agreed to pay $150 million upfront, including a $25 million equity investment, with Dren Bio eligible to receive up to $2.85 billion in future milestone payments. The partnership focuses on leveraging Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform to engineer novel biologics that activate myeloid cells for tumor destruction. This high-value deal highlights the continued focus of major pharmaceutical companies on expanding their pipelines within the Global Cancer Biologics Market through external innovation.
• In May 2024, the U.S. Food and Drug Administration granted accelerated approval to tarlatamab-dlle, a first-in-class bispecific T-cell engager, for the treatment of extensive-stage small cell lung cancer. Developed by Amgen, this biologic therapy targets delta-like ligand 3 on tumor cells and CD3 on T-cells, directing the patient's immune system to destroy cancer cells. The approval was supported by data from the Phase 2 DeLLphi-301 trial, which showed durable objective responses in patients with disease progression following platinum-based chemotherapy. This product launch marked a significant advancement in the Global Cancer Biologics Market, introducing a novel immunotherapeutic modality for a difficult-to-treat malignancy.

Key Market Players

• Roche Holding AG
• Novartis AG
• Merck & Co., Inc.
• Bristol-Myers Squibb Company
• Amgen Inc.
• Johnson & Johnson
• Pfizer Inc.
• AstraZeneca plc
• Eli Lilly and Company
• AbbVie Inc

By Product	By Application	By End User	By Region
Monoclonal Antibodies Cytokine-Based Immunotherapy Cancer Vaccines CAR-T Cell Therapy Immune Checkpoint Inhibitors	Non-small Cell Lung Cancer Prostate Cancer Breast Cancer Acute Myeloid Leukemia Lymphoma Others	Hospitals & Clinics Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cancer Biologics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cancer Biologics Market, By Product:

• Monoclonal Antibodies
• Cytokine-Based Immunotherapy
• Cancer Vaccines
• CAR-T Cell Therapy
• Immune Checkpoint Inhibitors

• Cancer Biologics Market, By Application:

• Non-small Cell Lung Cancer
• Prostate Cancer
• Breast Cancer
• Acute Myeloid Leukemia
• Lymphoma
• Others

• Cancer Biologics Market, By End User:

• Hospitals & Clinics
• Ambulatory Care Centers
• Others

• Cancer Biologics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE