Cancer Biologics Market - Global Forecast 2026-2032

The Cancer Biologics Market size was estimated at USD 108.88 billion in 2025 and expected to reach USD 116.58 billion in 2026, at a CAGR of 6.59% to reach USD 170.30 billion by 2032.

Biologics have ushered in a new era of cancer treatment by harnessing the specificity and complexity of living systems to combat malignant cells. Unlike small-molecule drugs, these therapies derive from living organisms and encompass a diverse array of modalities such as cancer vaccines, cell therapy, gene therapy, monoclonal antibodies, and recombinant proteins. Monoclonal antibodies in particular have undergone remarkable refinement with advances in antibody engineering giving rise to next-generation formats including bispecific antibodies that can simultaneously engage two distinct targets and antibody–drug conjugates that deliver cytotoxic payloads directly to tumor cells. In parallel, cell therapies such as chimeric antigen receptor T-cell (CAR-T) approaches and adoptive tumor-infiltrating lymphocyte therapies have demonstrated the power of personalized immunotherapy, while gene therapies continue to expand possibilities for genetic corrections and novel delivery vectors.

This introduction sets the stage for exploring how biologic modalities are reshaping oncology, offering unprecedented precision and adaptability. The convergence of advanced manufacturing, molecular engineering, and immunology is propelling a wave of innovation. Antibody-based treatments now not only block tumor-promoting signals but also actively recruit immune effector functions. Meanwhile, recombinant proteins such as growth factors and cytokines are being optimized to modulate the tumor microenvironment and enhance therapeutic indices. Collectively, these biologic platforms underscore a shift toward more targeted, effective, and safer cancer interventions that form the foundation of today’s personalized oncology paradigm.

The maturation of monoclonal antibody engineering continues to unlock powerful new treatment paradigms. Bispecific antibodies, capable of binding two different antigens, have crossed the threshold from proof-of-concept into broad clinical applications. Following FDA approvals of agents like Zenocutuzumab-zbco, Zanidatamab-hrii, and Epcoritamab-bysp, numerous trials are underway to evaluate their durability and safety in both hematologic and solid malignancies. Antibody–drug conjugates (ADCs) have similarly advanced, leveraging refined linker technologies to improve payload stability and minimize off-target toxicity. Recent acquisitions, such as Pfizer’s $43 billion purchase of Seagen, underscore the strategic emphasis on these targeted constructs.

In parallel, cell and gene therapies are rapidly evolving from experimental concepts into mainstream oncology treatments. CAR-T cell therapies have expanded beyond hematological cancers into solid tumor trials, with innovations addressing safety and manufacturing scalability. The February 2024 FDA accelerated approval of lifileucel (Amtagvi), an adoptive TIL therapy for advanced melanoma, exemplifies the potential to harness patient-derived immune cells against solid tumors. Meanwhile, gene editing and viral vector delivery systems are being refined to improve transduction efficiency and specificity, further broadening the therapeutic arsenal. These transformative shifts illustrate how biologic innovation is redefining the landscape of cancer care.

In April 2025, the U.S. government enacted a 10% global tariff on imported active pharmaceutical ingredients and finished therapeutic products with the stated goal of bolstering domestic manufacturing capacity. This policy, coupled with tariffs of up to 245% on Chinese imports, has introduced significant cost pressures across biologics supply chains. An Ernst & Young–commissioned analysis projected that a 25% tariff on finished pharmaceutical products could raise annual U.S. drug costs by nearly $51 billion and increase prices by up to 12.9% if fully passed to consumers. Companies reliant on imported reagents, cell culture media, and single-use technologies are grappling with higher operational expenses and supply chain disruptions that threaten production timelines.

These tariff measures are also impacting research and development investments. Over half of surveyed biotech firms reported that tariff-related cost increases would constrain their ability to fund clinical trials, with early-stage companies being particularly vulnerable. Significant concerns have arisen about potential manufacturer discontinuations of low-margin therapies, which could exacerbate drug shortages and compromise clinical trial continuity. A recent survey of U.S. cancer centers indicated that 89% experienced shortages of at least one systemic therapy within a single month, and 75% reported shortages of two or more treatments, signaling acute supply risks in oncology care.

The cancer biologics landscape can be understood through multiple dimensions of segmentation that reveal deeper market dynamics. Analysis by product type encompasses categories such as cancer vaccines, which stimulate antigen-specific immune responses, and cell therapies that engineer patient-derived immune cells. Gene therapies deliver genetic material via viral or nonviral vectors, aiming for durable corrective effects. Monoclonal antibodies remain dominant, subdivided into anti-CD20 agents like obinutuzumab and rituximab, anti-HER2 therapies such as pertuzumab and trastuzumab, immune checkpoint inhibitors targeting PD-1/PD-L1 pathways including atezolizumab, nivolumab, and pembrolizumab, and anti-VEGF agents exemplified by bevacizumab. Recombinant proteins, engineered for cytokine or growth factor functions, also play a pivotal role in modulating tumor environments.

Further stratification by cancer type highlights the distinct requirements of treating breast, colorectal, hematologic, lung, melanoma, and prostate malignancies, each presenting unique biological profiles and therapeutic endpoints. End user segmentation differentiates treatment venues-from ambulatory surgery centers offering outpatient infusions to specialized oncology centers centralizing complex biologic administrations. Distribution channels range from hospital pharmacies equipped for cold-chain management to specialty distributors and online platforms facilitating direct-to-patient access. These segmentation insights provide a multifaceted view of stakeholder needs and channel dynamics that drive both clinical adoption and commercial strategies.

The Americas continue to lead in biologics development and adoption, driven by substantial R&D investment and robust domestic manufacturing expansions. Merck’s announcement of a $1 billion investment in a Keytruda manufacturing facility in Delaware underscores the strategic emphasis on localized production amid tariff uncertainties and aims to secure uninterrupted supply for the U.S. market. Meanwhile, academic and contract-manufacturing entities across North America are scaling capacity to support both innovator and biosimilar pipelines, reinforcing the region’s position as a hub for biologic innovation.

In the Europe, Middle East & Africa region, regulatory frameworks balance rigorous evaluation with initiatives to enhance access. The European Medicines Agency’s reapproval of GSK’s Blenrep for multiple myeloma marks a regulatory win amid a complex benefit-risk landscape, while approval of 28 biosimilars in 2024 reflects a concerted drive to lower treatment costs and broaden patient access across oncology indications. However, emerging policy shifts-such as considerations to streamline biosimilar comparability trials-signal evolving requirements that manufacturers must navigate carefully.

Asia-Pacific is distinguished by rapid clinical trial activity and expanding manufacturing ecosystems. In 2024, China accounted for over half of all registered CAR-T studies globally, reflecting government prioritization of cell and gene therapies. Major ADC licensing deals and new facility investments, including AstraZeneca’s Singapore ADC plant, illustrate the region’s growing significance in advanced biologics production and development collaborations.

Roche has strategically fortified its oncology portfolio through targeted acquisitions and pipeline collaborations. The definitive agreement to acquire Poseida Therapeutics, valued at up to $1.5 billion, provides Roche with an off-the-shelf allogeneic CAR-T platform and complementary R&D capabilities in hematologic malignancies and solid tumors. This acquisition builds on their existing partnership and accelerates Roche’s entry into scalable cell therapies. However, the recent suspension of Elevidys gene therapy shipments outside the U.S. has highlighted the complexities of global distribution and regulatory oversight in advanced biologics.

Merck’s oncology leadership is anchored by Keytruda, which continues to expand its indications through new FDA approvals in head and neck cancers demonstrating significant reductions in recurrence and disease progression. In parallel, Bristol Myers Squibb’s CAR-T therapy Breyanzi has achieved multiple line extensions for non-Hodgkin lymphoma, underscoring its growing clinical relevance. These strategic milestones underscore how leading companies leverage both innovative biologics and operational investments to reinforce their market positions.

To mitigate tariff disruptions and safeguard supply chains, industry leaders should diversify their sourcing strategies by establishing multiple supplier relationships across geographies and investing in onshore manufacturing partnerships. Operational resilience can be enhanced through scenario planning that incorporates potential tariff escalations and regulatory shifts, allowing rapid adaptation of cost structures and supply networks.

Innovation pipelines must remain robust by maintaining balanced R&D portfolios that include both high-risk breakthrough modalities and more established biologic formats. Collaborations with biotech innovators and academia can help share development costs and accelerate access to emerging technologies. Engaging proactively with regulators through programs like the FDA’s Project Orbis and EMA’s Cancer Medicines Pathfinder initiative can streamline review timelines and clarify expectations for novel therapies. Finally, transparent stakeholder communication on pricing and value demonstration will be critical to securing reimbursement and sustaining patient access in fluctuating policy environments.

This research integrates a multidisciplinary approach combining secondary data analysis, expert interviews, and quantitative database reviews. Secondary sources included peer-reviewed literature accessed via PubMed and NCBI repository searches, providing mechanistic insights and clinical trial outcomes for biologic modalities. Regulatory guidance documents from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies and the European Medicines Agency’s CHMP meeting reports were systematically reviewed to map evolving approval pathways and post-approval requirements.

Primary qualitative insights were obtained through discussions with industry stakeholders, including supply chain experts and R&D leaders. Clinical trial activity and pipeline developments were cross-referenced using clinicaltrials.gov and company investor presentations to ensure alignment between reported advances and real-world progress. Data synthesis emphasized triangulating findings across sources to minimize bias and enhance the reliability of segmentation, regional, and company-level insights.

The biologics revolution in oncology is characterized by converging advances in antibody engineering, cell and gene therapies, and sophisticated delivery platforms. Segmentation by product type, cancer indication, end user, and distribution channel reveals nuanced dynamics that inform commercialization strategies. Regionally, the Americas lead in production capacity, EMEA balances rigorous regulatory standards with biosimilar access initiatives, and Asia-Pacific emerges as a hub for trial activity and biomanufacturing growth. Leading companies such as Roche and Merck exemplify strategic portfolio evolution through acquisitions, R&D investments, and operational expansions. Yet, the imposition of 2025 U.S. tariffs underscores vulnerabilities in global supply chains and R&D funding, compelling industry leaders to adopt resilient sourcing, diversified pipelines, and proactive regulatory engagement.

Looking ahead, the sustained momentum in biologic innovation will depend on balancing risk and reward across emerging modalities and established products. Collaboration between industry, regulators, and academia will be central to accelerating patient access while ensuring safety and efficacy. Ultimately, the ability to navigate evolving policy landscapes, harness cutting-edge science, and maintain supply chain agility will determine who leads the next wave of transformative cancer therapies.

Ready to transform your oncology strategy with unparalleled insights into the cancer biologics landscape? Connect with Ketan Rohom, Associate Director of Sales & Marketing at 360iResearch, to secure your copy of the comprehensive Cancer Biologics Market Research Report. Gain immediate access to in-depth analyses, proprietary segmentation insights, and expert recommendations to drive your competitive advantage. Contact Ketan today to learn how this report can empower your organization’s decision-making and accelerate your path to market leadership.