Cancer Biological Therapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Cancer Growth Blockers, Monoclonal Antibodies, Vaccines), By Distribution Channel (Hospitals, Retail & Mail Order Pharmacies), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 116.12 Billion
CAGR (2026-2031)	7.78%
Fastest Growing Segment	Monoclonal Antibodies
Largest Market	North America
Market Size (2031)	USD 182.03 Billion

Market Overview

The Global Cancer Biological Therapy Market will grow from USD 116.12 Billion in 2025 to USD 182.03 Billion by 2031 at a 7.78% CAGR. Cancer biological therapy constitutes a specialized category of treatment that utilizes living organisms, substances derived from them, or laboratory-produced versions to stimulate the body’s immune system to recognize and eliminate malignant cells. The primary drivers propelling this market include the escalating global incidence of cancer and the fundamental shift in clinical practice toward precision medicine, which necessitates targeted biological interventions over conventional non-specific treatments. According to the American Cancer Society, in 2024, 2,001,140 new cancer cases were projected to occur in the United States, indicating a substantial and growing patient base requiring effective therapeutic options.

Despite the robust demand, a significant challenge impeding market expansion is the exorbitant cost associated with the development and manufacturing of these complex biologics. This financial barrier results in high treatment prices that strain healthcare budgets and limit patient access, particularly in developing regions with constrained reimbursement frameworks.

Key Market Drivers

Accelerated regulatory pathways for novel biologics have fundamentally reshaped the Global Cancer Biological Therapy Market by compressing the timeline between clinical validation and patient access. Regulatory bodies have increasingly utilized expedited review mechanisms to facilitate the entry of innovative therapies, particularly for rare and refractory malignancies. This streamlined environment not only incentivizes pharmaceutical innovation but also ensures a rapid expansion of available treatment modalities. According to the American Association for Cancer Research, January 2024, in the 'Cancer Research Catalyst', the U.S. Food and Drug Administration approved 45 oncology drugs in 2023, highlighting the sustained velocity of market authorization for these complex interventions.

Simultaneously, the increasing adoption of targeted monoclonal antibodies remains a cornerstone of market revenue and clinical practice. These biologic agents have established themselves as the standard of care across multiple solid tumor indications, driving significant commercial growth through high utilization rates in both first-line and adjuvant settings. The financial magnitude of this segment is evident in the performance of leading checkpoint inhibitors; according to Merck & Co., February 2024, in the 'Fourth-Quarter and Full-Year 2023 Financial Results', annual sales of the monoclonal antibody Keytruda grew 19% to reach $25.0 billion in 2023. This commercial success is underpinned by massive capital commitment to further innovation, as demonstrated by Bristol Myers Squibb, which, according to its '2023 Annual Report' published in March 2024, invested $9.3 billion in research and development to advance its portfolio of medicines.

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Key Market Challenges

The exorbitant cost associated with the development and manufacturing of complex biologics stands as a substantial barrier to the expansion of the Global Cancer Biological Therapy Market. These elevated production expenditures compel pharmaceutical companies to implement premium pricing strategies to recover their research and development investments, thereby straining healthcare budgets and insurance frameworks globally. Consequently, payers in both developed and developing regions are increasingly enforcing stringent reimbursement criteria, which delays or denies coverage for these advanced treatments. This financial friction restricts the addressable patient population and limits the market penetration of otherwise effective therapies.

According to the American Cancer Society, in 2025, the annual list price for many new cancer prescription medicines exceeded $100,000, creating a severe financial burden for patients and healthcare systems. This pricing structure directly hampers market growth by fueling high rates of financial toxicity, which often forces patients to forgo or discontinue essential treatment. The resulting gap between clinical necessity and economic feasibility reduces the commercial adoption of biological therapies, preventing the market from realizing its full revenue potential.

Key Market Trends

The accelerated adoption of oncology biosimilars is fundamentally restructuring the market by introducing cost-effective alternatives to expensive reference biologics. This trend is primarily driven by the patent expiration of major blockbuster drugs and the intensified need for healthcare systems to optimize spending without compromising clinical outcomes. By offering clinically equivalent therapeutic options at reduced prices, biosimilars are expanding patient access to essential biological treatments, particularly in resource-constrained settings. This economic shift is substantial; according to the Association for Accessible Medicines, September 2025, in the '2025 U.S. Generic & Biosimilar Medicines Savings Report', the biosimilars industry has generated $56.2 billion in cumulative savings for patients and the healthcare system since the initial market entry of these agents.

Simultaneously, a surge in antibody-drug conjugate (ADC) development is establishing a new paradigm in targeted cancer intervention. Pharmaceutical companies are aggressively investing in this modality, which combines the specificity of monoclonal antibodies with the potency of cytotoxic agents to deliver cargo directly to tumor cells while minimizing off-target toxicity. This focus has translated into rapid commercial growth for approved ADCs, validating their potential to replace conventional chemotherapy in multiple indications. According to Pfizer Inc., August 2025, in the 'Second-Quarter 2025 Earnings' report, global sales of the antibody-drug conjugate Padcev increased 38% year-over-year to reach $542 million, underscoring the high clinical demand and market uptake for these precision therapeutics.

Segmental Insights

Monoclonal Antibodies represent the fastest-growing segment in the Global Cancer Biological Therapy Market, driven by their high specificity in targeting tumor antigens. This precision allows for the selective elimination of cancer cells while preserving healthy tissue, offering a distinct advantage regarding toxicity compared to conventional chemotherapy. The segment’s expansion is further supported by the increasing adoption of personalized medicine and continuous advancements in antibody engineering. Consequently, major regulatory bodies such as the U.S. FDA have granted numerous approvals for these therapies, validating their efficacy and reinforcing their essential role in modern oncology treatment protocols.

Regional Insights

North America maintains a dominant position in the Global Cancer Biological Therapy Market, driven primarily by substantial investments in research and development within the United States. The region benefits from the strong presence of major pharmaceutical companies and increasing cancer prevalence, which fuels demand for targeted treatments. Additionally, supportive regulatory frameworks provided by the U.S. Food and Drug Administration facilitate the rapid approval and commercialization of new therapies. Favorable reimbursement structures further enhance patient access to these treatments, ensuring North America remains the leading contributor to global market revenue.

Recent Developments

• In September 2024, Merck presented groundbreaking research data at the European Society for Medical Oncology (ESMO) Congress regarding its anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The company reported that the Phase 3 KEYNOTE-522 trial demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients with high-risk early-stage triple-negative breast cancer when the therapy was used in combination with chemotherapy. This result marked the first time an immunotherapy-based regimen showed a survival benefit in this specific patient population. The findings reinforce the role of this biological therapy as a standard of care in early-stage breast cancer treatment.
• In May 2024, Amgen announced that the U.S. Food and Drug Administration granted accelerated approval to Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer who have disease progression on or after platinum-based chemotherapy. This approval introduced the first and only delta-like ligand 3 (DLL3) targeting bispecific T-cell engager therapy to the market. The biological therapy works by directing the patient's own immune system to attack cancer cells expressing the DLL3 protein. The regulatory decision was based on positive response rates and duration of response data from a Phase 2 clinical trial, highlighting a significant advancement for this aggressive cancer type.
• In March 2024, AstraZeneca entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, for approximately $2 billion. This collaboration focuses on accelerating the development of next-generation radioconjugates, which are designed to deliver radioactive isotopes directly to cancer cells while minimizing damage to healthy tissue. The deal provides the company with access to a proprietary manufacturing and supply chain infrastructure essential for these complex biological therapies. The acquisition is expected to complement the company's existing oncology pipeline and offer new treatment options for patients with metastatic castration-resistant prostate cancer and other solid tumors.
• In February 2024, Bristol Myers Squibb completed the acquisition of RayzeBio, Inc., a clinical-stage radiopharmaceutical therapeutics company, for approximately $4.1 billion. This strategic transaction enhanced the company's oncology portfolio by adding a pipeline of actinium-based radiopharmaceutical therapeutics, including a lead program targeting gastroenteropancreatic neuroendocrine tumors. The acquisition underscores the organization's commitment to expanding its presence in the growing field of targeted cancer therapies. By integrating these novel modalities, the company aims to deliver precise and potent treatments to patients with solid tumors, further strengthening its position in the global cancer biological therapy market.

Key Market Players

• F Hoffmann-La Roche Ltd
• Novartis AG
• Merck KgAa
• Amgen Inc
• GSK PLC
• Celgene Corp
• Pfizer Inc
• Zydus Lifesciences Ltd
• Sun Pharmaceutical Industries Ltd
• Bayer AG

By Product	By Distribution Channel	By Region
Cancer Growth Blockers Monoclonal Antibodies Vaccines	Hospitals Retail & Mail Order Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Cancer Biological Therapy Market, By Product:

• Cancer Growth Blockers
• Monoclonal Antibodies
• Vaccines

• Cancer Biological Therapy Market, By Distribution Channel:

• Hospitals
• Retail & Mail Order Pharmacies

• Cancer Biological Therapy 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