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, 2020-2030F

Market Overview

Global Cancer Biological Therapy Market was valued at USD 112.08 Billion in 2024 and is expected to reach USD 147.92 Billion by 2030 with a CAGR of 7.69% during the forecast period. The global cancer biological therapy market refers to the rapidly evolving field of cancer treatment that utilizes biological agents, such as monoclonal antibodies, cytokines, and vaccines, to target and combat cancer cells. This market has witnessed significant growth and innovation over the years due to advances in biotechnology and a growing understanding of the molecular mechanisms underlying cancer. As the understanding of cancer genetics deepens, personalized medicine approaches are being employed to tailor cancer biological therapies to individual patients, optimizing treatment outcomes. The surge in cancer cases has prompted an increase in clinical trials for novel biological therapies. Regulatory agencies have also streamlined approval processes to expedite promising treatments to patients, further facilitating market growth. The global cancer biological therapy market is expanding beyond traditional markets, with emerging economies in Asia, Latin America, and the Middle East witnessing rapid growth. Improved healthcare infrastructure and increasing awareness of advanced cancer treatments are contributing to this expansion.

Key Market Drivers

Rising Cancer Incidence

Cancer has long been one of humanity's most formidable adversaries, affecting millions of lives across the globe. Recent years have witnessed a troubling surge in cancer incidence rates, with the disease becoming an ever-increasing public health concern. Paradoxically, this ominous trend has also created an environment ripe for innovation and advancement in the field of cancer treatment, particularly in the realm of cancer biological therapies. According to data from the World Health Organization (WHO), the incidence of cancer has been steadily climbing, with millions of new cases diagnosed each year. In May 2022, the United Kingdom secured an $11.4 million grant to sustain its ongoing cancer research efforts.This upward trajectory is driven by a combination of factors, including an aging population, lifestyle changes, environmental factors, and improved cancer detection methods.

The escalating cancer burden has created a pressing need for more effective and targeted treatments. Conventional treatments like chemotherapy and radiation therapy, while valuable, often come with severe side effects and limited efficacy. Biological therapies, on the other hand, offer the promise of better outcomes with fewer side effects. According to the latest data from IARC's Global Cancer Observatory, 10 types of cancer collectively accounted for approximately two-thirds of new cases and deaths globally in 2022. The data, which encompasses 185 countries and 36 types of cancer, reveals that lung cancer was the most prevalent worldwide, with 2.5 million new cases representing 12.4% of total new cases. Female breast cancer ranked second with 2.3 million cases (11.6%), followed by colorectal cancer (1.9 million cases, 9.6%), prostate cancer (1.5 million cases, 7.3%), and stomach cancer (970,000 cases, 4.9%). The genetic diversity of cancer is well-documented, and this diversity often necessitates personalized treatment approaches. Biological therapies, such as targeted therapies, are designed to pinpoint specific molecular abnormalities or mutations in cancer cells. This precision allows for the development of tailored treatment plans, increasing their effectiveness. Immunotherapy, a subset of biological therapy, has made remarkable strides in recent years. These treatments harness the body's immune system to identify and attack cancer cells, offering the potential for long-lasting remissions and even cures.

The increasing prevalence of immunotherapies like checkpoint inhibitors and CAR-T cell therapy is directly tied to their success in treating various cancer types. The pharmaceutical industry has responded to the rising cancer incidence by investing heavily in research and development. As the demand for more effective treatments grows, pharmaceutical companies are racing to develop and bring to market innovative cancer biological therapies, creating a competitive and dynamic landscape. Genetic testing and molecular profiling have become integral to cancer diagnosis and treatment planning. 

Advancements in Biotechnology In Cancer

Biotechnology has emerged as a game-changer in the field of cancer treatment, revolutionizing the way we combat this complex and devastating disease. Advancements in biotechnology have led to the development of innovative and highly targeted cancer biological therapies that offer new hope for patients worldwide. In May 2022, Enhertu received approval in the United States for use in patients with HER2-positive metastatic breast cancer who have previously undergone treatment with an anti-HER2-based regimen. Biotechnology encompasses a broad spectrum of techniques and technologies that leverage biological systems, living organisms, or their derivatives to develop new products and processes. In the context of cancer treatment, biotechnology has become instrumental in understanding the underlying mechanisms of the disease, discovering novel therapeutic targets, and designing precision treatments.

Advances in biotechnology have deepened our understanding of the molecular and genetic basis of cancer. Researchers can now identify specific genetic mutations, biomarkers, and signaling pathways that drive tumor growth. This knowledge has paved the way for the development of targeted therapies, a cornerstone of cancer biological treatments. Biotechnology has facilitated the production of monoclonal antibodies, which are engineered to bind to specific antigens on cancer cells. These antibodies can either block the growth signals of cancer cells or trigger the immune system to attack them. Monoclonal antibodies like trastuzumab (Herceptin) and rituximab (Rituxan) have revolutionized cancer treatment, particularly in breast and blood cancers.

Biotechnological advancements have enabled the development of cancer vaccines designed to stimulate the patient's immune system to recognize and attack cancer cells. Vaccines such as Provenge (sipuleucel-T) for prostate cancer and various therapeutic cancer vaccine candidates have shown promise in clinical trials.

Gene therapy, a cutting-edge biotechnological approach, involves modifying a patient's own genes to treat or prevent disease. In the context of cancer biological therapy, gene therapies are being developed to target and correct genetic mutations responsible for cancer. CAR-T cell therapies, which genetically engineer a patient's immune cells to fight cancer, exemplify this innovation. Biotechnology has transformed drug discovery processes. High-throughput screening, computational biology, and bioinformatics tools enable researchers to identify potential drug candidates more efficiently. This has led to the discovery of novel molecules for cancer treatment.

Biotechnology has facilitated the discovery and validation of biomarkers, which are crucial for patient stratification and treatment response prediction. Biomarker-driven approaches help identify patients who are most likely to benefit from specific cancer biological therapies, making treatments more effective and personalized. Biotechnology has improved bioprocessing and manufacturing techniques, ensuring the scalable production of biological therapies. This has lowered production costs and increased the availability of these treatments.

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Key Market Challenges

High Costs and Accessibility

One of the significant barriers to the widespread adoption of biological therapies for cancer is their high cost. The development, production, and administration of these treatments are inherently expensive due to their complexity and the specialized nature of the technologies involved. Biological therapies, such as immunotherapies and targeted therapies, often require extensive research and clinical trials before they can be approved, further driving up costs. The manufacturing processes for these treatments, which often involve biologic agents like monoclonal antibodies or CAR-T cells, require highly sophisticated facilities and expertise, contributing to their high price tags.

For patients, the cost of these therapies can be prohibitive, especially in regions without comprehensive health insurance coverage. Even with insurance, co-pays, and out-of-pocket expenses can place a significant financial burden on families. This issue is exacerbated in low- and middle-income countries where healthcare infrastructure may be limited, and access to advanced treatments is scarce. The disparities in access to life-saving cancer therapies are glaring, creating a gap between wealthier populations who can afford cutting-edge treatments and those who cannot. The global challenge of ensuring equitable access to these therapies requires concerted efforts from governments, pharmaceutical companies, and healthcare providers. Policy interventions, such as price regulation, subsidies, and international collaborations to reduce costs, could help mitigate these disparities. Initiatives like patient assistance programs or public health campaigns aimed at increasing awareness of available treatments may further address these challenges. Until such systemic solutions are in place, the high cost and limited accessibility of cancer biological therapies will remain a critical issue, preventing many patients from benefiting from potentially life-saving treatments.

Side Effects and Toxicities

Despite the targeted nature of many cancer biological therapies, they are not without their own set of side effects and toxicities. Unlike traditional treatments like chemotherapy, which indiscriminately affect both cancerous and healthy cells, targeted therapies are designed to act more selectively, minimizing damage to normal tissue. However, this increased specificity does not eliminate the potential for adverse reactions. For example, targeted therapies, including monoclonal antibodies and tyrosine kinase inhibitors, often cause skin reactions, rashes, or gastrointestinal disturbances such as nausea, diarrhea, or constipation. In addition to these relatively common side effects, more serious immune-related complications can also occur with immunotherapy treatments, particularly immune checkpoint inhibitors. These therapies work by unleashing the body’s immune system to attack cancer cells, but this heightened immune activity can sometimes lead to autoimmune reactions where the immune system mistakenly targets healthy tissues. This can result in conditions such as colitis, hepatitis, or even more severe organ damage. Managing these immune-related toxicities requires careful monitoring and, in some cases, the use of immunosuppressive drugs to dampen the immune response, which may reduce the effectiveness of the cancer treatment itself.

The challenge lies in balancing the management of these side effects with the need to maintain the therapeutic efficacy of the cancer treatment. In many cases, dose adjustments or treatment interruptions are required, potentially affecting the overall success of the therapy. Clinicians must navigate this delicate balance to ensure that patients receive the most effective treatment while minimizing discomfort and long-term health risks. As research advances, the development of strategies to predict and mitigate side effects will be essential for optimizing the benefit-risk profile of these therapies and improving the quality of life for cancer patients undergoing.

Key Market Trends

Growing Immunotherapy Revolution

Immunotherapy, a groundbreaking approach to cancer treatment, has ignited a revolution in the field of oncology. This remarkable advancement harnesses the body's immune system to fight cancer cells, providing hope to patients and transforming the landscape of cancer care. Immunotherapy represents a paradigm shift in cancer treatment. Unlike traditional therapies like chemotherapy and radiation, which directly target cancer cells, immunotherapy focuses on strengthening the body's own defenses against cancer. It stimulates the immune system to recognize and destroy cancer cells, offering several advantages.

Immunotherapy is highly precise. It targets only cancer cells while sparing healthy tissues, minimizing side effects. Some immunotherapies can induce durable responses, with the potential for sustained remission or even cures. Immunotherapy has expanded the arsenal of treatment options, particularly for advanced and hard-to-treat cancers. Immunotherapy has demonstrated efficacy in various cancer types, including melanoma, lung, bladder, and kidney cancers, among others. As research continues, the potential applications of immunotherapy are expected to grow, widening its reach in the market. Checkpoint inhibitors are a class of immunotherapies that block proteins that inhibit the immune response, allowing the immune system to recognize and attack cancer cells. Drugs like pembrolizumab (Keytruda) and nivolumab (Opdivo) have achieved remarkable success in clinical trials and have been approved for multiple indications, fueling market growth. CAR-T cell therapy is a type of immunotherapy that involves modifying a patient's T cells to express chimeric antigen receptors (CARs), which can recognize and target cancer cells. CAR-T therapies have shown exceptional results in treating certain blood cancers, such as leukemia and lymphoma. for instance, On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for the treatment of non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

Researchers are exploring the potential of combining immunotherapies with other treatments, such as chemotherapy and targeted therapies. These combination approaches aim to enhance the effectiveness of cancer treatment and broaden the scope of immunotherapy applications. The ongoing research and development of immunotherapies through clinical trials are expanding the portfolio of available treatments. New immunotherapeutic agents and novel combinations are continuously being tested, driving innovation and market growth.

Rise in Targeted Therapies

Targeted therapies represent a transformative approach to cancer treatment, offering new hope to patients by directly targeting the molecular and genetic abnormalities that drive cancer growth. In recent years, these precise and innovative treatments have played a pivotal role in shaping the landscape of the global cancer biological therapy market.

Targeted therapies minimize harm to healthy tissues, reducing the often-debilitating side effects associated with traditional treatments. By directly addressing the underlying genetic or molecular drivers of cancer, targeted therapies can be more effective, especially in cancers where traditional treatments have limited impact. According to the the World Health Organization (WHO)’s cancer agency, the International Agency for Research on Cancer (IARC), released the latest estimates of the global burden of cancer. In 2022, there were an estimated 20 million new cancer cases and 9.7 million deaths. The estimated number of people who were alive within 5 years following a cancer diagnosis was 53.5 million. About 1 in 5 people develop cancer in their lifetime, approximately 1 in 9 men and 1 in 12 women die from the disease. Targeted therapies are often tailored to individual patients based on genetic or molecular profiling, allowing for personalized treatment plans.

Advances in genomics and molecular biology have led to the discovery of numerous biomarkers and genetic mutations that drive cancer. Targeted therapies are developed to specifically address these aberrations, enabling more precise treatments. The pharmaceutical industry has invested heavily in research and development, leading to the creation of a wide range of targeted therapies. Drugs like imatinib (Gleevec), which targets the BCR-ABL gene in chronic myeloid leukemia (CML), have achieved remarkable success. Targeted therapies have demonstrated efficacy in various cancer types, including breast, lung, colorectal, and melanoma. As researchers uncover new targetable mutations, the scope of targeted therapy applications is expected to grow. Researchers are exploring the potential of combining targeted therapies with other treatments, such as immunotherapies and traditional chemotherapy. These combinations aim to enhance treatment effectiveness and broaden the range of treatable cancers. Ongoing clinical trials continue to expand the portfolio of available targeted therapies. New agents and innovative combinations are constantly being tested, driving innovation and market growth.

Segmental Insights

Distribution Channel Insights

Retail and mail-order pharmacies was expected to command a substantial market share in the Global Cancer Biological Therapy Market during the forecast period for several compelling reasons. The increasing prevalence of cancer worldwide necessitates easy access to advanced therapies, and retail and mail-order pharmacies provide a convenient distribution channel for these treatments. As patients and healthcare providers increasingly opt for personalized cancer therapies, the ability of retail and mail-order pharmacies to offer a wide range of biological therapies tailored to individual patient needs positions them favorably in the market.  the global trend toward home-based healthcare services further accentuates the significance of these pharmacies, as they enable patients to access and receive cancer biological therapies in the comfort of their homes, promoting greater patient compliance and treatment effectiveness. As a result, the retail and mail-order pharmacy segment is poised to play a pivotal role in the growth and accessibility of cancer biological therapies during the forecast period.

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Regional Insights

In the cancer biological therapy market  North America takes the lead as the most dominating region in 2024. The United States, in particular, emerges as the frontrunner both within North America and globally, attributed to a favorable reimbursement landscape coupled with substantial healthcare spending. The U.S. market benefits from an extensive network of cancer biological vaccine and drug manufacturers, bolstered by increased investments in research and development and government initiatives. Accessible health insurance policies covering life-threatening conditions incentivize individuals to seek these therapies, thereby driving market growth. The U.S. cancer gene therapy market has also witnessed significant expansion, thanks to a robust treatment pipeline and the increasing focus of industry players on pioneering cancer gene therapies and their delivery systems. An illustrative example of this trend is the extended collaboration agreement between the Cancer Institute, Inc. and McKesson Corporation, announced on June 27, 2022, which aims to enhance the delivery of cancer care by improving access to innovative treatments and streamlined services.  In the second position for market profitability is Europe, owing to its high disposable income levels and widespread awareness. The region's substantial cancer burden, a significant elderly patient population, and advancements in cancer therapies further contribute to the potential for market growth in the upcoming years. The introduction of novel molecular techniques, an evolving healthcare sector, and innovative technological approaches are expected to further augment the European market's prospects.

Recent Developments

• In June 2023, the FDA initiated a pilot program aimed at enhancing the safety of laboratory-developed tests for cancer biomarkers to improve diagnostic accuracy. The program is designed to enhance oncology patient care by ensuring transparency about the minimum performance standards required for in vitro diagnostic tests used with oncology drug products participating in the pilot.
• In March 2024, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for treating adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received at least two lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This approval is based on the response rate and duration of response and is granted under accelerated approval. Continued approval for this indication may depend on the verification and assessment of clinical benefit in confirmatory trials. For R/R CLL or SLL, Breyanzi is administered through a treatment process culminating in a single infusion containing 90 to 110 x 10^6 CAR-positive viable T cells.
• On January 8, 2024, Johnson & Johnson announced that it has entered into a definitive agreement to acquire Ambrx Biopharma, Inc., a clinical-stage biopharmaceutical company with a proprietary synthetic biology technology platform for designing and developing next-generation antibody drug conjugates (ADCs). The acquisition, valued at approximately $2.0 billion in total equity or $1.9 billion net of estimated cash acquired, will be conducted through an all-cash merger transaction. Ambrx is advancing a focused portfolio of clinical and preclinical programs aimed at optimizing the efficacy and safety of its candidate therapeutics across multiple cancer indications. These include ARX517, its proprietary ADC targeting PSMA for metastatic castration-resistant prostate cancer (mCRPC); ARX788, its proprietary ADC targeting human epidermal growth factor receptor 2 (HER2) for metastatic HER2+ breast cancer; and ARX305, its proprietary ADC targeting CD-70 for renal cell carcinoma.
• In April 2024, AGC Biologics announced the successful completion of the production of cancer-specific therapeutic antibody fragments in collaboration with Var2 Pharmaceuticals.

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

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:

o   Cancer Growth Blockers

o   Monoclonal Antibodies

o   Vaccines

• Cancer Biological Therapy Market, By Distribution Channel:

o   Hospitals

o   Retail & Mail Order Pharmacies

• Cancer Biological Therapy Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  Germany

§  United Kingdom

§  France

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  Japan

§  India

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cancer Biological Therapy Market.

Available Customizations:

Global Cancer Biological Therapy market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).