According to latest report, the global cancer biological therapy market size was estimated at USD 107.19 billion in 2023 and is projected to hit around USD 232.06 billion by 2033, growing at a CAGR of 8.03% during the forecast period from 2024 to 2033. North America dominated market with the largest revenue share of 36.00% in 2023.
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The Biological therapy, also known as biotherapy or immunotherapy, harnesses the body's natural immune system to combat diseases like cancer and other conditions.
Biological therapy for cancer has spurred rapid growth within the healthcare market. Utilizing the body's immune system to target and destroy cancer cells, this innovative treatment approach spans various cancer types, effectively slowing tumor growth and curbing metastasis. Compared to traditional treatments, biological therapy often results in fewer toxic side effects, enhancing patient outcomes and quality of life. Key to this therapy are biological response modifiers (BRMs), which are produced in larger quantities through advanced laboratory techniques.
This capability not only supports cancer treatment but also extends to managing conditions like rheumatoid arthritis and Crohn's disease, highlighting the expanding applications and market potential of biological therapies. It has emerged as a significant growth factor in the cancer biological therapy market by offering targeted treatments that can enhance the body's ability to fight diseases effectively. Biological therapies are increasingly utilized to mitigate side effects associated with conventional treatments, thereby expanding their therapeutic applications and market demand.
- In May 2024, Amgen announced FDA approval of IMDELLTRA (tarlatamab-dlle) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) after disease progression on platinum-based chemotherapy, expanding therapeutic options for this aggressive cancer type.
Cancer Biological Therapy Market Key Takeaways
- North America dominated market with the largest revenue share of 36.00% in 2023.
- By product, the monoclonal antibodies segment has captured revenue share of 39% in 2023.
- By route of administration, the injectable segment has held 42.5% revenue share in 2023.
- Oral segment has accounted revenue share of over 62.5% in 2022 and it is growing at a CAGR of 6.8% from 2024 to 2033.
- The phase II segment is projected to expand at the largest growth rate in 2023.
- The vaccine type segment is forecasted to grow at the largest growth between 2024 to 2033.
- The specialized cancer treatment centers distribution channel segment dominates the market.
- The hospitals and clinics distribution channel is the fastest-growing segment of the global market.
U.S. Cancer Biological Therapy Market Size & Trends
The U.S. cancer biological therapy market size was USD 27.01 billion in 2023, calculated at USD 29.24 billion in 2024, and is expected to reach around USD 59.71 billion by 2033, expanding at a CAGR of 8.26% from 2024 to 2033.
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North America stands as the forefront region in the cancer biological therapy market, driven by substantial new cancer diagnoses and mortality rates projected for 2022, with an estimated 1.9 million new cases and 609,360 deaths in the United States alone. The region's leadership is bolstered by advanced healthcare infrastructure and significant investments in oncological research and development. Institutions like the INCan in Mexico City play a crucial role, offering specialized cancer care to diverse patient demographics across the country, including those with limited financial means. This underscores North America's pivotal position in advancing cancer treatment innovations and enhancing patient outcomes through biological therapies.
- In March 2024, U.S. FDA approved Bristol Myers Squibb’s Breyanzi as the first CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marking a breakthrough in personalized cancer treatment.
Europe holds a prominent position in the cancer biological therapy market, driven by factors such as high disposable income and widespread awareness about cancer treatment options. Projected statistics for 2023 in the EU-27 indicate an estimated 1,261,990 cancer deaths, reflecting the region's significant healthcare challenges and the demand for advanced treatment modalities. European countries are renowned for their top-tier cancer care facilities offering personalized treatment at competitive costs, attracting a growing number of international patients seeking superior medical care.
Finland, in particular, stands out for its excellence in treating various cancers, bolstered by high survival rates and adherence to EU patient directives facilitating cross-border healthcare access. This highlights Europe's pivotal role in advancing cancer treatment standards and attracting a global patient base for biological therapies.
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Cancer Biological Therapy Market Dynamics
Driver
Advancements in Biological Therapies
Biological therapies are revolutionizing oncology by precisely targeting cancer cells while minimizing damage to healthy tissues. Ongoing innovations are focused on enhancing the effectiveness and accessibility of these therapies. Modifications to bispecific antibodies and CAR T cells aim to improve their efficacy and bioavailability, while research into oncolytic viruses is advancing to enhance therapy outcomes. Efforts are also underway to bolster the immunogenicity and stability of cancer vaccines. The synergy achieved by combining different biological therapies, such as immunotherapy with oncolytic viruses or cancer vaccines, is increasingly pivotal in cancer treatment strategies. The identification of new therapeutic targets, particularly neoantigens and tumor stroma-associated antigens, is driving significant growth in the cancer biological therapy market, promising enhanced treatment outcomes and expanding therapeutic options for patients worldwide.
- In June 2023, FDA launched a pilot program to enhance the safety of laboratory-developed tests for cancer biomarkers, aiming to improve diagnostic accuracy.
Restraint
Complexity of Cancer
The intricate nature of cancer poses significant challenges to the advancement of biological therapies. Each patient's cancer is uniquely complex, with variations even among cells within the same tumor and changes occurring over time. This inherent heterogeneity makes cancer difficult to effectively target and treat with biological therapies. The dynamic nature of cancer progression complicates treatment strategies, often necessitating personalized approaches tailored to individual patient profiles. These complexities pose barriers to achieving consistent therapeutic efficacy across diverse cancer types and stages, thereby limiting the growth potential of the cancer biological therapy market.
Opportunity
Advancement in Precision
Biological therapies in cancer treatment, encompassing monoclonal antibodies, adoptive cell transfer, gene therapy, cytokines, cancer vaccines, oncolytic viruses, immunoconjugates, and targeted therapies, are experiencing rapid growth. These therapies align closely with the emerging paradigm of precision oncology, which leverages next-generation sequencing (NGS) to identify novel mutations in cancer cells. By targeting genetic aberrations in oncogenes and tumor suppressor genes that drive tumor development, biological therapies enable personalized treatment strategies tailored to individual patient profiles.
This capability not only enhances therapeutic efficacy but also improves patient outcomes by minimizing adverse effects associated with traditional treatments. The evolving landscape of precision medicine in oncology presents significant opportunities for the expansion of the cancer biological therapy market, driving innovation and fostering advancements in targeted cancer therapies.
Cancer Biological Therapy Market Trends
Governments of various nations are implementing initiatives to raise awareness of cancer and its diagnosis
Worldwide, the burden of cancer is increasing, and cancer treatments may be altered following regional and national priorities. Cancer biological therapy aims to get the immune system to recognize and destroy cancer cells. There were approximately 19,298,790 new cases of cancer and 9,968,149 reported cases worldwide, according to the Globocan Report 2020.
The most common types of cancer are those found in the breast, lungs, colorectum, and prostate. In the treatment of various cancers, biological therapy is used to stop or slow the growth of the tumor and stop cancer from spreading. Biological therapy frequently has fewer toxic side effects compared to other cancer treatments.
In order to assist individuals in detecting cancer earlier, the governments of various nations are implementing initiatives to raise awareness of cancer and its diagnosis. For instance, the Health Minister of Tamil Nadu, India, stated in February 2022 that the Government of Tamil Nadu is participating in formulating a policy to identify 66% of cancer patients in the first and second stages by 2033 to provide appropriate treatment. The market is expected to expand as a result of these policies.
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Report Highlights
Product Insights
The Monoclonal antibodies segment is poised for significant growth in the upcoming years, driven by their precise targeting of specific proteins on cell surfaces, particularly in cancer therapy. This specificity enhances their effectiveness and reduces side effects compared to traditional anti-cancer drug therapies, thereby boosting patient preference for advanced biological treatments. These laboratory-produced antibodies are designed to attack protein molecules expressed by cancer cells, underscoring their pivotal role in the evolving landscape of cancer biological therapies.
The vaccine segment is projected to experience rapid growth within the cancer biological therapy market. Treatment vaccines aim to leverage the body's immune response against cancer cells by targeting tumor-associated antigens that are unique to or overexpressed by cancer cells. These vaccines are a type of immunotherapy designed to enhance the body's natural defenses to recognize and attack cancer cells effectively. Unlike preventive vaccines, which aim to prevent infections that can lead to cancer, treatment vaccines are specifically tailored for patients already diagnosed with cancer, offering targeted therapeutic benefits in cancer management and treatment.
By Phase Insights
The phase III clinical trials segment dominates the cancer biological therapy market, representing a critical stage where new therapies compete to capture significant market share. Their pivotal role, Phase III randomized controlled trials (RCTs) in oncology often face higher failure rates compared to other medical disciplines, posing challenges for drug registration. These trials are predominantly sponsored by the pharmaceutical industry, underscoring its growing role in advancing cancer therapeutics. Concerns persist over the reliability of preclinical models in assessing new anticancer agents, highlighting the need for robust evidence of biological efficacy before progressing to clinical development. As Phase III trials shape market dynamics and regulatory approvals, optimizing their design and ensuring rigorous scientific validation remain crucial for achieving successful outcomes in the competitive landscape of cancer biological therapies.
The phase II clinical trials segment is poised for rapid expansion within the cancer biological therapy sector. Following successful safety evaluations in Phase I trials, Phase II trials assess the efficacy of new treatments across specific cancer types. Physicians focus on various treatment goals, such as tumor reduction, prolonged disease stability, or delayed cancer recurrence. Typically, Phase II trials involve uniform dosing, although some studies employ random assignment to different treatment groups to optimize safety and treatment response evaluations. This phase plays a pivotal role in determining the therapeutic potential and optimal usage conditions of emerging cancer therapies, influencing subsequent clinical development pathways and market positioning within the competitive landscape of cancer biological therapies.
Route of Administration Insights
The Injectable route is the most preferred treatment option and hence accounted for dominating the market
Based on the route of administration, the cancer biological therapy market is divided into oral and injectable. Among these types, the injectable is the leading segment and holds the maximum market share. The intravenous injectable type is well-known for its rapid action due to its 100% bioavailability, hence preferred most in emergencies.
The oral segment will be the fastest growing segment due to rising preferences among physicians and patients as they are easy to administer and eliminate unfavorable side effects such as fever, chills, and soreness at the injection site. The extensive R & D activities and conduct of clinical trials are expected to boost the segment growth.
By Distribution Channel
Specialized cancer treatment centers play a dominant role in the distribution channel of the cancer biological therapy industry. These centers not only specialize in advanced cancer treatments but also serve as models for implementing high-quality clinical management practices that can be replicated across healthcare services. They offer a range of essential clinical and supportive services including diagnostic imaging, pathology, surgery, and palliative care, which are crucial for comprehensive cancer care. Innovative financing models within these centers contribute to the development of financial protection in healthcare, aligning with efforts towards achieving universal health coverage. This integrated approach ensures that cancer patients receive comprehensive, coordinated care that addresses both medical and financial aspects effectively.
Hospitals and clinics represent the fastest-growing sectors in the global cancer biological therapy industry. These institutions serve as pivotal distribution channels for biological therapies, leveraging the body's immune system to detect and combat cancer cells effectively. Biological therapy functions by inhibiting or controlling the proliferation of cancer cells and enhancing the immune system's ability to detect and target cancerous cells for destruction. Hospitals and clinics play a crucial role in administering these therapies, providing specialized medical infrastructure and expertise essential for delivering advanced cancer treatments. Their rapid growth underscores the increasing adoption of biological therapies worldwide, driven by their efficacy in cancer management and the growing demand for innovative treatment options among patients and healthcare providers.
- In November 2023, Pfizer and Astellas received FDA approval for XTANDI in the earlier treatment setting for prostate cancer, offering a new treatment option for patients.
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Recent Developments
- In March 2024, Astellas’ VYLOY (zolbetuximab) was approved in Japan for the treatment of gastric cancer, marking a significant advancement in cancer therapy options.
- In February 2024, Ipsen’s Onivyde regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, received FDA approval, enhancing treatment options for this challenging cancer type.
- In February 2024, ImmunityBio announced FDA approval of ANKTIVA, a first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer, offering a novel treatment option for patients.
- In November 2023, Truqap (capivasertib) plus Faslodex was approved in the US for patients with advanced HR-positive breast cancer, offering a new therapeutic option.
- In August 2023, Astellas and Poseida Therapeutics announced a strategic investment to support Poseida’s innovations in cancer cell therapy, contributing to advancements in personalized medicine.
- In April 2023, BioNTech and DualityBio formed a global strategic partnership to accelerate the development of antibody-drug conjugate therapeutics for solid tumors, aiming to enhance treatment efficacy.
- In June 2022, CureVac accelerated its oncology strategy with the acquisition of Frame Cancer Therapeutics, expanding its antigen discovery platform for cancer therapies.
- In April 2024, Pearl Bio and Merck partnered to discover new cancer therapies, aiming to advance treatment options in oncology.
Cancer Biological Therapy Market Companies:
- Incyte
- ELI Lilly
- Merck
- Sanofi
- Bayer
- Novartis International
- Roche
- Pfizer
- Bristol-Myers Squibb
- Amgen
- Seattle Genetics
- Takeda Pharmaceuticals
- Spectrum Pharmaceuticals
- GlaxoSmithKline
- Celgene Corporation
- Otsuka
- AstraZeneca, Plc.
- Abbvie
- Eisai
Cancer Biological Therapy Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cancer Biological Therapy market.
By Product
- Monoclonal antibodies (MAB)
- Naked MAB
- Conjugated MAB
- Bispecific MAB
- Vaccines
- Preventive vaccines
- Therapeutic vaccines
- Cancer growth blockers
- Tyrosine kinase inhibitors (TKI)
- Proteasome inhibitors (PI)
- mTOR inhibitors
- Blood cell growth factors (BCGF)
- Lenograstim
- Filgrastim
- Cytokines
- Interferons
- Interleukins
By Phases
- Phase I
- Phases II
- Phases III
By Route of Administration
- Oral
- Injectable
By Distribution Channel
- Specialized Cancer Treatment Centers
- Hospitals & Clinics
- Retail Pharmacies
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
Reasons to Purchase this Report
- Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
- Provision of market value (USD Billion) data for each segment and sub-segment
- Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
- Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
- Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled
- Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players
- The current as well as the future market outlook of the industry with respect to recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions
- Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis
- Provides insight into the market through Value Chain
- Market dynamics scenario, along with growth opportunities of the market in the years to com
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