Cancer Biologics Market

Market Overview

The global cancer biologics market size was valued at USD 114.8 billion in 2023 and is projected to reach USD 205.7 billion by 2032, registering a CAGR of 6.7% during the forecast period (2024-2032). The global cancer biologics market share is predicted to expand significantly over the forecast period as regulatory bodies approve more biologic drugs for cancer therapy. 

Cancer biologics, or biopharmaceuticals or biologics, are medicines used to treat cancer. These medications are made from living organisms or their components, such as proteins, antibodies, nucleic acids, and living cells. Unlike standard chemotherapy medications, which are produced chemically, cancer biologics are designed to target specific molecular pathways involved in cancer growth, progression, and immune response.

The emphasis on tailored medications, which represents a change from the old one-size-fits-all strategy, is considerably driving market growth. Personalized medicine, which is personalized to each cancer patient's unique genetic and molecular traits, provides more targeted and effective therapies, especially given cancer's heterogeneity. Furthermore, advances in genomics and molecular profiling technologies help to understand the molecular complexities of distinct malignancies better, allowing for the creation of therapies that precisely target the pathways that drive a specific patient's cancer. The increased acknowledgment of patients' inherent genetic uniqueness feeds the demand for individualized treatments, resulting in significant market growth over the predicted period.

Highlights

• Monoclonal Antibodies account for the largest share of the market by type.

Market Dynamics

Global Cancer Biologics Market Drivers

Increasing Cancer Incidence and Prevalence

The rising incidence and prevalence of cancer worldwide are significant drivers of the cancer biologics market trend. The World Health Organization (WHO) predicts a 77% increase in new cancer cases worldwide by 2050, from 20 million in 2022. The WHO also predicts that 2,001,140 new cancer cases and 611,720 cancer deaths will occur in the United States by 2024.

Furthermore, one of the most common cancer kinds worldwide is breast cancer, which is on the rise. According to the International Agency for Research on Cancer (IARC), one in every 12 women will be diagnosed with breast cancer throughout her lifetime, and one in every 71 will die from it in nations with a very high HDI. In low-HDI countries, only one in every 27 women is diagnosed with breast cancer during her lifetime, but one in every 48 dies from it. 

Moreover, the rising incidence of cancer highlights the critical need for effective treatment alternatives, fueling demand for novel medicines such as cancer biologics. These medicines provide targeted and individualized cancer treatment by treating specific biological pathways or genetic alterations associated with the disease. Monoclonal antibodies, such as trastuzumab (Herceptin) and pertuzumab (Perjeta), target the HER2 protein in breast cancer, leading to better outcomes for patients with HER2-positive tumors.

As the cancer burden grows, there is an increasing demand for effective and tailored medicines to enhance patient outcomes and fulfill unmet medical requirements. Cancer biologics are a potential approach to cancer treatment, providing personalized and creative treatments to battle this complex and challenging disease.

Global Cancer Biologics Market Restraints

High Cost of Biologics Therapies

Cancer biologics are frequently associated with higher development, manufacturing, and treatment costs than conventional chemotherapy medications. The complicated manufacturing methods, demanding quality control requirements, and specialized infrastructure required for biological production all contribute to increased production costs. Furthermore, the tailored nature of many biological medicines, such as monoclonal antibodies that target specific molecular pathways or abnormalities, might drive up treatment costs. The high cost of cancer biologics creates hurdles for patients, healthcare providers, and payers, limiting access to these medications and potentially affecting market growth. Biologics typically cost between USD 10,000 and USD 30,000 per year, with the most expensive costing more than USD 500,000. For example, Humira, a biologic drug, costs more than USD 6,000 for every carton, while Zolgensma, another biologic pharmaceutical, costs USD 2.1 million per treatment. 

Furthermore, monoclonal antibodies (mAbs) are a type of cancer biologic commonly used to treat various cancers. Drugs such as trastuzumab (Herceptin) for HER2-positive breast cancer and bevacizumab (Avastin) for colorectal, lung, and other malignancies have transformed cancer treatment, but they are expensive. Trastuzumab is priced at USD 49,915 for adjuvant treatment and USD 28,350 for metastatic breast cancer treatment, according to ncbi.nlm.nih.gov. According to a 2020 study, the lifetime discounted cost of one year of adjuvant trastuzumab plus chemotherapy is USD 4,878, compared to adjuvant chemotherapy alone at USD 1,575. 

Moreover, healthcare systems and payers bear the burden of high drug prices because they are responsible for financing the expenses of cancer treatment. Increased spending on pricey cancer biologics strains healthcare budgets, potentially leading to tough decisions about resource allocation, reimbursement practices, and patient access to therapy. 

Global Cancer Biologics Market Opportunity

Expansion of Immuno-Oncology

Immuno-oncology, or using the body's immune system to combat cancer, is a promising field of cancer biologics research and development. Immune checkpoint inhibitors, chimeric antigen receptor (CAR) T-cell treatments, and cancer vaccines are biologics under investigation in immuno-oncology. Pembrolizumab, commonly known as Keytruda, has demonstrated success in various cancers, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC). Pembrolizumab is a humanized monoclonal antibody that inhibits the protein PD-1, which prevents T lymphocytes from targeting inflammatory tissues and cancer cells. This boosts the immune system's ability to target melanoma cells and tumors.

Additionally, enfortumab vedotin (Padcev) in combination with pembrolizumab (Keytruda) was approved by the FDA in December 2023 for bladder cancer that has progressed to other parts of the body or could not be surgically removed. Immune checkpoint inhibitors and other immuno-oncology medicines are increasingly used in various cancer indications, boosting biopharmaceutical companies' market expansion and revenue generation.

Furthermore, the immuno-oncology pipeline is strong, with more clinical studies assessing novel immune checkpoint inhibitors, combination treatments, and next-generation biologics across various cancer types and treatment scenarios. Immuno-oncology therapies are expanding into new markets and healthcare settings, such as community oncology clinics, academic medical institutions, and emerging countries, creating prospects for market growth and patient access to breakthrough treatments.

Regional Analysis

The global cancer biologics market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global cancer biologics market shareholder and is estimated to grow at a CAGR of 6.9% over the forecast period. North America leads the cancer biologics market and is expected to increase at a considerable CAGR. The American Cancer Society (ACS) predicts that 1,958,310 new cancer cases and 609,820 cancer deaths will occur in the United States in 2023. These estimates are compiled by the American Cancer Society using data from central cancer registries and the National Center for Health Statistics. The primary drivers of growth include a well-developed and technologically advanced healthcare infrastructure and well-regulated legislation. Rising government initiatives and increased research and development activities in cancer biologics accelerate the creation of new biologics. At the same time, the number of pharmaceutical and biotechnology enterprises in this region promotes regional market growth. The trend toward generating fully humanized monoclonal antibodies is expected to accelerate, owing to a perceived low level. Approximately 70% of breast cancer cases and 55% of colorectal cancer cases are treated with biologics.

Additionally, payment programs in the United States cover biologics such as monoclonal antibodies. For example, UNITUXIN, an immunotherapy medication used to treat neuroblastoma, is covered by Medicare Part B. The high frequency of cancer and the availability of advantageous reimbursement systems are driving market expansion in the United States. Furthermore, organizations such as the American Cancer Society, the American Breast Cancer Foundation (ABCF), and the Esophageal Cancer Awareness Association (ECAA) are launching projects to help patients, caregivers, survivors, family members, and anyone else at risk from the disease. As a result, the regional market is expected to grow throughout the forecast period. 

Asia-Pacific is anticipated to exhibit a CAGR of 7.1% over the forecast period. Asia-Pacific has seen a consistent increase in cancer cases, which can be ascribed to factors such as population growth, age, and lifestyle changes. The rise in cancer incidence has raised the need for effective cancer treatments, such as biological medicines. India's growing biologic industry is the primary engine of expansion, with respondents noting 'India's increasing domestic demand, bio-investment, and potential for expanded exports to developed countries.' India has the most licensed biosimilars of any country, with over 95. The government is also one of the top 12 global biotechnology hotspots and Asia Pacific's third-largest hub. 

Furthermore, the biosimilar pipeline in India is also robust, owing to the Indian government's initiative to provide incentives to Indian biosimilar producers, the expiration of current biological patents, and India's Central Drugs Regulation Standard Control Organization, which closely aligns guidelines with global regulators such as the US FDA, MHRA, and others. According to recent sources, more than 40 biosimilars are now under clinical development in India. In China, 20 to 25% of newly diagnosed breast cancer patients receive biologic treatment.

In addition, improving healthcare infrastructure is another critical element driving the cancer biologics market size in Asia-Pacific. Countries in the region have made significant investments in healthcare infrastructure, including constructing modern hospitals, cancer centers, and research facilities. This increased infrastructure allows for the research, manufacturing, and delivery of biologic pharmaceuticals for cancer treatment, improving patient access to these therapies.

The European cancer biologics market is integral to the worldwide oncology biologics landscape. Europe is critical in developing, adopting, and commercializing cancer biologics because of its robust healthcare infrastructure, excellent research skills, and significant patient population. The European Medicines Agency (EMA) oversees Europe's well-established regulatory framework for approving and commercializing cancer biologics. The unified marketing authorization process allows biopharmaceutical companies to acquire clearance for cancer biologics in several European Union (EU) member states via a single application, expediting market access and enabling prompt patient access to novel medications.

Furthermore, in the second quarter of 2023, the European Medicines Agency (EMA) approved more than 21 new oncology drugs, including Nivolumab (Opdivo) for pediatric melanoma. The cancer kinds that received the most approvals were diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma and non-small cell lung cancer. 

Segmental Analysis

The global cancer biologics market is segmented based on type.

The market is further segmented by type into Monoclonal Antibodies, Growth Factors, Blood and Blood Products, Vaccines, and Toxins.

Monoclonal antibodies dominated the cancer biologics market and will expand at a significant CAGR over the projection period. Monoclonal antibodies (mAbs) are laboratory-created molecules that mimic the immune system's ability to combat dangerous infections, such as cancer cells. These biologics target specific proteins on cancer cells' surfaces or in the tumor microenvironment, thereby inhibiting tumor development, encouraging immune-mediated destruction, or delivering lethal payloads to cancer cells. Monoclonal antibodies, such as trastuzumab (Herceptin) for HER2-positive breast cancer and rituximab (Rituxan) for specific forms of lymphoma, have shown significant clinical efficacy and safety in cancer treatment.

Additionally, the rising prevalence of cancer, increased emphasis on genomic research and development, and the introduction of breakthrough genetic technologies such as next-generation sequencing have all benefited market growth. Furthermore, the affordable technologies required to create mAbs for research have resulted in market growth.

Other beneficial reasons for the sector include increased patient and clinician awareness of mAb therapy applications, enhanced medication availability, therapeutic antibodies in cost-sensitive markets, and regulators' rapid adoption of new medicines. Furthermore, speedy approvals of revolutionary mAbs are predicted to result in a high adoption rate. For example, if the FDA approves popular treatments such as Herceptin, Avastin, Rituxan, and Remicade, the industry will benefit even more. Furthermore, additional mAbs awaiting therapeutic licensure are currently undergoing clinical studies. Therefore, the expanding drug pipeline will present this sector with prospective growth possibilities.

Blood and blood products play an essential role in cancer treatment, especially in patients undergoing intense chemotherapy or stem cell transplant. Blood transfusions, platelet transfusions, and clotting factors obtained from blood plasma are critical for treating anemia, thrombocytopenia, and coagulation abnormalities caused by cancer and its treatments. Blood products such as intravenous immunoglobulin (IVIG) may also enhance immune function and avoid infections in immunocompromised cancer patients.

Cancer vaccines and toxoids are biological medicines that cause the immune system to recognize and fight cancer cells. Cancer vaccines contain tumor-specific antigens or antigens associated with malignant cells, stimulating the immune system and creating memory against cancer cells. Toxoids are pathogen-derived toxins made non-toxic while retaining immunogenic characteristics, acting as antigens to elicit immune responses. Cancer vaccines and toxoids show promise for cancer prevention, immunotherapy, and therapeutic vaccination techniques, with current research aimed at generating effective vaccinations for diverse cancer types such as cervical cancer, prostate cancer, and melanoma.

Recent Developments

• January 2024- The European Commission approved Roche's Tecentriq SC, the EU's first PD-L1 cancer immunotherapy subcutaneous injection for numerous cancer types.
• March 2024- Novartis offers new evidence on the safety and efficacy of Zolgensma, including sustained and increased motor milestones in older and heavier children with SMA.
• February 2024- Dupixent® sBLA has been accepted for FDA priority review for treating COPD with type 2 inflammation.