Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Research Report Segmented By product type (Anti- prostate-specific membrane antigen PSMA Monoclonal Antibody-Based, Anti-cytotoxic T-lymphocyte-associated antigen 4 CTLA-4 Monoclonal Antibody-Based, Anti-programmed cell death protein 1 (PD-1)/ligand PD-L1 PD-1/PD-L1 Monoclonal Antibody-Based); By Application (localized prostate cancer, metastatic prostate cancer, castration-resistant prostate cancer); By Distribution Channels (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies); By End-User (Hospitals and Clinics, Cancer Research Centers, Academic and Research institutes); and Region Forecast (2023 2030)

Market Size and Overview:

The Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market was estimated to be worth USD 74.79 Billion in 2022 and is projected to reach a value of USD 285.15 Billion by 2030, growing at a CAGR of 18.21% during the forecast period 2023-2030.

Monoclonal antibodies represent a viable approach for treating prostate cancer through immunotherapy, a therapeutic method employing synthetic proteins. These proteins are designed to selectively bind to specific locations on or around prostate cancer cells, thereby hindering their activities, delivering cytotoxic agents, or triggering an immune response. Various molecules, such as PSMA, prostatic acid phosphatase, CTLA-4, PD-1, PD-L1, and B7-H3, can be targeted by monoclonal antibodies. The utilization of these antibodies can be standalone or in combination with other modalities like chemotherapy, radiation, or alternative immunotherapies.

The advantages of monoclonal antibody treatment are manifold, encompassing exceptional specificity, an extended serum half-life, and the capacity for immune effector functions. This approach holds promise for significantly enhancing the quality of life for a substantial global population. The existing monoclonal antibody-based therapies and those anticipated in the future have the potential to bring about substantial improvements in the well-being of millions of individuals worldwide.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Drivers:

Sustained Dominance of Monoclonal Antibodies in the Global Immunotherapeutic Landscape:

The global cancer immunotherapy market is categorized based on the type of therapy employed, encompassing cancer vaccines, immune checkpoint inhibitors, PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, immune system modulators, monoclonal antibodies, and other modalities. Notably, monoclonal antibodies held a substantial market share in 2021, emerging as the most widely recommended immunotherapeutic agents globally. The advent of effective immunotherapeutic options began with Amgen's approval of Blincyto (blinatumomab), a bispecific antibody targeting B-cell lymphoblastic leukemia. Monoclonal antibodies have consistently been the preferred treatment method in a significant portion of the global healthcare market when compared to alternative segments. Their cost-effectiveness has contributed to their widespread adoption. Ongoing research and development in the application of monoclonal antibodies, including conjugated, bispecific, and naked antigen-binding antibodies, have unveiled new possibilities in cancer treatment.

Elevated Incidence of Prostate Cancer as One of the Most Prevalent Male Cancers Globally:

Prostate cancer, a malignant tumor affecting the prostate gland within the male reproductive system, manifests through symptoms such as urinary issues, erectile dysfunction, blood in urine or semen, and bone pain. Multiple factors, including age, ethnicity, family history, genetic predisposition, lifestyle, and environmental exposure, can influence the development of prostate cancer. The risk of prostate cancer escalates with age, predominantly affecting males over 50. Additionally, a genetic predisposition or familial history increases the likelihood of developing prostate cancer. The escalating incidence of prostate cancer underscores the urgent need for safe and effective therapies that enhance patient survival and quality of life. One such therapeutic approach targeting antigens or molecules expressed by prostate cancer cells or within their microenvironment is monoclonal antibody-based therapy. Monoclonal antibodies offer the capability to inhibit, poison, or engage the immune system in attacking cancer cells, presenting a promising avenue in prostate cancer treatment.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Challenges:

Potential Side Effects and Immune-Related Toxicities Associated with Monoclonal Antibody-Based Therapy for Prostate Cancer:

Upon the administration of monoclonal antibody-based therapy for prostate cancer, adverse reactions, commonly known as infusion reactions, may occur, including allergic reactions, rash, fatigue, fever, nausea, diarrhea, and infections. The spectrum of adverse effects encompasses anaphylaxis, anaphylactoid responses, serum sickness, tumor lysis syndrome, and cytokine release syndrome. The severity of these side effects varies from mild to moderate, severe to life-threatening, or potentially fatal, depending on factors such as the type, dosage, and schedule of monoclonal antibody-based therapy, along with the patient's health status and medical history. Stimulation or suppression of the immune system by monoclonal antibodies can lead to undesirable reactions, involving autoimmune diseases, inflammation, or organ damage. Organs and systems such as the skin, gastrointestinal tract, liver, lungs, endocrine glands, neurological system, and blood cells may be affected by these immune-related toxicities. Manifesting before, during, or after therapy, these toxicities may persist or resolve spontaneously or in response to immunosuppressive medications.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Segmentation: By Product Type

• Anti- Prostate Specific Membrane Antigen (PSMA) Monoclonal Antibody-Based
• Anti- Cytotoxic T-Lymphocyte Associated Antigen 4 (CTLA-4) Monoclonal Antibody-Based
• Anti-Programmed Cell Death Protein 1 PD-1/ligand PD-L1(PD-1/PD-L1) Monoclonal Antibody-Based
• Others

The sector witnessing the most rapid expansion is the Anti-Programmed Cell Death Protein 1 PD-1/ligand PD-L1 (PD-1/PD-L1) Monoclonal Antibody-Based sector. This growth is attributed to the favorable outcomes demonstrated by PD-1/PD-L1 inhibitors in treating various malignancies, including prostate cancer. These inhibitors function by inhibiting the interaction between PD-1, present in immune cells, and PD-L1, found in cancer cells. Consequently, the immune system becomes more adept at recognizing and combating cancer cells. The increasing incorporation of PD-1/PD-L1 inhibitors in prostate cancer immunotherapy is propelling the expansion of this market.

The market is dominated by the Anti-Prostate Specific Membrane Antigen (PSMA) Monoclonal Antibody-Based segment. PSMA, a protein extensively expressed on the surface of prostate cancer cells, serves as an attractive target for immunotherapy. Monoclonal antibodies targeting PSMA enable precise targeting of prostate cancer cells, facilitating the delivery of therapeutic drugs or activation of the immune system against cancer cells. The dominance of this market segment is attributed to the high prevalence of PSMA as a target in prostate cancer immunotherapy research and the increasing number of clinical studies exploring PSMA-targeted monoclonal antibodies.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Segmentation: By Application

• Early-Stage prostate cancer
• Metastatic prostate cancer
• Castration-resistant prostate cancer

The market category expected to experience the fastest growth is metastatic prostate cancer, characterized by the spread of cancer to other regions such as bones, lymph nodes, liver, or lungs. The projected high compound annual growth rate (CAGR) is driven by factors including the escalating incidence and mortality of metastatic prostate cancer, limited efficacy and survival benefits of traditional treatments, and the introduction of new monoclonal antibodies targeting metastatic lesions, thereby enhancing clinical outcomes. Notable examples include lutetium-177-PSMA-617, pembrolizumab, nivolumab, atezolizumab, and enoblituzumonoclonal antibody-based treatments for metastatic prostate cancer.

Castration-resistant prostate cancer (CRPC), signifying prostate cancer progression despite reduced testosterone levels due to hormonal treatment, is poised to be the most dominant category in market segmentation by application. This prominence is fueled by the high frequency and poor prognosis associated with CRPC, the availability of authorized monoclonal antibodies for CRPC, and the substantial demand and acceptance of monoclonal antibodies for CRPC. Examples include Sipuleucel-T, ipilimumab, pembrolizumab, nivolumab, atezolizumab, and enoblituzumonoclonal antibody-based treatments for CRPC.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Segmentation: By distribution channels

• Hospital pharmacies
• Retail pharmacies
• Online pharmacies

Online pharmacies, which directly provide monoclonal antibodies for prostate cancer immunotherapy to clients through e-commerce platforms, are expected to exhibit the highest growth in the market sector. This projection is driven by the increasing acceptance and penetration of e-commerce, growing demand for home delivery services, availability of discounts and offers, and the convenience and privacy offered by online pharmacies. The anticipated high CAGR underscores the potential growth of this market segment.

Hospital pharmacies, located within or in close proximity to hospitals and responsible for administering monoclonal antibodies for prostate cancer immunotherapy to patients or providers, are anticipated to be the most prevalent category in market segmentation by distribution channels. This anticipation is based on factors such as the high prescription and consumption rates of monoclonal antibodies for prostate cancer immunotherapy in hospital settings, the presence of trained and qualified pharmacists, assurance of quality and safety standards, and reimbursement policies and government support for hospital pharmacies. This segment is expected to hold the largest market share.
 

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Segmentation: By End User

• Hospitals and clinics
• Cancer research centers
• Academic and research institutes

Academic and research institutes, organizations engaged in research and education across various aspects of monoclonal antibody-based prostate cancer immunotherapy, are anticipated to exhibit the fastest growth rate among market segments. The high CAGR is attributed to increasing funding and support for monoclonal antibody-based research from diverse sources, including government agencies, non-governmental organizations, business partners, and philanthropic contributors. Notable examples include Stanford University, University of California San Francisco, Johns Hopkins University, National Cancer Institute, Cancer Research UK, and Parker Institute for Cancer Immunotherapy.

Hospitals and clinics, healthcare institutions providing diagnosis, treatment, and care for prostate cancer patients utilizing monoclonal antibodies for immunotherapy, are expected to be the most prevalent sector in market segmentation by end-user. This expectation is grounded in the widespread prescription and consumption of monoclonal antibodies for prostate cancer immunotherapy in hospital and clinic settings. Factors such as the availability of trained and qualified healthcare professionals, adherence to quality and safety standards, reimbursement policies, government support for hospitals and clinics, contribute to this segment's anticipated largest market share.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Segmentation: By Region

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

North America is projected to be a highly profitable market for cancer immunotherapy during the forecast period. This is primarily driven by the established healthcare infrastructure and increased government initiatives in the region. Factors contributing to North America's significant market share include the growing number of cancer patients, increased adoption of immunotherapy, and the development of bioinformatics tools facilitating drug development. Conversely, the market in Asia Pacific is anticipated to experience the fastest growth during the forecast period. The introduction of novel immunotherapy medications in China and Japan, approval of several innovative drug compounds and combination medicines by the FDA, and the ongoing clinical trials in these regions contribute to the rapid growth of the immunotherapy market in Asia Pacific. The approval of new medications is leading to increased utilization of immunotherapy for tumor treatment in China and Japan.

COVID-19 Impact on the Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market:

The monoclonal antibody-based market for prostate cancer has experienced both positive and adverse effects due to the COVID-19 pandemic. The global health crisis has triggered heightened interest in monoclonal antibody research and development, encompassing various diseases, with a particular focus on COVID-19. Notably, certain monoclonal antibody-based drugs approved or under investigation for COVID-19, such as basiliximab, imdevimab, and sotrovimab, target immune checkpoint molecules involved in both viral and tumor immune evasion. This dual applicability suggests potential utility in the context of prostate cancer, leading to increased awareness and demand for monoclonal antibody-based treatments among patients and healthcare professionals.

However, the monoclonal antibody-based market for prostate cancer has encountered several challenges amid the COVID-19 pandemic. The disruption caused by the pandemic has adversely affected the production process and supply chain of monoclonal antibodies, resulting in shortages and delays in certain regions. Furthermore, the recruitment and operation of clinical trials for monoclonal antibody-based prostate cancer treatments have been impeded by the epidemic, contributing to a slowdown in progress and a decrease in data quality. Additionally, the pandemic has introduced heightened costs and stress for prostate cancer patients, potentially limiting their access to and adherence to monoclonal antibody-based therapy.

Global Monoclonal Antibody-Based Prostate Cancer Immunotherapy Market Recent Developments:

• In December 2021, the U.S. FDA granted approval for lutetium-177-PSMA-617 (Lutathera), a radiolabeled anti-PSMA monoclonal antibody, for the management of metastatic castration-resistant prostate cancer (mCRPC). This approval is specifically for cases that have progressed following prior treatment with at least one androgen receptor-directed therapy and one taxane-based chemotherapy.
• In May 2021, Dostarlimab (Jemperli), an anti-PD-1 monoclonal antibody, received accelerated approval from the U.S. FDA. This approval is for the treatment of recurrent or advanced endometrial cancer that has shown progression during or after prior treatment with platinum-containing chemotherapy. The indication extends to tumors with a mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).

Key Players:

• Amgen, Inc.,
• NOVARTIS AG,
• GlaxoSmithKline plc,
• ELI LILY AND COMPANY,
• Pfizer, Inc.,
• BAYER AG
• Merck & Co
• Janssen Biotech
• Bristol-Myers Squibb Company,
• Spectrum Pharmaceuticals