HPV16+ Recurrent Anal Cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

Squamous cell carcinoma of the anus is an orphan disease, and after more than three decades of slow progress in disease understanding and treatment, it is now making headway thanks to the development of taxane-based chemotherapy and immunotherapy. Over the past few decades, anal cancer has become more prevalent. An era of greater compliance with screening protocols and greater compliance with cancer treatment generally is bringing this apparent increase in incidence to the attention of regulatory and professional bodies in the field. In cases of metastatic or incurable cancer, palliative chemotherapy is frequently administered, but the outlook is still dismal. There is an urgent need for novel medications for the systemic treatment of SCCA.

Description

After more than three decades of slow progress in disease understanding and treatment, the orphan disease squamous cell carcinoma of the anus is now making headway thanks to the development of immunotherapy and chemotherapy based on taxanes. About 20 active combination clinical trials using an anti-PD1/L1 in addition to chemotherapy, radiation, tumor vaccines, anti-CTLA4, anti-EGFR, or antiangiogenic drugs are currently being conducted. Both the localized and advanced phases of these trials are ongoing. Additionally, a novel biomarker known as HPV circulating tumour DNA (HPV ctDNA) by liquid biopsy is enhancing not only the prognostic evaluation but also the direction of the therapy plan for this illness. Though still uncommon, squamous cell carcinoma of the anus (SCCA), particularly in its advanced stages, is becoming more widespread worldwide. HPV infection, primarily genotype 16, is the root cause of 90% of cases.

HPV16+ Recurrent Anal Cancer (Epidemiology)

Over the past few decades, anal cancer has become more common. In an era of greater compliance with screening protocols and greater compliance with cancer treatment generally, this apparent increase in incidence is alarming and attracting the attention of regulatory and professional bodies in the field. Anal cancer incidence has increased by about 2.1% annually between 2009 and 2018, whereas the incidence of cervical cancer is declining by about 2% annually. According to data from Surveillance, Epidemiology and End Results (SEER), from 2014 to 2018, there were 2.0 new cases of anal cancer for every 100,000 men and women, while there were 0.3 deaths for every 100,000 men and women. The lifetime incidence of anal cancer is 0.2%, according to SEER data from 2016 to 2018. According to a study of trends in disease using the US Cancer Statistics dataset, squamous cell carcinoma of the anus (SCCA) incidence increased by 2.7% annually between 2001 and 2015, with notable increases in people 50 years of age and older. The frequency of regional-stage SCCA nearly doubled during that time, while the occurrence of distant-stage SCCA tripled. Between 2001 and 2016, the annual death rate from anal cancer increased by 3.1%, with statistically significant increases among those over 50. The American Cancer Society predicts that in 2022, there will be about 9440 new cases of anal cancer diagnosed (6290 in women and 3150 in men), and about 1670 fatalities (930 in women and 740 in men). Anal cancer accounts for just 2.8% of all digestive system cancers. Around 48% of cancer cases worldwide are HPV-related, with that percentage rising to 14-15% in less developed countries like India and sub-Saharan Africa. HPV infection is a global public health concern that is becoming more and more important. Other cancers than squamous cell carcinoma, one of many cancer types, are responsible for about 20% of anal cancers. Non-squamous cell cancers of the anus, such as melanoma and adenocarcinoma, have an epidemiology that is typically more closely linked to those histological entities at other body sites.

HPV16+ Recurrent Anal Cancer -Current Market Size & Forecast Trends

The market for HPV16-positive recurrent anal cancer is expected to experience notable growth, with the global anal cancer therapeutics market projected to reach approximately USD 1.5 billion by 2032, driven by increasing incidence rates and advancements in treatment options. HPV16 is implicated in about 70% of anal cancer cases, highlighting a significant unmet need for effective therapies targeting this specific demographic. The introduction of innovative immunotherapies and combination treatments is anticipated to enhance patient outcomes, as evidenced by ongoing clinical trials demonstrating improved overall survival rates with novel combinations. North America is likely to dominate the market due to its advanced healthcare infrastructure and strong focus on cancer research, while the Asia-Pacific region is expected to see rapid growth as awareness and access to treatment options improve. Overall, the HPV16-positive recurrent anal cancer market is well-positioned for robust expansion through 2035, supported by continuous advancements in therapeutic strategies and increased emphasis on early detection and prevention.

Palliative chemotherapy is frequently administered in cases of metastatic or untreatable cancer, but the outlook is still bleak. There is an urgent need for novel medications for the systemic treatment of SCCA. Immunotherapeutic methods, such as vaccines, adoptive T-cell therapies, immune checkpoint inhibitors, and immunotherapeutic methods, are the primary treatment option being researched for anal cancer. Combinations of immunotherapy with anti-EGFR monoclonal antibodies or with antiangiogenics have also been studied in clinical trials; these developments could lead to systemic therapy for SCCA advancements that could revolutionize the field in the coming years. In the coming years, several pipeline medications with the potential to revolutionize the market will be released, including Atezolizumab (Genentech), Axalimogene filolisbac (Advaxis), BI 836880 (Ablynx), and others.

Report Highlights

HPV16+ Recurrent Anal Cancer - Current Market Trends

HPV16+ Recurrent Anal Cancer - Current & Forecasted Cases across the G8 Countries

HPV16+ Recurrent Anal Cancer - Market Opportunities and Sales Potential for Agents

HPV16+ Recurrent Anal Cancer - Patient-based Market Forecast to 2035

HPV16+ Recurrent Anal Cancer - Untapped Business Opportunities

HPV16+ Recurrent Anal Cancer - Product Positioning Vis-a-vis Competitors' Products

HPV16+ Recurrent Anal Cancer - KOLs Insight