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PUBLISHER: Mellalta Meets LLP | PRODUCT CODE: 1634459

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PUBLISHER: Mellalta Meets LLP | PRODUCT CODE: 1634459

Anal intraepithelial neoplasia | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

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Anal cancer is at risk because of anal intraepithelial neoplasia (AIN). AIN is categorized according to whether it affects just the outer third of the skin (AIN1), the outer two thirds of the skin (AIN2), or the entire thickness of the skin (AIN3). Low grade anal squamous lesion (LSIL) is another name for AIN1. Anal cancer has become more common recently. The significant increase in incidence is concerning and has caught the attention of industry bodies and professional organizations at a time when screening guidelines are being followed and universal cancer treatment is being implemented. Historically, most doctors preferred surgical resection as the treatment. Despite this aggressive approach to treatment, patients are still susceptible to relapse, and repeat surgery can increase the risk of fecal stricture or incontinence, particularly in those with peripheral disease. Patients with multifocal disease or patients with a higher disease burden had a higher incidence of recurrence or incomplete resection.

Description

Anal intraepithelial neoplasia (AIN) is a risk factor for anal cancer. is categorized according to whether it affects just the outer third of the skin (AIN1), the outer two thirds of the skin (AIN2), or the entire thickness of the skin (AIN3). Low grade anal squamous lesion (LSIL) is another name for AIN1. Anal cancer has become more common recently. The significant increase in incidence is concerning and has caught the attention of industry bodies and professional organizations at a time when screening guidelines are being followed and universal cancer treatment is being implemented. Historically, most doctors preferred surgical resection as the treatment. Despite this aggressive approach to treatment, patients are still susceptible to relapse, and repeat surgery can increase the risk of fecal stricture or incontinence, particularly in those with peripheral disease. Patients with multifocal disease or patients with a higher disease burden had a higher incidence of recurrence or incomplete resection.

Anal intraepithelial neoplasia (Epidemiology)

Anal cancer has become more common over recent years. The significant increase in incidence is concerning at a time when universal cancer treatment is being implemented and screening protocols are being followed, and it has caught the attention of industry bodies and professional organizations. Between 2009 and 2018, the incidence of rectal cancer increased by roughly 21% per year, while the incidence of cervical cancer decreased by about 2% annually. Squamous cell carcinoma of the anus (SCCA) incidence increased among people 50 and older between 2001 and 2015, according to a study of trends in the disease that used the American Cancer Statistics data set. This increase was primarily due to the fact that this cancer is more common in people over 50. The frequency in the central regional phase nearly doubled in frequency during this time, while the frequency in the distal central phase tripled. Rectal cancer deaths increased by 31% annually from 2001 to 2016, with a particularly noticeable rise among those aged 50 and over. The incidence of AIN in the general population is difficult to estimate. Rectal cancer is uncommon, affecting 1 in 100,000 men and women on average. Anal intraepithelial neoplasia (AIN), a precursor lesion, is frequent in HIV-infected people. A tumor-causing virus called human papillomavirus (HPV) (HPV 16, 18) is linked to more than 90% of ASCCs. Around 4% of cancer cases worldwide are HPV-related, rising to 14 to 15% in less developed nations like India and sub-Saharan Africa. A significant global public health issue is HPV infection.

Anal intraepithelial neoplasia -Current Market Size & Forecast Trends

The market for anal intraepithelial neoplasia (AIN) is expected to grow steadily, with estimates indicating a value of approximately USD 0.91 billion in 2024, projected to reach around USD 1.26 billion by 2029, reflecting a compound annual growth rate (CAGR) of 6.60% during this period. Key drivers of this market expansion include the rising incidence of anal cancer and AIN, particularly among high-risk groups, alongside increasing awareness of the importance of early diagnosis and intervention. Advances in screening technologies, such as high-resolution anoscopy and anal cytology, are becoming more prevalent, enabling earlier detection and better management of AIN. Furthermore, the growing acceptance and implementation of HPV vaccination programs are expected to play a crucial role in reducing the incidence of AIN and its progression to cancer. As healthcare systems prioritize preventive care and innovative treatment options, the AIN market is likely to see enhanced investment in research and development, leading to improved therapeutic modalities and patient outcomes in the coming years.

The majority of doctors used surgical resection as their preferred procedure in the past. Patients can still relapse despite this aggressive treatment, and reoperation can increase the risk of fecal stricture or incontinence, especially in patients with peripheral disease. Patients with multifocal disease or patients with a higher disease burden had a higher incidence of recurrence or incomplete resection. After a broad local excision, recurrence rates have been reported to range from 9 to 63% in the literature. Some have suggested monitoring high-risk worms in light of these findings; chemotherapy would be the preferred course of action once rectal cancer has advanced. There hasn't been any research that contrasts the two strategies' morbidity or mortality rates. IHD can be thickened using electrocautery, or it can be used during anoscopy. In HIV-negative patients with high AIN scores and no disease recurrence, preliminary studies have demonstrated positive outcomes. Patients with HIV had an 80% relapse rate after two years of follow-up, though. Further research revealed that among HIV-positive patients, one third responded fully, another third partially, and the remaining third did not respond at all. The response is dependent on the amount of electrocautery, with a recurrence rate of 25% after 30 months. The morbidity of AIN treatment might be lessened by infrared or laser coagulation. The majority of patients tolerate it well and it can be done in the office. With limited penetration into deeper tissues, infrared and laser coagulation primarily target superficial lesions, allowing patients to get back to their normal routines quickly. Early studies have indicated some benefits, but the FDA has not yet approved this treatment for AIN. Patients who underwent IR coagulation did not develop rectal cancer, according to retrospective data; however, AIN recurrence is still a problem, particularly in patients who are HIV-positive. HIV-positive patients had a 1-year relapse rate of 61% compared to non-HIV-positive patients' 38%. Overall, this treatment may be successful, but more baseline information and standardization are required. In contrast to more invasive procedures, local treatment is an option. TCAs, imiquimod, and 5-FU make up the majority of topical medications. TCAs are generally safe, but they do have some serious side effects. It is well tolerated and can be used during an investigation. In 71-79% of patients, high-grade AIN is cleared by TCAs, according to retrospective studies, but large or bulky diseases may not respond well to TCAs. Topical application of the chemotherapy drug 5-FU, which prevents DNA synthesis, eliminates AIN. Although clearance rates vary, anticipated data indicate that at 6 months, a recurrence rate of 50% and a complete cure rate of 90% are both accurate. Hypopigmentation or skin irritability are side effects.

Report Highlights

Anal intraepithelial neoplasia - Current Market Trends

Anal intraepithelial neoplasia - Current & Forecasted Cases across the G8 Countries

Anal intraepithelial neoplasia - Market Opportunities and Sales Potential for Agents

Anal intraepithelial neoplasia - Patient-based Market Forecast to 2035

Anal intraepithelial neoplasia - Untapped Business Opportunities

Anal intraepithelial neoplasia - Product Positioning Vis-a-vis Competitors' Products

Anal intraepithelial neoplasia - KOLs Insight

Table of Content

1. Anal intraepithelial neoplasia Background

  • 1.1. Anal intraepithelial neoplasia Definition
  • 1.2. Signs and Symptoms
  • 1.3. Pathogenesis
  • 1.4. Clinical Manifestation
  • 1.5. Anal intraepithelial neoplasia biomarkers
  • 1.6. Diagnosis

2. Epidemiology Estimated and Forecast to 2035

  • 2.1. Epidemiology Research Method & Data Sources Used
  • 2.2. United States
    • 2.2.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.2.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.3. United Kingdom
    • 2.3.1. Incident Cases of Advance Biliary Tract Cancer
    • 2.3.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.4. Spain
    • 2.4.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.4.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.5. Germany
    • 2.5.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.5.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.6. France
    • 2.6.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.6.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.7. Italy
    • 2.7.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.7.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.8. Japan
    • 2.8.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.8.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.9. China
    • 2.9.1. Incident Cases of Anal intraepithelial neoplasia
    • 2.9.2. Diagnosed and treatable cases of Anal intraepithelial neoplasia by line of therapies (LOT)
  • 2.10. Current Unmet Needs in Anal intraepithelial neoplasia by line of therapies (LOT)

3. Current Treatment Paradigm

  • 3.1. Treatment/Prevention guidelines
  • 3.2. Regulatory Approvals/Indication and Current Benchmarks

4. KOLs Insight (US, EU, JP, CH)

  • 4.1. Unmet Needs
  • 4.2. Analysis of the progress in terms of approvals & current pipeline
  • 4.3. Impact on the treatment algorithm and product positioning
  • 4.4. Relevance of new targets/platforms/ Therapy Uptake Share %
  • 4.5. Physicians Preferences for the new pharmacological agents

5. What's New in 2024/2025

6. Future Treatment Paradigm

  • 6.1. Anal intraepithelial neoplasia Competitor Landscape and Approvals Anticipated
  • 6.2. Future Treatment Algorithms and Competitor Positioning
  • 6.3. Key Data Summary for Emerging Treatment

7. Late Phase Therapies Strategic Considerations in Anal intraepithelial neoplasia

8. Total Market Forecast

  • 8.1. Key Summary Findings
    • 8.1.1. G8 total Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 8.1.2. G8 total Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)

9. Market Forecast by Country

  • 9.1. United States
    • 9.1.1. United States Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.1.2. United States Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.2. Germany
    • 9.2.1. Germany Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.2.2. Germany Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.3. France
    • 9.3.1. France Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.3.2. France Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.4. Italy
    • 9.4.1. Italy Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.4.2. Italy Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.5. Spain
    • 9.5.1. Spain Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.5.2. Spain Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.6. United Kingdom
    • 9.6.1. United Kingdom Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.6.2. United Kingdom Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.7. Japan
    • 9.7.1. Japan Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.7.2. Japan Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)
  • 9.8. China
    • 9.8.1. China Market for Anal intraepithelial neoplasia 2022-2035 (USD Million)
    • 9.8.2. China Market for Anal intraepithelial neoplasia by Therapies 2022-2035 (USD Million)

10. Market Drivers and Barriers

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Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

+1-860-674-8796

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