Cervical Dysplasia – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Cervical Dysplasia Market Outlook and Forecast

Cervical Dysplasia – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Published Date : 2022-10-10

Updated On : 2023-07-06

Pages : 158

Cervical Dysplasia Market Outlook

Thelansis’s “Cervical Dysplasia Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Cervical Dysplasia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Cervical Dysplasia Overview

Cervical cancer ranks as the second most prevalent cancer in young women. It stands among the leading causes of cancer-related deaths in women, particularly in minorities and impoverished countries. The main precursor to cervical cancer is cervical dysplasia, a premalignant condition triggered primarily by an oncogenic strain of the human papillomavirus (HPV), a sexually transmitted infection. However, not all women infected with the virus develop cervical dysplasia or cancer, suggesting multiple host factors contribute to disease progression. Fortunately, many of these factors, such as nutrient deficiencies, can be reversed, leading to regression of dysplastic lesions. Cervical dysplasia arises from the persistent infection of the cervical tissue by HPV, with HPV 16 being the most common type responsible for 50% of cervical cancer cases. There are other HPV oncogenic types, including HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Normally, HPV infections clear within eight to 24 months of exposure, but if the infection persists, dysplasia may develop. If left untreated, dysplasia can progress to cervical cancer over several years. The slow progression allows for routine screening with a Pap smear and HPV testing, depending on the patient's age and medical history. Various risk factors increase the likelihood of developing cervical dysplasia, including smoking, having multiple sex partners, human immunodeficiency virus (HIV) infection, early sexual activity, early childbirth, immunosuppressant drug usage (e.g., post-organ transplant), maternal exposure to DES (diethylstilbestrol), having three or more full-term pregnancies, and having a family history of cervical cancer. Cervical dysplasia exists in three forms, classified based on the extent of abnormal cell growth in the cervix:

  1. CIN I - mild dysplasia (only the lower one-third of cells in the upper layer of the cervix are abnormal)
  2. CIN II - moderate dysplasia (up to two-thirds of the layer contains abnormal cells)
  3. CIN III - severe dysplasia to carcinoma in situ (precancerous cells are in the entire top layer of the cervix)

Treatment of cervical dysplasia depends on the degree of abnormality. Mild dysplasia may resolve spontaneously, and close monitoring with repeat Pap smears every three to six months is often sufficient. For moderate to severe dysplasia that does not resolve on its own, surgical removal of the abnormal tissue may be necessary to prevent the development of cervical cancer. There are several surgical procedures available, many of which can be performed on an outpatient basis, including cryo-cauterization or cryosurgery (using extreme cold to freeze or destroy abnormal cervical tissue), laser therapy (destroying abnormal tissue with a beam of light), loop electrosurgical excision procedure (LEEP, removing abnormal tissue with an electric current carried by a thin wire loop), and surgery (cone biopsy or cervical conization, involving the removal of a small cone-shaped sample of abnormal tissue from the cervix).

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2022-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Cervical Dysplasia Competitive Landscape

S. no Asset Company Stage
1 VB10.16 Nykode Therapeutics ASA Phase 2
2 ABI-2280 Antiva Biosciences Phase 2
3 BLS-ILB-E710c BioLeaders Corporation Phase 2
4 Artesunate Frantz Viral Therapeutics, LLC Phase 2
5 HPV9 GlaxoSmithKline Phase 2
6 Aminolaevulinic Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. Phase 2
7 Cevira® Asieris MediTech (Hong Kong) Co., Ltd. Phase 3
8 Fluorouracil Hoffmann-La Roche Phase 3
9 Pembrolizumab Merck Sharp & Dohme LLC Phase 2
10 VGX-3100 Inovio Pharmaceuticals Phase 3

Continued...

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Cervical Dysplasia Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Cervical Dysplasia Market Forecast

1.       Cervical Dysplasia – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Cervical Dysplasia market scenario 2022
                     1.2.2. Cervical Dysplasia market scenario 2025
                     1.2.3. Cervical Dysplasia market scenario 2032

2. Cervical Dysplasia Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Cervical Dysplasia
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Cervical Dysplasia Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Cervical Dysplasia management
         2.16.  Market Opportunity for Cervical Dysplasia
         2.17. KOL Comments on current and upcoming/expected treatment practices in Cervical Dysplasia

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Cervical Dysplasia Epidemiology in US (2022-2032)
                             3.2.1.1.              Incidence of Cervical Dysplasia
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Cervical Dysplasia Epidemiology in EU-5 (2022-2032)
                             3.2.2.1.              Incidence of Cervical Dysplasia
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Cervical Dysplasia Epidemiology in Japan (2022-2032)
                             3.2.3.1.              Incidence of Cervical Dysplasia
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Cervical Dysplasia Epidemiology in China (2022-2032)
                             3.2.4.1.              Incidence of Cervical Dysplasia
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Cervical Dysplasia Market Forecast 2022-2032
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Cervical Dysplasia Market Forecast 2022-2032
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Cervical Dysplasia Market Forecast 2022-2032
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Cervical Dysplasia Market Forecast 2022-2032
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Cervical Dysplasia Market Forecast 2022-2032
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Cervical Dysplasia Market Forecast 2022-2032
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Cervical Dysplasia Market Forecast 2022-2032
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Cervical Dysplasia Market Forecast 2022-2032
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Cervical Dysplasia
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Cervical Dysplasia Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Cervical Dysplasia
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Cervical Dysplasia Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer