Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

Advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) Market Outlook and Forecast

Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

Published Date : 2021-12-17

Updated On : 2022-09-07

Pages : 159

Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Outlook

Thelansis’s “Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Overview

Intrahepatic cholangiocarcinoma (iCCA) is a rare, highly aggressive, and often fatal primary epithelial cancer arising within the liver. iCCAs are diagnosed mainly at an advanced non-curable stage and usually occur sporadically in patients without recognizable risk factors. More than 90% of iCCAs are adenocarcinomas exhibiting biliary differentiation biomarkers and can be subdivided by genomic and epigenomic profiling into etiologically distinct subtypes. Unlike hepatocellular carcinoma (HCC), most iCCAs develop in the non-cirrhotic liver, although it has been reported that about 8–10% of all it occurs in patients with liver cirrhosis. Unlike conventional HCCs, mass-forming iCCAs are typically characterized by a prominent desmoplastic and hypovascularized tumor stroma, which often represents the dominant histological feature of the tumor. Curative intent surgical resection is the best option for achieving long-term survival outcomes. However, only a fraction of iCCA patients are candidates for corrective intent surgery. Moreover, the recurrence rates for iCCA after surgery are very high, from 40 to 80%, with less than one-third of the patients who undergo curative-intent surgery found to survive beyond five years after resection.

  • The incidence of Intrahepatic cholangiocarcinoma (iCCA) ranges from 0.5 to 1.04 per 100,000 population in the USA.

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: 2021-2032

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.

Visit our social media pages:
Linkedin Mini logo Thelansis Twitter Mini logoThelansis Facebook Mini logo

Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Competitive Landscape

S. no Asset Company Stage
1 LYTGOBI® (futibatinib) Taiho Oncology, Inc Phase 2
2 HMPL-453 Hutchison Medipharma Limited Phase 2
3 derazantinib Basilea Pharmaceutica Phase 2
4 Camrelizumab Jiangsu HengRui Medicine Co., Ltd. Phase 2
5 RLY-4008 Relay Therapeutics, Inc. Phase 2
6 Cabozantinib Exelixis Phase 2
7 Irinotecan Liposome Injection CSPC Ouyi Pharmaceutical Co., Ltd. Phase 2
8 KIN-3248 Kinnate Biopharma Phase 1
9 FT-2102 Forma Therapeutics, Inc. Phase 2
10 Enasidenib Celgene Phase 2

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

Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) 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.

Advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) Market Forecast

1.       Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) – 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. Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) market scenario 2021
                     1.2.2. Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) market scenario 2025
                     1.2.3. Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) market scenario 2032

2.       Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) 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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
         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. Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) 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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) management
         2.16.  Market Opportunity for Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1.  Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Epidemiology in US (2021-2032)
                             3.2.1.1.              Incidence of Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2.  Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Epidemiology in EU-5 (2021-2032)
                             3.2.2.1.              Incidence of Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3.  Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Epidemiology in Japan (2021-2032)
                             3.2.3.1.              Incidence of Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4.  Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Epidemiology in China (2021-2032)
                             3.2.4.1.              Incidence of Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
                             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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) Market Forecast 2021-2032
                     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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
                                      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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) 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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
         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 Advanced or Metastatic Intrahepatic Cholangiocarcinoma (iCCA) 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