This Biliary Tract Cancer (BTC)- Market Insights, Epidemiology, and Market Forecast - 2032 report delivers an in-depth understanding of the Biliary Tract Cancer, historical and forecasted epidemiology as well as the Biliary Tract Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Biliary Tract Cancer market report provides current treatment practices, emerging drugs, Biliary Tract Cancer market share of the individual therapies, current and forecasted Biliary Tract Cancer market Size from 2019 to 2032 segmented by seven major markets. The report also covers current Biliary Tract Cancer treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Biliary tract cancers (BTC) constitute epithelial malignancies of the biliary tree and include the following: Gallbladder cancer (GBC) and Cholangiocarcinoma (CCA). CCA is further divided into intra-hepatic CCA, perihilar (Klatskin's tumor), and distal CCA. Gallbladder cancer is a rare disease in which malignant (cancer) cells are found in the tissues of the gallbladder. It originates in the cells of the gallbladder and most are adenocarcinomas, which begin in the gland cells of the gallbladder lining. Cholangiocarcinoma is a type of cancer that develops within the bile duct system, which is a series of small tubes that transport bile fluid from the liver (where it is produced) to the gallbladder (where it is stored).
The signs and symptoms of Biliary Tract Cancer may include pruritus, abdominal pain, malaise, fatigue, jaundice, fever, and more. The majority of BTC cases develops in the absence of identifiable risk factors, as most cases are sporadic and have no identifiable risk factors. However, several conditions have been linked to carcinogenesis which can include primary sclerosing cholangitis, parasitic infections, intrahepatic biliary stones, Caroli's disease, and others.
Diagnosis
For a definitive diagnosis, patients usually undergo endoscopic retrograde cholangiopancreatography and several procedures named as cytology, brushing, FISH (fluorescence in situ hybridization)-polisomy, biopsy, ultrasonography, choledochoscopy, cholangioscopy, chromoendoscopy, confocal endoscopy, narrow-band imaging. MRI, CT, endoscopic ultrasonography, or 18FDG PET-CT cannot definitively demonstrate the stricture's neoplastic nature.
Endoscopic ultrasonography-guided fine-needle aspiration demonstrated good diagnostic performance for discriminating benign versus malignant biliary strictures and without apparent risk of tumor seeding linked with the procedure. As for iCCA, the risk of tumor seeding after transperitoneal biopsy of pCCA is based on limited evidence. The role of FISH-polisomy in detecting CCA in patients with PSC has been questioned by a meta-analysis due to its limited sensitivity. Better markers are therefore required for early CCA detection. In this regard, serum CA19-9 levels can be helpful for the detection of CCA. However, the CA19-9 serum level is biased by elevation due to cholangitis and cholestasis and is undetectable in Lewis-antigen-negative patients.
Treatment
Surgical treatments are the only potentially curative therapeutic options for all the subtypes of CCA. However, the majority of CCA patients are diagnosed at late-stage disease, and nearly more than one-fourth of patients considered resectable are found to be unresectable during explorative laparotomy. Few more aggressive surgical approaches and improved radiologic techniques have resulted in improved R0 (tumor-free margins) resection rates, but recurrence rates remain high.
As per the ESMO guidelines, adjuvant therapy (radiotherapy, chemoradiotherapy, or chemotherapy alone) may be offered to patients to understand that the evidence base is weak and only after a risk-benefit assessment; participation in clinical trials should be encouraged. Patients with the initially inoperable and non-metastatic disease should be discussed at the multidisciplinary tumor board to salvage surgery in the event of a good response to systemic and/or locoregional treatment, including participation in clinical trials.
As a part of palliative treatment, systemic chemotherapy is the treatment of choice for patients with locally advanced or inoperable disease - combination chemotherapy for PS 0-1 patients and monotherapy for PS 2 patients. Cisplatin/gemcitabine is the reference chemotherapy regimen for good PS (0-1) patients, and oxaliplatin may be substituted for cisplatin where there is a concern about renal function. Gemcitabine monotherapy can also be considered for PS 2 patients. A systematic review of trials concluded insufficient evidence is available to recommend second-line chemotherapy. In medical practice, a fluoropyrimidine-based regimen is often used when gemcitabine-based treatment fails.
The epidemiology segment also provides the Biliary Tract Cancer epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The drug chapter segment of the Biliary Tract Cancer report encloses the detailed analysis of Biliary Tract Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Biliary Tract Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Emerging Drugs
The report provides the details of the emerging therapies under the late and mid-stage of development for Biliary Tract Cancer treatment.
The Biliary Tract Cancer market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted Biliary Tract Cancer market trends by analyzing the impact of current therapies on the market, unmet needs, drivers, and barriers and demand of better technology.
This segment gives a thorough detail of Biliary Tract Cancer market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to the publisher, the Biliary Tract Cancer market in 7MM is expected to witness a major change in the study period 2019-2032.
The Biliary Tract Cancer market size in the 7MM is expected to change during the study period 2019-2032. The therapeutic market of Biliary Tract Cancer in the seven major markets is expected to increase during the study period (2019-2032). In 2021, the total market size of Biliary Tract Cancer was USD 480 million which is expected to rise during the study period (2019-2032).
The total market size of BTC by therapies for early stage disease in the year 2021 was 44.84 million which is expected to grow during the study period (2019-2032) in the 7MM.
The total market size of Biliary Tract Cancer in the United States accounted for USD 237 million in 2021 which is expected to rise during the study period (2019-2032).
In EU5, the total market size of Biliary Tract Cancer was USD 163 million in 2021, which is expected to rise during the study period (2019-2032).
In Japan, the total market size of Biliary Tract Cancer was USD 153 million in 2021, which is expected to rise during the study period (2019-2032).
Biliary Tract Cancer Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the Biliary Tract Cancer market or expected to get launched in the market during the study period 2019-2032. The analysis covers Biliary Tract Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Biliary Tract Cancer's key players involved in developing targeted therapeutics.
The report covers the detailed information of collaborations, acquisition, and merger, licensing patent details, and other information for Biliary Tract Cancer emerging therapies.
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
To keep up with current market trends, we take KOLs and SMEs ' opinions working in the Biliary Tract Cancer domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Biliary Tract Cancer market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
The publisher performs Competitively and Market Intelligence analysis of the Biliary Tract Cancer Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
The Biliary Tract Cancer market report provides current treatment practices, emerging drugs, Biliary Tract Cancer market share of the individual therapies, current and forecasted Biliary Tract Cancer market Size from 2019 to 2032 segmented by seven major markets. The report also covers current Biliary Tract Cancer treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Biliary Tract Cancer Understanding and Treatment Algorithm
Biliary tract cancers (BTC) constitute epithelial malignancies of the biliary tree and include the following: Gallbladder cancer (GBC) and Cholangiocarcinoma (CCA). CCA is further divided into intra-hepatic CCA, perihilar (Klatskin's tumor), and distal CCA. Gallbladder cancer is a rare disease in which malignant (cancer) cells are found in the tissues of the gallbladder. It originates in the cells of the gallbladder and most are adenocarcinomas, which begin in the gland cells of the gallbladder lining. Cholangiocarcinoma is a type of cancer that develops within the bile duct system, which is a series of small tubes that transport bile fluid from the liver (where it is produced) to the gallbladder (where it is stored).
The signs and symptoms of Biliary Tract Cancer may include pruritus, abdominal pain, malaise, fatigue, jaundice, fever, and more. The majority of BTC cases develops in the absence of identifiable risk factors, as most cases are sporadic and have no identifiable risk factors. However, several conditions have been linked to carcinogenesis which can include primary sclerosing cholangitis, parasitic infections, intrahepatic biliary stones, Caroli's disease, and others.
Diagnosis
For a definitive diagnosis, patients usually undergo endoscopic retrograde cholangiopancreatography and several procedures named as cytology, brushing, FISH (fluorescence in situ hybridization)-polisomy, biopsy, ultrasonography, choledochoscopy, cholangioscopy, chromoendoscopy, confocal endoscopy, narrow-band imaging. MRI, CT, endoscopic ultrasonography, or 18FDG PET-CT cannot definitively demonstrate the stricture's neoplastic nature.
Endoscopic ultrasonography-guided fine-needle aspiration demonstrated good diagnostic performance for discriminating benign versus malignant biliary strictures and without apparent risk of tumor seeding linked with the procedure. As for iCCA, the risk of tumor seeding after transperitoneal biopsy of pCCA is based on limited evidence. The role of FISH-polisomy in detecting CCA in patients with PSC has been questioned by a meta-analysis due to its limited sensitivity. Better markers are therefore required for early CCA detection. In this regard, serum CA19-9 levels can be helpful for the detection of CCA. However, the CA19-9 serum level is biased by elevation due to cholangitis and cholestasis and is undetectable in Lewis-antigen-negative patients.
Treatment
Surgical treatments are the only potentially curative therapeutic options for all the subtypes of CCA. However, the majority of CCA patients are diagnosed at late-stage disease, and nearly more than one-fourth of patients considered resectable are found to be unresectable during explorative laparotomy. Few more aggressive surgical approaches and improved radiologic techniques have resulted in improved R0 (tumor-free margins) resection rates, but recurrence rates remain high.
As per the ESMO guidelines, adjuvant therapy (radiotherapy, chemoradiotherapy, or chemotherapy alone) may be offered to patients to understand that the evidence base is weak and only after a risk-benefit assessment; participation in clinical trials should be encouraged. Patients with the initially inoperable and non-metastatic disease should be discussed at the multidisciplinary tumor board to salvage surgery in the event of a good response to systemic and/or locoregional treatment, including participation in clinical trials.
As a part of palliative treatment, systemic chemotherapy is the treatment of choice for patients with locally advanced or inoperable disease - combination chemotherapy for PS 0-1 patients and monotherapy for PS 2 patients. Cisplatin/gemcitabine is the reference chemotherapy regimen for good PS (0-1) patients, and oxaliplatin may be substituted for cisplatin where there is a concern about renal function. Gemcitabine monotherapy can also be considered for PS 2 patients. A systematic review of trials concluded insufficient evidence is available to recommend second-line chemotherapy. In medical practice, a fluoropyrimidine-based regimen is often used when gemcitabine-based treatment fails.
Country Wise- Biliary Tract Cancer Epidemiology
The epidemiology segment also provides the Biliary Tract Cancer epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Biliary Tract Cancer Drug Chapters
The drug chapter segment of the Biliary Tract Cancer report encloses the detailed analysis of Biliary Tract Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Biliary Tract Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Emerging Drugs
The report provides the details of the emerging therapies under the late and mid-stage of development for Biliary Tract Cancer treatment.
Biliary Tract Cancer Market Outlook
The Biliary Tract Cancer market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted Biliary Tract Cancer market trends by analyzing the impact of current therapies on the market, unmet needs, drivers, and barriers and demand of better technology.
This segment gives a thorough detail of Biliary Tract Cancer market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to the publisher, the Biliary Tract Cancer market in 7MM is expected to witness a major change in the study period 2019-2032.
Key Findings
The Biliary Tract Cancer market size in the 7MM is expected to change during the study period 2019-2032. The therapeutic market of Biliary Tract Cancer in the seven major markets is expected to increase during the study period (2019-2032). In 2021, the total market size of Biliary Tract Cancer was USD 480 million which is expected to rise during the study period (2019-2032).
The total market size of BTC by therapies for early stage disease in the year 2021 was 44.84 million which is expected to grow during the study period (2019-2032) in the 7MM.
The United States Market Outlook
The total market size of Biliary Tract Cancer in the United States accounted for USD 237 million in 2021 which is expected to rise during the study period (2019-2032).
EU-5 Countries: Market Outlook
In EU5, the total market size of Biliary Tract Cancer was USD 163 million in 2021, which is expected to rise during the study period (2019-2032).
Japan Market Outlook
In Japan, the total market size of Biliary Tract Cancer was USD 153 million in 2021, which is expected to rise during the study period (2019-2032).
Biliary Tract Cancer Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the Biliary Tract Cancer market or expected to get launched in the market during the study period 2019-2032. The analysis covers Biliary Tract Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Biliary Tract Cancer Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Biliary Tract Cancer's key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing patent details, and other information for Biliary Tract Cancer emerging therapies.
Reimbursement Scenario in Biliary Tract Cancer
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
KOL-Views
To keep up with current market trends, we take KOLs and SMEs ' opinions working in the Biliary Tract Cancer domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Biliary Tract Cancer market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
The publisher performs Competitively and Market Intelligence analysis of the Biliary Tract Cancer Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of Biliary Tract Cancer, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
- Comprehensive insight has been provided into the Biliary Tract Cancer epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for Biliary Tract Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
- A detailed review of the Biliary Tract Cancer market; historical and forecasted is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Biliary Tract Cancer market
Report Highlights
- In the coming years, the Biliary Tract Cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
- The companies and academics are working to assess challenges and seek opportunities that could influence Biliary Tract Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Major players are involved in developing therapies for Biliary Tract Cancer. The launch of emerging therapies will significantly impact the Biliary Tract Cancer market
- A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Biliary Tract Cancer
- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Biliary Tract Cancer Report Insights
- Patient Population
- Therapeutic Approaches
- Biliary Tract Cancer Pipeline Analysis
- Biliary Tract Cancer Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Biliary Tract Cancer Report Key Strengths
- 11 Years Forecast
- 7MM Coverage
- Biliary Tract Cancer Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Biliary Tract Cancer Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
Key Questions
Market Insights:
- What was the Biliary Tract Cancer drug class share (%) distribution in 2019 and how it would look like in 2032?
- What would be the Biliary Tract Cancer total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
- What are the key findings of the market across 7MM and which country will have the largest Biliary Tract Cancer market size during the forecast period (2019-2032)?
- At what CAGR, the Biliary Tract Cancer market is expected to grow by 7MM during the forecast period (2019-2032)?
- What would be the Biliary Tract Cancer market outlook across the 7MM during the forecast period (2019-2032)?
- What would be the Biliary Tract Cancer market growth till 2032, and what will be the resultant market Size in the year 2032?
- How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What are the disease risk, burden, and regional/ethnic differences of Biliary Tract Cancer?
- What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What is the historical Biliary Tract Cancer patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of Biliary Tract Cancer in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- Where will be the growth opportunities in the 7MM concerning the patient population about Biliary Tract Cancer?
- Out of all 7MM countries, which country would have the highest incident population of Biliary Tract Cancer during the forecast period (2019-2032)?
- At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the Biliary Tract Cancer treatment in addition to the approved therapies?
- What are the current treatment guidelines for the treatment of Biliary Tract Cancer in the USA, Europe, and Japan?
- What are the Biliary Tract Cancer marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
- How many companies are developing therapies for the treatment of Biliary Tract Cancer?
- How many therapies are in-development by each company for Biliary Tract Cancer treatment?
- How many are emerging therapies in mid-stage, and late stage of development for Biliary Tract Cancer treatment?
- What are the key collaborations (Industry - Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Biliary Tract Cancer therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Biliary Tract Cancer and its status?
- What are the current challenges faced in drug development?
- What are the key designations that have been granted for the emerging therapies for Biliary Tract Cancer?
- What are the global historical and forecasted markets of Biliary Tract Cancer?
Reasons to Buy
- The report will help in developing business strategies by understanding trends shaping and driving the Biliary Tract Cancer market
- To understand the future market competition in the Biliary Tract Cancer market and Insightful review of the key market drivers and barriers
- Organize sales and marketing efforts by identifying the best opportunities for Biliary Tract Cancer in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
- Organize sales and marketing efforts by identifying the best opportunities for the Biliary Tract Cancer market
- To understand the future market competition in the Biliary Tract Cancer market.
Table of Contents
1. Key Insights2. Report Introduction5. Epidemiology and Market Methodology10. Patient Journey11. Key Endpoints in Biliary Tract Cancer Clinical Trials14. Conjoint Analysis17. KOL Views18. Market Drivers19. Market Barriers20. SWOT Analysis21. Unmet Needs23. Publisher Capabilities24. Disclaimer25. About the Publisher
3. Biliary Tract Cancer (BTC) Market Overview at a Glance
4. Executive Summary of Biliary Tract Cancer (BTC)
6. Disease Background and Overview
8. Current Treatment Practices of Biliary Tract Cancer
9. Epidemiology and Patient Population
12. Marketed Therapies
13. Emerging Therapies
15. Biliary Tract Cancer (BTC): 7 Major Market Analysis
16. Market Access and Reimbursement
22. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Incyte Corporation
- Loxo Oncology
- Bayer
- Roche
- Genentech
- QED Therapeutics
- Agios Pharmaceuticals
- Servier Pharmaceuticals
- Merck Sharp & Dohme
- AstraZeneca
- Taiho Oncology
- Delcath Systems
- Eisai
- TransThera Sciences (Nanjing)
- Basilea Pharmaceutica
- Zymeworks
- BeiGene
