Biliary Tract Cancers (BTCs)- Market Insight, Epidemiology and Market Forecast -2030

Biliary Tract Cancers (BTCs)- Market Insight, Epidemiology and Market Forecast -2030

  • January 2021 •
  • 325 pages •
  • Report ID: 6010454 •
  • Format: PDF
‘Biliary Tract Cancer (BTC)– Market Insights, Epidemiology, and Market Forecast—2030’ report deliver an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of biliary tract cancer (BTC) 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, market share of the individual therapies, current and forecasted biliary tract cancer market Size from 2017 to 2030, segmented by seven major markets. The report also covers the current biliary tract cancer treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geographies Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Biliary Tract Cancer: Disease Understanding and Treatment Algorithm

Biliary Tract Cancer Overview
Biliary Tract Cancer constitutes epithelial malignancies of the biliary tree and includes the following: gallbladder cancer (GBC), intrahepatic CCA (iCCA) and extrahepatic CCA (eCCA). The extrahepatic disease may be split into perihilar (Klatskin’s tumor) and distal CCA. BTC constitutes approximately 3% of all gastrointestinal malignancies and is the most common hepatobiliary cancer after hepatocellular carcinoma. Primary sclerosing cholangitis (PSC), primary biliary cirrhosis (PBC), cirrhosis due to other causes, hepatitis C and congenital malformations such as choledochal cysts and multiple biliary papillomatosis are also associated with an increased risk of developing BTC. In addition, patients with germline mutations resulting in Lynch syndrome and BRCA1 and BRCA2 (breast cancer gene 1 and 2) genetic aberrations are also predisposed to BTC.
Gallbladder cancer originates in the cells of the gallbladder, and most are adenocarcinomas, which begin in the gland cells of the gallbladder lining. While, CCA is an epithelial malignancy originating from transformed cholangiocytes, with preclinical studies suggesting hepatic progenitor cells as the origin. iCCA can emerge at any point in the intrahepatic biliary tree, ranging from main bile ducts to the segmental bile ducts. In contrast to HCC, iCCA usually develops in non-cirrhotic liver. pCCA can arise in the right and/or left hepatic duct and/or at their junction (so-called perihilar bile ducts), and dCCA involves the common bile duct. The current term extrahepatic Cholangiocarcinoma (eCCA) is now discouraged from using as it combines subtypes with distinct clinicopathological features, origins, prognosis, and therapeutic options. Ampullary cancer originates in the area where the common bile duct meets the pancreatic duct, which is called the Ampulla of Vater.
Inflammation and cholestasis are key factors in cholangiocarcinogenesis. Next-generation sequencing has identified somatic mutations in oncogenes (i.e., KRAS), tumor suppressor (i.e., TP53 and SMAD4), and chromatin-modifying genes (i.e., ARID1A, BAP1, and PBMR1) in CCA. Furthermore, the tumor commonly metastasizes via lymphatic spread to the regional lymph nodes, followed by hematogenous metastasis to the liver, lungs, and peritoneum. The majority of cholangiocarcinomas are adenocarcinomas with variable grades of differentiation (mainly well-differentiated adenocarcinomas), although several uncommon types are also encountered, such as adenosquamous, squamous, mucinous, and anaplastic carcinomas. Jaundice and abdominal pain are the most common presentations of BTC.
A diagnosis of biliary tract cancer is usually based on the results of clinical examination of the abdomen, imaging scans using ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT), and a biopsy. Further investigations can help to determine how advanced the cancer is (the ‘stage’). For example, MRI of the biliary tract, a CT scan of the chest and an ultrasound scan of the lymph nodes are commonly used to see how far cancer has spread. Biliary tract cancer is staged according to tumor size, whether it has spread to the lymph nodes and whether it has spread into the liver, lungs or other parts of the body. This information is used to help decide the best treatment.
Treatment options for the early-stage disease include surgery followed by adjuvant chemotherapy. For patients with locally advanced disease, locoregional therapies (e.g., trans-arterial chemoembolization (TACE)) and external beam radiation therapy (EBRT) may be considered. However, these have not yet been validated in prospective randomized controlled trials, and therefore, their use is very variable. For patients with locally advanced and metastatic disease, the combination of gemcitabine and cisplatin has been shown to improve survival.

Biliary Tract Cancer Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the biliary tract cancer market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The Biliary Tract Cancer market report gives a thorough understanding of biliary tract cancer by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for biliary tract cancer in the US, Europe, and Japan.

Biliary Tract Cancer Epidemiology
The Biliary Tract Cancer epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings
The disease epidemiology covered in the report provides historical and forecasted Biliary Tract Cancer epidemiology segmented as the total incident cases of biliary tract cancer, age-specific cases of biliary tract cancer, stage-specific cases of biliary tract cancer and mutation specific cases of biliary tract cancer. The report includes the incident scenario of Biliary Tract Cancer symptoms in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.

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.
The total incident population of biliary tract cancer in the 7MM countries was estimated to be 70,111 cases in 2017.

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, Phase-II/III, Phase-II and Phase-I/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.
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.
Products detail in the report…

Biliary Tract Cancer Emerging Drugs
Ivosidenib (AG-120) (Agios Pharmaceuticals) is a first-in-class, oral, potent, reversible, targeted inhibitor of the mutant isocitrate dehydrogenase-1 (IDH1) enzyme. Agios Pharmaceuticals is developing Ivosidenib for the treatment of patients with cancers that harbor an IDH1 mutation. The company evaluated the product in late-stage clinical studies for cholangiocarcinoma with an IDH1 Mutation and presented the positive results of the phase III trial.
The company plans to submit a supplemental new drug application for Tibsovo in previously treated IDH1-mutant cholangiocarcinoma in the first quarter of 2021. Ivosidenib is marketed and commercialized under the brand name Tibsovo for Acute myeloid leukemia.
Infigratinib (BGJ398) (QED Therapeutics) is an investigational, orally administered FGFR1-3 tyrosine kinase inhibitor in development for the treatment of patients with FGFR-driven diseases, including cholangiocarcinoma (bile duct cancer) and others. It sparingly inhibits FGFR4; patients may tolerate it better than pan–FGFR1-4 inhibitors.
QED Therapeutics is developing Infigratinib in the phase III PROOF trial, in first Line Cholangiocarcinoma with FGFR2 Gene Fusions/Translocations and phase II in second-line cholangiocarcinoma (bile duct cancer). QED intends to submit an NDA with the US FDA for second and later-line cholangiocarcinoma in 2020. The FDA awarded infigratinib a Fast Track Designation for adults with first-line advanced or metastatic cholangiocarcinoma and an orphan drug designation for cholangiocarcinoma.
Products detail in the report…

Biliary Tract Cancer Market Outlook
The Biliary Tract Cancer market outlook of the report builds a detailed comprehension of the historical, 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 for 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 for 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 report, biliary tract cancer market in the 7MM is expected to change in the study period 2017–2030.
The BTC market consists of various unmet needs, which include lack of treatment, poor understanding of molecular components involved in signaling pathways, and lack of awareness. Various research studies have focused on developing treatments for CCA to counter the current unmet needs of the market and provide better treatment options for CCA. With the continuous efforts in research and development, few companies are developing therapies

Key Findings
This section includes a glimpse of the biliary tract cancer market in the 7MM. The market size of biliary tract cancer in the seven major markets was found to be USD 904 Million in 2017.

The United States: Market Outlook
This section provides the total biliary tract cancer market size and market size by therapies of biliary tract cancer in the United States.
The United States accounts for the highest market size of biliary tract cancer in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
Hitherto, 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 a part of palliative treatment, systemic chemotherapy is the treatment of choice for patients with locally advanced or inoperable disease Cisplatin/gemcitabine is the reference chemotherapy regimen.event.
Recently, with so much of efforts going into this area, Pemigatinib (Pemazyre) by Incyte Corporation was approved in the US and EU for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test.

EU-5 Countries: Market Outlook
The total biliary tract cancer market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook
The total biliary tract cancer market size and market size by therapies of biliary tract cancer in Japan are also mentioned.
Biliary Tract Cancer Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017–2030. 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 allow the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the 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 III, Phase II/III, Phase II and Phase I/II stage. It also analyses biliary tract cancer key players involved in developing targeted therapeutics.
Major players include QED Therapeutics, Delcath Systems, Taiho Oncology, Merck Sharp & Dohme, Agios Pharmaceuticals, whose key products are expected to get launched in the US market by 20XX.

Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for biliary tract cancer emerging therapies.
KOL Views
To keep up with current market trends, we take KOLs and SME’s opinion working in 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 trend. 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
We perform Competitive and Market Intelligence analysis of the Biliary Tract Cancer market by using various Competitive Intelligence tools: 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, 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 is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of 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, 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 developing 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-competitor, 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 Competitors
• 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 were the biliary tract cancer Market share (%) distribution in 2017, and how would it look like in 2030?
• What would be the biliary tract cancer total market Size and market Size by therapies across the 7MM during the forecast period (2017–2030)?
• What are the key findings pertaining to the market across 7MM, and which country will have the largest biliary tract cancer market Size during the forecast period (2017–2030)?
• At what CAGR, the biliary tract cancer market is expected to grow in the 7MM during the forecast period (2017–2030)?
• What would be the biliary tract cancer market outlook across the 7MM during the forecast period (2017–2030)?
• What would be the biliary tract cancer market growth till 2030, and what will be the resultant market Size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:
• What are the disease risk, burden, and unmet needs of the biliary tract cancer?
• 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?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to biliary tract cancer?
• Out of all 7MM countries, which country would have the highest incident of biliary tract cancer during the forecast period (2017–2030)?
• At what CAGR the population is expected to grow in the 7MM during the forecast period (2017–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of biliary tract cancer?
• What are the current treatment guidelines for treating biliary tract cancer in the USA, Europe, and Japan?
• What are the biliary tract cancer marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of biliary tract cancer?
• How many therapies are developed by each company for the treatment of biliary tract cancer?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of biliary tract cancer?
• 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 developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for biliary tract cancer and their status?
• What are the key designations that have been granted for the emerging therapies for biliary tract cancer?
• What are the global historical and forecasted market for 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 biliary tract cancer market.
• To understand the future market competition in the biliary tract cancer market.