Advance Biliary Tract Cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

Advanced bile duct cancer is cancer that has spread outside the bile duct to lymph nodes or organs near the bile duct, or it has spread to other parts of the body, such as the lungs. This is called secondary or metastatic cholangiocarcinoma. Most people with bile duct cancer already have advanced cancer when they are diagnosed. This is because bile duct cancer does not usually cause symptoms in its early stages. Biliary tract cancer, or cholangiocarcinoma, arises from the biliary epithelium of the small ducts in the periphery of the liver (intrahepatic) and the main ducts of the hilum (extrahepatic), extending into the gallbladder. The incidence and epidemiology of biliary tract cancer are fluid and complex. Worldwide, cholangiocarcinoma is the second most common primary hepatic malignancy, after hepatocellular carcinoma, comprising about 15% of all primary liver tumors. The incidence and mortality rates of cholangiocarcinoma have increased steadily over the past decades. Advanced biliary tract cancers (BTC) include a diverse collection of rare and heterogenous tumors with poor prognosis. The combination of gemcitabine and cisplatin is the established first-line therapy for advanced BTC. There are no accepted standard treatments in the second line setting, though there are several ongoing clinical trials that implement chemotherapy as a therapeutic strategy,

Description

Advanced bile duct cancer is cancer that has metastasized, which means it has spread to organs or lymph nodes outside the bile duct, as well as to other parts of the body like the lungs. When bile duct cancer is discovered, it has usually spread to the most advanced stages. This is due to the fact that early-stage bile duct cancer rarely exhibits symptoms. Biliary tract cancers are uncommon, and their incidence varies by region. A sizable portion of patients are present with unresectable or metastatic disease at diagnosis because clinical presentation is frequently hazy with non-specific symptoms. Cytotoxic chemotherapy is the mainstay of treatment for unresectable cancers; however, 5-year overall survival is still dreadfully low. Using next-generation sequencing, diagnostic molecular pathology has found a high incidence of targetable alterations in bile duct cancers, which is revolutionizing care. According to the etiology and anatomical location of the disease, there is significant genomic heterogeneity, with some alterations being more prevalent in subtypes. Immune checkpoint inhibitors with anti-PD-1/PD-L1 antibodies combined with chemotherapy are also on the verge of replacing other first-line treatments for this illness. Poor outcomes continue to be associated with biliary tract cancer (BTC), which includes intrahepatic and extrahepatic cholangiocarcinoma as well as gallbladder carcinoma. Liver function tests, the patient's physical examination and medical history, the analysis of the tumor markers CA 19-9 and CEA, as well as other tests like abdominal ultrasound, CT, or MRI, and MRCP (magnetic resonance cholangiopancreatography), are used to diagnose and stage this cancer. Percutaneous transhepatic cholangiography (PTC), endoscopic retrograde cholangiopancreatography (ERCP), and laparoscopy are all options for taking biopsy samples. The patient's overall health, the location of the cancer in the duct system, its stage (such as where it has spread), and whether surgery can be used to remove the cancer all affect the patient's prognosis and treatment options. The lymphatic system, the blood, and the tissue are the ways this cancer can spread. The range of cancer staging is stage 0 to stage IV (stage IV is further divided into stages IVA and stage IVB, with stage IVA being the most serious and stage IVB meaning cancer has spread to other internal organs of the body).

Advance Biliary Tract Cancer (Epidemiology)

Cholangiocarcinoma, also known as biliary tract cancer, develops from the biliary epithelium of the small ducts near the liver's edge and the main ducts of the hilum, which extend into the gallbladder (intrahepatic and extrahepatic, respectively). The epidemiology and incidence of biliary tract cancer are dynamic and complex. Cholangiocarcinoma makes up about 15% of all primary liver tumors worldwide and is the second most prevalent primary hepatic malignancy, after hepatocellular carcinoma. Over the past few decades, cholangiocarcinoma incidence and mortality rates have steadily increased. Cholangiocarcinoma currently has a mortality rate of 1-6/100,000 people and an incidence rate of 0.3-6/100,000 people per year. In some places, like South Korea, China, and Thailand, the incidence rates are particularly high. Israel and Japan both have the highest annual incidences, with 7.5 and 5.5 cases per 100,000 people, respectively. Workers at printing businesses in Japan have been found to have occupational cholangiocarcinoma after being exposed to high concentrations of chemical compounds, such as dichloromethane and/or 1,2-dichloropropane (1,2-DCP). Cholangiocarcinoma has been associated with severe liver fluke infestation, particularly by Opisthorchis viverrini, a liver fluke found in Southeast Asia, and Clonorchis sinensis, which is endemic to Asia and is particularly prevalent in countries like Korea, China, Taiwan, Vietnam, and far-eastern Russia. Cholangiocarcinoma affects approximately 1 out of every 100,000 people annually in the United States. The incidence in studies involving autopsies ranged from 0.01% to 0.46%. Patients with bile duct tumors are typically older; their average age is 60 to 65. There is very little difference in incidence between the sexes when compared to gallbladder cancer, and it is extremely rare in men. In comparison to the general US population, cholangiocarcinoma is more common in Israel, Japan, and among American Indians. There are 2 per 100,000 men and 2.8 per 100,000 women with gallbladder and bile duct cancer in England and Wales, respectively. The most prevalent biliary tract cancer was intrahepatic bile duct, with an incidence rate of 1.49 per 100,000 people. Cancer incidence rates per 100,000 people were 0.24 for overlapping or other biliary tract lesions, 0.45 for ampulla of Vater, and 0.96 for extrahepatic bile duct. Cancer mortality rates per 100,000 people were 1.66 for intrahepatic bile duct and 0.45 for other biliary tracts. The incidence and mortality rates of intrahepatic bile duct disease were higher in men than in women, among Hispanic, Asian, and Pacific Islander people compared to non-Hispanic Whites, and in the Northeast and in urban counties.

Advance Biliary Tract Cancer -Current Market Size & Forecast Trends

The market for advanced biliary tract cancer is projected to grow significantly, with an estimated value of approximately USD 3.32 billion in 2023 and expected to reach around USD 3.58 billion in 2024. By 2030, the market is anticipated to expand to about USD 5.71 billion, reflecting a compound annual growth rate (CAGR) of 8.02% during this period. Growth is driven by the increasing adoption of targeted therapies such as FGFR inhibitors (e.g., Pemigatinib) and immunotherapies. Overall, the biliary tract cancer market is well-positioned for substantial growth through 2035, as new therapies and improved diagnostic technologies continue to emerge.

With a poor prognosis, advanced biliary tract cancers (BTC) include a wide range of uncommon and heterogenous tumors. Advanced BTC is currently treated with a first-line regimen consisting of gemcitabine and cisplatin. Although there are numerous ongoing clinical trials using chemotherapy as a therapeutic approach, there are no accepted standard treatments for second-line patients. The identification of actionable genomic aberrations, such as FGFR2 gene fusions, IDH1/2, HER2, BRAC1/2, and BRAF mutations, has given rise to hope for targeted therapies thanks to the understanding of the molecular landscape of BTC. The first targeted treatment for BTC with FGFR2 fusion or other rearrangements has been approved, and it is called pembigatinib. With the recent approval of pembrolizumab for either advanced solid tumors with DNA mismatch repair deficient (dMMR) or solid tumors with high levels of microsatellite instability (MSI-H), including BTC, immunotherapy has opened new therapeutic avenues. Since single agent immunotherapy appears to offer only modest benefits in advanced BTC, the combination of immunotherapy with other modalities is currently being examined in various clinical trials. In this review, we summarize the current state of treatment options for advanced BTC, including systemic chemotherapy, targeted therapy, immunotherapy, and various combinations. For patients with advanced biliary tract cancers who are eligible for treatment, gemcitabine and cisplatin remain the standard-of-care first-line therapy. An ongoing multi-institutional phase III study is evaluating the value of adding nab-paclitaxel to the chemotherapy doublet based on the encouraging findings of a phase II study, and suitable patients should be taken into consideration for enrollment at participating centers. We advise early, thorough genomic profiling of tumors from patients to find potential targetable aberrations with available treatments. Tumors with microsatellite instability/inadequate mismatch repair, changes in FGFR, IDH1/2, and HER-2, and possibly other molecular vulnerabilities are among the findings with therapeutic ramifications. A suitable agent should be matched with patients who have a targetable genomic abnormality. Patients eligible for second-line therapy should be given consideration for clinical trial enrollment or a second-line cytotoxic chemotherapy regimen like modified FOLFOX if a targetable fusion or mutation is not found. Therefore, routine use of checkpoint inhibitors outside of a clinical trial is not advised. Strategies incorporating immunotherapy into the management of patients with microsatellite stable advanced biliary tract cancers have so far largely produced disappointing results. Patients with biliary tract cancer (BTC) typically have a dismal prognosis. Contrary to second-line treatment, which is hotly debated in the scientific community, combination chemotherapy has been shown to improve survival in the frontline setting. Recent data from the ABC-06 trial have offered some weak support for the use of second-line chemotherapy following progression on the cisplatin plus gemcitabine combination. As compared to ASC alone, mFOLFOX plus active symptom control (ASC) increased the 6- and 12-month OS rate after progression on the cisplatin-gemcitabine combination. The "Precision Medicine Era" in BTC is still restricted to intrahepatic cholangiocarcinoma and primarily focused on isocitrate dehydrogenase (IDH) and fibroblast growth factor receptor (FGFR) targeted therapies, even though genomic studies have paved the way for a new era in cancer management. With a focus on currently active and recruiting clinical trials, we review recent published data in this article regarding the use of second-line therapy in BTC patients who have failed standard first-line therapies.

Report Highlights

Advance Biliary Tract Cancer - Current Market Trends

Advance Biliary Tract Cancer - Current & Forecasted Cases across the G8 Countries

Advance Biliary Tract Cancer- Market Opportunities and Sales Potential for Agents

Advance Biliary Tract Cancer- Patient-based Market Forecast to 2035

Advance Biliary Tract Cancer- Untapped Business Opportunities

Advance Biliary Tract Cancer- Product Positioning Vis-a-vis Competitors' Products

Advance Biliary Tract Cancer- KOLs Insight