Cholangiocarcinoma Treatment Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Cholangiocarcinoma, also known as bile duct cancer, is a type of cancer that forms in the bile ducts. Symptoms of cholangiocarcinoma may include abdominal pain, yellowish skin, weight loss, generalized itching, and fever. Light-colored stool or dark urine may also occur. Other biliary tract cancers include gallbladder cancer and cancer of the ampulla of Vater. Risk factors for cholangiocarcinoma include primary sclerosing cholangitis (an inflammatory disease of the bile ducts), ulcerative colitis, cirrhosis, hepatitis C, hepatitis B, infection with certain liver flukes, and some congenital liver malformations. However, most people have no identifiable risk factors. The diagnosis is suspected based on blood tests, medical imaging, endoscopy, and sometimes surgical exploration. The disease is confirmed by examination of cells from the tumor under a microscope. It is typically an adenocarcinoma (a cancer that forms glands or secretes mucin).

Cholangiocarcinoma is typically incurable at diagnosis, so early detection is ideal. In these cases, palliative treatments may include surgical resection, chemotherapy, radiation therapy, and stenting procedures. In about a third of cases involving the common bile duct and less commonly with other locations, the tumor can be removed entirely by surgery, offering a chance of a cure. Even when surgical removal is successful, chemotherapy and radiation therapy are generally recommended.

In certain cases, surgery may include liver transplantation. Even when surgery is successful, the 5-year survival is typically less than 50%. Moreover, the rising prevalence of cholangiocarcinoma is the key factor driving the growth of the Cholangiocarcinoma Treatment Market. For instance, according to the American Cancer Society 2018, around 8,000 people in the US are diagnosed with cholangiocarcinoma each year. For instance, QED Therapeutics launched Truseltiq (Infigratinib) to treat metastatic cholangiocarcinoma. Moreover, to overcome challenges in therapy, various market players are developing innovative compounds and are in the various stages of clinical studies.

Key Market Developments:

• In April 2020, Incyte received FDA approval for its Pemazyre (Pemigatinib), which was indicated for treating metastatic cholangiocarcinoma.
• In September 2022, Taiho Oncology received FDA approval for its Lytgobi (Futibatinib) Tablets for previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma.

Approved Drug Molecules and Brand Names for Cholangiocarcinoma Treatment:

• Lytgobi (Futibatinib)
• Pemazyre (Pemigatinib)
• Truseltiq (Infigratinib)
• Tibsovo (Ivosidenib)

In May 2021, QED Therapeutics received FDA approval for its Truseltiq (Infigratinib) based on Phase 2 clinical study in which 108 patients who had undergone at least one prior treatment for advanced CCA received 125 mg of Truseltiq daily for 21 days of 28-day cycles. Of these patients, 107 (99%) had Stage IV CCA.