CHOLANGIOCARCINOMA MARKET ANALYSIS

Global Cholangiocarcinoma market is estimated to be valued at US$ 423.2 Mn in 2023 and is expected to reach US$ 1,600.7 Mn by 2030, exhibiting a Compounded Annual Growth Rate (CAGR) of 20.9% during the forecast period (2023-2030).

Analysts’ Views on the Global Cholangiocarcinoma Market:

Bile ducts are tiny canals that connect some of the digestive system's organs such as liver and gallbladder. Their function is to transport bile between these organs. The biliary system is made up of organs and bile ducts. It consists of the liver, gallbladder, and small intestine. Cholangiocarcinoma is a cancer that develops in the bile ducts. It is a rare yet aggressive form of cancer. Yellow skin and eyes (jaundice), intensely itchy skin, and white stool are some of the symptoms of cholangiocarcinoma. Product approvals of innovative drugs are anticipated to drive the market development over the forecast period. For instance, in September 2022, Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) had approved LYTGOBI tablets for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA), harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Figure 1. Global Cholangiocarcinoma Market Share (%), By Therapy Type, 2023

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Global Cholangiocarcinoma Market - Drivers

• Increasing inorganic growth strategies: Key players operating in the market are focusing on inorganic growth strategies such as purchase agreements for cholangiocarcinoma treatment which is expected to drive the global cholangiocarcinoma market growth over the forecast period. For instance, in October 2022, Sagard Healthcare, a multi-strategy alternative asset management firm, announced the acquisition of Agios Pharmaceuticals, Inc’s (a pharmaceutical company), rights of TIBSOVO. TIBSOVO is an oral, targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with an isocitrate dehydrogenase-1 (IDH1) mutation with acute myeloid leukemia (AML) or cholangiocarcinoma (bile duct cancer).
• Approvals of new drugs by regulatory authorities: Key market players are engaged in receiving approvals from regulatory authorities which is expected to drive the global cholangiocarcinoma market growth over the forecast period. For instance, in April 2020, Incyte, a biopharmaceutical company, announced that the U.S. FDA had approved Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement detected by an FDA-approved test. Pemazyre was granted under accelerated approval based on overall response rate and duration of response (DOR) and is the first and only FDA-approved therapy for this indication.

Figure 2. Global Cholangiocarcinoma Market Share (%), By Region, 2023

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Global Cholangiocarcinoma Market- Regional Analysis

Among regions, North America is estimated to hold a dominant position in the global cholangiocarcinoma market over the forecast period. North America is estimated to hold 59.1% of the market share in 2023. North America cholangiocarcinoma market is expected to witness significant growth in the near future, owing to approval of new drugs in the market. For instance, in May 2021, the U.S. FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc., a biotechnology company), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Global Cholangiocarcinoma Market - Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization (WHO) declared it a public health emergency on January 30, 2020.

The supply of raw materials required for the production of drugs intended for the treatment of cholangiocarcinoma was severely disrupted due to forced quarantine measures and lack of labor during the COVID-19 pandemic. Owing to disruptions in the link between regional warehouses, the transportation of raw materials between regions could not be carried out successfully. This shortage of raw materials and components hampered the supply chain of the global cholangiocarcinoma market.

Due to the unprecedented burden on healthcare resources, many healthcare activities such as chronic disease management, cancer screening, and cancer treatments were cancelled or delayed. Consequently, referrals of suspected new cancers have reduced, with increase in cancer-related deaths to be estimated during the pandemic period. According to data published by National Center for Biotechnology Information (NCBI), in July 2021, 63% of patients in Saudi Arabia reported a delay in treatment during the COVID-19 pandemic. The key reason behind this delay was hospital cancellations or procedure delays. A third of patients (30.8%) reported lack of cancer support and shortage of medications during the pandemic. Almost all were fearful of contracting the virus in healthcare settings and over 80% experienced an adverse impact on quality of life in 2020.

Global Cholangiocarcinoma Market- Segmentation

Global cholangiocarcinoma market is segmented based on cancer type, therapy type, route of administration, distribution channel, and region.

• By cancer type, the market is segmented into extrahepatic cholangiocarcinoma (perihilar, distal), and intrahepatic cholangiocarcinoma. Out of which, the extrahepatic cholangiocarcinoma segment is expected to hold a dominant position in the global cholangiocarcinoma market over the forecast period, owing to ongoing clinical and research studies being conducted by key market players.
• By therapy type, the market is segmented into targeted drug therapy (pemigatinib, ivosidenib, futibatinib, infigratinib), chemotherapy (5-fluorouracil, gemcitabine, cisplatin, capecitabine, oxaliplatin), immunotherapy (pembrolizumab, others (Late phase pipeline drugs)), and others (pain medications, and others). Out of which, the targeted drug therapy segment is anticipated to have the major share of the market over the forecast period, owing to new product approvals in this segment.
• By route of administration, the market is segmented into oral, subcutaneous, and intravenous. Out of which, the oral segment is anticipated to hold the highest CAGR over the forecast period as novel oral drugs are being approved for treatment of
• By distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and E-commerce. Out of which, the hospital pharmacies segment is expected to dominate the market over the forecast period, owing to increase in number of hospital pharmacies across the globe.
• By region, the market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Out of which, the North America region is anticipated to lead the market over the forecast period, owing to organic growth strategies such as facility expansion, new product launch, and others adopted by key market players.

Among all the segments, the immunotherapy segment is expected to develop at the highest CAGR over the forecast period, owing to the large number of ongoing clinical studies to study the efficacy of novel drugs to treat cholangiocarcinoma.

Global Cholangiocarcinoma Market - Cross Sectional Analysis

An increase in the adoption of inorganic growth strategies such as acquisition by the key players in Asia Pacific region is expected to drive the chemotherapy segment growth over the forecast period. For instance, on January 23, 2023, CHEPLAPHARM, a pharmaceutical company, announced the acquisition of the commercial rights for Xeloda (capecitabine) in China from F. Hoffmann-La Roche Ltd, a global pharmaceutical company. Capecitabine is a chemotherapy drug used for the treatment of cholangiocarcinoma. CHEPLAPHARM strengthens its cancer portfolio and expands its foothold in the world's second largest pharmaceutical market by adding China.

Global Cholangiocarcinoma Market- Key Developments

• On April 05, 2023, Verismo Therapeutics, a clinical-stage CAR T company and pioneer of the novel KIR-CAR platform technology, announced that it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SynKIR-110, an investigational new drug administered intravenously for the treatment of mesothelin-expressing mesothelioma, cholangiocarcinoma, and ovarian cancer.
• In October 2022, Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings Co., Ltd., announced that its U.S. subsidiary, Taiho Oncology, Inc. (“Taiho Oncology”) had received U.S. Food and Drug Administration (FDA) approval for Futibatinib for the treatment of advanced or metastatic intrahepatic cholangiocarcinoma (iCCA).
• In September 2022, AstraZeneca, a global pharmaceutical company, announced that Imfinzi (durvalumab), a human monoclonal antibody that binds to the PD-L1 protein, had been approved in the U.S. by the FDA for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
• In September 2022, Specialised Therapeutics, a pharmaceutical company, announced that its PEMAZYRE (pemigatinib), a fibroblast growth factor receptor (FGFR) inhibitor, had been provisionally approved by the Therapeutic Goods Administration (TGA) for the treatment of advanced or metastatic cholangiocarcinoma.
• In April 2021, PlantPraxis Biotecnologia, a biopharmaceutical company that focuses on the rapid development and production of specialty antibody and protein drugs, and Bio-Manguinhos, a pharmaceutical company, announced a collaborative research and development agreement to develop a biosimilar, named pembrolizumab for the Brazil market. Pembrolizumab is widely used in immunotherapy to treat a variety of cancers including melanoma, cholangiocarcinoma, lung cancer, head and neck cancer, and stomach cancer.
• In February 2021, Dr Reddy's Laboratories, a pharmaceutical company, launched the cancer treatment drug capecitabine tablets in the U.S. market. The product is a therapeutic equivalent generic version of Xeloda (capecitabine) tablets approved by the U.S. FDA. Dr. Reddy's Capecitabine Tablets, USP are available in dosages of 150 mg and 500 mg in bottle counts of 60 and 120, respectively.

Global Cholangiocarcinoma Market: Key Trends

• Increasing awareness about cholangiocarcinoma: Increasing awareness about cholangiocarcinoma is expected to drive the global cholangiocarcinoma market growth over the forecast period. For instance, in March 2022, The Pancare Foundation, a not-for-profit organization that raises awareness, supports families, and funds for research in upper gastrointestinal (GI) cancers, identified the month of February, global Gallbladder and Bile Duct Cancer awareness month, as an opportunity to begin its awareness campaign for biliary cancer in Australia. The initiatives include a new fellowship for research into biliary cancer, a new biliary cancer clinical trial, funding for a biliary cancer research program, and an animation detailing common symptoms of biliary cancer, aimed at improving awareness of biliary cancer in the general community.

Global Cholangiocarcinoma Market: Restraint

• High cost of cholangiocarcinoma treatment: High cost of cholangiocarcinoma treatment is expected to hamper the global cholangiocarcinoma market over the forecast period. For instance, on June 11, 2023, according to data published by Drugs.com, an online pharmaceutical encyclopedia, Keytruda (pembrolizumab) is a member of the anti-PD-1 monoclonal antibodies drug class and is commonly used for cholangiocarcinoma, breast cancer, cervical cancer, colorectal cancer, and others. The cost for Keytruda intravenous solution (25 mg/mL) is approximately US$ 5,747 for a supply of 4 milliliters. Moreover, according to the same source, the cost for pemazyre oral tablet 4.5 mg is around US$ 19,000 for a supply of 14 tablets.
• Counterbalance: Affordable treatment solutions from manufacturers or government intervention are needed in order to reduce the overall treatment cost.

Global Cholangiocarcinoma Market - Key Players

The major players operating in the global cholangiocarcinoma market include BridgeBio Inc., Sanofi, Eisai Co., Ltd., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Intas Pharmaceuticals Ltd., Fresenius SE & Co. KGaA, Sun Pharmaceutical Industries Ltd., Hikma Pharmaceuticals PLC, Incyte, TRISALUS LIFE SCIENCES, INC., GENFIT, Johnson & Johnson Private Limited, Blis Biopharmaceutical, Novartis AG, LES LABORATOIRES SERVIER, F. Hoffmann-La Roche Ltd, Mylan N.V. (Viatris.Inc), AstraZeneca, Compass Therapeutics, Inc, Otsuka Holdings Co., Ltd., and Senhwa Biosciences, Inc.           

Definition: Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) which carries the digestive fluid bile. The specific reason for the cause of cholangiocarcinoma is still unknown. The malignant tumor may arise from any portion of the bile duct i.e., from terminal ductules (canals of Hering) to the ampulla of Vater, also at the peribiliary glands (intramural and extramural) which may sometimes affect the gall bladder as well.