PRIMARY SCLEROSING CHOLANGITIS MARKET ANALYSIS

In primary sclerosing cholangitis, inflammation causes scars within the bile ducts. These scars make the ducts hard and narrow and gradually cause serious liver damage. A majority of people with primary sclerosing cholangitis also have inflammatory bowel diseases such as ulcerative colitis or Crohn's disease. Primary sclerosing cholangitis (PSC) is a condition causing long-term inflammation and scarring (fibrosis) of bile ducts in the liver. Primary sclerosing cholangitis (PSC) is a chronic disease of the biliary tree characterized by progressive inflammation and fibrotic structuring of the bile ducts. These ducts are tubes that allow the liquid (bile) produced by the liver to pass through the intestine allowing fat digestion. This disease predominantly affects men between the age of 25 and 40 years. The damage to the ducts causes accumulation of bile acids, essential components of bile to build up in the liver leading to liver tissue damage, portal hypertension (high blood pressure in the vessels connecting the liver and the gut), and liver failure, and it may increase the risk of liver cancer.

The global primary sclerosing cholangitis market is estimated to be valued at US$ 140.4 million in 2022 and is expected to exhibit a CAGR of 7.6% during the forecast period (2022-2030).

Figure 1. Global Primary Sclerosing Cholangitis Market Share (%), by Drug, 2022

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Increasing incidence of liver failure and bile cancer associated with primary sclerosing cholangitis is expected to drive the global primary sclerosing cholangitis market

The increasing prevalence of diseases associated with primary sclerosing cholangitis, such as liver cancer and inflammatory bowel disease, is expected to enhance the therapeutic adoption of efficient drugs to manage the condition, thus driving the growth of the primary sclerosing cholangitis market. For instance, in May 2021, according to an article published by Springer Nature Limited, a diagnosis of primary sclerosing cholangitis (PSC) has been associated with the increased risk of hepatobiliary cancers, colorectal cancer, and all-cause mortality in several studies, while associations with cardiovascular disease have been inconsistent. An incidence of 0.4–0.7 cases per 100,000 in the U.K. and a prevalence of 3.9–16.2 per 100,000 of liver failure. Inflammation in the colon is a predominant risk factor for primary sclerosing cholangitis with concomitant inflammatory bowel disease being reported in up to 60–80% of PSC patients. Prospective cohort studies have suggested strong positive associations between PSC and increased risk of several gastrointestinal cancers with extreme relative risks (RRs) in the range of 200–1560 for cholangiocarcinoma. According to the World Journal of Gastroenterology, 2017, inflammatory bowel disease (IBD) is diagnosed in around 50-80% of the patients with PSC, with ulcerative colitis (UC) comprising around 80-90% of these cases.

Figure 2. Global Primary Sclerosing Cholangitis Market Share (%), by Region, 2022

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Affordable options in comparison with the currently available liver transplantation treatments are expected to increase the adoption of primary sclerosing cholangitis drugs

Currently, liver transplant is the only known cure for primary sclerosing cholangitis and is one of the major causes for liver transplantation in the U.S. However, in February 2018 as per the survey by Mayo Clinic, the disease is expected to recur in the transplanted liver in 27.2% of the patients, thereby demanding efficient and affordable therapeutic solutions to cater to unmet patient needs. According to the United Network for Organ Sharing (UNOS), 2018, the estimated bill charges of a liver transplant procedure are around US$ 577,100 in the U.S.

Moreover, there are major risk factors associated with liver transplantation that causes death of the patient. For instance, in May 2019, according to the data published by the National Center for Biotechnology Information, pre-transplant malignancies were identified as those malignancies known prior to the transplant and those found only on pathologic evaluation of the explant. According to the data published in Mayo Clinic in March 2022, about 75% of people who undergo liver transplant live for at least five years. It means that for every 100 people who receive a liver transplant for any reason, about 75 will live for five years and 25 will die within five years.

Thus, the requirement of providing affordable treatment, owing to high costs associated with liver transplantation coupled with increasing risk factors resulting in the development of serious disorders, is one of the major factors that are expected to increase the adoption of primary sclerosing cholangitis drugs, and in turn favor market growth in the near future.

Global Primary Sclerosing Cholangitis 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 had declared it a public health emergency on January 30, 2020.

COVID-19 can affect the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with regard to the transportation of drugs from one place to another.

However, the COVID-19 pandemic had a positive impact on the global primary sclerosing cholangitis market, owing to the increased incidence which cause Primary Sclerosing Cholangitis like increasing stress, abdominal pain, diarrhea, hyperacidity etc. in patients infected with COVID-19 infection. Inflammation in the colon is a predominant risk factor for primary sclerosing cholangitis with concomitant inflammatory bowel disease being reported in up to 60–80% of PSC patients. For instance, according to an article published by the National Center for Biotechnology Information, providing access to biomedical and genomic information, in February 2022, the COVID-19 pandemic is reported to increase psychological distress, liver dysfunctioning, and jaundice.

Global Primary Sclerosing Cholangitis Market: Key Developments

In April 2022, Sirnaomics, a clinical-stage RNA therapeutics biopharmaceutical company, carried out Phase I clinical trial analyzing the potential of STP707 to treat liver fibrosis in primary sclerosing cholangitis in the U.S. A systemic small interfering ribonucleic acid (siRNA) therapy STP707 comprises two siRNA oligonucleotides that act on TGF-β1 and COX-2 mRNA, respectively. It is formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The randomized, single-center, dose-escalation, sequential cohort trial will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) single ascending dose of STP707 in healthy subjects.

Global Primary Sclerosing Cholangitis Market: Restraint

The major factors that hinder the growth of the global primary sclerosing cholangitis market include the unavailability of approved drugs targeting the condition in practical medical use. For instance, in December 2021, according to National Center for Biotechnology Information, there is no approved drug for treating primary sclerosing cholangitis; therefore, current treatment focuses on the reduction of cholestasis and management of disease manifestations and complications (e.g., fatigue, pruritis). Chemomab Therapeutics, Biotech Company established strong pre-clinical evidence that demonstrates the potent anti-cholestatic and anti-fibrotic effects of CM-101 in primary sclerosing cholangitis which are still in phase I clinical trial.

Key Players

Major players operating in the global primary sclerosing cholangitis market include Acorda Therapeutics, Inc., Gilead Sciences, Inc., NGM Biopharmaceuticals, Inc., Intercept Pharmaceuticals, Inc., Dr. Falk Pharma GmbH, Allergan Plc., Shire Plc., Durect Corporation, Conatus Pharmaceuticals, Inc., Sirnaomics, Inc., and Shenzhen HighTide Biopharmaceutical Ltd.