Spherix Global Insights

March 16, 2022

Spherix Global Insights Finds US Primary Biliary Cholangitis Market Poised for Transformation as Pipeline Therapies Progress in Clinical Development

Four pipeline product profiles were evaluated by US gastroenterologists to assess strengths, weaknesses, and physician receptivity

EXTON, Pa.March 16, 2022 /PRNewswire/ — Spherix recently surveyed 107 US gastroenterologists and conducted ten qualitative interviews (including a key opinion leader and six clinical trial participants) to assess the current and future management of primary biliary cholangitis (PBC). The combination of qualitative and quantitative research included in their Market Dynamix™: Primary Biliary Cholangitis (US) service evaluates, in detail, the diagnostic and treatment trends emerging with the condition, as well as physician reactions to potential therapies in development. Of note, more than one-third of the respondents were employed by facilities that include a liver transplant center.

The PBC market represents an intriguing opportunity for companies with therapies in development and for those seeking acquisitions in order to bolster their gastroenterology portfolio. Several factors contribute to this:

  • The PBC market size is noteworthy. Gastroenterologists in the survey averaged 25 PBC patients per year (median 20 PBC patients).
  • PBC is a chronic condition that often develops unknown to the patient for several years. More than one-third of PBC patients have been diagnosed and treated with PBC for more than five years.
  • The PBC market may be larger than anticipated. Gastroenterologists estimate that nearly 30% of PBC patients may be undiagnosed. A blood test, as part of an unrelated check-up or to evaluate a separate condition, is typically the starting point for an eventual PBC diagnosis.
  • While less than one in five PBC patients is rated as severe, current treatment options for moderate (and even some mild) patients usually have an eventual failure rate of 30% or more. In fact, 69% of gastroenterologists in the study say the unmet need for PBC treatments is high.

The report also addresses an important symptom of PBC: pruritis. Pruritis is very uncomfortable itching that is often experienced with many liver conditions like PBC, primary sclerosing cholangitis (PSC), and even non-alcoholic fatty liver disease (NAFLD).

According to many treating physicians, while slowing fibrosis of the liver (triggered by failed bile ducts) is the ultimate goal in treating PBC, mitigating often unbearable pruritis symptoms is also stated as highly important. Surveyed gastroenterologists identified several pruritis treatment options with limited benefit in addressing these symptoms across all afflicted patients.

Spherix’s Market Dynamix™ service assesses physician awareness of and familiarity with four pipeline PBC assets that have at least Phase 2 clinical data available. These pipeline therapies include:

  • Seladelpar (CymaBay Therapeutics)
  • Setanaxib (Calliditas Therapeutics)
  • Elafibranor (Genfit)
  • Saroglitazar magnesium (Zydus Lifesciences)

Gastroenterologists engaged in a thorough review of these pipeline product descriptions (based on publicly available clinical information). Quantitative data captured for these PBC pipeline therapies includes:

  • Most likely to prescribe therapy (likelihood rating if FDA-approved)
  • Most preferred pipeline therapy (ranking)
  • Advantages of each pipeline therapy (open-ended)
  • Limitation of each pipeline therapy (open-ended)
  • Reasons for ranking each therapy number one
  • Estimated number of PBC patients who would be started on each number-one ranked therapy

PBC represents just one of the emerging gastroenterological conditions introduced into Spherix’s gastroenterology offerings through their Market Dynamix™ service. Other conditions covered include eosinophilic esophagitis (EoE), non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH), celiac disease (CeD), and clostridium difficile (C. diff).

About Market Dynamix™
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Learn more about our services here.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

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