PUBLISHER: DelveInsight | PRODUCT CODE: 1226675
PUBLISHER: DelveInsight | PRODUCT CODE: 1226675
DelveInsight's 'Primary Biliary Cholangitis (PBC) - Market Insights, Epidemiology, and Market Forecast - 2032' report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of primary biliary cholangitis in the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, Japan, and China.
The primary biliary cholangitis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted primary biliary cholangitis market size from 2019 to 2032, segmented by the 7MM + China. The report also covers the current primary biliary cholangitis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.
Study period: 2019-2032.
According to the American Liver Foundation, primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, is a chronic liver disease resulting from the progressive destruction of the bile ducts in the liver, called the intrahepatic bile ducts. Prolonged hepatic cholestasis subsequently leads to cirrhosis and portal hypertension.
Patients with PBC can be asymptomatic or may present with jaundice, pruritus, and fatigue. Other symptoms may include abdominal pain, skin darkening, and xanthomas or xanthelasmas. Individuals may also complain of dry mouth, eyes, bone, muscle, and joint pain. As the disease progresses, symptoms of cirrhosis can develop, including jaundice, edema, ascites, and varices.
Since many people with PBC have no symptoms, the disease is often discovered incidentally due to abnormal results on routine liver blood tests. Once PBC is suspected, a blood test is done to check for anti-mitochondrial antibodies (AMA). This test is positive in nearly all people with PBC. A liver biopsy, where a small sample of liver tissue is removed with a small needle, can help confirm the diagnosis. Imaging studies may rule out other diseases or evaluate patients further once diagnosed with PBC.
There are only two medications approved by the Food and Drug Administration (FDA) to treat PBC; ursodeoxycholic acid (UDCA) and obeticholic acid (OCALIVA). UDCA is a hydrophilic bile salt that stabilizes hepatocyte membranes against toxic bile salts and inhibits apoptosis and fibrosis. While, obeticholic acid is a farnesoid X receptor agonist that helps reduce ALP, GGT, and transaminase levels due to its antifibrotic and choleretic properties. It can be given in combination with UDCA in adults with inadequate response to UDCA or as a single therapy in adults unable to tolerate UDCA.
It covers the details of conventional and current medical therapies and diagnoses available in the primary biliary cholangitis market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, EU-4 and the United Kingdom, Japan, and China.
The primary biliary cholangitis epidemiology division provides insights into the historical and current patient pool and the forecasted trend for the 7MM + China. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of KOL. The report also provides the prevalent patient pool, trends, and assumptions.
The disease epidemiology covered in the report provides historical and forecasted primary biliary cholangitis epidemiology segmented as the Diagnosed Prevalent Cases of Primary Biliary Cholangitis, Gender-specific Cases of Primary Biliary Cholangitis, and Age-specific Cases of Primary Biliary Cholangitis. The report includes the total cases of PBC in the 7MM + China covering the United States, Japan, China, EU4, and the United Kingdom from 2019 to 2032.
The epidemiology segment also provides the primary biliary cholangitis epidemiology data and findings across the United States, EU4 and the United Kingdom, Japan, and China.
In 2021, the total diagnosed prevalent cases of PBC were more than 1,000,000 in the 7MM + China.
As per the estimates, China had the highest diagnosed prevalent patient population of PBC in 2021. Among EU4 and the UK, Germany had the highest number of diagnosed cases of PBC, with around 32,000 cases, followed by the UK in 2021. On the other hand, Spain had the lowest number of diagnosed cases of PBC, with close to 10,000 cases in 2021.
The drug chapter segment of the primary biliary cholangitis report encloses a detailed analysis of primary biliary cholangitis-marketed drugs and late-stage (Phase III, Phase II/III, and Phase II) pipeline drugs. It also helps understand the primary biliary cholangitis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Despite the emergence of competing drugs, UDCA is still recognized as the universal first-line standard of care for PBC. This strong recommendation is based on the long-term efficacy of UDCA and its excellent safety profile and low cost. After UDCA, obeticholic acid (OCA), OCALIVA was the second drug to successfully meet the primary endpoint of a large placebo-controlled Phase III trial in PBC.
Drug developers are gradually shifting their attention toward primary biliary cholangitis to meet the patient pool's current demands and counter the unmet needs of the therapeutic market.
Many molecules are in the pipeline to treat primary biliary cholangitis patients across many countries to cater to their needs. Some of the major late-stage products are likely to hit the market during our study period 2019-2032 include seladelpar (CymaBay Therapeutics), elafibranor (Genfit), setanaxib (Genkyotex SA), saroglitazar Mg (Zydus), and linerixibat (GlaxoSmithKline).
Seladelpar (MBX-8025) is a potent, selective, orally active PPARd agonist in development for treating patients with PBC and an inadequate response to or intolerance to UDCA. The drug is currently in Phase III trial and has received multiple designations from regulatory authorities, likely to speed up the drug approval process.
Elafibranor is a dual PPARa/d agonist, developed by Genfit. It is currently being evaluated in the Phase III trial. With orphan and breakthrough therapy designation, the drug is expected to enter the market by 2024.
The market outlook of the primary biliary cholangitis report builds a detailed comprehension of the historical, current, and forecasted primary biliary cholangitis market trends by analyzing the impact of current therapies on the market, unmet needs, and demand for better technology.
This segment gives a thorough detail of the primary biliary cholangitis market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market, and KOL view. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
As per DelveInsight, the primary biliary cholangitis market in the 7MM + China is expected to change in 2019-2032.
This section includes a glimpse of the primary biliary cholangitis market in 7MM + China. The primary biliary cholangitis market size in the seven major markets and China was approximately USD 1,560 million in 2021.
This section provides the total primary biliary cholangitis market size, and it also provides the market size of anemia by therapies in the United States.
The United States accounts for the highest market size of primary biliary cholangitis than, EU4 and the United Kingdom, and Japan.
This section provides the total primary biliary cholangitis market size. It also provides primary biliary cholangitis market size by therapies in Germany, France, Italy, Spain, and the United Kingdom.
This section provides the total primary biliary cholangitis market size. It also provides the market size of primary biliary cholangitis by therapies in Japan.
This section provides the total primary biliary cholangitis market size. It also provides the market size of primary biliary cholangitis by therapies in China.
This section focuses on the uptake rate of potential drugs launched or expected to be launched in the market during 2019-2032. The analysis covers the primary biliary cholangitis market uptake by drugs, patient uptake by therapies, and sales of each drug.
This helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II. It also analyses primary biliary cholangitis's key players in developing targeted therapeutics.
Major players include: CymaBay Therapeutics, Genfit, Genkyotex SA, Zydus, and GlaxoSmithKline whose key products are expected to get launched in the US market by 20XX.
The report covers collaborations, acquisitions, mergers, licensing, and patent details for emerging primary biliary cholangitis therapies.
To keep up with current market trends, we take KOLs and SMEs' opinions working in the primary biliary cholangitis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging treatment patterns or primary biliary cholangitis market trends. This will support the clients in potential novel treatments by identifying the overall scenario of the market and the unmet needs.
We perform a competitive and market intelligence analysis of the primary biliary cholangitis market using various competitive intelligence tools: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.