primary biliary cholongitis market insight
DelveInsight’s ‘Primary Biliary Cholangitis – Market Insights, Epidemiology, and Market Forecast—2030’ report deliver an in-depth understanding of the Primary Biliary Cholangitis, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The Primary biliary cholangitis market report provides current treatment practices, emerging drugs and their market share of the individual therapies, current and forecasted Primary biliary cholangitis symptoms market size from 2017 to 2030 segmented by seven major markets. The report also covers current Primary biliary cholangitis symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities. It assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Study Period: 2017–2030
Primary Biliary Cholangitis Disease Understanding and Treatment Algorithm
Primary Biliary Cholangitis Overview
Primary Biliary Cholangitis is an autoimmune disease that results in liver damage due to the destruction of small bile ducts, which if left untreated, may lead to impaired quality of life, cirrhosis, and end-stage liver disease. Common early symptoms of primary biliary cholangitis are feeling tired and itchy skin. As the disease gets worse, there can be more symptoms. Although the exact cause of the disease is unknown, the immune system and environmental triggers may play a role. Doctors diagnose primary biliary cholangitis based on the medical and family history, a physical exam, and the results of medical tests. Medical tests to diagnose primary biliary cholangitis may include blood tests, imaging tests, and liver biopsy.
The diagnosis of PBC requires the presence of high alkaline phosphatase (ALP, a liver blood test) along with a positive anti-mitochondrial antibody (+AMA). If AMA testing is negative, then a patient would need a liver biopsy to confirm the diagnosis of PBC, since several diseases can cause a high ALP.
Primary Biliary Cholangitis Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the Primary Biliary Cholangitis market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight Primary biliary cholangitis market report gives a thorough understanding of PBC symptoms by including details such as disease definition, symptoms, causes, physiology, and diagnosis. It also provides PBC symptoms of treatment algorithms and treatment guidelines for PBC symptoms in the US, Europe, and Japan.
PBC diagnosis can be established if two of three objective criteria are present: positive AMA serologic testing; persistent unexplained biochemical cholestasis, defined as an abnormal ALP level over 24 weeks; and/or compatible liver histology, specifically non-suppurative cholangitis and interlobular bile duct injury. Confidence in an accurate diagnosis is critical to allow prompt initiation of effective therapy and timely identification of patients at risk of progressive disease.
Individuals with primary biliary cholangitis are initially identified because of: an incidental finding of altered liver biochemical tests (e.g., alkaline phosphatase), the development of symptoms of cholestasis, or positive anti-mitochondrial antibody after screening for extrahepatic autoimmune disease. Diagnosis can be made when two of the following three criteria are fulfilled: biochemical testing suggestive of cholestasis, the presence of characteristic serum autoantibodies, and histological demonstration of non-suppurative inflammation of interlobular bile ducts.
The goals of treatment are to slow the progression rate of the disease and to alleviate the symptoms (e.g., pruritus, osteoporosis, sicca syndrome). Liver transplantation appears to be the only life-saving procedure.
Primary Biliary Cholangitis Epidemiology
The Primary Biliary Cholangitis symptoms epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
The diagnosed prevalent cases of PBC is increasing in 7MM during the study period, i.e., 2017–2030.
The disease epidemiology covered in the report provides historical as well as forecasted PBC symptoms epidemiology segmented as the Total 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 prevalent scenario of PBC symptoms in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
Country-wise Primary Biliary Cholangitis Epidemiology
The epidemiology segment also provides the PBC epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The total diagnosed prevalent cases of Primary Biliary Cholangitis associated in 7MM countries was 235,859 in 2017.
Primary Biliary Cholangitis Drug Chapters
The drug chapter segment of the Primary Biliary Cholangitis report encloses the detailed analysis of PBC early-stage (Phase- II, III) pipeline drugs. It also helps understand the PBC 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.
Primary Biliary Cholangitis Emerging Drug
Seladelpar: CymaBay Therapeutics
Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor δ (PPARδ) agonist in development for the treatment of patients with the autoimmune liver disease, Primary Biliary Cholangitis.
Elafibranor: Genfit
Elafibranor (GFT505), a dual PPARα/δ agonist, is an experimental medication that is being studied and developed by Genfit for the treatment of cardiometabolic diseases, including diabetes, insulin resistance, dyslipidemia, and non-alcoholic fatty liver disease (NAFLD).
Products detail in the report…
Primary Biliary Cholangitis Market Outlook
The PBC market outlook of the report helps build a detailed comprehension of the historic, current, and forecasted PBC market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.
This segment gives a thorough detail of PBC market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the PBC market in 7MM is expected to grow in the study period 2017–2030.
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, together with its low cost. Ursodeoxycholic acid (UDCA) exerts anti-cholestatic properties among others by improved hepatobiliary secretory function and reduced bile toxicity. Some immunological indices of the disease, such as serum level of immunoglobulin M (IgM), and anti-mitochondrial antibody titer have also been shown to decrease in response to UDCA. Also, there is evidence to suggest that UDCA can slow down the histological progression and the development of portal hypertension. 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.
Key Findings
This section includes a glimpse of the PBC market in 7MM. The market size of PBC in the seven major markets was USD 686.3 million in 2017.
The United States Market Outlook
This section provides the total PBC market size and market size by therapies in the United States.
The United States accounts for the largest market size of PBC in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
EU-5 Countries: Market Outlook
The total PBC market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total PBC market Size and market Size by therapies in Japan are also mentioned.
Primary Biliary Cholangitis Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017–2030. The analysis covers PBC market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow 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 in making financial and regulatory decisions.
Primary Biliary Cholangitis Pipeline Development Activities
The report provides insights into the therapeutic candidate in Phase I, II, and III stages. It also analyses PBC key players involved in developing targeted therapeutics.
Major players include CymaBay Therapeutics, Genfit, Genkyotex SA, and Zydus Cadila.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for PBC emerging therapies.
Reimbursement Scenario in Primary Biliary Cholangitis
Approaching reimbursement, proactively, can have a positive impact both during the early stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Interconnect Support Services provides financial and insurance support. Interconnect is dedicated to getting access to OCALIVA (obeticholic acid) for as little as $0/month. Fifty-four percent (54%) of Medicare Part D and Medicare Advantage plans cover this drug.
A study by Pasha (1999) established the cost-effectiveness of ursodeoxycholic acid therapy in PBC. A conservative estimate of annual resource use for each major event was determined for both outpatient and inpatient medical services by constructing a typical profile for each event. These profiles were based on input from expert opinion and data from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The profiles included the average number of physician visits, medication use, laboratory use, and diagnostic and therapeutic interventions. Costs of medications were estimated using average 1995 wholesale prices.
KOL Views
To keep up with current market trends, we take KOLs and SME’s opinion working in the PBC domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or PBC market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform a Competitive and Market Intelligence analysis of the PBC Market by using various Competitive Intelligence tools that include – 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.
Scope of the Report
- The report covers the descriptive overview of Primary Biliary Cholangitis, explaining its causes, signs and symptoms, physiology, and currently available therapies
- Comprehensive insight has been provided into the Primary Biliary Cholangitis epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for Primary Biliary Cholangitis is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
- A detailed review of the Primary Biliary Cholangitis market; historical and forecasted is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Primary Biliary Cholangitis market
Report Highlights
- In the coming years, the Primary Biliary Cholangitis market is set to change due to the rising awareness of the disease, and the Favorable Environment for New Anti-infective Modalities; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
- The companies and academics are working to assess challenges and seek opportunities that could influence Primary Biliary Cholangitis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Major players are involved in developing therapies for Primary Biliary Cholangitis. The launch of emerging therapies will significantly impact the Primary Biliary Cholangitis market
- Our in-depth analysis of the pipeline assets across different stages of development (Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Primary Biliary Cholangitis Report Insights
- Patient Population
- Therapeutic Approaches
- Primary Biliary Cholangitis Pipeline Analysis
- Primary Biliary Cholangitis Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Primary Biliary Cholangitis Report Key Strengths
- 11 Years Forecast
- 7MM Coverage
- Primary Biliary Cholangitis Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Primary Biliary Cholangitis Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
Key Questions
Market Insights:
- What was the Primary Biliary Cholangitis Market share (%) distribution in 2017 and how it would look like in 2030?
- What would be the Primary Biliary Cholangitis total market Size as well as market Size by therapies across the 7MM during the forecast period (2017–2030)?
- What are the key findings of the market across 7MM and which country will have the largest Primary Biliary Cholangitis market Size during the forecast period (2017–2030)?
- At what CAGR, the Primary Biliary Cholangitis market is expected to grow in 7MM during the forecast period (2017–2030)?
- What would be the Primary Biliary Cholangitis market outlook across the 7MM during the forecast period (2017–2030)?
- What would be the Primary Biliary Cholangitis market growth till 2030, and what will be the resultant market Size in the year 2030?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What are the disease risk, burden, and unmet needs of the Primary Biliary Cholangitis?
- What is the historical Primary Biliary Cholangitis patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of Primary Biliary Cholangitis in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What will be the growth opportunities in the 7MM concerning the patient population about Primary Biliary Cholangitis?
- Out of all 7MM countries, which country would have the largest prevalent population of Primary Biliary Cholangitis during the forecast period (2017–2030)?
- At what CAGR the population is expected to grow in 7MM during the forecast period (2017–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of Primary Biliary Cholangitis along with the approved therapy?
- What are the current treatment guidelines for the treatment of Primary Biliary Cholangitis in the USA, Europe, and Japan?
- What are the Primary Biliary Cholangitis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of Primary Biliary Cholangitis?
- How many therapies are developed by each company for the treatment of Primary Biliary Cholangitis?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of Primary Biliary Cholangitis?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Primary Biliary Cholangitis therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Primary Biliary Cholangitis and their status?
- What are the key designations that have been granted for the emerging therapies for Primary Biliary Cholangitis?
- What are the global historical and forecasted market of Primary Biliary Cholangitis?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the Primary Biliary Cholangitis market
- To understand the future market competition in the Primary Biliary Cholangitis market and Insightful review of the key market drivers and barriers
- Organize sales and marketing efforts by identifying the best opportunities for Primary Biliary Cholangitis in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
- Organize sales and marketing efforts by identifying the best opportunities for the Primary Biliary Cholangitis market
- To understand the future market competition in the Primary Biliary Cholangitis market
