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The Primary Biliary Cholangitis (PBC) Therapeutics Market size is estimated to grow by USD 346.85 million at a CAGR of 8.75% between 2023 and 2028. The advent of telehealth and remote monitoring has significantly contributed to the market growth. In addition, the pandemic in 2020 accelerated the adoption of telehealth services, transforming healthcare delivery. Moreover, telehealth enables remote consultations, diagnosis, treatment, and monitoring for primary biliary cholangitis patients and others, improving access to care. In addition, telehealth platforms allow primary biliary cholangitis patients to consult specialists virtually. Hence, such factors are positively impacting the market.
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The Market is a vital component of the healthcare sector, with a strong emphasis on public–private investments to drive innovation. This market is primarily focused on addressing the challenges posed by autoimmune liver diseases such as Primary Biliary Cholangitis (PBC). These diseases, often influenced by genetic predispositions and environmental triggers, target the liver's small bile ducts, disrupting bile flow and leading to conditions like cirrhosis and liver failure. Within this market, clinical trials play a crucial role in evaluating combination therapies like Ursodeoxycholic acid and Obeticholic acid for their effectiveness in managing PBC. However, one of the key obstacles is the lack of awareness regarding PBC, which affects timely diagnosis and access to appropriate treatments. Efforts in patient advocacy and support are crucial, along with ensuring a robust healthcare infrastructure capable of handling the complexities of autoimmune liver diseases. The goal of PBC therapeutics is to continuously advance with advancements in treatment to improve patient outcomes and enhance overall liver health.
The primary drug segment is estimated to witness significant growth during the forecast period. There has been an increasing demand for the primary drug segment which is contributing to the dominant position of this segment in the market.
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The primary drug segment was the largest segment and was valued at USD 271.39 million in 2018. Moreover, factors including high adoption of the primary drug for the treatment of primary biliary cholangitis and the effectiveness of the primary drug, coupled with the rise in the number of patients suffering from primary biliary cholangitis and the availability of various primary drugs in the pipeline is fuelling this segment. Hence, such factors are fuelling this segment which in turn drives the market growth during the forecast period.
The growth of the drug stores and retain pharmacies segment in the global market is fuelled by the high sales of drugs from the drug stores and retail pharmacies. In addition, the geriatric population is more vulnerable to a number of diseases and increases the dependence on drug stores. Moreover, factors including the expanding geriatric population, increasing awareness and screening efforts, and the preference for outpatient care and follow-up treatment outside of hospital settings contribute to the drug stores and retail pharmacies segment in the market. Hence, such factors are fuelling the growth of this segment which in turn drives the market growth during the forecast period.
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North America is estimated to contribute 50% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers will shape the market during the forecast period. Some of the main factors that are contributing to the market growth in North America include the increase in the number of clinical trials, the availability of advanced healthcare facilities, and increasing healthcare expenditure from government organizations. Moreover, factors including the increasing awareness and the growing need for treating it in its early stages are contributing to the regional market growth. In addition, the presence of advanced healthcare infrastructure in the region and the availability of various patient assistance programs fuels the market growth in the region. Hence, such factors are driving the market growth in North America during the forecast period.
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
Abbott Laboratories: The company offers primary biliary cholangitis therapeutic treatment under rapid diagnostics, which includes infectious disease, cardiometabolic and informatics, toxicology, and consumer diagnostics.
AbbVie Inc., Alkem Laboratories Ltd., Eli Lilly and Co., GENFIT SA, Glenmark Pharmaceuticals Ltd., ICE S.p.a., Intercept Pharmaceuticals Inc., Ipsen Pharma, Leeford Healthcare Ltd., NGM Biopharmaceuticals Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Viatris Inc., and Zydus Lifesciences Ltd.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market is propelled by substantial public–private investments in the healthcare sector, driving innovation and treatment advancements. Key drivers include clinical trials focusing on combination therapies like Ursodeoxycholic acid and Obeticholic acid. However, challenges persist due to a lack of awareness leading to delayed diagnosis of PBC, highlighting the need for patient advocacy. Trends indicate a shift towards personalized treatments addressing genetic predispositions and environmental triggers, aiming to combat autoimmune liver diseases and their complications like cirrhosis and liver failure. Our researchers analyzed the market research and growth data with 2023 as the base year, along with the key market growth analysis, trends, and challenges. A holistic analysis of drivers, trends, and challenges will help companies refine their marketing strategies to gain a competitive advantage.
A key factor shaping the market growth is the increasing demand for R&D due to government healthcare expenditure. In several applications, from small laboratory studies to large-scale production of specialty pharmaceutical products, the ability to obtain an enriched sample of small molecules, cells, proteins, nucleic acids, or clean solutions is essential. In addition, complying with government regulations that deal with the purity and consistency of primary biliary cholangitis therapeutics requires a well-thought-out enrichment plan.
Moreover, several specialties pharmaceutical companies are investing heavily in R&D. For instance, on average, the pharmaceutical company spends around 15%-20% of its revenue on R&D activities. In addition, increased R&D spending by pharmaceutical manufacturers is expected to increase the number of therapeutics in the market which is positively impacting the market. Therefore, it is expected to drive the market trends during the forecast period.
Stringent government regulations is one of the key challenges hindering market growth. Several market players are offering primary biliary cholangitis therapeutics that are subject to government regulations, such as the US Food and Drug Administration (US FDA), the conformite European (CE) Marking in Europe, and other regulations in different regions and countries worldwide. In addition, commercialization of these products with different technologies is a challenging process.
Moreover, they require premarket approval from notified bodies, including private organizations recognized by the European Free Trade Association. In addition, these devices cannot be marketed without successfully completing clinical trials, which is time-consuming, expensive, and uncertain. Furthermore, the laws and regulations of the approval process vary across countries, which is a major challenge faced by multinational companies. Hence, such factors are negatively impacting the market. Therefore, it is expected to hinder market growth during the forecast period.
The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Customer Landscape
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Million" for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
The Market is significantly influenced by factors such as Ursodeoxycholic acid (UDCA) and Obeticholic acid, which are prominent treatments within the pharmaceutical industry for autoimmune liver disease. The market's dynamics are shaped by genetic predispositions and the rising emphasis on combination therapies due to chronic autoimmune liver disease. Challenges include lack of awareness, hindering early diagnosis of PBC. However, with robust healthcare infrastructure and patient advocacy, there's growing hope for effective therapies targeting the immune system and reducing liver damage. Public–private investments in healthcare and advancements in treatment modalities signal a positive trajectory for addressing the increasing prevalence of PBC and improving outcomes for healthcare professionals and patients.
Moreover, the Market is a critical sector within the pharmaceutical supply chain, dedicated to addressing complex issues related to autoimmune diseases affecting the liver's small bile ducts. Bile flow disruptions, often triggered by environmental factors, infections, and exposure to harmful substances, necessitate a deeper understanding of the underlying mechanisms to develop effective treatments. The market landscape depends on Small bile ducts within the liver, Genetic predisposition and environmental triggers, the Goal of PBC therapeutics, the increase in the number of patients suffering from PBC, Symptomatic therapies. The market emphasizes combinations of therapies, leveraging both primary and secondary drug types, available in drug stores & retail pharmacies for the growing patient pool. Healthcare investments and public–private collaborations are pivotal in advancing bile-acid modulators and innovative solutions for rare liver conditions, characterized by inflammation, destruction, and scarring of bile ducts leading to conditions like cirrhosis and liver failure. The market's goal is to enhance patient advocacy and support, aiming to address challenges like lack of early diagnosis and limited treatment options, especially with the increasing number of patients suffering from PBC and related autoimmune biliary diseases.
Market Scope |
|
Report Coverage |
Details |
Page number |
151 |
Base year |
2023 |
Historic period |
2018-2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 8.75% |
Market growth 2024-2028 |
USD 346.85 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
8.0 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 50% |
Key countries |
US, Canada, Germany, UK, and China |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks |
Key companies profiled |
Abbott Laboratories, AbbVie Inc., Alkem Laboratories Ltd., Eli Lilly and Co., GENFIT SA, Glenmark Pharmaceuticals Ltd., ICE S.p.a., Intercept Pharmaceuticals Inc., Ipsen Pharma, Leeford Healthcare Ltd., NGM Biopharmaceuticals Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Viatris Inc., and Zydus Lifesciences Ltd. |
Market dynamics |
Parent market analysis, Market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period. |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Type
7 Market Segmentation by Distribution Channel
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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