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세계의 원발성 담즙성 담관염 치료제 시장 보고서(2025년)
Primary Biliary Cholangitis Therapeutics Global Market Report 2025
상품코드 : 1811012
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

원발성 담즙성 담관염 치료제 시장 규모는 향후 수년간 급성장이 전망됩니다. 2029년에는 16억 4,000만 달러로 성장하며, CAGR은 12.9%에 달합니다. 예측 기간 중 성장의 원동력은 2차 치료제 사용 증가, 신규 치료제 파이프라인 강화, 병용요법 채택 증가, 진단 및 전문 의료에 대한 세계 접근성 확대, 환자 옹호 및 교육 활동 강화에 기인할 것으로 보입니다. 향후 예상되는 주요 동향으로는 개인 맞춤형 치료 전략, 2차 치료의 광범위한 가용성, 비침습적 바이오마커의 중요성, 증상 관리에 대한 관심 증가, 리얼월드에비던스(RWE)의 통합 등을 꼽을 수 있습니다.

간 질환의 유병률 증가는 향후 수년간 원발성 담즙성 담관염 치료제 시장의 성장을 촉진할 것으로 예측됩니다. 간 질환에는 정상적인 간 기능을 방해하는 다양한 질환이 포함되며, 종종 염증, 흉터, 간부전을 유발하는 경우가 많습니다. 과도한 음주는 간세포를 손상시키고 만성 염증을 유발하기 때문입니다. 원발성 담즙성 담관염 치료제는 담관의 염증을 표적으로 삼아 질병의 진행을 늦추고 간 기능을 유지함으로써 이러한 병태를 관리하는 데 도움을 줍니다. 이러한 치료는 증상을 완화하고, 삶의 질을 향상시키며, 간 이식의 필요성을 지연시켜 환자의 예후를 개선합니다. 예를 들어 2022년 3월 미국 질병예방통제센터(CDC)는 텍사스 주에서 만성 간질환으로 인한 사망자 수가 2021년 4,930명에서 5,079명으로 증가했다고 보고했습니다. 따라서 간질환 유병률 증가는 원발성 담즙성 담관염 치료제 시장의 성장을 지원하고 있습니다.

원발성 담즙성 담관염 치료제 시장의 주요 기업은 담즙산 대사를 개선하고 질병의 진행을 늦추는 퍼옥시좀 성장인자 활성화 수용체(PPAR) 작용제와 같은 약물의 혁신적 제품 개발 및 승인 확보에 주력하고 있습니다. PPAR 작용제는 대사, 염증, 에너지 균형에 관여하는 유전자를 조절하는 PPAR 단백질을 활성화합니다. 예를 들어 2024년 8월 미국 제약사 길리어드 사이언스는 우르소데옥시콜산(UDCA)에 충분한 효과를 얻지 못하거나 내약성이 없는 성인의 원발성 담즙성 담관염(PBC) 치료제로 리브델지(세라델파)를 미국 식품의약국(FDA)으로부터 조기 승인을 받았습니다. FDA)로부터 조기 승인을 받았습니다. 리브델지는 경구용 선택적 PPARδ 작용제로 PPARδ 수용체를 활성화하여 간 염증을 억제하고 담즙산 대사를 개선하며 PBC의 진행을 지연시키는 유전자를 조절합니다.

목차

제1장 개요

제2장 시장의 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세 및 Covid와 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별·국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 개요

제31장 기타 대기업과 혁신적 기업

제32장 세계의 시장 경쟁 벤치마킹과 대시보드

제33장 주요 합병과 인수

제34장 최근 시장 동향

제35장 시장 잠재력이 높은 국가, 부문, 전략

제36장 부록

KSA
영문 목차

영문목차

Primary biliary cholangitis (PBC) therapeutics are treatments aimed at managing and slowing the progression of primary biliary cholangitis, a chronic autoimmune liver disease that harms the bile ducts. These therapies function by improving bile flow, reducing inflammation, and preventing liver fibrosis. Their primary goal is to decrease liver inflammation, enhance bile drainage, prevent fibrosis, and delay liver failure.

The primary drug categories for PBC therapeutics include ursodeoxycholic acid, obeticholic acid, and others. Ursodeoxycholic acid is a bile acid that helps improve liver function by reducing bile accumulation and slowing liver damage, particularly in cholestatic liver conditions like PBC. These drugs operate through various mechanisms of action such as receptor agonists, receptor modulators, enzyme activators, enzyme inhibitors, and more. They are distributed through multiple channels including hospital pharmacies, retail drug stores, and online pharmacies, serving key users for both human and veterinary applications.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

The primary biliary cholangitis therapeutics market research report is one of a series of new reports from The Business Research Company that provides primary biliary cholangitis therapeutics market statistics, including the primary biliary cholangitis therapeutics industry global market size, regional shares, competitors with the primary biliary cholangitis therapeutics market share, detailed primary biliary cholangitis therapeutics market segments, market trends, opportunities, and any further data you may need to thrive in the primary biliary cholangitis therapeutics industry. This primary biliary cholangitis therapeutics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The primary biliary cholangitis therapeutics market size has grown rapidly in recent years. It will grow from $0.89 billion in 2024 to $1.01 billion in 2025 at a compound annual growth rate (CAGR) of 13.3%. Growth during the historic period was driven by increasing awareness of autoimmune liver diseases, expanding clinical evidence supporting liver function testing, growing investment in hepatology research, and a rising prevalence of autoimmune conditions.

The primary biliary cholangitis therapeutics market size is expected to see rapid growth in the next few years. It will grow to $1.64 billion in 2029 at a compound annual growth rate (CAGR) of 12.9%. Growth in the forecast period is expected to be driven by the increased use of second-line therapies, a growing pipeline of new therapeutics, rising adoption of combination treatments, expanded global access to diagnostics and specialty care, and enhanced patient advocacy and education efforts. Key trends anticipated include personalized treatment strategies, broader availability of second-line therapies, focus on non-invasive biomarkers, greater attention to symptom management, and the integration of real-world evidence (RWE).

The rising prevalence of liver diseases is anticipated to drive the growth of the primary biliary cholangitis therapeutics market in the coming years. Liver diseases encompass various conditions that disrupt normal liver function, often causing inflammation, scarring, or liver failure. This increase in liver disease cases is largely attributed to higher alcohol consumption, as excessive drinking damages liver cells and leads to chronic inflammation. Primary biliary cholangitis therapeutics help manage these conditions by targeting bile duct inflammation, slowing disease progression, and preserving liver function. These treatments improve patient outcomes by reducing symptoms, enhancing quality of life, and postponing the need for liver transplantation. For example, in March 2022, the US Centers for Disease Control and Prevention reported that deaths from chronic liver diseases in Texas rose to 5,079, up from 4,930 in 2021. Therefore, the growing prevalence of liver diseases is supporting the expansion of the primary biliary cholangitis therapeutics market.

Leading companies in the primary biliary cholangitis therapeutics market are focusing on developing innovative products and securing approvals for drugs like peroxisome proliferator-activated receptor (PPAR) agonists, which improve bile acid metabolism and slow disease progression. PPAR agonists activate PPAR proteins that regulate genes involved in metabolism, inflammation, and energy balance. For instance, in August 2024, Gilead Sciences Inc., a US pharmaceutical company, received accelerated approval from the U.S. Food and Drug Administration (FDA) for Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) in adults who have shown an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. Livdelzi is an oral, selective PPARδ agonist that activates the PPARδ receptor to regulate genes that reduce liver inflammation, improve bile acid metabolism, and slow the progression of PBC.

In March 2024, Gilead Sciences Inc. acquired CymaBay Therapeutics Inc. for $4.3 billion. This acquisition aims to enhance Gilead's liver disease portfolio by incorporating CymaBay's investigational therapy, seladelpar, which shows promise as a treatment for primary biliary cholangitis (PBC), a rare and chronic liver condition. CymaBay Therapeutics Inc. is a US-based pharmaceutical firm specializing in developing innovative therapies for PBC.

Major players in the primary biliary cholangitis therapeutics market are F. Hoffmann-La Roche Ltd, Parvus Therapeutics, Novartis AG, Gilead Sciences Inc., Viatris Inc., Ipsen Pharma, Hanmi Pharmaceutical Co. Ltd., Intercept Pharmaceuticals, Enanta Pharmaceuticals, Mirum Pharmaceuticals, Calliditas Therapeutics AB, Dr. Falk Pharma GmbH, NGM Biopharmaceuticals Inc., Durect Corporation, COUR Pharmaceuticals, HighTide Therapeutics Inc., Pliant Therapeutics Inc., Tiziana Life Sciences, Phenex Pharmaceuticals, and Synlogic Therapeutics.

North America was the largest region in the primary biliary cholangitis therapeutics market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in primary biliary cholangitis therapeutics report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the primary biliary cholangitis therapeutics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The primary biliary cholangitis therapeutics market consists of sales of Livdelzi, Iqirvo, Volixibat, fibrates, immunosuppressants, and emerging biologics. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Primary Biliary Cholangitis Therapeutics Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on primary biliary cholangitis therapeutics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for primary biliary cholangitis therapeutics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The primary biliary cholangitis therapeutics market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Primary Biliary Cholangitis Therapeutics Market Characteristics

3. Primary Biliary Cholangitis Therapeutics Market Trends And Strategies

4. Primary Biliary Cholangitis Therapeutics Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Primary Biliary Cholangitis Therapeutics Growth Analysis And Strategic Analysis Framework

6. Primary Biliary Cholangitis Therapeutics Market Segmentation

7. Primary Biliary Cholangitis Therapeutics Market Regional And Country Analysis

8. Asia-Pacific Primary Biliary Cholangitis Therapeutics Market

9. China Primary Biliary Cholangitis Therapeutics Market

10. India Primary Biliary Cholangitis Therapeutics Market

11. Japan Primary Biliary Cholangitis Therapeutics Market

12. Australia Primary Biliary Cholangitis Therapeutics Market

13. Indonesia Primary Biliary Cholangitis Therapeutics Market

14. South Korea Primary Biliary Cholangitis Therapeutics Market

15. Western Europe Primary Biliary Cholangitis Therapeutics Market

16. UK Primary Biliary Cholangitis Therapeutics Market

17. Germany Primary Biliary Cholangitis Therapeutics Market

18. France Primary Biliary Cholangitis Therapeutics Market

19. Italy Primary Biliary Cholangitis Therapeutics Market

20. Spain Primary Biliary Cholangitis Therapeutics Market

21. Eastern Europe Primary Biliary Cholangitis Therapeutics Market

22. Russia Primary Biliary Cholangitis Therapeutics Market

23. North America Primary Biliary Cholangitis Therapeutics Market

24. USA Primary Biliary Cholangitis Therapeutics Market

25. Canada Primary Biliary Cholangitis Therapeutics Market

26. South America Primary Biliary Cholangitis Therapeutics Market

27. Brazil Primary Biliary Cholangitis Therapeutics Market

28. Middle East Primary Biliary Cholangitis Therapeutics Market

29. Africa Primary Biliary Cholangitis Therapeutics Market

30. Primary Biliary Cholangitis Therapeutics Market Competitive Landscape And Company Profiles

31. Primary Biliary Cholangitis Therapeutics Market Other Major And Innovative Companies

32. Global Primary Biliary Cholangitis Therapeutics Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Primary Biliary Cholangitis Therapeutics Market

34. Recent Developments In The Primary Biliary Cholangitis Therapeutics Market

35. Primary Biliary Cholangitis Therapeutics Market High Potential Countries, Segments and Strategies

36. Appendix

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