세계 간섬유증 및 NASH/MASH 치료제 시장 규모는 2025년 183억 달러로 추정되며, 예측 기간 동안 CAGR 10.0%로 성장할 것으로 예상됩니다.
NASH/MASH 치료제 승인에 대한 규제 과제와 시장 장벽:
NASH/MASH는 간섬유화, 간경변증으로 진행되어 보건 보건 위기를 가속화하고 있습니다. MASH는 주로 제 2형 당뇨병 및 심혈관질환과 관련이 있습니다. 임상시험에서 NASH 치료제는 간 관련 결과와 관련된 복합 평가변수를 측정하여 질병의 진행을 늦추거나 발병을 예방하는 능력을 입증할 것입니다.
그러나 현재 NASH에 대한 효과적인 치료법이 없기 때문에 미국 FDA는 다른 승인 경로를 마련했습니다. 이 경로는 간 생검을 통한 병리조직학적 병태생리학적 평가와 임상시험 중 양호한 임상 결과를 대체 평가지표로 삼고 있습니다. 그 결과, 미국 FDA는 MASH의 악화 없이 섬유화 a*1 단계의 개선 또는 섬유화 악화를 동반하지 않는 MASH의 소실 중 하나를 입증하여 주요 평가항목을 충족하는 약물을 승인하고 있습니다.
반면, 유럽의약품청(EMA)의 규제 요건은 미국 FDA와 다른데, EMA는 두 가지 주요 평가 항목을 모두 충족해야 하며, 섬유증 개선과 함께 NASH의 완전한 소실을 요구하고 있습니다. 전 세계적으로 통일된 임상시험 요건이 없다는 것은 제약사들에게 큰 도전이 되고 있습니다.
세계의 간섬유증 및 NASH/MASH 치료제 시장을 조사했으며, 시장 개요, 시장 성장 촉진요인 및 시장 기회 분석, 시장 규모 추정 및 예측, 각종 부문별·지역별·주요 국가별 상세 분석, 경쟁 구도, 주요 기업 개요 등의 정보를 정리하여 전해드립니다.
목차
제1장 보고서 개요
제2장 주요 요약
제3장 시장 개요
주요 조사 결과
시장 역학
영향 분석
시장 성장 촉진요인
시장 성장 억제요인
시장 기회
규제 체계
Porter's Five Forces 분석
PEST 분석
제4장 간섬유증 치료제 시장 분석 : 질환 유형별
주요 조사 결과
시장 매력도 지수
시장 규모 추정과 예측
항바이러스제
알코올성 간질환(ALD)
자가면역성 간질환
항산화제
약물로 인한 간 손상(DILI)
시장 규모 추정과 예측 : 지역별
시장 점유율 : 지역별
제5장 NASH/MASH 치료제 시장 분석
주요 조사 결과
간섬유증/NASH//MASH 치료제 규모 : 시장 규모 예측
비타민 E와 피오글리타존
레즈디프라
세마글루타이드(오젬픽)
티르제파타이드
펨비두타이드
라니피브라노르
벨라펙틴
에프루시퍼민
페고사퍼민
드니판스타트
병용요법
제6장 NASH/MASH 치료제 시장의 파이프라인 의약품 분석
주요 조사 결과
2024년까지 다양한 임상시험 단계에 있는 NASH/MASH 파이프라인 수
단계 III 임상시험 : NASH/MASH 시장
단계 II 임상시험 : NASH/MASH 시장
파이프라인 병용요법 : NASH/MASH 시장
파이프라인 병용요법 : 간경변을 수반하는 NASH/MASH 시장
신규 참여자/신기술 임상시험 : NASH/MASH 시장
임상시험 : 약물 재이용 간섬유증 시장
제7장 NASH//MASH 치료제 시장 분석 : 주요 국가별
주요 조사 결과
NASH/MASH 시장 : 섬유화 단계별(%)
NASH/MASH 지역 분석 : 시장 점유율(%)
시장 규모 : 지역별
미국
영국
프랑스
이탈리아
스페인
독일
일본
중국
제8장 간섬유증 치료제 시장 분석 : 최종사용자별
주요 조사 결과
시장 매력도 지수
시장 규모 추정과 예측
병원 약국
전문 약국
기타 약국
시장 규모 추정과 예측 : 지역별
시장 점유율 : 지역별
제9장 간섬유증 및 NASH//MASH 치료제 시장 분석
주요 조사 결과
시장 규모 추정과 예측
제10장 북미의 간섬유증 시장 분석
제11장 유럽의 간섬유증 및 NASH/MASH 치료제 시장 분석
제12장 아시아태평양의 간섬유증 및 NASH/MASH 치료제 시장 분석
제13장 라틴아메리카의 간섬유증 및 NASH/MASH 치료제 시장 분석
제14장 중동 및 아프리카의 간섬유증 및 NASH/MASH 치료제 시장 분석
제15장 기업 개요
경쟁 구도
Madrigal Pharmaceuticals
Novo Nordisk.
Eli Lilly and Company
Gilead Sciences, Inc.
Inventiva Pharma
Galectin Therapeutics
Galmed Pharmaceutical
Akero Therapeutics
AstraZeneca plc
.Altimmune
Boehringer Ingelheim
제16장 결론과 제안
Visiongain에 의한 결론
진출 기업에 대한 제안
ksm
영문 목차
영문목차
The global Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035 market is estimated at US$18.3 billion in 2025 and is projected to grow at a CAGR of 10.0% during the forecast period 2025-2035.
The Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
Regulatory Challenges and Market Barriers in NASH/MASH Drug Approval
NASH/MASH is an escalating public health crisis, with the disease progressively leading to liver fibrosis and cirrhosis. MASH is primarily associated with type 2 diabetes and cardiovascular diseases. During clinical trials, NASH drugs must demonstrate their ability to delay disease progression and prevent its onset by measuring composite endpoints related to liver-associated outcomes.
However, due to the absence of effective treatments currently available for NASH, the U.S. FDA has provided an alternative approval pathway. This pathway relies on histopathological assessment of disease progression through liver biopsies as surrogate endpoints, along with positive clinical outcomes during trials. Consequently, the U.S. FDA approves drugs that meet the primary endpoints by either demonstrating an improvement of ,a*1 stage in fibrosis with no worsening of MASH or achieving MASH resolution without worsening fibrosis.
In contrast, the European Medicines Agency (EMA) has different regulatory requirements compared to the U.S. FDA. The EMA mandates that both primary endpoints be met, requiring complete resolution of NASH along with improvement in fibrosis. The lack of uniformity in clinical trial requirements at a global level poses a significant challenge for pharmaceutical companies.
Beyond meeting these endpoints, the effects of new therapies must also be evaluated for their impact on type 2 diabetes and cardiovascular risks. For complete regulatory approval, clinical outcomes should include mortality rates, cirrhosis progression reports, and other liver-related events. This necessitates long-term patient monitoring and follow-up during clinical trials, with the added risk of product failure in confirmatory trials. Additionally, patients receiving a placebo may be required to wait despite the drug being commercially available.
Thus, the lack of regulatory uniformity and the complexity of NASH as a disease hinder the timely commercialization of these drugs.
What Questions Should You Ask before Buying a Market Research Report?
How is the Liver Fibrosis & NASH/MASH Drugs market evolving?
What is driving and restraining the Liver Fibrosis & NASH/MASH Drugs market?
How will each Liver Fibrosis & NASH/MASH Drugs submarket segment grow over the forecast period and how much revenue will these submarkets account for in 2035?
How will the market shares for each Liver Fibrosis & NASH/MASH Drugs submarket develop from 2025 to 2035?
What will be the main driver for the overall market from 2025 to 2035?
Will leading Liver Fibrosis & NASH/MASH Drugs markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
How will the market shares of the national markets change by 2035 and which geographical region will lead the market in 2035?
Who are the leading players and what are their prospects over the forecast period?
What are the Liver Fibrosis & NASH/MASH Drugs projects for these leading companies?
How will the industry evolve during the period between 2025 and 2035? What are the implications of
Liver Fibrosis & NASH/MASH Drugs projects taking place now and over the next 10 years?
Is there a greater need for product commercialisation to further scale the Liver Fibrosis & NASH/MASH Drugs market?
Where is the Liver Fibrosis & NASH/MASH Drugs market heading and how can you ensure you are at the forefront of the market?
What are the best investment options for new product and service lines?
What are the key prospects for moving companies into a new growth path and C-suite?
You need to discover how this will impact the Liver Fibrosis & NASH/MASH Drugs market today, and over the next 10 years:
The report highlights key lucrative areas in the industry so you can target them - NOW.
It contains in-depth analysis of global, regional and national sales and growth.
It highlights for you the key successful trends, changes and revenue projections made by your competitors.
Forecasts to 2035 and other analyses reveal commercial prospects
In addition to revenue forecasting to 2035, our new study provides you with recent results, growth rates, and market shares.
You will find original analyses, with business outlooks and developments.
Discover qualitative analyses (including market dynamics, drivers, opportunities, and restraints), Porter's Five Forces Analysis, PEST Analysis and recent developments.
Segments Covered in the Report
Liver Fibrosis Disease Drug Type
Antiviral
Alcoholic Liver Disease
Antioxidants
Immunosuppressants
Drug Induced Liver Injury
NASH/MASH Market by Drugs by Type
Vitamin E & Pioglitazone
Rezdiffra
Semaglutide
Tirzepatide
Pemvidutide
Lanifibranor
Belapectin
Efruxifermin
Pegozafermin
Denifanstat
Combination Therapies
NASH/MASH Drugs by Clinical Pipeline
Phase III
Phase II
New Entrants
Combination Therapies
Repurposing Drugs
Liver Fibrosis Drugs Market by End Users
Hospital Pharmacies
Specialty Pharmacies
Online Pharmacies
In addition to the revenue predictions for the overall world market and segments, you will also find revenue forecasts for five regional and 20 leading national markets:
North America
U.S.
Canada
Europe
Germany
UK
France
Italy
Spain
Rest of Europe
Asia Pacific
Japan
China
India
Australia
South Korea
Rest of Asia Pacific
Latin America
Brazil
Mexico
Rest of Latin America
MEA
GCC
South Africa
Rest of MEA
The report also includes profiles for some of the leading companies in the Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035, with a focus on this segment of these companies' operations.
Leading companies and the potential for market growth
List of Companies Profiled in the Report
Madrigal Pharmaceuticals
Novo Nordisk
Eli Lilly
Gilead Sciences Inc.
Galectin Therapeutics
Galmed Pharmaceuticals
Akero Therapeutics
AstraZeneca plc
Altimmune
Boehringer Ingelheim
Overall world revenue for Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035 in terms of value the market will surpass US$18.0 billion in 2025, our work calculates. We predict strong revenue growth through to 2035. Our work identifies which organizations hold the greatest potential. Discover their capabilities, progress, and commercial prospects, helping you stay ahead.
How will the Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035 report help you?
In summary, our 240+ page report provides you with the following knowledge:
Revenue forecasts to 2035 for Liver Fibrosis & NASH/MASH Drugs Market 2025 to 2035, with forecasts for Type and Indication, each forecast at a global and regional level - discover the industry's prospects, finding the most lucrative places for investments and revenues.
Revenue forecasts to 2035 for five regional and 20 key national markets - See forecasts for the Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035 market in North America, Europe, Asia-Pacific, Latin America, and MEA. Also forecasted is the market in the US, Canada, Mexico, Brazil, Germany, France, UK, Italy, Spain, China, India, Japan, South Korea and Australia among other prominent economies.
Prospects for established firms and those seeking to enter the market - including company profiles for 11 of the major companies involved in the Liver Fibrosis & NASH/MASH Drugs Market, 2025 to 2035.
Find quantitative and qualitative analyses with independent predictions. Receive information that only our report contains, staying informed with invaluable business intelligence.
