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肝纖維化治療市場－全球產業規模、佔有率、趨勢、機會、預測：依藥物類別、通路、地區和競爭格局分類，2021-2031年

Liver Fibrosis Drugs Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Class, By Distribution Channel, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球肝纖維化治療市場預計將從 2025 年的 191.2 億美元大幅成長至 2031 年的 339.1 億美元，複合年成長率高達 10.02%。

該市場涵蓋旨在預防、延緩或逆轉肝臟中細胞外基質蛋白異常積累的治療方法，而這種異常積累通常是由慢性肝損傷引起的。推動這一市場成長的主要因素是全球慢性肝病發生率的上升，包括代謝功能障礙相關性脂肪肝（MASLD）和酒精相關性肝病（ALD）。

市場概覽
預測期 2027-2031
市場規模：2025年 191.2億美元
市場規模：2031年 339.1億美元
複合年成長率：2026-2031年 10.02%
成長最快的細分市場 核苷類似物
最大的市場 北美洲

全球人口結構變化，特別是人口老化和肥胖率上升，進一步推動了這項需求，而這些都是肝損傷的根本原因。顯然，大量患者需要有效的治療。根據美國國家肝臟基金會預測，到2024年，約有1億美國人將患有肝病。

市場促進因素

肝纖維化治療市場成長的主要促進因素是代謝紊亂相關性脂肪性肝炎（MASH，曾被稱為非酒精性脂肪性肝炎，NASH）在全球範圍內的發病率不斷上升。這種慢性疾病與肥胖和第二型糖尿病發生率的上升密切相關，因此迫切需要能夠阻止肝纖維化發展為不可逆性肝硬化的治療方法。 MASH已從一種「沉默的疾病」轉變為全球醫療保健的重點，其龐大的患者群體凸顯了有效治療方法的迫切需求。例如，根據諾和諾德公司2025年8月發布的報告，美國約有5%的成年人將患有MASH，凸顯了新型藥物療法的巨大市場潛力。

同時，強大的後期臨床管線和不斷成長的研發投入正在重振市場，克服長期存在的研發障礙，並最終產生顯著的療效數據。製藥公司在開發先進候選藥物方面穩步取得進展，例如FGF21類似物和GLP-1受體促效劑，這些藥物不僅展現出治療代謝功能障礙的潛力，而且有望直接逆轉現有的纖維化。 Akero Therapeutics於2025年1月發表的IIb期SYMMETRY試驗結果證實了這一臨床進展，該試驗中，接受50毫克effluxifermin治療的患者中有39%實現了肝硬化逆轉，且未出現疾病進展。這些科學突破的商業性可行性已顯而易見，Madrigal Pharmaceuticals在2025年公佈的數據顯示，其近期核准療法的2024年全年淨銷售額為1.801億美元，凸顯了成功的抗纖維化療法的巨大盈利潛力。

市場挑戰

肝纖維化治療市場成長的主要障礙在於臨床開發和監管核准流程固有的複雜性。監管機構通常要求組織學改善的證據，這需要在臨床試驗中進行侵入性肝臟切片檢查。由於此操作具有侵入性，因此會顯著阻礙受試者的招募和保留，導致受試者不願參與，脫落率居高不下。因此，製藥公司面臨試驗週期延長和研發成本增加的雙重壓力，從而延緩了新治療方法在開發平臺中的進展。

此外，肝纖維化的複雜發病機制導致後期臨床試驗失敗率居高不下，造成迫切的醫療需求與已通過核准的治療方法之間存在巨大差距。這套頸部阻礙了市場充分滿足龐大且不斷成長的患者群體的需求。例如，全球肝臟研究所估計，到2024年，代謝功能障礙相關的脂肪肝疾病將影響全球約30%的成年人口。無法針對如此大規模的患者群體快速檢驗藥物療效並實現商業化，直接限制了產生收入和市場擴張。

市場趨勢

將非侵入性生物標記作為臨床終點正在改變藥物研發格局，有效消除了依賴侵入性肝臟切片檢查這一主要障礙。監管機構和製藥公司正擴大核准影像學和循環生物標記作為替代終點，簡化患者招募流程，並實現對治療效果的即時評估。這項進展使得在無需承擔組織學取樣相關風險的情況下測量肝臟硬度和評估纖維化程度成為可能，從而直接加速新化合物的檢驗。支持此方法的一項重要監管進展是，美國食品藥物管理局（FDA）於2025年8月表示，計劃核准瞬時彈性成像測量的肝臟硬度作為臨床試驗中的有效替代終點（根據Fierce Biotech報告）。這種監管柔軟性的提高有望顯著縮短試驗週期，並降低傳統上與纖維化治療藥物研發相關的高失敗率。

同時，人工智慧（AI）在藥物研發領域的應用正從根本上改變抗纖維化候選化合物的辨識和開發速度及準確性。透過使用深度學習演算法分析龐大的體學資料集，企業可以省去多年傳統的試驗，以前所未有的效率預測新的治療標靶並最佳化分子結構。這些技術的整合已被證明對於降低早期研究風險、加速化合物轉化為臨床試驗以及最終降低創新成本至關重要。 Insilico In Silico在2025年12月的新聞稿中強調了這種效率提升的影響，該公司指出，其人工智慧驅動的平台僅用18個月就完成了關鍵纖維化候選化合物的早期藥物發現階段。這些進展凸顯了計算生物學在加速有效治療方法上市方面所扮演的關鍵角色。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：肝纖維化治療藥物的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 藥物分類（干擾素療法、馬洛替脂質、核苷類似物）
    • 銷售管道細分（醫院藥局、零售藥局、網路藥局）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美肝纖維化治療藥物市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲肝纖維化治療藥物市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區肝纖維化治療藥物市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章 中東和非洲肝纖維化治療藥物市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲肝纖維化治療藥物市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章 全球肝纖維化治療市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Gilead Sciences Inc
  • Merck & Co Inc
  • Bristol-Myers Squibb Co
  • Johnson & Johnson Services, Inc.
  • Novartis AG
  • Vertex Pharmaceuticals Inc
  • Pfizer Inc
  • FibroGen Inc
  • Pharmaxis Ltd

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 17549

The global market for liver fibrosis drugs is projected to expand significantly, rising from USD 19.12 billion in 2025 to USD 33.91 billion by 2031, demonstrating a robust Compound Annual Growth Rate (CAGR) of 10.02%. This market comprises therapeutic agents designed to halt, slow, or reverse the abnormal buildup of extracellular matrix proteins in the liver, a condition often stemming from chronic liver damage. Key factors driving this growth include the increasing worldwide occurrence of chronic liver diseases, notably metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-associated liver disease (ALD).

Market Overview
Forecast Period2027-2031
Market Size 2025USD 19.12 Billion
Market Size 2031USD 33.91 Billion
CAGR 2026-203110.02%
Fastest Growing SegmentNucleoside Analog
Largest MarketNorth America

Further bolstering demand are global demographic shifts, specifically an aging populace and escalating obesity rates, which fundamentally contribute to liver injury. The substantial patient base requiring effective treatments is evident, with nearly 100 million Americans affected by liver disease in 2024, as reported by the American Liver Foundation.

Market Driver

The primary driver for the liver fibrosis drugs market's growth is the rising global incidence of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis. This chronic condition, strongly linked to increasing rates of obesity and type 2 diabetes, generates a critical need for treatments that can halt liver scarring before it advances to irreversible cirrhosis. The significant patient population highlights the urgent demand for effective interventions, as MASH has evolved from a silent issue into a global healthcare priority. For instance, approximately 5% of US adults are affected by MASH, as per Novo Nordisk in August 2025, confirming a vast potential market for new pharmacological treatments.

Concurrently, robust late-stage clinical pipelines and increasing R&D investments are revitalizing the market, finally producing significant efficacy data after prolonged development hurdles. Pharmaceutical firms are successfully progressing advanced candidates, including FGF21 analogs and GLP-1 receptor agonists, which show promise not only in addressing metabolic dysfunction but also in directly reversing existing fibrosis. This clinical advancement is illustrated by trial results, such as Akero Therapeutics' January 2025 report from the Phase 2b SYMMETRY Study, where 39% of patients on 50mg efruxifermin experienced cirrhosis reversal without disease worsening. The commercial viability of these scientific breakthroughs is already apparent, with Madrigal Pharmaceuticals reporting full-year 2024 net sales of $180.1 million in 2025 for its recently approved therapy, affirming the considerable revenue potential of successful anti-fibrotic treatments.

Market Challenge

A major impediment to the growth of the liver fibrosis drugs market is the inherent complexity of clinical development and regulatory approval processes. Regulatory agencies frequently mandate evidence of histological improvement, requiring invasive liver biopsies during clinical trials. This stipulation significantly hinders patient recruitment and retention due to the procedure's invasive nature, leading to reluctance among participants and higher dropout rates. As a result, pharmaceutical companies encounter prolonged study durations and increased research expenses, thereby decelerating the progression of new therapies through the development pipeline.

Moreover, the intricate underlying mechanisms of liver fibrosis contribute to a high incidence of late-stage clinical trial failures, creating a substantial void between the pressing medical need and the availability of approved treatments. This bottleneck prevents the market from adequately addressing a massive and expanding patient population; for instance, the Global Liver Institute estimated that metabolic dysfunction-associated steatotic liver disease affected around 30 percent of the global adult population in 2024. The inability to rapidly validate and commercialize drugs for such a large demographic directly constrains revenue generation and market expansion.

Market Trends

The development landscape is being transformed by the incorporation of non-invasive biomarkers as clinical endpoints, effectively resolving the major hurdle posed by the reliance on invasive liver biopsies. Regulatory authorities and drug developers are increasingly validating imaging and circulating biomarkers as surrogate endpoints, which simplifies patient recruitment and enables real-time assessment of treatment effectiveness. This evolution permits the measurement of liver stiffness and fibrosis reduction without the risks linked to histological sampling, thereby directly accelerating the validation of new compounds. A significant regulatory step affirming this approach occurred in August 2025, when the FDA indicated its acceptance of liver stiffness measured by transient elastography as a reasonably likely surrogate endpoint for clinical trials, as reported by Fierce Biotech. This increased regulatory adaptability is anticipated to substantially shorten study durations and mitigate the high failure rates historically associated with fibrosis drug development.

Concurrently, the application of artificial intelligence (AI) in drug discovery is fundamentally reshaping the pace and accuracy with which anti-fibrotic candidates are identified and advanced. By employing deep learning algorithms to analyze extensive omics datasets, companies can now predict novel therapeutic targets and optimize molecular structures with unmatched efficiency, bypassing years of conventional trial-and-error. This technological integration is proving vital for de-risking early-stage research and expediting the transition of compounds into clinical stages, thereby reducing innovation costs. The impact of this efficiency was underscored by Insilico Medicine's December 2025 press release, noting that its AI-driven platform facilitated the completion of the early discovery phase for its primary fibrosis candidate in just 18 months. These advancements highlight the crucial role of computational biology in bringing effective treatments to market more swiftly.

Key Market Players

  • Gilead Sciences Inc
  • Merck & Co Inc
  • Bristol-Myers Squibb Co
  • Johnson & Johnson Services, Inc.
  • Novartis AG
  • Vertex Pharmaceuticals Inc
  • Pfizer Inc
  • FibroGen Inc
  • Pharmaxis Ltd

Report Scope

In this report, the Global Liver Fibrosis Drugs Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Liver Fibrosis Drugs Market, By Drug Class

  • Interferon Therapy
  • Maloti Lipid
  • Nucleoside Analog

Liver Fibrosis Drugs Market, By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Liver Fibrosis Drugs Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Liver Fibrosis Drugs Market.

Available Customizations:

Global Liver Fibrosis Drugs Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Liver Fibrosis Drugs Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Drug Class (Interferon Therapy, Maloti Lipid, Nucleoside Analog)
    • 5.2.2. By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Liver Fibrosis Drugs Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Drug Class
    • 6.2.2. By Distribution Channel
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Liver Fibrosis Drugs Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Drug Class
        • 6.3.1.2.2. By Distribution Channel
    • 6.3.2. Canada Liver Fibrosis Drugs Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Drug Class
        • 6.3.2.2.2. By Distribution Channel
    • 6.3.3. Mexico Liver Fibrosis Drugs Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Drug Class
        • 6.3.3.2.2. By Distribution Channel

7. Europe Liver Fibrosis Drugs Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Drug Class
    • 7.2.2. By Distribution Channel
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Liver Fibrosis Drugs Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Drug Class
        • 7.3.1.2.2. By Distribution Channel
    • 7.3.2. France Liver Fibrosis Drugs Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Drug Class
        • 7.3.2.2.2. By Distribution Channel
    • 7.3.3. United Kingdom Liver Fibrosis Drugs Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Drug Class
        • 7.3.3.2.2. By Distribution Channel
    • 7.3.4. Italy Liver Fibrosis Drugs Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Drug Class
        • 7.3.4.2.2. By Distribution Channel
    • 7.3.5. Spain Liver Fibrosis Drugs Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Drug Class
        • 7.3.5.2.2. By Distribution Channel

8. Asia Pacific Liver Fibrosis Drugs Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Drug Class
    • 8.2.2. By Distribution Channel
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Liver Fibrosis Drugs Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Drug Class
        • 8.3.1.2.2. By Distribution Channel
    • 8.3.2. India Liver Fibrosis Drugs Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Drug Class
        • 8.3.2.2.2. By Distribution Channel
    • 8.3.3. Japan Liver Fibrosis Drugs Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Drug Class
        • 8.3.3.2.2. By Distribution Channel
    • 8.3.4. South Korea Liver Fibrosis Drugs Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Drug Class
        • 8.3.4.2.2. By Distribution Channel
    • 8.3.5. Australia Liver Fibrosis Drugs Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Drug Class
        • 8.3.5.2.2. By Distribution Channel

9. Middle East & Africa Liver Fibrosis Drugs Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Drug Class
    • 9.2.2. By Distribution Channel
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Liver Fibrosis Drugs Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Drug Class
        • 9.3.1.2.2. By Distribution Channel
    • 9.3.2. UAE Liver Fibrosis Drugs Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Drug Class
        • 9.3.2.2.2. By Distribution Channel
    • 9.3.3. South Africa Liver Fibrosis Drugs Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Drug Class
        • 9.3.3.2.2. By Distribution Channel

10. South America Liver Fibrosis Drugs Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Drug Class
    • 10.2.2. By Distribution Channel
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Liver Fibrosis Drugs Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Drug Class
        • 10.3.1.2.2. By Distribution Channel
    • 10.3.2. Colombia Liver Fibrosis Drugs Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Drug Class
        • 10.3.2.2.2. By Distribution Channel
    • 10.3.3. Argentina Liver Fibrosis Drugs Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Drug Class
        • 10.3.3.2.2. By Distribution Channel

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Liver Fibrosis Drugs Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Gilead Sciences Inc
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Merck & Co Inc
  • 15.3. Bristol-Myers Squibb Co
  • 15.4. Johnson & Johnson Services, Inc.
  • 15.5. Novartis AG
  • 15.6. Vertex Pharmaceuticals Inc
  • 15.7. Pfizer Inc
  • 15.8. FibroGen Inc
  • 15.9. Pharmaxis Ltd

16. Strategic Recommendations

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