肝硬変市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 主要7ヶ国の肝硬変の市場規模は2023年に約31億米ドルとなりました。同市場は、2024年から2034年の予測期間中に大幅なCAGRでさらに増加すると予測されます。
• 肝硬変は、健康な肝組織が瘢痕組織に置き換わることを特徴とする慢性かつ進行性の肝疾患であり、主要7ヶ国における2023年の診断有病者数は約339万人と推定されます。
• 肝硬変は米国における重要な健康問題であり、その有病率は過去数十年にわたり増加し続けています。DelveInsightの推計別と、主要7ヶ国の中で肝硬変の症例数が最も多いのは米国だけで61%を占め、次いで日本、ドイツ、イタリアが2023年に続きます。
• 肝硬変の市場規模は、肝硬変を管理するために利用可能な医薬品や治療オプション、肝硬変の有病率、治療オプションの進歩、ヘルスケアインフラ、償還政策など様々な要因に影響されます。
• 2023年、肝硬変の市場規模は主要7ヶ国の中で米国が最も大きく、約21億8,000万米ドルを占め、2034年までにさらに拡大すると予測されています。
• 日本における肝硬変の市場規模は、2023年には約3億6,100万米ドルで、主要7ヶ国の総市場の12%を占め、2034年にはさらに増加すると予測されます。
• 肝硬変の総市場規模は、エフルキシフェルミン（EFX）、ベラペクチンなどを含む新興治療薬の参入が見込まれるため、予測期間中に急増すると予想されます。
• ニューカッスル大学、エジンバラ大学、主要研究主導型バイオ医薬品企業であるBoehringer Ingelheimにより、世界中で実施された肝硬変に関する最も大規模な臨床研究が発表されました。
• ADVANCE（Accelerating Discovery：Actionable NASH Cirrhosis Endpoints）研究は、この種の研究の中で最も詳細な観察研究であり、最も多くの患者を登録し、肝臓の健康状態を詳細に分析します。これはMASH肝硬変の理解を深めるだけでなく、将来の治療法開発を加速させるトランスレーショナルバイオマーカーの同定にも役立ちます。
• 長期にわたる過度のアルコール摂取は肝臓に大きなダメージを与え、炎症、線維化、そして最終的には肝硬変を引き起こします。今回の分析では、アルコール性肝疾患（ALD）が主要7ヶ国で最も多くの肝硬変症例を引き起こしていることが示されました。

当レポートは、米国、EU4ヶ国および英国（ドイツ、フランス、イタリア、スペイン）、日本における肝硬変、歴史的および予測疫学、肝硬変治療薬の市場動向を詳細にお届けします。

現在の治療法、新薬、個々の治療法の市場シェア、2020年から2034年までの主要7ヶ国肝硬変市場規模の現状と予測を提供しています。また、肝硬変治療の現状、市場促進要因、市場障壁、SWOT分析、償還と市場アクセス、アンメットメディカルニーズなどを網羅し、最良の機会を発掘し、市場の潜在力を評価します。

肝硬変は、慢性的な肝障害に反応して線維束に囲まれた再生結節が組織学的に開発され、門脈圧亢進症や末期肝疾患に至るものです。この末期肝疾患では、健康な肝組織が瘢痕組織に置き換わり、肝臓は永久に損傷を受け、瘢痕組織によって肝臓が正常に機能しなくなります。肝硬変には、疲労感や皮膚のひどいかゆみなど多くの徴候や症状があり、肝臓がひどく損傷するまで現れないこともあります。原因としては、アルコール性肝疾患、非アルコール性脂肪性肝疾患、C型慢性肝炎、B型慢性肝炎などがあります。

欧州肝臓学会（EASL）、日本消化器病学会（JSGE）、アメリカ肝臓病学会（AASLD）などの団体が肝硬変の診断基準を発表しています。

早期の肝硬変患者のほとんどは症状を示しません。肝硬変は定期的な血液検査や健康診断で発見されることが多いです。診断を確定するために、一般的に臨床検査や画像検査が行われます。肝硬変を確定する重要な診断は、侵襲的診断法である生検です。経皮的肝生検（PLB）は死亡率や罹患率が非常に低いとはいえ、患者はしばしば不快で恐ろしいと感じる。

黄疸のような目に見える症状が現れ始めると、病気は末期まで進行し、不可逆的で治すことができなくなり、肝移植が最後の選択肢となります。不可逆的な病気が発症する前に診断を受ければ、介入（アルコールの短期介入、抗ウイルス療法、減量など）が可能になります。したがって、健康ではあるがリスクのある患者を優先的に診る時間を見つけることは、すでに確立した疾患を持つ人々に質の高いケアを提供しようとしている医療システムにおいては困難です。

肝硬変治療におけるアンメットニーズの一つは、肝硬変が重症化する前に早期発見するためのより良い方法です。肝硬変を早期に発見するためには、非侵襲的検査やバイオマーカーなどのスクリーニングや診断ツールの改善が必要です。また、肝硬変の診断、モニタリング、管理のためのバイオマーカーの必要性も高いです。バイオマーカーは生物学的プロセスの測定可能な指標であり、疾患の進行の同定や追跡、治療反応の予測、治療効果のモニタリングに用いることができます。

バイオマーカーは、肝硬変の症状が現れる前の早期の段階で発見するために用いることができます。また、病気の進行や治療に対する反応をモニターするためにも使用することができます。これにより、ヘルスケアプロバイダーは治療計画を調整し、患者の転帰を改善することができます。バイオマーカーは、臨床試験において、特定の治療法に反応しやすい患者を特定するために使用することができ、最終的には、薬剤開発者が肝硬変に対してより効果的な治療法を設計するのに役立ちます。

現在、肝硬変の診断とモニタリングは、主に画像検査と肝機能を測定する血液検査に頼っています。これらの検査は有用ではありますが、早期の肝硬変を発見したり、病気の進行を予測したりするには、必ずしも十分な精度や感度があるとは言えないです。したがって、肝硬変の診断、モニタリング、管理を改善するためには、より正確で信頼性の高いバイオマーカーの開発が不可欠です。

肝硬変の治療は、その原因によって異なります。通常、肝硬変を治癒させることはできませんが、症状や合併症を管理し、症状の悪化を食い止める方法はあります。肝硬変の原因となる病気の中には治るものもあります。肝硬変の根本的な原因を治療することで、肝硬変の悪化を防ぎ、肝不全を予防することができます。治療が成功すれば、肝臓の瘢痕の一部が徐々に改善することもあります。

肝障害の根本的な原因を治療する-例えば、肝炎（B型またはC型）ウイルス感染の治療や、ヘモクロマトーシスの鉄濃度を下げるための血液の除去など。

食事と生活習慣の改善-栄養価の高い、低脂肪、高タンパクの食事と運動は、栄養失調を防ぐのに役立ちます。

慢性肝疾患の患者、特に肝硬変の患者は、日常生活や生活の質に重大な影響を及ぼし、生命を脅かす可能性のあるいくつかの結果に直面することが多いです。慢性肝疾患患者には、その障害とそれに伴う複雑な治療のために、高レベルの支持療法に対する特別なニーズがあります。

適切なケアを提供するためには、徹底した病歴聴取、診察、検査によって肝硬変の根本的な原因を特定することが極めて重要です。肝硬変になると、腹水（お腹に水がたまること）、肝性脳症（肝不全による脳機能障害）、静脈瘤出血（食道や胃の静脈が拡張して出血すること）など、さまざまな合併症を引き起こす可能性があります。これらの合併症には治療法があるが、効果がないことが多く、副作用も大きいです。血液透析、抗生物質の静脈内投与、バンディング手術はいずれも治療の一形態であり、高額な費用がかかります。これらの合併症を管理し、肝硬変患者の生活の質を改善するためには、より良い治療法が必要です。

肝硬変の最も重要な治療は肝移植であるが、これは費用がかかり、患者とその家族に負担を強います。肝移植を必要とする患者は肝臓の提供者よりも多いことが注目されており、肝硬変患者の治療は極めて重要な課題であり、約30％が待機中に死亡しています。急性期医療施設では肝硬変の機能低下が頻発し、致死率も高いです。ケアバンドルは、患者が体系的に困難に対する適切な管理を受けられるようにするのに役立ちます。新しい治療法の開発がさらに進めば、治療費を削減することで患者の生活への大きな負担を軽減することができるはずです。

本レポートの肝硬変疫学の章では、患者ベースのモデルを用いて市場を予測しているため、2020年から2034年までの米国、EU4ヶ国カ国（ドイツ、フランス、イタリア、スペイン）、英国、日本を対象とした主要7ヶ国における肝硬変の総有病者数、および病因論別の肝硬変の有病者数で区分した疫学の過去および予測を提供しています。

• 米国では2023年に約207万人が肝硬変と診断され、予測期間中に増加すると予測されています。
• 米国は主要7ヶ国の肝硬変有病者数のうち最も多く、次いでEU4ヶ国、英国、日本がそれぞれ24％、14％を占めています。
• 肝硬変の病因別有病率分布をみると、日本ではMASHが13％、HCVが45％、HVBが15％、ALDが26％、PBCが2％でした。
• EU4ヶ国と英国は、2023年に約83万人の肝硬変有病者と診断されました。このうちドイツが最も多いです。

肝硬変レポートにおける薬剤の章では、肝硬変の適応外薬や後期（フェーズIIIおよびフェーズII）パイプライン薬の詳細な分析を掲載しています。また、肝硬変の臨床試験の詳細、表現力豊かな薬理作用、契約と共同研究、承認と特許の詳細、含まれる各薬剤の利点と欠点、最新のニュースとプレスリリースの理解にも役立ちます。

肝硬変の新薬

エフルキシフェルミン（AKR-001）：Akero Therapeutics, Inc.

AKR-001を前身とするエフルキシフェルミン（EFX）は、MASH肝硬変に対するAkeroの主力製品候補です。EFXは、便利な週1回のSC投与が可能なように設計されています。観察された効果の一貫性と大きさから、EFXは承認されればクラス最高の医薬品となる可能性があります。EFXは現在、生検でNASHが確認された肝硬変患者を対象とした第IIb相臨床試験（代償性F4線維症を有する肝硬変患者を対象としたSYMMETRY試験）で評価されています。EFXは、MASHによる肝硬変患者に対する有効な治療薬となる可能性を示しています。現在、MASH肝硬変の治療薬として臨床開発の第Ⅱ相段階にあります。

ベラペクチン（GR-MD-02）：Galectin Therapeutics Inc.

ガレクチン-3阻害剤であるベラペクチン（GR-MD-02）は、前臨床モデルにおいて肝線維化および肝硬変を逆転させることが証明されており、臨床試験において門脈圧亢進症を減少させ、その合併症である食道静脈瘤の開発を予防することが証明されています。ベラペクチンは、ガレクチン-3が線維化、免疫細胞の機能と免疫、細胞分化、細胞成長、アポトーシス（細胞死）など複数の重要な生物学的経路に関与していることから、多くの疾患を治療できる可能性があります。線維化プロセスにおけるガレクチン-3の重要性は実験的証拠によって裏付けられています。ガレクチン-3遺伝子を"ノックアウト"した動物は、無傷のガレクチン-3遺伝子を持つ動物に比べて、実験的刺激に反応して線維症を発症しなくなります。同社はガレクチン-3阻害剤をMASH患者の進行した肝線維症や肝硬変の治療に使用しています。同社は2つの第I相臨床試験、進行した線維化を有するMASH患者を対象とした第II相臨床試験（NASH-FX）、代償性肝硬変と門脈圧亢進症を有するMASH患者を対象とした第2の第IIb相臨床試験（NASH-CX）を完了しています。

ベラペクチン（GR-MD-02）は、ガラクツロン酸、ガラクトース、アラビノース、ラムノース、および少量の他の糖からなる独自のガラクトアラビノ-ラムノガラクツロナン多糖ポリマーです。構造研究により、ベラペクチンはガレクチン-1およびガレクチン-3に結合し、ガレクチン-3により高い結合親和性があることが示されています。ベラペクチンは細胞外のガレクチンを標的とします。

NASH肝硬変におけるベラペクチンの第II相臨床試験は、静脈瘤のないNASH肝硬変患者において、門脈圧亢進症や肝生検で臨床的に意味のある改善を示した最初の大規模無作為臨床試験でした。

ジボテンタン/ダパグリフロジン：Astrazeneca

アストラゼネカの併用療法であるジボテンタン/ダパグリフロジンは、肝硬変を対象として現在第II相臨床開発中です。この革新的な治療は、エンドセリンA受容体拮抗薬であるジボテンタンと、米国ではファルキシガ、世界ではフォルキシガとして販売されているSGLT2阻害薬であるダパグリフロジンの相乗メカニズムを活用したものです。この低分子化合物は、ZEAL-UNLOCK試験（第IIb相試験）で安全性プロファイルが評価されています。2024年2月に開始されたこの試験は、2025年1月までの一次終了を目指しています。本試験の衝撃的な結果は、肝硬変の治療戦略を再定義し、重大なアンメット・メディカル・ニーズに対応する可能性があります。

2024年に進行性肝硬変に対する最初の治療法が承認されることから、肝硬変の市場展望は拡大すると予想されます。

肝硬変の治療に最もよく使用される薬剤クラス別には、抗ウイルス薬、抗生物質、抗線維化薬などがあります。重症の肝硬変では、早期の抗ウイルス療法が重要です。B型慢性肝炎に対する抗ウイルス療法の第一の目的は、肝機能障害を軽減し、患者を死亡から救うことです。インターフェロンα（IFN）とヌクレオス（t）イデアナログが臨床的に使用されている抗ウイルス薬です。

現在、肝硬変に対して承認された治療薬はないです。最近、2024年3月、Madrigal Pharmaceuticalsの画期的な製品である1日1回経口THR-B作動薬REZDIFFRA（レスメチロム）が、第III相MAESTRO-NASH試験の結果に基づき、米国FDAから加速承認されました。REZDIFFRAは、線維化ステージF2-F3に相当する中等度から高度の肝瘢痕化（線維化）を伴う非硬変性MASHの成人患者に対する初めての、そして唯一のFDA承認治療薬となり、この承認は医療情勢における大きな前進となります。Resmetirom（MGL-3196）は肝硬変の治療薬としては承認されていません。

レスメチロムの第III相臨床試験の除外基準は、特に線維化ステージ4と定義された肝硬変患者を除外しています。さらに、MAESTRO-NAFLD-1試験の抄録には、レスメチロムが非アルコール性脂肪性肝疾患と推定されるMASHの成人を対象に評価されたと記載されているが、肝硬変については言及されていません。

Belapectin/GR-MD-02（Galectin Therapeutics Inc.）、Efruxifermin（Akero Therapeutics, Inc.）、Zibotentan/dapagliflozin（Astrazeneca）などの新興治療薬の発売は、市場にプラスの影響を与えると予想されます。これらの治療薬が承認されれば、市場のダイナミクスに大きな影響を与える可能性がありますが、その成功率はまだ不透明です。

• 主要7ヶ国における肝硬変の市場規模は2023年に約31億米ドルであり、予測期間中にさらに拡大すると予測されます。
• 2023年の肝硬変の市場規模は、EU4ヶ国と英国が約5億6,600万米ドルを占めています。
• EU諸国の中では、ドイツが2023年に約1億5,200万米ドルと最も市場規模が大きく、スペインは2023年に7,700万米ドルと最も市場規模が小さいです。
• BelapectinやEfruxiferminなど、今後の治療薬の発売が期待されることから、肝硬変の総市場規模は今後数年で変化を見せると予想されます。

治療費が高いことは、世界の医薬品市場の成長を抑制する大きな要因です。高コストのために経済的負担が増大し、患者が適切な治療から逃避することにつながっています。

当レポートでは、主要7ヶ国における肝硬変市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 肝硬変市場概要

第4章 肝硬変の疫学と市場の調査手法

第5章 肝硬変のエグゼクティブサマリー

第6章 主要な出来事

第7章 肝硬変の疾患背景と概要

• 肝硬変イントロダクション
• 肝硬変の病因
• 肝硬変の危険因子
• 肝硬変の病因に寄与する複数の細胞型
• 肝硬変の病因
• 肝硬変の段階
• 兆候と症状
• 肝硬変の合併症
• 病態生理学
• 肝硬変の診断
  • 診断アルゴリズム
  • 診断ガイドライン
• 肝硬変の治療
  • 肝硬変治療アルゴリズム
  • 治療ガイドライン

第8章 疫学と患者人口

• 主な調査結果
• 前提と根拠：主要7ヶ国
  • 米国
  • EU4ヶ国と英国
  • 日本
• 主要7ヶ国における肝硬変の診断症例総数
• 米国
  • 米国における肝硬変の診断症例数
  • 米国における病因別肝硬変の有病率
• 欧州主要4カ国と英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本
  • 日本における肝硬変の診断症例数
  • 日本における肝硬変の病因別有病率

第9章 肝硬変の患者動向

第10章 肝硬変の新たな治療法

• キークロス競合
• ベラペクチン（GR-MD-02）：Galectin Therapeutics Inc.
• エフルキシフェルミン（AKR-001）：Akero Therapeutics, Inc.
• ジボテンタン/ダパグリフロジン：Astrazeneca
• LPCN 1148：Lipocine Inc.
• OP-724：Ohara Pharmaceutical
• ADR-001：Shionogi/Rohto

第11章 肝硬変：市場分析

• 主な調査結果
• 主要な市場予測の前提条件
• 肝硬変市場の見通し
• コンジョイント分析
• 主要7ヶ国における肝硬変の市場規模
• 主要7ヶ国における肝硬変治療薬市場規模
• 米国における肝硬変の市場規模
• EU4ヶ国と英国における肝硬変の市場規模
• 日本における肝硬変の市場規模

第12章 主要オピニオンリーダーの見解

第13章 SWOT分析

第14章 肝硬変のアンメットニーズ

第15章 市場アクセスと償還

• 米国
  • メディケア・メディケイドサービスセンター（CMS）
• EU4ヶ国と英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本
  • 厚生労働省

第16章 付録

第17章 DelveInsightのサービス内容

第18章 免責事項

List of Tables

• Table 1 Summary of Liver Cirrhosis Market and Epidemiology (2020-2034)
• Table 2 Key Events
• Table 3 Complications of Liver Cirrhosis
• Table 4 Common Physical Examination Findings in Patients With Cirrhosis
• Table 5 Clinical Laboratory Studies Used in Diagnosing Chronic Liver Disease
• Table 6 Level of Evidence and Grade of Recommendations
• Table 7 Grading Evidence and Recommendations (Adapted From Grade System)
• Table 8 EASL Clinical Practice Guidelines
• Table 9 Overview of the Utility of Investigation in PBC
• Table 10 Recommendation of EASL
• Table 11 The British Society of Gastroenterology/UK Recommendations
• Table 12 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the 7MM, in '000' (2020-2034)
• Table 13 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the US (2020-2034)
• Table 14 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the US (2020-2034)
• Table 15 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the EU4 and the UK (2020-2034)
• Table 16 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the EU4 and the UK (2020-2034)
• Table 17 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Germany (2020-2034)
• Table 18 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Germany (2020-2034)
• Table 19 Total Diagnosed Prevalent Cases of Liver Cirrhosis in France (2020-2034)
• Table 20 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in France (2020-2034)
• Table 21 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Italy (2020-2034)
• Table 22 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Italy (2020-2034)
• Table 23 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Spain (2020-2034)
• Table 24 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Spain (2020-2034)
• Table 25 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the UK (2020-2034)
• Table 26 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the UK (2020-2034)
• Table 27 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Japan (2020-2034)
• Table 28 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Japan (2020-2034)
• Table 29 Comparison of Emerging Drugs Under Development
• Table 30 GR-MD-02, Clinical Trial Description, 2024
• Table 31 Zibotentan/dapagliflozin, Clinical Trial Description, 2024
• Table 32 EFX, Clinical Trial Description, 2024
• Table 33 LPCN 1148, Clinical Trial Description, 2024
• Table 34 OP-724, Clinical Trial Description, 2024
• Table 35 ADR-001, Clinical Trial Description, 2024
• Table 36 Key Market Forecast Assumptions for Efruxifermin
• Table 37 Key Market Forecast Assumptions for Belapectin
• Table 38 Key Market Forecast Assumptions for Zibotentan/dapagliflozin
• Table 39 Total Market Size of Liver Cirrhosis in the 7MM, in USD million (2020-2034)
• Table 40 Market Size of Liver Cirrhosis by Therapies in 7MM, in USD million (2020-2034)
• Table 41 Total Market Size of Liver Cirrhosis in the US, in USD million (2020-2034)
• Table 42 Market Size of Liver Cirrhosis by Therapies in the US, in USD million (2020-2034)
• Table 43 Total Market Size of Liver Cirrhosis in the EU4 and the UK, in USD million (2020-2034)
• Table 44 Market Size of Liver Cirrhosis in EU4 and the UK, in USD million (2020-2034)
• Table 45 Total Market Size of Liver Cirrhosis in Germany, in USD million (2020-2034)
• Table 46 Market Size of Liver Cirrhosis by Therapies in Germany, in USD million (2020-2034)
• Table 47 Total Market Size of Liver Cirrhosis in France, in USD million (2020-2034)
• Table 48 Market Size of Liver Cirrhosis by Therapies in France, in USD million (2020-2034)
• Table 49 Total Market Size of Liver Cirrhosis in Italy, in USD million (2020-2034)
• Table 50 Market Size of Liver Cirrhosis by Therapies in Italy, in USD million (2020-2034)
• Table 51 Total Market Size of Liver Cirrhosis in Spain, in USD million (2020-2034)
• Table 52 Market Size of Liver Cirrhosis by Therapies in Spain, in USD million (2020-2034)
• Table 53 Total Market Size of Liver Cirrhosis in the UK, in USD million (2020-2034)
• Table 54 Market Size of Liver Cirrhosis by Therapies in the UK, in USD million (2020-2034)
• Table 55 Total Market Size of Liver Cirrhosis in Japan, in USD million (2020-2034)
• Table 56 Market Size of Liver Cirrhosis by Therapies in Japan in USD million (2020-2034)
• Table 57 Liver With and Without Cirrhosis
• Table 58 Pathogenesis of Liver Cirrhosis
• Table 59 Stages of Liver Damage
• Table 60 Difference Between Compensated and Decompensated Cirrhosis
• Table 61 Symptoms of Liver Cirrhosis

List of Figures

• Figure 1 Complications of Liver Cirrhosis
• Figure 2 Pathophysiology of Liver Cirrhosis
• Figure 3 Diagnostic Algorithm of Liver Cirrhosis
• Figure 4 Treatment Algorithm of Liver Cirrhosis
• Figure 5 EASL The BSG/UK-PBC Consensus Care Pathway for Patients With PBC
• Figure 6 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the 7MM, in '000' (2020-2034)
• Figure 7 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the US (2020-2034)
• Figure 8 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the US (2020-2034)
• Figure 9 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the EU4 and the UK (2020-2034)
• Figure 10 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the EU4 and the UK (2020-2034)
• Figure 11 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Germany (2020-2034)
• Figure 12 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Germany (2020-2034)
• Figure 13 Total Diagnosed Prevalent Cases of Liver Cirrhosis in France (2020-2034)
• Figure 14 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in France (2020-2034)
• Figure 15 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Italy (2020-2034)
• Figure 16 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Italy (2020-2034)
• Figure 17 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Spain (2020-2034)
• Figure 18 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Spain (2020-2034)
• Figure 19 Total Diagnosed Prevalent Cases of Liver Cirrhosis in the UK (2020-2034)
• Figure 20 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the UK (2020-2034)
• Figure 21 Total Diagnosed Prevalent Cases of Liver Cirrhosis in Japan (2020-2034)
• Figure 22 Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Japan (2020-2034)
• Figure 23 Patient Journey of Liver Cirrhosis
• Figure 24 Total Market Size of Liver Cirrhosis in the 7MM, in USD million (2020-2034)
• Figure 25 Market Size of Liver Cirrhosis in the 7MM by Therapies, in USD million (2020-2034)
• Figure 26 Total Market Size of Liver Cirrhosis in the US, in USD million (2020-2034)
• Figure 27 Market Size of Liver Cirrhosis by Therapies in the US, in USD million (2020-2034)
• Figure 28 Total Market Size of Liver Cirrhosis in EU4 and the UK, in USD million (2020-2034)
• Figure 29 Market Size of Liver Cirrhosis by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 30 Total Market Size of Liver Cirrhosis in Germany, in USD million (2020-2034)
• Figure 31 Market Size of Liver Cirrhosis by Therapies in Germany, in USD million (2020-2034)
• Figure 32 Total Market Size of Liver Cirrhosis in France, in USD million (2020-2034)
• Figure 33 Market Size of Liver Cirrhosis by Therapies in France, in USD million (2020-2034)
• Figure 34 Total Market Size of Liver Cirrhosis in Italy, in USD million (2020-2034)
• Figure 35 Market Size of Liver Cirrhosis by Therapies in Italy, in USD million (2020-2034)
• Figure 36 Total Market Size of Liver Cirrhosis in Spain, in USD million (2020-2034)
• Figure 37 Market Size of Liver Cirrhosis by Therapies in Spain, in USD million (2020-2034)
• Figure 38 Total Market Size of Liver Cirrhosis in the UK, in USD million (2020-2034)
• Figure 39 Market Size of Liver Cirrhosis by Therapies in the UK, in USD million (2020-2034)
• Figure 40 SWOT Analysis of Liver Cirrhosis
• Figure 41 Unmet Needs of Liver Cirrhosis
• Figure 42 Health Technology Assessment
• Figure 43 Reimbursement Process in Germany
• Figure 44 Reimbursement Process in France
• Figure 45 Reimbursement Process in Italy
• Figure 46 Reimbursement Process in Spain
• Figure 47 Reimbursement Process in the United Kingdom
• Figure 48 Reimbursement Process in Japan

Key Highlights:

• The Liver Cirrhosis market size in the 7MM was nearly USD 3,100 million in 2023, which is further anticipated to increase with a siginificant CAGR during the forecast period from (2024-2034).
• Liver cirrhosis is a chronic and progressive liver disease characterized by the replacement of healthy liver tissue with scar tissue estimated to approximately 3,390 thousand diagnosed prevalent population in 2023 in the 7MM.
• Liver cirrhosis is a significant health issue in the United States, and its prevalence has been increasing over the past few decades. According to DelveInsight estimates, among the 7MM, the US has most number of cases of Liver Cirrhosis accounting for 61% of cases alone, followed by Japan, Germany, and Italy in 2023.
• The market size of liver cirrhosis influenced by various factors such as the pharmaceuticals and treatment options available for managing the condition, prevalence of liver cirrhosis, advancements in treatment options, healthcare infrastructure, and reimbursement policies.
• In 2023, the market size of Liver Cirrhosis was highest in the US among the 7MM, accounting for approximately USD 2,180 million which is further expected to increase by 2034.
• The market size of Liver Cirrhosis in Japan was nearly USD 361 million in 2023, accounting for 12% of the total market of the 7MM, which is expected to rise by 2034.
• The total market size of liver cirrhosis is anticipated to upsurge during the forecast period due to the expected entry of emerging therapies that includes Efruxifermin (EFX), Belapectin and others.
• The most extensive clinical study into liver cirrhosis ever conducted worldwide has been announced by Newcastle University, University of Edinburgh and leading research-driven biopharmaceutical company, Boehringer Ingelheim.
• The ADVANCE (Accelerating Discovery: Actionable NASH Cirrhosis Endpoints) study will be the most detailed observational study of its kind enrolling the largest number of patients and providing a detailed analysis of liver health. This will not only enhance the understanding of MASH cirrhosis, but also help to identify translational biomarkers that will accelerate the development of future therapies.
• Prolonged and excessive alcohol consumption can cause significant damage to the liver, leading to inflammation, fibrosis, and eventually cirrhosis. The analysis showed that Alcohol liver Disease (ALD) causes the highest number of liver cirrhosis cases in the 7MM.

DelveInsight's "Liver Cirrhosis Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Liver Cirrhosis, historical and forecasted epidemiology as well as the Liver Cirrhosis therapeutics market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Liver Cirrhosis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Liver Cirrhosis market size from 2020 to 2034. The Report also covers current Liver Cirrhosis treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Liver Cirrhosis Treatment Market

Liver Cirrhosis Overview

Cirrhosis is the histological development of regenerative nodules surrounded by fibrous bands in response to chronic liver injury, leading to portal hypertension and end-stage liver disease. In this late-stage liver disease, the healthy liver tissue is replaced with scar tissue, and the liver is permanently damaged, and scar tissue keeps the liver from working properly. Cirrhosis has many signs and symptoms, such as fatigue and severe itchy skin, and they may not appear until the liver is badly damaged. Causes include alcoholic liver disease, nonalcoholic fatty liver disease, chronic hepatitis C, and chronic hepatitis B.

Liver Cirrhosis Diagnosis

Organizations like the European Association for the Study of the Liver (EASL), the Japanese Society of Gastroenterology (JSGE), and the American Association for the Study of Liver Diseases (AASLD), and others have published criteria for diagnosing liver cirrhosis.

Most people with early-stage liver cirrhosis do not exhibit any symptoms. Cirrhosis is frequently initially identified during a regular blood test or checkup. Laboratory and imaging tests are typically performed to help confirm a diagnosis. The key diagnosis that confirms cirrhosis is the biopsy, an invasive diagnostic procedure. Even though percutaneous liver biopsy (PLB) has very low mortality and morbidity rates, patients frequently find it uncomfortable and frightening.

When visible symptoms like jaundice start to show up, the disease progresses to the end stage, which is irreversible and cannot be cured, leaving liver transplantation as the last option. Before the onset of an irreversible disease, a diagnosis would allow for interventions (such as alcohol brief interventions, antiviral therapies, and weight loss). Hence, finding time to prioritize patients who are healthy but at-risk patients is difficult in a health system already trying to deliver good quality care to people with established diseases.

One of the major unmet needs in cirrhosis treatment is better methods to detect cirrhosis early before it progresses to a more severe stage. Improved screening and diagnostic tools, such as noninvasive tests and biomarkers, are needed to detect cirrhosis earlier. Also, there is a significant need for biomarkers to diagnose, monitor, and manage cirrhosis. Biomarkers are measurable indicators of a biological process, and they can be used to identify and track disease progression, predict treatment response, and monitor the effectiveness of therapy.

Biomarkers can be used to detect cirrhosis at an early stage before symptoms develop. They can also be used to monitor disease progression and response to treatment. This can help healthcare providers adjust treatment plans and improve patient outcomes. Biomarkers can be used in clinical trials to identify patients more likely to respond to a particular therapy which will eventually help drug developers design more effective treatments for cirrhosis.

Currently, the diagnosis and monitoring of cirrhosis rely mainly on imaging tests and blood tests that measure liver function. While these tests are helpful, they are not always accurate or sensitive enough to detect early-stage cirrhosis or predict disease progression. Therefore, developing more accurate and reliable biomarkers is critical for improving the diagnosis, monitoring, and management of cirrhosis.

Liver Cirrhosis Treatment

The treatment for cirrhosis depends on what has caused it. Cirrhosis cannot usually be cured, but there are ways to manage the symptoms and complications and stop the condition from worsening. Some of the diseases that cause cirrhosis can be cured. Treating the underlying causes of cirrhosis may keep cirrhosis from worsening and help prevent liver failure. Successful treatment may slowly improve some liver scarring.

Treating the underlying cause of liver damage - for example, treating underlying hepatitis (B or C) virus infection, or the removal of blood to lower iron levels in hemochromatosis

Making dietary and lifestyle changes - a nutritious, low-fat, high-protein diet and exercise can help people to avoid malnutrition.

Chronic liver disease patients, especially those with decompensated cirrhosis, often face several potentially life-altering consequences that can significantly affect daily activities and quality of life. They have specific needs for high levels of supportive care due to their disabilities and the complicated treatments that go along with them.

To provide the proper care, it is crucial to identify the underlying cause of hepatic decompensation through a thorough history, examination, and investigations. Cirrhosis can lead to a variety of complications, such as ascites (fluid accumulation in the abdomen), hepatic encephalopathy (brain dysfunction due to liver failure), and variceal bleeding (bleeding from enlarged veins in the esophagus or stomach). Although treatments are available for these complications, they are often ineffective and have significant side effects. Hemodialysis, IV antibiotics, and banding surgeries are all forms of treatment and are expensive. Better therapies are needed to manage these complications and improve the quality of life for patients with cirrhosis.

The most significant treatment for liver cirrhosis is a liver transplant, which is costly and burdens the patients and their families. It has been noticed that patients who require liver transplants are more than donors of the liver, making the treatment of cirrhosis patients a crucial task, and about 30% die waiting. Decompensated cirrhosis is frequent in acute care facilities and has a high fatality rate. A care bundle can help ensure that patients receive the right management of their difficulties systematically. The further development of new and novel treatments should take care of the significant burden on patient life by reducing the cost of therapies.

Liver Cirrhosis Epidemiology

As the market is derived using the patient-based model, the Liver Cirrhosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Liver Cirrhosis, and Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034.

• The total diagnosed prevalent cases of Liver Cirrhosis in the US comprised approximately 2,070 thousand in 2023 and are projected to increase during the forecast period.
• As per DelveInsight's estimates, the US alone accounts the highest number of total diagnosed prevalent cases, of liver cirrhosis in the 7MM, followed by EU4 and the UK and Japan, contributing to 24% and 14% of all liver cirrhosis cases respectively.
• The etiology-specific distribution of diagnosed prevalent cases of liver cirrhosis showed MASH, HCV, HVB, ALD, and PBC comprised 13%, 45%, 15%, 26%, and 2% cases in Japan, respectively.
• EU4 and the UK accounted for around 830 thousand diagnosed prevalent cases of liver cirrhosis in 2023. Of these cases, Germany accounted for the highest number of cases.

Liver Cirrhosis Drug Chapters

The drug chapter segment of the Liver Cirrhosis report encloses a detailed analysis of Liver Cirrhosis off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Liver Cirrhosis 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.

Liver Cirrhosis Emerging Drugs

Efruxifermin (AKR-001): Akero Therapeutics, Inc.

Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for MASH cirrhosis. EFX is designed to offer convenient once-weekly SC dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine if approved. EFX is currently being evaluated in Phase IIb clinical trials in patients with biopsy-confirmed NASH: the SYMMETRY study in cirrhotic patients with compensated F4 fibrosis. EFX shows the potential to be an effective treatment for patients with cirrhosis due to MASH. Currently the drug is in Phase II of clinical development for the treatment of MASH cirrhosis.

Belapectin (GR-MD-02): Galectin Therapeutics Inc.

Belapectin (GR-MD-02), a galectin-3 inhibitor, has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension and prevent its complication: the development of esophageal varices. Belapectin can potentially treat many diseases due to galectin-3's involvement in multiple key biological pathways such as fibrosis, immune cell function and immunity, cell differentiation, cell growth, and apoptosis (cell death). The importance of galectin-3 in the fibrotic process is supported by experimental evidence. Animals with the galectin-3 gene "knocked-out" can no longer develop fibrosis in response to experimental stimuli compared to animals with an intact galectin-3 gene. The company is using galectin-3 inhibitors to treat advanced liver fibrosis and liver cirrhosis in MASH patients. They have completed two Phase I clinical studies, a Phase II clinical study in MASH patients with advanced fibrosis (NASH-FX) and a second Phase IIb clinical trial in MASH patients with compensated cirrhosis and portal hypertension (NASH-CX).

Belapectin (GR-MD-02) is a proprietary galactoarabino-rhamnogalacturonan polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars. Structural studies have shown that belapectin binds to galectin-1 and galectin-3, with greater binding affinity to galectin-3. Belapectin targets extracellular galectins.

A Phase II clinical trial of belapectin in NASH cirrhosis was the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in portal hypertension or liver biopsy in patients with NASH cirrhosis without varices.

Zibotentan/dapagliflozin: Astrazeneca

AstraZeneca's combination therapy, zibotentan/dapagliflozin, is currently in Phase II clinical development targeting liver cirrhosis. This innovative treatment leverages the synergistic mechanisms of zibotentan, an endothelin A receptor antagonist, and dapagliflozin, a SGLT2 inhibitor marketed as Farxiga in the US and Forxiga globally. The small molecule duo is being evaluated in the ZEAL-UNLOCK study (Phase IIb) to assess its safety profile. Initiated in February 2024, this trial aims for a primary completion by January 2025. The study's impactful results could redefine therapeutic strategies for liver cirrhosis, addressing a significant unmet medical need.

Liver Cirrhosis Market Outlook

With first approved therapy for advanced hepatic cirrhosis in 2024, the market outlook for liver cirrhosis is expected to expand.

The most popular drug classes used to treat Liver Cirrhosis include antivirals, antibiotics, antifibrotics, etc. For individuals with severely decompensated cirrhosis, early antiviral therapy is crucial. Antiviral therapy for Chronic Hepatitis B's primary objective is to reduce hepatic dysfunction and save patients from death. Interferon alpha (IFN) and nucleos (t) ide analogs are antiviral medications that are clinically used.

Currently there are no approved therapies for Liver Cirrhosis. Recently, in March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-B agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2-F3 fibrosis. Resmetirom (MGL-3196) is not approved for the treatment of liver cirrhosis.

The exclusion criteria for the Phase III clinical trial of resmetirom specifically excluded patients with cirrhosis, defined as stage 4 fibrosis. Additionally, the abstract of the MAESTRO-NAFLD-1 trial states that resmetirom was evaluated in adults with nonalcoholic fatty liver disease and presumed MASH, but does not mention cirrhosis.

The launch of emerging therapies, such as Belapectin/ GR-MD-02 (Galectin Therapeutics Inc.), Efruxifermin (Akero Therapeutics, Inc), Zibotentan/dapagliflozin (Astrazeneca), and others are expected to impact the market positively. The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.

• The market size of Liver Cirrhosis in the 7MM was nearly USD 3,100 million in 2023, which is further anticipated to increase during the forecast period.
• The EU4 and the UK accounted for the approximately USD 566 million market size of Liver Cirrhosis approximately in 2023.
• Among the EU countries, Germany had the highest market size with nearly USD 152 million in 2023, while Spain had the lowest market size for Liver Cirrhosis with USD ~77 million in 2023.
• With the expected launch of upcoming therapies, such as Belapectin and Efruxifermin, among others, the total market size of Liver Cirrhosis is expected to show change in the upcoming years.

Liver Cirrhosis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Belapectin in the US is expected to be launched by 2026 with a peak share of 4.0%. Efruxifermin is anticipated to take 6 years to peak with a medium uptake.

Liver Cirrhosis Pipeline Development Activities

The report provides insights into different Liver Cirrhosis clincial trials within Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Liver Cirrhosis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Liver Cirrhosis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from the University of Florida Gainesville, Stanford University, Liver Unit, Hospital Clinic of Barcelona, Iwate Medical University, Leipzig University Hospital, University of Florida Gainesville, Florida, Service des Maladies de l'Appareil digestif, Hopital Huriez, CHU, Lille, France, Liver Unit, Hospital Clinic of Barcelona, Barcelona, Spain, Division of Hepatology, Department of Internal Medicine, Iwate Medical University, Morioka, and others.

Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Liver Cirrhosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Liver Cirrhosis Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of Liver Cirrhosis, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Liver Cirrhosis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Liver Cirrhosis market.

Liver Cirrhosis Report Insights

• Liver Cirrhosis Patient Population
• Liver Cirrhosis Therapeutic Approaches
• Liver Cirrhosis Pipeline Analysis
• Liver Cirrhosis Market Size and Trends
• Existing and Future Market Opportunity

Liver Cirrhosis Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Liver Cirrhosis Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Liver Cirrhosis Drugs Uptake
• Key Liver Cirrhosis Market Forecast Assumptions

Liver Cirrhosis Report Assessment

• Current Liver Cirrhosis Treatment Practices
• Liver Cirrhosis Unmet Needs
• Liver Cirrhosis Pipeline Product Profiles
• Liver Cirrhosis Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Liver Cirrhosis Market Drivers
• Liver Cirrhosis Market Barriers

Key Questions Answered In The Liver Cirrhosis Market Report:

Liver Cirrhosis Market Insights

• What was the Liver Cirrhosis market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Liver Cirrhosis total market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Liver Cirrhosis market size during the forecast period (2024-2034)?
• At what CAGR, the Liver Cirrhosis market is expected to grow at the 7MM level during the forecast period (2024-2034)?
• What would be the Liver Cirrhosis market outlook across the 7MM during the forecast period (2024-2034)?
• What would be the Liver Cirrhosis market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Liver Cirrhosis Epidemiology Insights

• What is the disease risk, burden, and unmet needs of Liver Cirrhosis?
• What is the historical Liver Cirrhosis patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient population of Liver Cirrhosis at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Liver Cirrhosis?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Liver Cirrhosis during the forecast period (2024-2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024-2034)?

Current Liver Cirrhosis Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Liver Cirrhosis along with the approved therapy?
• What are the current treatment guidelines for the treatment of Liver Cirrhosis in the US, Europe, And Japan?
• What are the Liver Cirrhosis 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 Liver Cirrhosis?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Liver Cirrhosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Liver Cirrhosis therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Liver Cirrhosis and their status?
• What are the key designations that have been granted for the emerging therapies for Liver Cirrhosis?
• What are the 7MM historical and forecasted market of Liver Cirrhosis?

Reasons to Buy Liver Cirrhosis Market Forecast Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Liver Cirrhosis Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), 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.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What is the forecast period covered in the report?

The Liver Cirrhosis Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Liver Cirrhosis market?

The Liver Cirrhosis market is quite robust. The major layers are Akero Therapeutics, Inc., Galectin Therapeutics Inc., and others which are currently developing drugs for the treatment of Liver Cirrhosis.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Liver Cirrhosis market?

The increase in diagnosed prevalent cases of Liver Cirrhosis and the launch of emerging therapies are attributed to be the key drivers for increasing the Liver Cirrhosis market.

5. What is the expected impact of emerging therapies or advancements in Liver Cirrhosis treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Liver Cirrhosis treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Liver Cirrhosis marke

Table of Contents

1 Key Insight

2 Report Introduction

3 Liver Cirrhosis Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Liver Cirrhosis by Therapies in 2020
• 3.2. Market Share (%) Distribution of Liver Cirrhosis by Therapies in 2034

4 Methodology of Liver Cirrhosis Epidemiology and Market

5 Executive Summary of Liver Cirrhosis

6 Key Events

7 Disease Background and Overview of Liver Cirrhosis

• 7.1. Introduction to Liver Cirrhosis
• 7.2. Etiology of Cirrhosis
• 7.3. Risk Factors of Liver Cirrhosis
• 7.4. Multiple Cell Types Contributing to Pathogenesis of Liver Cirrhosis
• 7.5. Pathogenesis of Liver Cirrhosis
• 7.6. Stages of Liver Cirrhosis
• 7.7. Signs and Symptoms
• 7.8. Complications of Liver Cirrhosis
• 7.9. Pathophysiology
• 7.10. Diagnosis of Liver Cirrhosis
  • 7.10.1. Diagnosis Algorithm
  • 7.10.2. Diagnosis Guidelines
    • 7.10.2.1. EASL Clinical Practice Guidelines for the Management of Patients With Decompensated Cirrhosis
    • 7.10.2.2. Evidence-based Clinical Practice Guidelines for Liver Cirrhosis 2020
    • 7.10.2.3. American Association for the Study of Liver Diseases (AASLD) Diagnostic Guidelines for HBV, 2018
    • 7.10.2.4. European Association for the Study of the Liver (EASL) Diagnostic Guidelines for HBV, 2017
    • 7.10.2.5. Diagnostic Guidelines for PBC
• 7.11. Treatment of Liver Cirrhosis
  • 7.11.1. Liver Cirrhosis Treatment Algorithm
  • 7.11.2. Treatment Guidelines
    • 7.11.2.1. EASL Clinical Practice Guidelines for the Management of Patients with decompensated cirrhosis
    • 7.11.2.3. Evidence-based clinical practice guidelines for liver cirrhosis 2020
    • 7.11.2.4. EASL-ALEH Clinical Practice Guidelines (European Association for the Study of the Liver)
    • 7.11.2.5. AASLD 2018 Practice Guidelines for Treatment of Chronic Hepatitis
    • 7.11.2.6. European Association for the Study of the Liver (EASL) 2017 Clinical Practice Guidelines for Hepatitis
    • 7.11.2.7. The British Society of Gastroenterology/UK PBC Treatment and Management Guidelines

8 Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
  • 8.2.1. The United States
  • 8.2.2. EU4 and the UK Countries
  • 8.2.3. Japan
• 8.3. Total Diagnosed Prevalent Cases of Liver Cirrhosis in the 7MM
• 8.4. The United States
  • 8.4.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis in the United States
  • 8.4.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the United States
• 8.5. Major Four European Countries and the United Kingdom
  • 8.5.1. Germany
    • 8.5.1.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis
    • 8.5.1.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis
  • 8.5.2. France
    • 8.5.2.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis
    • 8.5.2.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis
  • 8.5.3. Italy
    • 8.5.3.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis
    • 8.5.3.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis
  • 8.5.4. Spain
    • 8.5.4.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis
    • 8.5.4.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis
  • 8.5.5. The United Kingdom
    • 8.5.5.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis
    • 8.5.5.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis
• 8.6. Japan
  • 8.6.1. Total Diagnosed Prevalent Cases of Liver Cirrhosis in Japan
  • 8.6.2. Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in Japan

9 Liver Cirrhosis Patient Journey

10 Liver Cirrhosis Emerging Therapies

• 10.1. Key Cross Competition
• 10.2 Belapectin (GR-MD-02): Galectin Therapeutics Inc.
  • 10.2.1 Product Description
  • 10.2.2 Other Development Activities
  • 10.2.3 Clinical Development
  • 10.2.4 Clinical Trials Information
  • 10.2.5 Safety and Efficacy
  • 10.2.6 Product Profile
  • 10.2.7 Analyst Views
• 10.3 Efruxifermin (AKR-001): Akero Therapeutics, Inc.
  • 10.3.1 Product Description
  • 10.3.2 Other Development Activities
  • 10.3.3 Clinical Development
  • 10.3.4 Clinical Trial Information
  • 10.3.5 Safety and Efficacy
  • 10.3.6 Product Profile
  • 10.3.7 Analyst Views
• 10.4 Zibotentan/dapagliflozin: Astrazeneca
  • 10.4.1 Product Description
  • 10.4.2 Other Development Activities
  • 10.4.3 Clinical Development
  • 10.4.4 Clinical Trials Information
  • 10.4.5 Safety and Efficacy
  • 10.4.6 Product Profile
  • 10.4.7 Analysts' Views
• 10.5 LPCN 1148: Lipocine Inc.
  • 10.5.1 Product Description
  • 10.5.2 Other Development Activities
  • 10.5.3 Clinical Development
  • 10.5.4 Clinical Trials Information
  • 10.5.5 Product Profile
• 10.6 OP-724: Ohara Pharmaceutical
  • 10.6.1 Product Description
  • 10.6.2 Other Development Activities
  • 10.6.3 Clinical Development
  • 10.6.4 Clinical Trials Information
  • 10.6.5 Product Profile
  • 10.6.6 Analysts' Views
• 10.7 ADR-001: Shionogi/Rohto
  • 10.7.1 Product Description
  • 10.7.2 Other Development Activities
  • 10.7.3 Clinical Development
  • 10.7.4 Clinical Trials Information
  • 10.7.5 Product Profile

11 Liver Cirrhosis: Market Analysis

• 11.1 Key Findings
• 11.2 Key Market Forecast Assumptions
• 11.3 Liver Cirrhosis Market outlook
• 11.4 Conjoint Analysis
• 11.5 Market Size of Liver Cirrhosis in the 7MM
• 11.6 Total Market Size of Liver Cirrhosis by Therapies in the 7MM
• 11.7 Market Size of Liver Cirrhosis in the United States
  • 11.7.1 Total Market Size of Liver Cirrhosis
  • 11.7.2 Market Size of Liver Cirrhosis by Therapies
• 11.8 Market Size of Liver Cirrhosis in EU4 and the UK
  • 11.8.1 Germany
    • 11.8.1.1 Total Market Size of Liver Cirrhosis
    • 11.8.1.2 Market Size of Liver Cirrhosis by Therapies
  • 11.8.2 France
    • 11.8.2.1 Total Market Size of Liver Cirrhosis
    • 11.8.2.2 Market Size of Liver Cirrhosis by Therapies
  • 11.8.3 Italy
    • 11.8.3.1 Total Market Size of Liver Cirrhosis
    • 11.8.3.2 Market Size of Liver Cirrhosis by Therapies
  • 11.8.4 Spain
    • 11.8.4.1 Total Market Size of Liver Cirrhosis
    • 11.8.4.2 Market Size of Liver Cirrhosis by Therapies
  • 11.8.5 The United Kingdom
    • 11.8.5.1 Total Market Size of Liver Cirrhosis
    • 11.8.5.2 Market Size of Liver Cirrhosis by Therapies
• 11.9 Market Size of Liver Cirrhosis in Japan
  • 11.9.1 Total Market Size of Liver Cirrhosis
  • 11.9.2 Market Size of Liver Cirrhosis by Therapies

12 Key Opinion Leaders' Views

13 SWOT Analysis

14 Liver Cirrhosis Unmet Needs

15 Market Access and Reimbursement

• 15.1. The United States
  • 15.1.1 Centre for Medicare and Medicaid Services (CMS)
• 15.2 In EU4 and the UK
  • 15.2.1 Germany
  • 15.2.2 France
  • 15.2.3 Italy
  • 15.2.4 Spain
  • 15.2.5 The United Kingdom
• 15.3 Japan
  • 15.3.1 MHLW

16 Appendix

• 16.1 Bibliography
• 16.2 Acronyms and Abbreviations
• 16.3 Report Methodology

17 DelveInsight Capabilities

18 Disclaimer