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市場調查報告書

系統性硬皮病:到 2030 年的全球藥物預測和市場分析

Systemic Sclerosis - Global Drug Forecast and Market Analysis to 2030

出版商 GlobalData 商品編碼 1010015
出版日期 內容資訊 英文 160 Pages
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系統性硬皮病:到 2030 年的全球藥物預測和市場分析 Systemic Sclerosis - Global Drug Forecast and Market Analysis to 2030
出版日期: 2021年05月31日內容資訊: 英文 160 Pages
簡介

在預測期內,世界七大國家的全身性強皮膚病 (SSc) 市場(美國、法國、德國、意大利、西班牙、英國、日本)預計將以 14% 的複合年增長率增長,預計銷售額將從 2020 年的 4.89 億美元增至 2030 年的 18 億美元。市場的全球增長包括勃林格殷格翰(BI)最近推出的 Ofev(尼達尼布)和羅氏/基因泰克 SSc 相關 ILD 治療藥物 Actemra/RoActemra(托珠單抗)的採用,以及六種管道治療藥物。將由批准推動以及對發佈的期待。然而,這種增長可能會受到尼達尼布仿製藥和生物仿製藥銷量下降的限制。

用於治療 SSc 相關的指趾血管病、皮膚纖維化和 ILD 的藥物大部分是免疫抑製劑(甲氨蝶呤、嗎替麥考酚酯、環磷□胺等)和血管擴張劑。它是一個十年前的仿製藥。從其他適應症中重複使用,例如一些心血管藥物(鈣通道阻滯劑、PDE5抑製劑、前列環素類似物等),而SSc的大部分治療都是在適應症外使用。然而,最近SSc的市場環境發生了翻天覆地的變化,新的公司開始進入市場。

本報告調查系統性硬皮病,並提供有關收入、年度治療成本、預測期內關鍵管道產品銷售、增長因素和障礙、發展趨勢、管道分析等方面的信息。它提供。

目錄

目錄

第 1 章系統性硬皮病:執行摘要

  • 由於新藥獲批,預計 SSc 將強勁增長
  • 結合新舊研發戰略的當前 SSc 市場動態
  • 儘管 SSc 的前景有所改善,但仍有機會改善患者的預後。
  • 一種針對 SSc 管道的皮膚、肺和血管系統的新 MOA
  • 醫生的觀點

第 2 章介紹

  • 催化劑
  • 相關報導
  • 未來相關報導

第 3 章疾病概述

  • 發病機制和病理生理學
    • 發病機制
    • 病理生理學
  • 疾病分類

第 4 章流行病學

  • 疾病背景
  • 風險因素和合併症
  • 世界和歷史趨勢
  • 7個主要國家市場的預測調查方法
    • 來源
    • 預測的先決條件和方法
    • 預測先決條件和方法:7 大市場 SSc 常見診斷病例
    • 先決條件和預測方法:按亞型診斷的 SSc 常見病例
    • 指趾血管病診斷SSc一般病例
    • 通過其他內臟器官受累和合併症診斷的常見病例
  • 系統性硬皮病的流行病學預測(2020-2030)
    • 診斷為 SSc 的常見病例
    • 按年齡:診斷為 SSc 的常見病例
    • 性別:診斷為 SSc 的常見病例
    • 按亞型:診斷為 SSc 的常見病例
    • 指趾血管疾病:診斷為 SSc 的一般病例
    • 其他內臟器官受累:診斷為 SSc 的常見病例
    • 診斷為 SSc 並伴有惡性腫瘤的常見病例
  • 討論
    • 流行病學預測見解
    • COVID-19 的影響
    • 分析的局限性
    • 分析的優勢

第 5 章疾病管理

  • 診斷
  • 處理
    • 指狀血管病
    • 皮膚和肺纖維化
    • 其他器官受累

第六章競爭性評價

  • 概述

第 7 章未滿足需求和機會的評估

  • 概述
  • 缺乏改善疾病的療法
  • 缺乏抗纖維化藥物
  • 早期介紹和治療
  • 改進的預後生物標誌物

第八章研發戰略

  • 概述
    • 用於自身免疫和心血管疾病的藥物轉移
    • 主要製藥公司獲得 SSc-ILD 批准
    • 早期 Dc-SSc 的新作用機制
  • 臨床試驗設計
    • 早期的 DC-SSc
    • SSc-ILD
    • 腳趾血管病

第9章管道評估

  • 概述
  • 臨床開發中的有前途的藥物
    • Civi-030
    • HZN-825
    • 甲磺酸芐酯
    • 德爾西梅拉貢
    • Lumisev Tremfia
  • 其他值得注意的藥物
    • 莉娜巴斯姆

第10章管道評估分析

  • 概述
  • 競爭評估
    • 皮膚纖維化
    • 肺纖維化
    • 指狀血管病

第11章當前和未來的企業

  • 概述
  • 交易趨勢

第 12 章市場展望

  • 世界市場
    • 預測
    • 增長因素和障礙——世界問題
  • 美國
    • 預測
    • 重要事件
    • 增長因素和障礙
  • 歐盟 5 國
    • 預測
    • 重要事件
    • 增長因素和障礙
  • 日本
    • 預測
    • 重要事件
    • 增長因素和障礙

第 13 章附錄

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目錄
Product Code: GDHC221PIDR

Systemic sclerosis (SSc) is a rare, multisystem autoimmune disease that causes progressive fibrosis of the skin and internal organs, as well as vascular dysfunction. The presentation of the disease is heterogeneous, both in the organ systems affected and the overall severity of symptoms. The most common complications of SSc include digital vasculopathy (Raynaud's phenomenon and digital ulcers), skin fibrosis, lung fibrosis or interstitial lung disease (ILD), pulmonary arterial hypertension, gastrointestinal issues, arthritis, myopathy, and scleroderma renal crisis. As there are no systemic disease-modifying therapies currently available that significantly alter the course of the disease, the SSc treatment paradigm is to manage complications within individual organ systems as they occur.

GlobalData's report and forecast model focus specifically on the treatment of SSC-associated digital vasculopathy, skin fibrosis, and ILD. Most of the drugs used to treat these disease manifestations are decades-old generic agents that have been repurposed from other indications, including immunosuppressive agents (such as methotrexate, mycophenolate mofetil, and cyclophosphamide) and vasodilative cardiovascular drugs (such as calcium channel blockers, PDE5 inhibitors, and prostacyclin analogs). The vast majority of SSc therapies are used off-label. However, there has recently been a major shift in the SSc market landscape, and new players are beginning to enter the space.

GlobalData projects that the global SSc market, which comprises the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan), will experience strong growth during the forecast period, at a Compound Annual Growth Rate (CAGR) of 14.0%, with sales growing from $498.0M in 2020 to $1.8B in 2030. Global growth in the SSc market will be driven by uptake of Boehringer Ingelheim's (BI) recently launched Ofev (nintedanib) and Roche/Genentech's Actemra/RoActemra (tocilizumab) for the treatment of SSc-associated ILD, along with the anticipated approval and launch of six pipeline therapies. This growth will be limited by sales erosion from generic nintedanib and biosimilars.

In this report, GlobalData focuses its market forecast analysis on six Phase III and late Phase II products expected to be licensed for SSc between 2020 and 2030. These include four small molecule drugs-Civi BioPharma/Eicos Sciences' IV Civi-030 (iloprost), Horizon Therapeutics' HZN-825, Kadmon Corporation's belumosudil mesylate, and Mitsubishi Tanabe Pharma's dersimelagon-and two monoclonal antibodies currently marketed for the treatment of PSO and PsA-Kyowa Kirin's Lumicef (brodalumab) and J&J's Tremfya (guselkumab).

Although key opinion leaders (KOLs) interviewed by GlobalData were pleased to see such an innovative late-stage pipeline for SSc, they did highlight major, lingering unmet needs in the field. These include needs for the development of disease-modifying and anti-fibrotic therapies, earlier diagnosis and treatment, and improved prognostic biomarkers. KOLs were optimistic about the future of SSc but believed there was significant work left to be done in this space.

Key Highlights

  • The greatest drivers of growth in the global SSc market will be the recent launches of Ofev and Actemra/RoActemra for the treatment of ILD associated with SSc, the anticipated approval and launch of six pipeline therapies, a steadily climbing diagnosed prevalence rate, and a growing overall treatment rate due to growing access to new therapies.
  • The main barriers to growth in the SSc market will be significant market share erosion from biosimilars and nintedanib generics as well as a historical treatment paradigm that focuses on the off-label use of inexpensive generic products.
  • KOLs expressed enthusiasm for the six pipeline agents in development. Of these agents, KOLs were most interested in Civi Biopharma/Eicos Sciences' Civi-030, Horizon Therapeutics' HZN-825, and Kadmon Corporation's belumosudil mesylate.
  • The most important unmet needs in SSc are those for the development of disease-modifying and anti-fibrotic therapies, earlier diagnosis and treatment, and improved prognostic biomarkers.

KEY QUESTIONS ANSWERED

For the first time ever, treatment options for patients with SSc are beginning to expand.

  • What impact will the recently launched drugs, Ofev and Actemra/RoActemra, have on the treatment of SSc throughout the 7MM?
  • What pipeline agents are currently in late-stage clinical development, and which are the most promising?

Growing interest in SSc by the pharmaceutical industry is transforming research and development practices in the field.

  • What are the main R&D trends in the SSc market and which companies are leading the way?
  • How is clinical trial design for SSc changing and in what ways does it differ depending on disease manifestation?

KOLs interviewed by GlobalData have indicated that there are still many remaining unmet needs within the SSc indication.

  • What are the main unmet needs in the SSc market?
  • How can the pharmaceutical industry address these needs?
  • To what degree will the therapies under development fulfill these unmet needs?

Scope

  • Overview of SSc including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline SSc therapeutics market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting SSc therapeutics sales in the 8MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global SSc therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global SSc therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SSc market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global SSc therapeutics market from 2020-2030.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

Table of Contents

1 Systemic Sclerosis: Executive Summary

  • 1.1 New Drug Approvals Expected to Drive Strong Growth in SSc
  • 1.2 Current SSc Market Dynamics Reflect a Blend of New and Old R&D Strategies
  • 1.3 While Outlook in SSc Improves, Opportunities Remains to Improve Patient Outcomes
  • 1.4 SSc Pipeline Targets the Skin, Lungs, and Vasculature with New MOAs
  • 1.5 What Do Physicians Think?

2 Introduction

  • 2.1 Catalyst
  • 2.2 Related Reports
  • 2.3 Upcoming Related Reports

3 Disease Overview

  • 3.1 Etiology and Pathophysiology
    • 3.1.1 Etiology
    • 3.1.2 Pathophysiology
  • 3.2 Disease Classification

4 Epidemiology

  • 4.1 Disease Background
  • 4.2 Risk Factors and Comorbidities
  • 4.3 Global and Historical Trends
  • 4.4 7MM Forecast Methodology
    • 4.4.1 Sources
    • 4.4.2 Forecast Assumptions and Methods
    • 4.4.3 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SSc - 7MM
    • 4.4.4 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SSc by Subtype
    • 4.4.5 Diagnosed Prevalent Cases of SSc by Digital Vasculopathy
    • 4.4.6 Diagnosed Prevalent Cases of by other Internal Organ Involvement and Comorbidities
  • 4.5 Epidemiological Forecast for Systemic Sclerosis (2020-2030)
    • 4.5.1 Diagnosed Prevalent Cases of SSc
    • 4.5.2 Age-Specific Diagnosed Prevalent Cases of SSc
    • 4.5.3 Sex-Specific Diagnosed Prevalent Cases of SSc
    • 4.5.4 Diagnosed Prevalent Cases of SSc by Subtype
    • 4.5.5 Diagnosed Prevalent Cases of SSc by Digital Vasculopathy
    • 4.5.6 Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement
    • 4.5.7 Diagnosed Prevalent Cases of SSc with Comorbid Malignancy
  • 4.6 Discussion
    • 4.6.1 Epidemiological Forecast Insight
    • 4.6.2 COVID-19 Impact
    • 4.6.3 Limitations of the Analysis
    • 4.6.4 Strengths of the Analysis

5 Disease Management

  • 5.1 Diagnosis
  • 5.2 Treatment
    • 5.2.1 Digital Vasculopathy
    • 5.2.2 Skin and Lung Fibrosis
    • 5.2.3 Other Organ Involvement

6 Competitive Assessment

  • 6.1 Overview

7 Unmet Needs and Opportunity Assessment

  • 7.1 Overview
  • 7.2 Lack of Disease-Modifying Therapies
  • 7.3 Lack of Anti-Fibrotic Drugs
  • 7.4 Earlier Referral and Treatment
  • 7.5 Improved Prognostic Biomarkers

8 R&D Strategies

  • 8.1 Overview
    • 8.1.1 Repurposing of Drugs Used for Autoimmune and Cardiovascular Diseases
    • 8.1.2 Big Pharma Forges Ahead in SSc-ILD Approvals
    • 8.1.3 New Mechanisms of Action for Early Dc-SSc
  • 8.2 Clinical Trial Design
    • 8.2.1 Early Dc-SSc
    • 8.2.2 SSc-ILD
    • 8.2.3 Digital Vasculopathy

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Promising Drugs in Clinical Development
    • 9.2.1 Civi-030
    • 9.2.2 HZN-825
    • 9.2.3 Belumosudil Mesylate
    • 9.2.4 Dersimelagon
    • 9.2.5 Lumicef and Tremfya
  • 9.3 Other Drugs of Note
    • 9.3.1 Lenabasum

10 Pipeline Valuation Analysis

  • 10.1 Overview
  • 10.2 Competitive Assessment
    • 10.2.1 Skin Fibrosis
    • 10.2.2 Lung Fibrosis
    • 10.2.3 Digital Vasculopathy

11 Current and Future Players

  • 11.1 Overview
  • 11.2 Deal-Making Trends

12 Market Outlook

  • 12.1 Global Markets
    • 12.1.1 Forecast
    • 12.1.2 Drivers and Barriers - Global Issues
  • 12.2 US
    • 12.2.1 Forecast
    • 12.2.2 Key Events
    • 12.2.3 Drivers and Barriers
  • 12.3 5EU
    • 12.3.1 Forecast
    • 12.3.2 Key Events
    • 12.3.3 Drivers and Barriers
  • 12.4 Japan
    • 12.4.1 Forecast
    • 12.4.2 Key Events
    • 12.4.3 Drivers and Barriers

13 Appendix

List of Tables

List of Tables

  • Table 1: SSc Key Metrics in the 7MM
  • Table 2: Classification Groups for SSc
  • Table 3: Risk Factors and Comorbidities for SSc
  • Table 4: Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement
  • Table 5: 2013 ACR/EULAR Criteria for the Classification of SSc
  • Table 6: Frequency and Clinical Correlation of Select SSc-associated Nuclear Autoantibodies
  • Table 7: Treatment Guidelines for SSc
  • Table 8: Comparison of Provisional ACR-CRISS and Revised ACR-CRISS
  • Table 9: Key Deals in SSc Market, 2016-2021
  • Table 10: SSc Market - Global Drivers and Barriers, 2020-2030
  • Table 11: Key Events Impacting Sales for SSc in the US, 2020-2030
  • Table 12: SSc Market - Drivers and Barriers in the US, 2020-2030
  • Table 13: Key Events Impacting Sales for SSc in the 5EU, 2020-2030
  • Table 14: SSc Market - Drivers and Barriers in the 5EU, 2020-2030
  • Table 15: Key Events Impacting Sales for SSc in Japan, 2020-2030
  • Table 16: SSc Market - Drivers and Barriers in Japan, 2020-2030
  • Table 17: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

List of Figures

  • Figure 1: Global (7MM) Sales Forecast by Country for SSc in 2020 and 2030
  • Figure 2: Analysis of the Company Portfolio Gap in SSc During the Forecast Period
  • Figure 3: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Skin Fibrosis, MMF and MTX
  • Figure 4: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Lung Fibrosis, MMF and Ofev
  • Figure 5: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC for SSc-Associated Digital Vasculopathy, Generic Epoprostenol
  • Figure 6: SSc Pathophysiology and Associated Therapeutic Mechanisms
  • Figure 7: 7MM, Diagnosed Prevalence of SSc, Men and Women, %, Ages ≥18 Years, 2020
  • Figure 8: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of SSc
  • Figure 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Subtype
  • Figure 10: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Digital Vasculopathy
  • Figure 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement - ILD, PAH, and Kidney Disease
  • Figure 12: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement - Cardiac Involvement, Gastrointestinal Involvement, Musculoskeletal Involvement, and Neuromuscular Involvement; and Comorbidity - Malignancy
  • Figure 13: 7MM, Diagnosed Prevalent Cases of SSc, N, Both Sexes, Ages ≥18 Years, 2020
  • Figure 14: 7MM, Diagnosed Prevalent Cases of SSc by Age, N, Both Sexes, 2020
  • Figure 15: 7MM, Diagnosed Prevalent Cases of SSc by Sex, N, Ages ≥18 Years, 2020
  • Figure 16: 7MM, Diagnosed Prevalent Cases of SSc by Subtype, N, Both Sexes, Ages ≥18 Years, 2020
  • Figure 17: 7MM, Diagnosed Prevalent Cases of SSc by Digital Vasculopathy, N, Both Sexes, Ages ≥18 Years, 2020
  • Figure 18: 7MM, Diagnosed Prevalent Cases of SSc with Comorbid Malignancy, N, Both Sexes, Ages ≥18 Years, 2020
  • Figure 19: General Treatment Algorithm for SSc-Associated Digital Vasculopathy, 2021
  • Figure 20: General Treatment Algorithm for SSc-Associated Skin and Lung Fibrosis, 2021
  • Figure 21: Unmet Needs and Opportunities in SSc
  • Figure 22: Overview of the Development Pipeline in SSc
  • Figure 23: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects Be Licensed for SSc in the 7MM During the Forecast Period
  • Figure 24: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Skin Fibrosis, MMF and MTX
  • Figure 25: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Lung Fibrosis, MMF and Ofev
  • Figure 26: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC for SSc-Associated Digital Vasculopathy, Generic Epoprostenol
  • Figure 27: Analysis of the Company Portfolio Gap in SSc During the Forecast Period
  • Figure 28: Global (7MM) Sales Forecast by Country for SSc in 2020 and 2030
  • Figure 29: Global (7MM) Sales Forecast by Drug Class for SSc in 2020 and 2030
  • Figure 30: Sales Forecast by Drug Class for SSc in the US in 2020 and 2030
  • Figure 31: Sales Forecast by Drug Class for SSc in the 5EU in 2020 and 2030
  • Figure 32: Sales Forecast by Drug Class for SSc in Japan in 2020 and 2030