Summary

The 7 major systemic sclerosis markets reached a value of US$ 1.3 Billion in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 2.4 Billion by 2034, exhibiting a growth rate (CAGR) of 6.07% during 2024-2034.

The systemic sclerosis market has been comprehensively analyzed in IMARC's new report titled "Systemic Sclerosis Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Systemic sclerosis, also referred to as scleroderma, is a rare autoimmune condition that affects the skin, blood vessels, and internal organs in the body. It is characterized by the production of excessive amounts of collagen, a fibrous protein that generally provides support and structure to the skin and other tissues. The most common symptom is the thickening and hardening of the skin, which can be either in localized or diffuse forms. In addition to skin changes, many people experience Raynaud's phenomenon, a condition in which the fingers and toes turn white or blue in response to cold or stress. Various other indications may include joint pain and stiffness, muscle weakness, fatigue, difficulty swallowing, heartburn, diarrhea, shortness of breath, coughing, high blood pressure in the lungs, etc. The diagnosis of systemic sclerosis is based on a combination of clinical features, laboratory tests, and imaging procedures. Numerous imaging studies, such as chest X-rays, echocardiograms, pulmonary function tests, etc., may also be used to assess the extent of organ involvement. In some cases, a skin biopsy or other tissue sample may be taken to confirm the diagnosis.

The increasing cases of endothelial cell dysfunction, which lead to abnormalities in blood vessel structure and function, are primarily driving the systemic sclerosis market. In addition to this, the rising prevalence of several associated risk factors, including exposure to silica, viral infections, genetic predisposition, etc., is also bolstering the market growth. Furthermore, the widespread adoption of calcium channel blockers, such as nifedipine and diltiazem, to manage Raynaud's phenomenon, a common symptom of systemic sclerosis that causes narrowing of blood vessels in the hands and feet, leading to coldness, numbness, and pain, is acting as another significant growth-inducing factor. Apart from this, the escalating demand for nailfold capillaroscopy, a non-invasive diagnostic technique, since it can distinguish systemic sclerosis from other connective tissue disorders and monitor disease progression effectively, is further creating a positive outlook for the market. Moreover, the inflating utilization of prostacyclin analogs, including epoprostenol, treprostinil, iloprost, etc., for managing pulmonary arterial hypertension by dilating blood vessels and reducing blood pressure is also augmenting the market growth. Additionally, the ongoing advancements in genomics and proteomics are enabling a better understanding of the underlying molecular mechanisms of the disease, which is further leading to the development of new treatment strategies. This, in turn, is expected to drive the systemic sclerosis market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the systemic sclerosis market in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report the United States has the largest patient pool for systemic sclerosis and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario and unmet medical needs, etc. have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the systemic sclerosis market in any manner.

Time Period of the Study

Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the systemic sclerosis market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the systemic sclerosis market
Reimbursement scenario in the market
In-market and pipeline drugs
Competitive Landscape:
This report also provides a detailed analysis of the current systemic sclerosis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:
Market Insights

How has the systemic sclerosis market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the systemic sclerosis market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the systemic sclerosis market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (2018-2034) of systemic sclerosis across the seven major markets?
What is the number of prevalent cases (2018-2034) of systemic sclerosis by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of systemic sclerosis by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with systemic sclerosis across the seven major markets?
What is the size of the systemic sclerosis patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of systemic sclerosis?
What will be the growth rate of patients across the seven major markets?

Systemic Sclerosis: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for systemic sclerosis drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the systemic sclerosis market?
What are the key regulatory events related to the systemic sclerosis market?
What is the structure of clinical trial landscape by status related to the systemic sclerosis market?
What is the structure of clinical trial landscape by phase related to the systemic sclerosis market?
What is the structure of clinical trial landscape by route of administration related to the systemic sclerosis market?

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Table of Contents

1 Preface

2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Systemic Sclerosis - Introduction
4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence

5 Systemic Sclerosis - Disease Overview
5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 Patient Journey

7 Systemic Sclerosis - Epidemiology and Patient Population
7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
7.2.1 Epidemiology Scenario (2018-2023)
7.2.2 Epidemiology Forecast (2024-2034)
7.2.3 Epidemiology by Age (​2018-2034​)
7.2.4 Epidemiology by Gender (​2018-2034​)
7.2.5 Diagnosed Cases (​2018-2034​)
7.2 6 Patient Pool/Treated Cases (​2018-2034​)
7.3 Epidemiology Scenario - United States
7.3.1 Epidemiology Scenario (2018-2023)
7.3.2 Epidemiology Forecast (2024-2034)
7.3.3 Epidemiology by Age (​2018-2034​)
7.3.4 Epidemiology by Gender (​2018-2034​)
7.3.5 Diagnosed Cases (​2018-2034​)
7.3.6 Patient Pool/Treated Cases (​2018-2034​)
7.4 Epidemiology Scenario - Germany
7.4.1 Epidemiology Scenario (2018-2023)
7.4.2 Epidemiology Forecast (2024-2034)
7.4.3 Epidemiology by Age (​2018-2034​)
7.4.4 Epidemiology by Gender (​2018-2034​)
7.4.5 Diagnosed Cases (​2018-2034​)
7.4.6 Patient Pool/Treated Cases (​2018-2034​)
7.5 Epidemiology Scenario - France
7.5.1 Epidemiology Scenario (2018-2023)
7.5.2 Epidemiology Forecast (2024-2034)
7.5.3 Epidemiology by Age (​2018-2034​)
7.5.4 Epidemiology by Gender (​2018-2034​)
7.5.5 Diagnosed Cases (​2018-2034​)
7.5.6 Patient Pool/Treated Cases (​2018-2034​)
7.6 Epidemiology Scenario - United Kingdom
7.6.1 Epidemiology Scenario (2018-2023)
7.6.2 Epidemiology Forecast (2024-2034)
7.6.3 Epidemiology by Age (​2018-2034​)
7.6.4 Epidemiology by Gender (​2018-2034​)
7.6.5 Diagnosed Cases (​2018-2034​)
7.6.6 Patient Pool/Treated Cases (​2018-2034​)
7.7 Epidemiology Scenario - Italy
7.7.1 Epidemiology Scenario (2018-2023)
7.7.2 Epidemiology Forecast (2024-2034)
7.7.3 Epidemiology by Age (​2018-2034​)
7.7.4 Epidemiology by Gender (​2018-2034​)
7.7.5 Diagnosed Cases (​2018-2034​)
7.7.6 Patient Pool/Treated Cases (​2018-2034​)
7.8 Epidemiology Scenario - Spain
7.8.1 Epidemiology Scenario (2018-2023)
7.8.2 Epidemiology Forecast (2024-2034)
7.8.3 Epidemiology by Age (​2018-2034​)
7.8.4 Epidemiology by Gender (​2018-2034​)
7.8.5 Diagnosed Cases (​2018-2034​)
7.8.6 Patient Pool/Treated Cases (​2018-2034​)
7.9 Epidemiology Scenario - Japan
7.9.1 Epidemiology Scenario (2018-2023)
7.9.2 Epidemiology Forecast (2024-2034)
7.9.3 Epidemiology by Age (​2018-2034​)
7.9.4 Epidemiology by Gender (​2018-2034​)
7.9.5 Diagnosed Cases (​2018-2034​)
7.9.6 Patient Pool/Treated Cases (​2018-2034​)

8 Systemic Sclerosis - Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 Systemic Sclerosis - Unmet Needs

10 Systemic Sclerosis - Key Endpoints of Treatment

11 Systemic Sclerosis - Marketed Products
11.1 List of Systemic Sclerosis Marketed Drugs Across the Top 7 Markets
11.1.1 Actemra (Tocilizumab) - Chugai Pharmaceutical/Roche
11.1.1.1 Drug Overview
11.1.1.2 Mechanism of Action
11.1.1.3 Regulatory Status
11.1.1.4 Clinical Trial Results
11.1.1.5 Sales Across Major Markets
11.1.2 Ofev (Nintedanib) - Boehringer Ingelheim
11.1.2.1 Drug Overview
11.1.2.2 Mechanism of Action
11.1.2.3 Regulatory Status
11.1.2.4 Clinical Trial Results
11.1.2.5 Sales Across Major Markets

Kindly note that the above only represents a partial list of marketed drugs, and the complete list has been provided in the report.

12 Systemic Sclerosis - Pipeline Drugs
12.1 List of Systemic Sclerosis Pipeline Drugs Across the Top 7 Markets
12.1.1 KHK4827 - Kyowa Kirin Co
12.1.1.1 Drug Overview
12.1.1.2 Mechanism of Action
12.1.1.3 Clinical Trial Results
12.1.1.4 Safety and Efficacy
12.1.1.5 Regulatory Status
12.1.2 MT-0551 - Mitsubishi Tanabe Pharma Corporation
12.1.2.1 Drug Overview
12.1.2.2 Mechanism of Action
12.1.2.3 Clinical Trial Results
12.1.2.4 Safety and Efficacy
12.1.2.5 Regulatory Status
12.1.3 EHP101 - Emerald Health Pharmaceuticals
12.1.3.1 Drug Overview
12.1.3.2 Mechanism of Action
12.1.3.3 Clinical Trial Results
12.1.3.4 Safety and Efficacy
12.1.3.5 Regulatory Status
12.1.4 PRA023 - Prometheus Biosciences
12.1.4.1 Drug Overview
12.1.4.2 Mechanism of Action
12.1.4.3 Clinical Trial Results
12.1.4.4 Safety and Efficacy
12.1.4.5 Regulatory Status

Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.

13. Systemic Sclerosis - Attribute Analysis of Key Marketed and Pipeline Drugs

14. Systemic Sclerosis – Clinical Trial Landscape
14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 Systemic Sclerosis - Market Scenario
15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
15.2.1 Systemic Sclerosis - Market Size
15.2.1.1 Market Size (2018-2023)
15.2.1.2 Market Forecast (2024-2034)
15.2.2 Systemic Sclerosis - Market Size by Therapies
15.2.2.1 Market Size by Therapies (2018-2023)
15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
15.3.1 Systemic Sclerosis - Market Size
15.3.1.1 Market Size (2018-2023)
15.3.1.2 Market Forecast (2024-2034)
15.3.2 Systemic Sclerosis - Market Size by Therapies
15.3.2.1 Market Size by Therapies (2018-2023)
15.3.2.2 Market Forecast by Therapies (2024-2034)
15.3.3 Systemic Sclerosis - Access and Reimbursement Overview
15.4 Market Scenario - Germany
15.4.1 Systemic Sclerosis - Market Size
15.4.1.1 Market Size (2018-2023)
15.4.1.2 Market Forecast (2024-2034)
15.4.2 Systemic Sclerosis - Market Size by Therapies
15.4.2.1 Market Size by Therapies (2018-2023)
15.4.2.2 Market Forecast by Therapies (2024-2034)
15.4.3 Systemic Sclerosis - Access and Reimbursement Overview
15.5 Market Scenario - France
15.5.1 Systemic Sclerosis - Market Size
15.5.1.1 Market Size (2018-2023)
15.5.1.2 Market Forecast (2024-2034)
15.5.2 Systemic Sclerosis - Market Size by Therapies
15.5.2.1 Market Size by Therapies (2018-2023)
15.5.2.2 Market Forecast by Therapies (2024-2034)
15.5.3 Systemic Sclerosis - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
15.6.1 Systemic Sclerosis - Market Size
15.6.1.1 Market Size (2018-2023)
15.6.1.2 Market Forecast (2024-2034)
15.6.2 Systemic Sclerosis - Market Size by Therapies
15.6.2.1 Market Size by Therapies (2018-2023)
15.6.2.2 Market Forecast by Therapies (2024-2034)
15.6.3 Systemic Sclerosis - Access and Reimbursement Overview
15.7 Market Scenario - Italy
15.7.1 Systemic Sclerosis - Market Size
15.7.1.1 Market Size (2018-2023)
15.7.1.2 Market Forecast (2024-2034)
15.7.2 Systemic Sclerosis - Market Size by Therapies
15.7.2.1 Market Size by Therapies (2018-2023)
15.7.2.2 Market Forecast by Therapies (2024-2034)
15.7.3 Systemic Sclerosis - Access and Reimbursement Overview
15.8 Market Scenario - Spain
15.8.1 Systemic Sclerosis - Market Size
15.8.1.1 Market Size (2018-2023)
15.8.1.2 Market Forecast (2024-2034)
15.8.2 Systemic Sclerosis - Market Size by Therapies
15.8.2.1 Market Size by Therapies (2018-2023)
15.8.2.2 Market Forecast by Therapies (2024-2034)
15.8.3 Systemic Sclerosis - Access and Reimbursement Overview
15.9 Market Scenario - Japan
15.9.1 Systemic Sclerosis - Market Size
15.9.1.1 Market Size (2018-2023)
15.9.1.2 Market Forecast (2024-2034)
15.9.2 Systemic Sclerosis - Market Size by Therapies
15.9.2.1 Market Size by Therapies (2018-2023)
15.9.2.2 Market Forecast by Therapies (2024-2034)
15.9.3 Systemic Sclerosis - Access and Reimbursement Overview

16 Systemic Sclerosis - Recent Events and Inputs From Key Opinion Leaders

17 Systemic Sclerosis Market - SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 Systemic Sclerosis Market – Strategic Recommendations

19 Appendix