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Systemic Sclerosis Market Size, Trends, Growth, Analysis: By Diagnosis: Skin Biopsy, Imaging Techniques, Blood Test, Electrocardiogram, Pulmonary Function Test; By Type: Limited Systemic Sclerosis, Diffuse Systemic Sclerosis, Sine Systemic Sclerosis; By Drug Class, By End User; Regional Analysis; Market Dynamics; Supplier Landscape; 2024-2032
Systemic Sclerosis Market Outlook
The systemic sclerosis market size is expected to grow at a CAGR of 6.3% during the forecast period of 2024-2032. The growth of the market in the seven major markets is driven by increased research and development efforts to provide effective treatment alternatives to patients, along with growing focus on offering patient centric care.
Systemic Sclerosis Market Overview
Systemic sclerosis (SSc) is an autoimmune disorder that involves skin tightening and hardening due to excessive collagen production in the body. It first affects the fingers, hands, feet, and face. Raynaud’s phenomenon is also common and observed in more than 95% of the people with the condition. It occurs due to exaggerated contraction of small blood vessels in toes and fingers in response to cold or emotional distress.
The global incidence of systemic sclerosis is estimated to be 8.64 per 100,000 people annually. The prevalence is relatively higher in high income level countries. Adult females are more prone to develop the condition than males with an average of 5:1 .Children and teens below 15 years of age are less susceptible to the disease. The systemic sclerosis market demand is driven by increasing drug development activities and a subsequent growth in approvals from the regulatory authorities.
Surge in FDA Approvals to be a Key Driver
The market growth is driven by the increasing number of drug approvals developed by employing the latest technologies. In October 2023, Kyverna Therapeutics’ new investigational drug called KYV-101 received the application approval by the FDA for treating scleroderma. It is an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy aiding deep B cell depletion.
In February 2023, ChemomAb Ltd.’s new investigation drug for systemic sclerosis called CM-101 gained FDA clearance as per the results of phase 2 trials conducted in adults. CM-101 is a monoclonal antibody designed to interfere with vital biological pathways that are related to SSc. It has been well tolerated and helped with inflammatory reduction in patients.
Emphasis on Developing Effective Drugs that Address Disease Complications
Managing complications and side-effects is one of the major systemic sclerosis market trends. Interstitial lung disease (ILD) is a leading cause of death in systemic scleroderma disease affecting approximately half of the patients. To combat the number of mortalities associated with SSc-ILD, Benlysta (belimumab) , a B-cell inhibiting monoclonal antibody developed by GSK plc has been granted orphan drug designation (ODD) by the FDA in February 2023. It is the first and only approved biologic for the condition and can be administered to the pediatric population as well. The newly assigned status is aimed at offering further research to address a wider section of patients suffering from the condition.
Development in Non-Pharmacological Interventions
The growing application of alternative therapeutics is also expected to boost the systemic sclerosis market growth globally. Along with pharmacological interventions, haematopoietic stem cell transplantation (HSCT) is another treatment option for severe systemic sclerosis. Physiotherapy, occupational therapy, diet, psychology, and podiatry are some of the common management techniques suggested by the European Alliance of Associations for Rheumatology (EULAR).
Systemic Sclerosis Market Segmentation
Market Breakup by Diagnosis
- Skin Biopsy
- Imaging Techniques
- Blood test
- Electrocardiogram
- Pulmonary Function Test
Market Breakup by Type
- Limited Systemic Sclerosis
- Diffuse Systemic Sclerosis
- Sine Systemic Sclerosis
Market Breakup by Drug Class
- Immunosuppressors
- PDE-5 Inhibitors
- Endothelin Receptor Antagonist
- Prostacyclin Analogues
- Others
Market Breakup by End User
- Hospitals
- Clinics
- Research Institutes
- Others
Market Breakup by Region
- United States
- EU-4 and the United Kingdom
- Germany
- France
- Italy
- Spain
- United Kingdom
- Japan
Systemic Sclerosis Market Regional Analysis
The United States is a major market with a robust medical ecosystem that works continuously to improve the therapeutic options available in the market. The presence of key healthcare providers also drives the market growth in the region. In October 2023, Certa Therapeutics’ systemic sclerosis candidate FT011 gained FDA’s orphan drug designation. It demonstrated clinically meaningful improvements for over 60% of the patients after 12-week treatment.
Europe is among the largest markets for systemic scleroderma with a substantial portion of geriatric population which is more prone to developing the condition. Having several academic and well-equipped research institutions at home also boosts the systemic sclerosis market growth. Mergers and acquisitions between vital pharmaceutical companies to adopt better technologies and develop effective solutions is a major market trend in the region.
In the Asia Pacific region, Japan is a leading region with the largest systemic sclerosis market share. However, other regions such as Australia, China, and India are also emerging as a prominent market with the help of growing investments in the region. For instance, ‘Shine Like a Sunflower’ funding drive in Australia aims to raise a significant amount to facilitate a cure and improve treatment in patients.
Systemic Sclerosis Market: Competitor Landscape
In April 2023, Merck & Co. acquired Prometheus Biosciences for a USD 10.8 billion to expand their immunology drug pipeline. Prometheus’ lead candidate, PRA023, a humanized monoclonal antibody is aimed at treating several autoimmune conditions including Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). Such mergers and acquisitions are a frequent occurrence in the market, especially with larger companies showing keen interest in small biotech firms to adapt their latest technologies and develop effective solutions.
The key features of the systemic sclerosis market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- F. Hoffmann La Roche Ltd.
- Johnson & Johnson Services
- United Therapeutics
- Boehringer Ingelheim International GmbH
- GlaxoSmithKline plc
- Pfizer
- Eli Lilly and Company
- Bayer AG
- Mylan N.V.
- Teva Pharmaceutical Industries Ltd.
- Gilead Sciences Inc
- Novartis AG
- Cumberland Pharmaceuticals
- Organon LLC
- Lupin Ltd
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
| Base Year | 2023 |
| Historical Period | 2017-2023 |
| Forecast Period | 2024-2032 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Diagnosis |
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| Breakup by Type |
|
| Breakup by Drug Class |
|
| Breakup by End User |
|
| Breakup by Region |
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| Market Dynamics |
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| Competitive Landscape |
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| Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Systemic Sclerosis Overview
3.1 Guidelines and Stages
3.2 Pathophysiology
3.3 Screening and Diagnosis
3.4 Treatment Pathway
4 Patient Profile
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Systemic Sclerosis Epidemiology Analysis – Seven Major Markets
5.1 7MM Epidemiology Scenario Overview (2017-2032)
5.2 United States Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.3 EU-4 and United Kingdom Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.3.1 Germany Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.3.2 France Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.3.3 Italy Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.3.4 Spain Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.3.5 United Kingdom Systemic Sclerosis Epidemiology Forecast (2017-2032)
5.4 Japan Systemic Sclerosis Epidemiology Forecast (2017-2032)
6 Systemic Sclerosis Market Overview – Seven Major Markets
6.1 Systemic Sclerosis Market Historical Value (2017-2023)
6.2 Systemic Sclerosis Market Forecast Value (2024-2032)
7 Systemic Sclerosis Market Landscape – Seven Major Markets
7.1 Systemic Sclerosis Developers Landscape
7.1.1 Analysis by Year of Establishment
7.1.2 Analysis by Company Size
7.1.3 Analysis by Region
7.2 Systemic Sclerosis Product Landscape
7.2.1 Analysis by Products
7.2.2 Analysis by Indications
7.2.3 Analysis by Route of Administration
8 Systemic Sclerosis Challenges and Unmet Needs
8.1 Treatment Pathway Challenges
8.2 Compliance and Drop-Out Analysis
8.3 Awareness and Prevention Gaps
9 Cost of Treatment
10 Systemic Sclerosis Market Dynamics
10.1 Market Drivers and Constraints
10.2 SWOT Analysis
10.3 Porter’s Five Forces Model
10.4 Key Demand Indicators
10.5 Key Price Indicators
10.6 Industry Events, Initiatives, and Trends
10.7 Value Chain Analysis
11 Systemic Sclerosis Market Segmentation – Seven Major Markets
11.1 Systemic Sclerosis Market by Diagnosis
11.1.1 Market Overview
11.1.2 Skin Biopsy
11.1.3 Imaging Techniques
11.1.4 Blood Test
11.1.5 Electrocardiogram
11.1.6 Pulmonary Function Test
11.2 Systemic Sclerosis Market by Type
11.2.1 Market Overview
11.2.2 Limited Systemic Sclerosis
11.2.3 Diffuse Systemic Sclerosis
11.2.4 Sine Systemic Sclerosis
11.3 Systemic Sclerosis Market by Drug Class
11.3.1 Market Overview
11.3.2 Immunosuppressors
11.3.3 PDE-5 Inhibitors
11.3.4 Endothelin Receptor Antagonist
11.3.5 Prostacyclin Analogues
11.3.6 Biologics
11.3.7 Others
11.4 Systemic Sclerosis Market by End User
11.4.1 Market Overview
11.4.2 Hospitals
11.4.3 Clinics
11.4.4 Research Institutes
11.4.5 Others
11.5 Systemic Sclerosis Market by Region
11.5.1 Market Overview
11.5.2 United States
11.5.3 EU-4 and the United Kingdom
11.5.3.1 Germany
11.5.3.2 France
11.5.3.3 Italy
11.5.3.4 Spain
11.5.3.5 United Kingdom
11.5.4 Japan
12 United States Systemic Sclerosis Market
12.1 Systemic Sclerosis Market Historical Value (2017-2023)
12.2 Systemic Sclerosis Market Forecast Value (2024-2032)
12.3 Systemic Sclerosis Market by Diagnosis
12.4 Systemic Sclerosis Market by Drug Class
13 EU-4 and United Kingdom Systemic Sclerosis Market
13.1 Systemic Sclerosis Market Historical Value (2017-2023)
13.2 Systemic Sclerosis Market Forecast Value (2024-2032)
13.3 Germany Systemic Sclerosis Market Overview
13.3.1 Systemic Sclerosis Market by Diagnosis
13.3.2 Systemic Sclerosis Market by Drug Class
13.4 France Systemic Sclerosis Market Overview
13.4.1 Systemic Sclerosis Market by Diagnosis
13.4.2 Systemic Sclerosis Market by Drug Class
13.5 Italy Systemic Sclerosis Market Overview
13.5.1 Systemic Sclerosis Market by Diagnosis
13.5.2 Systemic Sclerosis Market by Drug Class
13.6 Spain Systemic Sclerosis Market Overview
13.6.1 Systemic Sclerosis Market by Diagnosis
13.6.2 Systemic Sclerosis Market by Drug Class
13.7 United Kingdom Systemic Sclerosis Market Overview
13.7.1 Systemic Sclerosis Market by Diagnosis
13.7.2 Systemic Sclerosis Market by Drug Class
14 Japan Systemic Sclerosis Market
14.1 Systemic Sclerosis Market Historical Value (2017-2023)
14.2 Systemic Sclerosis Market Forecast Value (2024-2032)
14.2.1 Systemic Sclerosis Market by Diagnosis
14.2.2 Systemic Sclerosis Market by Drug Class
15 Patent Analysis
15.1 Analysis by Type of Patent
15.2 Analysis by Publication year
15.3 Analysis by Issuing Authority
15.4 Analysis by Patent Age
15.5 Analysis by CPC Analysis
15.6 Analysis by Patent Valuation
15.7 Analysis by Key Players
16 Grants Analysis
16.1 Analysis by year
16.2 Analysis by Amount Awarded
16.3 Analysis by Issuing Authority
16.4 Analysis by Grant Application
16.5 Analysis by Funding Institute
16.6 Analysis by NIH Departments
16.7 Analysis by Recipient Organization
17 Clinical Trials Analysis
17.1 Analysis by Trial Registration Year
17.2 Analysis by Trial Status
17.3 Analysis by Trial Phase
17.4 Analysis by Therapeutic Area
17.5 Analysis by Geography
18 Funding Analysis
18.1 Analysis by Funding Instances
18.2 Analysis by Type of Funding
18.3 Analysis by Funding Amount
18.4 Analysis by Leading Players
18.5 Analysis by Leading Investors
18.6 Analysis by Geography
19 Partnership and Collaborations Analysis
19.1 Analysis by Partnership Instances
19.2 Analysis by Type of Partnership
19.3 Analysis by Leading Players
19.4 Analysis by Geography
20 Supplier Landscape
20.1 F. Hoffmann La Roche Ltd.
20.1.1 Financial Analysis
20.1.2 Product Portfolio
20.1.3 Demographic Reach and Achievements
20.1.4 Mergers and Acquisition
20.1.5 Certifications
20.2 Johnson & Johnson Services
20.2.1 Financial Analysis
20.2.2 Product Portfolio
20.2.3 Demographic Reach and Achievements
20.2.4 Mergers and Acquisition
20.2.5 Certifications
20.3 United Therapeutics
20.3.1 Financial Analysis
20.3.2 Product Portfolio
20.3.3 Demographic Reach and Achievements
20.3.4 Mergers and Acquisition
20.3.5 Certifications
20.4 Boehringer Ingelheim International GmbH
20.4.1 Financial Analysis
20.4.2 Product Portfolio
20.4.3 Demographic Reach and Achievements
20.4.4 Mergers and Acquisition
20.4.5 Certifications
20.5 GlaxoSmithKline plc
20.5.1 Financial Analysis
20.5.2 Product Portfolio
20.5.3 Demographic Reach and Achievements
20.5.4 Mergers and Acquisition
20.5.5 Certifications
20.6 Pfizer
20.6.1 Financial Analysis
20.6.2 Product Portfolio
20.6.3 Demographic Reach and Achievements
20.6.4 Mergers and Acquisition
20.6.5 Certifications
20.7 Eli Lilly and Company
20.7.1 Financial Analysis
20.7.2 Product Portfolio
20.7.3 Demographic Reach and Achievements
20.7.4 Mergers and Acquisition
20.7.5 Certifications
20.8 Bayer AG
20.8.1 Financial Analysis
20.8.2 Product Portfolio
20.8.3 Demographic Reach and Achievements
20.8.4 Mergers and Acquisition
20.8.5 Certifications
20.9 Mylan N.V.
20.9.1 Financial Analysis
20.9.2 Product Portfolio
20.9.3 Demographic Reach and Achievements
20.9.4 Mergers and Acquisition
20.9.5 Certifications
20.10 Teva Pharmaceutical Industries Ltd.
20.10.1 Financial Analysis
20.10.2 Product Portfolio
20.10.3 Demographic Reach and Achievements
20.10.4 Mergers and Acquisition
20.10.5 Certifications
20.11 Gilead Sciences Inc.
20.11.1 Financial Analysis
20.11.2 Product Portfolio
20.11.3 Demographic Reach and Achievements
20.11.4 Mergers and Acquisition
20.11.5 Certifications
20.12 Novartis AG
20.12.1 Financial Analysis
20.12.2 Product Portfolio
20.12.3 Demographic Reach and Achievements
20.12.4 Mergers and Acquisition
20.12.5 Certifications
20.13 Cumberland Pharmaceuticals
20.13.1 Financial Analysis
20.13.2 Product Portfolio
20.13.3 Demographic Reach and Achievements
20.13.4 Mergers and Acquisition
20.13.5 Certifications
20.14 Organon LLC
20.14.1 Financial Analysis
20.14.2 Product Portfolio
20.14.3 Demographic Reach and Achievements
20.14.4 Mergers and Acquisition
20.14.5 Certifications
20.15 Lupin Ltd
20.15.1 Financial Analysis
20.15.2 Product Portfolio
20.15.3 Demographic Reach and Achievements
20.15.4 Mergers and Acquisition
20.15.5 Certifications
21 Systemic Sclerosis Market - Distribution Model (Additional Insight)
21.1 Overview
21.2 Potential Distributors
21.3 Key Parameters for Distribution Partner Assessment
22 Key Opinion Leaders (KOL) Insights (Additional Insight)
23 Company Competitiveness Analysis (Additional Insight)
23.1 Very Small Companies
23.2 Small Companies
23.3 Mid-Sized Companies
23.4 Large Companies
23.5 Very Large Companies
24 Payment Methods (Additional Insight)
24.1 Government Funded
24.2 Private Insurance
24.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
Key Questions Answered in the Report
The market is anticipated to grow at a CAGR of 6.3% during the forecast period of 2024-2032, driven by rising research and development efforts to provide effective therapeutic options to patients, along with increased emphasis on offering patient centric care.
The market demand is primarily driven by growing focus on developing alternate therapies that help patients with a wide spectrum of symptoms and addressing internal organ related complications.
The major market trend involves rising clinical trials and approvals to explore multiple therapeutic approaches including targeted therapies and immunosuppressive drugs. In October 2023, a new investigational drug called KYV-101 developed by Kyverna Therapeutics’ received application approval by the FDA for treating scleroderma.
The types of sclerosis can be divided into limited systemic sclerosis, diffuse systemic sclerosis, and sine systemic sclerosis.
Based on drug class, the market is divided into immunosuppressors, PDE-5 Inhibitors, endothelin receptor antagonist, and prostacyclin analogues, among others.
Major diagnosis methods include skin biopsy, imaging techniques, blood tests, electrocardiograms, and pulmonary function tests.
Major end users include hospitals, research institutes, and clinics, among others.
The major regions of the market include the United States, Japan, EU-4 which is segmented into Germany, France, Italy, Spain, and the United Kingdom.
Key players involved in the market are F. Hoffmann La Roche Ltd., Johnson & Johnson Services, United Therapeutics, Boehringer Ingelheim International GmbH, GlaxoSmithKline plc, Pfizer, Eli Lilly and Company, Bayer AG, Mylan N.V., Teva Pharmaceutical Industries Ltd., Gilead Sciences Inc, Novartis AG, Organon LLC, Lupin Ltd., and Cumberland Pharmaceuticals.
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