Scleroderma Therapeutics Market by Drug Class (Immunosuppressor, Phosphodiesterase 5 Inhibitors – PHA, Endothelin Receptor Antagonists, Prostacyclin Analogues, Calcium Channel Blockers, Analgesics, and Others), Indication (Systemic and Localized), and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

The global scleroderma therapeutics market size is anticipated to register a substantial CAGR during the forecast period, 2021–2028. The growth of the market is attributed to the Off-label usage of medications approved for symptomatic indications, such as rheumatoid arthritis.

Scleroderma is an autoimmune illness in which normal tissue is replaced with dense, thick fibrous tissue. It is a chronic, although rare, condition. The immune system normally aids in the body's defense against sickness and illness. The immune system in scleroderma patients causes other cells to create too much collagen (a protein). This excess collagen builds up in the skin and organs, causing thickness and hardness (similar to the scarring process). Scleroderma along with skin can damage the gastrointestinal tract, lungs, kidneys, heart, blood vessels, muscles, and joints. Scleroderma can be life threatening in its most severe forms. Scleroderma is divided into two types: localized and systemic. Diffuse and limited scleroderma are the two basic kinds of systemic scleroderma. Scleroderma is divided into two types localized and systemic. Systemic scleroderma is further classified as diffuse and limited scleroderma.

Scleroderma's actual cause is uncertain. Scleroderma can run in families, though this is uncommon. In the vast majority of instances, there is no evidence of a family history of the condition. Scleroderma is a not contagious disease. Scleroderma can be difficult to diagnose. Scleroderma is sometimes misdiagnosed as rheumatoid arthritis or lupus because it can affect other regions of the body, such as the joints. The medical professional will first conduct a thorough physical examination. Tests will be performed if scleroderma is suspected, both to confirm the diagnosis and to establish the severity of the condition. The test includes blood tests, pulmonary function tests, electrocardiogram, echocardiogram, gastrointestinal tests, and kidney function.

Market Trends, Drivers, Restraints, and Opportunities

• Lack of effective medicines and a high rate of off-label drug usage is expected to boost the market growth during the forecast period.
• Increase in the prevalence of scleroderma and an increase in the incidence of genetic alterations, as well as drastic environmental changes are projected to drive the market growth in the coming years.
• Increasing awareness regarding preventive healthcare is anticipated to push the market growth during the forecast period.
• Increasing disposable income, increase expenditure on healthcare are projected to boost the market growth during the market period.
• Increasing initiatives by government for spreading the awareness regarding scleroderma treatment is expected to drive the market growth during the forecast period.
• Stringent regulations by government, high cost of treatment, and adverse side effects related to drugs are key factors that can challenges that can hamper the market growth during the market during the forecast period.
• Increased emphasis on R&D in the field of scleroderma diagnosis and therapeutics is estimated to offer lucrative opportunities for the market players.

Scope of the Report

The report on the global scleroderma therapeutics market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Immunosuppressants segment is expected to account for a key share of the market
Based on drug class, the scleroderma therapeutics market is segmented into immunosuppressor, phosphodiesterase 5 inhibitors – PHA, endothelin receptor antagonists, prostacyclin analogues, calcium channel blockers, analgesics, and others. The immunosuppressants segment is expected to account for a key share of the market during the forecast period owing to prevalence of various biologics from major players such as Roche. Biologics and small molecule immunosuppressants are becoming more prevalent, with several scleroderma pipeline medicines focused on this class.

On the other hand, the endothelin receptor antagonists segment is anticipated to expand at a rapid pace during the forecast period owing to its increased adoption.

Systemic segment is expected to constitute a key share of the market
Based on indication, the scleroderma therapeutics market is bifurcated into systemic and localized. The systemic segment is expected to constitute a key share of the market during the forecast period due increased usage of high-priced immunosuppressants. SSc-induced symptoms and disorders such as interstitial lung disease and pulmonary arterial hypertension fall within the category of systemic scleroderma indications.

On the other hand, the localized segment is anticipated to expand at a rapid pace during the forecast period due to expected launch of some effective therapies. Therapies such as FCX-013 by Fibrocell, Fibrocell's FCX-013 is an orphan medicine with a fast-track classification, making it the first gene therapy for localized scleroderma if authorized. The goal of this treatment is to stop fibrosis in its early phases. Corbus Pharmaceuticals' Lenabasum is the first oral medication with a high cure rate for diffuse cutaneous systemic sclerosis, which is associated with a significant comorbidity burden.

North America is anticipated to dominate the market
On the basis of regions, the scleroderma therapeutics market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is anticipated to dominate the market at an impressive CAGR during the forecast period. The regional market growth can be attributed to newly developed immunosuppressants combined with a good reimbursement policy.

Europe lags behind the US in terms of market share, owing to a higher use of generics and biosimilars for off-label scleroderma treatment. Generic and over-the-counter medications constitute the major therapy for scleroderma and related symptoms in developing countries. Despite price decreases, the Japan market has easier access to innovative orphan medicines.

Segments

• Immunosuppressor
• Phosphodiesterase 5 Inhibitors - PHA
• Endothelin Receptor Antagonists
• Prostacyclin Analogues
• Calcium Channel Blockers
• Analgesics
• Others

• Systemic
• Localized

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

• F. Hoffman La-Roche Ltd.
• Bristol-Myers Squibb Company
• Celgene Corp.
• arGentis Pharmaceuticals, LLC
• Bayer AG
• Boehringer Ingelheim International GmbH
• Akashi Therapeutics
• Prometic Life Sciences, Inc.
• Emerald Health Pharmaceuticals
• Kadmon Holdings, Inc.
• Seattle Genetics, Inc.
• Cytori Therapeutics, Inc.
• Fibrocell Science, Inc.
• Chemomab
• Corbus Pharmaceuticals Holdings, Inc.
• Genkyotex

Competitive Landscape

Key players competing in the scleroderma therapeutics market are F. Hoffman La-Roche Ltd.; Bristol-Myers Squibb Company; Celgene Corp.; arGentis Pharmaceuticals, LLC; Bayer AG; Boehringer Ingelheim International GmbH; Akashi Therapeutics; Prometic Life Sciences, Inc.; Emerald Health Pharmaceuticals; Kadmon Holdings, Inc.; Seattle Genetics, Inc.; Cytori Therapeutics, Inc.; Fibrocell Science, Inc.; Chemomab; Corbus Pharmaceuticals Holdings, Inc.; and Genkyotex.

The market is highly competitive, with Roche leading the way with a strong market dominance. In 2018, Roche's Cellcept, Actemra, Rituxan, and Esbriet generated the majority of revenue. The main reason for this is a strong preference of immunosuppressants in the treatment of PAH and ILD caused by scleroderma. Due to the increased penetration of this class of medications and their superior efficacy over existing options such as cyclophosphamide, methotrexate, and mycophenolate mofetil, these therapies will reign until the introduction of curatives in clinical trials.