Scleroderma Therapeutics Market Size, Share & Trends Analysis Report By Drug Class (Immunosuppressors, ERA, CCBs, PA), By Indication (Systemic, Localized), By Region (North America, Europe), And Segment Forecasts, 2019 - 2026

Industry Insights

The global scleroderma therapeutics market size was valued at USD 1.60 billion in 2018 and is estimated to expand at a CAGR of 6.0% from 2019 to 2026. The market is mainly driven by the off-label use of drugs approved for its symptomatic indications, such as rheumatoid arthritis. Lack of curative therapies and high prevalence of off-label drug use are underlying factors spurring interest in rare disease markets.

This is expected to fuel the development of targeted biologics and small molecule combination therapies. Increasing prevalence of scleroderma and rising incidences of genetic mutations coupled with drastic changes in the environment are also expected to be the key factors driving the market. In addition, increasing disposable income levels, enabling a higher spending capacity, and the presence of a well-defined regulatory framework supporting the emergence of effective therapies in developed regions fuel the market growth.

The emergence of first-in-class curatives that are currently undergoing clinical development will also boost market growth over the forecast period. Furthermore, supplemental approvals for existing treatment options will reinforce growth.

Comorbidities associated with this disease account for the involvement of a wide range of drug classes prescribed in first- and second-line treatment of the condition. Among the indications, Pulmonary Arterial Hypertension (PAH) garnered the maximum sales. Medication for this comorbidity includes more than one drug class and several branded drugs. In addition, the two approved drugs in this market, bosentan, and iloprost are used to target PAH.

Drug Class Insights

On the basis of drug class, the market is segmented into immunosuppressors, Phosphodiesterase 5 Inhibitors - PHA, endothelin receptor antagonists, prostacyclin analogs, calcium channel blockers, analgesics, and others. Without a curative therapy for this disease, an expansive range of drug classes are prescribed to provide symptomatic relief. Immunosuppressants hold prominence as this class contains several biologics from established players such as Roche. Biologics and small molecule immunosuppressants are a growing segment with several pipeline drugs for scleroderma focusing on this class.

Novel therapies including Lenabasum and Ofev are expected to enter within the forecast period that is classed under ‘other drug classes’. PDE-5 inhibitors market by drug classes is facing headwinds due to the patent expiration of Revatio that bring down the revenue. ERAs remain in focus as this class of drugs mostly includes branded therapies and due to their use in the treatment of the indication with high incidence i.e. PAH.

Indication Insights

Based on indication, the scleroderma therapeutics market is categorized into localized and systemic scleroderma. The indications falling under systemic scleroderma include SSc-induced symptoms and conditions that range from interstitial lung disease to pulmonary arterial hypertension. Systemic indications account for the majority of share due to the use of high-priced immunosuppressants.

Localized scleroderma currently holds a small share in this market but is expected to grow over the forecast period with the expected launch of a first-in-class therapy, FCX-013 by Fibrocell. Fibrocell’s FCX-013 holds the orphan drug and fast track designation and if approved, it would be the first gene therapy for localized scleroderma. This treatment aims to arrest the fibrosis in the early stages of the disease. Lenabasum by Corbus Pharmaceuticals is the first oral therapy with high curative potential targeting diffuse cutaneous systemic sclerosis that is associated with a high burden of comorbidities.

Regional Insights

North America was the dominant regional market in 2018. Access to recently developed immunosuppressants coupled with favorable reimbursement scenario is the key revenue driver. Europe trails with a lower share as compared to the U.S. majorly due to higher use of generics and biosimilars for off-label treatment of scleroderma.

In developing regions, generics and OTC drugs are the mainstay therapy for scleroderma and its symptoms. The Japan market although experiencing price cuts has faster access to new orphan therapies. The expected increase in access to biosimilar and generic immunosuppressants will drive growth in Latin America and MEA regions.

Scleroderma Therapeutics Market Share Insights

Some of the key companies in the 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 fragmented with Roche leading with a commanding market position. Roche’s Cellcept, Actemra, Rituxan, and Esbriet drew the highest revenue in 2018. The underlying factor is a high preference for immunosuppressants in the treatment of scleroderma induced PAH and ILD. With the growth in penetration of this class of drugs and their improved efficacy in comparison to existing alternatives - cyclophosphamide, methotrexate, and mycophenolate mofetil - these therapies will reign until the launch of curatives that are undergoing clinical development.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2026. For the purpose of this study, Grand View Research has segmented the global scleroderma therapeutics market report on the basis of drug class, indication, and region:

• Drug Class Outlook (Revenue, USD Million, 2014 - 2026)

  • Immunosuppressors

  • Phosphodiesterase 5 Inhibitors - PHA

  • Endothelin Receptor Antagonists

  • Prostacyclin Analogues

  • Calcium Channel Blockers

  • Analgesics

  • Others

• Indication Outlook (Revenue, USD Million, 2014 - 2026)

  • Systemic

  • Localized

• Regional Outlook (Revenue, USD Million, 2014 - 2026)

  • North America

    • The U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Spain

    • France

    • Italy

  • Asia Pacific

    • China

    • Japan

    • India

    • Hong Kong

    • Singapore

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Qatar