The global systemic scleroderma treatment market size was valued at USD 1.53 Bn in 2022 and is likely to reach USD 2.16 Bn by 2031, expanding at a CAGR of 3.9% during, 2023–2031. The market is driven by the supplemental approvals for a pre-existing treatment option and the emergence of first-in-class treatments.
Scleroderma is a skin disorder resulting from the frequent accumulation of scar tissue or fibrosis on the skin and other organs. Fibrosis is a condition of overproducing a protein called collagen, which can affect the skin and other organs without proper treatment. The condition can damage several internal organs such as kidneys, heart, and lungs due to malfunctioning effects. Systemic medications help to control disease activity or inflammation caused by the immune system.
Collagen makes up the body’s connective tissue, including the skin. Scleroderma is a result of cells producing collagen as if there is an injury that needs treatment. If this does not normalize, they generate excessive collagen. This disturbs the normal functioning of body organs, and skin can stretch, harden, and thicken. Scleroderma skin contains more amount of collagen and fibronectin than normal skin.
Diagnosis of scleroderma involves a blood test called antinuclear antibody (ANA) testing. A lab technician performs this particular test, placing a drop of blood on a slide and studying the cells using a fluorescent microscope.
Systemic types of sclerodermas are typically diagnosed between ages 30 and 50. Dermatologists sometimes perform a skin biopsy if someone has hard or thickened skin. Researchers are focusing on developing innovative methods and novel treatments to prevent or delay complications resulting from sclerodermas. For instance,
- In September 2020, Kadmon Holdings, Inc. announced that US Food and Drug Administration gave a nod to Belumosudil (KD025), an innovative drug designed to treat systemic sclerosis. It is a Rho-associated coiled-coil kinase 2 inhibitor and offers a dual mode of action to target fibrotic and immunological components.
- In 2021, Genentech announced that tocilizumab (Actemra) was approved by the US Food and Drug Administration (FDA), to treat scleroderma-induced interstitial lung disease. Tocilizumab is an IL-6 inhibitor, it blocks an inflammatory protein or “cytokine”. It is taken as an injection or as an infusion.
Immunosuppressants are highly used in the treatment of scleroderma-induced ILD and PAH. Mycophenolate mofetil, methotrexate, and cyclophosphamide are expected to be used in the treatment until the launch of curatives undergoing clinical development.
The market report finds that the COVID-19 pandemic affected the market. It hampered the supply chain, global business operations, and several industries. The pandemic has had a great impact on the healthcare and manufacturing industry.
In March 2021, as per the research study published by the Lancet Rheumatology Journal, a high prevalence of coronavirus was reported in patients suffering from systemic sclerosis-related interstitial lung involvement compared to those without it. The same study states that the risk of severe COVID-19 is high in patients suffering from systemic sclerosis.
Systemic Scleroderma Treatment Market Dynamics
Major Drivers
Rapid approval of new drugs and a robust drug pipeline is expected to boost the market in the coming years. In 2022, FDA permitted 37 new first-in-class and orphan drugs; in 2023, several new drug approvals are expected. In September 2019, USFDA and European Medical Agency approved Ofev (nintedanib) drug from Boehringer Ingelheim International.
This drug treats Systemic Sclerosis with Interstitial Lung Disease (SSc-ILD). Moreover, European Medical Agency also approved this drug in April 2020. New treatments based on ziritaxestat and nilotinib are anticipated to be launched soon to propel the market.
Existing Restraints
Current challenges in drug development and a lack of validated measures are anticipated to hinder market growth. One out of ten novel drugs passes clinical trial testing and regulatory approval.
Drug development for this disease faces challenges due to the failure of clinical trial results. For instance, in September 2020, Corbus Pharmaceuticals Holdings Inc. pipeline product Lenabasum failed to deliver the expected phase 2 clinical trial results. Furthermore, rising failures cases of previous treatment pose unique hurdles in drug development. This is projected to impede market expansion.
Emerging Opportunities
Successful commercialization of various medication classes and branded medications available for treating this skin disorder presents lucrative opportunities for market players. Pharmaceutical companies use various marketing strategies to highlight efficient drug candidates. Several companies successfully bring drugs to the market and have a strong pipeline.
Scope of Systemic Scleroderma Treatment Market Report
The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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Systemic Scleroderma Treatment Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2022
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Historic Data
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2016–2021
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Forecast Period
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2023–2031
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Segmentation
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Drug Class (Immunosuppressors, Phosphodiesterase 5 inhibitors - PHA, Endothelin Receptor Antagonists, Prostacyclin Analogues, Calcium Channel Blockers, and Others), Route of Administration (Oral and Parenteral), Disease Type (Diffused Systemic Sclerosis, Limited Systemic Sclerosis, and Systemic Sclerosis Sine Scleroderma), and Distribution Channel (Retail Pharmacies, Hospital Pharmacies, and Online Pharmacies)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast
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Key Players Covered in the Report
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F. Hoffmann La Roche Ltd.; Johnson & Johnson Services, Inc.; United Therapeutics; Boehringer Ingelheim International GmbH; GlaxoSmithKline plc; Pfizer, Inc.; Eli Lilly and Company; Bayer AG; Mylan N.V.; and Teva Pharmaceutical Industries Ltd.
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Systemic Scleroderma Treatment Market Segment Insights
Drug Class Segment Analysis
Based on drug class, the market is divided into immunosuppressors, phosphodiesterase 5 inhibitors, endothelin receptor antagonists, prostacyclin analogues, calcium channel blockers, and others.
The immunosuppressors segment is expected to hold a significant share of the market in the coming years, due to increasing product launches and approvals. Immunosuppressors are widely used at the time of organ and tissue transplantation. These drugs also treat autoimmune diseases.
Several immunosuppressors are prescribed for symptomatic relief, as there is no therapy for this disease. Several key players provide biologics in immunosuppressants which are anticipated to propel the segment. Small molecule immunosuppressors and biologics are evolving due to the rising focus of numerous pipeline drugs for treating systemic scleroderma with immunosuppressants.
The phosphodiesterase 5 inhibitors segment is projected to contribute to considerable revenue generation for the market. This drug class inhibits the action of phosphodiesterase type V and acts as a vasodilator. It is an enzyme that destroys cyclic guanosine monophosphate (cGMP) molecules. Thus, inhibitors prevent the breakdown of these useful molecules, resulting in increased blood flow in the damaged tissues. This factor is anticipated to fuel the segment.
Route of Administration Segment Analysis
On the basis of the route of administration, the market is segregated into oral and parenteral. The parenteral segment is anticipated to expand at a substantial CAGR during the forecast period, owing to the increasing number of novel drug formulations. Parenteral drugs easily absorb in the gastrointestinal tract, which is similar to oral drug administration. Furthermore, the high safety & efficacy, and ease of administration are likely to propel the segment.
The oral segment is expected to hold a significant market share, as it is a cost-effective, convenient, and commonly used method. This type of drug is majorly absorbed in the small intestine. The bioavailability of the drugs depends on the amount of drug absorbed through the intestinal epithelium. The drugs in this route of administration are applied in two ways: buccal (cheek) or sublingual (under the tongue). The medication in these processes undergoes diffusion across the venous blood in the oral cavity. The medication passes the hepatic portal vein and reaches to vena cava.
Disease Type Segment Analysis
In terms of disease type, the systemic scleroderma treatment market is segmented into diffused systemic sclerosis, limited systemic sclerosis, and systemic sclerosis sine scleroderma. The limited systemic sclerosis segment is projected to expand at a considerable CAGR during the forecast period. Sine scleroderma is another name for limited systemic sclerosis, which is characterized by Raynaud’s phenomenon.
Limited systemic sclerosis appears as accumulated cystic fibrosis (scar tissue) on organs but not on the skin. This fibrosis affects organs such as the heart, esophagus, kidneys, and lungs. The effect of fibrosis on internal organs is indicated by difficulty swallowing (dysphagia), heartburn, high blood pressure, diarrhea, kidney problems, and intestinal pseudo-obstruction (disability of muscles to move food forward in the digestive tract).
The diffused systemic sclerosis segment is anticipated to account for a major market share during the forecast period. It is caused by the improper functioning of numerous organs and skin accumulation (fibrosis).
Some of the indications and symptoms of this disease type are Raynaud's phenomenon, telangiectasias (spider veins) on the face, thorax, fingers, and lips; formation of noticeable fibrosis on the tips of fingers, and on the face; and gastroesophageal reflux. Some conditions commonly observed in diffused systemic sclerosis disease are diarrhea, vomiting, weight loss, kidney & lung dysfunction, muscular & joint pain (arthralgias), and dental issues.
Distribution Channel Segment Analysis
Based on distribution channel, the market is segmented into retail pharmacies, hospital pharmacies, and online pharmacies. The hospital pharmacies segment is projected to register a major market share in the coming years.
Systemic sclerosis treatment is employed in hospitals and pharmacies for treating patients with uncontrolled autoimmune disorders, including lupus erythematosus, rheumatoid arthritis, and systemic sclerosis. The online pharmacies segment is anticipated to hold a key market share due to the rising penetration of the internet across the globe.
Regional Analysis
In terms of region, the global systemic scleroderma treatment market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa.
North America is expected to dominate the market during the forecast period, due to the rising R&D investments for improving healthcare operations by various small & medium enterprises (SMEs). The government of the U.S. has a lower tax credit which increases the demand for the market in the region. The rising geriatric population in the region is expected to boost the market in the coming years.
The market in the Asia Pacific is anticipated to expand rapidly during the forecast period, due to rising demand for drug delivery systems, catheters and cannulas, and equipment used for systemic scleroderma treatment. Moreover, the rising demand for minimally invasive medical procedures and an increasing healthcare accessibility rate drive the regional market. The region has innovative manufacturing techniques for efficient medical devices.
Segments
The global systemic scleroderma treatment market has been segmented on the basis of
Drug Class
- Immunosuppressors
- Phosphodiesterase 5 inhibitors - PHA
- Endothelin Receptor Antagonists
- Prostacyclin Analogues
- Calcium Channel Blockers
- Others
Route of Administration
Disease Type
- Diffused Systemic Sclerosis
- Limited Systemic Sclerosis
- Systemic Sclerosis Sine Scleroderma
Distribution Channel
- Retail Pharmacies
- Hospital Pharmacies
- Online Pharmacies
Region
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
Competitive Landscape
Key players competing in the global systemic scleroderma treatment market are F. Hoffmann La Roche Ltd.; Johnson & Johnson Services, Inc.; United Therapeutics; Boehringer Ingelheim International GmbH; GlaxoSmithKline plc; Pfizer, Inc.; Eli Lilly and Company; Bayer AG; Mylan N.V.; and Teva Pharmaceutical Industries Ltd.
The market for systemic scleroderma treatment has wider opportunities for expansion while fulfilling various unmet medical needs. Mergers and acquisitions, as well as partnership strategies, are also being used by pharmaceutical corporations to gain a greater global market share.
- In 2017, Janssen Pharmaceutical, a division of Johnson & Johnson Services, Inc., completed the acquisition of Actelion Pharmaceuticals Ltd., making it the leading player in the pulmonary hypertension market.
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