Scleroderma Diagnostics & Therapeutics Market - Forecast(2025 - 2031)

Scleroderma Diagnostics & Therapeutics Market Overview

Scleroderma Diagnostics & Therapeutics Market Size is estimated to reach $5085.4 Million by 2030, and it is poised to grow at a CAGR of 10.2% over the forecast period of 2024-2030.

Scleroderma is a long-lasting disease that affects skin, connective tissue and internal organs. It occurs when the body produces an excessive amount of the protein collagen. Internal organs like the blood vessels, heart, lungs, stomach and kidneys may sustain an injury with this disease. Scleroderma is most prevalent in women than in males. Scleroderma comes in a variety of forms with varying degrees of severity. While some varieties can result in serious and life-threatening issues, others are rather moderate and may eventually improve on their own. As per the National Health Service of the United Kingdom, Scleroderma is categorized mainly into two types, localized scleroderma and systemic sclerosis. Scleroderma is diagnosed by using antibodies tests/blood tests, capillaroscopy, cardiac diagnosis, gastrointestinal diagnosis, imaging, pulmonary diagnosis, skin viscoelasticity and general. And for treatment corticosteroids, immunosuppressive agents, endothelin receptor antagonists, calcium channel blockers, PDE-5 inhibitors, chelating agents, prostacyclin analogs and other types of drugs are used.

Scleroderma is a chronic disease and to diagnose and treat such type of disease various key market players focus on research and development for new products launched in the market. For instance, in April 2022, aTyr Pharma announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for its lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis. Such innovative products are available in the market and the high demand for diagnosis and treatment of Scleroderma disease fuel the growth of the Scleroderma Diagnostics & Therapeutics industry over the forecast period 2024-2030.

Scleroderma Diagnostics & Therapeutics Market Report Coverage

The report: “Scleroderma Diagnostics & Therapeutics Market Forecast (2024-2030)" by Industry ARC, covers an in-depth analysis of the following segments in the Scleroderma Diagnostics & Therapeutics Market.

Key Takeaways

• Geographically, North America held a dominant market share in the year 2021, owing to the high expenditure on healthcare services and good healthcare infrastructure for research and developments of new drugs and diagnostic techniques fuel the growth of the Scleroderma Diagnostics & Therapeutics Market Size.
• The Scleroderma Diagnostics & Therapeutics Market is predicted to increase owing to the increasing cases of genetic mutations and sudden drastic changes in the environment.
• However, the stringent government regulation, adverse effects of drugs and high cost of healthcare services may limit the growth of the Scleroderma Diagnostics & Therapeutics Market over the forecast period 2024-2030.
• A detailed analysis of strengths, weaknesses, opportunities and threats will be provided in the Scleroderma Diagnostics & Therapeutics Market Report.

Scleroderma Diagnostics & Therapeutics Market: Market Share (%) by region, 2021

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Scleroderma Diagnostics & Therapeutics Market Segment Analysis - by Type

Scleroderma Diagnostics & Therapeutics Market based on type can be further segmented into Systemic and Localised. The Systemic segment held a dominant market share in the year 2021. This is owing to the impact of systemic sclerosis on the skin, joints and internal organs, especially the esophagus, lower gastrointestinal tract, lungs, heart and kidneys. It is also linked with Interstitial lung disease (ILD) and is one of the leading causes of mortality in patients. The reported prevalence of systemic sclerosis was 7.2–33.9 and 13.5–44.3 per 100,000 individuals in Europe and North America as per a research published by National Center for Biotechnology Information (NCBI), in 2019. Such a high risk of mortality creates the need for Scleroderma Diagnostics & Therapeutics and fuels the growth of the Scleroderma Diagnostics & Therapeutics Market Share.

However, the Localised segment is estimated to grow with the fastest CAGR of 10.7% over the forecast period 2022-2027. This is owing to the thickening of the skin from localized scleroderma. According to the American College of Rheumatology, there is 75,000 to 100,000 people in the U.S., suffered from this disease in 2021. Owing to such a high prevalence, the demand for corticosteroids, immunosuppressive agents, endothelin receptor antagonists, calcium channel blockers, chelating agents, prostacyclin analogs and other medications surged in recent years. Also, it creates demand for diagnostic services for the detection of Scleroderma. Such growing demand for Scleroderma diagnosis and therapeutics propel the growth of the Scleroderma Diagnostics & Therapeutics Market Share over the forecast period 2024-2030.

Scleroderma Diagnostics & Therapeutics Market Segment Analysis - by Drugs

Scleroderma Diagnostics & Therapeutics Market based on the drugs can be further segmented into Corticosteroids, Immunosuppressive Agents, Endothelin Receptor Antagonists, Calcium Channel Blockers, PDE-5 Inhibitors, Chelating Agents, Prostacyclin Analogues and Others. The Immunosuppressive Agents segment held a dominant market share in the year 2021. Scleroderma disease is linked with the immune system in which the body's immune system is attacked by connective tissue. Immunosuppressants help to reduce symptoms of scleroderma. Hence the demand for immunosuppressant for the treatment of Scleroderma disease is increasing which drive the growth of the Scleroderma Diagnostics & Therapeutics Market Share.

However, PDE-5 Inhibitors are estimated to grow with the fastest CAGR rate of 11.3% over the forecast period 2022-2027. A phosphodiesterase type 5 inhibitor is a vasodilating drug and plays an important role in smooth muscle cells lining the blood vessels supplying various tissues. It is used as the first line of treatment for Systemic sclerosis. Also, they are used as an alternative to calcium channel blockers and can be taken orally. Such functions of PDE-5 inhibitors surge demand for treatment of scleroderma disease and fuel growth of the Scleroderma Diagnostics & Therapeutics Market Share over the forecast period 2024-2030.

Scleroderma Diagnostics & Therapeutics Market Segment Analysis - by Geography

The Scleroderma Diagnostics & Therapeutics Market based on Geography can be further segmented into North America, Europe, Asia-Pacific, South America and the Rest of the World. North America held a dominant market share of 34% in the year 2021. This is the result of developed healthcare facilities and a high number of diagnostics facilities available in this region. According to a Medscape article published in June 2020, in the United States, there are 20 cases per million population and its prevalence has been estimated at 276 cases per million population. Such growing cases of Scleroderma Disease and high healthcare and diagnostics facilities available in this region drive growth of the Scleroderma Diagnostics & Therapeutics Market Size.

Furthermore, Europe is estimated to grow with the fastest CAGR over the forecast period 2024-2030. This is owing to an increase in the prevalence of Scleroderma disease in European countries. According to research paper findings published in Oxford Academic in July 2021, it is found from 24 studies (30 independent populations) varying in size, design and case definition in Europe, the prevalence of Scleroderma disease is 14.8 per 100000. Also, according to European Respiratory Journal, SSc is associated with a 250% increase in mortality risk compared with healthy controls in the year 2020. Such a high prevalence of Scleroderma disease and high mortality rate create demand for diagnostics and therapeutics services in this region fueling the growth of the Scleroderma Diagnostics & Therapeutics Market Size over the forecast period 2024-2030.

Scleroderma Diagnostics & Therapeutics Market Drivers:

Innovative Treatment and Therapies Introduced by Developed Region Drive Market Growth.

Scleroderma is a chronic and rare disease and to diagnose various effective treatments are used nowadays. The increase in healthcare expenditure in developed countries create a favorable market for research and development and to evolve new drug, treatment, or diagnostic procedure to fight against such life-threatening disease. A study led by Michigan Medicine from 2011 to 2020, found that in the United States a rare form of scleroderma has a greater chance of dying from related kidney, heart and lung problems, despite taking medications used to treat most patients with the disease. According to a research paper published by BMC Advance in Rheumatology in March 2022, from the study of total of 7,857 patients with systemic sclerosis (SSc) and 1140 patients with SSc-associated pulmonary hypertension (PH), Patients with SSc-associated PH had a higher pooled risk of mortality than patients with SSc without PH. To fight such a disease global key market players research and developed a number of therapies and medicines. For instance, in March 2021, Genentech, a member of the Roche Group developed get approval for the first biologic therapy ‘Actemra’ which helps to reduce the rate of progressive loss of lung function in people with SSc-ILD compared to placebo. Such a growing number of research in scleroderma drugs and therapies drive the growth of the Scleroderma Diagnostics & Therapeutics Industry over the forecast period 2024-2030.

Growing Prevalence of Scleroderma is Driving the Market Growth.

Scleroderma has a growing prevalence in developed and developing countries. This affects more than 75,000 to 100,000 persons in the United States in 2021, according to the University of Michigan Health. According to National Center for Biotechnology Information (NCBI), from 1,774 prevalent cases, with a median age of 65 years and 84% of women, the prevalence of scleroderma is 22.7 per 100,00. Such a growing prevalence of scleroderma disease create demand for various treatment such as corticosteroids, immunosuppressive agents, endothelin receptor antagonists, calcium channel blockers, chelating agents and prostacyclin analogs. Such growing demands for scleroderma treatment and the growing prevalence of scleroderma disease drive the growth of the Scleroderma Diagnostics & Therapeutics Industry over the forecast period 2024-2030.

Scleroderma Diagnostics & Therapeutics Market Challenges

High Cost Associated with Scleroderma Diagnostic and Treatment is Hampering the Market Growth

Scleroderma is a life-threatening disease without proper diagnosis and medication. The diagnosis of scleroderma disease includes various tests such as antibodies tests/blood tests, capillaroscopy, cardiac diagnosis, gastrointestinal diagnosis, imaging, pulmonary diagnosis, skin viscoelasticity, & general. And for treatment, various therapy and drugs are used like corticosteroids, immunosuppressive agents, endothelin receptor antagonists, calcium channel blockers, PDE-5 inhibitors, chelating agents, prostacyclin analogs and others. Such diagnosis treatment and medication require high costs which can’t be afforded by the middle-income group. According to a research paper published in National Center for Biotechnology Information (NCBI) in February 2022, the direct cost for treatment of scleroderma disease is varied from $3,356 (Hungary) to $27,032 (Germany) with hospitalization and medication & the indirect costs for lost productivity varied from $2,433 (Italy) to $20,663 (UK). Such a high cost for scleroderma disease may hamper Scleroderma Diagnostics & Therapeutics Industry over the forecast period 2024-2030.

Scleroderma Diagnostics and Therapeutics Industry Outlook

Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the Scleroderma Diagnostics & Therapeutics Market. The top 10 companies in the Scleroderma Diagnostics & Therapeutics Market are:

1. Actelion Pharmaceuticals Inc.
2. MitogenDx
3. Pfizer Inc.
4. Merck KGaA
5. Cumberland Pharmaceuticals Inc.
6. Gilead Sciences Inc.
7. Bayer AG
8. Active Biotech AB
9. BioLineRx Ltd.
10. Bristol-Myers Squibb Company

Recent Developments

• In July 2022, Boehringer Ingelheim, a leading research-driven biopharmaceutical company, the life science company Evotec SE and bioMérieux, a world leader in in vitro diagnostics, announced a joint venture to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance (AMR). Aurobac Therapeutics SAS will combine the best capabilities of the three founding companies towards developing a new precision medicine approach, from diagnosis to cure.

• In April 2022, Bayer announced an agreement to acquire Ginkgo Bioworks to create Ag Biologicals Powerhouse. Ginkgo Bioworks will become a multi-year microbial strategic partner with Bayer in their work to develop biological solutions in fields like nitrogen optimization, carbon sequestration and next-generation crop protection.

• In January 2022, Cumberland Pharmaceuticals Inc. a specialty pharmaceutical company announced to enter into a definitive agreement to acquire the FDA-approved oncology-supportive care medicine SANCUSO, from Kyowa Kirin, Inc. the U.S. affiliate of Japan-based Kyowa Kirin Co., Ltd. a global specialty pharmaceutical company focused on discovering and delivering novel medicines.

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