Scleroderma Diagnostics and Therapeutics Market Size, Share, Growth Report 2032

Industry Prospective:

The global scleroderma diagnostics and therapeutics market was approximately USD 2232.5 million in 2021 and is anticipated to reach nearly USD 4127.6 million by 2028, with a compound annual growth rate (CAGR) of about 9.2 percent over the forecast period. The report studies the scleroderma diagnostics and therapeutics market’s drivers, restraints/challenges, and the consequence they have on the demands during the projection period. In addition, the report sightsees evolving opportunities in the scleroderma diagnostics and therapeutics market.

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Scleroderma Diagnostics and Therapeutics Market: Overview

Scleroderma is an autoimmune disease wherein healthy tissue is substituted with thick, dense, fibrous tissue. It is a chronic, albeit rare, condition. The immune system normally aids in the body's defense against sickness and infection. The immune system in scleroderma patients causes other cells to create excessive collagen. This excess collagen builds up in the organs and skin, causing hardness and thickness similar to the process of scarring. While scleroderma has no cure, therapy can help to alleviate symptoms, reduce progression, and enhance the quality of life. Scleroderma can impact several other body parts, such as the gastrointestinal system, joints, muscles, blood vessels, kidneys, and lungs, in addition to the skin. Scleroderma can be life-threatening in its most severe forms.

COVID-19 Impact:

The global scleroderma diagnostics and therapeutics market witnessed low to moderate impact during the Covid-19 pandemic. Initially, in the first half of the year 2020, owing to strict regulations of government and an increase in focus on Covid patients, a decline in the growth of the market was observed. Also, a decrease in the number of scleroderma patient visits, as well as a halt in clinical trials, limited the market growth. However, the market bounced back with ease in regulations and all the operations of key players were back on track. The growth is also expected to grow at a healthy rate during the forecast period.

Scleroderma Diagnostics and Therapeutics Market: Growth Drivers

Growing prevalence of scleroderma is fostering the growth of the market.

In developed as well as developing countries, the prevalence of scleroderma is growing at a rapid rate. This condition affects between 75,000 to 100,000 persons in the United States, the majority of whom are females between the ages of 30 to 50. Twins and family members of people with scleroderma or even other autoimmune connective tissue illnesses like lupus are at an increased risk of developing the condition. Scleroderma can affect children, although the condition affects them differently than it does adults. Such a huge burden of disease has led to increase in awareness and need for diagnosis of the disease. This is ultimately driving the market growth. In addition to this, favorable reimbursement policies, well-developed health infrastructure, and growing necessity for developed diagnostic techniques are some of the key factors that are boosting the growth of the market for scleroderma diagnostics and therapeutics.

Scleroderma Diagnostics and Therapeutics Market: Restraints

High cost associated with scleroderma diagnostic and treatment is likely to hamper the market growth.

The multi-organ nature of systemic sclerosis necessitates long-term monitoring and a variety of approaches to patient management. As a result, it's no surprise that systemic sclerosis is one of the most expensive rheumatic illnesses, with patients using more healthcare dollars per year than their age and sex-matched colleagues with inflammatory myopathies, and psoriatic arthritis, and/or RA. Additionally, some of the direct costs for patients with systemic sclerosis include acute-care hospitalization, assistive devices, medications, diagnostic tests as well as visits to healthcare professionals. Thus, the financial cost of systemic sclerosis is substantial, and disease & health conditions have a significant influence on the economic burden thereby impeding the growth of the global scleroderma diagnostics and therapeutics market. In addition to this, factors such as low penetration of the market in underdeveloped countries, adverse effects associated with the drugs, and low spending power in rural areas are also hampering the market growth.

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Scleroderma Diagnostics and Therapeutics Market: Opportunities

Growing focus on development of innovative methods is estimated to drive the market during the forecast period.

Systemic sclerosis is a multifaceted autoimmune disease with a wide range of symptoms and degrees of internal organ damage. All consequences have a substantial influence on the patient's quality of life as well as morbidity and death rates. As a result, there is a growing interest in novel ways of assessing, diagnosing, and monitoring organ involvement. In addition to this, there is an increase in investment in R&D activities by major players for the development of new and effective treatments. Major players are also focusing on the completion of clinical trials for the drugs and looking forward to the approval of the drug for the treatment of scleroderma. All such factors coupled with technological advancements including the implementation of artificial intelligence and internet of things in the field of medical devices are anticipated to generate numerous opportunities for the growth of the global scleroderma diagnostics and therapeutics market during the forecast period.

Report Scope:

Scleroderma Diagnostics and Therapeutics Market: Challenges.

Strict regulations for the approval of drugs and diagnostic devices for scleroderma may act as a challenge to the market growth

By far there are very less approved drugs for the treatment of scleroderma. Scleroderma is a rare disease and its diagnosis is also challenging. The vague clinical presentation of scleroderma might make diagnosis difficult, resulting in a delayed diagnosis. This also interferes in the development of drugs that can be effectively used to treat the disease. The lack of sufficient data on the efficacy and safety of the drugs leads to the failure of clinical trials. The regulatory bodies across different countries have imposed strict regulations for the approval of drugs and diagnostic devices in order to have appropriate diagnosis and treatment of the disease. This may act as a major challenge to the growth of the market.

Scleroderma Diagnostics and Therapeutics Market: Segmentation

The global scleroderma diagnostic and therapeutics market is categorized based on diagnostic test type, indication, drug class, and region. The diagnostic test type segment comprises blood tests, imaging techniques, skin biopsy, pulmonary function tests, and electrocardiogram & echocardiogram. Based on the indication, the global market is bifurcated into systemic scleroderma and localized scleroderma. The drug class segment is classified into prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase 5 inhibitors – PHA, immunosuppressors, analgesics, calcium channel blockers, and others.

Recent Developments

• In March 2021, Roche received approval for Actemra®/RoActemra® (tocilizumab) subcutaneous injection from the US Food and Drug Administration (FDA) for decreasing the rate of drop in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a chronic condition with few treatment options. The FDA has approved Actemra/RoActemra as the first biologic medication for the treatment of the condition.
• In April 2020, Boehringer Ingelheim received approval from the European Commission for nintedanib for the treatment of people with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Scleroderma Diagnostics and Therapeutics Market: Regional Landscape

North America is estimated to rule the market for scleroderma diagnostics and therapeutics

Among the regions, North America is expected to dominate the global scleroderma diagnostics and therapeutics market. Major factors such as favorable reimbursement policies, heavy investment in R&D and drug development, and well-established healthcare infrastructure are boosting the growth of the market in this region. Additionally, the growing prevalence of the disease and technological advancement in the field of medical devices are also propelling the growth of the market in this region. Europe is anticipated to hold the second-most position in the market owing to an increase in initiatives and proactive awareness regarding the diagnostics for scleroderma. On the other hand, the market in Asia Pacific is likely to grow at the highest CAGR during the forecast period. This is majorly due to the wide and easy availability of generic & biosimilar immunosuppressants for the treatment of scleroderma.

Scleroderma Diagnostics and Therapeutics Market: Competitive Landscape

Bayer AG; Boehringer Ingelheim International GmbH, arGentis Pharmaceuticals, LLC, Celgene Corp., Bristol-Myers Squibb Company, F. Hoffman La-Roche Ltd., Corbus Pharmaceuticals Holdings, Seattle Genetics, Inc., Kadmon Holdings, Inc., Emerald Health Pharmaceuticals, and Prometic Life Sciences, Inc. are some of the major players that are successfully operating in the global scleroderma diagnostics and therapeutics market.

Global scleroderma diagnostics and therapeutics market is segmented as follows:

By Diagnostic Test Type

• Blood Tests
• Imaging Techniques
• Skin Biopsy
• Pulmonary Function Tests
• Electrocardiogram & Echocardiogram

By Indication

• Systemic Scleroderma
• Localized Scleroderma

By Drug Class

• Prostacyclin Analogues
• Endothelin Receptor Antagonists
• Phosphodiesterase 5 Inhibitors – PHA
• Immunosuppressors
• Analgesics
• Calcium Channel Blockers
• Others

By Region

• North America
  • The U.S.
  • Canada
• Europe
  • France 
  • The UK
  • Spain
  • Germany
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa