본 보고서에서는 피부 석회화를 상세하게 조사하여 유병자 총수, 진단이 끝난 유병자 수, 유형별, 연령별, 성별, 치료별 사례 수 등 과거 및 장래의 역학 데이터를 제시하고 있습니다. 게다가, 환자 집단에 관한 다각적인 시점으로서 진단 프로세스, 처방 패턴, 의사의 견해, 시장 접근, 치료 옵션, 장래적인 시장 동향 등을 미국·EU4(독일, 프랑스, 이탈리아, 스페인)·영국·일본의 주요 7개 시장을 대상으로, 2020년부터 2034년까지의 기간으로 분석했습니다. 게다가 현행 치료실태와 미충족 요구를 상세하게 평가하여 시장의 잠재력과 새로운 사업 기회를 파악하고 있습니다.
DelveInsight's comprehensive report titled "Calcinosis Cutis - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of calcinosis cutis. The report presents historical and projected epidemiological data covering total prevalent cases, total diagnosed prevalent cases, type-specific cases, age-specific cases, gender-specific cases, treated cases of calcinosis cutis. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.
The report analyzes the existing treatment practices and unmet medical requirements in calcinosis cutis. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.
Calcinosis Cutis Overview
Calcinosis cutis is the abnormal deposition of calcium salts in the skin and subcutaneous tissue. It is classified into dystrophic, metastatic, iatrogenic, idiopathic, and calciphylaxis types, based on the underlying cause. Dystrophic calcinosis, the most common form, occurs in damaged tissue with normal calcium and phosphate levels and is associated with autoimmune diseases like systemic sclerosis, dermatomyositis, and lupus, as well as trauma, chronic inflammation, or tumors. Metastatic calcinosis results from elevated serum calcium or phosphate, often due to chronic kidney disease, hyperparathyroidism, hypervitaminosis D, or malignancy. Iatrogenic calcinosis arises from medical interventions such as calcium-containing infusions or repeated injections. In idiopathic cases, no clear cause is identified, as seen in conditions like scrotal calcinosis or subepidermal calcified nodules. The most severe form, calciphylaxis, occurs in end-stage renal disease and involves vascular calcification leading to painful skin necrosis.
Calcinosis Cutis Diagnosis and Treatment Algorithm
Diagnosis is based on clinical examination, imaging (X-ray, ultrasound, or CT), and skin biopsy confirming calcium deposits. Blood tests assess calcium, phosphate, parathyroid hormone, and renal function to determine the type and underlying cause. Differentiation from other calcifying skin conditions or infections is essential for proper management.
Treatment targets the underlying cause and severity. Options include managing autoimmune or metabolic disorders, using medications like diltiazem, bisphosphonates, or sodium thiosulfate (especially in calciphylaxis). Surgical excision may be considered for symptomatic or infected lesions. Supportive care with wound management and pain control is crucial, particularly in severe or ulcerated cases.
The epidemiology section of the calcinosis cutis market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.
This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of calcinosis cutis. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.
The calcinosis cutis therapeutics market is projected to grow steadily during the forecast period (2025-2034), driven by the rising prevalence of autoimmune and renal disorders, improved diagnostic awareness, emerging treatment options, and significant unmet clinical needs due to the lack of therapies.
Emerging calcinosis cutis Drugs
The calcinosis cutis market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as INZ-701 by Inozyme Pharma, among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.
INZ-701: Inozyme Pharma
INZ-701 is an ENPP1 enzyme replacement therapy (ERT) given as an injection under the skin (subcutaneous injection) that is designed to increase PPi and adenosine in the body to help improve or prevent symptoms of calciphylaxis.
In October 2024, Inozyme announced positive interim results from its Phase I SEAPORT 1 trial of INZ-701 in patients with ESKD on hemodialysis. INZ-701 significantly increased PPi levels and was well tolerated, low PPi levels are associated with calciphylaxis. Company plans to initiate a registrational trial in calciphylaxis in 2025 subject to regulatory alignment and sufficient funding.
Calcinosis Cutis Market Segmentation
DelveInsight's 'Calcinosis Cutis- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future calcinosis cutis market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.
Calcinosis Cutis Market Size by Countries
The calcinosis cutis market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) calcinosis cutis market. This dominance is projected to persist, especially with the potential introduction of new products.
Calcinosis Cutis Market Size by Therapies
Calcinosis cutis Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.
This section focuses on the sales uptake of potential calcinosis cutis drugs that have recently been launched or are anticipated to be launched in the calcinosis cutis market between 2020 and 2034. It estimates the market penetration of calcinosis cutis drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the calcinosis cutis market.
The emerging calcinosis cutis therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the calcinosis cutis market.
Calcinosis Cutis Market Access and Reimbursement
DelveInsight's 'Calcinosis Cutis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of calcinosis cutis.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
KOL Views
To keep up with current calcinosis cutis market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the calcinosis cutis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or calcinosis cutis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the calcinosis cutis unmet needs.
DelveInsight's analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of California, Johns Hopkins University, Massachusetts General Hospital, University of Barcelona, University of Naples Federico II, University Institute of Health Sciences Research, and University of Tokyo, Tohoku University, among others.
Competitive Intelligence Analysis
We conduct a Competitive and Market Intelligence analysis of the calcinosis cutis Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.
Calcinosis Cutis Pipeline Development Activities
The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for calcinosis cutis. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.
Pipeline Development Activities
The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging calcinosis cutis therapies.
Frequently Asked Questions
The primary treatment goals for calcinosis cutis are to reduce existing calcium deposits, prevent further progression, relieve symptoms such as pain and inflammation, and improve mobility and quality of life. Management also focuses on addressing underlying conditions like autoimmune or metabolic disorders to minimize recurrence and prevent complications such as ulceration or infection.
Management of calcinosis cutis is challenging due to the lack of approved treatments, limited efficacy of available options, and its association with complex underlying diseases. Pain, ulceration, and functional impairment, along with unpredictable progression, further complicate care.
The growth of the calcinosis cutis market is driven by the rising prevalence of autoimmune and metabolic disorders, such as systemic sclerosis and chronic kidney disease, which increase the at-risk population. Advancements in targeted therapies and procedural treatments are expanding therapeutic options, while improved disease awareness and diagnostic capabilities are leading to earlier detection and increased treatment demand.
The report will provide comprehensive insights into the current calcinosis cutis market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.