Calciphylaxis Market Size, Share & Trends Analysis Report By Type (Non-uremic calciphylaxis, Ulcers and wounds, Debridement of wounds), By Treatment (Drug Therapy, Hyperbaric Oxygen Therapy), By End-Use (Hospital and Clinics, Homecare, Ambulatory Centers), By Diagnostics (Skin Biopsy, Lab Testing, Imaging ) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global calciphylaxis market size was valued at USD 5.9 billion in 2022 and is projected to reach USD 16.4 billion by 2031, registering a CAGR of 12.1% during the forecast period (2023-2031). The increasing prevalence of cardiovascular calcification in patients with end-stage renal illness is a primary driver of the calciphylaxis market growth.

Calciphylaxis, also known as calcific uremic arteriolopathy (CUA), is an uncommon and deadly medical illness characterized by calcification of tiny and medium-sized blood arteries, which occurs mostly in people with end-stage renal disease (ESRD) or kidney dysfunction. This disorder causes painful skin sores tissue necrosis, and can be fatal due to the possibility of sepsis and organ failure.

Kidney illness, hyperparathyroidism, and malfunction in the control of calcium and phosphorous metabolism boost the Calciphylaxis market share. Furthermore, as the population ages, the prevalence of diabetes and hypertension illnesses rises year after year, and so do the potential patients for the Calciphylaxis market.

Market Dynamics

Global Calciphylaxis Market Drivers:

Rising Incidence of End-Stage Renal Disease (ESRD)

The rising prevalence of ESRD, which is commonly caused by conditions such as diabetes, hypertension, and aging populations, is a major driver of the calciphylaxis industry. Patients with ESRD are more likely to develop calciphylaxis, resulting in an increasing patient pool. Diabetes is the primary cause of end-stage renal disease in the United States. According to the Centers for Disease Control and Prevention (CDC), about 37.3 million persons in the United States had diabetes as of 2022. ESRD is a potentially fatal consequence of uncontrolled diabetes that frequently requires dialysis or kidney transplantation.

According to the Pan American Health Organization, the age-standardized death rate from kidney illnesses is expected to be 15.6 deaths per 100,000 people in 2022, a forerunner to ESRD. Furthermore, according to the United States Renal Data System (USRDS), the number of ESRD patients in the United States has been gradually increasing, with over 800,000 people getting dialysis or living with a kidney transplant in recent years. Hence, The Calciphylaxis market trend is projected to evolve as the number of ESRD cases continues to rise during the forecast period.

Global Calciphylaxis Market Restraints:

Treatment Cost

Effective calciphylaxis treatment can be costly, especially when therapies such as sodium thiosulfate or hyperbaric oxygen treatment are considered. Some patients may have limited access to these treatments. One of the potential treatments for calciphylaxis is sodium thiosulfate. The cost of sodium thiosulfate treatment varies based on several factors, including the patient's condition, the length of treatment, and the healthcare facility. A course of sodium thiosulfate treatment can cost thousands of dollars per dosage in the United States.

The high expense of calciphylaxis treatment can strain healthcare systems and cause gaps in care access. Patients with minimal financial resources may have difficulty receiving these costly procedures. Furthermore, the cost of treatment can create a significant financial burden on patients and their families. Some people may struggle to meet the costs of calciphylaxis care, resulting in financial stress.

Global Calciphylaxis Market Opportunity:

Emerging Therapies

Novel therapeutics for calciphylaxis are being investigated, including sodium thiosulfate, bisphosphonates, and hyperbaric oxygen therapy. These new medicines have shown promise in terms of improving patient outcomes. Clinical research and case reports show that Sodium thiosulfate therapy has potential advantages. While research is ongoing, there have been reports of people experiencing dramatic changes in their condition.

Bisphosphonates, routinely used to treat illnesses such as osteoporosis, are being investigated for their ability to suppress vascular calcification. Clinical trials and research are being conducted to determine their efficacy in preventing or treating calciphylaxis. Continuous research is required to validate the safety and efficacy of developing medicines. Collaboration between healthcare facilities and research organizations provides opportunities to broaden the calciphylaxis treatment choices. 

Emerging medicines have the potential to address the calciphylaxis' limited therapeutic choices and high fatality rate. The worldwide calciphylaxis market has the potential to provide more effective and individualized care to individuals affected by this ailment by researching and validating these treatments through research and clinical trials.

Regional Analysis

The global calciphylaxis market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global Calciphylaxis market shareholder and is estimated to grow at a CAGR of 12.3% over the forecast period. The North American region accounts for a significant portion of the market owing to the presence of a patient population, well-developed technology, high healthcare expenditure, the focus of research institutions on updating new versions of technology for new and advanced treatment methods, and the presence of the leading players. Furthermore, modern hospital infrastructures and the availability of experienced healthcare personnel are fueling market expansion.

Furthermore, because of the high frequency of end-stage renal disease (ESRD), one of the leading causes of calciphylaxis in the United States. According to The Regents of the University of California, the rate of ESRD in the United States is increasing by 5% per year. Calciphylaxis primarily affects dialysis patients; this might be another crucial factor favorably influencing market growth in the next years. According to the University of California Regents, end-stage renal disease (ESRD) affects around 650,000 patients in the United States each year, with a predicted 2 million sufferers worldwide. This could be a significant element in the growth of the global market for calciphylaxis treatment. Furthermore, according to the U.S. Renal Data System Annual Data Report, more than 660,000 Americans were receiving treatment for renal disease in 2018, with 468,000 on dialysis. This is anticipated to be another element driving the calciphylaxis industry shortly.

Europe is anticipated to exhibit a CAGR of 12.8% over the forecast period. Europe is divided into two regions: Western Europe and Eastern Europe. Western Europe comprises the following countries: Germany, the United Kingdom, France, Italy, Spain, and the rest of Western Europe. The rising prevalence of cardiovascular calcification in ESRD patients is a major driver of this market's expansion in Europe. Furthermore, rising healthcare expenditure, increased research and development activities, and increased patient awareness of treatment alternatives all contribute to the growth of the calciphylaxis market. Japan, China, India, Australia, the Republic of Korea, and the rest of Asia-Pacific make up Asia-Pacific. Chronic renal failure is becoming more common in Asia-Pacific. Furthermore, the expansion of this category is linked to rapid population increase, rising environmental degradation, and urbanization. 

The Asia-Pacific region's rise has been fueled by an increase in the incidence of calciphylaxis, improved healthcare infrastructure, and more understanding of the treatment procedure because of the greater number of developing nations present in this region, such as India and China, according to calciphylaxis market insights. These countries are promoting the expansion of the healthcare industry. The growing cancer patient population in emerging countries would immediately increase demand for various diagnostics and treatment approaches, assisting in market expansion.

The Middle East and Africa, on the other hand, have the smallest market share of the calciphylaxis market due to less development in healthcare services, such as new and enhanced diagnosis and treatment methods in the healthcare domain. However, countries such as Qatar and Kuwait are focusing more on healthcare and expanding medical facilities, which is expected to increase the size of the calciphylaxis market in this area.

Segmental Analysis

The Global Calciphylaxis Market is segmented based on type, treatment, end-use, Diagnosis, and region.

Type is further segmented into Non-Uremic Calciphylaxis, Ulcers and Wounds, and Debridement of Wounds.

Ulcers and Wounds holds the major market share. This subsegment focuses on the treatment of calciphylaxis-related ulcers and wounds. These ulcers can be painful, take a long time to heal, and are prone to infection. Calciphylaxis ulcers frequently have a distinct look, with necrotic tissue and eschar patches. Wound care and debridement are critical for promoting healing and avoiding complications. Wound debridement to remove necrotic tissue, dressings to create a moist wound environment, pain control, and antibiotic therapy if infection is present are all possible treatments.

Non-uremic calciphylaxis (NUCA), also known as non-uremic calcific arteriolopathy, is a type of calciphylaxis that occurs in people who do not have end-stage renal disease (ESRD). While ESRD-related calciphylaxis is well-known, non-uremic calciphylaxis is less common and can afflict people with normal kidney function.

The market is sub-segmented based on treatment: Drug Therapy, Hyperbaric Oxygen Therapy.

Drug Therapy accounts for the largest share of the market. To treat calciphylaxis, drug therapy entails the use of medicines. Several medicines are being investigated for their potential efficacy in treating calciphylaxis. Sodium thiosulfate, bisphosphonates, and calcimimetics are some drugs used or proposed for calciphylaxis treatment. The capacity of sodium thiosulfate, particularly to dissolve calcium deposits in blood vessels and promote wound healing, is attracting interest. Drug therapy may also involve pain relief and treatment of underlying disorders that contribute to calciphylaxis.

Pure oxygen is administered in a pressurized chamber during hyperbaric oxygen therapy. This medication is used to treat various medical disorders, and its application to calciphylaxis is a new study area.

The segment can be further bifurcated by end-use into Hospitals and clinics, home care, and Ambulatory centers.

Hospitals and clinics generate the most revenue. Many calciphylaxis patients obtain initial Diagnosis and acute care at hospitals and clinics, which are critical healthcare services. These hospitals have the essential medical equipment and specialists to treat calciphylaxis, particularly in severe cases. Diagnostic procedures, surgical interventions, wound debridement, and specialized care are all performed in hospitals and clinics. They are prepared to handle serious problems caused by calciphylaxis, such as sepsis and organ failure.

Homecare is the provision of healthcare services to patients in the comfort of their own homes. Homecare may be an appropriate option for those with less severe or stable calciphylaxis instances to get continuing care and assistance.

Based on Diagnosis, the market is fragmented into Skin Biopsy, Lab Testing, and Imaging.

Lab Testing is a significant contributor to the market. Blood samples are analyzed in the lab and certain indicators and parameters that can suggest the presence of calciphylaxis are evaluated. These markers may include calcium, phosphate, parathyroid hormone, and other pertinent blood parameters. Lab tests can assist in determining the underlying causes of calciphylaxis, such as changes in calcium and phosphate metabolism. Abnormal laboratory results, such as high calcium and phosphate levels, can raise the possibility of calciphylaxis and direct additional investigation.

The surgical excision of a small piece of skin tissue for examination under a microscope is known as a skin biopsy. A skin biopsy is conducted in the context of calciphylaxis to check the existence of typical skin lesions and confirm the diagnosis.

Recent Developments

• October 2023- Amgen (NASDAQ: AMGN) announced the completion of its acquisition of Horizon Therapeutics plc.
• July 2023- Tandem Diabetes Care and Convatec collaborate on a novel infusion set for the groundbreaking Tandem Mobi system.