The Hypoparathyroidism Market Report 2034 by DelveInsight provides an in-depth analysis of current treatment practices for hypoparathyroidism, upcoming drugs in the pipeline, market shares of individual therapies, and forecasts the growth trajectory of the hypoparathyroidism market from 2020 to 2034 across the 7MM (the United States, the EU-4 countries—Italy, Spain, France, and Germany—the United Kingdom, and Japan).
Recent Breakthroughs in the Hypoparathyroidism market:
On August 12, 2024, the FDA approved Yorvipath as a subcutaneous injection for adults with hypoparathyroidism.
Key highlights from the Hypoparathyroidism Market Report:
In 2023, the market size for hypoparathyroidism across the seven major markets (7MM) was estimated at approximately USD 370 million. Hypoparathyroidism is a rare condition marked by low serum calcium levels, elevated serum phosphorus levels, and absent or inappropriately low levels of parathyroid hormone (PTH) in circulation. In the United States, its prevalence is estimated at 24 to 37 cases per 100,000 individuals.
The most common cause of hypoparathyroidism is postoperative complications following thyroidectomy, leading to insufficient PTH levels. Non-surgical causes include rare genetic conditions, autoimmune destruction of the glands, tumors, radiation, infiltration by substances like iron or copper, hypomagnesemia, magnesium depletion, and idiopathic origins.
Diagnosis involves assessing levels of albumin-corrected total calcium, plasma PTH, serum magnesium, and 25-hydroxyvitamin D. The hallmark of the disease is a low or inappropriately normal serum PTH concentration in the presence of hypocalcemia, distinguishing it from other causes of hypocalcemia, such as vitamin D deficiency. Reliable second- or third-generation assays for measuring serum PTH are essential for accurate diagnosis.
Treatment focuses on maintaining serum calcium levels within the low-normal range, managing symptoms, and preventing hypercalciuria. The standard of care (SoC) includes dietary and oral calcium supplements, active vitamin D analogs, thiazide diuretics to manage hypercalciuria when necessary, magnesium supplementation, and a low-salt diet. For patients who are difficult to manage with traditional therapies, daily subcutaneous injections of recombinant human PTH are an option. PTH replacement therapy reduces oral calcium and calcitriol requirements, enhances physiological bone turnover, and improves quality of life.
Currently, NATPARA is the only approved drug specifically for treating hypoparathyroidism. However, in September 2019, Takeda recalled all doses of NATPARA in the United States due to concerns about rubber particulate contamination. The company has also announced plans to discontinue global production of the drug by the end of 2024.
Several therapies are under development for hypoparathyroidism. Key candidates include AZP-3601 (Amolyt Pharma), TransCon PTH (Ascendis Pharma), and encaleret (Calcilytix Therapeutics).
The prevalence of hypoparathyroidism varies across the 7MM countries, influenced by age and demographics. In the United States, the highest prevalence is observed in individuals aged 65 and older. In the EU4 and the UK, the 55–64 age group represents the largest patient population. Additionally, the disease is more common in females than males, with an approximate gender ratio of 4:1.
Driving Forces Behind the Hypoparathyroidism Market Growth
The market is expected to grow by factors like an increase in the patient pool, and expected entry of emerging therapies.
Discover the Anticipated Evolution and Growth of the Market @ Hypoparathyroidism Therapeutics Market Forecast
Hypoparathyroidism Market Dynamics
In November 2021, Ascendis Pharma shared top-line results from Week 84 of its Phase II PaTH Trial. The findings demonstrated that patients treated with TransCon PTH maintained stable mean serum calcium levels and normal urinary calcium excretion. Notably, 93% of participants were free from active vitamin D supplementation and required less than 600 mg/day of calcium supplements. The innovative TransCon platform positions TransCon PTH as a strong contender in the hypoparathyroidism market, potentially rivaling Natpara.
In addition to TransCon PTH, EB612 has shown promising advancements in treating hypoparathyroidism. This oral PTH formulation has effectively delivered the hormone into the bloodstream, activating key PTH-dependent biological pathways that are insufficiently stimulated in patients with hypoparathyroidism.
Based on our analysis, TransCon PTH stands out as the most promising emerging therapy, followed by EB612 (PTH 1-34) and Encaleret. This evaluation considers multiple factors, including efficacy, safety, route of administration, and other critical parameters detailed in the attribute analysis.
Hypoparathyroidism Treatment Market
The hypoparathyroidism market is poised for significant advancements with the anticipated launch of new therapies, including TransCon PTH by Ascendis Pharma, EB612 by EnteraBio, and Encaleret by BridgeBio/Calcilytix Therapeutics.
TransCon PTH is a prodrug designed for once-daily hormone replacement therapy, delivering sustained parathyroid hormone (PTH) levels throughout the day. However, in April 2023, the FDA raised deficiencies in Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH, affecting discussions on labeling and post-marketing requirements.
EB612 is an oral formulation of human parathyroid hormone (1-34) (PTH) developed to regulate calcium and phosphorus levels in the blood. It received Orphan Drug designation from the FDA in April 2014 and a positive assessment from the European Medicines Agency (EMA) in May 2016. EnteraBio published results from a Phase IIa study in February 2021, demonstrating its potential for hypoparathyroidism treatment.
Encaleret is an investigational small-molecule antagonist of the calcium-sensing receptor (CaSR), being developed to treat disorders of calcium homeostasis, including autosomal dominant hypocalcemia type 1 (ADH1). The FDA has granted orphan drug designations for Encaleret to address ADH1 and ADH2, as well as Fast Track designation for ADH1 in June 2021. The therapy is currently in Phase III clinical development.
These innovative treatments represent a transformative shift in managing hypoparathyroidism, addressing unmet needs with varied mechanisms of action and administration routes.
Leading Hypoparathyroidism Companies and Emerging Drugs: Leading companies such as Takeda, Ascendis Pharma, EnteraBio, Bridgebio, and Calcilytix Therapeutics, among others, are actively advancing novel drugs for potential entry into the hypoparathyroidism market.
Hypoparathyroidism Therapeutic Landscape: Key therapies under development for the treatment of hypoparathyroidism include TransCon PTH, EB612, Encaleret, and others.
Hypoparathyroidism Overview:
Hypoparathyroidism is a condition characterized by low calcium levels (hypocalcemia) and elevated phosphorus levels (hyperphosphatemia) caused by insufficient secretion or activity of parathyroid hormone (PTH). It may occur as part of an autoimmune disorder affecting multiple glands or as a congenital anomaly, such as autosomal dominant DiGeorge syndrome or hypoparathyroidism, deafness, and renal dysplasia (HDR) syndrome.
The most common cause of hypoparathyroidism is damage to or removal of all four parathyroid glands, which can unintentionally occur during thyroid surgery. In some cases, individuals are born without parathyroid glands, while others may experience impaired gland function for reasons that remain unclear.
Symptoms of hypocalcemia include tingling around the mouth (perioral numbness), abnormal sensations (paresthesia), cognitive difficulties, muscle weakness, and spasms in the hands and feet (carpopedal spasms). Severe cases can lead to complications such as irregular heart rhythms, laryngeal spasms, tetany, and seizures.
Treatment typically involves personalized calcium supplementation and active vitamin D therapy to maintain calcium balance. Recombinant human PTH is an additional therapeutic option but is often reserved due to its high cost and limited data on long-term safety.
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Hypoparathyroidism Epidemiology Segmentation:
In 2023, the United States had the highest prevalence of hypoparathyroidism among the 7MM countries, accounting for approximately 45% of all cases, with around 130,000 individuals affected. The UK ranked second in prevalence, while Spain reported the lowest, with approximately 11,000 cases. Japan recorded about 33,000 prevalent cases in 2023, with steady growth anticipated through 2034.
Chronic hypoparathyroidism was significantly more common than transient forms, constituting nearly 90% of all cases. In the U.S. alone, approximately 16,800 cases were diagnosed in males in 2023.
The Hypoparathyroidism market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
• Total Prevalence of Hypoparathyroidism
• Prevalent Cases of Hypoparathyroidism by severity
• Gender-specific Prevalence of Hypoparathyroidism
• Type-specific Prevalence of Hypoparathyroidism
• Age-specific Prevalence of Hypoparathyroidism
• Diagnosed Cases of Hypoparathyroidism
DelveInsight’s comprehensive report provides a thorough exploration of the Hypoparathyroidism market, covering key Hypoparathyroidism players, emerging Hypoparathyroidism therapies, treatment dynamics, and market challenges.
For in-depth insights, access the full report @ Hypoparathyroidism Market Outlook 2034
Table of Contents
1. Hypoparathyroidism Market Report Introduction
2. Executive Summary for Hypoparathyroidism
3. SWOT analysis of Hypoparathyroidism
4. Hypoparathyroidism Patient Share (%) Overview at a Glance
5. Hypoparathyroidism Market Overview at a Glance
6. Hypoparathyroidism Disease Background and Overview
7. Hypoparathyroidism Epidemiology and Patient Population
8. Country-Specific Patient Population of Hypoparathyroidism
9. Hypoparathyroidism Current Treatment and Medical Practices
10. Hypoparathyroidism Unmet Needs
11. Hypoparathyroidism Emerging Therapies
12. Hypoparathyroidism Market Outlook
13. Country-Wise Hypoparathyroidism Market Analysis (2019–2032)
14. Hypoparathyroidism Market Access and Reimbursement of Therapies
15. Hypoparathyroidism Market Drivers
16. Hypoparathyroidism Market Barriers
17. Hypoparathyroidism Appendix
18. Hypoparathyroidism Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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