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).
Key highlights from the Hypoparathyroidism Market Report:
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In 2023, the market size for hypoparathyroidism in the United States was approximately USD 200 million, representing around 60% of the total 7MM market.
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Among the EU4 countries and the UK, Germany had the largest market share in the same year. Teriparatide generated the highest revenue of approximately USD 120 million across the 7MM in 2023. Looking ahead, TransCon PTH (palopegteriparatide) is projected to achieve the highest revenue in the 7MM by 2034.
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In 2023, the market size for hypoparathyroidism in the 7MM was estimated to be approximately USD 370 million. Hypoparathyroidism is a rare condition characterized by low serum calcium levels, elevated serum phosphorus levels, and either absent or inadequately low levels of parathyroid hormone (PTH) in the bloodstream. The prevalence of hypoparathyroidism in the United States is estimated at 24 to 37 cases per 100,000 individuals.
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The condition often results from postoperative complications following thyroidectomy, leading to insufficient PTH levels. Other causes include rare genetic disorders, autoimmune destruction of the parathyroid glands, damage or invasion from tumors, radiation therapy, iron or copper deposition, hypomagnesemia, and idiopathic factors.
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Diagnosis involves measuring albumin-corrected total calcium, plasma PTH, serum magnesium, and 25-hydroxyvitamin D levels. The key diagnostic feature is low or inappropriately normal serum PTH levels in conjunction with hypocalcemia, which distinguishes hypoparathyroidism from other hypocalcemic conditions such as vitamin D deficiency. Therefore, accurate PTH assays (second/third-generation) are crucial for diagnosis.
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The primary treatment goals are to maintain serum calcium levels within the low-normal range, control symptoms, and prevent hypercalciuria. Standard care typically includes dietary and oral calcium supplements, active vitamin D analogs, and thiazide diuretics if necessary. Magnesium supplementation may also be required. For patients who are difficult to manage with conventional therapies, daily subcutaneous injections of recombinant human PTH can be used. This PTH replacement therapy helps reduce the need for oral calcium and calcitriol, enhances physiological bone turnover, and improves quality of life.
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Currently, NATPARA is the only approved drug for treating hypoparathyroidism. However, in September 2019, Takeda recalled all doses of NATPARA due to potential issues with rubber particulates and plans to discontinue its global manufacturing by the end of 2024.
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Several therapies are under investigation for hypoparathyroidism, with key players including Amolyt Pharma (AZP-3601), Ascendis Pharma (TransCon PTH), and Calcilytix Therapeutics (encaleret).
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Prevalence of hypoparathyroidism varies across the 7MM countries, with the highest proportions observed in individuals aged 65+ years in the US and those aged 55-64 years in the EU4 and the UK. Additionally, the condition is more common in females than in males, with an approximate 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 announced the top-line results from Week 84 of its Phase II PaTH Trial. The data revealed that subjects treated with TransCon PTH maintained stable mean serum calcium levels and urinary calcium excretion within the normal range. Additionally, 93% of participants remained free from active vitamin D supplementation and were taking less than 600 mg/day of calcium supplements. The TransCon platform could significantly impact the hypoparathyroidism market, positioning TransCon PTH as a notable competitor to Natpara.
Beyond TransCon PTH, EB612 has also shown promising progress for treating hypoparathyroidism. Oral PTH has been effectively delivered into the bloodstream, activating PTH-dependent biological pathways that are inadequately activated in hypoparathyroidism patients. According to our analysis, TransCon PTH is the most promising upcoming drug, followed by EB612 (PTH 1-34) and Encaleret. This assessment is based on various parameters including efficacy, safety, route of administration (ROA), and other relevant factors, which are detailed in the attribute analysis.
Hypoparathyroidism Treatment Market
The current hypoparathyroidism market is anticipating the launch of new therapies, including TransCon PTH from Ascendis Pharma, EB612 from EnteraBio, and Encaleret from Bridgebio/Calcilytix Therapeutics.
TransCon PTH is a potential prodrug of parathyroid hormone (PTH) designed for once-daily hormone replacement therapy, aiming to provide continuous PTH levels throughout the day. However, in April 2023, Ascendis Pharma received feedback from the FDA about deficiencies in their New Drug Application (NDA) for TransCon PTH, impacting discussions on labeling and post-marketing requirements.
EB612 is an oral formulation of human parathyroid hormone (1-34) (PTH) that helps regulate calcium and phosphorus levels in the blood. EnteraBio’s efforts for EB612 received Orphan Drug designation from the FDA in April 2014 and positive assessments from the EMA in May 2016. Phase IIa study results were published in February 2021.
Encaleret is an investigational small molecule antagonist targeting the calcium-sensing receptor (CaSR), being studied for calcium homeostasis disorders, including autosomal dominant hypocalcemia type 1 (ADH1). Bridgebio/Calcilytix Therapeutics obtained orphan drug designations from the FDA for Encaleret to address autosomal dominant hypocalcemia types 1 and 2. In June 2021, the FDA also granted Fast Track designation for Encaleret in the treatment of ADH1. The drug is currently in Phase III clinical development.
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 characterized by low calcium levels (hypocalcemia) and elevated phosphorus levels (hyperphosphatemia) due to insufficient secretion or function of parathyroid hormone (PTH). This condition can occur as part of an autoimmune disorder affecting multiple glands or as a congenital anomaly, such as in autosomal dominant DiGeorge syndrome or the hypoparathyroidism, deafness, and renal dysplasia (HDR) syndrome.
The primary cause of hypoparathyroidism often results from injury to or removal of all four parathyroid glands, which can accidentally happen during thyroid surgery. Some individuals are born without these glands, while others may experience inadequate gland function for unknown reasons.
Symptoms of hypocalcemia include tingling around the mouth (perioral numbness), abnormal sensations (paresthesia), cognitive impairment, muscle weakness, and spasms in the hands and feet (carpopedal spasms). Severe complications can include irregular heartbeats, laryngeal spasms, tetany, and seizures.
Treatment typically involves personalized calcium supplementation and essential vitamin D administration. Recombinant human PTH is available as a therapeutic option but is often considered secondary due to its high cost and the incomplete understanding of its long-term safety profile.
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Hypoparathyroidism Epidemiology Segmentation:
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In 2023, the United States had the highest prevalence of hypoparathyroidism, accounting for about 45% of all cases in the 7MM with approximately 130,000 cases. The UK followed as the next highest in prevalence. Conversely, Spain reported the lowest prevalence, with around 11,000 cases. Japan had approximately 33,000 prevalent cases of hypoparathyroidism in 2023, with expectations for steady growth through 2034.
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Among the different forms of hypoparathyroidism, chronic hypoparathyroidism was significantly more common than transient hypoparathyroidism, representing nearly 90% of all cases. In the US alone, around 16,800 cases of hypoparathyroidism 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
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