Hypoparathyroidism - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• Hypoparathyroidism is a rare disease characterized by low serum calcium levels, elevated serum phosphorus levels, and absent or inappropriately low levels of parathyroid hormone (PTH) in the circulation.
• The most common cause of hypoparathyroidism is the removal of all four parathyroid glands or postoperative complications of thyroidectomy, leading to insufficient PTH levels in the body.
• Nonsurgical causes of hypoparathyroidism include rare genetic conditions and syndromes, autoimmune destruction of the glands, destruction or invasion due to the tumor, radiation or infiltration by iron or copper, hypomagnesemia and magnesium depletion, and idiopathic.
• The onset of the disease is very gradual, and symptoms include tingling, muscle cramps, fatigue/weakness, seizures, anxiety, dry scalp, brittle nails, and brain fog.
• Diagnosis of hypoparathyroidism is based on family history, physical examination, and certain laboratory tests to check the presence of albumin-corrected total calcium, plasma parathyroid hormone, serum magnesium, and 25-hydroxyvitamin D levels in the body.
• The treatment goals are normalization of serum calcium levels and provision of symptom relief, preservation of kidney function, and preservation of bone safety.
• The standard of care (SoC) consists of dietary and oral calcium supplements, active vitamin D analogs, thiazide diuretics when necessary to help manage hypercalciuria, low salt diet, and magnesium supplementation, in some cases.
• NATPARA was the only approved drug for its treatment, but in September 2019, Takeda issued a recall for all doses of NATPARA due to a potential issue related to rubber particulates in injections and has also planned to discontinue manufacturing of the drug globally by the end of 2024.
• Some key players involved in the development of new treatments for hypoparathyroidism are Amolyt Pharma (eneboparatide), Ascendis Pharma (TRANSCON PTH), and Calcilytix Therapeutics (encaleret).

Report Summary

• The detailed report provides significant knowledge about epidemiological segments, including the historical and forecasted patient pool data, thus providing a thorough picture of anticipated future development in diagnostic rates and treatment guidelines. It gives deep insights into various areas, allowing for a complete examination of the subject.
• The report also includes an all-inclusive account of current management techniques and emerging therapies and elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift. The therapy profiles include a detailed assessment of the current and emerging therapies, information regarding the approval-based and ongoing trials, and a thorough drug description.
• The report also encompasses a comprehensive analysis of the hypoparathyroidism market, providing an in-depth examination of its historical and projected market size (2019-2032). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative as well as quantitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, which gives an overview of the patient landscape commencing from detection of the disease to treatment being administered to the patients, with the treatment preferences that help shape and drive the 7MM hypoparathyroidism market.

Market

Various key players are currently investigating their drugs for hypoparathyroidism, such as Amolyt Pharma, Ascendis Pharma, Calcilytix Therapeutics (a subsidiary of BridgeBio), and others. The details of the country and therapy-wise market size have been provided below.

• In the 7MM region, the United States captured the largest market size in 2022. In 2022, the market size of the United States was ~USD 200 million
• Among the 7MM countries, Spain accounted for the smallest market size in 2022, ~USD 13 million.
• By therapies, Vitamin D analogs accounted for the highest market size in 2022, ~ USD 60 million.

Hypoparathyroidism Drug Chapters

The Hypoparathyroidism report's drugs section includes an in-depth examination of marketed drugs and late-stage pipeline therapeutics (Phase III and Phase II) for hypoparathyroidism.

The drug chapters section contains useful information on various aspects of hypoparathyroidism clinical trials, including specific details such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. It also includes the most recent news updates and press releases on drugs that treat hypoparathyroidism.

Emerging Therapies

TRANSCON PTH: Ascendis Pharma

TRANSCON PTH is an investigational prodrug of parathyroid hormone (PTH) and is under development as a once-daily hormone replacement therapy. It is designed to restore physiologic levels of PTH for 24 h each day. The company aims to provide a PTH replacement therapy that normalizes serum and urinary calcium and serum phosphate levels, addressing both the short-term symptoms and long-term complications of hypoparathyroidism and improving the quality of life of its patients.

Encaleret: Calcilytix Therapeutics (a subsidiary of BridgeBio)
Encaleret is an investigational small molecule antagonist of the calcium-sensing receptor (CaSR) studied in calcium homeostasis disorders, including autosomal dominant hypocalcemia type 1 (ADH1). Individuals with ADH1 have gain-of-function mutations in the CaSR, causing low serum calcium and a range of debilitating symptoms. ADH1 may also lead to relatively high calcium levels in the urine, a condition called hypercalciuria, which can impair kidney function and cause kidney stone formation. The drug is a potential first-in-class CaSR antagonist for ADH1, which was given Fast Track Designation by the US FDA in June 2021.

Note: Detailed assessment will be provided in the final report of hypoparathyroidism…
Discontinued Assets
NATPARA (parathyroid hormone): Shire (Takeda)
Natpara is a bio-engineered replica of the parathyroid hormone, which raises serum calcium by increasing renal tubular calcium reabsorption, intestinal calcium absorption, and bone turnover, which then releases calcium into the circulation. It was indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism, but in October 2022, Takeda decided to discontinue manufacturing NATPAR/NATPARA injection globally by the end of 2024 due to unresolved supply issues that were specific to the product.

Note: Detailed assessment will be provided in the final report of hypoparathyroidism…

Hypoparathyroidism Market Outlook

Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amounts of parathyroid hormone or the parathyroid hormone produced lacks biological activity. The treatment of hypoparathyroidism is directed toward the specific symptoms apparent in each individual and the lab tests. Treatment aims to raise calcium levels to relieve symptoms without causing abnormally high calcium levels in the blood (hypercalcemia) or the urine (hypercalciuria). The specific therapies used may vary depending on the disease severity, the specific symptoms present, an individual's age and overall health, personal preference, and additional factors.

Oral calcium supplements can increase calcium levels in the blood. However, calcium supplements can cause gastrointestinal side effects at high doses, such as constipation, in some people. Several different types of calcium supplements are available; some brands may work better for certain people. High doses of vitamin D, generally calcitriol, can help the body absorb calcium and eliminate phosphorus. Another form of vitamin D that may be used is ergocalciferol or cholecalciferol; outside the US, doctors use alpha calcidol. Ergocalciferol and cholecalciferol have a longer duration of action than calcitriol or alpha calcidol because the former two forms of vitamin D are stored in the body for a long time.

If the magnesium level is low and the patient experiences symptoms of hypoparathyroidism, the doctor may recommend taking a magnesium supplement. If the calcium levels remain low even with treatment, thiazide diuretics can help decrease the amount of calcium lost through the urine. However, some people with hypoparathyroidism, including people who inherited the condition, should not take thiazide diuretics.

Some individuals, especially those with severe symptoms due to low blood calcium levels, may require immediate relief through intravenous calcium therapy, even if their calcium levels are only mildly reduced. Intravenous therapy means a substance (e.g., calcium) is delivered into the bloodstream through an injection or infusion directly into a vein.

Recently, in January 2015, the US FDA approved the use of recombinant human parathyroid hormone (1-84) (rhPTH[1-84]), NATPARA, as a treatment for adult patients with chronic hypoparathyroidism who are uncontrolled with conventional therapy (calcium and activated vitamin D). However, this therapy was later discontinued due to a manufacturing defect.

Note: Detailed assessment will be provided in the final report of hypoparathyroidism…

Hypoparathyroidism Understanding and Treatment

Hypoparathyroidism Cancer Overview

Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amounts of parathyroid hormone or lack biological activity. The secretion of the parathyroid hormone is inversely related to the concentration of ionized calcium in the extracellular fluid. The activity of the calcium-sensing receptor (CaSR), a G-protein coupled receptor, is affected by calcium concentration changes. As the calcium concentration in the extracellular fluid increases, this receptor is activated, and parathyroid cells decrease the secretion of parathyroid hormone. Conversely, the activity of the CaSR decreases, and parathyroid hormone secretion increases as calcium levels decline.

Parathyroid hormone (along with vitamin D and calcitonin, produced by the thyroid gland) plays a role in regulating the levels of calcium and phosphorus in the blood and in determining bone growth and bone cell activity. Due to a parathyroid hormone deficiency, individuals may exhibit abnormally low levels of calcium in the blood (hypocalcemia) and high levels of phosphorus (hyperphosphatemia).

A detailed overview will be provided in the final report…

Hypoparathyroidism Diagnosis

The diagnostic biochemical hallmark of hypoparathyroidism is hypocalcemia in association with deficient production of PTH. It is thus readily distinguished from pseudohypoparathyroidism, a genetic disorder of PTH resistance in which the circulating PTH concentration is elevated. The diagnosis of hypoparathyroidism is also readily distinguished from secondary causes of hypocalcemia (e.g., vitamin D deficiency), in which the PTH level is also high. In hypoparathyroidism, circulating active vitamin D (1,25-dihydroxyvitamin D3) and bone turnover markers are usually in the lower normal range.

Further details related to diagnosis are provided in the report…

Hypoparathyroidism Treatment

Unlike most other hormonal deficits, hypoparathyroidism is not treated by replacing the missing parathyroid hormone (PTH). The standard treatment consists of activated vitamin D (calcitriol) and calcium supplements; some may also need magnesium supplementation. Conventional therapy requires many pills to be taken throughout the day.

Diet recommendations usually include eating foods high in calcium, such as dairy products, breakfast cereals, fortified orange juice, and green, leafy vegetables, or avoiding foods high in phosphorus, such as meat, poultry, fish, nuts, whole grains, and beans. Conventional therapy with vitamin D and calcium may lead to calcium buildup in the kidneys. This buildup may lead to problems, including kidney stones and deposits of calcium, reduced kidney function, tissue damage, or even kidney failure.

Further details related to treatment and management are provided in the report…..

Hypoparathyroidism Epidemiology

The Hypoparathyroidism epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Hypoparathyroidism, Total Diagnosed Prevalent Cases of Hypoparathyroidism, Gender-specific Cases of Hypoparathyroidism, Age-specific Cases of Hypoparathyroidism, Type-specific Cases of Hypoparathyroidism, and Cause-specific Cases of Hypoparathyroidism, covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

• The total diagnosed prevalent cases of hypoparathyroidism in the United States were ~82,500 in 2022. The cases are expected to increase by 2032.
• In Japan, the highest number of cases of hypoparathyroidism were found in the 55-64 age group. The least number of patients belonged to the < 18 years age group.
• The total cause-specific cases of hypoparathyroidism in EU4 and the UK in 2022 were ~55,500 cases caused by surgery, while ~23,500 cases were caused by other causes.

Further details related to epidemiology will be provided in the report…

KOL Views

In order to stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of hypoparathyroidism, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

The team of analysts connected with more than 10 KOLs across the 7 Major Markets (7MM). We contacted institutions such as Oregon Health & Science University and others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the hypoparathyroidism market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We conduct qualitative and market intelligence analysis employing various methods, including SWOT analysis and Conjoint Analysis. Strengths, weaknesses, opportunities, and threats in disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are described in the SWOT analysis. These recommendations are based on the Analyst's evaluation of the patient burden, cost analysis, and the current and emerging therapy landscape. Conjoint Analysis compares the effectiveness and safety of numerous approved and emergent drugs depending on key criteria such as frequency of administration, designation, route of administration, and order of entry. To assess the success of therapy, several factors are evaluated.

Furthermore, the drug's safety is analyzed, in which acceptability, tolerability, and adverse events are closely monitored, and it establishes a firm grasp of the side effects of the drugs used in the trials. Furthermore, for each therapy, the rating is based on the route of administration, sequence of entrance and designation, chance of success, and addressable patient pool. These characteristics determine the ultimate weightage score and ranking of developing therapeutics.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Hypoparathyroidism Insights

• Patient Population
• Therapeutic Approaches
• Market size of each therapy
• Hypoparathyroidism Market Size and Trends
• Existing Market Opportunity

Hypoparathyroidism Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Hypoparathyroidism Epidemiology Segmentation (Segmented by diagnosed prevalent cases, gender, age, type, and cause-specific Cases)

- Key Cross Competition evaluating the marketed as well as emerging therapies

Hypoparathyroidism Report Assessment

• Current Treatment and Management Practices
• Unmet Needs
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis)

Key Questions Answered

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in hypoparathyroidism management recommendations?
• Would research and development advances pave the way for future tests and therapies for hypoparathyroidism?
• Would the innovations in diagnostic tests of hypoparathyroidism space experience a significant impact and lead to a positive shift in the treatment landscape of hypoparathyroidism?
• What kind of uptake will the new therapies witness in the coming years in hypoparathyroidism patients?