DelveInsight’s ‘Hypoparathyroidism -Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the Hypoparathyroidism, historical and forecasted epidemiology as well as the Hypoparathyroidism market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The Hypoparathyroidism market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Hypoparathyroidism market size from 2018 to 2030. The Report also covers current Hypoparathyroidism treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2018–2030
Hypoparathyroidism Disease Understanding and Treatment Algorithm
Hypoparathyroidism (hypoPTH) is a rare condition in which the parathyroid glands fail to produce sufficient amounts of parathyroid hormone or lacks biological activity. The parathyroid glands are part of the endocrine system—the network of glands that secrete hormones into the bloodstream, where they travel to various body areas. These hormones regulate the chemical processes (metabolism) that influence various organs and activities within the body. Hormones are involved in numerous vital processes, including regulating heart rate, body temperature, blood pressure, cell differentiation and growth, and modulation of several metabolic processes. Parathyroid hormone (along with vitamin D and the hormone calcitonin, which is 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 deficiency of the parathyroid hormone, individuals may exhibit abnormally low levels of calcium in the blood (hypocalcemia) and high levels of phosphorus (hyperphosphatemia).
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A diagnosis of hypoPTH is made based upon the identification of characteristic symptoms, a detailed patient history, a thorough clinical evaluation, and a variety of specialized tests. Blood tests can reveal abnormal levels of calcium, phosphorus, magnesium, creatinine, and intact parathyroid hormone. Urine tests can reveal if the body is excreting too much calcium.
In addition, the Food and Drug Administration (FDA) has approved the use of the synthetic parathyroid hormone teriparatide as a diagnostic agent to distinguish hypoPTH from pseudohypoparathyroidism.
Additional tests may be performed to detect complications that may be associated with hypoPTH. For example, an electrocardiogram, a test that records the heart's electrical activity, can reveal arrhythmias that are sometimes associated with low calcium levels and hypoPTH. An ophthalmologic exam should also be done to check for cataracts.
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Unlike most other hormonal deficits, hypoPTH is not treated with replacing the missing hormone, parathyroid hormone (PTH).
Currently, the standard treatment consists of activated vitamin D (calcitriol) and calcium supplements. Some people may also need magnesium supplementation. Conventional therapy requires many pills 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 a buildup of calcium 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. In January 2015, the US Food and Drug Administration approved PTH 1-84 for adult hypoPTH patients who do not respond well to standard treatment as an add-on to that treatment
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The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Hypoparathyroidism, Diagnosed Prevalent Cases of Hypoparathyroidism, Gender-specific Diagnosed Prevalent Cases of Hypoparathyroidism, Type-specific Diagnosed Prevalent Cases of Hypoparathyroidism, Cause-specific Diagnosed Prevalent Cases of Hypoparathyroidism, and Age-specific Diagnosed Prevalent Cases of Hypoparathyroidism scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.
- The total prevalent population of hypoparathyroidism in the 7MM ranges from 262,542 in 2020 growing at a CAGR of 1.22% during the study period [2018–2030].
- Among the European five countries, Germany had the highest prevalent population of hypoparathyroidism with 28,604 cases, followed by UK and France in 2020. On the other hand, Spain had the lowest prevalent population.
- Japan had 33,276 prevalent cases of hypoparathyroidism in 2020.
- As per DelveInsight’s analysis, a higher percentage of prevalence was observed for females, in comparison to males, in all the 7MM countries.
- According to DelveInsight’s analysis, it has been observed that hypoparathyroidism prevalence varied across the 7MM countries, based on the age-specific prevalence of the disease. For instance, the highest proportion was observed in the 65+ Years age group in the US, while in the EU-5 countries, people aged 55-64 Years accounted for the maximum patient pool.
- Among the major types of hypoparathyroidism, i.e., Chronic and transient hypoparathyroidism, the former one accounts for a higher number of prevalent cases of hypoparathyroidism.
Country Wise Hypoparathyroidism Epidemiology
The epidemiology segment also provides the Hypoparathyroidism epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Hypoparathyroidism Drug Chapters
Hypoparathyroidism Marketed Drugs
Natpara (parathyroid hormone/rhPTH [1-84]): Shire (Takeda)
Natpara (parathyroid hormone) for injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The drug is a bioengineered replica of the human parathyroid hormone. It was approved in the US, and EU in 2015, and 2017, respectively. But in September 2019, the company recalled the drug from the US market.
Products detail in the report…
Hypoparathyroidism Emerging Drugs
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 believes that this therapy can address both the short-term symptoms and long-term complications of hypoparathyroidism (HP).
The company’s goal is to provide a PTH replacement therapy that normalizes serum and urinary calcium, as well as serum phosphate levels, and improves the quality of life. In September 2020, the company submitted an amendment to IND to initiate PaTHway, a global Phase III clinical trial evaluating the safety, tolerability, and efficacy of the therapy in adults with HP following discussions with FDA and European regulatory authorities. In addition, the company is planning to conduct a Phase III study in Japan designed to evaluate the safety, tolerability, and efficacy of the therapy
Products detail in the report…
EB612, an oral human parathyroid hormone (1-34) (PTH), the parathyroid glands are part of the endocrine system, a network of glands that secrete hormones into the bloodstream, which then travel to various areas of the body. PTH (along with vitamin D and the hormone calcitonin, which the thyroid gland produces) plays a role in regulating the levels of calcium and phosphorus in the blood. Due to a deficiency of PTH, individuals may exhibit abnormally low levels of calcium in the blood (hypocalcemia) and high levels of phosphorus (hyperphosphatemia). The common practice in treating these patients is with calcium and Vitamin D supplements at high doses in addition to other various drugs to treat the symptoms
Products detail in the report…
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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 parathyroid glands are part of the endocrine system, the network of glands that secrete hormones into the bloodstream, where they travel to various areas of the body. The severity of the condition can range from mild symptoms such as a tingling or numbness in the fingers, toes, or around the lips (paresthesias) to severe muscle cramps and muscle spasms.
The treatment of hypoparathyroidism is directed toward the specific symptoms that are apparent in each individual and the lab tests. Treatment is aimed at raising calcium levels high enough to provide symptom relief without causing abnormally high levels of calcium in the blood (hypercalcemia) or the urine (hypercalciuria). The specific therapies used may vary depending upon 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, at high doses, calcium supplements can cause gastrointestinal side effects, such as constipation, in some people. There are several different types of calcium supplements available. Some brands may work better for certain people. High doses of vitamin D, generally in the form of 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 long times.
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 that a substance (e.g., calcium) is delivered into the bloodstream through an injection or infusion directly into a vein.
Furthermore, some may be encouraged to make dietary changes to help treat their condition. Affected individuals may be encouraged to eat foods high in calcium, such as dairy products, breakfast cereals, and fortified orange juice, and green, leafy vegetables.
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- The market size of hypoparathyroidism in the 7MM was anticipated to be USD 247 million in 2020, at a CAGR of 17.70% for the study period (2018–2030).
- The current therapeutic landscape of hypoparathyroidism in the 7MM is driven by several approved therapy, including those with off-labeled products.
- Natpara (parathyroid hormone/rhPTH [1-84]) is the only approved drug for the treatment of hypoparathyroidism, which is approved in the US as well as in Europe.
- Of all the therapies, in the 7MM the majority of the market share is accommodated by TransCon PTH, which is expected to generate a market size of USD 1,615 million, in 2030.
Ascendis Pharma’s TransCon PTH, a long-acting version of PTH, showed strong data in a Phase II trial. It eliminated the need for a standard of care – defined as active vitamin D and ≤600 mg/day of calcium supplements – in around 91% of subjects and maintained calcium in the normal range. TransCon platform could prove to be a major value driver for the hypoparathyroidism market, making TransCon PTH a competitor of Natpara. Apart from TransCon PTH, EB612 has also continued to make good progress for hypoparathyroidism. It has been observed that oral PTH is effectively delivered into the bloodstream and activates PTH-dependent biological pathways inadequately activated in patients with hypoparathyroidism. As per our analysis, TransCon PTH was found to be the most promising upcoming drug, followed by EB612 (PTH 1-34) and Encaleret. The analysis is based on different parameters such as efficacy, safety, ROA, and various other factors, further explained in detail in the attribute analysis.
The United States Market Outlook
This section provides the total Hypoparathyroidism market size and; market size by therapies in the United States.
EU-5 Market Outlook
The total Hypoparathyroidism market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Hypoparathyroidism market size and market size by therapies in Japan are provided.
Hypoparathyroidism Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the Hypoparathyroidism market or expected to get launched in the market during the study period 2018–2030. The analysis covers the Hypoparathyroidism market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Hypoparathyroidism Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapies.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Hypoparathyroidism emerging therapies.
Reimbursement Scenario in Hypoparathyroidism
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Hypoparathyroidism market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of Hypoparathyroidism, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
- Comprehensive insight has been provided into the Hypoparathyroidism epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for Hypoparathyroidism is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the Hypoparathyroidism market; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Hypoparathyroidism market.
- The robust pipeline with novel MOA and oral ROA, increasing prevalence, effectiveness of drugs as both mono and combination therapy will positively drive the Hypoparathyroidism market.
- The companies and academics are working to assess challenges and seek opportunities that could influence Hypoparathyroidism R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- Major players are involved in developing therapies for Hypoparathyroidism. The launch of emerging therapies will significantly impact the Hypoparathyroidism market.
- Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
Hypoparathyroidism Report Insights
- Patient Population
- Therapeutic Approaches
- Hypoparathyroidism Pipeline Analysis
- Hypoparathyroidism Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Hypoparathyroidism Report Key Strengths
- 10 Years Forecast
- 7MM Coverage
- Hypoparathyroidism Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Hypoparathyroidism Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- SWOT analysis
- What was the Hypoparathyroidism market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the Hypoparathyroidism total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest Hypoparathyroidism market size during the forecast period (2021–2030)?
- At what CAGR, the Hypoparathyroidism market is expected to grow at the 7MM level during the forecast period (2021–2030)?
- What would be the Hypoparathyroidism market outlook across the 7MM during the forecast period (2021–2030)?
- What would be the Hypoparathyroidism market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- What are the disease risk, burdens, and unmet needs of Hypoparathyroidism?
- What is the historical Hypoparathyroidism patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
- What would be the forecasted patient pool of Hypoparathyroidism at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Hypoparathyroidism?
- Out of the above-mentioned countries, which country would have the highest prevalent population of Hypoparathyroidism during the forecast period (2021–2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of Hypoparathyroidism along with the approved therapy?
- What are the current treatment guidelines for the treatment of Hypoparathyroidism in the US and Europe?
- What are the Hypoparathyroidism marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of Hypoparathyroidism?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of Hypoparathyroidism?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hypoparathyroidism therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Hypoparathyroidism and their status?
- What are the key designations that have been granted for the emerging therapies for Hypoparathyroidism?
- What are the 7MM historical and forecasted market of Hypoparathyroidism?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving Hypoparathyroidism.
- To understand the future market competition in the Hypoparathyroidism market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Hypoparathyroidism in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the Hypoparathyroidism market.
- To understand the future market competition in the Hypoparathyroidism market.