Hypoparathyroidism Market Size - North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, China, France, Japan, Canada, India, Italy, Brazil - Trends and Forecast Report 2024-2028

Hypoparathyroidism Market Size 2024-2028 

The hypoparathyroidism market size is forecast to increase by USD 474.9 million at a CAGR of 7.6% between 2023 and 2028.

• The market is experiencing significant growth due to increased awareness initiatives for thyroid treatment and the implementation of stringent regulations. companies in this market are adopting inorganic growth strategies, such as mergers and acquisitions, to expand their product portfolios and gain a competitive edge. Both hospitals and homecare settings are major contributors to the market, with a growing preference for oral and parenteral medications. Additionally, genetic conditions and autoimmune destruction of parathyroid glands contribute to the disease.  The role of hospital pharmacies and online pharmacies in the distribution of hypoparathyroidism medications is increasingly significant. Surgery remains a common treatment option, with specialized centers offering advanced surgical procedures. Overall, the market is characterized by a focus on improving patient outcomes and reducing healthcare costs.

What will be the Size of the Market During the Forecast Period?

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The hypoparathyroidism treatment market encompasses various interventions aimed at managing this endocrine disorder characterized by deficient parathyroid hormone (PTH) production. Hypoparathyroidism may result from autoimmune, hereditary, or idiopathic causes, leading to impaired calcium and phosphate homeostasis. Parathyroid hormone plays a crucial role in maintaining calcium and phosphate balance in the body. In hypoparathyroidism, reduced PTH levels result in hypocalcemia (low serum calcium levels) and hypophosphatemia (low serum phosphate levels). Consequently, treatment modalities for hypoparathyroidism include medication, protein supplements, calcium supplements, Vitamin D analogues, and hormonal therapy.

Furthermore, calcium supplements are often administered to maintain adequate calcium levels. These supplements can be taken orally or parenterally, depending on the severity of the condition and the patient's response to treatment. Calcium salts, such as calcium carbonate and calcium chloride, are common forms of calcium supplements. Vitamin D analogues, such as calcitriol, are used to enhance intestinal calcium absorption and maintain calcium homeostasis. These medications are particularly useful in patients with severe hypocalcemia or those who do not respond adequately to calcium supplementation. Hormonal therapy, including PTH replacement therapy, is another treatment option for hypoparathyroidism. Synthetic PTH or its analogues can be administered subcutaneously or intravenously to restore calcium and phosphate balance.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• Product
  • Parathyroid hormone
  • Vitamin D analogue
  • Calcium supplement
  • Others
• Distribution Channel
  • Hospital pharmacy
  • Retail pharmacy
  • Online pharmacy
• Geography
  • North America
    • Canada
    • US
  • Europe
    • Germany
    • UK
    • France
    • Italy
  • Asia
    • China
    • India
    • Japan
  • Rest of World (ROW)

By Product Insights

The parathyroid hormone segment is estimated to witness significant growth during the forecast period. The market in the US is driven by the advancements in the development and approval of Parathyroid Hormone (PTH) therapies. Despite a recent setback with the US Food and Drug Administration (FDA) denying approval, the European Commission approved YORVIPATH in November 2023, a treatment for Chronic hypoparathyroidism. This rare disease is characterized by insufficient parathyroid hormone production due to gland dysfunction, leading to low serum calcium levels and high serum phosphorus levels, causing neuromuscular irritability. Patients with hypoparathyroidism may experience symptoms such as muscle pain (myalgias), spasms, twitching, and, in severe cases, seizures and tetany. The severity of these symptoms can depend on the calcium levels and the duration of the hormone deficiency.

Furthermore, retail pharmacies play a crucial role in providing access to these treatments for patients, ensuring proper management of their conditions. The pipeline analysis of potential treatments for hypoparathyroidism is ongoing, offering hope for improved patient outcomes.

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The parathyroid hormone segment accounted for USD 345.10 million in 2018 and showed a gradual increase during the forecast period.

Regional Insights

North America is estimated to contribute 39% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The North American market, with a significant focus on the US, is experiencing notable expansion due to progress in treatment methods and escalating healthcare expenditures. Ascendis Pharma A/S is leading this growth trajectory, intending to finalize the manufacturing of TransCon PTH, a novel therapy for adult hypoparathyroidism, primarily for the US market. The first shipment of this product is projected for the first quarter of 2025.  This market growth is underpinned by the rising prevalence of endocrine disorders such as hypoparathyroidism, including autoimmune, hereditary, and idiopathic forms. The condition is characterized by insufficient parathyroid hormone (PTH) secretion, leading to imbalances in calcium and phosphate levels. Calcitriol is a commonly used treatment to manage these imbalances. The introduction of innovative therapies, like TransCon PTH, offers promising solutions to address the unmet medical needs in this area.

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Market Driver

Increased awareness programs for thyroid treatment is the key driver of the market. The market in the United States is witnessing notable expansion due to a heightened focus on thyroid health awareness. Notable observances, such as World Thyroid Day on May 25th and thyroid Awareness Month in January, contribute significantly to this growth. These initiatives, led by health organizations, medical professionals, and healthcare facilities, aim to educate the public about thyroid conditions, their causes, and treatment options.

Furthermore, calcium supplements, Vitamin D analogues, hormonal therapy, biologics, and personalized medicines are commonly used treatments for hypoparathyroidism. Drug recalls and hospitalizations can impact the long-term management of this condition, emphasizing the importance of ongoing research and innovation. Key players in the market include pharmaceutical companies and research institutions dedicated to advancing hypoparathyroidism treatments. Stay informed about the latest developments in this field by following reputable healthcare publications and industry reports.

Market Trends

The growing use of inorganic growth strategies by companies is the upcoming trend in the market. The market is experiencing significant growth through strategic acquisitions. For instance, AstraZeneca's acquisition of Amolyt Pharma in March 2024 marks a notable development. Amolyt Pharma, a biotechnology company specializing in rare endocrine diseases, brings with it a promising late-stage pipeline, particularly in the bone metabolism sector. The acquisition includes eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide. Eneboparatide's unique mechanism of action makes it a valuable addition to AstraZeneca's portfolio, addressing critical therapeutic goals for hypoparathyroidism.

Further, this strategic move expands AstraZeneca's reach in the rare disease market and strengthens its position in the bone metabolism space. In the treatment of hypoparathyroidism, both medication and surgery are common approaches. Oral and parenteral medications are often prescribed to manage calcium and phosphate levels. Hospitals, specialty centers, and home care settings are common places where patients receive treatment. Hospital pharmacies and online pharmacies play crucial roles in supplying these medications. The global market for hypoparathyroidism treatment is expected to grow steadily, driven by increasing disease awareness, new product launches, and advancements in treatment methods.

Market Challenge

Implementation of stringent regulations is a key challenge affecting the market growth. The market in the US is subject to rigorous regulatory oversight, as evidenced by the extended review process for TransCon PTH, a potential new therapy for adult hypoparathyroidism patients. TransCon PTH, a once-daily, long-acting prodrug of parathyroid hormone, aims to maintain optimal hormone levels for 24 hours. In late 2023, Ascendis Pharma A/S resubmitted the New Drug Application (NDA) for TransCon PTH following a Complete Response Letter (CRL) from the Food and Drug Administration (FDA). The CRL identified deficiencies in the original submission, necessitating additional information and amendments.

Further, the FDA deemed these changes a major amendment to the NDA, extending the review timeline under the Prescription Drug User Fee Act from May 14, 2024, to August 14, 2024. This prolonged regulatory process highlights the importance of adhering to stringent guidelines in the biopharma industry, ensuring the delivery of safe and effective treatments for hypoparathyroidism patients. The market for hypoparathyroidism treatments in the US continues to evolve, with ongoing clinical trials investigating the use of parathyroid hormone, vitamin D analogues, and calcium supplements. Enhanced patient awareness and advocacy efforts are also driving increased medical care expenditure in this space.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

AdvaCare Pharma - The company offers calcium gluconate injection, which is intended to treat problems caused by insufficient calcium levels in the body.

The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Alkem Laboratories Ltd.
• Ascendis Pharma AS
• AstraZeneca Plc
• Cipla Inc.
• COSCIENS BIOPHARMA
• Extend Biosciences Inc
• F. Hoffmann La Roche Ltd.
• La Renon Healthcare Pvt. Ltd.
• LLOYD Inc.
• Lupin Ltd.
• Merck and Co. Inc.
• Pfizer Inc.
• Sigmapharm Laboratories LLC
• Sun Pharmaceutical Industries Ltd.
• VISEN Pharmaceuticals Co Ltd
• Wockhardt Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Research Analyst Overview

The hypoparathyroidism treatment market is witnessing significant growth due to the increasing prevalence of endocrine disorders, including hypoparathyroidism. Hypoparathyroidism is an endocrine disorder characterized by low levels of parathyroid hormone (PTH), leading to imbalances in calcium and phosphate levels in the body. This condition can be hereditary, autoimmune, or idiopathic. The treatment landscape for hypoparathyroidism includes calcium supplements, vitamin D analogues, and hormonal therapy. Calcium supplements and vitamin D analogues help maintain calcium and phosphate levels in the body, while hormonal therapy involves the use of PTH or its analogues to restore normal calcium homeostasis. Calcitriol, a vitamin D analogue, and oral and parenteral calcium supplements are commonly used medications for the treatment of hypoparathyroidism.

Further, hospitals, specialty centers, hospital pharmacies, online pharmacies, and retail pharmacies are major distribution channels for these medications. The biopharma industry is focusing on developing personalized medicines and biologics for the treatment of hypoparathyroidism. Emerging therapies, such as fast-track designation drugs, are undergoing clinical trials to address the unmet needs of patients with this condition. The long-term management of hypoparathyroidism requires close monitoring of serum calcium and phosphate levels, as well as serum magnesium levels. Patients may also require hospitalization for postoperative complications following thyroidectomy. A black box warning has been issued for certain calcium supplements due to potential risks, highlighting the importance of proper patient education and awareness. The medical care expenditure for hypoparathyroidism is expected to increase due to the rising prevalence of the disease and the development of new treatments. Patient epidemiology and pipeline analysis are crucial for understanding the treatment landscape and patient journey for hypoparathyroidism.

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What are the Key Data Covered in this Market Research and Growth Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behaviour
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies

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