The hypoparathyroidism market is estimated to be valued at USD 731.1 Mn in 2024 and is expected to reach USD 1213.4 Mn by 2031, growing at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2031. Advancements in drug research and development have enabled manufactures to explore novel treatment approaches for hypoparathyroidism. Growing access to healthcare infrastructure and services in developing regions is also supporting patients to seek and initiate early treatment.

Market Driver - Growing Incidence Due to Thyroid Surgeries and Autoimmune Disorders

The number of hypoparathyroidism cases has been rising steadily over the past decade, primarily driven by the increasing incidence of thyroid surgeries as well as a sharp rise in autoimmune disorders that can potentially lead to underactive parathyroid glands.

It is estimated that over 90% of hypoparathyroidism cases stem directly from some form of thyroid surgery. On the other hand, conditions that trigger an autoimmune attack on the parathyroid glands like Graves' disease have seen a considerable uptrend in many countries. Since parathyroid failure can arise as a complication of such autoimmune thyroid disorders, their rising prevalence has translated into elevating numbers of hypoparathyroidism patients over time as well.

Furthermore, advancements in diagnostic techniques have enabled more reliable identification of hypoparathyroidism cases that may previously have gone undiagnosed or misdiagnosed. Combined with the general population growth globally, these determining factors have widened the patient pool suffering from inadequate or no parathyroid hormone production.

Unless corrective steps are taken to minimize inadvertent removal of all parathyroid tissue during thyroid operations, or autoimmune conditions are better controlled, the mounting pressures will continue propelling the hypoparathyroidism market higher in the future.

Market Driver - Development of Recombinant Parathyroid Hormone Therapies Enhancing Patient Outcomes

A successful parathyroid hormone replacement regimen is pivotal to mitigating complications arising from long-term hypoparathyroidism such as hypocalcemia. Traditionally, supplements containing calcium carbonate and vitamin D derivatives were relied upon to artificially boost calcium levels. However, relying solely on these approaches often fell short of comprehensively addressing the multifaceted hormonal deficiencies associated with hypoparathyroidism. The last decade has thus witnessed encouraging progress on the drug development front, including approvals of the first recombinant parathyroid hormone therapies.

These human parathyroid hormone analogues designed to mimic the body's natural PTH have significantly improved hypoparathyroidism management. Not only are they highly effective at restoring serum and urine calcium to standard levels, but also aid renal reabsorption of phosphorus and skeletal mineralization by directly stimulating bone-forming cells.

Compared to conventional treatments, recombinant drugs enable more physiologic restoration of hormone signaling pathways deficient in hypoparathyroidism patients.

As a result, use of recombinant therapies is gathering momentum as the new cornerstone of hypoparathyroidism treatment globally. This transition to more effective management holds promise for slowing disease progression and hospitalization rates associated with inadequately controlled symptoms over the long run.

Market Challenge - Expensive Therapies Limiting Patient Access, Especially in Developing Regions

One of the key challenges currently facing the hypoparathyroidism market is the expensive nature of existing therapies, which severely limits patient access in many developing regions worldwide. Hypoparathyroidism is a rare condition requiring lifelong treatment, yet the cost of drugs can amount to thousands of dollars per patient annually.

For many patients in lower-income countries, gaining regular access to prescription medications is simply not financially feasible. Even in regions with some form of universal healthcare, the high drug prices may mean hypoparathyroidism treatments are not widely reimbursed.

As a result, patients in developing areas often have to rely on alternative therapies like calcium supplements, which are generally less effective at managing symptoms and long-term complications. The prohibitive costs pose severe limitations on treatment rates and disease management outcomes.

Unless more affordable treatment options emerge, a large proportion of hypoparathyroidism sufferers globally will remain without proper care.

Market Opportunity - Growing Healthcare Infrastructure Presents New Market Opportunities

The gradual expansion of healthcare infrastructure and services in emerging markets presents considerable opportunities for players in the hypoparathyroidism treatment landscape. As access to basic medical care spreads to underserved populations worldwide, more patients are gaining familiarity with diagnostic tests and lifelong chronic conditions.

Where public hospitals and clinics have previously lacked resources to identify rare diseases, improving facilities and trained staff open new avenues for hypoparathyroidism screening, diagnosis and long-term support. A developing middle-class also increases the percentage of people with insurance or the means to regularly purchase medications.

Entering these nascent but rapidly developing markets early would allow companies to educate local physicians and patients about treatment alternatives. It could also lead to partnerships with national health programs seeking to cover novel therapies. If addressed properly, the enhancement of infrastructure across scores of rising economies worldwide may substantially expand the reach and revenue potential of innovators in this field.

Hypoparathyroidism is typically treated via a stepwise approach based on the severity of symptoms. For mild cases with only periodic symptoms, prescribers may first recommend oral calcium and vitamin D supplements like Tocomin and Caltrate. These aim to maintain appropriate calcium levels and prevent long term complications.

However, for moderate to severe continuous symptoms, the first-line treatment is calcium carbonate supplements combined with an activated vitamin D medication such as calcitriol (Rocaltrol). This aims to more actively regulate calcium and parathyroid hormone levels. For patients who do not respond adequately, the next treatment considered is parathyroid hormone therapy. This may involve injections of teriparatide (Forteo), a recombinant form of PTH, which can help build bone density.

In refractory cases where the above options provide insufficient control, surgical parathyroid gland implantation is explored. This aims to permanently restore endogenous PTH production. Post-surgery, lifelong supplemental activated vitamin D and calcium are still required in most cases. Brands like Rocaltrol and OsCal are commonly prescribed long-term for maintenance.

Other factors like a patient's age, lifestyle, dietary preferences and compliance history also play a role in prescribers' medication decisions at each disease stage.

Hypoparathyroidism treatment depends on the severity and stage of the condition. Mild cases are often treated with calcium and vitamin D supplements. However, more severe long-term cases may require additional therapies.

There are four main stages of hypoparathyroidism based on symptom severity. Stage 1 involves few symptoms controlled by lifestyle changes. Stage 2 symptoms are bothersome but controlled by calcium and vitamin D supplements alone. Stage 3 involves frequent symptoms despite supplements. Stage 4 symptoms are incapacitating without additional treatment.

For stage 3-4 patients, oral calcitriol (Rocaltrol) or injectable parathyroid hormone drugs like teriparatide (Forteo) are prescribed. Calcitriol promotes calcium absorption from food while replenishing vitamin D levels. It is preferred first due to its low cost. However, it provides less reliable control than parathyroid hormone therapies. Forteo is a recombinant form of PTH that more effectively regulates calcium and phosphate levels. It is self-administered daily by injection, making it more inconvenient but more effective for long-term management of advanced disease.

Surgery to implant a parathyroid tissue auto-transplant may also be considered for refractory cases. This restores natural PTH production and regulation of calcium levels.

Focus on new product development - Leading companies like Shire, Roche, AbbVie have aggressively invested in R&D to develop new treatment options for hypoparathyroidism. In 2018, Shire launched Natpara, the first FDA approved recombinant parathyroid hormone treatment for hypoparathyroidism.

Acquisitions and partnerships - Companies have made strategic acquisitions and partnerships to enhance their product pipelines and market reach. For example, in 2019, Takeda acquired Shire for $62 billion, gaining access to Shire's large portfolio of drugs including Natpara. Earlier, Shire had partnered with Anthropic to develop an AI platform for personalized hypoparathyroidism treatment. These strategic moves helped companies expand their offerings.

Patient support programs - Pharmaceutical companies run patient support programs to improve patient adherence and outcomes. For instance, NatparaAccess, Shire's support program, provides insurance verification, co-pay support and product delivery assistance.

Awareness campaigns - Major players regularly conduct awareness initiatives to educate public and physicians about hypoparathyroidism management options. For example, between 2015-2020, Shire cumulatively invested over $25 million in disease awareness campaigns highlighting symptoms, diagnosis process and available treatments. Increased awareness has benefited all market participants by growing the overall patient pool seeking care and treatment.

Insights, By Treatment: Maintaining Optimal Calcium and Vitamin D Levels Drive Hormone Replacement Therapy Segment

In terms of treatment, hormone replacement therapy is estimated to account for 60.3% share of the hypoparathyroidism market in 2024, owing to its effectiveness in maintaining optimal calcium and vitamin D levels. Hormone replacement therapy helps restore parathyroid hormone levels through administration of synthetic forms of PTH, which regulate calcium and phosphate metabolism. It promotes calcium absorption in the gut and bones and reduces urinary calcium excretion.

PTH also aids renal reabsorption of calcium and encourages production of vitamin D, which enhances intestinal calcium absorption. Maintaining healthy levels of calcium and vitamin D is critical for neurological function, muscle contraction, vascular integrity and cellular signaling in patients with hypoparathyroidism. The ease of use and consistent results achieved through PTH supplementation drive its preference over other treatment options.

Insights, By Route of Administration: Oral Administration Dominates Due to Convenience

In terms of route of administration, oral route of administration is estimated to hold 54.8% share of the hypoparathyroidism market in 2024. This is because oral administration through tablets and capsules offers superior convenience compared to parenteral modes such as injections. Patients find it effortless to consume oral medication without the need for hospital visits or clinical supervision.

The non-invasive nature of oral drugs boosts compliance, as they do not cause pain or discomfort associated with injections. Additionally, oral drugs have lesser safety concerns and infection risks than parenteral routes. Together, the easy self-administration and risk-free profile of oral medications make them the preferred choice for hypoparathyroidism treatment.

Insights, By End User: Hospitals Lead Due to Holistic Care

In terms of end user, hospitals contribute the highest share of the hypoparathyroidism market. This is because hospitals can provide multidisciplinary care centered around hypoparathyroidism management. They have endocrinologists, dieticians, surgeons and nursing staff well-equipped to monitor calcium, vitamin D, phosphate and PTH levels regularly through blood tests and imaging.

Timely adjustments can be made to drug types and dosages under medical guidance. Hospitals also offer specialized services like ultrasound-guided parathyroid gland surgery. The availability of round-the-clock care during emergencies and complications drives hospitalization. Moreover, the reliance on hospitals is higher during initial diagnosis and establishment of effective medical routines for hypoparathyroidism patients.

• Prevalence: Hypoparathyroidism affects approximately 70,000 people in the United States, with surgical procedures accounting for about 75% of cases.
• Economic Burden: The high cost of lifelong treatment, including supplements and monitoring, places a significant financial burden on patients and healthcare systems.
• Regional Insights: North America dominates the hypoparathyroidism market with a 40% share, followed by Europe at 30%. The Asia-Pacific region is expected to witness the fastest growth due to increasing healthcare investments.
• Regulatory Approvals: The introduction of recombinant human parathyroid hormone (rhPTH) therapies has revolutionized treatment, providing physiological hormone replacement and reducing dependency on high-dose supplements.
• Clinical Trials: Ongoing studies are exploring gene therapies and novel delivery mechanisms, such as transdermal patches and long-acting injectables, which could significantly impact future treatment strategies.

The major players operating in the hypoparathyroidism market include Takeda Pharmaceutical Company Limited, Ascendis Pharma A/S, Amgen Inc., Entera Bio Ltd., Shire Plc, Roche Holding AG, Eli Lilly and Company, Forte Biosciences Inc., AbbVie Inc., and Novartis International AG.

• In September 2023, Entera Bio Ltd. announced positive results from their Phase 2 clinical trial of EB612, an oral parathyroid hormone (PTH) therapy. This trial focused on treating hypoparathyroidism, and the data demonstrated that EB612 was safe and effective in managing key clinical markers such as calcium and phosphate levels in patients. The successful outcomes from this trial represent a key milestone in developing EB612 as a first-in-class oral PTH therapy, positioning it as a promising alternative to injectable treatments for hypoparathyroidism​.
• In June 2023, Ascendis Pharma A/S received FDA approval for TransCon PTH, now marketed as Yorvipath. This once-daily injectable treatment is designed for adults with hypoparathyroidism, a rare condition caused by insufficient parathyroid hormone, leading to low calcium and high phosphorus levels in the blood. This approval was significant as it provides a new therapeutic option for hypoparathyroidism, especially after Takeda ceased the production of Natpara, which was previously the only FDA-approved treatment for this condition​.
• In October 2022, Ascendis Pharma received FDA priority review for TransCon PTH, a hormone replacement therapy for adult patients with hypoparathyroidism. This investigational prodrug aims to restore physiological levels of parathyroid hormone (PTH) over a 24-hour period, addressing both short-term symptoms like muscle cramps and long-term complications such as calcium deposits and impaired renal function. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for April 30, 2023, and no advisory committee meeting was scheduled. TransCon PTH holds the potential to be the first hormone replacement therapy to treat the underlying cause of hypoparathyroidism.
• In June 2021, BridgeBio Pharma and its affiliate Calcilytix received Fast Track designation from the FDA for Encaleret, a calcium-sensing receptor (CaSR) antagonist. Encaleret is being developed to treat autosomal dominant hypocalcemia type 1 (ADH1), a rare genetic condition caused by mutations in the CASR gene, which disrupts calcium regulation in the body. This designation aims to expedite the development of Encaleret, recognizing its potential to address significant unmet needs in managing calcium homeostasis, which is not fully managed by current standard therapies like calcium and vitamin D supplements​.

• • By Treatment
    • Hormone Replacement Therapy
      • Recombinant Parathyroid Hormone (rhPTH)
      • Vitamin D Analogues
      • Calcium Supplements
    • Adjunctive Therapies
      • Magnesium Supplements
      • Phosphate Binders
• By Route of Administration
  • Oral
    • Tablets
    • Capsules
  • Parenteral
    • Injections
• By End User
  • Hospitals
  • Specialty Clinics
  • Homecare Settings