The Global Hyperparathyroidism Treatment Market is estimated to be valued at USD 780.1 Mn in 2024 and is expected to reach USD 991.2 Mn by 2031, growing at a compound annual growth rate (CAGR) of 6.9% from 2024 to 2031.

The hyperparathyroidism treatment market is expected to witness positive growth over the forecast period due to the rising prevalence of hyperparathyroid disorders and increasing adoption of minimally invasive surgeries. According to a recent survey, hyperparathyroidism affects around 1 in 1000 adults annually in the United States. With growing geriatric population, the cases of primary hyperparathyroidism are increasing at a faster pace thus driving the demand for treatment solutions. Moreover, technological advancements in medical imaging techniques have enabled precise localization of abnormal parathyroid glands thereby enabling minimally invasive surgeries such as minimally invasive parathyroidectomy (MIP). MIP procedures require smaller incision resulting in lower healthcare costs, less surgical complications, and faster recovery time. This trend towards less invasive surgeries is favoring the growth of hyperparathyroidism treatment market during the forecast period.

Market Driver - Increasing Prevalence of Hyperparathyroidism and Advancements In Early Diagnosis and Management.

Hyperparathyroidism condition occurs due to overproduction of parathyroid hormone from the parathyroid glands located in the neck region. The exact causes behind the overproduction of this hormone are yet to be fully understood, however genetic and environmental factors are known to play a significant role. With changing lifestyle patterns and dietary habits, the prevalence of hyperparathyroidism has been steadily increasing over the past few decades. Long term intake of diet low in calcium and vitamin D makes individuals prone to this disorder. Also, family history of this condition elevates the risk. As per estimates, about 1 in every 1000 individuals might be suffering from hyperparathyroidism without even realising it.

Advancements in diagnostic methods have enabled physicians to detect hyperparathyroidism at a much early stage compared to past. Tests like serum intact parathyroid hormone (PTH) level analysis and ultrasonography of the neck are widely used as first line screening and diagnostic tools. These tests have made diagnosis a non-invasive procedure avoiding risks associated with invasive tests like four gland surgical exploration of neck earlier. Besides, physicians are also able to better differentiate between normal and pathological parathyroid hormone levels owing to robust assays available today. This early diagnosis allows for timely intervention slowing down disease progression.

Along with early diagnosis, management of hyperparathyroidism has also improved significantly in recent times. Minimal invasive surgical methods like video-assisted parathyroidectomy and radioimmuno-guided parathyroidectomy are gaining popularity over traditional bilateral neck exploration. These focussed localization approaches result in lower complication rates and swifter recovery compared to conventional surgery.

Market Driver - Rising Demand for Innovative Therapies Targeting Secondary Hyperparathyroidism in Chronic Kidney Disease Patients.

Chronic kidney disease (CKD) has emerged as a major public health concern globally with rising incidence of diabetes and hypertension. Secondary hyperparathyroidism, characterized by abnormally elevated PTH levels, is a frequent complication observed in patients with moderate to advanced CKD. Sustained elevated PTH can further exacerbate kidney damage accelerating progression towards end stage renal failure. Conventional CKD-mineral bone disorder therapies employing calcium supplements, vitamin D sterols and phosphate binders have limitations in effectively controlling PTH levels over long term. This has fuelled the demand for novel treatment approaches from both patients and physicians' standpoint.

Recently, recombinant human PTH (rhPTH) has shown promising results as an adjunct treatment to conventional regimens. Drugs like teriparatide acts by intermittent administration of PTH analogous to normal daily hormonal fluctuations helping restore normal bone remodelling. Other emerging therapies are antibodies targeting excess PTH like burosumab. Cinacalcet continues to play a significant role as an additional PTH lowering option for those refractory or intolerant to conventional lines. Currently, late phase clinical trials are evaluating next generation therapies combining calcimimetics with other agents or drug delivery systems like nanoparticles for prolonged efficacy. Should ongoing research efforts prove fruitful, availability of superior treatment alternatives are certain to strengthen market potential further in coming years.

In summary, the above outlined market drivers highlight how shifts in disease epidemiology coupled with ongoing innovation are collectively strengthening the business case for companies operating in this therapeutic area. Continuous medical progress holds promise for improved clinical outcomes boosting uptake of both established and novel treatment modalities over the long run.

Market Challenge - High Costs Associated with Novel Treatment Options Like Calcimimetics and Challenges In Long-Term Patient Management.

One of the major challenges faced by the hyperparathyroidism treatment market is the high costs associated with novel treatment options like calcimimetics. Calcium-sensing receptor agonists or calcimimetics are increasingly being used to manage hypercalcemia in patients with primary hyperparathyroidism or secondary hyperparathyroidism. However, these drugs come with a significant cost burden and insurance coverage is also limited in many countries. For instance, cinacalcet, a leading calcimimetic marketed by Amgen, has an annual drug cost of over USD10,000 per patient in the United States. The high costs of long-term medication negatively impact treatment adherence and poses considerable strain on public healthcare budgets. Moreover, while these drugs have shown good efficacy in controlling parathyroid hormone and calcium levels, their long-term safety and effects on bone mineral density are still being evaluated. This necessitates regular monitoring of patients on calcimimetics, further escalating the overall treatment costs. Unless generic alternatives emerge or pricing of novel therapies comes down substantially, high treatment expenditure will continue to restrict market growth prospects.

Market Opportunity - Ongoing Clinical Trials for Innovative Therapies Fuels Current Opportunities.

One of the key opportunities in the hyperparathyroidism treatment market lies in the ongoing clinical trials for innovative new therapies. For instance, Paladin Labs' investigational drug PLS-240 is currently being evaluated in Phase 3 trials for the management of secondary hyperparathyroidism in patients on hemodialysis. If successful, PLS-240 has the potential to address an important unmet need as an oral therapy offering an alternative to existing injectable drugs like calcimimetics. Several other drug candidates targeting parathyroid hormone, calcium sensing receptors and phosphate homeostasis are also in early to mid-stage trials. A strong clinical pipeline offers hope that the next few years could see the approval and launch of novel treatment options addressing the shortcomings of current therapies. This would help drive market revenues by expanding treatment patterns and enabling more effective long-term management of both primary and secondary hyperparathyroidism. Promising candidates emerging from the trial phases bode well for sustained growth opportunities in the future.

Hyperparathyroidism is typically treated in a step-wise manner based on disease severity and symptoms. For mild asymptomatic cases, initial treatment involves lifestyle modifications like diet and exercise to control serum calcium levels.

However, for moderate to severe cases, drug therapy is prescribed. First line treatment involves oral calcimimetics like Sensipar (cinacalcet). By reducing parathyroid hormone (PTH) secretion, calcimimetics help normalize calcium levels and reduce symptoms effectively in over 80% of patients.

For those who fail medical therapy or are intolerant to side effects, surgery becomes the preferred option. Parathyroidectomy, which involves removing one or more of the parathyroid glands causing the excess hormone secretion, provides the best chance of cure. Over 95% of patients experience complete remission after surgery when all abnormal glands are correctly identified and removed.

For recurrent or persistent cases even after surgery, physicians often prescribe phosphate binders like Fosrenol (lanthanum carbonate) and calcium supplements. By controlling phosphate absorption from the gut and maintaining adequate calcium intake, serum PTH and calcium levels can be stabilized long-term.

Other factors influencing treatment choices include disease severity, comorbidities, progression of symptoms, costs, patient preferences and risks of invasive procedures. Close monitoring of lab parameters allows prescribers to customize therapy based on each case's unique profile.

Hyperparathyroidism has different stages of progression based on severity of symptoms. Early stage or asymptomatic hyperparathyroidism may only require lifestyle modifications and monitoring. Advanced stages may require drug therapies or surgery.

For mild cases, lifestyle changes focus on diet and exercise to strengthen bones. Maintaining adequate calcium and vitamin D through diet helps control parathyroid hormone levels.

In moderate cases, drug options are considered. Cinacalcet (Sensipar) is a first-line drug that reduces calcium levels by inhibiting parathyroid hormone secretion. It is taken orally and generally well-tolerated long-term with minimal side effects.

For more severe presentations, surgery is the preferred option. Parathyroidectomy involves removing the affected parathyroid gland(s). This corrects the underlying cause of excessive hormone production. Minimally invasive radioguided parathyroidectomy is the gold standard, using pre-operative scanning and intra-operative gamma probe detection to precisely locate and remove diseased glands.

In recalcitrant cases where all glands appear overactive, total parathyroidectomy with auto transplantation of parathyroid tissue is performed. This offers the best chance of cure while maintaining post-operative calcium metabolism.

The treatment plan is customized based on symptom severity, comorbidities, and specialist evaluation. While lifestyle changes serve early disease, drugs offer non-invasive control and surgery provides a definitive cure for advanced hyperparathyroidism.

Focus on R&D and New Product Launches: Several players have focused aggressively on R&D activities to develop new and improved treatment options for hyperparathyroidism.

Acquisitions and Partnerships: Companies have expanded their hyperparathyroidism product portfolios and geographic reach through strategic acquisitions and partnerships. Similarly, Abbvie has partnered with strong regional players in emerging markets like China to commercialize its hyperparathyroidism drug Zemplar, helping drive international growth.

Focus on Specialized Segments: Some players have developed winning strategies targeting specific patient segments like those with moderate-to-severe hypercalcemia.

The above examples show how new product launches, acquisitions/partnerships and focus on specialized patient groups have helped key players gain significant leadership positions and sales growth.

Insights, By Product, Parathyroid Hormone Drives the Product Segment Due to Its Targeted Mechanism of Action.

By Product, Parathyroid hormone is expected to account for 55.8% share in 2024. This is because parathyroid hormone offers a targeted mechanism of action for treating hyperparathyroidism that is not found in other product types.

Hyperparathyroidism is caused by excessive levels of parathyroid hormone in the body. Parathyroid hormone plays a key role in regulating calcium and phosphate levels. When parathyroid hormone levels are too high, it can lead to bone loss, kidney stones, and other health issues. Treating the underlying cause by lowering parathyroid hormone levels is pivotal for managing hyperparathyroidism.

Parathyroid hormone acts directly on the parathyroid glands to help restore normal parathyroid hormone secretion. By targeting the glands that produce excess parathyroid hormone, it addresses the root cause in a precise manner. Other product types like vitamin D analogues and calcium supplements do not focus treatment in the same targeted way.

Vitamin D and calcium supplements aim to indirectly influence parathyroid hormone levels through their roles in calcium regulation. However, they do not get to the core issue of reducing parathyroid hormone secretion from malfunctioning parathyroid glands. Due to its direct mechanism of action, parathyroid hormone is able to control hyperparathyroidism more effectively than these indirect treatment approaches.

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

Within the route of administration segment, oral administration is projected to account for 54.8% in 2024. This is because oral treatment provides unmatched convenience compared to other administration routes.

For patients needing lifelong control of their hyperparathyroidism, oral therapy offers lifestyle practicality that intravenous and subcutaneous options cannot match. With oral medications, patients do not need to undergo injections or infusions. This eliminates burdens like visiting clinicians' offices or self-administering treatments. The ease of oral therapy promotes higher medication adherence. Patients are more likely to strictly follow their prescribed oral regimen without disruptions. This improves health outcomes, as maintaining close control of hyperparathyroidism is important. Other administration routes risk non-adherence due to issues like inconvenient scheduling of visits or patient discomfort with medical procedures.

Additionally, oral medications allow for discreet, private dosing without others needing to observe or assist. This privacy aspect is valued by hyperparathyroidism patients. Overall, oral administration's unmatched convenience drives its popularity and largest market share over intravenous or subcutaneous alternatives. This convenience also resonates with healthcare providers.

Hyperparathyroidism is a common endocrine disorder marked by the overproduction of parathyroid hormone (PTH), which causes elevated calcium levels in the blood and associated complications like kidney stones, bone weakness, and fatigue. Diagnosis typically involves blood tests to measure calcium and PTH levels, along with imaging to detect any gland abnormalities. There are three forms of hyperparathyroidism: primary, secondary, and tertiary, each with distinct causes and treatment approaches. Primary hyperparathyroidism is often caused by a benign tumor, while secondary hyperparathyroidism is usually linked to chronic kidney disease or vitamin D deficiency. Treatment can range from watchful waiting in asymptomatic cases to surgical removal of the affected glands or the use of medications like bisphosphonates or calcimimetics. Pathalys Pharma is developing PLS240, an emerging calcimimetic in Phase III trials, which promises to enhance the treatment of secondary hyperparathyroidism in patients undergoing dialysis. The development of new therapies such as PLS240, along with advances in early detection and management, is expected to drive growth in the hyperparathyroidism therapeutics market in the coming years.

The major players operating in the Hyperparathyroidism Treatment Market include Pathalys Pharma, Amgen Inc., Takeda Pharmaceutical Company Limited, Sanofi S.A., Roche Holding AG, Novartis AG, AbbVie Inc., Kyowa Kirin Co., Ltd., Shire Pharmaceuticals, Radius Health Inc. and OPKO Health, Inc.

In May 2024, Pathalys Pharma announced the development of PLS240 (upacicalcet), a novel calcimimetic currently in Phase III clinical trials for the treatment of secondary hyperparathyroidism in hemodialysis patients. This drug offers the potential to improve the management of elevated parathyroid hormone levels, providing a new treatment option for patients suffering from chronic kidney disease.

• By Product
  • Parathyroid Hormone
  • Vitamin D Analogue
  • Calcium Supplements
• By Route of Administration
  • Oral
  • Intravenous
  • Subcutaneous