The global hypoparathyroidism treatment market was valued at USD 777.4 million as of 2022 and is likely to reach USD 841.9 million in 2023. During the 2023 to 2033 forecast period, the market is expected to incline at a CAGR of 7.7%, and is expected to total USD 1,767.4 million by the end of the said period of assessment.
Parathyroid hormone (PTH) plays a pivotal role in maintaining the optimum level of calcium, phosphate, and calcitriol (active Vitamin D) in the blood and bones. Hypoparathyroidism is an uncommon endocrine disorder that develops due to low production or absence of parathyroid hormone.
Globally, hypoparathyroidism affects approximately 200, 000 people, out of which most cases are associated with accidental damage or removal of the parathyroid gland during thyroid surgery. Other cases are associated with autoimmune, hereditary, and idiopathic issues. The current standard treatment involves the use of calcium and vitamin D analogues (Vitamin D2 & Vitamin D3).
On the other hand, hormonal therapy is also gaining attention, where the primary treatment has found success in cases of severe hypoparathyroidism. The side effects include potential risks associated with developing osteosarcoma has limited adoption rates. Manufacturers in the market are focusing on investing significantly in the development of safe, and effective hormonal therapies in long-term strategies.
| Attributes | Details |
|---|---|
| Hypoparathyroidism Treatment Market Value (2022) | USD 777.4 million |
| Hypoparathyroidism Treatment Market Value (2023) | USD 841.9 million |
| Hypoparathyroidism Treatment Market Expected Value (2033) | USD 1,767.4 million |
| Hypoparathyroidism Treatment Market Projected CAGR (2023 to 2033) | 7.7% |
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Between 2018 and 2022, the demand for calcium supplements for treating hypoparathyroidism dominated the global market mainly owing to cost and efficacy benefits over hormonal therapies and other drugs. Subsequently, rising research and development activities supported market growth.
NATPARA (Takeda), and Rocaltrol (Roche) are some of the commonly prescribed drugs to treat moderate to severe hypoparathyroidism. Issues of product recall and the resultant mismanagement of treatments have led to hospitalizations in severe cases. Manufacturers such as Ascendis Pharma A/S, EnteraBio Ltd, ProLynx, Inc., and Extend Biosciences, Inc. have hormonal therapies in the pipeline which have delivered superior patient outcomes.
The market is expected to witness an increase in patient screening for several thyroid conditions owing to growing patient awareness. The approval and designation of hypothyroidism drugs as orphan products by the United States FDA and the European Commission (EC), coupled with the untapped patient population is expected to have a positive impetus on market growth.
The emergence of personalized medicines, the rapid rise in demand for biologics for hypothyroidism, and consolidation activities by market players will create significant opportunities for the expansion of the hypothyroidism treatment market size over the forecast period, which is projected to expand at a CAGR of 7.7% through 2033.
Government Initiatives to Propel Market Growth
Government support in terms of receiving an orphan drug designation from regulatory bodies such as the United States FDA and European Commission (EC) and financial and tax incentive factors are expected to result in a high return on investment for companies developing novel drugs for treating hypoparathyroidism.
The United States FDA’s orphan drug status is given to biologics affecting fewer than 200,000 people in the United States alone with the benefits of various incentives including tax incentives for qualified clinical trials and market exclusiveness on receiving regulatory approval.
For hypoparathyroidism, NATPARA is the only drug issued with a black box warning, which was notified by United States FDA, in January 2015, and currently has exclusivity until 2022. Also, the treatment is covered by several insurance companies and co-pay policies. Such initiatives are expected to boost the production of novel drugs, which is expected to positively influence the growth of the market shortly.
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Side Effects Owing to the Usage of NATPARA to Restrict the Market Expansion
Currently, NATPARA is the only available drug to treat hypoparathyroidism. Because of its side effects including a potential risk of osteosarcoma, high blood calcium levels, and reduced sense of touch or pain sensation in joints, which could result in hospitalization. The drug is only made available through NAPTARA Risk Evaluation and Mitigation Strategy (REMS) Programs.
Hence, in most of the cases, oral medications are considered as standard treatment for hypoparathyroidism. This limits the adoption of available hormonal therapy. Further, long-term beneficial drug usage symptoms have still not been demonstrated across clinical trials, which might limit the adoption of therapy in patients given the high price of the injection. Drug literature review 2018 states that therapy with rhPTH (1-84) is a long-term management option, where more long-term efficacy and safety data are needed in humans. EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for NATPARA instead of these side effects. Thus, labeling restrictions are expected to hold back the penetration of NATPARA in the major global markets, thereby hampering the overall growth of the market.
The Development of Biologics is Anticipated to Drive Market Growth
The hypoparathyroidism treatment market is shifting towards the demand for biologics over conventional drug alternatives. The efficacy of biologics and their ability to mimic natural body hormones is greater as compared to small molecule options in conventional therapy. This benefit is an essential influencing factor driving the demand for biologics.
Bologics promote the conversion of vitamin D into active forms, which increases the absorption of oral calcium supplements, resulting in synergies with conventional calcium in supplement therapy. Considering the aforementioned factors, the emergence of biologics is expected to offer lucrative opportunities for the growth of the hypothyroidism treatment market.
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United States to Take Over the North American Market
NATPARA (parathyroid hormone), is a recombinant hormonal therapy approved in the United States for the treatment of hypoparathyroidism. It is prescribed to patients who do not show positive results from standard therapies including calcium supplements and vitamin D.
In September 2019, Takeda Pharmaceutical Company Limited announced the recall for all its doses of NATPARA injections in the United States This recall was attributed to the presence of small rubber particles in solution samples, which originated from the rubber septum of the NATPARA cartridge.
This recall of injectable PTH in the United States has created distress among the patients and had a significant impact on treatment cycles. Around 2,700 patients have been affected by the shortage. Patients who are currently being treated with the therapy, have been pushed back to oral medications including calcium supplements and activated vitamin D to control their symptoms.
This transition has created a negative impact on disease management, leading some patients to hospitalization because of severe hypocalcemia. Further, manufacturers anticipate that the PTH injectable will require another year to return to the market. United State has emerged as a leading market, held over 37.7% of the total demand registered in 2022.
High Incidence of Parathyroid Diseases in Germany to Propel The Market Growth
Factors such as rising occurrences of parathyroid diseases, rising government initiatives, increasing medical care expenditure, better regulatory scenarios, and rising reimbursement policies and funding are persistently aiding the expansion of the hypoparathyroidism treatment market in Germany. As indicated by the information proposed by Eurostat, it is seen that among the EU Member States, the largest share of medical care expenditure was recorded in Germany in 2019.
Further, growing approvals and orphan drug designation from the European Commission (EC), increasing candidates in clinical trials for the development of hormonal therapy, presence of pharmaceutical players, which leads to better availability of products across the continent, are some of the factors that are responsible for making Germany, one of the largest market for hypoparathyroidism in Europe. Germany held a market share of 8.2% in 2022.
Adoption of Sophisticated Technology to Raise The Market Demand in India
Implementation of government programs aimed at offering affordable and quality healthcare is expected to complement the growth of India's biopharma industry, in turn creating opportunities for the hypoparathyroidism treatment market. Increasing adoption of technologically advanced treatment and rising awareness among people in India is fuelling the demand for hypoparathyroidism treatment.
India is also considered one of the top destinations of thyroid related disorders in the world, increasing the need for the Hypoparathyroidism Treatment market in the region. Increasing patient pool due to the rise in population, emergence of new diseases, and lifestyle changes are also boosting demand for biopharmaceuticals, which is expected to provide a high opportunity for providers of hypoparathyroidism treatment. The market in the India is poised to grow at a CAGR of 8.6% over the upcoming decades.
Calcium Supplements Segment to Grow Owing to The Lowered Side Effects
Hypoparathyroidism is characterized by low parathyroid hormone secretions which results in low calcium levels in the body. Calcium supplements are preferred as the first line of treatment by doctors to normalize the deficiency.
These supplements show a reduced risk of side effects as compared to hormonal therapy. The recent United States recall of the NATPARA compelled patients to opt for oral medication such as calcium supplements to treat the symptoms. These factors will drive demand for calcium supplements, accounting for the largest share of the global market. The calcium supplements segment accounted for a market revenue of 38.29% in 2022.
Oral Segment to Dominate the Industry
The oral segment by route of administration, held the highest market share due to rising product launches and the presence of a solid pipeline. Various factors like a rapid delivery of drugs, high efficacy, and a higher rate of bioavailability are projected to impel the oral segment development. For drugs having medium to high oral availability, the oral route of administration is effective.
Oral treatments limit the utilization of central lines for intravenous drug administration and accordingly, decrease the danger of complications related to it and also a hospital stay. The advancement of promising new medications and potential clinical pipeline applicants are a portion of the major factors expected to boost segment development. The oral segment held a market revenue of 66.67% in 2022.
Hospital Segment is to Expand Owing to The Rapid Delivery of Medications
The hospital and retail sales are expected to show the maximum share in the market among all distribution channels due to the increasing number of facilities and easy accessibility to patients. Also, the quick delivery of medicines is one of the major factors driving the market growth during the forecast period.
As there are rising numbers of cases of hypoparathyroidism, there is increasing demand for faster accessibility and availability of medicine to treat the disorder as rapidly as possible. Thus, hospitals and retail providers can provide medicines to patients at a faster rate which in turn increases the hypoparathyroidism treatment market.
The global hypoparathyroidism treatment market is dominated by top manufacturers -Takeda Pharmaceutical Company Limited., Entera Bio Ltd., F. Hoffmann-La Roche Ltd, Amgen Inc., and Ascendis Pharma A/S Manufacturers are focusing on enhancing their global and regional presence through acquisitions and collaboration strategies.
| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2033 |
| Historical Data Available for | 2018 to 2022 |
| Hypoparathyroidism Treatment Market Value (2023) | USD 841.9 million |
| Hypoparathyroidism Treatment Market Expected Value (2033) | USD 1,767.4 million |
| Market Analysis | USD million for Value |
| Key Regions Covered | North America; Latin America; Europe; East Asia; South Asia; Oceania; Middle East & Africa |
| Key Countries Covered | United States, Canada, Brazil, Mexico, Germany, United Kingdom, France, Spain, Italy, India, Malaysia, Singapore, Thailand, China, Japan, South Korea, Australia, New Zealand, GCC Countries, South Africa, Israel |
| Key Segments Covered | Product Type, Route of Administration, Distribution Channel, Region |
| Key Companies Profiled | Takeda Pharmaceutical Company Limited.; Entera Bio Ltd.; Amgen Inc.; Ascendis Pharma A/S; F. Hoffmann-La Roche Ltd; ProLynx, Inc.; Extend Biosciences, Inc.; BionPharma Inc.; Teva Pharmaceuticals Ltd. |
| Customization & Pricing | Available upon Request |
The global hypoparathyroidism treatment market is estimated to be valued at USD 841.9 million in 2023.
The global market for hypoparathyroidism treatment rose at a CAGR of 5.1% from 2017 to 2022
The global hypoparathyroidism treatment market is expected to progress at a CAGR of 7.7% from 2023 to 2033
The market in India is projected to rise at a CAGR of 8.6% over the upcoming decade
The global hypoparathyroidism treatment market is predicted to account for USD 1,767.4 million by 2033.
United States has emerged as a leading market, holding over 37.7% of the total demand registered in 2022.
The market in China is projected to rise at a CAGR of 7.9% over the upcoming decade
The calcium supplements segment accounted for a market revenue of 38.29% in 2022.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product Type 5.1. Parathyroid Hormone 5.1.1. Natpara 5.1.2. Others 5.2. Vitamin D Analogue 5.2.1. Vitamin D2 5.2.2. Vitamin D3 5.3. Calcium Supplements 6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Route of Administration 6.1. Oral 6.2. Parenteral 7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Distribution Channel 7.1. Hospital Pharmacies 7.2. Retail Pharmacies 7.3. Online Sales 8. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region 8.1. North America 8.2. Latin America 8.3. Europe 8.4. South Asia 8.5. East Asia 8.6. Oceania 8.7. MEA 9. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 10. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 11. Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 12. South Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 13. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 14. Oceania Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 15. MEA Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 16. Key Countries Market Analysis 17. Market Structure Analysis 18. Competition Analysis 18.1. Takeda Pharmaceutical Company Limited. 18.2. Entera Bio Ltd. 18.3. Amgen Inc. 18.4. Ascendis Pharma A/S 18.5. F. Hoffmann-La Roche Ltd 18.6. ProLynx, Inc. 18.7. Extend Biosciences, Inc. 18.8. BionPharma Inc. 18.9. Sun Pharmaceutical Industries Ltd. 18.10. Teva Pharmaceuticals Ltd. 19. Assumptions & Acronyms Used 20. Research Methodology
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Hypoparathyroidism Treatment Market
