The global hypoparathyroidism treatment landscape that only gained much significance post the FDA approval of Natpara in 2015, is projected grow at a rather robust CAGR of approximately 8% through 2026. As per a recent in-depth analysis by Future Market Insights (FMI), the valuation of global hypoparathyroidism treatment market is expected to stand at US$ 663.7 Million in 2019. Although the growth rate is expected to showcase similar trends, the global hypoparathyroidism treatment market is still in its infancy, with most of the treatment options in various phases of clinical programs.
“The global hypoparathyroidism treatment market holds the potential to exceed the US$ 1.1 Billion mark by 2026, in terms of revenue. The treatment landscape for hypoparathyroidism—a rare endocrine disorder, characterized by high phosphate and low calcium levels, during low or inappropriately normal PTH level—will mostly be driven by increasing incidences of thoracic surgeries and cancer combined with Rising screening rates of thyroid diseases. Moreover, considering the rarity, hypoparathyroidism was classified as an orphan disease in European Union and United States. Considering which, favorable government schemes relating to orphan drug combined with tax incentives such as tax credits for qualified clinical trials and market exclusivity upon regulatory approval are some expected to translate into high return on investment for companies innovating drugs in hypoparathyroidism treatment market”, explains a senior analyst.
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A Comprehensive Analysis of the Pipeline Clinical Programs for Hypoparathyroidism Treatment by FMI, Reveals:
- There are around 47 ongoing clinical programs, globally, at different stages of development, wherein, 43 are interventional studies and 19 involve API with high potential market equity.
- Most of these clinical programs are aimed at evaluating the efficacy of different treatment lines for hypoparathyroidism treatment, involving Calcitriol, calcium supplements, and magnesium.
- Moreover, since hypoparathyroidism is the state of decreased secretion or activity of parathyroid hormone (PTH), close to 12 such clinical trials are focused on parathyroid hormone.
- Of the total active clinical programs, phase III and phase IV clinical trials, collectively account for approximately 37.3 percent.
- FMI, in its market study on hypoparathyroidism treatment also indicates that nearly 7 percent clinical programs stand terminated, suspended or withdrawn given their side-effects and failed efficacy.
- Although approximately 45 percent clinical trials stand completed, most of the trials do not meet or partially meet the hypoparathyroidism treatment guidelines set by regulatory authorities.
- Of the 47 percent active clinical trials, Shire continues to remain the leader in Hypoparathyroidism treatment clinical space with over 7 such active programs, followed by Entera Bio Ltd.
- North America, accounting for nearly 57 percent leads the clinical trials landscape for hypoparathyroidism treatment, followed by Europe at 29 percent, as in 2017.
Natpara Holds Approximately $2 Billion Market Opportunity, Reveals FMI
- Considering a significant patient pool for hypoparathyroidism treatment and extremely low competition, Natpara is projected to showcase maximum revenue opportunity, with its demand expanding at magnificent CAGR of 145.8 percent, in the last few years.
- Ever since its approval in 2015, Natpara has demonstrated a year-on-year growth of 72.8 percent through 2017
- Despite labeling restrictions (Natpara Risk Evaluation and Mitigation Strategy (REMS) Program), considering Natpara’s side effects including possible bone cancer (osteosarcoma) and high blood calcium (hypercalcemia), the U.S. currently accounts for 99 % of the total Natpara sales. In EU, sales of Natpara reached US$ 109.8 Million, in H1 2018—both the regions representing substantial revenue growth opportunities.
- The bioengineered replacement biologic is also projected to drive significnat adoption of drug titration based on individual cases, translating into personalized medicines.
Hypoparathyroidism Treatment Market Showcases a Fairly Consolidated Landscape
Largely dominated by branded drug manufacturers, the competition in Hypoparathyroidism Treatment Market is projected to remain low through the forecast period of 2018-2026. Key leaders including EnteraBio Ltd., Shire-NPS Pharmaceuticals, Inc., and Teva Pharmaceutical Industries Ltd. account for nearly 50 percent market share, with a key focus on developing novel treatment options for hypoparathyroidism. Apart from new product innovations, key players are also expected to take the ‘strategic acquisitions to expand global presence combined with increasing distribution channel’ route to reach untreated patient pool. In Asia, India accounts for the highest hypoparathyroidism-related mortality incidences, compared to any other region, arising from lack of sufficient screening and treatment lines. However, on the other hand, large unmet treatment needs combined with long clinical trials, will translate into patients opting for alternative medications available in the form of calcium and vitamin generics, thereby increasing the buyer advantage.
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Insights Drawn From Segmentation Analysis of Hypoparathyroidism Treatment Market
- While US dominates the hypoparathyroidism treatment landscape with 86 percent market share considering reasons mentioned, Asia Pacific is also projected to witness strong growth.
- In terms of drug class, calcium supplements will remain the most preferred, with 38 percent market share. PTH will also showcase substantial growth rate.
- On the basis of route of administration, parenteral method will remain the fastest growth segment, compared to oral methods.
- Sales of hypoparathyroidism treatment drugs through retail pharmacies will generate maximum revenue, followed by hospital pharmacies.