Hyperparathyroidism – Analysis and Market Forecasts to 2019

New Report Forecasts Hyperparathyroidism Therapeutics Market at $2.62 Billion by 2019
 
Nov. 8, 2012 - PRLog -- Hyperparathyroidism (HPT) patients can expect a slow but steady change in treatment options, as pharmaceutical companies work through stringent clinical trials, states a new report published by healthcare experts GlobalData.

The new report* looks at the drug pipeline and subsequent market forecasts for the endocrine disorder, which sees excessive amounts of the Parathyroid Hormone (PTH) produced from the parathyroid glands located in the lower neck.

Parathyroid glands respond to low calcium levels by increasing production of PTH, which controls calcium, phosphorus and vitamin D levels within the blood and bones. This reaction results in higher levels of calcium in the blood and urine, loss of calcium from bones and hypercalcemia.

According to the report, the hyperparathyroidism patient population is expected to increase over future years, primarily due to increasing Chronic Kidney Disease (CKD) prevalence and an increase in the elderly population.

Treatment options currently available for hyperparathyroidism can effectively control PTH levels, while offering moderate safety profiles, but a space still exists in the market for novel products with superior efficacy, lower adverse effects, improved patient compliance and increased affordability.

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Significant opportunities still exist for novel molecules and novel formulations, and several new treatments are anticipated - including CTAP101 capsules, expected to be launched in the US in 2015, KAI-4169 IV in the US in 2016, and KAI-4169 IV in the EU5 (France, Germany, Italy, Spain, and the UK) in 2017.

Cytochroma’s CTAP101 is a First-in-Class (FIC), vitamin D pro-hormone, which is hoped will enable the effective control of elevated PTH levels and correction of underlying vitamin D insufficiency in CKD stage 3 and 4 patients. Currently, CTAP101 is the only molecule in Phase III clinical trials.

KAI Pharmaceuticals (an Amgen company) is developing KAI-4169 IV,an FIC, second-generation, optimized Calcium-Sensing Receptor (CaSR) agonist, which has shown improved efficacy, tolerability and patient compliance with low adverse effects in CKD stage 5 patients, in Phase II trial results. The company is also developing a transdermal form of the drug for both pre-dialysis and dialysis HPT patients; this delivery system is in the preclinical phase of development.

In addition to the launches of these novel drugs, patent expiries are anticipated during the forecast period for the current market leaders—Zemplar in 2012, Hectorol in 2014 and Sensipar/Mimpara in 2015—which will change the competitive landscape in the foreseeable future. Despite the promising profiles of CTAP101 and KAI-4169 IV, the hyperparathyroidism pipeline as a whole is weak, with only seven molecules, and only one molecule in Phase III trials. The years of study necessitated for most new molecules will restrict the market growth over the forecast period. Furthermore, in the US market, recent and upcoming changes to the bundled dialysis payment system will hinder growth, as capped reimbursement amounts for Medicare recipients result in lower overall sales of marketed drugs, and even deter companies from pursuing R&D in the HPT space.

The hyperparathyroidism therapeutics market is forecast to show moderate growth during the forecast period. GlobalData estimates the global hyperparathyroidism therapeutics market in 2011 at $2.01 billion, and expects it to grow at a Compound Annual Growth Rate (CAGR) of 3.3% to reach $2.62 billion by 2019.

This report gives an overview of hyperparathyroidism, including epidemiology, etiology, symptoms, diagnosis, pathophysiology, management and treatment guidelines. It provides annualized hyperparathyroidism therapeutics market revenue, annual cost of therapy and forecast for eight years to 2019, and analyses current and future market competition in the global hyperparathyroidism therapeutics market.

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