Addison’s Disease Therapeutics Market is Forecast to Display Moderate Growth until 2019

Friday 27 July 2012, Amsterdam

The new Addison’s Disease (Primary or Chronic Adrenal Insufficiency) Therapeutics - Pipeline Assessment and Market Forecasts to 2019 report is an essential source of information on the global Addison’s disease therapeutics market, and provides analysis of a number of key areas. The report identifies the key trends shaping and driving the global Addison’s disease therapeutics market and insights into the current competitive landscape and emerging companies expected to significantly alter the positioning of the current market leaders. Most importantly, the report provides valuable insights into the pipeline products within the global Addison’s disease sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.

Addison’s Disease Therapeutics Market is Forecast to Display Moderate Growth until 2019

The report estimates that the global Addison’s disease therapeutics market was worth $57.9m in 2011, after increasing at a Compound Annual Growth Rate (CAGR) of 9.7% during 2006-2011. The market is expected to record a CAGR of 10.8% from 2011-2019 to reach $131.6m by 2019. Addison’s patients require lifelong treatment with steroid replacement therapy. Glucocorticoid and mineralocorticoid replacement therapy are currently the most widely used drug classes for the treatment of Addison’s disease. Hydrocortisone belongs to the glucocorticoid class and is one of the most widely preferred drugs, mainly due to its short half life, which enables it to be quickly absorbed into the blood stream. Other long acting glucocorticoids such as prednisone and dexamethasone have the advantage of a once daily dosing schedule, although they do not mimic the physiological circadian rhythm of endogenous cortisol production in the body. This causes excess glucocorticoid levels overnight. Fludrocortisone belongs to the mineralocorticoid class, which is often prescribed along with hydrocortisone or other glucocorticoid drugs.

This analysis found that the high growth recorded in the Addison’s disease therapeutics market during 2006-2011 can be primarily attributed to increasing prevalence and awareness among patients and physicians of the disease. The market is expected to grow at high rate during the forecast period, due to the expected launch of Plenadren (hydrocortisone), a modified release formulation of hydrocortisone at a higher price than the currently available glucocorticoid drugs. It will also increase patient compliance due to its once daily dosing schedule.

Significant Unmet Need in Terms of Convenient Dosing Schedule and Side Effects Associated with Long Term Usage of Currently Marketed Drug

This analysis suggests that Addison’s disease therapeutics market has significant unmet need in terms of health related quality of life such as fatigue, lack of energy, depression, and anxiety. Short acting glucocorticoids such as hydrocortisone have a thrice daily dosing schedule, which many patients see as inconvenient. The long term usage of steroid replacement therapy results in side effects such as increased mortality and morbidity due to cardiovascular disease, cerebrovascular disorders and respiratory infections. Patients are also at high risk of developing conditions such as osteoporosis, weight gain and fatigue. Another disadvantage of long term glucocorticoid replacement therapy is reduced bone mineral density. These long term side effects are a prime concern for physicians. In November 2011, DuoCort Pharma’s Plenadren was approved by the European Medicines Agency (EMA). It is a novel once daily oral modified release formulation of hydrocortisone for Addison’s patients. The once daily dosage regimen will increase patient compliance and improve quality of life.

Thus, there is a scope for novel products with better efficacy and safety profiles and more convenient dosing regimens compared to existing products in the Addison’s disease therapeutics market.

Competition in the Addison’s Disease Therapeutics Market is Currently Strong

This analysis suggests that competition in the Addison’s disease therapeutics market is currently strong. The market is dominated by generic drugs such as hydrocortisone, cortisone, prednisone, dexamethasone and fludrocortisones, all of which are marketed by a number of different pharmaceutical companies as their patent exclusivity has long since expired. This means that pharmaceutical companies are forced to price their products competitively, ultimately resulting in strong competition. The recent approval of Plenadren in Europe will further increase competition. It is also anticipated that Plenadren will be available at a higher price than the existing synthetic glucocorticoids drugs due to its once daily dosing regimen. Although hydrocortisone has been available in the market for 50 years, its modified release version has only just been approved. DuoCort Pharma’s orphan drug designation for Plenadren for the treatment of adrenal insufficiency will afford the company various incentives such as market exclusivity, tax incentives and reduced registration fees. Its approval will foster market growth in the forecast period.

Weak Pipeline in the Addison’s Disease Therapeutics Market

This analysis shows that the Addison’s disease therapeutics pipeline is weak with only one molecule, Chronocort, in Phase I of clinical development for the treatment of adrenal insufficiency. The late stage pipeline molecule Plenadren has recently been approved by the EMA and will further increase patient compliance due to its convenient once daily dosing schedule. Overall, this analysis suggests that the pipeline for Addison’s disease is weak, as it has only one molecule in Phase I of clinical development.