Strong Competition in the Hereditary Angioedema Therapeutics Market

Wednesday 18 April 2012, Amsterdam

The “Hereditary Angioedema Therapeutics - Pipeline Assessment and Market Forecasts to 2019” report is an essential source of information and analysis on the global Hereditary Angioedema Therapeutics market. The report identifies the key trends shaping and driving the global Hereditary Angioedema Therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global Hereditary Angioedema Therapeutics 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.

Hereditary Angioedema Therapeutics Market is Forecast to Show High Growth Until 2019

The report estimated the global Hereditary Angioedema (HAE) therapeutics market at $338.5m in 2011. It is forecast to grow at a Compound Annual Growth Rate (CAGR) of 17.0% to $1,189.4m in 2019. The condition is characterized by recurrent attacks of angioedema; therefore the management of HAE comprises treatment of acute attacks and long term prophylaxis. Factors such as low prevalence, poor diagnosis, and lack of disease awareness are responsible for the small market size. Prior to 2008, Berinert (C1 esterase inhibitor) was the only therapy approved in Europe, while the US lacked any approved therapies. Five HAE therapies were approved during 2008-2011, comprising of Cinryze (C1 esterase inhibitor), Firazyr (icatibant), Berinert and Kalbitor (ecallantide) in the US; and Cinryze, Firazyr and Ruconest (conestat alfa) in Europe. Ruconest will be available (expected approval in 2014) under the brand name Rhucin in the US. Of these, Firazyr, Kalbitor, Ruconest and Berinert are indicated for the treatment of acute attacks. At present, Cinryze is the only drug approved for the prophylaxis of HAE; and therefore in spite of its high treatment cost, it achieved global (the US, Europe and rest of world) sales of $251m in 2011.

The cost of treatment for approved therapies is high in comparison to older therapies such as attenuated androgens and antifibrinolytic agents. The high treatment cost is not a deterrent for the physicians to prescribe the new treatment options. This is largely due to the fact that they have superior efficacy in relation to control of symptoms such as subcutaneous and abdominal swelling. The high priced drugs have captured a high prescription share, resulting in growth of 57.1% during 2006-2011.

During the forecast period 2011-2019, Kalbitor (Europe), Rhucin (the US), Firazyr (Japan), Kalbitor (Japan) and Cinryze (Japan) are expected to be approved. Similarly, Kalbitor (the US), Cinryze (the US) and Ruconest (Europe) are likely to be approved for the treatment of pediatric HAE. The approval of these products across various geographies will contribute to growth at a CAGR of 17.0% to 2019.

Low Disease Awareness Results in Under Diagnosis of Hereditary Angioedema

HAE is a rare and complex disease which suffers from lack of awareness among physicians and the general population. The frequency and intensity of symptoms vary significantly between patients and can change considerably over time. It is an extremely rare condition and many physicians will never have treated a sufferer of HAE, which poses a problem for accurate diagnosis.

A survey conducted in 2010 by HAEi (International Association for Patients with C1 Inhibitor Deficiency) among 11,600 patients from various patient organizations of 12 countries indicated that HAE is under-recognized and under diagnosed, resulting in low treatment rates. The lack of awareness among physicians also results in delayed diagnosis, significantly affecting a patient’s Quality of Life (QoL). Therefore, it is necessary to raise awareness of HAE in order to increase the rate of accurate diagnoses and improve disease management.

Various national associations such as the Hereditary Angioedema Association in the US (HAEA), and the Associazione Italiana Angioedema Ereditario in Italy (AAEE) are trying to raise awareness of the disease in their respective countries by providing accurate and readily accessible information to patients and physicians. Certain companies are also trying to raise of the disease. CSL Behring launched the Patient Awareness Program in 2010 for healthcare practitioners, while Dyax has launched an online portal named HAE Hope through which it provides information for patients and physicians. As a result of joint efforts by associations and companies, awareness of HAE is predicted to increase, resulting in a higher treatment rate.

Strong Competition in the Hereditary Angioedema Therapeutics Market

The current HAE therapeutics market comprises patented drugs, and competition is strong between companies such as Dyax Corp, ViroPharma, Shire, Pharming Group and CSL Behring. CSL Behring has strong presence in the European HAE market, as its product Berinert has been used in Europe for treating acute attacks for the past 30 years. With the approval of Berinert in the US in 2009, CSL Behring was able to enter the US HAE market.

Shire and ViroPharma also have presence in both the US and European markets. Dyax Corp’s drug Kalbitor is only approved in the US. Pharming Group entered European HAE market following the approval of Ruconest in Europe in 2011. As there are so few sufferers, companies must compete fiercely to gain the biggest share of prescriptions. This analysis suggests that these companies are likely to maintain their position in the HAE therapeutics market.

Weak Pipeline is Unlikely to Impact the Market Significantly

The developmental pipeline for HAE therapeutics comprises six molecules, with only one in Phase III. There are four molecules in Phase II and only one in the Pre-clinical stage. The pipeline includes molecules such as C1 inhibitors, recombinant C1 inhibitors and kallikrein inhibitors, all of which are already approved for the treatment of HAE, meaning that the weak pipeline will not have a significant impact on the market.