Global Orphan Autoimmune Disorders Therapeutics Market

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GBI Research, the leading business intelligence provider, has released its latest research, “Orphan Autoimmune Disorders to 2017 – Strong Performance by Nplate and Promacta and Future Launches of Immunoglobulin Therapies will Drive the ITP Market”.

It provides in-depth analysis of the drivers and barriers that affect the global orphan autoimmune disorders therapeutics market. The report analyzes the markets for orphan autoimmune disorders in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Treatment usage patterns, sales, price and volume are forecast until 2017 for the key geographies as well as the leading therapeutic segments (ITP, myasthenia gravis and ALS). Furthermore, the report provides competitive benchmarking for the leading companies and analyzes the mergers, acquisitions and licensing agreements that shape the global markets.

It is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
The Global Orphan Autoimmune Disorder Therapeutics Market Will Grow Steadily with Very Few Promising Molecules in the Pipeline

The orphan autoimmune disorder therapeutics market is one of the steadily growing markets in autoimmune therapeutics and is expected to show a significant growth in forecast period. The ITP and ALS market are the leading contributors to the global orphan autoimmune disorder therapeutics market in 2010. Moreover, the market for myasthenia gravis has shown a steady growth in terms of revenue and is expected to grow at a greater pace in the future.

Orphan Autoimmune Disorders, Global, Revenue ($m), 2002- 2017
Source: GBI Research, FDA (Food and Drug Administration), NCBI (National Center for Biotechnology Information), EMEA (European Medicines Agency), PMDA (Pharmaceuticals and Medical Devices Agency), NICE (National Institute for Health and Clinical Excellence)

The ITP market has witnessed a significant growth between 2008 and 2010 due to the launch of two novel second-line therapies, namely Nplate (romiplostim) and Promacta (eltrombopag), which stimulate platelet production in adults with chronic ITP. The ALS market has also shown a steady growth in terms of revenue in the presence of Rilutek, which is the only FDA approved drug for this indication. The myasthenia gravis market is dominated by generics and over-the-counter (OTC) drugs. However the approval of Prograf (tacrolimus hydrate) in Japan (October 2009) and the future launch of Venoglobulin-IH, a human immunoglobulin therapy is expected to boost the myasthenia gravis market in the forecasted period.

The Idiopathic Thrombocytopenic Purpura (ITP) Market is the Major Contributor to the Orphan Autoimmune Disorders Therapeutics Market
The ITP market has shown significant growth between 2008 and 2010 as two new drugs (thrombopoietins), namely Nplate and Promacta, were launched. Moreover, these drugs have shown a substantial growth in their revenue, which boosted the ITP market during this period (2008-2010). In addition, three immunoglobulin products (Rhophylac, Carimune and Privigen) of CSL Behring were launched with ITP as their extended indication. With long-term patent protection and exclusivity of Nplate and Promacta and existing immunoglobulin therapies, the global ITP market is anticipated to grow at a steady pace during the forecast period.

Low Prevalence Rates of Orphan Autoimmune Disorders Affect the Market Size and Growth
Orphan autoimmune disorders fall into the “rare diseases” category, which consists of indications with very low prevalence and incidence. According to one estimate, the average prevalence of ITP is just 9.5 to 20 per 100,000 people. The incidence of ITP in US adults is approximately 66 cases per 1,000,000 per year. On the other hand, the prevalence of myasthenia gravis in the US is estimated to be 14 to 20 per 100,000 people. According to ALS association data, around 30,000 Americans may currently be affected by ALS. The above statistics indicate that these orphan autoimmune disorders have very low prevalence rates and diseased populations, which has a great impact on their market size in terms of revenue.

Stiff Competition from Generics and Off-Label Products is Restraining the Growth of the Orphan Autoimmune Disorders Therapeutics Market
The global orphan autoimmune disorder therapeutics market faces tough competition from generics and off-label drugs. Myasthenia gravis, an orphan autoimmune disorder is a very small market in terms of revenue, where generic and off-label drugs together accounted for 100% of the market in 2010. Mestinon, a branded anticholinesterase inhibitor went off patent in 2003 in the US. Though Venoglobulin-IH is anticipated to launch in the forecast period, it would not have much impact on the generic share as it is estimated that the generic share will be declining by at a slow rate to reach approximately 74% by 2017.

In ITP and ALS markets ’branded drugs’ take a significant market share. However the late-stage R&D pipelines for orphan autoimmune disorders principally comprises immunoglobulin therapies, a few corticosteroids and immunosuppressants. All these factors, coupled with lack of novel molecules in the pipeline, could be a major restraint to the market.

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