The global amyotrophic lateral sclerosis market is estimated to have reached a value of around $112 million in 2011, and is suggested to decline in value in the coming years falling to $70 million by 2019. This suggests a CAGR of -5.7% between 2011 and 2019. Reasons for the decline in the global amyotrophic lateral sclerosis market include the fact that treatment options are currently limited to Rilutek (riluzole) and off-label medications that offer symptomatic relief. With Rilutek the only approved drug, there is considerable unmet need in this market. Drivers in market between 2011 and 2019 include an increasing global population and an increase in disease awareness.
The ALS pipeline has a few late-stage therapies that could potentially launch in the forecast period, such as ALS-02 (2015) and Radicut (edaravone) (in Japan only, 2013). While these products will expand the market, they will not transform the treatment paradigm. According to Key Opinion Leaders (KOLs), these new products will be mainly used as add-on treatments to Rilutek; KOLs believe a combination therapy would be most beneficial to patients due to the distinctive mechanisms of action of each drug. The primary barrier to market growth will be the anticipated patent expiry of Rilutek in 2013.
As the manufacturer of Rilutek, Sanofi has had a stronghold in the ALS market for over a decade now. Pipeline products, such as ALS-02 (2015), won't enter the market until the latter half of the forecast period, if at all. Companies competing in the ALS market, including Biogen, Avicena, Mitsubishi Tanabe, and Sanofi, are all following the same strategy: to collaborate with or acquire smaller companies that have a well-established history of R&D in developing drugs for rare diseases.
Given the lack of disease-modifying treatment options and the orphan drug status of the disease (which provides numerous financial, marketing, and drug approval benefits), a huge market opportunity exists for companies that can develop an efficacious drug to treat and significantly improve the prognosis of the disease.
There are two first-in-class products in Phase III of development, namely, ALS-02 and Radicut. ALS-02 is an ultra-pure, clinical form of creatine, being developed by Avicena. Radicut (edaravone) is a free radical scavenger being developed by Mitsubishi Tanabe in Japan only. Healthcare professionals expect both of these products to be used as an add-on therapy to Rilutek. Therefore, the new products are expected to drive the ALS market in the forecast period but not transform the treatment paradigm or overcome revenue loss from Rilutek's patent expiration. A recent setback for the ALS therapeutics pipeline has been the failure of dexpramipexole (KNS-760704), an orally administered drug in late-stage clinical development from Biogen.
ALS experts (neurologists and researchers alike) believe that lack of understanding of the pathophysiology and underlying etiology is a major barrier in the treatment of ALS. Various hypotheses have been proposed and studies are being conducted to understand the pathophysiology of ALS. With a better understanding of the mechanisms that cause the disease, researchers hope to unveil new pathways and molecular targets for novel therapies. In addition to the benefit of expanded and more efficacious treatment options, healthcare professionals believe that better tools and physician awareness for early diagnosis of ALS will help improve the prognosis of ALS patients.
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