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(Medical-NewsWire.com, March 26, 2020 ) Market Overview
• The Global Amyotrophic Lateral Sclerosis (ALS) Market is expected to grow at a high CAGR during the forecasting period (2019-2026).
• Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease is a neurological disease that affects the nerve cells (neurons) responsible for controlling voluntary muscle movement that affects nerve cells in the brain and spinal cords which controls the activity of voluntary muscles.
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Market Dynamics
• The global Amyotrophic Lateral Sclerosis (ALS) market is growing due to several factors such as, rising incidence of ALS, rising treatment awareness, increasing pipeline products, and favorable reimbursement policies.
• According to the National Organization for Rare Disorders (NORD), Amyotrophic Lateral Sclerosis (ALS) affects approximately 30,000 people in the United States, approximately 5,000 new cases are diagnosed each year in the United States. In 2015, a total of 16,583 persons were diagnosed with ALS. The estimated prevalence of ALS in 2015 was 5.2 per 100,000 population. Hence, with rising incidence of ALS lead to increase in demand for its treatment.
• Currently, there is no cure for ALS; however treatments are available to control symptoms and to prevent complications. The key players are continuously doing research to cure the disease. For instance, the launch of BrainStorm Therapeutics' NurOwn stem cell therapy in 2019 has the potential to significantly slow the progression of the disease and is, expected to expand the market in the future. Biologic products have a high cost of therapy and as such are expected to generate high sales.
• Owing to the high number of unmet needs, manufacturers are focusing on innovation and technological advances in treatment options which would further drives the growth of ALS treatment market globally. The ALS clinical pipeline is strong and diverse, including late-stage programs which aims at enhancing muscle function, immune modulation, and neuroprotection, as well as mid or early-stage gene therapy or gene silencing approaches, stem-cell therapies, and immune-targeting agents and experts contend that regimens combining multiple mechanisms of action could hold significant clinical promise in the management of ALS. Thus, considerable commercial opportunity exists for developers that can overcome the scientific and clinical hurdles blocking the path to regulatory approval for the treatment of this devastating disease.
• However, due to the rarity of the disease, recruiting a representative patient sample for clinical trials can be difficult and may slow the clinical trial development process. Also, major brands are expected to see their patents expire during the forecast period (2019-2026), which will act as a block as cheap generic versions of the drug will enter the market.
Market Segmentation
• By drug type, the market is classified into Rilutek (Riluzole), Edaravone (Radicava), and others. The drugs did not meet the standard regulatory requirements for approval, but due to the increase in survival of patients, they were granted FDA approval. Radicava remains patent protected, but Rilutek, which was launched in 1995, saw its patent expire in 2013, and cheap generic versions of the drug are on the market. In 2018, Rilutek (Riluzole) ccounted for the largest revenue generating segment because riluzole was the only approved drug for a treatment of ALS, however patent expiry of Rilutek in 2013 has been negatively impacting the ALS treatment market growth. On the other hand, Edaravone (Radicava) expected to show highest growth rate during forecast period (2019-2026), owing to its applicability and higher cost. Edaravone (Radicava) is another treatment in the form of infusion therapy approved by the FDA in 2017 to treat ALS. It protects nerve cells and slows down disease progression by removing free radicals. The treatment has been shown to slow the decline in physical functioning in some ALS patients.
• In addition, robust pipeline molecule such as Methycobal (mecobalamin), AB-1010 (masitinib), Arimoclomol, CK-2017357 (CK-357, tirasemtiv) would assist ALS treatment market growth during forecast period (2019-2026).
Geographical Analysis
• North America holds the dominant market share for Amyotrophic Lateral Sclerosis (ALS) in 2018, and it is expected to maintain the growth over the forecast period, due to the factors, such as increasing prevalence of the neurological diseases and higher treatment awareness, rising funding by government agencies and private organizations in healthcare system. According to the ALS Association, approximately 5,000 people in the U.S. are diagnosed with ALS each year, which averages to about 15 new cases each day. It is estimated that up to 20,000 Americans have the disease at any given time.
• The Asia-Pacific Amyotrophic Lateral Sclerosis (ALS) market is expected to grow at a significant CAGR during the forecast period (2019-2026) due to rising awareness towards treatment of ALS, growing investment in research and development of ALS treatment.
Competitive Landscape
• The Amyotrophic Lateral Sclerosis (ALS) market is highly competitive with presence of large number of players. Some of the major players in the global Amyotrophic Lateral Sclerosis (ALS) market are: Brainstorm Cell Therapeutics, Sanofi, Biogen, Valeant Pharmaceuticals, Roche, Ionis Pharmaceuticals, Apotex, Mylan Pharma, Sun Pharma, Orion Pharmaceuticals, ViroMed, Mitsubishi Tanabe Pharma America, AB Science, Orphazyme, among others.
• The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the Amyotrophic Lateral Sclerosis (ALS) market globally. For instance,
• In May 2019, Biogen Inc. announced the interim results of a phase 1/2 study of tofersen, an antisense oligonucleotide (ASO) being studied for the potential treatment of amyotrophic lateral sclerosis (ALS) in adults with a confirmed superoxide dismutase 1 (SOD1) mutation.
• In April 2018, Target ALS today launched a new study that connects the CReATe Consortium (Clinical Research in ALS and Related Disorders for Therapeutic Development), the Muscular Dystrophy Association and 10 pharmaceutical companies to validate the most promising ALS biomarker candidates, and immediately make all results broadly available to the worldwide ALS research community.
• In 2018, Biogen and Ionis Pharmaceuticals have launched a 10-year, $1 billion-plus expanded collaboration to develop more neurological drugs after six years they began partnering to successfully develop the spinal muscular atrophy (SMA) treatment Spinraza® (nusinersen).
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