BURLINGTON, Mass.--()--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, through 2021, the number of disease-modifying therapies approved for the treatment of multiple sclerosis (MS) will double in the world’s major pharmaceutical markets—the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. In this new era of enhanced therapeutic potential and complex treatment choices, market fragmentation will intensify as the MS field strives towards a more-individualized approach to treatment.
“However, while each new product will establish a role in treatment, we forecast a continued reliance on time-tested mainstays owing to near-term gaps in clinical experience and long-term data with new entrants, coupled with the absence of prognostic or therapeutic response markers to guide more-precise treatment selections.”
Investigational MS therapies comprise a diverse mix of oral and parenteral agents, novel compounds, next-generation products and reformulations. Among new oral agents projected to launch at this time, Decision Resources forecasts that Biogen Idec’s oral immunomodulator BG-12 will enjoy the greatest commercial success, garnering major-market sales of approximately $3 billion in 2017 thanks to clinical data that support a highly favorable risk/benefit profile. Also in 2017, first-to-market oral agent Gilenya/Imusera (Novartis/Mitsubishi Tanabe Pharma) is forecast to exceed $2 billion in major-market sales. Other emerging oral competitors including Sanofi/Genzyme’s Aubagio, which recently launched in the United States, are not expected to achieve blockbuster status owing to more-limited clinical advantages.
The Pharmacor advisory service entitled Multiple Sclerosis also finds that the anti-CD52 monoclonal antibody (MAb) Lemtrada (Genzyme/Sanofi/Bayer HealthCare) and the anti-CD20 MAb ocrelizumab (Roche/Genentech) will serve as important alternatives for MS patients who respond suboptimally to prior therapy, or for patients who exhibit aggressive or worsening disease activity. However, Decision Resources expects outstanding safety concerns will constrain the adoption of these potentially high-risk/high-reward therapies by a generally conservative neurologist prescriber base. Together with emerging anti-CD25 MAb daclizumab (Biogen Idec/Abbott), emerging MAbs are expected to earn major-market sales of approximately $2 billion in 2021.
In response to the influx of promising new agents, clinicians’ reliance on platform injectable therapies such as the interferon-betas (IFN-βs) and Teva’s Copaxone is projected to wane over time, yielding an aggregate six percent annual decline in major-market sales through 2021. Decision Resources expects follow-on products from Biogen Idec (pegylated IFN-β-1a) and Teva (Copaxone 40 mg, three-times-weekly) will represent useful—albeit somewhat incremental—advances in this evolving market, with both products capturing more than 40 percent of their respective major-market drug-level patient shares in 2021. The findings also reveal that, by way of risk-factor stratification, Biogen Idec/Elan’s Tysabri is expected to remain a valuable treatment option in the face of growing competition, capturing approximately 15 percent total market share in 2021.
“A clear takeaway from the recently concluded 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis is that the MS field remains primed for new disease-modifying alternatives to treat patients across the clinical spectrum,” said Decision Resources Analyst Jonathan Searles. “However, while each new product will establish a role in treatment, we forecast a continued reliance on time-tested mainstays owing to near-term gaps in clinical experience and long-term data with new entrants, coupled with the absence of prognostic or therapeutic response markers to guide more-precise treatment selections.”
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