including Enbrel, Remicade and Humira, for the treatment of RA patients that are refractory to MTX has triggered unparalleled growth in the market. Globally, there are at least 12 biological therapies, including monoclonal antibodies( mAb), biosimilars and therapeutic proteins, competing as second-line therapies for this sub-population. Over the past 16 years, the therapeutic market for RA has become extremely competitive as a result of the high number of new drug approvals. Competition for Tumor Necrosis Factor Alpha( TNF-a) inhibitors is particularly fierce, and now dominates the treatment market for RA patients who are refractory to first-line Disease Modifying Anti-Rheumatic Drugs( DMARD). In 2013, three TNF-a targeting mAbs, Humira( adalimumab), Remicade( infliximab) and Enbrel( etanercept), were ranked among the top-10 best-selling drugs in the world, with global revenues of $ 11.1 billion, $ 9.9 billion and $ 8.9 billion respectively, reflecting their groundbreaking clinical and commercial success. Despite this, 30 % of RA patients fail to achieve clinical responses when treated with TNF-a inhibitors( Rubbert-Roth and Finckh, 2009). However, patients who are unresponsive to TNF-a inhibitors can also be medicated with the cytokine modulators Rituxan and Xeljanz. Thus, the extensive range of available therapies is addressing the need for efficacious therapies for a broad spectrum of RA patients.
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Modest Rate of Market Growth Expected between 2013 and 2020
The market for disease-modifying RA therapeutics is expected to increase from $ 56.6 billion in 2013 to $ 80.7 billion in 2020, at a Compound Annual Growth Rate( CAGR) of 5.2 %. First-line DMARDs are expected to remain stagnant, as the late-stage pipeline predominantly constitutes second-line therapies. The high number of clinically and commercially strong products in the current market represents a barrier for the market infiltration of such emerging therapies. In the EU market, the patent expiration of blockbuster drugs from 2015 is expected to cause a strong uptake of biosimilars. However, uncertainty over the regulatory guidelines that govern the approval pathway of biosimilars into the US, the largest RA market across the eight key territories, may not measurably affect the pricing of the currently marketed drugs.
Scope The report covers and includes-
- A brief introduction to RA, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
- Detailed analysis of the drugs currently marketed for this indication: MTX, Remicade, Humira, Enbrel, Rituxan, Orencia, Simponi, Cimzia and Xeljanz, including key characteristics such as safety and efficacy, clinical trial outcomes, tolerability, dosing, administration, historical sales, price, and overall competitive strength, as well as a comprehensive heat map comparison
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