Increasingly Crowded Market for Second-Line Therapies Improving Treatment Options for Moderate-to-Severe Rheumatoid Arthritis Patients
Rheumatoid Arthritis (RA) is a chronic, progressive and currently incurable autoimmune disease that primarily affects joints. It is characterized by synovial inflammation and gradual bone erosion over many years, and disease progression results in stiffness and pain, especially in the hands and feet, which hinders patient mobility. Without treatment, the disease leads to joint destruction and disability.
Prior to 1998, treatment options were limited to small-molecule disease-modifying therapies, such as Methotrexate (MTX), sulfasalazine and anti-malarials. However, while MTX is efficacious in controlling RA symptoms in a large percentage of patients, approximately 33% are unresponsive to these first-line drugs. The approval of revolutionary biological therapies, 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.
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.
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
– Detailed analysis of the pipeline for RA by stage of development, molecule type, program type, mechanism of action, and molecular target, as well as analysis of recent clinical trials by enrollment, duration, failure rate, and promising late-stage pipeline molecules
– Forecasts for the RA market, including epidemiology, treatment usage pattern, pricing, and market size for the 2013–2020 period, for which data are presented at country level with further analysis of key market drivers and barriers
– Major deals that have taken place in the global RA market since 2006, analyzing licensing and co-development agreements by stage of development, year, molecule type, mechanism of action and value; network graphs of these deals are also included
Reasons to buy
Primarily, the report will allow clients to gain a strong understanding of RA, helping to identify and clarify market opportunities and the competitive environment. It will also allow you to –
– Understand the RA pipeline and the key trends in the current product development landscape
– Observe detailed profiles for the promising pipeline products, including revenue forecasts, and gain an insight into how they are likely to compete in the market, and what their main competitors will be
– Follow the trends in RA clinical trial size and duration in relation to industry averages and assess the potential risk of future developmental programs for RA therapeutics, depending on the mechanism of action, by considering the recorded clinical trial failure rates
– Observe the potential growth patterns expected for the RA market over the forecast period, and identify which countries are expected to make the biggest contribution to this growth
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