This BCC Research report determines the current status of the market for rheumatoid arthritis treatments, and assesses their growth potential over a five-year period from 2016 through 2020.
Use this report to:
Analyze rheumatoid arthritis therapeutic products on the market in the U.S. and around the world. Learn about marketed products and also products in different stages of clinical development. Gain insight into the agents that are currently disallowed by the FDA. Receive information about the companies supplying therapeutic products for rheumatoid arthritis.
The global market for therapies for rheumatoid arthritis reached $19.0 billion in 2014. The market is expected to reach nearly $21.3 billion by 2020 from $19.9 billion in 2015, increasing at a compound annual growth rate (CAGR) of 1.3% from 2015 to 2020. Anti-interleukin biologics therapeutic class is expected to grow from nearly $1.2 billion in 2015 to $1.5 billion in 2020 at a CAGR of 4.4% for the period 2015-2020. Biosimilars therapeutic class will grow from $368 million in 2015 to nearly $5.4 billion in 2020 at a CAGR of 71.0% for the period 2015-2020.
STUDY GOALS AND OBJECTIVES
BCC Research’s goal in conducting this study was to determine the current status of the market for rheumatoid arthritis treatments, and to assess their growth potential over a five-year period from 2016 through 2020. Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by progressive joint damage, disability and systemic complications. The disease demonstrates variability in clinical course and severity among patients, which could be due to genetic or environmental factors. The goal of treatment in RA is to achieve clinical remission.
When remission, which is defined by the absence of signs and symptoms of inflammation, is not attainable, the target of treatment is to lower disease activity, particularly in patients with established RA. Prevalence of RA has been estimated to be about 0.5% to 1.5% of the population worldwide. It is normally two to three times more common in women than men and age of onset peaks internationally between 35 and 45 years. However, the reasons for variations in prevalence of the disease across geographies cannot be explained. Although the number of patients suffering from RA is expected to increase with an increasingly aging population worldwide, no accurate projections of future prevalence are available.
This report will provide perspective on drugs and therapies used for the management of RA, including forecasted trends and sales through 2020. Important manufacturers, technologies and factors influencing demand are discussed. In 2015 it was noted that sales for RA therapeutics were $19.9 billion and there are expectations that there will be CAGR of 1.3% in global sales of RA therapeutics and related products in the period of review.
Several therapeutic categories of drugs are useful in the management of RA. Nonsteroidal analgesics and anti-inflammatory drugs are used for symptomatic relief but it is advocated that disease-modifying antirheumatic drugs (DMARDs) be initiated within three months of diagnosis of RA. While introduction of biologic therapy has been recommended after failure of a first DMARD, restrictions on the use of biologics exist in countries with or without a national health service or as a result of health insurance policy restrictions. Pfizer’s Xeljanz (tofacitinib), which was launched in 2012 in the U.S. and later in Japan and the European Union in 2013, fulfilled the unmet need for oral formulation. Cosentyx by Novartis has become available for other indications but has not been approved for RA. The overall pipeline also contains “me-too” therapies and biosimilars. The “me-too” drugs and biosimilars will provide some relief to the high cost of RA treatment, though likely not to the same level as traditional generics.
An American College of Rheumatology (ACR) panel published new rheumatoid arthritis guidelines in 2015. These guidelines address six major topics: 1) use of traditional disease-modifying antirheumatic drugs (traditional/conventional DMARDs, herein referred to as DMARDs), biologic DMARDs (herein referred to as biologics), and tofacitinib, including tapering and discontinuing medications, and a treat-to-target approach; 2) use of glucocorticoids; 3) use of biologics and DMARDs in high-risk populations (i.e., those with hepatitis, congestive heart failure, malignancy and serious infections); 4) use of vaccines in patients starting/receiving DMARDs or biologics; 5) screening for tuberculosis (TB) in the context of biologics or tofacitinib; and 6) laboratory monitoring for traditional DMARDs and included first-time information on glucocorticoids and tofacitinib. Despite the treatment advances achieved with biologics, most patients do not reach the American College of Rheumatologist 50% response (ACR50) target, and few actually achieve remission. Moreover, responses are often not durable, prompting frequent treatment switching. In addition, there is no cure for RA, so curative therapy remains at the top of the list for unmet needs. While physicians agree that biologics are relatively safe and effective, these therapies are still lacking because of their high cost and mode of administration (intravenous or subcutaneous).
Companies supplying therapeutic products for RA are discussed in this report. With an in-depth pipeline analysis, biologic agents, both anti-TNF and non-TNF-related currently under investigation or newly approved for use by the FDA are highlighted. Those agents that are currently disallowed by the FDA will also be discussed. Specifically excluded from the study as considered beyond the scope of this report include detailed reviews of nonpharmacologic therapy utilized for supplemental treatment or disability management.
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