Albany, NY -- (SBWIRE) -- 01/23/2014 -- Rheumatoid arthritis (RA) is a chronic disorder for which there is currently no cure. It affects around 23.5 million adults in the world (WHO, 2013) and approximately 294,000 children under the age of 18 are affected by pediatric arthritis and other rheumatologic conditions (PhRMA, 2013).
In 2012, immunology drugs generated global sales of around US$36.6bn of which two thirds were associated with the management rheumatology related conditions (US$24.5bn), the remainder of sales were split evenly between the treatment of dermatological and gastroenterology related conditions. Revenues growth has been driven by improvements in diagnosis and early, more aggressive treatment of RA, the approval of new disease modifying anti rheumatic drugs (DMARDs), new formulations/devices and line extensions.
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By 2018, we forecast the immunology market will be worth over US$38.5bn as leading players focus on growing their RA franchises in the emerging markets, launch innovative targeted synthetic DMARDs and biologic DMARDs to address unmet clinical needs and biosimilars emerge in the European market to carve out US$3bn share of revenues.
The market is on the cusp of change as the first orally active biologic Xeljanz (tofacitimib) from Pfizer/Takeda entered the US market at the end of 2012; several new synthetic and biological DMARDs are in late stage clinical development and Europe approved the first biosimilar generic infliximab (Remicade) from Celltrion/Egis and Hospira in September 2013. Generic entanercept (Enbrel) is not far behind from Baxter/Cogerus and several manufacturers have begun to make copycat versions of Humira which goes off patent in the US in 2016.
This report examines in more detail the recent developments that have occurred in the RA market, including the expansion of approved products for new indications, formulations and new market launches and analyses the progression of pipeline products. It assesses how the new American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) guidelines will impact product uptake and discusses the potential impact of biosimilars on the global RA market.
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List of Tables
Table 1: Leading oral synthetic DMARDs.11
Table 3: Leading bDMARDs SC formulations.22
Table 4: Leading bDMARDs IV formulations.23
Table 5: Line extensions of leading DMARDs.24
Table 6: Enbrel regional sales 2012.33
List of Figures
Figure 1: Main pharmacological strategies for rheumatoid arthritis.6
Figure 2: Classification of DMARDs for the management of RA.7
Figure 3: ACR Guidelines for the Management of Early RA.8
Figure 4: Guidelines for the Management of Established RA.9
Figure 5: EULAR Guidelines for the Management of RA - Phase I .10
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