Table of Contents
Scope and Methodology
•This research service evaluates the market for prescription drugs and biologics for the long-term treatment of rheumatoid arthritis (RA) prescribed in addition to standard of care. It does not evaluate the market for corticosteroids, non-steroidal anti-inflammatory agents (NSAIDs), and other analgesics or background disease-modifying antirheumatic drug (DMARD) therapy.
•The study takes into account products in the market as well as those in development and discusses market challenges, drivers, and restraints. Segmentation by drug class is also provided along with additional supporting information such as clinical trial timelines and results, projected launch timelines, and epidemiology.
•The information provided in the research service has been derived from primary research with key opinion leaders and secondary research from published sources including disease control organization websites, public health organization websites, company publications including annual reports, SEC filings and press releases, government sources, and published articles in scientific journals.
•The number of people globally with RA is x million in 2014. The chronic disease is more prevalent in elderly patients.
•The overall disease prevalence is not expected to change significantly in the near term with the expected rise in the number of patients being x million in the next four years.
•The tumor necrosis factor (TNF) inhibitors Enbrel, Humira, and Remicade dominate the market as first-line standards of care.
•The TNF inhibitors are well entrenched and are expected to continue to dominate the market during 2015 and 2016, until the launch of new drug classes for the treatment of RA.
•New biologics arriving in the market will impact TNF inhibitors’ share. However, novel orals and biologics are generally reserved for anti-TNF refractory patients.
•High costs make biologics inaccessible to many patients, resulting in a need for less costly options without sacrificing safety or efficacy. Biosimilars, such as infliximab, which were launched in emerging markets, are expected to be the choice of many patients who are not able to purchase biologics.
•There are 11 marketed products globally, and 14 are in Phase III clinical trials. The research and development (R&D) trend is to develop TNF, interleukin, and Janus kinase (JAK) inhibitors, as well as Anti-Cluster of Differentiation (CD) products. R&D is focused on increasing efficacy and safety as well as lifestyle quality by changing the administration forms from subcutaneous to oral.
•Three products are expected to be launched in the United States in 2016.
•Bariticinib, developed by Eli Lilly, is an oral medication which causes fewer side effects than Pfizer’s tofacitinib, Xeljanz.
•BCD-020, developed by Biocad, is expected to make a major impact in the market for being the first anti-CD20 biosimilar approved for RA.
•SAR153191/REGN88, developed by Sanofi and Regeneron, is the first fully human monoclonal antibody anti-IL-6.
Rheumatoid arthritis is a highly complex disease, pharmacological management of which is challenging.
The market is dominated by three entrenched biologic products—Embrel, Humira, and Remicade.
The high cost of biologics limits patient access and leaves a large portion of the market untapped.
Changes in clinical practice trends, such as earlier diagnosis and early initiation of treatment, could expand the market.
In the light of availability of several safe and effective therapies, the bar for the approval of new therapies has been significantly raised.
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