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Survey: RA Drug Market Driven by Uptake of Oral Jak Inhibitors and Non–TNF-Alpha Biologics

Biosimilars expected to challenge branded biologics

Decision Resources Group, a health care research firm located in Burlington, Mass., finds that the rheumatoid arthritis (RA) disease-modifying antirheumatic drug market will increase from $14 billion in 2013 to more than $18.2 billion in 2023 in the U.S., Europe, and Japan.

According to the report, tumor necrosis factor (TNF)-alpha inhibitors will remain the leading drug class in both sales and patient shares in the RA market, but growth will be constrained and patient shares will decline because of the uptake of oral Janus kinase (Jak) inhibitors and the entry of alternative biologic agents. In particular, the growth of the Jak inhibitor drug class — driven by the anticipated approval of tofacitinib (Xeljanz, Pfizer) in Europe and two emerging drugs (baricitinib [Eli Lilly/Incyte] and VX-509 [Vertex]) — will be the major contributor to the growth of the RA market from 2013 to 2023.

“Xeljanz will compete for patient share in two areas of the RA treatment algorithm,” said analyst Ronnie Yoo, PhD. “First, with the non-TNF-alpha inhibitor biologics for patients who fail to respond to TNF-alpha inhibitors. Second, to a lesser degree, it has the potential to compete at the same line of therapy as the TNF-alpha inhibitors in patients with an inadequate response to methotrexate.”

Biosimilars of major TNF-alpha inhibitors — infliximab (Remicade, Janssen Biotech), followed by etanercept (Enbrel, Immunex/Amgen) and adalimumab (Humira, AbbVie) — are expected to launch by the end of 2014. While the uptake of biosimilars will constrain the sales of TNF-alpha inhibitors, it may help maintain the patient share of this drug class in the face of emerging therapies, the report says.

In other key findings, the report notes that TNF-alpha inhibitors are deeply entrenched as first-line biologics in the RA treatment algorithm, as rheumatologists remain relatively satisfied with their efficacy and are comfortable with their long-term safety profiles.

“TNF-alpha inhibitors continue to dominate as first-line biological agents, accounting for 71 percent of major-market sales in 2013,” Yoo said. “However, interviewed rheumatologists estimate that 15 to 40 percent of biologic-treated RA patients do not respond to the currently marketed biologics, and many experience diminishing efficacy over the course of long-term TNF-alpha inhibitor treatment.”

Rheumatologists are increasingly turning to alternative biologics — abatacept (Orencia, Bristol-Myers Squibb), tocilizumab (Actemra, Genentech), or rituximab (Rituxan, Biogen Idec; MabThera, Roche) — for patients who fail TNF-alpha inhibitor therapy because of clinicians’ growing familiarity with the agents and with their long-term safety data.

The report states that, although oral agents have the potential to alter the RA treatment algorithm, increasing regulatory pressure to demonstrate strong efficacy against structural progression endpoints will likely be a hurdle for approval and initial uptake.

Source: Decision Resources Group; September 16, 2014.

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