The unmet need for a safe rheumatoid arthritis (RA) treatment option without adverse side effects has set the stage for a spate of drug launches in the near future. As a result of this demand, some pipeline drugs have the potential to be blockbusters, especially the oral treatments in late-stage development.
In 2010, the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) revised the 1987 classification criteria for RA to enable early detection. The classification facilitates diagnosing RA patients and gives a boost to the treatment market.
New analysis from Frost & Sullivan’s U.S. Rheumatoid Arthritis Market Assessment of Biologics and New Treatments research finds that the market for RA (biologics and new treatments) earned revenues of $5.78 billion in 2010 and is expected to increase to $8.34 billion in 2017.
The first-line of biologic agents, after methotrexate, is Enbrel and Humira; Remicade, Simponi, and Cimzia are additional anti-tumor necrosis factor (TNF) options. If patients experience TNF failure, physicians then will either change to a second anti-TNF or switch classes to Orencia, Actemra or Rituxan.
Compounds in the late stages of development include CP-690,550 and fostamatinib disodium. CP-690,550 (tasocitinib) is a Janus kinases (JAK) 1/3 inhibitor, which is expected to be the first oral compound to reach the RA market for disease-modifying antirheumatic drugs (DMARDs) inadequate responders (IR). As tasocitinib is being developed as an oral medication, it has the potential to be used ahead of TNF antagonists in the RA treatment paradigm.
R788 is also being evaluated as an oral twice-a-day treatment, as it can be an improvement on the expensive TNF blockers that are delivered subcutaneously or intravenously and have side effects.
Small molecules such as Pfizer’s CP-690,550 can have an impact on the market if they demonstrate positive safety and efficacy data due to the convenience and low cost of oral therapy.
“With the number of biologics on the market and in development for RA, the RA treatment market is becoming crowded,” says Frost & Sullivan industry manager Jennifer Brice. “Biologics entering this market must be able to show efficacy and safety data that is comparable, if not superior, to TNF blockers to gain any market share.”
Many biologics such as TNF antagonists are associated with severe adverse events such as infections and lymphoma. Safety concerns and the annual cost of RA treatment, which can vary from $10,000 to $20,000, can restrain patients–especially uninsured ones–from opting for biologics.
With the patent of the first-line biologic, Enbrel, due to expire in 2012, the entry of biosimilars could be a game changer. Although they can increase adoption rates and availability, these low-priced generics could reduce revenue generation rates.
If adequate reimbursements are not available, patients may choose biosimilars over expensive novel therapies, which will slow down the market’s growth rate. Tight budgets from insurance companies will further restrict the use of novel therapies and encourage generics.
“Biosimilars are expected to influence the U.S. market in the next three years to four years,” says Brice. “To fight back the challenge from these generics, pharmaceutical and biotech companies need to continue to address unmet needs in the treatment of RA by developing novel medications.”
Release Date: Nov. 17, 2011
Source: Frost & Sullivan
