Based on Phase II results, these products appear to significantly increase the cure rate (65–70% versus 40–50% for SOC) and have the potential to cut the treatment duration in half for some patients. Many clinicians and patients are aware that these new drugs are advancing rapidly and some of the patients who can afford to wait are holding off on starting treatment until these new drugs are approved.
It remains to be seen how much the new drugs will expand the market. Based on the precedent set when the current SOC was introduced and the market roughly doubled, market expansion could be staggering. As new drugs with better cure rates are introduced, a greater proportion of the diagnosed patient population will be willing to be treated. Further growth could be driven by the large treatment-failure population that needs new treatment options.
Despite the excitement among clinicians, patients, and investors, these new drugs have their own drawbacks. Most importantly is that, at least at first, the new drugs will be administered in conjunction with SOC. As a result, cure rates will likely improve, but the poor tolerability of therapy will not.
In addition, the new therapies have side effects, including severe rash, severe anemia, nausea, and vomiting, that will add to the burden of the current SOC. Also, both telaprevir and boceprevir are dosed three times a day (though there is some data to suggest that telaprevir could be dosed twice a day); drugs dosed less frequently would offer improved convenience and lower the likelihood of missed doses (which could lead to drug resistance).
While these new drugs will likely see strong market adoption, they will probably be displaced over time by more effective, better tolerated, and/or more convenient drugs that could make it to market in the two to three years after boceprevir and telaprevir are approved. Literally dozens of drugs are currently in the pipeline.
A handful of companies are taking a different approach. Given the tolerability issues with SOC, firms including Roche, Bristol-Myers Squibb, and Vertex are pursuing development of combinations of new oral drugs with the goal of eliminating IFN and RBV. If any of these oral cocktails are successful, they have the opportunity to displace SOC and grow the market significantly. The holy grail is the oral cocktail, similar to what has been successful in HIV treatment (Gilead and BMS’ Atripla).
The best new drugs will have the right balance of potency, convenience, tolerability, low likelihood of resistance, and options for safely combining with other drugs. Key issues for the size and longevity of the market include: pricing, improvement in diagnosis, finding the right approach to encourage patients to come out of the woodwork, and how long patients and doctors will wait to treat, as treatment regimens improve with each new wave of drugs. In any case, there are big dollars at stake and the excitement over these new potential blockbusters seems downright infectious.