Hematological practices can expect a slate of new generics to replace long-established brand drugs going off patent, as well as new blockbuster blood therapies that will significantly improve the treatment of some malignancies, according to an analysis of the hematology drug pipeline through 2022 by GBI Research, of Britain.
In addition, lifestyle factors and the aging of the baby boom population in the United States will contribute to a rise in the number of patients requiring hematological care, resulting in a domestic market expansion to $39.3 billion by 2022, up from $18 billion currently, according to the GBI forecast. The US market for hematological drugs is expected to grow at a compound annual rate of 11.8% through 2022, by which time the US market will amount to just about half of the global total, according to GBI.
The rosy outlook on spending and blockbuster drug potential comes at a time when US hematologists are worried that CMS may trim Medicare Part B drug compensation. Because the reduction would bite deeply into the payments hematologists receive for high-cost drugs administered in their offices, The American Society of Hematology is particularly opposed to it. According to GBI, significant drug pricing changes could happen as three leading brand-name targeted therapy drugs lose their patent protection: Rituxan (rituximab), Gleevec (imatinib), and Velcade (bortezomib). Rituximab, approved in the United States for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia, and rheumatoid arthritis, faces patent expiration in September of this year. However, it is a monoclonal antibody (mAb) therapy and its competition would fall into the biosimilar category. Because the barriers to approval and market entry are high for biosimilars in the United States, the price of this therapy is not expected to drop precipitously in the near term, according to GBI.
The tyrosine-kinase inhibitor imatinib, for chronic myelogenous leukemia and other cancers, is already exposed to competition by patent expiration, and bortezomib, a proteasome inhibitor for multiple myeloma and mantle cell lymphoma, will face competition in 2017. Imatinib and bortezomib, being small molecule drugs and relatively easy to reproduce, are likely to face substantial price competition from generics, GBI stated.
Figure 1: Hematological Cancers Therapeutics Market, Global, Annual Revenue for Rituxan ($bn), 2006–2022
Source: GBI Research
So far, manufacturers have not succeeded in developing a biosimilar equivalent that could capture a share of the market from Rituxan. FDA requirements for market introduction of biosimilars have been a factor. Teva Pharmaceuticals, Samsung, and Boehringer Ingelheim Pharmaceuticals each have dropped attempts to reproduce the drug. However, the high revenues earned by rituximab, a Genentech drug, combined with the broad number of therapeutic uses for the drug, make it likely that biosimilar competition will eventually emerge for this product, said Yasser Mushtaq, a senior analyst at GBI. He noted that pharmaceutical company Amgen is an example of a company that continues to work on its own version of rituximab.
Mushtaq expects that competition will lower Rituxan sales to $4 billion by 2022 from the current $7.5 billion mark, “which is not an insignificant sum in comparison to the revenue losses expected for Gleevec and Velcade,” he said. These two drugs will face strong generic price competition, he predicts.
A generic version of imatinib has already been developed by Sun Pharmaceuticals and approved by the FDA. “It’s forecast that the revenue for Gleevec will be almost completely diminished by 2021,” Mushtaq said. A similar picture could develop for Velcade. GBI predicts that Velcade sales will measure $3 billion in 2017, when the drug loses its patent, and will drop to $0.9 billion by 2022.
Two pipeline drugs that promise to revolutionize care and command high prices in the marketplace are KTE-C19, a Kite Pharma chimeric antigen receptor T-cell (CART) therapy for refractory aggressive NHL, and CTL019, a Novartis CART therapy for use in relapsed or refractory NHL. In the realm of aggressive B-cell malignancies, “there are very limited treatment options,” so these therapies may have significant market exclusivity, according to Mushtaq. Kite Pharma’s KTE-C19 could fetch $1.5 billion in revenues by 2022, and the Novartis therapy could generate $1.1 billion in annual revenues by then, GBI estimates.