The 2017 edition of the annual Drugs to Watch report forecasts that eight new drugs will enter the market in 2017 and achieve blockbuster sales of >$1 billion by 2021, as evaluated by consensus sales forecast data from Clarivate Analytics Cortellis Competitive Intelligence (source Thomson Reuters I/B/E/S).
The forecast top seller
Roche’s Ocrevus, the first anti-CD20 monoclonal antibody in multiple sclerosis, was approved in the U.S. in March 2017. Twice yearly injection reduces the rate of relapse of the disease by 46% more than that of the former standard of care, Rebif; the drug also delays disease progression and reduces the number of new brain lesions. Ocrevus is also the first to prove effective in an aggressive form of the disease known as primary progressive multiple sclerosis.
The multiple sclerosis market has been moving towards novel oral therapies in recent years (Tecfidera, Gilenya, Aubagio) and away from the older injectable interferon options that were used in the 1990s. However the fervor over oral drugs has faded in the last two years as Ocrevus has neared the market. The drug’s potency, tolerability and convenience suggest it will be received favorably when it is launched, despite the possibility of a rare association with serious brain infection, and the positive label given by the U.S. regulatory agency means the drug will see use in patients when they initially present with the disease. Some caution may be required initially, as prescribers may continue to favor the oral options until they are more familiar with Ocrevus, but specialists will likely be rapid adopters and strong uptake may be expected in the medium term. Cortellis Competitive Intelligence forecasts sales of $3.328 billion in 2021.
The top 10 forecasts we report in Drugs to Watch, as well as available forecasts for more than 1,500 drug assets in Cortellis Competitive Intelligence, serve to highlight many of the key trends at play in the pharmaceutical industry. The following sector trends are expected to be key factors in 2017:
Potentially the biggest headwind facing the industry at the moment is the volatility that is beginning to be felt as the political backdrop changes in both the U.S. and Europe and the sector becomes sensitive to the uncertainty. President Trump has stated he will pursue an agenda against high U.S. drug prices and has already sought, unsuccessfully so far, to repeal the Affordable Care Act. In Europe, meanwhile, Brexit casts further unknowns in regulatory authorization procedures, trade, and pricing.
Industry leaders may start to find it more difficult to strategize accurately for the future, and companies may begin to become more reserved in their outlook until they better understand how these new factors will shape the industry.
Complexity in oncology
The increasing knowledge of the molecular complexity of cancer has presented opportunities, as well as fundamental challenges, in the quest to treat and control cancer. Better understanding has led to development of highly complex potential new therapies, as highlighted by the CAR-T therapies (chimeric antigen receptor T-cells) which are seeing much company focus and investment at the moment. This technology involves removing immune-boosting T-cells from a patient, engineering them to target their specific cancers, then re-infusing them to target and destroy cancer cells throughout the body.
Clinical data for these engineered T-cells has been compelling in blood cancers, even in patients with late-stage disease, which has prompted big players to enter the field (Novartis, Pfizer) as well as smaller, more specialized companies (Juno, Kite, Bluebird). However, there appear to be some universal side effects, and some patient deaths have occurred; in addition, optimizing the production of CAR-T and manufacturing considerations could be daunting. Key for their wider success perhaps hinges on their ability to be used in patients with solid tumors, and this will be another important area for future research.
Combinations in immuno-oncology
Immuno-oncology, defined as harnessing the innate purpose of the immune system to self-destruct cancer cells, has become the hottest topic in the industry, and monotherapy use of the first of these new drugs (Opdivo, Keytruda, Tecentriq) has now taken its place in the routine treatment of cancer. The future in this category is likely to be in combination use, with the possibility of synergistic combinations with targeted agents, chemotherapies and radiotherapy appearing limitless. Achieving enduring remissions and managing toxicities will be key as the industry continues to seek to understand a more rational combinatorial approach in this category.
A pricing crisis in the U.S.
The reverberations from strong criticism of price hiking during the U.S. election – on both branded and generic products – are likely to continue to be felt as demands persist for new drug pricing models. The industry will need to find ways of better defining, demonstrating and driving the value of the medicines it produces, and the tools and metrics used by payers to evaluate the cost-effectiveness of novel and innovative products will similarly have to adapt.