By Kevin E. Noonan --
BioWorld Today posted an article last week about the top 25 biotech drugs currently on the market. Written by Michael Harris, Executive Editor, the piece represents a précis of a longer report by BioWorld, entitled "Market-Leading Biotechnology Drugs 2009: Blockbuster Dynamics in an Ailing Economy."
In its brief overview,
the piece mentions the pitfalls and opportunities evident to anyone familiar
with the technology. These include
what Mr. Harris calls an "innovation glut" of good ideas, novel and
ground-breaking technologies, and inspired and dedicated scientists. On the "downside," Mr. Harris writes,
the "technologies are just as complicated as they are inspired," and as a
result, "they tend to take a long time to go from dreams to drugs or to evolve
through the concept-to-currency cycle."
He quotes a term for a successful clinical trial as taking about nine
years, not including discovery, preclinical testing, or the time it takes for
the Food and Drug Administration to approve a biologic drug after filing of a
difficulties, the future looks promising to Mr. Harris:
The truth is, people will continue to be susceptible to disease and drug development innovation, an aesthetic dynamic, unlike material products, that will never fall out of favor. Investors know that ideas are the primary origins of drug development and that foundation must be nurtured with money in order to cultivate the process to a marketed stage.
The proof is in the biologic drug pipeline: the biotech industry has already produced "more than 200 prescription [drug] products, hundreds of diagnostics tools and tests and also has more than 400 candidates in clinical trials." The following chart illustrates these successes:
As shown, while the number of approved biotechnology-based products approved per year is variable, the trend is upward. Mr. Harris characterized biotechnology drugs as being the fastest-growing sector for drug development, and predicts that biotech drugs will comprise over 50% of all drug approvals by 2015 and more than 75% by 2025. These predictions are supported by the expected benefits of increased understanding of drug targets and the molecular and genetic bases of disease, as well as the declining conventional small-molecule drug pipelines in most major pharmaceutical companies.
The table below represents information from Mr. Harris' article, setting forth the revenues for each of the 25 top biotechnology drugs in 2008, and in addition includes the date each drug product was first approved by the FDA and when patents protecting each drug are due to expire. It should be kept in mind that one feature of all these drugs is that they have been approved for more than one indication; indeed, Mr. Harris reports that Genentech's Avastin is being tested in more than 450 clinical trials for treating more than 30 different types of cancer. It should also be kept in mind that 7 of the 25 "biotech" drugs are small molecules, and another 6 are antibodies. We leave it as an exercise for the reader to assess the relative levels of protection provided by patents and data exclusivity should Congress pass a follow-on biologics bill this year.
Finally, the article includes a prediction of the estimated sales and the identities of the top 10 biotech drugs expected in 2014 (see table below). Eight of the ten are top 25 biotech drugs today, with the other two being the small molecule drugs Crestor (rosuvastatin, used for lowering cholesterol) and Spiriva (tiotropium, a bronchodilator for treating asthma and COPD).
This list is the same as the list compiled by EvaluatePharma, a market forecasting firm specializing in the life sciences sector, earlier in this year (see "Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation"). Interestingly, the top three current drugs reported by EvaluatePharma (Lipitor, Plavix, and Advair) are all small molecule drugs having higher revenues than the highest biologic drug, Enbrel (Lipitor's revenues are more than double Enbrel's), and half the top ten in that survey are small molecule drugs and three are antibodies; Amgen's Epogen and Enbrel are the only recombinant drug products in EvaluatePharma's top ten. In contrast, 11 of the 19 drugs in BioWorld's top 25 are recombinant products.
The BioWorld report follows other recent reports indicating that the biotechnology sector continues to improve, weathering serious threats caused by the economic downturn last year (see "Biotech/Pharma Financing Improving, R&D Spending Up"; "Investors Saw Biotech Rebound Coming"; and "Is Biotech/Pharma Beginning to Bounce Back?"). In view of the sentiments expressed by Mr. Harris about the reality that the need for new drugs is never-ending, that constitutes good news for biotech and pharma companies and the public combined.