The medicine pipeline – is innovation matching the need?

PhRMA, the trade group of the Pharmaceutical Research and Manufacturers of America, recently released a report: “Innovation in the Biopharmaceutical Pipeline: A Multidimensional View”. The report provides a look at the number of products in the development pipeline. Data are provided that help to understand the number of pipeline products by development phase and by therapy area.  I wondered how the number of projects by therapy area correspond to need in healthcare. My need measure was US death rates for each condition. [A caveat, these data are fairly broad in categorization; for example, Infection can include vaccines for prevention as well as conventional antibiotics for treatment. Neurology can include Alzheimer’s, MS, etc…]

Development Pipeline and Therapy Area

Figure 1 shows the percentage of products by therapy area.

Figure 2 shows the percentage of total products in development by therapy area by time.  I created two buckets for time: Future (sum of Preclinical and Phase I products; estimated available in perhaps 6-10 years) and Near Term (sum of Phase 2-3 and those Filed/Approved but not yet marketed products; estimated available within 1-5 years).

The highest number of products in development are for cancer with 20% of the Near Term and 25% of the Future products.  The next highest grouping is for Infections, which represent about half of those for Cancer.

Is Development Matching Need?

Figure 3 illustrates the percentages of leading causes of death in the US (an obvious measure of need) versus the percentage of pipeline products being developed for the therapy area (a measure of  innovation and investment). There appears to be a  mismatch of pipeline effort vs. need for heart disease (not enough pipeline). You might think the reverse for Septicemia (too much pipeline) but given the immediate crises with resistant bacteria such an investment is warranted.

Questions

What cannot be determined from this report is the motivation behind the support for the pipeline projects. There is almost always need for a new and improved therapeutic no matter the condition. But in the spirit of being candid, I offer some questions, perhaps rhetorical:

• How many of these cancer pipeline products will offer only a modicum of therapeutic outcome improvement (say statistically increased but realistically not a meaningful increased survival of a few weeks/months) versus available therapies, with the innovating company wanting to charge a premium price for their new product? Of the 12 cancer medications approved by the Food and Drug Administration in 2012, 11 cost more than $100,000 annually, reported physicians in an article in Blood, the journal of the American Society of Hematology, published online in April 2013.
• Can the health care funding system continue to pay multiple thousands of dollars per cancer patient per month of therapy with really no significant change in outcomes?
• Are there too many cancer products being developed just to take advantage of a high-priced therapy area?
• Could the effort/expense developing these excess cancer products be better applied to an area with higher unmet needs, say Alzheimer’s product development?

Moving Forward

Given the future payer environment, the value of future innovations in cancer and other disease therapies will have to meet or exceed the needs of patients, prescribers, and payers. To remain relevant and to survive, companies in the biopharmaceutical industry must understand this reality and adjust business strategies and tactics accordingly. Biopharmaceutical companies operate in a high risk environment but if innovation satisfies significant medical need, the systems are in place to properly reward the innovator.