New York – Nov. 10, 2014 – Diaceutics (www.diaceutics.com) today released the four-year update to its Pharma Readiness for Personalized Medicine Report, which examines how prepared leading pharmaceutical companies are for the emerging personalized medicine (PM) business model.
The report reveals that leading pharmaceutical companies fall into two clear groups: those starting to build the internal and external capability for a personalized medicine predominant future, and those still on a learning curve. Within the twelve companies analyzed only three; Janssen, Novartis and Roche, have made the necessary internal and external investments currently to lead the PM Field.
The report also highlights that although only 19% of total sales revenue from these leading companies currently comes from therapies with biomarkers prominently in the label, their share of PM drugs in their Phase three pipelines have advanced from 46% to 74%.
“Since our first Readiness Report in 2010 we can see that most companies have improved their organizational readiness, but not all have advanced their commercial readiness or created the market infrastructure to capitalize on targeted therapy launches. This seems at odds with the PM share within their phase three pipelines and suggests that the R&D investments have still not been matched with adequate commercial focus ,” said Peter Keeling, Diaceutics CEO.
The report includes a comprehensive review and update of twelve leading pharmaceutical companies with at least one targeted therapy on the market, and ranked them according to their potential to capitalize on opportunities in PM.
Methodology: The three-part analysis included a detailed quantitative and qualitative review of each company based on publicly available information, interviews with industry leaders, and an evaluation and company ranking derived from Diaceutics’ analysis of the data available on the twelve companies. Company analysis included a review of corporate structure and leadership, R&D structure, phase 3 pipeline, management and marketing of existing therapies, business deals and strategic partnerships and communications. The 2010 to 2015 analysis uses three categories to rank the companies:
- “Disrupters” – companies which have demonstrated the ability to competitively reshape therapy areas via personalized medicine;
- “Breakaway” – companies that have made proactive investments positioning themselves to migrate operating models and corporate structure to successfully commercialize targeted therapies; and
- “Followers” – companies most likely to respond to the actions of others with little central PM management and little commercial experience with PM therapies.
The analysis indicates that Janssen has now joined Roche and Novartis in the “Disruptors” category. BMS, Pfizer and AstraZeneca have made clear advances over the past four years moving closer to the Disruptor category; followed by the remaining companies Boehringer Ingelheim, Merck, GSK, Amgen, Sanofi and Eli Lilly lagging the pack as “Followers”.
Another key observation of change over the past four years is the integration of “safety biomarkers” into labels of 57 already marketed therapy by the FDA.
“Since 2010 when the FDA incorporated CYP2C19 genetic testing requirement into the Plavix drug label the FDA has continued to retrofit therapy labels with markers of patient metabolism. We are not sure when this becomes a commercial issue for the pharmaceutical industry or merely one of physician choice, however the goal of the updated report and analysis is to cut through the fog of hyperbole and preconceptions surrounding personalized medicine in the interest of furthering the debate over the role the pharmaceutical industry will play in it,” said Keeling.
What’s new in 2015 PM Readiness Report:
- Janssen and Boehringer Ingelheim added to original ten companies analyzed
- Tracks key competitive changes from 2010
- Includes new PM brand index score metric to illustrate how Pharma is executing PM commercially
- Tracks to a vision of PM commercial readiness (optimal example)