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Special Report: Successes and Lessons Learned in the Pharmaceutical Industry, 2009
Decision Resources, Inc., Dec 2009, Pages: 34
Eli Lilly CEO John C. Lechleiter, Ph.D., has said that the biopharma innovation engine is broken and needs repair. At the October 2009 dedication of the new Lilly Biotechnology Centre in San Diego, Lechleiter acknowledged that “at a time when the world desperately needs more new medicines” the pharma industry is “taking too long, spending too much, and producing far too little.” He also noted that pharma companies “mostly have ourselves to blame” for “a loss of trust in product safety and in the honesty of pharmaceutical businesses.” This candid appraisal of the pharma industry at year-end 2009 is refreshing for two reasons: (1) industry stakeholders are no longer focused on trying to defend the indefensible and (2) they are now earnestly focusing on strategies that can be implemented to improve the outlook for an industry that desperately wants to recapture its prior glory of double-digit growth year over year. In this report, we discuss the pharma industry’s successes in 2009 and lessons that can be learned from events that occurred during the year.
Questions Answered in This Report
Biologics represent a significant growth opportunity for the pharmaceutical industry. What new BLAs did the FDA approve in the first 11 months of 2009? Which two Johnson & Johnson biologics do Decision Resources analysts predict will become blockbusters in 2013-2015?
- Drug approvals and best-selling drugs on the market are metrics of success for the 2009 pharma industry. Which pharmaceutical company do Spectrum analysts consider the top pharmaceutical company of the year in 2009? Which three Big Pharma do Decision Resources’ Pharmaview analysts forecast will stand out based on their success in bringing multiple top-ten-ranked drugs to global markets between 2009 and 2015? Which drug will replace Lipitor as the best-selling dyslipidemia drug by 2012?
- By mid 2009, the biotech sector of the biopharmaceutical industry was in freefall. What lifted biotech’s prospects during the third quarter of 2009? What radically different biotech structure will reduce the financial drag of full-time employees and specialist facilities?
- Big Pharma’s flurry of interest in generics heralds a diversification strategy for companies that want to reduce their dependence on producing a string of blockbusters. What nine requirements must innovative Big Pharma conquer in order to effectively compete in generics markets? Is Big Pharma’s new infatuation with generic drugs equivalent to this year’s must-have fashion accessory or will Big Pharma make a real and long-lasting commitment to generics?
- Future success for Japanese pharma lies, in part, in expanding onto the global scene. Why have leading Japanese pharmaceutical companies fallen behind their Western counterparts in terms of scale? Why do Japanese pharma tend to lose out in acquisition deals to Western acquirers?
- The global economic crisis made life even more difficult for biopharmaceutical companies in 2009. What five successes and five lessons from events that occurred in 2009 will influence the industry going forward?
Scope
- Experts: Barrie G. James, Ph.D., principal, Pharma Strategy Consulting; Peter Wittner, principal, Interpharm Consultancy; John Ansell, M.A., principal, John Ansell Consultancy.
- U.S. approvals: Centre for Drug Evaluation and Research (CDER), 87 CDER approvals for new drug applications (NDAs) and new biologic license applications (BLAs), approvals by therapy areas, approvals by type, Centre for Biologics Evaluation and Research (CBER), antiretrovirals, U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), first transgenic-animal-derived product approval, vaccine approvals, H1N1 influenza virus, seasonal influenza virus, king of 2009 U.S. drug approvals.
- Top-ranked drugs: World’s top-selling drugs, 2009-2015; sales trend for statins, 2004-2015; 13 drugs ranked among the world’s top ten best drugs between 2009 and 2015; new market leader in dyslipidemia by 2012; Phase IV clinical studies.
- Biotech industry: Financings in the U.S. biotechnology sector, chapter 7 and chapter 11 bankruptcies, successful initial public offerings (IPOs), financing dynamics, new business strategies.
- Industry consolidation: Supersized companies, ten years of mega-mergers, Pfi zer/Wyeth, Genentech/Roche, Merck & Co./Schering-Plough.
- Generics infatuation: Recent Big Pharma interest in generic drug companies, nine requirements to compete effectively, OTC products, generic penetration in mature markets.
- Japanese pharma: Relative size of Japanese companies, waves of Japanese pharma’s acquisition of Western companies, top ranked Japanese pharmaceutical companies by sales.
- Outlook: Top five successes and top five lessons to be learned from events in 2009.
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