6 Key Drivers for Biotechnology's 2012 Outlook

Defensive Sector and Economic Driver
During periods of economic uncertainty, the biotechnology sector is often portrayed as defensive given that disease is relentless in both good economic times and bad. Despite recent medical advances, there remains a need for quality, innovative products to diagnose and treat a broad variety of diseases such as cancer, central nervous system disorders, cardiovascular diseases, diabetes, and respiratory and infectious diseases.

Beyond its defensive characteristics, the sector plays a critical role in the US economy. Innovative new medicines developed by life science companies provide better patient outcomes, improved quality of care, and increased life expectancy, and they lead to economic gains and job creation.

While the strengths and weaknesses of the US health care system remain the subject of great debate, my firm believes new medicines should be viewed as investments in the future, not only in patient health – but also in economic recovery and growth. For example, as indicated in my article “Innovative New Medicines are Key to Economic Growth,” a permanent 1% reduction in mortality from cancer alone has a present value to current and future generations of Americans of nearly $500 billion, and a cure would be worth about $50 trillion.

New Drug Approvals
As highlighted in recent years, legislation passed in 2008 gave the Food and Drug Administration more money and resources, but hiring and training hundreds of new employees takes time. With that process well under way, combined with increased familiarity of the risk evaluation and mitigation strategies (REMS) program, my firm and I expected the drug approval process to gradually improve.

Encouragingly, the total number of approvals for new molecular entities and biologic license applications by the FDA's Center for Drug Evaluation and Research in fiscal year 2011 was 35. This is an improvement from 21 approvals in 2010 and 25 approvals in 2009. In fact, according to a press announcement by the FDA, this is among the highest number of approvals in the past decade, surpassed only by 37 approvals in 2009. 

However, an article in Nature Reviews by Asher Mullard listing the annual number of drug approvals going back to 1996 shows that 36 approvals in 2004 (not 2009) was the record for the past decade. The same article also shows that new drug approvals peaked at a high of 56 in 1996.

Notable new drug approvals in 2011 include Johnson & Johnson’s (JNJ) Zytiga (abiraterone) for late-stage prostate cancer; Roche’s Zelboraf (vemurafenib) and Bristol-Myers Squibb’s (BMY) Yervoy (ipilimumab), both for melanoma; Human Genome Sciences’ (HGSI) Benlysta (belimumab) – the first new drug for lupus in 50 years; and Seattle Genetics’ Adcetris (brentuximab vedotin) for a rare lymphoma known as systemic anaplastic large cell lymphoma.

Record Pipeline and Investment
According to the latest report by the Pharmaceutical Research and Manufacturers of America, there are a record number of biotechnology product candidates currently in development. In the US alone, there are more than 900 biotechnology products in development, including 300 monoclonal antibodies, 298 vaccines, 78 recombinant proteins, 50 gene therapy products, 64 cell therapy products, and 23 antisense products. More than one-third of these product candidates are targeting cancer and related conditions, and more than 20% are targeting infectious diseases.

Annual research and development expenditures by PhRMA member companies for 2009 was an estimated $45.8 billion, more than tripling the $15.2 billion level of investment in 1995. However, skeptics will point to the fact that despite growing R&D expenditures, the number of new drug approvals has declined since the mid-1990s (see chart below).


Click to enlarge

Access to Capital
During the second week of January, more than 8,000 registrants gathered in San Francisco for the thirtieth annual J.P. Morgan Healthcare Conference to hear 25-minute presentations from 395 life science companies. For industry executives and investors, the annual event typically serves as a good barometer for the rest of the year.

Between meetings, we roamed the familiar halls of the Westin St. Francis Hotel to assess the mood among participants and also monitored social media outlets throughout the event. In general, the plane flights and networking receptions were crowded as usual, industry observers tweeted a sense of optimism, and attendees appeared more upbeat than in 2011.