From multiple perspectives, the biopharmaceutical industry is a study in contrasts. As measured by the major stock indices, it would appear that the sector is performing well. The Amex Biotechnology Index (BTK) has more than doubled since the September 2008 financial crisis. The Nasdaq Biotechnology Index (NBI) is at an all-time high and has outperformed the technology-heavy Nasdaq by more than three times and the broader S&P 500 by an astounding seven times since the beginning of 2011.
At the same time, much of the sector appears to be in a state of upheaval. An analysis of companies with market capitalizations under $300 million indicates these smaller companies have lost an appreciable portion of their value over the same period. News headlines underscore the significant challenges faced by many, with companies struggling to make a successful public market debut, often pricing well below the expected range and then only with significant insider support.
Many others are simply abandoning the effort. Venerable venture firms whose names have become synonymous with the industry are turning away from the sector or shutting down. A host of sector influences best explain this divergence in market performance.
The long-recognized predicament of faltering new product development facing the pharmaceutical industry explains much of biotech’s strength.
Over $75 billion in U.S. drug sales are at risk to generic competition over the next five years, representing 30% of all domestic revenues generated by the industry and a staggering sum. At the same time, rather than ushering in a new paradigm in drug development, the mapping of the human genome and subsequent scientific and technological advances have only come to underscore its complexity.
Indicative of the complexity is the cost to bring a new drug to market. As illustrated in Figure 1, in little more than a decade, the R&D investment required to bring a new drug to market has tripled, from $770 million per new molecular entity in 1999 to $2.3 billion in 2010. Nothing has emerged to suggest a shift in the trajectory of these expenditures.
Moreover, the continued disaggregation of the pharmaceutical value chain has increased the industry’s reliance on the biopharmaceutical sector as the source for product innovation. Simultaneous to big pharma increasing the percentage of its R&D budget targeting downstream clinical trial expenditures has been its reduction in preclinical discovery and development spending.
The numbers illustrate just how precipitous this drop has been. As late as 1989, the allocation for preclinical R&D was over 50% of total R&D expenditures. By the late 1990s, that figure had dropped to just over 40%. That percentage continued to drop through the first decade of the new millennium and is estimated to today stand at less than 25%.
Not surprisingly there has been a change in the origins of new therapeutics. In the mid 1990s, 60% of new drugs came from big pharma. Today, 60% of new drugs originate with biopharma.
This would be even more skewed toward biopharma absent the recent wave of acquisitions including Millennium’s acquisition by Takeda, Sanofi’s hostile bid for Genzyme, and Roche’s purchase of Genentech among others, which have distorted the comparison as industry boundaries continue to blur. Acquisitions, and big pharma’s insatiable appetite for new products underlying that activity, have been and appear likely to remain a dominant industry influence for some time.