Birthdays, holidays, and special occasions often seem to provoke retrospection and, sometimes, even introspection. Toward that end, the editors and readers of Pharmaceutical Technology took some time on the occasion of the magazine's 30th anniversary to look back on where the industry has been in order to look forward and make predictions about where it's going. We've converged on three factors that have influenced, indeed shaped the course of the modern pharmaceutical industry: regulation, globalization, and "biologization."
Starting with ingredients themselves—active and auxiliary—we see that biologics-based drugs are expected to be the new growth area. To accommodate these dramatically new products, the industry had to invent dramatically new manufacturing technologies and techniques. And with the advent of new ingredients and classes of ingredients (not to mention some well-publicized failures) comes new regulation. The last couple of years in particular have seen large-scale procedural and philosophical changes at the US Food and Drug Administration, US Pharmacopeia, and other regulatory bodies. These, in turn, necessitated even more technological innovation.
Finally, no one in this industry can deny that manufacturing and research conducted offshore is having and will continue to have a major impact on the way the industry does business. In many cases, offshoring provides for lower labor costs while elevating living standards of overseas workers and creating new consumers. On the other hand, it opens new doors to product counterfeiting and adulteration—issues that can only be addressed through international cooperation and, you guessed it, more regulation.Still, it's been a remarkable 30 years. The following pages report on this time, based on data from you. Some 320 Pharmaceutical Technology readers responded to our email survey, conducted in April–May 2007. Respondents' primary business activities included: branded pharmaceuticals (35%), biologics or biotechnology (16%), generic drugs (10%), consumer healthcare (4%), contract manufacturing (8%), excipient or chemical supply (3%), diagnostics (3%), equipment manufacturing (3%), analytical testing (3%), and other (15%). Respondents' firms brought in: $50 million or less (26%), $51–250 million (14%), $251–500 million (7%), $501 million–1 billion (10%), $1.1–5 billion (13%), $5.1–10 billion (9%), $10.1–50 billion (14%), and greater than $50 billion (7%).
Survey respondents point to shifting portfolios and production sources for active pharmaceutical ingredients (APIs). Almost half (45%) of survey respondents identified the reduction of late-stage drug candidates and 54% cite the increased number of biologics-based drugs as impact factors in API manufacturing. Even more respondents see this pattern continuing during the next 5–10 years. More than half (56%) point to the reduction of the number of small molecules in the industry's pipeline and almost two-thirds (65%) point to an increase in biologic APIs as factors that will influence pharmaceutical manufacturing.
Historical data and forecasts confirm these trends. Big Pharma's sales of biologics are expected to grow at a compound annual growth rate (CAGR) of 13% from 2004 to 2010, according to Datamonitor PLC (London). In contrast, sales of small-molecule products are expected to increase only at a CAGR of just over 1.0% (1).