Overall industry trends
PharmTech: Reviewing 2011, what would you identify as the most significant issues shaping the bio/pharmaceutical industry?
Kleinrock (IMS): One of the most significant issues, by far, is the policy-driven actions that imposed additional costs to manufacturers or cut prices on medicines. These were largely motivated by fiscal and debt issues and impacted markets across the world.
Second is the unprecedented number of patent expirations that took place in 2011, which are driving the growth of generic drugs. We [IMS Institute for Healthcare Informatics] expect to see future spending on generic drugs coming from increased competition and incentives as patents on innovative products expire. The US will see the largest expansion of generic-drug spending compared with other global developed markets. US generic-drug spending is anticipated to be 7–8% through 2015.
Villax (Hovione): The increased speed and severity of regulatory activity reached a crescendo in 2011—Warning Letters, import alerts, recalls, and consent decrees. Some of it was clear evidence of global medicine agencies acting to recover control over the generic-drug industry whose lightning-speed development and globalization has caught regulators off guard. Take for example, an EU inspectorate report leading to a FDA Warning Letter.
The intensity of outsourcing by innovator-drug companies also is a significant trend, and here the most notable stories are in line with regulatory actions: a string of Warning Letters hitting Big Pharma because of their Indian-based supply chains. As one industry executive noted at a recent conference, 'A firm can have all the SOPs [standard operating procedures], systems, and controls required, but without [a] quality culture, product quality and business continuity are not assured.' Expect customers to be looking for evidence of a true quality culture across the organization and at every level.
Zak (Avantor): During 2011, the pharmaceutical industry has shown a renewed emphasis on all aspects of security and overall quality throughout an increasingly more complex supply chain. Global supply-chain security initiatives are critical tools to prevent what has become an abundance of counterfeit pharmaceutical raw materials and therapeutics found in both developed and emerging markets. They also play an important part in addressing concerns about potential adulteration for economic gain, contamination, theft, and lack of appropriate regulatory compliance. With patient safety as the public's fundamental expectation of the industry, pharmaceutical companies have made supply-chain security a primary responsibility that applies across the organizational boundaries of procurement, manufacturing, packaging, and regulatory compliance. Collaboration within the industry across suppliers and manufacturers allows for the determination, sharing, and implementation of best practices that will continue to enhance supply-chain security and build patient confidence.
Craig (ATMI): In 2011, we noticed a continued push toward gains in manufacturing efficiency. In recent years, manufacturers have qualified and validated single-use technologies to accelerate milestones and address productivity demands. Currently, we are focused on scaling manufacturing processes and optimizing supply-chain infrastructure. Right now, single-use technologies are in the early stages of industrialization. The cycle of innovation is ongoing even as single-use products and systems are being integrated for more efficient manufacturing platforms. Many positive steps were made in 2011 to help solve efficiency challenges. Ultimately, a new approach to manufacturing will be realized through these new technologies.