Good morning and welcome to the start of a new workweek. We hope you enjoyed a refreshing weekend, as the familiar rhythm of online meetings, calls, and tight deadlines resumes. While the hustle and bustle of life continues, why not take a moment to start your day off right with something energizing? Today’s pick is pistachio crème. As you prepare to tackle your tasks, here are some notable updates that might interest you. We wish you a productive and manageable day ahead—best of luck, and remember to keep in touch.
In significant industry news, GSK has announced its intention to leave the Biotechnology Innovation Organization (BIO), the largest trade group in the biotechnology sector. This decision marks GSK as the fifth company to withdraw from BIO in approximately a year, following similar moves by Pfizer and UCB. The departures appear to coincide with a noted decrease in lobbying expenditures by the group, as well as other challenges it has faced, including a recent restructuring that resulted in the layoff of 30 employees, among them several senior leaders. This upheaval has been compounded by the fact that the group has seen four different CEOs in the last four years, with the latest leader, John Crowley—a biotech executive focused on rare diseases—taking charge in March. Notably, despite leaving BIO, GSK has increased its lobbying spending this year, totaling $3.87 million in the first three quarters of 2024 compared to $3.63 million in the same period last year. Moreover, the pharmaceutical sector may find new opportunities for adjustments in the recently enacted Medicare drug pricing negotiation law now that the GOP has gained control of both the White House and Senate.
On a global scale, manufacturing of active pharmaceutical ingredients (APIs) continues to be dominated by companies in India, China, and Europe. According to data from U.S. Pharmacopeia, only 4% of the APIs noted in Drug Master Files (DMFs) filed with the U.S. Food and Drug Administration (FDA) in 2023 were produced in the U.S. In contrast, 50% of these APIs were reported by India, followed by China at 32% and the European Union at 10%. It is essential to recognize that DMFs are submitted confidentially by companies providing drug constituents to other firms and do not comprise proprietary information. While not every drug product is made with APIs referenced in DMFs, the U.S. Pharmacopeia emphasizes that this geographical analysis can reveal significant trends in global manufacturing. When examining the total active DMFs, India leads with a substantial 48%, succeeded by the EU at 17%, China at 16%, and the U.S. at 9%.
This information underscores the interconnected nature of the pharmaceutical supply chain and highlights emerging trends that could shape the industry’s future. As GSK and others reassess their affiliations, there remains a significant opportunity for innovation and adaptation in the healthcare landscape, especially in the face of evolving government policies.