The changing pharmaceutical landscape is a popular discussion point as of late. Armed with a fresh, non-blockbuster-reliant business model and treatment options that are expanding from small molecules to a range of new, more targeted therapies, the industry is at what PwC calls, “a critical juncture.”
Parenteral drug delivery is the second largest segment of this transformative pharmaceutical market — eclipsed only by the more mature oral solid dosage forms — accounting for nearly 30 percent of total pharma market share. According to Freedonia Group research, the market for parenteral drug delivery products is projected to rise over 10 percent annually to $86.5 billion in 2019.
Parenteral drugs — which enter the body via injection or infusion, rather than through the gastrointestinal tract — are taking a strong position alongside the more established oral solid dose forms and are quickly coming into their own.
As biologic drug approvals rise, the parenteral drug pipeline has followed suit by shifting from small molecules to complex biologics. A significant percentage of new drugs in the product pipeline are biologics. Of the Novel Drug Approvals for 2015, 32 were small molecules and 12 were biologics. All 12 approved biologics are delivered parenterally, as well as seven of the 32 new small molecules. Including Astella’s Cresemba (approved in both parenteral and capsule form), the 2015 parenteral drug approval total is 20.
No matter what the dosage form, pharmaceutical manufacturers are up against the same challenges: pressures to increase speed and reduce costs, expand product pipelines and meet more stringent regulatory requirements.
According to Hal Baseman, CEO, Valsource LLC and Immediate past Chair of the PDA (Parenteral Drug Association), several specific challenges are at the forefront of parenteral drug discussions, so much so that task forces and initiatives by trade organizations, such as PDA, have been formed to address these topics and help identify areas in which manufacturers can improve. Examples include:
Aging facilities: Aging facilities with ineffective process control systems may be a signifcant contributor to the drug shortage problem. Owners of aging facilities are often choosing between continuing to use old, perhaps outdated technologies previously validated, or modernizing the facility with new, more effective technology closer to the industry standard.
Offshore manufacturing: The need to reduce costs has increased the number of pharmaceuticals and APIs manufactured and sourced from abroad, especially from India and China. While more mature markets have spent decades defining quality culture, companies in emerging markets may lack the experience level necessary for effective contamination control, especially when it comes to the complexity of sterile injectables.
Harmonization of global requirements/regulations: While the FDA used to be what Baseman calls the “gold standard” for regulatory guidance, advancements made in Europe and Asia have created multiple levels of regulatory expectations. Differing requirements often create redundant efforts and drug approval challenges.
“Oftentimes it does not appear that regulatory expectations from different countries are aligned. But this is often a misconception stemming from differing terminology and nuances,” explains Baseman. “But on a positive note, there is an increase in awareness and discussion between regulators, and they are working to better harmonize expectations.”
Quality management: The number of industry drug shortages that have impacted parenteral medications is significant. Many of these drug shortages, according to Martin VanTrieste, senior vice president, Quality at Amgen Inc., could be avoided by developing a robust quality system, designing in product quality and establishing a culture of quality.
“I believe that there are three essential elements for product quality in parenteral medications. First, a modern quality system that is robust, simple and sustainable that provides knowledge to individuals and the organization. Second, strong support from R&D to develop and characterize robust raw materials, manufacturing processes and products using a Quality by Design approach. Third, a culture of quality that instills flawless execution and continuous improvement at all levels of the organization. By having developed these three elements, an organization can achieve quality beyond compliance,” says VanTrieste.
PICKING UP THE PACE