New Pharmaceutical Regulations Could Influence Market in the Future

A recent report from MarketsandMarkets found that North America, Europe, and Japan account for more than 70% of the pharmaceutical packaging market in 2012. For the most part, that stems from the fact that the U.S. and Japan are the top consumers of those products in the world. The key markets in Europe are Germany, the U.K., France, Spain, and Italy. By 2018, the Asia-Pacific market is actually expected to surpass North America and Europe.

Plastic bottles and blister packs have the greatest market share currently, at nearly 36%, but could be replaced in the future.

“Maximum growth in the near future is expected to come from pre-fillable syringes and inhalers, medication tubes, vials, labels & accessories,” Jack Fitzgerald notes. “Plastics and polymers are the largest consumed raw material for the pharmaceutical packaging products and are fast replacing other raw materials such as glass and metals due to its ease in design, excellent barriers properties, and cost-effectiveness.”

One concern that manufacturers in every region need to have is safety and fraud prevention. Consumers all over, particularly in the EU, have unwillingly purchased and taken falsified medications. In Europe, the Falsified Medicines Directive (FMD), which was approved in 2011, has worked to counter false medication production and has seized nearly 30 million counterfeit medications.

On top of that, regulations like quality controls on imported items and heavier requirements for wholesalers are starting to take hold. Though rules associated with authenticity and verification on packages are turning out to be complex, they are vital for preventing the distribution of falsified pharmaceuticals.

“What’s clear now is that the rules will bring in one of the biggest production changes in the pharmaceutical industry for a long time because for the first time there will be a need to have a unique identifier code on each pack,” says Craig Stobie, global life sciences manager at Domino Printing Sciences, Cambridge, England.

While that change should be a good thing for consumers, there are concerns about the cost relative to the tangible influence it will have. “The implementation of safety features will add significant costs for low-priced medicines even though only 0.005% of medicines in the EU legal supply chain are alleged to be falsified,” Maarten van Baelen, medical affairs manager at the European Generic Medicines Association (EGA) of Brussels says.

It is hard to speculate how the new regulations will influence the global pharmaceutical marketplace. In the short term, it might slow growth for European manufacturers, but a guarantee of increased quality could be beneficial over time and the EU could gain an edge on the U.S. and Japan.