It is no secret that South Asia is home to a vast and booming pharmaceutical market, one that is poised to serve more and more customers and patients both locally and far beyond its borders. Over the past several years, one of the fastest growing segments in the region is biologic drugs, which are used to treat chronic conditions because of their potential to offer patients better long-term outcomes and fewer side effects than traditional, chemical-based therapies. The biosimilar market is also growing driven by the fact that many biologics are scheduled to come off patent in the coming years.
And the shift is not going anywhere. According to the recent Quintiles IMS report, ‘Outlook for Global Medicines through 2021,’ pharmerging markets such as India will continue to be driven by non-original products over the next several years. At the same time, there is also a shift toward regulatory bodies in India and elsewhere across the Asia Pacific region increasing their focus on quality standards and lower particle burden for injectable drug products. Greater regulatory scrutiny and quality standards are placing added demands on drug manufacturers, suppliers and contract service providers. Motivated by concerns for patient safety, regulatory agencies in India and around the world are asking drug and packaging manufacturers to build quality into their products from the start to ensure consistent quality throughout a drug product’s lifecycle.
An evolving containment market
Given this increased focus on safety from regulatory agencies, pharmaceutical companies must now take a closer look at how they will contain their drug. For the majority of drugs, glass remains the preferred containment material. However, glass containment – while suitable for many drug products – can present compatibility challenges with biologics. Undesirable interactions include breakage, delamination, particulates in the suspension and design limitations that don’t allow for higher doses. The latter is relevant because biologic drugs are often made in larger doses and given less frequently.
Enter cyclic olefin polymers (COPs), which can be molded into a variety of shapes and designs. These systems can be designed to enable larger fill volumes and tighter dimensional tolerances, meaning manufacturers can optimize functionality and performance. The factors contributing to the increase of COPs include:
Breakage: A single dose of a biologic drug can cost hundreds or even thousands of dollars. And unlike chemical drugs, for which a 90% price drop can be seen for generic versions, biosimilars commonly cost only 20-30% less than their biologics counterparts. Given these prices, breakage in a clinic or at home presents not only a patient or employee safety issue, but also a major cost concern. Plastics solve that problem.
Supplying a global market: As regulatory agencies crack down on the safety of drugs and their delivery devices and South Asian biopharmaceutical manufacturers of biologics and biosimilars set their sights on supplying a more global market, it will be increasingly important to show regulatory agencies that quality measures are built into the products that deliver their drug. This quality assurance will be essential in order to become leaders in the biologic and biosimilar market. COPs help to address many of the concerns of glass containment for biologics and therefore provide an attractive alternative.
Cost: Problems with primary containment materials can result in delayed regulatory approvals, packaging variability and shortages of needed drug product on the market. All three problems can significantly damage a company’s bottom line as well as its reputation. But higher quality can come with higher investment, so the challenge for drug containment manufacturers becomes achieving the balance between managing the costs of provide higher-quality products while staying mindful of the customers’ total cost and profitability. Polymers can help companies to address this intersection of higher quality and improved overall cost.