Pharmaceutical market responds to new drugs and challenges

Pharmaceutical & Medical Packaging News staff

Regulations, the development of technology, and an increased awareness of counterfeiting will spur the growth of the pharmaceutical packaging market in the year ahead.

Erik Swain, Senior Editor

With new and pending regulations on bar coding, stability, aseptic processing, child-resistant/senior-friendly packaging, and other areas, packaging is in the spotlight more than ever before. At the same time, heightened awareness of counterfeiting and technical developments, such as the use of packaging systems for drug delivery, results in packaging that can no longer be an afterthought.

“In the past, packaging has been seen as necessary, but it wasn’t as reviewed or as commented upon as many other aspects of a product,” says Julie Clifford, assistant director of package development, Alcon Laboratories (Fort Worth, TX). “The level of detail and scrutiny is increasing in the area of packaging. Regulators are viewing the packaging more as an integral part of the product, versus the container for the product. That means it’s incumbent upon us to stay abreast of new technologies and new regulations that could impact our packaging activities.”

GROWTH PROJECTED

According to a 2002 study by The Freedonia Group Inc. (Cleveland), U.S. demand for pharmaceutical packaging will rise 4.3% per year to reach approximately $5.2 billion in 2006.

Blister packages are expected to show the highest revenue growth, jumping 6% per year to reach $1.035 billion in 2006. The report attributes the increase to regulatory changes that will prompt more blister use in clinical trials and for appetite suppressants and ephedrine-based products. Plastic bottles, the study states, will account for the heaviest unit demand among pharmaceutical containers. They are expected to grow 3.7% annually to $905 million in 2006. This, according to the report, is due to low cost and better functional capabilities. Like blisters, pouches and strip packs will see healthy growth due to an increase in unit-dose applications. 

Among parenteral packages, prefilled syringes will see the fastest gains in sales, the report states, thanks to the benefits they bring to emergency responses and infection prevention. Innovative designs and more uses for delivery of allergy and asthma medications will spur prefillable inhalers to the strongest growth among all products in the sector. Ease of use and dosage accuracy are also cited as positive factors.

Secondary pharmaceutical packaging is expected to grow 2.7% per year to reach $710 million by 2006. Paperboard boxes and cartons will continue to dominate the sector, thanks to more applications in over-the-counter (OTC) drugs, dietary supplements, and alternative medicines. Plastic prescription vials with child-resistant, senior-friendly, and compliance closures will remain the most-used prescription dispensing containers. Convertible display cartons will show the fastest growth among shipping containers. The market for closures may not grow as fast as before, thanks to increased use of nonreclosable packaging such as blisters. But child-resistant, senior-friendly, and dispensing closures should fare well, as they should be able to accommodate new package designs and regulatory developments.

The outlook for packaging machinery purchases is strong as well. The pharmaceutical and medical device sector has the best sales potential of any industry surveyed, according to a purchasing plans study conducted by the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA). 

The report projects U.S. pharmaceutical and medical device industries will spend $648 million on packaging machinery in 2003. That would be a jump of 8–10% over 2002 and would account for 12.7% of the total for all industries.

PROMISING AREAS

One area that should see significant growth in the coming years is coding and printing. The driving factor is FDA’s proposed rule requiring bar coding on all pharmaceutical packages and some OTC packages. The agency has collected industry feedback. A final rule is expected sooner rather than later, as the initiative is a priority of Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan. 

However, the proposal has raised a number of questions that must be answered. One is how to define which OTC products are subject to the rule. Another is how to fit the required information on the smallest packages. A third is whether to require, or to provide incentives for, manufacturers to print the bar codes down to the unit-dose level. “FDA says specifically that it wants healthcare personnel to scan a patient’s wristband before administering the drug,” says Peter Mayberry, executive director of the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA). “We question how they will do that if the drugs are shipped in a bulk container with a single bar code.”

Regardless of how the regulation turns out, a lot of work lies ahead. “The implementation of the bar coding rule will take a lot of resources in the next few years,” says consultant Frank Bieganousky of Montesino Associates LLC(Wilmington, DE). “Some companies seem to be ahead of the game, but some companies are just beginning to take a look at it, because they are required to.”

The forecast for blister growth is strong. Some in industry believe the use of blisters and other nonreclosable packages could increase further if the Consumer Product Safety Commission’s (CPSC; Washington, DC) testing protocol for child-resistance and senior-friendliness is changed. Blister suppliers contend the protocol for nonreclosable packaging is too subjective, as it requires pharmaceutical manufacturers to make guesses about a drug’s potential toxicity. As a result, HCPC has petitioned CPSC to change the nonreclosable protocol test. The petition calls for deeming access to more than eight units a failure for all drugs. If CPSC decides to make a change, a proposed rule could come as soon as early 2004. 

Pharmaceutical manufacturers have more options for their blister packaging now that cyclic olefin copolymer (COC) has been used with an FDA-approved drug. “COC blisters are thermoformable and offer good economics,” says Thomas J. Ambrosio, PhD, of Performance Packaging Consultants (Somerville, NJ). “A lot of major firms can extrude and convert them. Little by little, COC may take business away from PVC composites.” 

Also of help to industry, Ambrosio says, are newer grades of polychlorotrifluoroethylene (PCTFE), which are more thermoformable than their predecessors and come in a wider variety of strengths and prices. 

Many in the industry see delivery systems and combination product packages as potential areas of great growth. “We’re seeing a coming together of plastic components to create whole systems of functional packaging,” says Ambrosio. “Now, more and more, it’s dispensing systems that matter.” He cites dry-powder inhalers, pumps for nasal delivery, and injectable pens as examples of systems that are coming into wider use. He also sees lower-cost unit-dose injectables as an area of great potential.

CHALLENGES

While much progress has been made in some sectors of the industry, a number of issues remain to be resolved in other areas. 
Industry and regulators might take on repackaging in the coming year. While there are a number of regulations and standards for pharmaceutical manufacturers to follow when manufacturing and testing their packages, few exist for repackagers. And repackagers often do not have access to data that would help them make better decisions about how to repackage drugs. In fall 2003, the United States Pharmacopeia’s (USP; Rockville, MD) Packaging, Storage, and Distribution Project Team is planning to convene a meeting on how to improve repackaging practices. This could have an impact on any firm involved in the distribution chain.

“A lot of blisters will get repackaged into PVC, and I don’t know why that is the case if the stability tests indicate they should be in something else,” says Ambrosio. “This might be OK in the short term, but for the long term, repackagers should consider using more-protective blister materials.”

Another segment about to see a lot of activity is labeling. Just before this issue went to press, FDA held a public hearing on patient labeling, which could lead to patients receiving more comprehensive medication guides when they pick up their prescription drugs.

The paperless labeling initiative from the Pharmaceutical Research and Manufacturers Association (PhRMA; Washington, DC) is continuing to progress. Alpha testing on systems that would allow pharmacists access to up-to-date labeling information by electronic means has been completed, and beta testing is beginning. 

There should be a number of developments concerning aseptic processing and barrier isolation. In fall 2002, FDA made public a draft concept paper that will be the basis of the first aseptic processing guidance since 1987 and the first-ever formal written guidance on barrier isolation. The agency expects to publish a draft guidance soon. Industry hopes the guidance will be a blueprint that will help spur the adoption of isolator technology, though some are concerned that if the guidance is too onerous it could have the opposite effect. 

Consultant Douglas Stockdale, president of Stockdale Associates Inc. (Rancho Santa Margarita, CA), says he hopes FDA will address campaign filling with isolation technology. “Some companies are hoping to better leverage their equipment by going to campaign filling, but there has been very limited guidance about it,” he said. “The jury is still out on what constitutes it and how it operates.”

Industry is also anticipating the final draft of a guidance on stability, and a first draft of PACPAC, a long-awaited document that will help firms choose what tasks to perform when making postapproval packaging changes. 

“A lot of companies have had debates internally about whether to include interchangeability protocols in their NDAs (new drug applications),” says Bieganousky. “If you have it, you must maintain it. In some cases, implementation of these has been held up until it is known what is going on with PACPAC. So that will have tremendous impact when it comes out.” 

GROWTH POTENTIAL

There are a number of areas in which spending for packaging could increase in the near future due to new regulations or market conditions.

Security features for packaging should continue to increase in popularity as concerns about counterfeiting and diversion grow. This year’s major domestic recall of the blockbuster cholesterol drug Lipitor could prompt firms to step up or reevaluate their packaging security strategies. PhRMA has pledged to FDA that its members will notify the agency if counterfeits are found. 
Biologics companies will need to pay more attention to packaging, 

Bieganousky says. “During processing, bags are used for storage but also for the growth and processing of the biologic drug or its components,” he says. “Is it considered bulk packaging? It is, but it is also integral to the process itself. I’m not sure it’s an area that has necessarily received a lot of attention. There could be more issues as far as their raw materials and their traceability.”

Another market that may start paying more attention to packaging is dietary supplements. FDA has proposed a rule that would require dietary supplement firms to follow many of the same good manufacturing practices (GMPs) as pharmaceutical firms. That could mean dietary supplement manufacturers could start spending more on higher-end packaging and more to ensure that the packaging process is being performed correctly.

Packaging that caters to the elderly and disabled could also become a promising area, says Laura Bix, PhD, an assistant professor at the Michigan State University School of Packaging (East Lansing, MI). “I see a lot of interest in human ergonomics and universal design concepts,” she says. “This goes beyond the needs of the healthy, average adult to meet the needs of people with challenges such as the elderly and disabled. With the aging of the population, people in pharmaceutical packaging, and packaging in general, are starting to take more interest. I hope this is a trend with a lot of momentum behind it. It’s a good business move as well as the right thing to do.”

CONCLUSION

The pharmaceutical packaging industry is growing, but it is also growing more complicated. Newer drugs that have complex formulations or rely on a medical device for delivery present a number of challenges that will have to be met if the industry is to maintain its strength.

“My gut feeling is that there is more and more blurring of lines between pharmaceuticals and medical devices and biologics in terms of products, packages, and delivery forms,” says Perry Fan, a consultant at Montesino. “Things may not be as easily defined in the future.”

Bieganousky agrees. “Device companies are now learning what packaging professionals in the drug industry have known for years, and vice versa,” he says. “There is certainly a gap of knowledge. Experience needs to be shared, as well as understanding the different regulatory issues.”