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Volume 7, Issue 3 - May 21, 2008
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Keyence Corp. of America, a complete source for sensors, measurement systems, machine vision, safety light curtains, laser markers, and digital microscopes. |
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 Industry Trends Favor Innovation
Drug companies are facing a multitude of challenges, at a time when new drug approvals are lagging, and healthcare interests are on high alert over drug safety.
New drug approvals hit a 25-year low in 2007. And exposure to generic competition will erode the sales of many top-selling brands over the next decade.
Industry is addressing these grim realities with new programs and technologies on a number of fronts, as cost-control is emphasized to an unprecedented extent.
Anticounterfeiting solutions promise to save billions in lost drug sales. Patient communication is shifting to Web-based strategies for e-marketing and helping patients with their therapies.
Manufacturers are populating their pipelines with promising new treatments.
At the Pharmaceutical Printed Literature Association (PPLA) meeting during Interphex, Thani Jambulingam, PhD, chair and associate professor, department of pharmaceutical marketing, Saint Joseph’s University (Philadelphia) highlighted notable pharma industry trends.
Among the trends identified by Dr. Jambulingam:
- “2007 was the worst year since 1983 for drug approvals. This trend needs to change, and that is happening.” With industry focused on drug safety issues, 19 new drugs were approved by FDA in 2007. Since 1996, when the agency approved 60 new drugs, approvals have trended downward, with intermittent upticks.
- Drug development costs are increasing, with an average “out-of-pocket” cost of $430 million per successful drug. “Capitalized to the point of market approval, the cost is $802 million.”
- Patent expirations create $38 billion of unprotected sales from 2007 to 2009. “After 2009, there is a great explosion in brand exposure through 2016. Companies cannot survive if their pipelines are hurting.”
- “Companies have figured out they need two new drug applications approved a year. You need to have 12 compounds entering development (to sustain that rate). Failure at the Phase 3 stage (after high investment) is not acceptable.”
- GlaxoSmithKline, AstraZeneca, and Sanofi-Aventis rank with the most drugs in development. And companies are developing potential blockbusters, targeting disease states such as Alzheimer’s, osteo- and rheumatoid arthritis, cholesterol, cardiovascular diseases, and cancer.
- Pharma is in cost-control mode, out sourcing manufacturing, packaging, and clinical trials domestically and abroad. “Product managers are going to be incentivized to control costs.”
- Since 1996, direct-to-consumer advertising in dollars and as a percentage of sales has increased every year, hitting $4.2 billion, or 2.6% of sales, in 2005. “Companies are already taking their money away from direct to consumer. The Web will be the next marketing domain
Web marketing captures and leverages patient data, as patients are driven to secure sites by caregivers, community services, public relations events, direct mail, radio, and TV.
- FDA proposed guidance on the distribution of information on unapproved, or off-label, use of drugs is “a huge step forward for the industry.”
- As managed care drives pricing pressures and tighter margins, outcomes-based reimbursement as a cost-containment measure will be favored. “The Medicare Part D program is shaping up very well. But the cost will be way over initial projections.”
These trends have imposed cost-control requirements on suppliers of packaging. New machine designs and lean Six Sigma methods are helping partners reduce costs through improved production efficiency and supply chain responsiveness.
As therapies shift to the home setting, and industry grapples with the costly issue of non-adherence, the opportunity for new packaging styles and delivery system innovation remains large. And packaging will have a key role to play as government and managed-care programs seek to demonstrate that therapies are ensuring patient quality care, and limiting runaway healthcare costs.
David Vaczek
Senior Editor
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One Step Ahead of Demand
Contract packagers are investing in lines and facilities to handle outsourcing growth, but prudent measures are needed to ensure on-demand capacity without adding costs for customers.
Branding through Packaging
Drug companies are challenged to maintain and create powerful brands that inspire, inform, and protect patients. |
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Laser Marking Additive
An additive for laser marking can be safely used on caps and closures. The Micabs additive laser-marks closures to apply anticounterfeiting technology for the pharmaceutical packaging industry. Micabs’ high definition accommodates micromarkings and 2-D Data Matrix or bar codes. The additive can mark closures in complex recesses that are difficult to reach with conventional printing technology. Its high-speed laser technology can apply larger marks on closures, such as opening instructions on child-resistant packaging, without a reduction in line speed. Micabs’ additive in PP and HDPE formulations suits use with a fully automated laser marking system. This allows high-speed marking of text and logos with production speeds of up to 90,000 caps per hour. DSM Micabs, Evansville, IN; 800/333-4237; www.micabs.com. |
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Small Format Thermoformer
A form-fill-seal machine suits small-run production needs. The KBS-GS provides turnkey blister packaging with smaller format range, smaller quick-change tooling, and a decreased footprint from larger systems. The KBS-GS has a maximum forming and sealing area of 250 × 150 mm and output of up to 15 cycles per minute. Overall machine width adjusts to maximize material utilization. Full servo drive and IPC controls maintain precise control of process parameters. Koch Packaging Systems LP, Towaco, NJ; 973/541-7312; www.kochpackaging.com. |
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