Pharma Market: “Much has Changed in the Past 5 Years”
December 18, 2012
Director, Member Communications
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Pharma Market: “Much has Changed in the Past 5 Years”
PMMI report predicts continuing changes and new equipment needs to accommodate increasing product diversity, globalization and morphing regulations
Reston, Va.; December 18, 2012 — Expiring patents, counterfeit products, globalization, automation and innovation are just a few of the drivers in the changing pharmaceutical/medical devices market, according to PMMI’s “Pharmaceutical/Medical Device Market Assessment 2012,” published this week.
Pharmaceutical manufacturers contend with the same trends other packaged good manufacturers face, such as incorporating sustainable packaging materials and implementing easier, faster changeovers. But that’s just the beginning, says Jorge Izquierdo, vice president, Market Development, PMMI.
“There are major differences between the pharmaceutical market of today and the one we reported on in our 2008 market assessment. Together, regulatory changes around the world, globalized production and packaging, and the increasing diversity in products and devices are reinventing manufacturers’ equipment needs,” Izquierdo says.
Extreme growth in counterfeit drugs and medical devices has led to calls for national serialization and tracking procedures, the report notes, but the only standard thus far is California’s e-Pedigree law. That poses a dilemma for manufacturers: They can wait for the U.S. Food & Drug Administration (FDA) to release its solution, or they can work under the assumption that California’s regulations will be sufficient to comply with future regulations. Regardless, track-and-trace technology cannot be ignored.
“Regulations are changing, and companies are looking to the OEM to provide better documentation and be more accountable for the validation/qualification testing,” Izquierdo explains.
He adds, “Since 2008, counterfeiting has gone beyond tablets and capsules to include all type of medical products and devices. That extreme expansion is a major factor behind the spread of serialization technology, and it’s just one example of the rapidly-changing needs of pharmaceutical and medical device manufacturers.”
As with so many industries, a global customer base is prompting manufacturers to expand off-shore production — and to find local resources and services to support the new plants. But regulatory requirements vary between jurisdictions. One respondent, a packaging engineer for a leading over-the-counter pharmaceutical/medical device company, said understanding the requirements for a variety of worldwide markets is a major hurdle as his firm attempts to implement serialization solutions.
Others noted the increase in FDA-approved facilities off shore is in part to ensure these plants are subjected to the same rules as domestic plants — including equal inspections conducted at the same frequency. Professional groups, including the Bulk Pharmaceutical Task Force of the Society for Chemical Manufacturers and Affiliates and the European Find Chemicals Group of the European chemical Industry Council, have called on the FDA to address disparities in this area.
Expired patents are also changing pharmaceutical landscape. In the 10-year span 2007–2016, the patents for more than 80 major brand-name prescription drugs will expire in the United States. Drug patents will also expire in Japan, the United Kingdom, France and Germany. As a result, spending on these products will drop $127 billion, the report notes.
The subsequent increase in generics is giving the market another facelift, as brand name manufacturers search for new delivery methods to make the brands “new” again, and help them retain market share. Single dose dispensing is gaining traction, with formats such as blister packs and pre-filled syringes leading the pack.
To accomplish their goals, pharmaceutical manufacturers will look to their suppliers, including original equipment manufacturers (OEMs), for guidance.
“OEMs will, once again, need to step up as partners,” Izquierdo says, noting that OEMs will have the expertise to provide assistance in machine validation and qualification, adherence to good manufacturing practices and documentation for installation qualification, performance qualification, operation qualification and factory acceptance testing.
He adds that OEMs who take the time to understand the needs of manufacturers, can build machines that improve operations and better meet customer needs for flexible changeovers, robotics, validation, real-time data capture/analytics, and operator safety.
“We suggest OEMs and manufacturers act in partnership, assessing equipment needs, suggesting specialized equipment to replace aging machinery and developing machines that answer the challenges of the future,” Izquierdo says.
PACK EXPO Las Vegas 2013 (Las Vegas Convention Center, Sept. 23–25) will address the changing face of the pharmaceutical market with more than 1,600 exhibitors and customer-centric features including The Pharmaceutical Pavilion. To learn more about how PACK EXPO can help you advance your business, visit www.packexpolasvegas.com and sign up to be notified as soon as registration opens.
PMMI is a trade association of more than 600 member companies that manufacture packaging, processing and related converting machinery in the United States, Canada or Mexico; machinery components and packaging containers and materials. PMMI’s vision is to be the leading global resource for the packaging and processing supply chain, and its mission is to improve and promote members' abilities to meet the needs of their customers.
PMMI organizes the PACK EXPO trade shows: PACK EXPO International, PACK EXPO Las Vegas and EXPO PACK México, connecting participants in the packaging and processing supply chain with their customers around the world. Coming Up: PACK EXPO International at McCormick Place in Chicago, Oct. 28–31, 2012; EXPO PACK Guadalajara, Feb. 27–March 1, 2013, in Guadalajara, Mexico. EXPO PACK México, June 18-21, 2013 in Mexico City, Mexico; PACK EXPO Las Vegas at the Las Vegas Convention Center, September 23-25, 2013. .