The global pharmaceutical industry is projected to grow markedly through the decade, reaching $1.4 trillion and 4.5 trillion doses of medicines by 2020. The pharmaceutical packaging market is growing rapidly in kind and is expected to surpass $100 billion globally by 2019. In fact, according to a new study from PMMI, the pharmaceutical packaging sector is expected to grow the fastest among all packaging industry sectors, growing at a five-year CAGR of 3.9 percent through 2019.
Several factors are converging at once for the pharmaceutical industry, contributing to the growth and importance placed on packaging. These factors include global demographic shifts, advances in serialization to meet new requirements and the influence of the generics and biosimilars markets.
GLOBAL DEMOGRAPHICS
Many developing regions — including Asia/Pacific, Latin America and much of the Middle East and Africa — will continue to see population growth coupled with economic development. The resultant rise in the middle class will lead to a greater global population that can afford access to drugs. In developed regions where population growth is typically slower, general improvements in healthcare have contributed to an aging population. According to the U.S. Census Bureau, people age 65 and over accounted for around 8.5 percent of the global population in 2015. It is projected that it will reach 12 percent by 2030. This trend is particularly impactful on the pharmaceutical market, as elderly people are large consumers of medicines. Both trends will contribute to an increase in the use of pharmaceutical packaging, as well as pharmaceutical packaging equipment, throughout the decade.
SERIALIZATION
The importance and consideration placed on packaging in the world of pharmaceuticals has expanded considerably as a result of serialization requirements. Packaging plays a vital role in ensuring the traceability of products across the supply chain. Several pieces of legislation mandating various serialization requirements have been enacted globally in recent years. In the U.S., the Drug Quality and Security Act (DQSA) has created national, rather than statewide, regulations for serialization. DQSA mandates will come into force for manufacturers in 2017.
The cost and time associated with meeting these regulations can be high. Many manufacturers will require new labeling, coding and scanning equipment to become compliant. Packaging equipment in such categories is expected to see growth prior to serialization deadlines and a downturn immediately following them. For some pharmaceutical manufacturers, installation of new equipment may require an expansion of the packaging line. For those with space limitations, this means potentially turning to robots, where enhanced flexibility offers the capability to handle multiple products in the same space with the same equipment. While working to upgrade their packaging lines to gain compliance with serialization laws, many pharmaceutical manufacturers are turning to co-packers to help fill the gaps in technology and capacity.
Also, proper serialization will require the effective transfer of information among all parties throughout the supply chain. As a result, demand for improved integrated, software-based solutions has risen, a trend that is expected to continue for the foreseeable future.
GENERICS AND BIOSIMILARS
As patents for several blockbuster drugs expire — known as the patent cliff — the market becomes increasingly competitive with the flood of generics entering the market. Production of the number of pharmaceutical products increase, therefore increasing the number of packaging types employed. Additionally, last year, the FDA approved the use of the first biosimilar product. According to the FDA, a biosimilar is “a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product.” Biosimilars are thought to have a comparable effect on the market as generics, potentially increasing competition and the number of packaging types.
As competition steepens, many pharmaceutical companies — particularly original patent owners — are turning to packaging as an important point of differentiation. Packaging technology that can improve convenience and quality, combat counterfeiting or increase patient compliance can set a pharmaceutical product apart.
PMMI, PHARMA EXPO 2016, PACK EXPO
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components and materials for processing and packaging. Pharmaceutical manufacturers looking to find the latest packaging solutions can turn to resources provided by PMMI, co-producer of Pharma EXPO 2016 (November 6-9; McCormick Place, Chicago, Illinois) with ISPE, the International Society for Pharmaceutical Engineering. Co-located with PACK EXPO International,the two will serve as the largest resource for processing and packaging innovation in North America. The shows will bring together over 2,300 suppliers in 1.2 million net square feet of exhibit space to showcase a wide range of processing and packaging solutions to 50,000 attendees.
REFERENCES
1 “Global Medicines Use in 2020: Outlook and Implications.” IMS Institute. Web. 1 Dec. 2015.
2 “World Pharmaceutical Packaging - Demand and Sales Forecasts, Market Share, Market Size, Market Leaders.” Freedonia.Web. 1 Dec. 2015.
3 “Global Trends Impacting the Market for Packaging Machinery.” PMMI, 2016.