A lot goes into the process of assembling a pharmaceutical product into its final finished packaging and its subsequent movement through the supply chain. Outsourcing these secondary operations to pharmaceutical contract packagers is a growing market, as pharma and biopharma companies seek advanced packaging solutions to help increase patient compliance, brand awareness, and consumer preference. According to IMARC Group, the global pharmaceutical contract packaging market was worth $19.2 billion in 2019, and according to a market research report by Technavio, it is expected to post a CAGR of more than 17% during the period 2019-2023.

According to IMARC’s study “Pharmaceutical Contract Packaging Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025,” plastic bottles represent the largest packaging category, which accounts for about a fifth of the total global market, followed by caps and closures, blister packs, prefilled syringes, parenteral vials and ampules, prefilled inhalers, pouches and medication tubes.

Industry Trends
Over the past few years, there has been a significant rise in the number of new drugs approved by the U.S. FDA. In 2019, the FDA approved 48 novel drugs.¹ The agency approved a record 1,171 generic drugs, following a record 971 approvals in Fiscal Year 2018 and a record 937 approvals in Fiscal Year 2017.² The increasing number of new drug approvals by FDA is having a positive impact on the growth of the global pharmaceutical contract packaging market.

Pharma/biopharmaceuticals are changing and evolving at a rapid pace, requiring flexible solutions. Among the key pharmaceutical packaging trends are production flexibility, growth in self-medication and multi-drug protocols, product and patient engagement, safety and compliance, and serialization.

Packaging that engages patients by making it easier to manage dosing and drug compliance is among the foremost trends. Additionally, contract packaging companies are growing their businesses to accommodate unique requirements for self-injectables, cold storage and distribution of these products.   

According to Mike DeAngelo, Vice President at Sharp Packaging, “In the solid dose market, we have seen sustained growth in blister compliance packaging to improve patient adherence and new product sample presentations. Similarly, there is stable demand for outsourced bottling services in the larger volume market; we’re seeing a focus on 30-60-90 day presentations for maintenance drugs as well as demand for efficient go-to-market packaging options for new products.”

Smaller production lots and advances in biologics and other personalized medicines are also driving packaging trends. Pre-filled syringes, in particular are a fast growing segment replacing traditional vials and syringes. Jeff Benedict, Chief Commercial Officer of Sharp Packaging, said, “Specialty drugs, rare disease medicines and personalized medicines that serve smaller patient populations are on the rise—in 2018, more than 40% of the pharmaceutical pipeline was constituted by biologics.³ This has been driving greater demand for injectable device formats such as pre-filled syringes, auto-injectors and pens, as well as sterile capabilities which require complex packaging services.”

Brad Rayner, Executive Vice President, Sales & Business Development, Legacy Pharmaceutical Packaging, LLC, added, “With growth of injectables market, there is increased demand for secondary packaging of medical devices and the unique requirements associated with them.”  The specialist capabilities required for packaging, storage and distribution for such products are very niche, according to Jeff Benedict of Sharp Packaging, and it’s creating a lot of business for contract packaging organizations with the expertise needed to deliver these services.

With the ongoing COVID-19 pandemic, the demand for certain medications as well as test kits has grown. Nic Hunt, Chief Strategy Officer, Jones Healthcare Group, said “We have seen a sharp increase in folding carton, pressure sensitive label, convenience vial filling, blistering and pouching order volumes for analgesic and upper respiratory products such as headache, cough and cold medications. As a result, we have flexed our capacity to manage this demand in support of global consumer health brands as they provide our communities with essential products throughout the COVID-19 situation.” 

As a result of the global pandemic, Jones is seeing a significant increase in medical device test kit project work. Nic added, “Whether it’s designing and prototyping COVID-19 test kit packaging or assembling kits for providers, Jones Healthcare Group is helping a number of companies launch new kits to market quickly.”

Joe Luke, Vice President of Sales and Marketing for Reed-Lane added, “We are experiencing growth and more inquiries for secondary packaging and kitting of vials with some of it requiring cold storage. This is the reason that we added cold storage and a dedicated packaging suite for these products in 2019. Over the last few years we have also seen more growth in bottle filling and packaging, and more recently, we have been seeing more demand for blister packaging.”

Evolving Packaging Requirements
Contract packagers play an integral role in the global pharmaceutical supply chain. With increasingly complex drug products, come increasingly complex supply chain requirements and protocols. “There’s been a notable increased demand for international specialty logistics support, said Jeff Benedict of Sharp. “Demand for temperature controlled and cold-chain logistics is on the rise – mostly driven by the uptick in the biologics and biosimilars on the market. As part of continued supplier consolidation efforts, companies are also increasingly looking for partners that can label, store, pack and distribute to multiple global markets at one site.”

Technology solutions are being leveraged to assist in the packaging and tracking of these sensitive products. According to Jeff Benedict, “Data management including security, storage, transmission and real-time accessibility of product records and information by customers and stakeholders is another key trend. Incorporating cloud-based digital document collaboration and workflow management platforms could streamline regulated processes and related communications between contract packagers and brand owners that are, by today’s standards, slow and burdensome.”

The supply-demand balance for pharmaceutical products is anything but smooth. According to Nic Hunt, of Jones Healthcare Group, “While the technical and regulatory requirements for packaging are unchanged in this environment—packaging still has the same purpose to protect and inform—what has changed, is the need for packaging suppliers to be agile, including adapting to multiple short-notice changes to the product mix, volumes, sequencing and logistics. The ability to source components and manage changeovers while maintaining tractability and schedules is critical to help pharmaceutical companies keep product on-shelf.”

Requirements for pharmaceutical packaging are also changing. Ward Smith, Director of Marketing & Business Development for Keystone Folding Box Company, said “Packaging is, appropriately, now being looked at more earnestly as part of the overall medication/treatment itself rather than just a platform for its shipment, storage, etc. The quality of a pharmaceutical product’s packaging plays an integral role in preserving the quality and effectiveness of medication through shelf life, ease of use and mission-critical patient adherence and usage information. This means materials used to package pharmaceutical products must be subject to stringent quality assurance requirements.”

 Joe Luke of Reed-Lane added, “In the last year or two there have been changes to USP test requirements for package components, some of which require more detailed tests, meaning longer turnaround times and increased costs. Not all customers fully understand the requirement and are not always sure what to request. Reed-Lane advises customers as to the test requirement parameters. It really comes down to how a customer interprets the requirements and it is the customer’s final decision as to what test to utilize and the frequency. Unfortunately, there is no standard and not all customers follow the same protocol.”

Challenges & Opportunities
Speed to market is at the forefront of pharmaceutical expectations. Complex packaging and labeling expertise is essential in this market. In addition, packaging suppliers have to maintain flexible capacity to support surges in demand. Within these challenges, lie opportunities.

Sharp Packaging’s Jeff Benedict, said, “Though there are still plenty of demands for traditional presentations (i.e. blisters, bottles, pouches), there are tremendous opportunities with secondary assembly, labeling and packaging of injectable devices and vials in both our U.S. and European facilities.” Dan Stehn, Director of Injectable Packaging at Sharp, added,“A common challenge is that injectable devices often require custom assembly and labeling equipment and processing due to the various device platforms and production requirements.” He added that the capital investment needed to equip facilities to deliver these services can be too significant for many contract packagers and brand owners, presenting a notable growth opportunity for businesses with existing expertise and capabilities.

In addition to having packaging expertise and capabilities, flexibility and insight are key to addressing challenges. Brad Rayner of Legacy Pharmaceutical Packaging, added, “Understanding the fluctuations in demand is crucial; what is cautionary planning vs overreaction to the pandemic, for example. Maintaining cost competitive considering increased regulatory demands can be a challenge, particularly as increased lead-times and costs are to be expected from component vendors and equipment.”

Speed to market continues to be a challenge for pharmaceutical companies. Nic Hunt of Jones Healthcare Group said, “It’s more important than ever for packaging suppliers to have flexible capacity to support demand surges. Given product development cycles continue to become shorter, it’s also important for us to help companies launch new products and product line extensions quickly.”

He added, “Companies are also challenged to find new ways to collect useful data to drive decision-making for product development and operations, while omnichannel distribution is placing higher demands on inventory management and real-time inventory visibility to protect against counterfeiting and optimize supply chain performance. As organizations implement the above items, this raises the bar for other companies to compete.”

To help address these challenges, Jones Healthcare Group is seeing a rise in intelligent, connected packaging as an important player in the Internet of Things (IoT). According to Nic Hunt, “By integrating technologies such as Near-Field Communications and RFID into packaging, it can instantly connect to the Internet for a range of applications that enhance the consumer experience, promote product integrity, and better manage inventory and product lifecycles, helping consumers make informed decisions, ensure the right products reach consumers safely, and to help launch products to market quickly.”

Latest Packaging Innovations
New drug delivery technologies are driving demand for unique packaging solutions. Among the latest innovations is monitored medication adherence solutions. Also, as serialization expands, companies are increasingly leveraging information technology for greater connectivity and more efficient supply chains.

“Differentiated drug delivery technologies such as injectable devices, transdermal patches, oral dissolvable films and digital pills are all driving demand for different types of packaging equipment and engineering,” said Jeff Benedict of Sharp Packaging. This too provides an opportunity for contract packagers to further develop specialization to meet outsourcing needs.

Recent Industry investment in serialization compliance has laid a foundation of connectivity and information-sharing. According to Jeff Benedict, “The industry has spent the last 3-5 years in the IT space delivering connectivity, now it’s about figuring out what we can do with data to remove manual activity and use our resources more effectively elsewhere.”

He concluded, “As a consequence of the immense R&D being performed in pursuit of Artificial Intelligence (AI), we are seeing breakthroughs in quantum computing. This is likely to yield huge benefits in the near future, allowing analysis of colossal data sets in new ways. For contract businesses, this means the ability to analyze internal operational efficiency more effectively and implement continuous improvement initiatives. It also opens the door for greater collaboration as pharma brands seek to gather and interpret downstream data and create more efficient supply chains.”

To support patient compliance, innovative packaging solutions now help to dispense and monitor medication schedules. Nic Hunt of Jones Healthcare Group, added, “We are working on a range of monitored medication adherence solutions that help patients take the right prescription medications at the right time. This includes blister packaging with embedded, transmitting printed electronics.”

Nic Hunt concluded, “This type of packaging not only supports those who manage complex medication schedules, but can also support adherence and data collection for clinical trials and other research applications.”

References
1. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019
2. https://www.hhs.gov/about/news/2019/10/16/secretary-azar-statement-on-fda-2019-generic-drug-approval-record.html
3. https://www.biosimilardevelopment.com/doc/growth-of-biologics-and-biosimilars-will-drive-above-average-demand-0001