Jorge Izquierdo, VP Market Development at PMMI
The pharmaceutical industry is in a period of sustained growth, experiencing mid-single-digit compound annual growth rates (CAGRs) for the past several years, a trend that is projected to continue through 2030, according to a new report entitled 2026 Trends and Challenges in Pharmaceutical Manufacturing from PMMI, The Association for Packaging and Processing Technologies.
Breakthrough drugs like specialized oncology treatments and new applications for existing drugs — such as the explosion of GLP-1 prescriptions for weight management — are leading the charge on industry growth.
However, even with steady growth, pharmaceutical manufacturers face a host of challenges, ranging from regulatory burdens and throughput demands. Some major industry changes also shaking up the market include:
- The expiration of drug patents over the next several years, which are valued at more than $300B in annual sales
- A roughly 35% increase in research and development (R&D) activity for new drugs
- A continued push toward digitization/digitalization as the final Drug Supply Chain Security Act (DSCSA) deadline approaches
Pharmaceutical manufacturers currently have a significant opportunity to capitalize on a growing market, driven by new developments in generics and the R&D pipeline, but they will need support from original equipment manufacturers (OEMs) and suppliers to overcome operational challenges and chart a new course for growth.
Meeting Regulations Still a Stumbling Block
The process of reporting and documentation is a major concern, with 71% of end users surveyed by PMMI saying it is their top challenge. To address this and other regulatory requirements, end users report making several changes, including:
- 62% expanded employee training
- 56% purchased new equipment
- 53% implemented predictive/preventive maintenance
DSCSA outlines steps to achieve an interoperable, electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain to prevent harmful drugs from entering the U.S. drug supply chain, detect them if they do, and enable rapid removal to protect patients. Product serialization and aggregation requirements are central to these efforts. (Most DSCSA deadlines have already passed, with one final compliance date for dispensers based on size in November 2026.)
In addition, the FDA ensures the quality of drug products by carefully monitoring manufacturers’ compliance with its current good manufacturing practice regulations, which establish minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of drug products. Essentially, these regulations are designed to ensure products are safe for use and contain the ingredients and their strengths as stated on their labels.
Certain states also require their own approved licensing, certifications, and oversight for the manufacturing of all or certain drug types. In addition, some pharmaceutical products are more tightly regulated than others, as governed by regulations such as the Controlled Substances Act, which designates certain drugs as Schedule I-V with varying requirements based on classification.
Any manufacturer of medicines intended for the European Union (EU) market also must comply with EU Good Manufacturing Practice, regardless of where they are located.
The EU Pharma Package is the first major revision of EU pharmaceutical laws since 2004. Intended to help better meet patient needs, boost Europe’s competitiveness, and support innovation, it introduces new rules for all medicines, including those for rare diseases and for children. It also includes recommendations to strengthen efforts to combat antimicrobial resistance.
At this point, OEM services to support regulatory compliance are largely in line with end-user needs, but OEMs and suppliers would be wise to consider offering additional assistance around reporting requirements. This is evidenced by the PMMI report, which found most end users (71%) indicate difficulties with documentation and reporting, and 42% note they are pursuing digitization strategies for reporting.
However, addressing these issues often requires specialized skills, such as digital infrastructure construction and extensive digital process integration, which many manufacturers lack internally, forcing them to seek outside help. Despite this need, only 10% of OEMs indicate they offer digitization services to support regulatory compliance, and just 14% say they provide the digital integration services necessary to achieve reporting digitization.
Given that documentation remains a persistent challenge for end users, OEMs and suppliers should evaluate the feasibility of expanding digital infrastructure and digitization services to better support regulatory reporting needs. This only makes sense because OEMs and suppliers with experience in building digital infrastructures and transitioning operations from manual to digital processes will be better positioned to support manufacturers struggling with regulatory reporting.
Pharmaceutical leaders continue to express uncertainty about future regulatory burdens. In a recent survey, about one-third of respondents noted concerns about potential changes to U.S. regulations, while 37% were uncertain about the future of global regulatory frameworks. As a result, keeping up with regulatory changes was the top challenge reported by end users (44%) according to PMMI’s research.
|
What steps has your organization taken to meet regulatory requirements for pharmaceutical manufacturing?
|
|
Expanded employee training 62%
|
|
Purchased new equipment 56%
|
|
Using predictive/preventive maintenance 53%
|
|
Upgraded or retrofitted equipment 49%
|
Source: PMMI 2026 Trends and Challenges in Pharmaceutical Manufacturing
Automation and Connectivity Support Operational Excellence
In addition to addressing regulatory concerns, end users are seeking ways to increase production while enhancing safety. Consequently, increased speed and throughput are now the top features end users look for when evaluating new pharmaceutical manufacturing equipment, followed by automation and robotics, and easy-to-clean designs. These three features can be grouped into one category: process efficiency. Each is focused on minimizing downtime, improving uptime, and increasing production output.
Capabilities such as remote monitoring and predictive/preventive maintenance require a high degree of digital connectivity, a key area of expansion for pharmaceutical manufacturers. Even for operations that currently lack the necessary digital infrastructure, connectivity-ready machines can help future-proof equipment investments by ensuring systems are prepared for integration when digital infrastructures are built out.
According to a director of pharmaceutical engineering surveyed by PMMI, automation with verification systems will be important in the future. Plus, as compliance requirements become stricter, online verification systems like 3D cameras, sensors, and electronic counting will be essential for equipment selection.
Current OEM technology features align closely with end-user needs, emphasizing throughput and connectivity. For instance, end users cite throughput as a top challenge, and OEMs report automation and robotics as their most-offered technology feature. With robotics capable of increasing pharmaceutical throughput by 30% to 50% compared with manual processes, OEMs are already deploying tools that address end-user needs.
OEMs are also signaling developments in machine sophistication. Many plan to incorporate more advanced technologies, such as artificial intelligence (AI), in the coming years, including AI-empowered processes. With many OEMs surveyed by PMMI noting they already include well-established features like robotics and predictive/preventive maintenance routines, the next frontier of pharmaceutical equipment is expected to include more data and connectivity features.
In addition, technologies like AI-supported features need robust operational data to feed modeling and analytics tools. On the individual machine level, AI-powered machine learning programs require a steady stream of high-quality data to function optimally. However, end users will need help from OEMs and suppliers to build out digital infrastructure and deploy physical data-gathering sensors to bolster data volumes. OEMs already appear to be responding to this need, with nearly half indicating they will be adding more sensors to their machinery.
Connectivity will also play an important role in pharmaceutical manufacturing. While slower to incorporate remote connectivity features than some other manufacturing sectors due to heightened cybersecurity concerns and regulatory requirements, the pharmaceutical industry is poised for greater adoption. And, as the technology matures and becomes more standard, and cybersecurity safeguards improve in efficacy and sophistication, remote connectivity is likely to see greater use in pharmaceutical manufacturing.
Labor Issues Continue to Be a Challenge
The demand for employees with specialized digital skills has been growing in pharmaceutical manufacturing. For example, in one analysis, 83% of biopharma supply chain leaders indicated a need for enhanced technological skills among employees. Companies are actively seeking to fill this gap, with life sciences companies’ job postings for digital roles such as data engineers and data scientists increasing exponentially. End users are also retraining employees, with 65% noting they are actively engaged in upskilling and reskilling.
OEMs and suppliers also have an excellent opportunity to provide more specialized services like process integration and automation expansion. However, strategies reported by end users, such as predictive/preventive maintenance schedules, automation, and robotics, often require skills beyond in-house expertise, increasing reliance on OEM and supplier support to achieve full value.
The Next Frontier for Efficiency
Pharmaceutical packaging continues to evolve as technology-focused packaging features gain traction, enhancing customer experiences and connecting manufacturers, care providers, and patients through a network of digital data.
In many cases, these features achieve numerous goals at once. For example, QR codes allow manufacturers to better track product movement both internally and in the supply chain, ensuring quality and authenticity. Distributors can also scan the codes to double-check origin, destination, product type, and authenticity. On the consumer side, customers can scan codes to verify their products, receive instructions for dosage and compliance, and connect with the manufacturer directly.
As digital infrastructures grow and consumer technological sophistication continues to expand, technology-oriented packaging features will play a key role in protecting manufacturers, products, and consumers in the pharmaceutical supply chain.
|
Are you currently utilizing these technology-focused features in your pharmaceutical packaging formats?
|
|
Temperature/humidity monitoring 69%
|
|
QR codes or other scannable features 67%
|
|
RFID tags 33%
|
Source: PMMI 2026 Trends and Challenges in Pharmaceutical Manufacturing
From verifying products in the supply chain to monitoring patient compliance and tracking clinical trials, digital connectivity in pharmaceutical packaging is the next frontier of efficiency. This new kind of connectivity holds enormous promise for all stakeholders, allowing manufacturers to more carefully control their internal processes, efficiently monitor their products in the supply chain, and curate better customer experiences through interactive features and direct connection with the brand. Connectivity features also support manufacturers’ personalization/customization efforts, a trend that 92% of industry leaders acknowledged is an important opportunity, and 84% have already begun to plan into their production strategies.
Whether a manufacturer pursues printed augmented reality labels or physical sensors embedded in the packaging, OEMs and suppliers need to be ready for these connectivity features, as the equipment must be able to handle them without damage or interference. As with other new developments, manufacturers may require assistance in designing, testing, and deploying new formats that incorporate technology-focused features.
The can’t-miss industry trade show exploring the automation, regulatory, and labor issues facing the pharmaceutical industry, PACK EXPO East, takes place Feb. 17–19, 2026, at the Pennsylvania Convention Center in Philadelphia.
This year’s most comprehensive packaging and processing event in the Northeast and Mid-Atlantic will bring together over 8,000 attendees and more than 500 exhibitors, spread across 125,000 net square feet of exhibit space.
A Hub for Solutions
PACK EXPO East provides in-person interaction with machines, materials, and other products related to pharmaceutical packaging and processing. It also features free educational sessions on the show floor covering best practices, industry trends, new technology, and key concerns such as sustainability, AI, productivity improvement, automation, and workforce development.
With an abundance of leading pharmaceutical manufacturers located in the Northeast and Mid-Atlantic regions of the U.S., attending PACK EXPO East 2026 is a smart move for nearby packaging and processing professionals. At the comprehensive event, attendees can explore a wide array of solutions to fast-track projects and make better business decisions — all without leaving the East Coast.
At the event, attendees will discover solutions for addressing downtime, labor issues, regulatory compliance, and supply chain obstacles before they can impact production. The show’s location also provides an opportunity to motivate and mentor younger employees by allowing them to experience the power of automation solutions, thereby building a stronger and more engaged team.
PACK EXPO East offers many opportunities for networking with fellow team members, peers, industry experts, and personnel from established suppliers and prospective vendors. In fact, the event is large enough to provide all the solutions manufacturers need, but intimate enough for productive, face-to-face conversations.
Register now for PACK EXPO East.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from American Pharmaceutical Review delivered to your inbox!
Sign up now!