From The Editor | April 2, 2018

6 Challenges For BioPharma Packaging

Louis Garguilo

By Louis Garguilo, , Chief Editor, Outsourced Pharma Follow Me On Twitter @Louis_Garguilo

6 Challenges For BioPharma Packaging

The Pharma Smart Pack and Label Forum suggests there are five drivers of packaging in the biopharma industry. I’ve reworked their five a bit, added serialization as a specific sixth, and included their country map as a serialization guide.

New And Improved!

We talk a lot about innovation in drug development and manufacturing outsourcing at Outsourced Pharma, in these pages and at our conferences. So do a lot of other folks.

At the recent DCAT meeting in Manhattan, it seemed none of the education sessions could finish without at least some mention of the role technology is increasingly playing in drug development, manufacture, delivery and packaging.

In the Pharma Smart Pack and Label Forum marketing piece mentioned above, we’re reminded that 46 new drugs were approved by the FDA in 2017 — the most new molecular entities (NMEs) since 1996, and more than double the number in 2016. And approvals in the U.S. look set to remain elevated over the next five years.

“However,” continues the Forum, “the rising popularity of new biological drug formulations continues to fuel some unanticipated packaging challenges. These new drugs are quite different from traditional small-molecule formulations, and in some cases, there have been some drug interactions with packaging materials. As a result, we are seeing a demand for new formats and materials.”

So from diverse angles – shapes and sizes – expect new-tech to continue to drive drug packaging innovation.

It’s A Small World After All

Nowadays, to denote any successful biopharma – those with commercial product(s), revenues and profitability – as “global” is akin to calling NCAA March Madness exciting. (I hope you’re at least a bit of a college basketball fan.)

Yet regarding that “global” moniker, the Forum purposefully points to emerging markets as representing “an exceptional opportunity for the pharmaceutical industry.”

It notes that industry experts at McKinsey “believe emerging markets could potentially see a doubling of pharma revenues for the top 20 markets in the next 10 years. Brazil, Mexico, Turkey, and various other countries of the Asia/Pacific, Central and South America, and Africa/Mideast regions are among developing markets that are expected to expand and diversify drug-producing industries and register above average gains in pharmaceutical packaging product demand.”

For biopharma executives and their teams, it could be packaging and packed suitcases that keep them ahead of the biopharma competition for innovative product delivery to emerging – and indeed all – markets.

Let’s now turn directly to consumers/patients for our next two packaging drivers.

Aging Like Fine Wine?

The Forum states that the global elderly population (65 and over) is expected to nearly double by 2025 … and triple by 2050. Make that more elderly with increasing lifespans, propelling pharmaceutical and medical services consumption. Packagers more than ever will need to focus on ensuring “their products are not only tamper proof but easy to open. In addition, to ensure seniors don’t get discouraged by tiny font and give up reading the instructions, usage instructions must be easy to read. Label constructions like booklet labels or foldout labels allow more space for printing and should be increasingly utilized.”

Aging and longevity will drive package design.

Conditions Not Improving

Despite the new products our industry has brought to patients over the years – and all we’ve learned about good-health habits – we have not reached a point of overall decreasing levels of acute and chronic conditions. Conditions such as arthritis, asthma, inflammation and gastrointestinal diseases are on the rise worldwide.

“According to the World Health Organization,” states the Forum, “chronic disease prevalence is expected to rise by 57% by the year 2020. Diabetes alone is expected to rise to 642 million people by 2040 due to rapid urbanization, sedentary lifestyles, changing diets and rising obesity levels.”

Here in the U.S., the Centers for Disease Control and Prevention (CDC) say more than one-third (36.5%) of U.S. adults have obesity.

The clever packaging of foods not particularly good for us entice the consumer, and our industry must counterpunch. We must learn how to better package our biopharma products to encourage consumers and patients to comply with the medicines and therapies that improve their health. And even – somehow – add to preventing the bad behavior from continuing.

Time For Tracking And Tracing

We’ve learned from Outsourced Pharma Editorial Advisory Board Member Charles Forsaith (see Physical Security For The Pharma Supply Chain) – founder and now Senior Director, Healthcare Distribution Alliance for the Pharmaceutical Cargo Security Coalition (PCSC) – how extensive counterfeiting and the theft of drugs actually is. A few weeks of receiving his newsletter will sufficiently prove the point: There are many bad actors looking to do harm indiscriminately.

The Forum points to a report by Grand View Research, Inc., indicating the global anti-counterfeit packaging market is expected to reach $184.87 billion by 2025. “Increasing concerns pertaining to the losses incurred by goods manufacturers through the sales of counterfeit products is expected to drive the industry growth. As of now, it's estimated that globally, around 10% - 15% of medicines are counterfeit.”

We’ll need further assistance throughout the packaging industry to help reverse this worrying trend.

Suspended But Finally Serialization

Biopharma serialization experts are prone to say things such as, “It’s still a country-by-country approach, and the U.S. is actually late to the game.” Enforcing the assertion again, in an upcoming article (part one of which is here) Jim Betzig, site leader at Pfizer’s enormous Kalamazoo manufacturing campus, said this:

“Our site services 110 markets around the world. And while the U.S. isn’t mandating full implementation of serialization until the end of 2018, we have a series of other markets – for example, Saudi Arabia, South Korea, Turkey – that have required some sort of serialization for years. We had a full court press on making sure that we were capable of meeting their requirements, and ours in the U.S., too.  It’s not easy to do. And we’re still learning.”

So here’s the map* showing that fragmentation from the Pharma Smart Pack and Label Forum that I mentioned above.

Back in a January 2016 post on Pharmafile.com, the obvious need was made clear: “Harmonization at a global level will not only be beneficial to the consumer world, but will also help various industrial players to implement efficient and universally proven solutions. Further, it will also ensure secure traceability of the entire supply chain at a global level.”

Countless others have called for much of the same. Unfortunately, serialization might be the one factor on our list acting more like a break than a driver. 

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Link to download the Pharma Smart Pack and Label Forum map.