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PHARMACEUTICAL/MEDICALDEVICES
D

PackagingMachineryManufacturersInstitute
11911FreedomDrive,Suite600
Reston,Virginia20190
(703)2438555

PublicationDate:December2012
PaulaFeldman,Director,BusinessIntelligencePMMI

Copyright 2012 Packaging Machinery Manufacturers Institute, Inc. All rights reserved. The information contained herein shall not
be distributed or shared by the recipient. No part of this document may be reproduced without the express written permission of
PMMI.

Pharmaceutical / Medical Device

2012 Industry Segment Report

Table of Contents
EXECUTIVE
SUMMARY AND
PERSPECTIVE
1 Overview
1 Patents Expiring
3 Innovative Drug
Delivery
5 Serialization
6 Globalization
8 Contract Mfg
9 Sustainability
10 Future Machinery
Needs
12 Actionable Checklist

Executive
Summary
and Industry
Perspective

Counterfeiting has
become one of the biggest
problems facing the
pharmaceutical industry.

Sr. Packaging Development Engineer

Executive Summary and Perspective

2012 Pharmaceutical / Medical Device Industry Segment Report

I. Executive Summary
In 2008 PMMI released a comprehensive report about the pharmaceutical industry. The current 2012
PMMI Pharmaceutical and Medical Device Industry Segment Report compares the changes that have
taken place the past 5 years in the following areas:

Patents expiring

Innovative drug delivery methods

Counterfeit drugs

Offshoring and globalized manufacturing

Worldwide spendable incomes increasing

FDAs global influence

Automated, integrated, smart machinery

Fifty industry professionals discussed the trends, challenges and progress in the pharma and medical
device industries over the last 5 years and their conversations are the foundation for this report.
Participates included:
8 out of the top 10 ten ranked pharmaceutical companies
5 out of the top 10 ranked generic companies
8 out of the top 10 ranked medical device companies.
Overview
Much has changed the past 5 years for pharmaceutical manufacturers when it comes to packaging.
Counterfeiting has become one of the biggest problems facing the pharmaceutical industry as criminals
are now counterfeiting all types of products and medical devices, not just tablets or capsules. The
increased threat from counterfeiting which extends all the way to product packaging in order to fool
unsuspecting consumers - has not only increased the health risk these products pose to the public, it has
led to calls for the Food and Drug Administration (FDA) to impose national standards in the United States
for serialization and tracking procedures. Subsequently, the clamor for FDA standards has left many
manufacturers in a quandary over whether to pattern their serialization strategies after Californias
impending e-Pedigree law or wait and see what the FDA does before acting.
Patents Expiring
In addition to battling the growing problem of counterfeiting, the pharmaceutical industry is facing a rash
of expiring patents for brand-name prescription drugs that will result in an increase in generic drug
production. More than 80 major branded drug patents will have expired between 2007 and 2016 in the
U.S. In addition, drug patents will also be expiring in Japan, the United Kingdom (U.K.), France and
Germany. As reported by the IMS Institute for Healthcare Informatics, once the patents on these brand

name prescription products expire in mature markets such as the United States, U.K. and European
Union, spending on them is expected to be reduced by as much as $127 billion by 2016.
From a marketing standpoint, the advantage generics have over branded prescription drugs is that they
use the same active ingredients as brand-name drugs and meet the same FDA requirements as their
brand name counterparts, but are much less expensive to purchase. That makes them a popular choice
for patients, especially in emerging markets. Consequently, each expiring patent increases the pressure
on pharma manufacturers to release new products capable of replacing the expected loss in market
share to generics.
How Are Companies Reacting
To protect their market share in the wake of competition from generics, many leading pharma
manufacturers have been engineering mergers and acquisitions the past 5 years. While this trend has
created a glut of used machinery in the market, many manufacturers interviewed said the excess of used
machinery is only slightly delaying the purchase of new equipment. Manufacturers said that after a
merger they need to evaluate the equipments compatibility with their existing manufacturing operations.
Used equipment, despite its lower cost, does not always fit their needs.
An alternative to using mergers
and acquisitions to bolster

Big pharma companies are investigating the following:

market share is diversification of

OTC market through mergers and acquisitions with 7 of the

product portfolios to include

top 10 pharma/biopharma companies acquiring a leading

over-the-counter (OTC)

consumer-healthcare business

medications. Seven of the top

Innovating new drugs - new molecular entities

10 pharma/biopharma
companies are leading
manufacturers of OTC drugs

New drug packaging

New formulations that enhance patient compliance and safety
and are easier to use

which are typically branded.

Some leading pharma
manufacturers are even forming strategic partnerships with smaller pharma companies to produce an
OTC version of branded prescription medications.
Such partnerships benefit both companies. The larger manufacturer gains access to a popular
prescription drug it can market in an OTC version under its existing brand name to boost overall sales
and market share, while the smaller company gains marketing and distribution resources that can
enhance the brand value of its product.
Despite the trend of product portfolio diversification to help sustain and grow market share, pharma and
medical device manufacturers face myriad challenges bringing new products to market, not the least of
which is testing and gaining regulatory approval, which can take years.

Nevertheless, innovation remains the key to success in the pharma industry, which is why manufacturers
continue to put forth drugs formulated from chemical structures never before used in clinical settings that
offer patients hope of treating and eventually curing their ailment. These products are typically referred to
as new molecular entities (NMEs). In addition, pharma companies are also developing duplicate therapies
to compete with existing prescription and OTC medications. In some cases, these medications add a new
twist, such as time release capsules or patches that can reduce the number of doses taken per day.
Product Change Causes Change in Packaging
With every new product comes the need for new packaging to protect it and provide easy patient access.
For manufacturers, the need for new packaging typically creates a need for new packaging machinery.
Its not surprising then that pharma and medical device manufacturers surveyed cited new products as
one of the primary reasons for new equipment purchases or updating existing equipment. This need has
risen in importance compared to when PMMI surveyed the pharma industry in 2008. At that time the need
for new equipment due to the introduction of new products ranked sixth in importance.
Changes in how medications are administered, such as
unit dosage packaging that comes in blister packs, dial-a-

2012
Results

Top Reasons for New Equipment

#1

New Product

influencing changes in packaging. The same goes for

#2

Increasing Output/Demand

more extensive package testing to ensure the medication

#3

Replace Aging Equipment

#4

OEE

#5

Operational Cost Savings

#6

Meet Compliance
Regulations/Validation

#8

Serialization/Track & Trace

dose syringes, inhalers and prefilled syringes, are also

is protected from elements that can degrade its quality,

such as light and moisture as well as protect the product
from damage during shipping.
Eco-friendly materials are another area causing change in
packaging. More manufacturers are looking for ways to
introduce sustainable packaging practices that enhance

package quality, product safety or accessibility that dont substantially raise packaging costs.
Medical device manufacturers, which were not surveyed by PMMI in 2008, face the same packaging
challenges, all of which are happening against the back drop of constant product innovation in both
industries that is dramatically increasing the availability of healthcare around the world.
Innovative Drug Delivery
Innovation in packaging that can improve how patients manage their healthcare is also spurring the need
for new packaging equipment. Blister packs, pre-filled syringes, transdermal patches and inhalers are all
forms of packaging capable of improving patient compliance in taking a medication and make it easier to
deliver the correct dosage.

Survey participants expect use of these packaging innovations to increase.

1 in 5 manufacturers using blister packs expect to increase their
use, while 3 out of 5 predict their use will remain the same.
2 out of 3 manufacturers of intravenous drugs are moving towards
an increased usage of single dose injectables.
1 out of 4 manufacturers of inhalation therapies predict new
inhalation devices in the coming years.
1 out of 2 manufacturers of skin absorption drug products predict
growth for high-tech patches.

One of the primary packaging challenges facing pharma manufacturers is

the need for stronger barriers to moisture, light, oxygen and unexpected temperature swings that can
occur during shipping and compromise the integrity of the product. At the same time, better packaging is
needed to prevent physical damage, such as dents or being placed under crushing weights that can
break open vacuum seals, during shipping and handling.
Other challenges pharma and medical device manufacturers face when it comes to packaging is:
Complying with FDA packaging regulations
Better brand recognition
Patient safety due to tampering
Accurate dispensing and patient compliance
Prevention and counterfeit detection
Having machinery that meets their primary packaging needs is only one piece
of the packaging equipment puzzle for pharma and medical device
manufacturers. Both are grappling with how best to produce labels containing
more information about a medicine or medical device and what patients need
to know when taking or using it. To accommodate the need for more labeling
space, some manufacturers are using packaging inserts, extended text labels,
booklet labels with peel back pages and labels featuring links to web pages that contain additional
information.
Pharma manufacturers must also be cognizant of child-proofing their products without making them less
accessible for seniors. While child resistant packaging protects children from accidentally poisoning
themselves through the ingestion of medications containing such ingredients as aspirin, paracetamol and
iron, the goal of packaging is to retain child resistant features and make it senior-friendly.
It's hard to incorporate the needs for an aging population in packaging when child resistant requirements
need to be met, because the needs of both demographics contradict one another, says an equipment
engineer for an over the counter (OTC) pharmaceutical company. We actually test packaging with
children and seniors through our packaging research and development group.

Key to OEMs satisfying the complex and changing needs of pharma and medical device manufacturers is
an understanding of;
How the size and scope of the pharma and medical device markets influence equipment needs
How globalization is impacting where products are produced and packaged
How the regulatory environment in which manufacturers must operate is changing
What kinds of new products are fostering packaging innovation
Additionally, OEMs must understand the impact and complexity of serialization to ensure product
authenticity, reduce counterfeiting and detect product diversion, as well as what expectations
manufacturers have of them when it comes to developing serialization strategies and compliance.
The Need for Serialization
In addition to safety and patient convenience, pharma and some medical device manufacturers face a
major challenge developing serialization solutions that encompass coding and data management to
improve tracking and tracing their products through the supply chain. In the 2008 PMMI pharmaceutical
report just one pharmaceutical company talked about complying with e-Pedigree laws. Since then,
serialization has climbed to a top-of-mind discussion.
The increasing interest in serialization solutions stems from the need for
pharma and medical device manufacturers to authenticate their product
and provide a method for the supply chain to detect counterfeiting.
Counterfeit drugs represent an estimated 10% of all medications in the
U.S., according to the FDA. In the European Union between 1% and 3%
of medicines sold are considered fakes. Counterfeiting not only poses
potential harm to unsuspecting patients, it undermines the reputation of a manufacturers brand. The
World Health Organization believes that as much as 70% of the drug supply in underdeveloped countries
is counterfeit.
Besides helping ensure product authenticity to healthcare providers and patients, track and trace helps
manufacturers combat product diversion, whereby legitimate products are diverted from one market to
another, which undermines licensing and distribution agreements. For example, a product distributor may
order medications to be shipped to Europe, but the shipment is diverted to China where the product can
be resold for a much higher price.
Despite the complexity and cost of aggregating product information across the supply chain, many
pharma manufacturers are of the opinion their business will ultimately benefit from tracking products at
the unit, case and pallet levels. However, the challenge increases as companies strive to implement a
communications infrastructure that can securely store the serialized data and transfer that data through a
global supply chain. Hence, the need for a global or centralized system to share serialized information is
paramount.

Aggregation of product information is accurately

capturing the child-parent hierarchy from the unitto-case serial numbers as shown in the illustration
to the right.
For the time being, however, the uncertainty around
serialization standards and regulations remain a deterrent for the implementation of serialization
strategies. Californias e-Pedigree law for tracking and tracing products across the supply chain - which is
scheduled to go into effect in 2015 - will not carry the same weight as an FDA regulation. In addition, 7
other states have passed pedigree legislation and 21 others have pending serialization laws on the books
in the U.S.
Although the FDA has not yet mandated serialization guidelines for track and trace, that may soon
change as it has put its pharmaceutical packaging barcode rule under review due to recent high profile
cases of counterfeit drugs finding their way into the U.S.
Meanwhile, pharma manufacturers producing or importing drugs into the U.S. face a dilemma over
whether to develop a national serialization strategy around Californias e-Pedigree law, which will only be
enforced in-state. Since there is no guarantee the California law will be the model for an FDA regulation,
manufacturers do not want to create separate serialization strategies.
Pharma
manufacturers would

When asked what aspects of serialization his company is struggling with

prefer guidance from

the most when it comes to implementing a serialization solution, a

the FDA on how to do

packaging engineer for a leading OTC pharma and medical device

serialization and

company said: We are at the stage of trying to understand requirements

provide standards,

for different markets worldwide.

says a pharma
industry consultant.
In the absence of a global standard, as well as an FDA standard for the U.S. manufacturers must
navigate what regulations are in place on a country-by-country basis, which makes compliance a
challenge. Some manufacturers are either tabling serialization development efforts or slowing
development of current serialization strategies until there is a clearer picture of the regulatory landscape.
Globalization and Offshoring
The trend toward globalization has not only provided a boon for pharma and medical device
manufacturers in the form of sales to new markets, it has opened the door to lower cost manufacturing by
locating plants in countries where:
Low-cost labor is abundant
Regulatory guidelines are more lenient
Highly attractive tax rates are offered

Thanks to globalization, sales of pharmaceuticals are expected to grow from $956 billion ($U.S.) in 2011
1

to $1.2 trillion in 2016. Medical devices, on the other hand, have two different projections in the industry.
The Medical Device and Diagnostic Industry magazine pegs medical devices to be a $350-billion industry
2

globally. Espicom projects the industry to reach $307 billion in 2012 and rise to $434 billion in 2017.

With global demand for pharma products and medical devices rising, U.S.-based manufacturers in both
industries are locating plants outside the U.S. to not only produce closer to distant global markets, but
take advantage of the cost, financial and regulatory benefits of manufacturing abroad.
Figure 1: Shifts to manufacturing offshore
In the first grouping of bars in
Figure 1 to the right:
50%

50%

Medical Device

45%

Pharma 2012

40%
35%

38%
34%

30%

34%
31%

Pharma 2008

those products being imported

19%20%
14%

14%
12% 12%

10%

in offshore production with

34% in 2008.

22%

15%

manufacturers see an increase

back to the U.S., compared to

25%
20%

38% of pharma

50% of medical device

manufacturers see an increase
in offshore production with

5%

those devices being imported

0%
Increasing

Staying the
Same

Decreasing

Not Sure

back to the U.S.

We are increasing our

offshore manufacturing due to tax advantages and low overheads and reduced labor costs, says a
packaging engineer for a medical device manufacturer. Our CEO's number one goal for now is to design,
source and build closer to market.
Manufacturing as close to the market as possible ensures better time to market, better patient feedback
and an improved ability to meet regional requirements, according to a senior packaging engineer for a
pharma and medical device manufacturer. For these reasons, some leading pharma companies are
closing existing plants in the U.S. as soon as prescription drugs come off patent and re-establishing them
in countries where it is much cheaper to produce the product as a way to offset the loss of revenue due to
competition from generics, according to the managing director for a compliance surety consultancy.
Assumingly, the FDA has expanded its influence on manufacturers that produce outside the U.S. and
import back into the country.
1

IMS Institute for Healthcare Informatics, July, 2012 The Global Use of Medicines. www.imshealth.com

Medical Device and Diagnostic Industry Magazine. http://www.meddonline.com/article/medtech-2012

Global Medical devices growth forecast: http://www.espicom.com/world-medical-market-forecasts

62% of the manufacturers interviewed for this report expect an increase in FDA-approved
facilities overseas, compared to 20% in 2008.
The most often mentioned locations are the Asia Pacific region, particularly China and India.
In addition to more regulatory oversight, the FDA is expected to expand its reach when it comes
to process validation and equipment qualification for offshore plants.
According to the director of engineering at a global pharma leader, there needs to be a more "level or fair"
playing field globally so that inspections for both domestic and foreign manufacturers are conducted
equally. Currently, overseas facilities are not inspected on a regular basis while domestic facilities are
inspected annually, which is a problem, he added.
As more manufacturers set up plants around the world, they are looking to source their processing and
packaging equipment from global suppliers, as opposed to suppliers in each market. In 2008, U.S. OEMs
were the supplier of choice with 58% of companies purchasing most of their equipment from U.S. OEMs,
compared to 42% purchasing from offshore manufacturers (Figure 2).
Figure 2: Equipment purchases, U.S. versus offshore
In 2012, that trend reversed. 59% of
60%

58%
2008

50%
40%

Medical
Device

59%
55% 2012
2012

45%
2012 41%
2012

Pharma 2012

42%
2008

pharma manufacturers are purchasing

more of their equipment from offshore
suppliers, compared to 41% of pharma
manufacturers purchasing more of

Pharma 2008

their equipment from U.S. suppliers.

Medical device manufacturers are

30%

following suit with 55% purchasing

20%

more of their equipment from offshore

suppliers and 45% purchasing from

10%

U.S. suppliers.
0%

U.S.

Offshore

Typically, secondary packaging

equipment is sourced from U.S.

manufacturers, like case packers, palletizers, cartoning equipment and over wrap machinery. In
comparison, labeling and filling equipment and blister pack machines are typically sourced offshore.
There are a limited number of pharma processing equipment manufacturers in the U.S. so this
equipment tends to come from Europe, says an engineer from a pharmaceutical company of prescription
drugs.

The Role of Contract Manufacturers

Just as pharma and medical device manufacturers are looking to set up plants offshore to take advantage
of cost reductions, they are turning to contract manufacturers and packagers not only for cost savings, but
to gain greater flexibility for packaging smaller batches and to gain a local presence.

Today,
42% of pharma manufacturers and 21% of medical device manufacturers using contract
packagers plan to increase their reliance on contract manufacturers.
32% of the pharma manufacturers and 36% of medical device manufacturers using contract
packagers expect their reliance on contract packagers to remain the same.
In 2008, the trend toward a greater reliance on the use of contract packagers was just emerging. At that
time, 88% of manufacturers planned to increase their relationships with contract manufacturers and just
8% expected their use of
contract manufacturers to
remain the same.

The equipment engineer at a leading manufacturer of laboratory

analyzers said, If they are selling anything back to U.S. market

Then, as now, the

the contract manufacturers have to be FDA-approved facilities.

advantages of using
contract manufacturers
and packagers remain the same:
Saving on capital costs
More flexible line changes
Reducing the number of dedicated in-house packaging lines
Obtaining local presence
Smaller batch runs

Sustainability and Eco-friendliness

Sustainability continues as a key trend among pharma and medical device manufacturers, as it has
across multiple segments of the packaged goods industry, because of the proven benefits sustainability
brings to the environment and the bottom line.
The rising cost of raw materials is making packaging a greater percentage of the total, which is prompting
some manufacturers to seek out materials that are less expensive. Also impacting the cost of packaging
is the rising cost of energy needed to operate the production line, which is driving manufacturers to
consider more energy efficient equipment.
Pharma manufacturers continue to implement similar sustainable strategies today as they did 5 years ago
to increase the efficiency of their packaging lines and lower their overall operating costs and medical
device manufacturers are jumping on the bandwagon for the same reasons. Those reasons include:
Reducing the overall amount of packaging material used
Using eco-friendly materials made from recycled packaging
Thinner gauge materials that do not compromise the strength or protective qualities
Minimize and reuse waste materials

At the same time, pharma and medical device manufacturers are looking for packaging machinery that
can not only handle the new generation of eco-friendly packaging materials without jamming, but which
reduce energy, air and water consumption to lower their overall carbon footprint and run their plants more
efficiently.
We have a big focus on sustainability, reducing corrugate weight and finding the lowest level of
packaging weight, and still being able to retain sterility, says a packaging engineer for a medical device
manufacturer that produces procedure trays for minor surgery.

Future Machinery Needs

As is the case with manufacturers in many industries the primary needs in new packaging equipment are:
Greater flexibility in changing over product lines
Easier cleaning
Less maintenance and more diagnostic alerts
Higher operating speeds for faster throughput
Improved operator safety
Intuitive, user-friendly HMI
The need for more flexible changeover is being driven by an increase in the number of different SKUs run
on a packaging line, which can be as high as several hundred. Different types of SKUs mean more
product changeovers and the longer it takes to complete a changeover the more downtime and less
productivity on the line.
Validation, the process by which any change in the packaging process is treated as a product/process
design change and must follow a full design change procedure, is a major and complex undertaking for
manufactures. Documentation is required for compatibility and integrity, shelf life, sterile barrier and
distribution testing of the packaged product.
Just as in 2008, manufacturers are looking to OEMs to help them with:
Equipment validation and qualification
Documentation, particularly for FAT, IQ, OQ, PQ

Demonstrate good manufacturing practices

Another underlying factor driving new equipment purchases is the opportunity to introduce more robotics
into the packaging line. What makes robotics attractive is a greater efficiency compared to manual
processes such as placing primary packages into secondary packages and placing secondary packages
on to pallets.

FAT-Factory Acceptance Testing. IQ-Installation Qualification, OQ-Operation Qualification, PQ-Performance

Qualification

10

Manufacturers are also looking for control systems, operating interfaces and safety systems standards to
minimize human contact with their packaging machinery and improve quality control, operating efficiency
and operator safety. In addition, manufacturers also expressed a need for real-time global production
data. Two out of
three manufacturers
say they need

Robotics for end-of-line packaging equipment remains as important now

as it did 5 years ago for both pharma and medical device companies.

machinery capable
of capturing and
communicating performance--an indication this trend is becoming more important.
Better training for machine operators remains a critical component in the purchasing decision. Knowledge
of Key Performance Indicators (KPI's) among personnel on the plant floor is key to operating efficiency
and troubleshooting minor issues before they become full-blown problems that require the line to be shut
down.
Finally, manufacturers are looking to OEMs to help them support aging equipment by improving
The availability of parts
Helping raise safety standards
Integrate smarter components
Communications and recommend equipment improvements as needed
Be a Manufacturing Partner
By taking the time to understand the needs of manufacturers, OEMs can build machines that improve
operations when it comes to;
Flexible changeover
Robotic solutions
Validation
Real-time data capture / analytics
Operator safety
OEMs are being asked to be a manufacturing partner, which can be achieved through:
Regular on-site visits to assess equipment requirements
Suggesting specialized equipment to replace aging machinery
Designing new machinery that answers the challenges of the future
In doing so, OEMs will not only deliver better solutions, but deepen relationships with pharma and
medical device manufacturers at a time when their business are undergoing tremendous change.

11

PMMI Headquarters:
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