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Strategic Implications of Packaging Choice in the Generic
Sector


David Barker
is Marketing Development Manager for Honeywell Healthcare & Packaging. As a world leader in
pharmaceutical packaging materials, Honeywell Healthcare & Packaging is working to develop
industry leading packaging solutions which can deliver increased competitive advantage to the
generics industry.


Charles Rowlands and Amy Morgan
are founding partners of RM Consulting, an international market and competitive intelligence
consultancy focused on providing management support services to the global pharmaceutical,
biotechnology, chemical and healthcare sectors. Jointly they have more than three decades’
experience and have worked on numerous strategy development and market research projects
in both developed and emerging markets.


Keywords: generics, profitability, primary packaging, competitive advantage, high barrier,
thermoforming, blister film, Aclar®, Alu/Alu, Switch-IN, Switch-OUT.


Abstract
This paper reports on the issues highlighted at the recent Honeywell Generics Forum and
examines the strategic implications of packaging choice in the generics industry. It looks at how
companies are leveraging ultra high barrier thermoform solutions like Aclar® to create new value
propositions. Meeting regulatory and quality needs are a basic standard and a given
requirement for any primary packaging solution. However, in order to meet the challenges of
today’s generics marketplace, innovative generic companies are now looking beyond these basic
technical needs and are optimising packaging platform choice to realise market advantage and
profitability gains. It is now recognised that pack differentiation offers an ideal opportunity to
create a sustainable competitive market advantage.




                                                                                                1
Introduction – Issues Highlighted at the           packaging. Generic companies need to find
Honeywell Generics Forum                           cost savings and efficiencies to maintain
                                                   profit margins.    One approach is to
The Honeywell Generics Forum, held in              standardise primary packaging as much as
January 2009 in Brussels, brought together         possible on efficient high barrier
over 20 senior management attendees from           thermoforming solutions such as Aclar®.
15 companies in 11 countries for a topical
debate on the current issues facing the
industry as well as to examine new                 Alu/Alu Pipeline
packaging strategies.
                                                   Recent market research conducted by
The generics sector has been experiencing          Honeywell with generic manufacturers
an unprecedented period of growth and              highlighted some major concerns:
generic firms are set to further capitalise on
the opportunities offered by patent expiry             •   Large numbers of pipeline products
on an estimated $150 bn worth of revenues                  packed in Alu/Alu even when not
                                                           necessary for barrier reasons
by 2015. Generics contribute to the long-
term affordability of healthcare systems.              •   Increasing Capex       required     to
Drivers such as aging populations,                         accommodate latest Alu/Alu pipeline
increasing medical consumption, cost                   •   The need to increase OEE and plant
containment and restrictions in government                 utilisation
healthcare budgets have all brought about
                                                       •   Internal strategic marketing teams
increasing focus on the cost savings offered               demanding differentiated packaging to
by the generic drug industry. On closer                    exploit profit pools
examination; however, this is an industry in
                                                       •   Wholesalers and pharmacies       both
transition as the implications of existing
                                                           demanding smaller pack sizes
trends work their way through the sector:
                                                   Not all products packed in Alu/Alu actually
    -   Increasing pressure to lower drug costs
        as healthcare cost containment gains       need to be in Alu/Alu – many can be moved
        greater impetus driven by the              to high barrier thermoform materials. But
        Economic Crisis                            why does the generics sector continue to
                                                   use so much Alu/Alu? The answer often
    -   Globalisation of the industry increasing
                                                   results from 2 simple reasons … firstly
        pressure for companies to develop
        both regional and global strategies        generic companies are copying originator
                                                   choices, and secondly they are not fully
    -   Fewer launches by innovators in recent     considering all packaging options in the
        years will translate into fewer
                                                   development phase. Generic companies can
        opportunities for generic companies
                                                   be too restrictive in material choices with
        down the line
                                                   only 2-3 materials on stability.
    -   Increasing number of          originator
        evergreening strategies       to stop      At the time of patent expiry the originator’s
        generics coming to market                  packaging decision may be 16 years old. It
                                                   was probably taken in a hurry with little
The result will be intense competition and
                                                   regard to pack size and prior to the launch
to survive generic companies need to
                                                   and common use of ultra high barrier
seriously improve product profitability
                                                   thermoform materials. Therefore the major
while avoiding commoditisation through
                                                   question for generic developers is: “Do we
innovative competitive strategies … e.g.



                                                                                               2
really want to copy an old product or should     Increasingly     generic companies      are
we develop something better?”                    choosing to revisit packaging choices. Many
                                                 have already initiated a switch-OUT
                                                 strategy1 and are turning existing
Generics Can Be Different                        “inefficient packs” into “efficient packs.”
                                                 Others are initiating switch-IN strategies2
Generic     drugs    are    pharmaceutical
                                                 and building packaging material flexibility
preparations that contain the same active
                                                 into their development process by adding a
ingredients in the same concentration as
                                                 high barrier thermoform material such as
the originator product. On one hand they
                                                 Aclar® to their stability protocols.
must be therapeutically equivalent to the
originator drug; but on the other, the
generic product’s shape, size, colour ... and
                                                 Thermoforming Advantages
packaging material can be different and
better!                                          One of the greatest challenges for generic
                                                 companies is managing very large drug
The old maxim: “originators innovate while
                                                 portfolios often consisting of 200+ drugs in
generics differentiate,” is often forgotten in
                                                 multiple pack variants for different
the race to get a new product to market.
                                                 countries. This vast array of products and
Pack differentiation is an ideal opportunity
                                                 packs creates massive complexity in
to create a sustainable competitive market
                                                 packaging and operations and drives up
advantage.        Increased         marketing
                                                 costs. The situation has been further
considerations     during      the     generic
                                                 complicated by industry consolidation with
development phase are already tipping the
                                                 some companies struggling to maximise site
balance in favour of high barrier
                                                 and machine utilisation across multiple
thermoforming - a process which enables a
                                                 sites, multiple geographies and multiple,
broader selection of design possibilities for
                                                 non-uniform capabilities.
a differentiated pack solution.
                                                 Initial packaging material choices have far-
                                                 reaching and long-lasting impact. The
Packaging Decisions                              choice affects total packaging costs beyond
                                                 the cost of material per square meter due
Pharmaceutical packaging is no longer
                                                 to factors such as: cost of secondary
purely functional. It can deliver value both
                                                 materials, material usage, scrap rate,
internally (improved operational efficiency,
                                                 maintenance and production rates, etc. In
reduced complexity, reduced total costs)
                                                 addition, choice of packaging platform has
and to the end-user (wholesalers, patient,
                                                 major supply chain implications. Industry
care-giver); but to leverage this value,
                                                 feedback strongly indicates that pack size
packaging decisions should result from
                                                 can be the main differentiator after price
informed, cross-functional, collaborative
                                                 for major wholesalers and pharmacies.
processes. Primary packaging decisions that
may have been correct for R&D during             Figure 1 demonstrates that by choosing an
development may not be correct, or may           ultra high barrier thermoform material such
even hamper, manufacturing operations
and marketing post launch and for years to       1
                                                   Migrating a product already launched in
come. The strategic impact of packaging          Alu/Alu into an ultra high barrier thermoform
choice on crucial factors such as pack size,     pack
                                                 2
total costs and machine utilisation is often       Migrating a product out of Alu/Alu and into an
not fully considered.                            ultra high barrier thermoform material prior to
                                                 launch


                                                                                                3
Switch-IN
as Aclar® instead of Aluminium Cold Form
Foil can result in a 55% reduction in pack     Adding a high barrier thermoform material
size.                                          to a stability protocol can have a relatively
                                               low impact on development time, resources
Thermoform packaging can dramatically
                                               and costs while increasing the potential for
increase tablet density providing cost
                                               launch in the most advantageous material.
savings across the board. The increase in
                                               This in turn can potentially offer substantial
tablets packaged per machine stroke
                                               benefits in downstream costs and
increases the effective capacity and speed
                                               efficiencies as well as increased sales.
of each packaging line compared to
                                               Generic companies are greatly increasing
Aluminium Cold Form Foil. Faster
                                               their product advantage by simply adding
production rates and the ability to use
                                               Aclar® to stability studies.
machines interchangeably can be translated
into fewer packaging lines required, lower
maintenance labour costs, and lower capital
equipment expenditures. Thermoforming          Switch-OUT
offers increased production capacity and       Switch-OUT is a process to change an
flexibility which impacts on the bottom-line   existing launched product from Alu/Alu to
and a major reason why many generic firms      an ultra-high thermoform pack e.g. Aclar®.
are now developing robust Switch-IN and        The resultant reduction in pack size and
Switch-OUT strategies - see Figure 2.          increased     efficiencies   offer  many
                                               advantages to Generic firms.


                                                                                           4
There are cost and resource implications in           format. Equally a competitive advantage
making this variation but increasingly                can be obtained by cost reduction and/or
generic companies are finding that                    efficiency gains thus improving product
resources spent maximising the profitability          margins and overall portfolio profitability.
of existing packs can offer greater returns
                                                      Choice of packaging platform has strategic
than launching new products alone. Smart
                                                      implications for generic firms because it can
companies are now choosing to piggyback
                                                      have profound implications on overall
material switch-OUT on top of existing
                                                      company profitability. Standardising where
scheduled variations.
                                                      possible on high barrier thermoforming
                                                      materials such as Aclar® can enable generic
                                                      companies to reduce complexity costs,
Conclusion
                                                      improve operational flexibility and overall
Ever strengthening competition in the                 profitability. While Cold Form Foil has a
generics sector is placing more importance            vital part to play in blistering in the future,
on creating and exploiting a competitive              when total barrier is not required generic
advantage through packaging choice. A                 firms have much to gain by moving to a high
marketing advantage can be achieved by                barrier thermoform solution.
offering   wholesaler      and    pharmacy
advantages through an improved pack


                                    PVC                   ACLAR®                Alu/Alu
                                (low barrier)       (ultra high barrier)    (highest barrier)

                                                      Quick & easy,
       Change-overs              Quick & easy
                                                    comparable to PVC
                                                                                  Slower


                                                    Fast, comparable to
       Run Rate                      Fast
                                                            PVC
                                                                                  Slower

                                                                              More difficult:
       Controlling
                                                                           → pinholes
       Properties                    Easy                  Easy
                                                                           → delamination
       (quality)                                                           → product feeding

                                                                                   High
       Cost of Tooling             Standard              Standard               (increased
                                                                               maintenance)

      Figure 2: OEE considerations. Thermoforming vs. Cold Forming.




                                                                                                   5
RM Consulting is now part of Parioforma Limited (www.parioforma.com), an
independent business consultancy headquartered in London, UK.
For further information on our services or for an informal discussion on your
information and/or research needs please don't hesitate to contact us:
      Either by telephone on: +44 (0) 207 225 3538; or by
      Email at: charles.rowlands@parioforma.com



LONDON OFFICE                       ASSOCIATE OFFICES


                                                   Intrix Corp, Darien
Charles Rowlands                    USA
                                                   Connecticut
Senior Partner
                                    Eastern
                                                   IMRP, Moscow
55 Prince’s Gate                    Europe
Exhibition Road
London SW7 2PN
                                    Brazil         Intrix Corp, São Paulo
United Kingdom
Tel: +44 (0) 7803 907577
www.parioforma.com                  Japan          TRN, Tokyo




                                                                                6

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Strategic implications of packaging for generics

  • 1. Strategic Implications of Packaging Choice in the Generic Sector David Barker is Marketing Development Manager for Honeywell Healthcare & Packaging. As a world leader in pharmaceutical packaging materials, Honeywell Healthcare & Packaging is working to develop industry leading packaging solutions which can deliver increased competitive advantage to the generics industry. Charles Rowlands and Amy Morgan are founding partners of RM Consulting, an international market and competitive intelligence consultancy focused on providing management support services to the global pharmaceutical, biotechnology, chemical and healthcare sectors. Jointly they have more than three decades’ experience and have worked on numerous strategy development and market research projects in both developed and emerging markets. Keywords: generics, profitability, primary packaging, competitive advantage, high barrier, thermoforming, blister film, Aclar®, Alu/Alu, Switch-IN, Switch-OUT. Abstract This paper reports on the issues highlighted at the recent Honeywell Generics Forum and examines the strategic implications of packaging choice in the generics industry. It looks at how companies are leveraging ultra high barrier thermoform solutions like Aclar® to create new value propositions. Meeting regulatory and quality needs are a basic standard and a given requirement for any primary packaging solution. However, in order to meet the challenges of today’s generics marketplace, innovative generic companies are now looking beyond these basic technical needs and are optimising packaging platform choice to realise market advantage and profitability gains. It is now recognised that pack differentiation offers an ideal opportunity to create a sustainable competitive market advantage. 1
  • 2. Introduction – Issues Highlighted at the packaging. Generic companies need to find Honeywell Generics Forum cost savings and efficiencies to maintain profit margins. One approach is to The Honeywell Generics Forum, held in standardise primary packaging as much as January 2009 in Brussels, brought together possible on efficient high barrier over 20 senior management attendees from thermoforming solutions such as Aclar®. 15 companies in 11 countries for a topical debate on the current issues facing the industry as well as to examine new Alu/Alu Pipeline packaging strategies. Recent market research conducted by The generics sector has been experiencing Honeywell with generic manufacturers an unprecedented period of growth and highlighted some major concerns: generic firms are set to further capitalise on the opportunities offered by patent expiry • Large numbers of pipeline products on an estimated $150 bn worth of revenues packed in Alu/Alu even when not necessary for barrier reasons by 2015. Generics contribute to the long- term affordability of healthcare systems. • Increasing Capex required to Drivers such as aging populations, accommodate latest Alu/Alu pipeline increasing medical consumption, cost • The need to increase OEE and plant containment and restrictions in government utilisation healthcare budgets have all brought about • Internal strategic marketing teams increasing focus on the cost savings offered demanding differentiated packaging to by the generic drug industry. On closer exploit profit pools examination; however, this is an industry in • Wholesalers and pharmacies both transition as the implications of existing demanding smaller pack sizes trends work their way through the sector: Not all products packed in Alu/Alu actually - Increasing pressure to lower drug costs as healthcare cost containment gains need to be in Alu/Alu – many can be moved greater impetus driven by the to high barrier thermoform materials. But Economic Crisis why does the generics sector continue to use so much Alu/Alu? The answer often - Globalisation of the industry increasing results from 2 simple reasons … firstly pressure for companies to develop both regional and global strategies generic companies are copying originator choices, and secondly they are not fully - Fewer launches by innovators in recent considering all packaging options in the years will translate into fewer development phase. Generic companies can opportunities for generic companies be too restrictive in material choices with down the line only 2-3 materials on stability. - Increasing number of originator evergreening strategies to stop At the time of patent expiry the originator’s generics coming to market packaging decision may be 16 years old. It was probably taken in a hurry with little The result will be intense competition and regard to pack size and prior to the launch to survive generic companies need to and common use of ultra high barrier seriously improve product profitability thermoform materials. Therefore the major while avoiding commoditisation through question for generic developers is: “Do we innovative competitive strategies … e.g. 2
  • 3. really want to copy an old product or should Increasingly generic companies are we develop something better?” choosing to revisit packaging choices. Many have already initiated a switch-OUT strategy1 and are turning existing Generics Can Be Different “inefficient packs” into “efficient packs.” Others are initiating switch-IN strategies2 Generic drugs are pharmaceutical and building packaging material flexibility preparations that contain the same active into their development process by adding a ingredients in the same concentration as high barrier thermoform material such as the originator product. On one hand they Aclar® to their stability protocols. must be therapeutically equivalent to the originator drug; but on the other, the generic product’s shape, size, colour ... and Thermoforming Advantages packaging material can be different and better! One of the greatest challenges for generic companies is managing very large drug The old maxim: “originators innovate while portfolios often consisting of 200+ drugs in generics differentiate,” is often forgotten in multiple pack variants for different the race to get a new product to market. countries. This vast array of products and Pack differentiation is an ideal opportunity packs creates massive complexity in to create a sustainable competitive market packaging and operations and drives up advantage. Increased marketing costs. The situation has been further considerations during the generic complicated by industry consolidation with development phase are already tipping the some companies struggling to maximise site balance in favour of high barrier and machine utilisation across multiple thermoforming - a process which enables a sites, multiple geographies and multiple, broader selection of design possibilities for non-uniform capabilities. a differentiated pack solution. Initial packaging material choices have far- reaching and long-lasting impact. The Packaging Decisions choice affects total packaging costs beyond the cost of material per square meter due Pharmaceutical packaging is no longer to factors such as: cost of secondary purely functional. It can deliver value both materials, material usage, scrap rate, internally (improved operational efficiency, maintenance and production rates, etc. In reduced complexity, reduced total costs) addition, choice of packaging platform has and to the end-user (wholesalers, patient, major supply chain implications. Industry care-giver); but to leverage this value, feedback strongly indicates that pack size packaging decisions should result from can be the main differentiator after price informed, cross-functional, collaborative for major wholesalers and pharmacies. processes. Primary packaging decisions that may have been correct for R&D during Figure 1 demonstrates that by choosing an development may not be correct, or may ultra high barrier thermoform material such even hamper, manufacturing operations and marketing post launch and for years to 1 Migrating a product already launched in come. The strategic impact of packaging Alu/Alu into an ultra high barrier thermoform choice on crucial factors such as pack size, pack 2 total costs and machine utilisation is often Migrating a product out of Alu/Alu and into an not fully considered. ultra high barrier thermoform material prior to launch 3
  • 4. Switch-IN as Aclar® instead of Aluminium Cold Form Foil can result in a 55% reduction in pack Adding a high barrier thermoform material size. to a stability protocol can have a relatively low impact on development time, resources Thermoform packaging can dramatically and costs while increasing the potential for increase tablet density providing cost launch in the most advantageous material. savings across the board. The increase in This in turn can potentially offer substantial tablets packaged per machine stroke benefits in downstream costs and increases the effective capacity and speed efficiencies as well as increased sales. of each packaging line compared to Generic companies are greatly increasing Aluminium Cold Form Foil. Faster their product advantage by simply adding production rates and the ability to use Aclar® to stability studies. machines interchangeably can be translated into fewer packaging lines required, lower maintenance labour costs, and lower capital equipment expenditures. Thermoforming Switch-OUT offers increased production capacity and Switch-OUT is a process to change an flexibility which impacts on the bottom-line existing launched product from Alu/Alu to and a major reason why many generic firms an ultra-high thermoform pack e.g. Aclar®. are now developing robust Switch-IN and The resultant reduction in pack size and Switch-OUT strategies - see Figure 2. increased efficiencies offer many advantages to Generic firms. 4
  • 5. There are cost and resource implications in format. Equally a competitive advantage making this variation but increasingly can be obtained by cost reduction and/or generic companies are finding that efficiency gains thus improving product resources spent maximising the profitability margins and overall portfolio profitability. of existing packs can offer greater returns Choice of packaging platform has strategic than launching new products alone. Smart implications for generic firms because it can companies are now choosing to piggyback have profound implications on overall material switch-OUT on top of existing company profitability. Standardising where scheduled variations. possible on high barrier thermoforming materials such as Aclar® can enable generic companies to reduce complexity costs, Conclusion improve operational flexibility and overall Ever strengthening competition in the profitability. While Cold Form Foil has a generics sector is placing more importance vital part to play in blistering in the future, on creating and exploiting a competitive when total barrier is not required generic advantage through packaging choice. A firms have much to gain by moving to a high marketing advantage can be achieved by barrier thermoform solution. offering wholesaler and pharmacy advantages through an improved pack PVC ACLAR® Alu/Alu (low barrier) (ultra high barrier) (highest barrier) Quick & easy, Change-overs Quick & easy comparable to PVC Slower Fast, comparable to Run Rate Fast PVC Slower More difficult: Controlling → pinholes Properties Easy Easy → delamination (quality) → product feeding High Cost of Tooling Standard Standard (increased maintenance) Figure 2: OEE considerations. Thermoforming vs. Cold Forming. 5
  • 6. RM Consulting is now part of Parioforma Limited (www.parioforma.com), an independent business consultancy headquartered in London, UK. For further information on our services or for an informal discussion on your information and/or research needs please don't hesitate to contact us:  Either by telephone on: +44 (0) 207 225 3538; or by  Email at: charles.rowlands@parioforma.com LONDON OFFICE ASSOCIATE OFFICES Intrix Corp, Darien Charles Rowlands USA Connecticut Senior Partner Eastern IMRP, Moscow 55 Prince’s Gate Europe Exhibition Road London SW7 2PN Brazil Intrix Corp, São Paulo United Kingdom Tel: +44 (0) 7803 907577 www.parioforma.com Japan TRN, Tokyo 6