A Datamonitor Report
Global Generics Guide,
Third Edition
Benchmarking Generics Company
Capabilities and Strategy
Published: Dec-04 Product Code: DMHC2034
Providing you with:
• Capabilities and portfolio analysis
of the top 20 generics companies operating
in the US, Germany, UK, France, Spain
and Italy
Use this Report to...
Identify the optimal portfolio
management strategy for your
company and the implications
of those of your rivals
• Case study-based insight into the
effectiveness of 15 portfolio management,
marketing and growth strategies available
to generics players
• Strategic profiles of 20 leading generics
companies, including growth strategy,
competitive positioning and alliance
network analysis
• Analysis of the country-specific patent
expiries for global blockbuster drugs
www.datamonitor.com/healthcare
Global Generics Guide 3rd Edition: Benchmarking Generics Company Capabilities and Strategy
DMHC2034
Introduction
With cost-containment, a focus for all healthcare payers,
the growth of the generics market is outpacing the branded
sector by a considerable margin. However, the operating
environment for generics is becoming increasingly
competitive pushing existing players further up the
pharmaceutical value chain. Brand and generics
companies alike must be prepared for this new
competition.
The Global Generics Guide Third Edition: Benchmarking Generics Company
Capabilities and Strategy provides in-depth analysis and insight into the current
and future competitive environment within the generics markets of the US, UK,
Germany, France, Spain and Italy. Based on comprehensive analysis of the
capabilities and portfolios of the leading players in each market, Datamonitor maps
the competitive landscape for generic versions of multiple formulation types in each
country. Effective evaluation of the competitive environment facing your brand
or generic is critical to successful strategic planning.
Key findings and highlights
• With 79.7% of 2003 blockbuster sales potentially exposed to generic competition
by 2010, equating to $103.7 billion worth of products at 2003 sales value,
the growth opportunities in the generics sector are significant. However,
understanding how different country dynamics shape the competitive landscape
is critical to evaluating risk and return.
• Effective portfolio management is critical to future success in the generics
market. Maintaining breadth of portfolio and low cost supply is critical for
commodity generics players, forcing many players to evaluate higher value
generic sectors, thus generating new competitors to brand pharma.
• In the US, the generic injectables sector retains high barriers to entry, but
in Europe, competitive analysis suggests that the market place is more crowded.
As such, injectable products may represent a less valuable proposition
to European generics players than US analysis would suggest.
Reasons to buy
• Identify the optimal portfolio management strategy for your company and the
implications of those of your rivals
• Identify the likely rivals to your brand or generic in each of the six major markets
• Assess the implications of generics company strategic development on the
success of your late-stage lifecycle management strategies
For more information...
Contact Neal Hansen, Lead Consultant - Lifecycle Management
tel:
+44 20 7675 7459
fax:
+44 20 7675 7016
email:
nhansen@datamonitor.com
www.datamonitor.com/healthcare
Sample pages from the analysis
Key Generics Strategies for Success
Partnerships case study – Teva
To analyze the types of alliances entered by generics companies, Datamonitor has
considered Teva as a case study. Teva, as might be expected of the world’s largest
generics company, has an extensive network of alliances. These can be grouped
under several alliance types: where Teva acts as a marketing partner; in-licensing
and collaborations; technology licensing; and co-development or co-marketing. The
most important of Teva’s alliances are outlined below:
Generics Market Dynamics
Figure 57:
Teva’s alliance network
Biovail
Impax
Andrx
Israeli
academic
network
Aventis
Eisai
Acorda
BioGeneriX
(ratiopharm)
Co-development /
Co-marketing
Teva
CAGR of sales of oral generic products,
1999-2003 (%)
Lundbeck
Figure
24:
Leading generics companies’ sales in Germany of oral generic
As a marketing
Baxter
products
partner
40% In-licensing
/
Savient
collaboration BetaPharm
Technology
30%
licensing
CyDex
Note: This is not an exhaustive list of Teva’s alliances
Sandoz
Woerwag
Microbia
NeuraxPharm
10%
Teva
-200
Active
Biotech
ratiopharm
West Johann Lohmann
Mylan, Watson, Schwarz and Par also have some topical sales, although these are of
limited importance to each of these companies. Alpharma’s generic topical portfolio
Alpharma
has experienced a sharp decline over the last five years, from 12.6% to 5.7% of
DATAMONITOR
200
400
800
1,000
1,200
company 600
sales.
Verla
0%
Source: Datamonitor; company reported information
Acorda
STADA
Hexal
Generics Market Dynamics
20%
0
PLIVA
-10% Schwarz
2003 sales of oral generic products ($m)
© Datamonitor (Published 12/2004)
This report is a licensed product and is not to be photocopied
30%
20%
10%
0%
Dr Reddy's
Sanofi
Abbott
STADA
Par
Apotex
Ranbaxy
Sandoz
ratiopharm
Schwarz
Impax
PLIVA
Alpharma
IVAX
Teva
Barr
Watson
Mylan
Taro
Andrx
BI
Mayne
APP
Baxter
Hospira
Merck
Biovail
Global Generics Guide, 3rd Edition
Percentage of sales of Top 20 products derived from each
Product Class
It is worth noting that of these four alliance types, the first three involveMajor
a flowcompanies’
of
strategic areas of focus
Note: Bubble
size represents
the percentageand
of total
product or technology rights into Teva,
whereas
the co-development
co-company Germany sales derived from
oralSales
products
marketing deals involve the flow of product rights out of Teva (as indicated
by of
thethe top 20 products of each of the major participants in the US generics
market
Source:
MIDAScompanies,
sales data, IMSwho
Health,
Aprilhave
2004 been split according to the product type (commodity generic, specialty
direction of the arrows in the figure).
For Datamonitor;
most generics
have
a
generic,
supergeneric or branded product); according to formulation (oral, modified
lesser market presence than Teva, it could be expected that out-licensing
deals
D Atransdermal
TAMONITOR
release, injectable, inhalable or
patch), and according to the magnitude
would be more prevalent than in-licensing.
of sales of the originator drug in the 12 months before its patent expiry. These figures,
shown below, therefore give an insight into the current product focus of leading
As a marketing partner (product sourcing)
In line with their shares of the total generics
market,
the market.
key players ratiopharm,
companies
within this
Hexal and STADA also dominate the oral generics marketplace. Although ratiopharm
Teva has an unmatched presence in the global generics market, and is seen as a
also has a broad range of generic formulations,
its oral
franchise
is stillofthe
clear
Figure
15:
Sales
breakdown
major
generics companies’ top 20 US
“world-class marketer of generic pharmaceuticals” by its partner Impax. As a result,
market leader. All three companies have seen very healthy
growthsplit
ratesby
over
the last
products,
product
type (commodity, specialty,
Teva has entered many deals to act as a marketing partner for companies with lesser
five years, but Hexal and STADA appear to be closingsupergeneric
the gap on ratiopharm’s
oral
or branded)
generics business, with both Hexal and STADA realizing five-year CAGRs of well
Global Generics Guide, 3rd Edition
DMHC2034
over 20%, at 24.5% and 24.8% respectively.
Within the smaller players, BetaPharm
100%
© Datamonitor (Published 12/2004)
Page 186
and Sandoz have both been achieving impressive
90% growth rates of 35.5% and 34.5%
This report is a licensed product and is not to be photocopied
respectively. NeuraxPharm’s unusual strategy
80% of focusing exclusively on one
therapeutic area—CNS products—also appears70%
to be paying dividends with its 22.6%
Brand
Supergeneric
CAGR. At the other end of the scale, the oral60%
businesses of Alpharma, PLIVA and
Specialty
Schwarz have not fared so well, with sales declining
50% at CAGRs of -0.2%, -2.7% and Commodity
5.1% respectively.
40%
DMHC2034
Page 51
Source: Datamonitor; MIDAS sales data, IMS Health, April 2004
DATAMONITOR
rd
Global Generics Guide, 3 Edition
© Datamonitor (Published 12/2004)
DMHC2034
Page 38
This report is a licensed product and is not to be photocopied
“...While the uptake of generics in the UK is expected to continue to rise,
the increased competition will make it a less attractive market
over the next five years...”
Generics Company Executive
Global Generics Guide 3rd Edition: Benchmarking Generics Company Capabilities and Strategy
DMHC2034
Table of contents
EXECUTIVE SUMMARY
•
GENERICS MARKET DYNAMICS
• Key findings
• Global market sizes
- Future market potential
• Company positioning
- Geographic focus of major generics companies
• Country-specific analysis
- US
Overview
Company positioning by product type
Major companies' strategic areas of focus
Future market potential
- UK
Overview
Major companies' strategic areas of focus
Future market potential
- Germany
Overview
Company positioning by product type
Major companies' strategic areas of focus
Future market potential
- France
Overview
Company positioning by product type
Major companies' strategic areas of focus
Future market potential
- Spain
Overview
Company positioning by product type
Major companies' strategic areas of focus
Future market potential
- Italy
Overview
Company positioning by product type
Major companies' strategic areas of focus
Future market potential
KEY GENERICS STRATEGIES FOR SUCCESS
• Key findings
• Overview
Portfolio management strategies
- Commodity generics focus
Case study – Apotex
Case study – Sandoz
Outlook
- Paragraph IV challenges
Terms of 180-day exclusivity
Potential revision of 180-day exclusivity provision
30-month stays
An increasingly favourable environment for patent
challenges
Launching generics ‘at-risk’
The threat from 'authorized generics'
Case study – Barr Laboratories
Case study – Teva
Case study – Ranbaxy
Case study – Dr Reddy's
Outlook
- Specialty generics focus
Modified-release generics
Injectable generics
Inhalable generics
Topical generics
Transdermal generics
Products requiring regulatory support or handling
restrictions
Outlook
- Supergenerics focus
Is there a market for supergenerics?
Regulatory situation
Outlook
- Biogenerics focus
Uncertainty over regulatory situation
Progress with the US regulatory pathway
The EU regulatory pathway – one step ahead
Early approvals – limited to first generation
products?
Cost and marketing of biogenerics
Biogenerics development in the less regulated
markets
Companies well-placed to lead the biogenerics
market
Outlook
For more information...
Contact Neal Hansen, Lead Consultant - Lifecycle Management
tel:
+44 20 7675 7459
fax:
+44 20 7675 7016
email:
nhansen@datamonitor.com
www.datamonitor.com/healthcare
- Branded/innovative products focus
-
Key companies involved in in-house R&D
Key companies involved in branded product
licensing/acquisitions
Outlook
- Niche markets
Case study – Impax
Outlook
- Therapeutic focus
Case study – Barr, seizing the opportunity in
women's health
Case study – NeuraxPharm, entirely focused
on CNS generics
Case study – Alpharma in Germany
Case study – Teva
Outlook
Marketing Strategies
- Branded generics
Specialty branded generics
Branded generics in specific geographic markets
such as Germany
- 'Authorized' or 'friendly' generics
Case study – Mylan, strongly opposed to authorized
generics
Case study – GSK's settlement with Par, authorizing
generic Paxil
Case study – STADA's ‘early entry’ with
mirtazapine in Germany
- Generic alliances
Case study – Teva and Alpharma partnering
on gabapentin
Case study – licensing of first-to-file status for
omeprazole
Case study – Mayne Pharma licensing paclitaxel
Growth Strategies
- Vertical integration
-
-
•
•
Advantages of integration
Advantages of out-sourcing API
- Geographical growth
US companies
Other companies
- Growth through Mergers and Acquisitions
- Partnerships
-
STRATEGIC COMPANY PROFILES
• Financial measures
- Benchmarking by profitability
- Benchmarking by operating costs
- Benchmarking by financial strength
• Profiles of leading companies
- Teva Pharmaceutical Industries
- Sandoz
- IVAX Pharmaceuticals
- Merck KGaA
- Watson Pharmaceuticals
- Ratiopharm
- Hexal
- Barr Pharmaceuticals
- Mylan Laboratories
- Apotex
- Alpharma
- Ranbaxy
- STADA
- Par Pharmaceutical
- PLIVA
- Mayne Pharma
- Taro Pharmaceuticals
- Gedeon Richter
- Andrx
- Dr Reddy's
APPENDIX
TABLES
Table 1:
-
API sourcing partnerships
Marketing partnerships
Partnerships case study – Teva
Table 2:
Table 3:
Table 4:
Table 5:
Number of analyzed generics companies offering
any oral and injectable generic products in each
market, 2003
Size of key global generics markets, 2002-2003
Global positioning of major generics companies
by sales
US generic sales of selected leading generics
companies, 2002-2003
German generics market shares of leading
generics companies
“...Successful players in the commodity generics markets must balance
a broad portfolio with maximum geographic reach to generate
economies of scale, while managing cost-effective producing
and sourcing with a strong corporate brand image ...”
Datamonitor Lead Consultant for Lifecycle Management
Global Generics Guide 3rd Edition: Benchmarking Generics Company Capabilities and Strategy
DMHC2034
Table 6:
Table 7:
Table 8:
Table 9:
French generics market shares of leading
generics companies
Analysis of Impax's top-selling generics, 2003
Profitabilities of leading generics companies,
2003, ranked by operating profitability
Long-term financial stability of selected generics
companies
FIGURES
Figure 1: Primary patent expiry years of 2003 blockbuster
drugs
Figure 2: Leading generics companies' US sales of
injectable generic products
Figure 3: Leading generics companies' sales in Germany
of injectable generic products
Figure 4: Percentages of analyzed generics companies
offering any oral and injectable generic products
in each market, 2003
Figure 5: Breakdown of the global generics market by
sales
Figure 6: Growth of major generics markets, 2002-2003
Figure 7: Generic penetration as a percentage of total
pharmaceutical sales, by country
Figure 8: Primary patent expiry years of 2003 blockbuster
drugs
Figure 9: Global positioning of selected major generics
companies
Figure 10: Geographic focus of major generics companies
Figure 11: US generics market shares of leading generics
companies
Figure 12: Leading generics companies' US sales of oral
generic products
Figure 13: Leading generics companies' US sales
of injectable generic products
Figure 14: Leading generics companies' US sales
of inhalable, topical and transdermal generic
products
Figure 15: Sales breakdown of major generics companies'
top 20 US products, split by product type
(commodity, specialty, supergeneric or branded)
Figure 16: Sales breakdown of major generics companies'
top 20 US products, split by product formulation
Figure 17: Sales breakdown of major generics companies'
top 20 US products, split by peak sales
of originator's branded product
Figure 18: US 2003 sales of blockbuster products that are
expected to lose primary patent protection each
year from 2003-2010
Figure 19: Sales breakdown of major generics companies'
top 20 UK products, split by product type
(commodity, specialty, supergeneric or branded)
Figure 20: Sales breakdown of major generics companies'
top 20 UK products, split by product formulation
Figure 21: Sales breakdown of major generics companies'
top 20 UK products, split by peak sales
of originator's branded product
Figure 22: UK 2003 sales of blockbuster products that are
expected to lose primary patent protection each
year from 2003-2010
Figure 23: German generics market shares of leading
generics companies
Figure 24: Leading generics companies' sales in Germany
of oral generic products
Figure 25: Leading generics companies' sales in Germany
of injectable generic products
Figure 26: Leading generics companies' sales in Germany
of inhalable, topical and transdermal generic
products
Figure 27: Sales breakdown of major generics companies'
top 20 products in Germany, split by product type
(commodity, specialty, supergeneric or branded)
Figure 28: Sales breakdown of major generics companies'
top 20 products in Germany, split by product
formulation
Figure 29: Sales breakdown of major generics companies'
top 20 products in Germany, split by peak sales
of originator's branded product
Figure 30: 2003 sales in Germany of blockbuster products
that are expected to lose primary patent
protection each year from 2003-2010
Figure 31: French generics market shares of leading
generics companies
Figure 32: Leading generics companies' sales in France
of oral generic products
Figure 33: Leading generics companies' sales in France
of injectable generic products
Figure 34: Leading generics companies' sales in France
of inhalable, topical and transdermal generic
products
Figure 35: Sales breakdown of major generics companies'
top 20 products in France, split by product type
(commodity, specialty, supergeneric or branded)
For the full list of figures, email hcinfo@datamonitor.com
with ‘DMHC2034 TOC’ in the subject line.
For more information...
Contact Neal Hansen, Lead Consultant – Lifecycle Management
tel:
+44 20 7675 7459
fax:
+44 20 7675 7016
email:
nhansen@datamonitor.com
www.datamonitor.com/healthcare
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