DMHC2620

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Commercial Insight: Osteoporosis

Market Players Maximize Revenue Growth
Before the Next Challenging Phase
Report summary
Analysis of global osteoporosis
prescriptions from 200509, split
by geographical region (including
emerging markets), drug class,
and brand
Use this report to gain insight into the main

opportunities and threats specific to the
osteoporosis market
Discussion of key commercial

opportunities and threats in the
US, Japan, and five major
European markets
In-depth profiles of 13 key
osteoporosis brands and pipeline
agents with SWOT analyses and
country-specific sales forecasts to
2019
Detailed analysis of key developer
trends, strategies and portfolios
including a case study of
Novartiss Aclasta (zoledronic
acid)
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Commercial Insight: Osteoporosis Market Players Maximize Revenue Growth Before the
Next Challenging Phase
RESEARCHSTORE
About this report

Introduction
Globally, the osteoporosis market displayed a 3.5 per cent compound annual growth rate (CAGR) between 200509, reaching $9.4 billion in 2009.
However, the launch of generic alendronate in the majority of markets resulted in a temporary decline in sales during 2009. The market will stabilize
during the next five years due to generic incursion and then resume growth from 2015 as new drugs are launched.
The aging population and potential blockbuster revenues make the osteoporosis arena highly attractive to pharmaceutical and biotech companies. While
the market awaits new growth, driven by the launch of several promising pipeline drugs from 2015, including Amgens Prolia (denosumab), companies
are looking for innovative ways to maximize revenues from their products nearing the end of their lifecycles.
Key findings and highlights

The rest of the world, outside of the seven major markets, achieved osteoporosis-specific sales of $2.4 billion in 2009 with an impressive CAGR of
8.7 per cent from 2005. Brazil, Russia, India, and China were the fastest growing nations, driving a combined 200509 CAGR of 17 per cent.
The osteoporosis market offers multiple opportunities for current and future market players. In addition to increasing awareness, diagnosis and
treatment, there is the need to develop new drugs that promote bone building. However, the increase in cost pressure resulting from generic
penetration poses a major barrier to entry.
Leading market players continue to pursue their direct-to-consumer advertising campaigns, sponsoring events to raise awareness of the disorder
and of respective treatments. Innovative strategies to increase brand loyalty and confidence, such as risk-sharing schemes, have also been
implemented by Novartis and Sanofi-Aventis.
Reasons to buy
Understand historical (200509) and future (201019) osteoporosis drug market dynamics and competitive environment
Gain insight into the main opportunities and threats specific to the osteoporosis market
Evaluate the sales forecasts of marketed, generic, and key pipeline drugs to 2019 in the US, Japan, France, Germany, Italy, Spain, and the UK
Even though everyone has been talking about osteoporosis for ultimately
15 years now, it is still the minority of patients who are actually being
diagnosed and treated.
US Key Opinion Leader
Datamonitor Report
Published: Jun 10 | Code: DMHC2620
RESEARCHSTORE
Sample pages
Brand Dynamics
Brand Dynamics
out-patient hospital setting, with over 71% of patients being diagnosed by a specialist and 71% of these being diagnosed in
I mean the main plus [for Fosamax] is the price because it is the cheapest, the main problem nowadays is the
an out-patient setting.
availability of drugs which are more convenient [such as] once monthly. I would not say that side effects is a
major issue because once weekly [formulation] is well tolerated.
Datamonitor identified three main trigger points during the patient care where physicians can be influenced with regards to
what treatment to choose for their patients. These are discussed below.
Figure 34:
EU key opinion leader
Osteoporosis patient care path in the seven major markets, 2010

Fosamax has been positioned as the clear leader within the osteoporosis market for some time and benefits from strong
brand familiarity among both physicians and patients. Fosamax was first launched as a 10mg daily oral formulation. Since
Patient experiences a
fracture at any site
Patient presents for BMD

screening
its launch, numerous reformulations of Fosamax have been gradually introduced. These included weekly 70mg dosing and
an injectable formulation to cater for a wider patient base, in an attempt to increase treatment compliance and reduce the
gastric side effects associated with the oral Fosamax version. Indeed, it was the launch of weekly Fosamax that finally
Patient is referred to specialist
Patient presents to
specialist
transformed the drug into the leading brand for the treatment of osteoporosis. While some patients still found the gastric
Patient presents to PCP
side effects annoying, they were probably more likely to continue the once-weekly therapy.
Testing for low

BMD
SWOT analysis
Figure 40:
Low BMD
Fosamax brand franchise (alendronate; Merck & Co): SWOT analysis, 2010
Strengths
Yes
No
Osteopenia/osteoporosis/
severe osteoporosis
Prevention of
osteoporosis
1st line treatment

discussion
Yes
No
Lifestyle advice
Lifestyle advice
Calcium/vitamin D
only
Calcium/vitamin D
only1
Prescription drug
only
Prescription drug
only
Patient follow-up
Continue current
therapy
Compliance
issues
Dosing
Side effects
Change dosing/
class/drug
Change class or
drug
Weaknesses
x Established osteoporosis treatment

gold standard
x Established market presence and
brand awareness
x Approved for several indications
including osteoporosis prevention
x Launch of Fosamax Plus D
x Availability of multiple dosing and
administration routes
x Large financial reserves
x Available across seven major
markets
x Merck has a strong sales force
Fracture
x Molecule is easy to manufacture

limiting protection against generic
launch
x Gastric side effects
x Complicated dosing schedule
x Low compliance and persistence
x Does not affect anabolic bone
formation
Opportunities
Threats
x Launch of Fosamax Plus D in Japan

x Fosamax can strongly increase its
presence in the emerging markets
x Fosamax Plus D market
differentiation can provide a steady
flow of revenue for the Fosamax
brand franchise
x Patent expiry across the seven

major markets
x Patent litigation in the EU has
allowed generic incursion
x Particularly strong generic
penetration following US patent
expiry in 2008
x Launch of third generation
bisphosphonates with less frequent
dosing regimens
x Bad press due to osteonecrosis of
the jaw and cardiac arrythmias
Change class or
drug
BMD = bone mineral density; PCP = primary care physician

DATAMONITOR
Source: Datamonitor, Stakeholder Insight 2008: Osteopenia and Osteoporosis, DMHC2396
DMHC2620/Published 06/2010
Page 107
Datamonitor. This report is a licensed product and is not to be photocopied
Source: Datamonitor

Datamonitor. This report is a licensed product and is not to be photocopied
DATAMONITOR
DMHC2620/Published 06/2010
Page 118
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Table of contents
OVERVIEW
BRAND DYNAMICS
Catalyst
Overview of competitive landscape
Summary
Patient acquisition process

- Introduction
- Patient care path
- Points of influence in the patient care path
- Drivers of drug choice
EXECUTIVE SUMMARY
Strategic scoping and focus
US formulary tier status for leading brands

Datamonitor insight into the osteoporosis market
EU osteoporosis reimbursement policies
Related reports
Upcoming related reports
MARKET DEFINITION
Market definition for this report
MARKET OVERVIEW
Seven major markets
- Current and future market overview
- Opportunities and threats
US
- Current and future market assessment
Japan
Five major EU markets
France
Germany
Italy
Spain
UK
Rest of the world snapshot
- Current market assessment
Datamonitor Report
Trends in marketing strategies

- Marketing strategy for leading brands
- Sponsorship/disease awareness campaigns
- Direct-to-consumer advertising
Bisphosphonates: Fosamax/Fosamax Plus D (alendronate;
Merck & Co)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2019
Bisphosphonates: Actonel/Actonel with Calcium (risedronic
acid; Sanofi-Aventis/Warner Chilcott)
- Drug profile
- SWOT analysis
Bisphosphonates: Bonviva/Boniva (ibandronic acid;
Roche/GlaxoSmithKline)
- Drug profile
- SWOT analysis
Bisphosphonates: Aclasta (zoledronic acid; Novartis)
- Drug profile
- SWOT analysis
Bisphosphonates: Bonoteo/Recalbon (minodronic acid;
Astellas/Ono Pharmaceutical)
- Drug profile
- SWOT analysis
Selective estrogen receptor modulators: Evista (raloxifene; Eli
Lilly)
- Drug profile
- SWOT analysis
RESEARCHSTORE
Table of contents (continued)

Selective estrogen receptor modulators: Conbriza/Viviant
(bazedoxifene; Pfizer)
- Drug overview
- SWOT analysis
Selective estrogen receptor modulators: Fablyn (lasofoxifene;
Pfizer/Ligand)
- Drug overview
- SWOT analysis
Parathyroid hormones: Forteo (teriparatide; Eli Lilly)
- Drug profile
- SWOT analysis
Parathyroid hormones: Preotact (full-length parathyroid
hormone PTH 1-84; NPS/Nycomed)
- Drug profile
- SWOT analysis
Dual acting bone agents: Protelos (strontium ranelate; Servier)
- Drug profile
- SWOT analysis
Calcitonins: Miacalcic (calcitonin-salmon; Novartis)
- Drug profile
- SWOT analysis
Calcitonins: Fortical (calcitonin-salmon; Unigene)
- Drug profile
- SWOT analysis
Pipeline drugs: Prolia (denosumab; Amgen/GlaxoSmithKline)
- Drug profile
- Development overview
- SWOT analysis
- Drug forecast to 2019
Pipeline drugs: Eldecalcitol (ED-71; Chugai/Taisho)
- SWOT analysis
- Drug forecast to 2019
KEY DEVELOPERS
Strategic overview
- Trends in corporate strategy
- Recent strategic partnerships/deals
Merck & Co
- Corporate strategy
- Osteoporosis portfolio assessment
Eli Lilly
- Corporate strategy
- Osteoporosis portfolio assessment
Portfolio assessment of other leading companies
- Novartis: continued interest in the market is reflected in the
pipeline activity
- GlaxoSmithKline: deal with Amgen allows GlaxoSmithKline to
keep market share
- Pfizer: Wyeth acquisition allows Pfizer to finally enter this
market
CASE STUDIES
Aclasta: the market leader that never was
- Once yearly addresses compliance, but mode of administration
limits use
- Access to Aclasta remains problematic in many major markets
- Overall the cost for Aclasta does not exceed other
bisphosphonate therapies
- Reimbursement policies can affect the frequency with which the
drug is used
- Patient and physician education
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
Conferences attended
APPENDIX A
Market assumptions
- New product launches and expiries
Data definitions, limitations and assumptions
- Standard units
- Country group definitions
Derivation of sales forecasts and pricing trends
Indication-specific sales calculations
- Caveats to using Prescribing insight
Forecast methodology
Datamonitor Report
RESEARCHSTORE
Table of contents(continued)
APPENDIX B
Contributing experts
Conferences attended
Report methodology
About Datamonitor
- About Datamonitor Healthcare
- About the Genitourinary analysis team
- Disclaimer
LIST OF TABLES
Table 1:
Table 2:
Table 3:
Table 4:
Table 5:
Table 6:
Table 7:
Table 8:
Table 9:
Table 10:
Table 11:
Table 12:
Table 13:
Table 14:
Table 15:
Table 16:
Table 17:
Table 18:
Table 19:
Table 20:
Table 21:
Summary of therapeutic classes in osteoporosis by

Anatomical Therapeutic Chemical (ATC) code, 2009
Summary of the ICD-10 codes used to derive osteoporosisspecific sales from each brand
Regional osteoporosis market value sales ($m) in the seven
major markets, 2005-2019
Anatomical Therapeutic Chemical (ATC) class sales
dynamics ($m) in osteoporosis across the seven major
markets, 2005-2019
Osteoporosis brand sales ($m) dynamics across the seven
major markets, 2009-2019
Key events impacting the osteoporosis market, by region,
2010-2019
Osteoporosis global market opportunities and threats, 20102019
Summary of key osteoporosis drug patent expiries in the
seven major markets, 2010-2020
Prices of key osteoporosis drugs in the US and the five
major EU markets, 2009
Osteoporosis sales ($m) dynamics in the US by Anatomical
Therapeutic Chemical (ATC) class, 2005-2019
Osteoporosis brand sales ($m) dynamics in the US, 20092019
Osteoporosis market opportunities and threats in the US,
2010-2019
Uninsured osteoporosis population in the US aged 50-64
years, 2010
Medicare payments, 2009
Price per year ($) of key osteoporosis brands in the US,
2009
Osteoporosis sales ($m) dynamics in Japan by Anatomical
Osteoporosis brand sales ($m) dynamics in Japan, 20092019
Osteoporosis market opportunities and threats in Japan,
2010-2019
Osteoporosis sales ($m) dynamics in the five major EU
markets, 2005-2019
Osteoporosis sales ($m) dynamics in the five major EU
markets by Anatomical Therapeutic Chemical (ATC) class,
2005-2019
Osteoporosis brand sales ($m) dynamics in the five major
EU markets, 2009-2019
Datamonitor Report
Table 22: Osteoporosis market opportunities and threats in the five

major EU markets, 2010-2019
Table 23: Implementation of EU recommendations in the five major
EU markets, 2008
Table 24: Osteoporosis sales ($m) dynamics in France by Anatomical
Table 25: Osteoporosis sales forecasts in France ($m), 2009-2019
Table 26: Osteoporosis sales ($m) dynamics in Germany by
Anatomical Therapeutic Chemical (ATC) class, 2005-2019
Table 27: Osteoporosis sales forecasts in Germany ($m), 2009-2019
Table 28: Osteoporosis sales ($m) dynamics in Italy by Anatomical
Table 29: Osteoporosis sales forecasts in Italy ($m), 2009-2019
Table 30: Osteoporosis sales ($m) dynamics in Spain by Anatomical
Table 31: Osteoporosis sales forecasts in Spain ($m), 2009-2019
Table 32: Osteoporosis sales ($m) dynamics in the UK by Anatomical
Table 33: Osteoporosis sales forecasts in the UK ($m), 2009-2019
Table 34: Global sales ($m) dynamics of the osteoporosis market,
2005-09
Table 35: Regional split of the global osteoporosis market sales, 200509
Table 36: Rest of the world osteoporosis sales by Anatomical
Table 37: Leading branded drug sales for osteoporosis in the seven
major markets ($m), 2009-2019
Table 38: Key products in late-stage R&D pipeline for osteoporosis,
2010
Table 39: Results from the Timeless Woman Study, 2008
Table 40: Representative formulary tier status in the US for leading
brands in osteoporosis, 2010
Table 41: EU osteoporosis treatment reimbursement policies, 2008
Table 42: Marketing strategies employed by the companies behind the
top three pain market brands, 2010
Table 43: Fosamax (alendronate; Merck & Co): key facts, 2010
Table 44: Impacting factors on the revenues of the Fosamax brand
franchise (alendronate; Merck & Co), 2010-2019
Table 45: Actonel (risedronic acid; Sanofi-Aventis/Warner Chilcott):
key facts, 2010
Table 46: Impacting factors on the revenues of the Actonel brand
franchise, 2010-2019
Table 47: Bonviva (ibandronic acid; Roche/GlaxoSmithKline): key
facts, 2010
Table 48: Impacting factors on the revenues of the Bonviva brand
franchise, 2010-2019
Table 49: Aclasta (zoledronic acid; Novartis): key facts, 2010
Table 50: Impacting factors on the revenues of Aclasta, 2010-2019
Table 51: Bonoteo (minodronic acid; Astellas/Ono Pharmaceutical):
key facts, 2010
Table 52: Evista: key facts, 2010
For a full list of tables and figures please to refer to

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RESEARCHSTORE

Commercial Insight: Osteoporosis

Use this report to gain insight into the main

Discussion of key commercial

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About this report

Key findings and highlights

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EU key opinion leader

Osteoporosis patient care path in the seven major markets, 2010

Patient presents for BMD

Patient is referred to specialist

Patient presents to PCP

Testing for low

1st line treatment

x Established osteoporosis treatment

x Molecule is easy to manufacture

x Launch of Fosamax Plus D in Japan

x Patent expiry across the seven

BMD = bone mineral density; PCP = primary care physician

Source: Datamonitor, Stakeholder Insight 2008: Osteopenia and Osteoporosis, DMHC2396

Commercial Insight: Osteoporosis

Datamonitor. This report is a licensed product and is not to be photocopied

Commercial Insight: Osteoporosis

Contact our customer service team for more sample pages...

tel: +44 20 7675 7764

fax: +44 20 7990 9988

tel: +1 212 686 7400

fax: +1 646 365 3362

tel: +971 4 407 2720

fax: +971 4 335 2647

tel: +61 2 8705 6900

fax: +61 2 8705 6901

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Overview of competitive landscape

Patient acquisition process

US formulary tier status for leading brands

Trends in marketing strategies

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Table of contents (continued)

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Summary of therapeutic classes in osteoporosis by

Table 22: Osteoporosis market opportunities and threats in the five

For a full list of tables and figures please to refer to

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Other reports in this series

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