osteoporosis treatment and prevention world drug market 2014-2024

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Osteoporosis Treatment and Prevention: World Drug Market Forecast 2014-2024 & Future Prospects for Leading Companies ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.

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Page 1: Osteoporosis Treatment and Prevention World Drug Market 2014-2024

Osteoporosis Treatment and Prevention: World Drug Market Forecast 2014-2024 & Future Prospects for Leading Companies

©noticeThis material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.

Page 2: Osteoporosis Treatment and Prevention World Drug Market 2014-2024

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Osteoporosis Treatment and Prevention: World Drug Market Forecast 2014-2024 & Future Prospects for Leading Companies

1.1 The Global OsteoporosisDrug Market Review

1.2 The Global Osteoporosis Drug Market Segmentation

1.3 Why You Should Read This Report

1.4 How This Report Delivers

1.5 Key Questions Answered by This Analytical Report

1.6 Who is This Report For?

1.7 Methodology

1.8 Frequently Asked Questions (FAQ)

1.9 Associated Visiongain Reports

1.10 About Visiongain

2.1 Osteoporosis Prevalence and Incidence, 2014

2.2 Osteoporosis: The Silent Killer

2.3 Osteoblasts are Critical in Bone Healing

2.4 Classifying Osteoporosis by Types

2.5 Classifying Osteoporosis by Treatments

2.5.1 Antiresorptive Medication

2.5.2 Anabolic Medication

2.6 Osteoporosis Risk Factors

1. Report Overview

2. Introduction to Osteoporosis

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3.1 Scope of this Report

3.2 The Global Osteoporosis Drug Market in 2013

3.3 The Global Osteoporosis Drug Market: Sales Forecast 2014-2024

3.4 Breakdown of the World Osteoporosis Drug Market by Therapeutic Classes, 2013

3.5 The Global Osteoporosis Drug Market by Therapeutic Classes: Sales Forecast 2014-2024

3.6 Breakdown of the World Osteoporosis Drug Market by Leading Drugs, 2013

3.6.1 The Global Osteoporosis Drug Market by Leading Drugs: Sales Forecast 2014-2024

3.7 Which Osteoporosis Drugs Will Lead the Market in 2024?

3.7.1 Osteoporosis Products Pipeline, 2014

3.7.2 Forteo (Teriparatide) -Eli Lilly, 2014

3.7.3 Evista(Raloxifene) - Eli Lilly, 2014

3.7.4 Prolia (Denosumab) - Amgen, GSK and Daiichi Sankyo, 2014

3.7.5 Actonel/Atelvia (Risendronate) -Sanofi, Actavis, Ajinomoto Pharmaceuticals and Eisai,

2014

3.7.6 Fosamax (Alendronate) - Merck, 2014

3.7.7 Reclast/Aclasta (Zoledronic Acid) - Novartis, 2014

3.7.8 Boniva (Ibandronate) –Roche and GSK, 2014

3.7.9 Duavee (Bazedoxifene/Conjugated Estrogens) – Pfizer and Ligand Pharmaceuticals,

2014

3.7.10 Odanacatib (MK 0822) - Merck, 2014

3.7.11 Romosozumab (AMG 785) – Amgen and UCB, 2014

3.7.12 The Global Osteoporosis Drug Market: Drivers and Restraints 2014-2024

3. The Global Osteoporosis Drug Market, 2014-2024

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4.1 Regional Breakdown of the World Osteoporosis Drug Market, 2013

4.2 Regional Breakdown of the World Osteoporosis Drug Market: Sales Forecast by Region,

2014-2024

4.3 How Will Regional Market Shares Change to 2024?

4.4 The US Osteoporosis Drug Market, 2013

4.4.1 The US Osteoporosis Drug Market: Forecast 2014-2024

4.5 Reimbursement Situation in the US, 2014

4.5.1 The US Keeps Dominating the Osteoporosis Drug Market: What About Healthcare

Coverage?

4.6 The US Osteoporosis Drug Market: Drivers and Restraints, 2014-2024

4.7 The Leading European Osteoporosis Drug Markets, 2013

4.7.1 The Leading European Osteoporosis Drug Markets: Forecasts 2014-2024

4.7.2 The German Osteoporosis Drug Market Forecast, 2014-2024

4.7.3 The French Osteoporosis Drug Market Forecast, 2014-2024

4.7.4 The UK Osteoporosis Drug Market Forecast, 2014-2024

4.7.5 The Italian Osteoporosis Drug Market Forecast, 2014-2024

4.7.6 The Spanish Osteoporosis Drug Market Forecast, 2014-2024

4.8 The Japanese Osteoporosis Drug Market, 2013

4.8.1 The Japanese Osteoporosis Drug Market Forecast, 2014-2024

4.8.2 Recent Trends in the Japanese Osteoporosis Drug Market, 2014

4.9 The BRICK CountriesOsteoporosis Drug Market, 2013

4.9.1 The BRICK Countries Osteoporosis Drug Market Forecast, 2014-2024

4.9.2 The Chinese Osteoporosis Drug Market Forecast, 2014-2024

4. Leading National Osteoporosis Drug Markets, 2014-2024

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4.9.2.1 Main Companies in the ChineseOsteoporosis Drug Market, 2014

4.9.2.2 Growth Drivers in the Chinese Osteoporosis Drug Market, 2014-2024

4.9.3 The Indian Osteoporosis Drug Market Forecast, 2014-2024

4.9.4 The Russian Osteoporosis Drug Market Forecast, 2014-2024

4.9.5 The Brazilian Osteoporosis Drug Market Forecast, 2014-2024

4.9.6 The South Korean Osteoporosis Drug Market Forecast, 2014-2024

4.9.7 The BRICK Countries Osteoporosis Drug Market: Drivers and Restraints, 2014-2024

4.10 The Osteoporosis Drug Market Forecast in the Rest of the World, 2014-2024

4.10.1 Additional Considerations: Challenges for Aging Populations by Region, 2014

5.1 The Global Antiresorptive Drugs Market Forecast 2014-2024

5.1.1 Breakdown of the Antiresorptive Drugs Market by Drug Category, 2013

5.2 The Global Antiresorptives Drug Market by Drug Category: Sales Forecast 2014-2024

5.3 The Global Bisphosphonates Market, 2013

5.4 The Global Bisphosphonates Drug Market: Sales Forecast 2014-2024

5.5 Breakdown of the Global Bisphosphonates Market: Sales Forecast by Leading Drugs 2014-

2024

5.5.1 Actonel/Atelvia (Risedronate)

5.5.1.1 History of Actonel/Atelvia (Risedronate)

5.5.1.2 Generic Competition for Actonel/Atelvia (Risedronate), 2014

5.5.1.3 Actonel/Atelvia (Risedronate) Sales Forecast 2014-2024

5.5.2 Fosamax (Alendronate)

5.5.2.1 History of Fosamax (Alendronate)

5. Global Antiresorptive Drugs Market, 2014-2024

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5.5.2.2 Generic Competition for Fosamax (Alendronate), 2014

5.5.2.3 Fosamax (Alendronate) Sales Forecast 2014-2024

5.5.3 Reclast/Aclasta (Zoledronic Acid)

5.5.3.1 Reclast/Aclasta (Zoledronic Acid) Strengths and Weaknesses, 2014

5.5.3.2 Reclast/Aclasta (Zoledronic Acid) in the Leading Regional Markets, 2014

5.5.3.3 Generic Competition for Reclast/Aclasta (Zoledronic Acid), 2014

5.5.3.4 Reclast/Aclasta (Zoledronic Acid) Sales Forecast 2014-2024

5.5.4 Boniva (Ibandronate)

5.5.4.1 Boniva (Ibandronate): Sales Forecast 2014-2024

5.6 The Global SERMs Drug Market: Sales Forecast 2014-2024

5.7 Breakdown of the Global SERMs Market: Sales Forecast by Leading Drugs 2014-2024

5.7.1 Evista (Raloxifene)

5.7.1.1 Generic Competition for Evista (Raloxifene), 2014

5.7.1.2 Evista (Raloxifene) Sales Forecast 2014-2024

5.7.2 Duavee/Aprela (Bazedoxifene and Conjugated Estrogens)

5.7.2.1 Duavee/Aprela (Bazedoxifene and Conjugated Estrogens) in the Leading

Regional Markets, 2014

5.7.2.2 History of Duavee/Aprela (Bazedoxifene and Conjugated Estrogens)

5.7.2.3 Duavee/Aprela (Bazedoxifene and Conjugated Estrogens) Sales Forecast 2014-

2024

5.8 The Global RANKL Antibody Market: Sales Forecast 2014-2024

5.8.1 Prolia (Denosumab)

5.8.1.1 History of Prolia (Denosumab)

5.8.1.2 Prolia to Drive the Market in 2017

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5.8.1.3 Safety Profile

5.8.1.4 Prolia: Patent Expiries

5.8.1.5 Prolia (Denosumab) Sales Forecast 2014-2024

5.9 The Global Cathepsin K Inhibitors Market: Sales Forecast 2014-2024

5.9.1 Odanacatib

5.9.1.1 Odanacatib Sales Forecast 2014-2024

5.10 Other Antiresorptive Drugs, 2014

5.10.1 Protelos

5.10.2 Calcitonin-Salmon

5.10.3 Binosto

5.11 Drivers and Restraints for the Global Antiresorptives Drug Market, 2014-2024

6.1 The Global Anabolic Drugs Market, 2013

6.2 The Global Anabolics Drug Market by Drug Category: Sales Forecast 2014-2024

6.3 The Human Recombinant Parathyroid Hormone Peptides Market, 2014

6.3.1 Forteo (Teriparatide) Market: Sales Forecast 2014-2024

6.3.1.1 Forteo Offers a Differentiating Factor in 2014

6.4 The Anti-Sclerostin Market, 2014

6.4.1 Romosozumab: Sales Forecast 2014-2024

6.5 Other Anabolic Drugs

6.5.1 Blosozumab (LY2541546): Second in Class Sclerostin Antibody

6.5.2 ZP-PTH: Parathyroid by Way Micro Needle Patch

6.5.3 ZT-034: Will Need More Than Biomarkers for Approval

6. The Global Anabolic Drugs Market, 2014-2024

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6.5.4 Preotact/Preos: Will it be Introduced in the Market Again?

6.5.5 BA-058 (Abaloparatide): Potential Competitor for Forteo

6.5.6 PTH(1-31)NH2: Future Dual-Action Drug

7.1 Leading Companies in the Osteoporosis Drug Market, 2013

7.2 Expected Company Leaders in the Osteoporosis Drug Market in 2024

7.3 Eli Lilly and Co

7.3.1 Eli Lilly Osteoporosis Drug Sales Forecast, 2014-2024

7.4 Amgen

7.4.1 Amgen’s Osteoporosis Product Portfolio

7.4.2 Amgen Osteoporosis Drug Sales Forecast, 2014-2024

7.5 UCB

7.5.1 UCB Osteoporosis Drug Sales Forecast, 2014-2024

7.6 GSK

7.6.1 GSK Osteoporosis Drug Sales Forecast, 2014-2024

7.7 Merck

7.7.1 Merck Osteoporosis Drug Sales Forecast, 2014-2024

7.8 Actavis

7.9 Sanofi

7.10 Pfizer

7.11 Novartis

7. Leading Companies in the Osteoporosis Drug Market, 2014

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8.1 Pestel Analysis

8.1.1 Political Factors

8.1.2 Economic Factors

8.1.3 Socio-Cultural Factors

8.1.4 Technological Factors

8.1.5 Environmental Factors

8.1.6 Legal Factors

8.2 Porter’s Five Forces Analysis of the Osteoporosis Drugs Market

8.2.1 Competitive Rivalry: High Rivalry Among Competitors

8.2.1.1 Eli Lilly and Amgen Dominate the Biological Osteoporosis Drug Market

8.2.2 Potential Entrants into the Osteoporosis Drug Market: Low Threat of New Entrants

8.2.3 Medium Threat of Substitutes: Who Are The Latent Substitutes?

8.2.4 High Power of Suppliers: Drug Manufacturers Still Have the Power to Lead the Market

8.2.5 High Power of Buyers: Big Pharma to Engulf Smaller Companies

8.3 SWOT Analysis and Strategies

8.3.1 Strengths: Smart Thinking

8.3.2 Weaknesses: Not An Easy Market

8.3.2.1 Patent Expiries

8.3.3 Opportunities: Changing Social Trends

8.3.4 Threats: Highly Stringent but Necessary Regulations

8.3.4.1 Drug Side-Effect Publicity

8. Qualitative Analysis of the Global Osteoporosis Drug Market,

2014-2024

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8.3.4.2 Reimbursement for Bone Metabolism Drugs

8.4 Challenges to Overcome for the Future Osteoporosis Drug Market

9.1 Interview with Dr. Karl Grindulis, Consultant Rheumatologist at Sandwell General Hospital,

West Bromwich, UK

9.1.1 Calcitonin-Salmon in the UK

9.1.2 Personalised Medicine

9.1.3 Expert Views on Romosozumab

9.1.4 Key Factors for the Future

9.2 Interview with Dr. Matthew Drake, Consultant in the Department of Medicine, Division of

Endocrinology, Mayo Clinic Rochester, Minnesota, US

9.2.1 Skeletal Anabolic Agents Remain the Biggest Unmet Need

9.2.2 Calcitonin-Salmon: not Recommendable

9.2.3 Shifting to Generics

9.2.4 Romosozumab: Potential Blockbuster

9.2.5 Odanacatib: Intriguing Future Performance

9.2.6 Focusing on Patients with Rare Skeletal Disorders may Give Some Answers

10.1 The World Osteoporosis Drug Market by Therapeutic Classes, 2013

10.2 The World Osteoporosis Drug Market Forecast by Drug Category, 2014-2024

10.3 The Global Osteoporosis Drug Market Forecast by Regional Markets, 2014-2024

9. Expert Opinions

10. Conclusions

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10.4 The Global Osteoporosis Drug Market Forecast by Leading Drugs, 2014-2024

10.4.1 Leading Companies for the Osteoporosis Drug Market

10.5 Drivers for the Osteoporosis Drugs Market, 2014-2024

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Table 3.9 Osteoporosis Drugs in Development, 2014

Product Target Phase of Development Company

Duavee/Aprela Bazedoxifene and conjugated estrogens

Approved in Oct 2013

Ligand Pharmaceuticals

Odanacatib Cathepsin K Inhibitors Phase 3 Merck

Romosozumab Anti-Sclerostin Mab Phase 3 Amgen / UCB

Blomosozumab Anti-Sclerostin Mab Entering Phase 3 Eli Lilly

BA-058 (Abaloparatide) Synthetic parathyroid hormone

Entering Phase 3 Radius Health

ZP-PTH Teriparatide patch Phase 2 Zosano

ZT-034 Teriparatide nasal spray Phase 2 Azelon Pharmaceuticals

rhPTH(1-31)NH2 (Ostabolin)

Recombinant human parathyroid hormone

Phase 2 Unigene

Ostora Recombinant salmon calcitonin

Phase 3 Tarsa / QS Pharma

Source: Visiongain 2014

Figure 3.9 Hisctoric and Projected Development of the Osteoporosis Drug Market, 1986-2016

Source: Visiongain 2014

Hormone Replacement

Therapy

Calcitonins Raloxifene

Teriparatide

1986 1991

Oral Bisphosphonates

Denosumab

1995 1999 2002 2006/7

Cathepsin K Inhibitors

Anti-Sclerotin

2010 2015 2016

IV Bisphosphonates

1991

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4.7 The Leading European Osteoporosis Drug Markets, 2013

In 2013, the osteoporosis drug market for the top 5 countries in the EU generated combined sales

worth $2.16bn (see Table 4.5). The EU5 markets leading the osteoporosis drug market by value

were Germany, France, Italy, Spain and UK in that order. These five markets currently hold a

global market share of 27.3% worldwide.

Germany and Italy are the countries with the highest median ages in the world after Japan. By

2050, Bosnia and Herzegovina, Germany, Malta, Portugal, Serbia and Spain are projected to attain

median ages of 50 years or more. In this sense, the aging population in this region is increasing

steadily driving the osteoporosis drug market. However, the growth in the European markets is

expected to be lower than in other markets, especially due to the ongoing economic crisis.

Table 4.5 The EU5 Osteoporosis Drug Market: Revenue ($bn) and Global / Regional Market Shares (%) by Country, 2013

EU5 Revenue ($bn)

Global Market

Share (%)

Regional Market

Share (%)Germany 0.65 8.2 30.1France 0.64 8.1 29.6UK 0.37 4.7 17.3Italy 0.29 3.7 13.4Spain 0.21 2.6 9.6Total EU5 Osteoporosis Drug M k t

2.16 27.3 100.0

Source: Visiongain2014

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In contrast, adherence to Prolia treatment is simple. A sub-cutaneous injection is performed once

every six months, either in a secondary care setting or by the patient. Amgen conducted a study to

compare treatment compliance and persistence between Prolia and alendronate. 88.1% adhered

to Prolia treatment in the first year, with only 76.6% adhering to weekly alendronate dosing. For the

second year of treatment, adherence rates were 92.5% for Prolia and 63.5% for alendronate.

Cumulative adherence rates over the two year trial were 82.2% for Prolia treatment and 48.6% of

alendronate. Visiongain believes that this improvement in compliance will drive Prolia uptake

across the developed markets.

Ease of compliance has been an important driver in previous market growth. When Fosamax

(Alendronate; Merck& Co) was launched as a weekly rather than daily treatment sales accelerated,

physicians began prescribed the drug to new patients who would not have complied with daily

dosing. The potential for Prolia to capitalise on the non-compliant patient group is a huge

opportunity.

5.8.1.3 Safety Profile

As advised by Yasuhiro Takeuchi, denosumab inhibits bone resorption more powerfully than

bisphosphonates, such as alendronate, health-care providers should be aware of the risks of

atypical fracture and osteonecrosis of the jaw when patients are treated with denosumab.

Furthermore, they are in charge to watch patients carefully, because it may decrease serum

calcium level significantly within a week or so.

5.8.1.4 Prolia: Patent Expiries

In September 2012, Prolia was approved by the FDA for the treatment to increase bone mass in

men with osteoporosis at high risk for fracture in the US. A phase 3 study of Prolia for the

treatment of glucocorticoid-induced osteoporosis was initiated in 2012.

Currently Prolia holds several patents which expire in 2017, 2018, 2021, 2022, 2023 and 2025;

however the most important patents will expire in 2017 which is related to the methods of use in

US and RANKL antibodies in EU. These patents can vary by country.

5.8.1.5 Prolia (Denosumab) Sales Forecast 2014-2024

In 2011, AstraZeneca made a co-promotion agreement for denosumab with Daiichi Sankyo for

sales of the drug in Japan. As mentioned, the drug was originated by Amgen.