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Osteoporosis Therapeutics - Pipeline Assessment and Market Forecasts to 2018 Published: November 2011 No. of Pages: 147 Price: $ 3500

GlobalData, the industry analysis specialist, has released its new report, “Osteoporosis Therapeutics - Pipeline Assessment and Market Forecasts to 2018�. The report is an essential source of information and analysis on the global osteoporosis therapeutics market. The report identifies the key trends shaping and driving the global osteoporosis therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global osteoporosis therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

GlobalData analysis shows that the global osteoporosis therapeutics market stood at $6.9 billion in 2005 and grew at a Compound Annual Growth Rate (CAGR) of 4.5% to reach $8.5 billion in 2010. GlobalData forecasts that the global osteoporosis therapeutics market will grow moderately at a CAGR of 3.3% over the next eight years to reach $11.1 billion by 2018. The current competitive landscape consists mainly of bisphosphonates, selective estrogen receptor modulators (SERM), receptor activator of nuclear factor kappa-B (RANK) ligand (RANKL) inhibitor drugs and hormone therapy, which includes parathyroid hormone apart from estrogen and progesterone. The recent launch of Prolia (denosumab), a monoclonal antibody from the therapeutic class RANKL inhibitor, has also opened new avenues for the treatment of osteoporosis with improved safety, efficacy and compliance to medication by the patient. The bisphosphonates are the preferred drug for treatment and are used as the first line of therapy for the treatment of osteoporosis. The expected moderate growth can be attributed to the increase in awareness among people regarding osteoporosis, especially among females about postmenopausal osteoporosis (PMO) which contributes the largest number of patient pool to osteoporosis. GlobalData also predicts that an increase in the patient population as a consequence of the ageing population will drive the moderate growth in the osteoporosis therapeutics market. The modest growth observed in the osteoporosis therapeutics market during 2010 to 2018 can also be attributed to the expected launch of pipeline products such as Odanacatib (MK 0822), NB S101 during the late forecast period. The patent expiry of Actonel (risedronate sodium), Boniva (ibandronate), Reclast (zoledronic acid), Evista (raloxifene) and Protelos (strontium malonate) during 2012 to 2014 will act as the major barriers for the growth of osteoporosis therapeutics market during the forecast period. The impending patent expiry of Boniva in 2012; Actonel and Reclast in 2013; and Evista in 2014 means patients will have access to

treatment at much lower prices reflecting brand erosion of these drugs. The sales growth will also be affected by Fosamax (alendronate) generics, which lost its patent exclusivity in 2008. The main treatment options available in the osteoporosis therapeutics market include alendronate, Reclast, Actonel, Boniva, Evista, Prolia, Forteo (teriparatide), Miacalcin (calcitonin salmon), Prempro (estrogen) and Premarin (conjugated estrogens and medroxyprogesterone acetate) among others. Scope The report provides information on the key drivers and challenges of the osteoporosis therapeutics market. Its scope includes - Annualized seven key markets (the US, France, Germany, Italy, Spain, the UK and Japan) osteoporosis therapeutics market revenues data from 2005 to 2010, forecast for eight years to 2018. - Pipeline analysis data providing a split across the different phases, mechanisms of action being developed and emerging trends by seven key markets. Pipeline candidates fall under major therapeutic classes such as osteoclast activity inhibitors, osteoclast activity promoters, bone anabolic agents, SERMs, SARMs, RANKL inhibitors, dual acting bone agents, PTH release stimulator, cathepsin K inhibitor, bone morphogenetic protein signaler, aminobisphosphonate, DKK1 Protein inhibitor and osteoblast level promotor - Analysis of the current and future competition in the seven key countries osteoporosis therapeutics market. Key market players covered are Amgen, Merck, Novartis, Pfizer, Osteologix, EffRx, Zydus, Astellas and Radius. - Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide a qualitative analysis of its implications. - Key topics covered include strategic competitor assessment, market characterization, unmet needs and the implications for the osteoporosis therapeutics therapeutics market. - Analysis of key recent licensing and partnership agreements in osteoporosis therapeutics market Reasons to buy The report will enhance your decision making capability. It will allow you to - Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies and by identifying the companies with the most robust pipeline. - Develop business strategies by understanding the trends shaping and driving the global osteoporosis therapeutics market.

- Drive revenues by understanding the key trends, innovative products and technologies, market segments and companies likely to impact the global osteoporosis therapeutics market in future. - Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. - Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. - Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships. - What’s the next big thing in the global osteoporosis therapeutics market landscape? – Identify, understand and capitalize. 1 Table of Contents 1 Table of Contents 2 1.1 List of Tables 6 1.2 List of Figures 7 2 Osteoporosis Therapeutics: Executive Summary 9 2.1 The Osteoporosis Therapeutics Market Forecast to Show Moderate Growth Through 2018 Due to Genericization of Branded Drugs 9 2.2 Availability of Different Treatment Options in the Current Osteoporosis Therapeutics Market, Catering Inadequately to the Needs of Patients 10 2.3 Strong Pipeline Products Likely to Enter the Market, Uncovering Better Treatment Options 11 2.4 Significant Unmet Need in Osteoporosis Therapeutics Market Accounted by Low Levels of Drug Safety and Compliance to Medication 12 3 Osteoporosis Therapeutics: Introduction 14 3.1 Disease Overview 14 3.2 Epidemiology 17 3.3 Etiology 18 3.4 Pathophysiology 19 3.5 Signs and Symptoms 21 3.6 Diagnosis 22 3.6.1 Physical Examination 22 3.6.2 Medical History 23 3.6.3 BMD Testing 23 3.6.4 Laboratory Tests 25 3.7 Treatment and Management Options 25 3.8 GlobalData Pipeline Report Guidance 29 4 Osteoporosis Therapeutics: Market Characterization 31 4.1 Osteoporosis Therapeutics Market Size (2005–2010) – Global 31 4.2 Osteoporosis Therapeutics Market Forecast (2010–2018) – Global 32 4.3 Osteoporosis Therapeutics Market Size (2005–2010) – The US 34 4.4 Osteoporosis Therapeutics Market Forecast (2010–2018) – The US 35 4.5 Osteoporosis Therapeutics Market Size (2005–2010) – France 37

4.6 Osteoporosis Therapeutics Market Forecast (2010–2018) – France 38 4.7 Osteoporosis Therapeutics Market Size (2005–2010) – Germany 39 4.8 Osteoporosis Therapeutics Market Forecast (2010–2018) – Germany 40 4.9 Osteoporosis Therapeutics Market Size (2005–2010) – Italy 41 4.10 Osteoporosis Therapeutics Market Forecast (2010–2018) – Italy 42 4.11 Osteoporosis Therapeutics Market Size (2005–2010) – Spain 44 4.12 Osteoporosis Therapeutics Market Forecast (2010–2018) – Spain 45 4.13 Osteoporosis Therapeutics Market Size (2005–2010) – The UK 46 4.14 Osteoporosis Therapeutics Market Forecast (2010–2018) – The UK 47 4.15 Osteoporosis Therapeutics Market Size (2005–2010) – Japan 49 4.16 Osteoporosis Therapeutics Market Forecast (2010–2018) – Japan 50 4.17 Drivers and Barriers for the Osteoporosis Therapeutics Market 51 4.17.1 Drivers for the Osteoporosis Therapeutics Market 51 4.17.2 Barriers for the Postmenopausal Osteoporosis Therapeutics Market 52 4.18 Opportunity and Unmet Need 54 4.19 Key Takeaway 57 5 Osteoporosis Therapeutics: Competitive Assessment 58 5.1 Overview 58 5.2 Strategic Competitor Assessment 58 5.3 Product Profile for the Major Marketed Products in the Osteoporosis Therapeutics Market 60 5.3.1 Fosamax (alendronate sodium) 60 5.3.2 Actonel (risedronate sodium) 62 5.3.3 Boniva (ibandronate sodium) 64 5.3.4 Reclast (zoledronic acid) 66 5.3.5 Evista (raloxifene hydrochloride) 68 5.3.6 Prolia (denosumab) 70 5.3.7 Forteo (teriparatide [rDNA origin]) injection 71 5.3.8 Miacalcin (salmon calcitonin) 74 5.3.9 Activella (estradiol, norethindrone acetate) 75 5.3.10 Premarin (estrogen) 76 5.3.11 Prempro (conjugated estrogens and medroxyprogesterone acetate) 77 5.4 Key Takeaway 78 6 Osteoporosis Therapeutics: Pipeline Assessment 79 6.1 Overview 79 6.2 Strategic Pipeline Assessment 79 6.3 Osteoporosis Therapeutics – Pipeline Analysis by Clinical Phase of Development 79 6.3.1 Osteoporosis Therapeutics – Phase III and Regulatory Filed Clinical Pipeline 80 6.3.2 Osteoporosis Therapeutics – Phase II Clinical Pipeline 81 6.3.3 Osteoporosis Therapeutics – Phase I Pipeline 82 6.3.4 Osteoporosis Therapeutics –Pre-clinical and Discovery Phase Pipeline 83 6.4 Osteoporosis Therapeutics – Pipeline by Mechanism of Action 84 6.5 Technology Trends Analytical Framework 85 6.6 Osteoporosis Therapeutics – Most Promising Drugs in Clinical Development 87 6.7 Most Promising Drugs in Clinical Development 88 6.7.1 Viviant 88 6.7.2 Fablyn 89 6.7.3 Aprela 90 6.7.4 EX101 91 6.7.5 Odanacatib (MK-0822) 92

6.7.6 NB S101 93 6.7.7 SMC 021 94 6.7.8 Ostora 94 6.7.9 BA058- injection 96 6.7.10 UNI-PH (1-34), rhPTH 1-34 96 6.7.11 YM529 / ONO-5920 --- Astellas/ ONO 97 6.8 Key Takeaway 97 7 Osteoporosis Therapeutics: Clinical Trials Mapping 98 7.1 Clinical Trials by Region/Country (The US, EU5 and Japan) 98 7.2 Clinical Trials by Phase of Clinical Development 99 7.3 Clinical Trials by Trial Status 100 7.4 Prominent Sponsors 101 7.5 Clinical Trials by Sponsors 102 7.6 Top Companies Participating in Osteoporosis Therapeutics Clinical Trials 103 8 Osteoporosis Therapeutics: Strategic Assessment 105 8.1 Key Events Impacting the Future Market 105 8.2 Future Market Competition Scenario 105 9 Osteoporosis Therapeutics: Future Players 108 9.1 Introduction 108 9.2 Company Profiles 108 9.2.1 Amgen Inc. 108 9.2.2 Astellas Pharma, Inc. 111 9.2.3 EffRx, Inc. 113 9.2.4 Merck & Co., Inc. 114 9.2.5 Novartis AG 115 9.2.6 Osteologix, Inc. 117 9.2.7 Pfizer Inc. 118 9.2.8 Radius Health, Inc 122 9.2.9 Tarsa Inc. 123 9.2.10 Zyduscadila Inc. 123 9.3 Other Companies in the Osteoporosis Therapeutics Market 126 9.4 Key Takeaway 129 10 Osteoporosis Therapeutics: Licensing & Partnership Deals 129 11 Osteoporosis Therapeutics: Appendix 140 11.1 Market Definitions 140 11.2 Abbreviations 140 11.3 Research Methodology 142 11.3.1 Coverage 142 11.3.2 Secondary Research 142 11.3.3 Forecasting 143 11.3.4 Primary Research 145 11.3.5 Expert Panel Validation 146 11.4 Contact Us 146 11.5 Disclaimer 146 11.6 Bibliography 147

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GlobalData analysis shows that the global osteoporosis therapeutics market stood at $6.9 billion in 2005 and grew at a Compound Annual Growt...