Top 10 Healthcare Trends in 2011

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GBI Research

2011 Mar 31

194 Pages (PDF)




Top 10 Healthcare Trends in 2011

Summary

GBI Research has released its latest report, Top 10 Healthcare Trends in 2011 that provides key data, information and analysis of the major trends in the biopharmaceutical and medical devices industry. The report provides a comprehensive insight into the ten major trends in the biopharmaceutical and medical devices industry in 2011. A detailed analysis of each of the major trends is presented in the report. Major trends in the medical and pharmaceutical industry covered in the report include: Refurbished Systems: Soft Hospital Spending Drives Demand for Refurbished Medical Devices and Capital Equipment, Hospital Information Systems: Government Aid and Cost Savings Driving Development and Adoption, Big Medical Device Companies Turn to Life Sustaining Product Portfolio For Growth, The Regulatory Ecosystem: Changes in the US and Europe to impact industry, The Large Pharmaceutical Companies are Diversifying through Inorganic Growth, Trends in Oncology (the most promising therapeutic market segment) - Market size, forecasts, pipeline analysis, profiles of the most promising molecules under development for each of the major cancer therapeutic segments, Reduction of healthcare costs and drug safety issues will remain the main focus of regulatory authorities and biopharmaceutical industries, Upcoming Sales & Marketing Models will offset the issues/pitfalls of traditional models, Outsourcing Will Remain the Key Strategy for Biopharmaceutical Companies: CRO, CMO And Drug Discovery Outsourcing Will Continue to Grow at a greater pace, and Biologics Price Competition and Innovation Act, 2009 Opens the Gates for Approval of Biosimilars in the US This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Researchs team of industry experts.

Scope

The report analyses the major trends in biopharmaceutical and medical devices market along with the major forces driving the current market and the potential challenges that can restrain the growth. The scope of the report includes - 
- Detailed overview of strategies and trends of pharmaceutical and medical device industry in 2010.
- Annualized market data, forecast and pipeline analysis for oncology, along with profiles of promising pipeline molecules in lung cancer, breast cancer, colorectal cancer, non-hodgkins lymphoma and prostate cancer.
- Detailed overview of outsourcing strategies and models employed by major pharmaceutical companies and Key strategies and upcoming regulatory changes affecting the industry.
- Overview of the upcoming sales and marketing models in the industry.
- Focus of pharmaceutical industry on healthcare cost reduction and its implications
- Analysis of the regulatory system in the US and Europe.
- Analysis of the key segments that are gaining attention from medical device companies.
- Analysis of partnership deals in 2010 along with segmentation by indication, deal type, geography and companies
- Analysis of M&A deals in 2010 along with segmentation by value geography and companies

Reasons to buy

- Develop market-entry and market expansion strategies by identifying the key therapeutic areas for high growth and high opportunities.
- Understand the factors shaping the pharmaceutical and medical devices market.
- Exploit partnership and acquisition opportunities by identifying the therapy areas/products that could fill the portfolio gaps.
- Align your product portfolio to the markets with high growth potential.
- Identify and develop better strategies and models to ensure better marketing and sales of products.
- Understand the changes in regulatory system and upcoming regulatory models to effectively design clinical trials and/or ensure fast approval of drugs and devices.
- Analyze the trends in licensing and M&A deals and explore potential investment opportunities
- Understand upcoming trends that are poised to drive growth in pharmaceutical and medical devices industry
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 8
1.2 List of Figures 10
2 Top 10 Healthcare Trends in 2011 13
2.1 Introduction 13
2.2 GBI Research Report Guidance 14
3 Refurbished Systems: Soft Hospital Spending Drives Demand for Refurbished Medical Devices and Capital Equipment 15
3.1 Introduction 15
3.2 Standardization and Regulations 15
3.3 Refurbishment Process 15
3.4 Brand Factor 16
3.5 Clean Green Approach 16
3.6 Value Chain Key Driver for Refurbished Systems 16
3.7 Conclusion 17
4 Hospital Information Systems: Government Aid and Cost Savings Driving Development and Adoption 18
4.1 Introduction 18
4.2 Global Hospital Information Systems: Market Characterization 19
4.3 Global Hospital Information Systems: Market Dynamics 20
4.3.1 Key Drivers of Adoption 21
4.4 Global Hospital Information Systems Market: Strategic Competitive Assessment 23
5 Big Medical Device Companies Turn to Life Sustaining Product Portfolio For Growth 24
5.1 Introduction 24
5.2 Company Profiles 25
5.2.1 Medtronic: 25
5.2.2 Boston Scientific: 25
5.2.3 St Jude Medical: 25
5.2.4 Roche 26
5.3 Key Therapeutic Areas 27
5.3.1 Cardiovascular 27
5.3.2 Neurology 34
5.3.3 Diabetes Care Devices: 37
6 The Regulatory Ecosystem: Changes in the US and Europe to impact industry 41
6.1 United States: The 510 (k) Reform 41
6.2 European Union EU Medical Device Directive (MDD) Changes 41
6.2.1 Summary of Changes 41
6.2.2 Impact on the Medical Device Market 41
6.3 Post Marketing Guidance: A Safety Net against Recalls and Safety Issues 42
6.3.1 Summary of Changes 42
6.3.2 Impact on the Medical Device Market 42
6.3.3 Conclusions 42
6.3.4 Key Points: 42
7 The Large Pharmaceutical Companies are Diversifying through Inorganic Growth 43
7.1 Novartis Acquires Alcon 43
7.1.1 Overview 43
7.1.2 Deal Rationale 44
7.1.3 Deal Analysis 44
7.1.4 Company Profile 46
7.2 Abbott Acquires Advanced Medical Optics 46
7.2.1 Overview 46
7.2.2 Deal Rationale 46
7.2.3 Deal Analysis 47
7.2.4 Company Profile 48
7.3 Johnson & Johnson Consolidates Medical Device Portfolio by Acquiring Mentor and Omrix 48
7.3.1 Overview 48
7.3.2 Deal Rationale 48
7.3.3 Deal Analysis 49
7.3.4 Company Profile 51
7.4 Biopharmaceutical companies will continue to extend and expand their portfolio and geographic reach through Mergers, Acquisitions & Licensing Agreements 52
7.4.1 Mergers and Acquisitions 52
7.4.2 Deals by Value 53
7.4.3 Top 10 Mergers and Acquisitions in 2010 54
7.5 Licensing Agreements 55
7.5.1 Deals by Therapy Area 55
7.5.2 Deals by Value 56
7.5.3 Deals by Value 57
8 Pharmaceutical Companies Focus More on Oncology Market Owing to Increased utilization of high-cost targeted and long duration therapies 58
8.1 Introduction 58
8.2 Oncology Therapeutics: Market Overview 58
8.3 The Global Oncology Therapeutics Market Is Expected To Reach Revenues of $33 Billion By 2016 59
8.3.1 Sales Value 59
8.3.2 Avastin, Rituxan and Herceptin are the major selling brands and are expected to lead the market through 2015 60
8.3.3 Increased Interest of Pharmaceutical Companies in Targeted and Customized Therapies 61
8.4 Oncology Therapeutics Market Is Backed By Strong R&D Activity 62
8.5 R&D Trends 65
8.5.1 Discovery of Unknown Mutations that Play Key Role in Cancers 65
8.5.2 Pairing Therapeutics and Diagnostics 66
8.6 Key Late Stage Pipeline Drugs 67
8.6.1 Lung Cancer 67
8.6.2 Breast Cancer 68
8.6.3 Colorectal Cancer 70
8.6.4 Non-Hodgkins Lymphoma 74
8.6.5 Prostate Cancer 77
9 Outsourcing Will Remain the Key Strategy for Biopharmaceutical Companies: CRO, CMO And Drug Discovery Outsourcing Will Continue to Grow at a greater pace 81
9.1 Introduction 81
9.2 Contract Manufacturing Organizations will receive significant impetus from emerging economies 82
9.3 Contract Manufacturing Organizations (CMO) in Eastern Europe are set to Grow at a Faster Rate 83
9.4 Market Forecasts 85
9.5 Comparative Analysis of Eastern European Countries 86
9.5.1 Infrastructural Facilities  Railways, Roadways, Airways, Power and Overall Logistics Support 87
9.5.2 Labor - Availability of Skilled Labor at Affordable Rates and Labor Flexibility 88
9.5.3 Broad Economic Indicators  GDP, Availability of Credit, Taxation Policies 89
9.5.4 Ease of Doing Business  Overall Government and Regulatory Support 90
9.6 Contract Research Outsourcing Market will continue to Grow, Driven by the Demand by the Biopharmaceutical Industry 92
9.6.1 Introduction 92
9.6.2 Market Characterization 93
9.7 Contract Research Outsourcing Service Model 94
9.7.1 Fully Integrated Service Model 95
9.7.2 Functional Service Model 96
9.8 India and China are the fastest growing markets with regard to drug discovery research 97
9.8.1 Introduction 97
9.8.2 Drug Discovery in India and China  Market Characteristics 98
9.8.3 Why India and China? 99
9.8.4 Availability of Skilled Manpower 99
9.8.5 Scale of Available Resources for Clinical Development 101
9.8.6 Major Therapeutic Areas under Research 101
9.8.7 Improved IP Protection in India and China 102
9.8.8 Government Support for the Drug Discovery Development 103
9.8.9 Risk Sharing Agreements: A Step Forward by Indian and Chinese Companies 105
9.8.10 SWOT Analysis 106
10 Reduction Of Healthcare Costs And Drug Safety Issues Will Remain The Main Focus Of Regulatory Authorities And Biopharmaceutical Industries 108
10.1 Risk Evaluation and Mitigation Strategy (REMS) 108
10.1.1 What is REMS? 108
10.1.2 Risk Evaluation and Mitigation Strategies - Food and Drug Administration Amendments Act (FDAAA) of 2007 109
10.1.3 Components of REMS 109
10.1.4 FDA Approved REMS (2008-2010) 110
10.2 Opioids and REMS 117
10.3 Erythropoiesis-Stimulating Agents (ESAs) 118
10.4 Case Studies 119
10.4.1 Accutane (Isotretinoin) 119
10.4.2 Tysabri (Natalizumab) 120
10.5 Major Players Are Becoming Increasingly Aligned around Personalized Medicine and Companion Diagnostics  Oncology Continues to be the Prime Focus 121
10.6 Global Companion Diagnostics Market, Oncology, Revenue Forecasts ($m), 2009-2016 124
10.7 Biomarkers Facilitate Quick Turnover of Drugs and Significant Reduction in Drug Discovery and Development Costs 127
10.8 The Biomarkers Market Is Forecast To Reach $6.3 Billion By 2016 128
10.8.1 Breast cancer biomarkers contributed to a majority (24%) of the total market revenue 129
10.9 Biomarkers in Cancer Research  Pipeline by Indication 132
11 Upcoming Sales & Marketing Models will offset the issues/pitfalls of traditional models 134
11.1 Introduction 134
11.1.1 Layoff in the Pharmaceutical Companies 134
11.2 Key Account Management Will Be Implemented In All Large and Medium Sized Pharmaceutical Companies 135
11.2.1 Introduction 135
11.2.2 Key Account Management Process 135
11.2.3 Types of Key Account Management 142
11.2.4 Case Studies 143
11.3 Contract Sales Outsourcing Will Increase Due to its Strategic Advantage to Improve Productivity 149
11.3.1 Contract Sales Representatives 150
11.3.2 Sales Team Recruitment and Training 150
11.3.3 Sales Data Analytics and Management 151
11.3.4 Shared Sales Teams and Telesales 151
11.3.5 Medical Science Liaisons 151
11.3.6 The Evolving Model 152
11.3.7 Case Study 153
11.4 Closed Loop Marketing Adoption Has Increased Over the Last Few Years 154
11.4.1 Benefits for Sales & Physicians 155
11.4.2 Benefits for Analytics 155
11.4.3 Benefits for Legal & Regulatory Departments 155
11.4.4 Benefits for Marketing 155
11.4.5 Case Study 155
12 Biologics Price Competition and Innovation Act, 2009 Opens the Gates for Approval of Biosimilars in the US 159
12.1 Biosimilars Approval Pathways in the US and Europe  Market Characterization 159
12.1.1 Global Biosimilar Market Size and Forecast 160
12.1.2 The US Biosimilar Market Size and Forecast 162
12.1.3 Europe Biosimilar Market Size and Forecast 163
12.1.4 Japan Biosimilars Size and Market Forecasts 164
12.2 Biosimilars Approval Pathways in the US and Europe  Drivers and Restraints 165
12.2.1 Drivers 166
12.2.2 Restraints 171
12.3 Market Forecasts for Biosimilars 174
12.3.1 Human Growth Hormone (hGH) Biosimilars Markets 174
12.3.2 Erythropoietin (EPO) Biosimilars Markets 176
12.3.3 Granulocyte  Colony Stimulating Factor (G-CSF) Biosimilars Markets 178
12.4 Opportunity Analysis - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment 180
12.4.1 Interferon alfa Biosimilars 180
12.4.2 Interferon beta Biosimilars 182
12.4.3 Insulin and Insulin Analogs Biosimilars 183
12.4.4 TNF alfa Inhibitor Biosimilars 185
12.4.5 Biosimilars for Monoclonal Antibodies against Cancer 186
13 Appendix 189
13.1 Abbreviations 189
13.2 Research Methodology 192
13.2.1 Coverage 192
13.2.2 Secondary Research 192
13.2.3 Primary Research 193
13.2.4 Expert Panel Validation 193
13.3 Contact Us 193
13.4 Disclaimer 193
13.5 Sources 194
Medtronic
Boston Scientific
St Jude Medical
Roche				
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