Dallas, TX -- (SBWIRE) -- 09/20/2010 -- ReportsandReports announce The Top 10 Biosimilar Players: Positioning, performance and SWOT analyses Market Research Report in its Store.

Browse complete Report at: http://www.reportsandreports.com/market-reports/the-top-10-biosimilar-players-positioning-performance-and-swot-/

Report Description:
Biologics continue to outperform the global Parma market, driven by premium priced therapies for conditions that cannot be managed by conventional drugs. The rapid penetration of novel biologics and the gradual expiry of their patents will create significant market opportunities for biosimilars developers through to 2016. In the short term, biosimilar market growth will be driven by drug classes including erythropoietin, filgrastim, human growth hormone (hGH) and insulin. ‘The Top 10 Biosimilars Players: Positioning, performance and SWOT analyses’ is a report published by Business Insights that examines the competitive landscape of the global biosimilars industry. The latest key issues and evolving business models in the biosimilars market are identified and the leading companies in this sector are profiled in detail. This report examines the portfolio sales performances, pipelines and growth strategies of each of the top 10 biosimilars companies. The opportunities and threats facing each of these leading players are also assessed. This report also examines the size, growth and major trends of the global biosimilars industry, in addition to providing to an assessment of leading biosimilars companies outside of the top 10.

Key findings

The global biosimilars market reached $1bn in 2007, representing an increase of 5.9% over 2006. The increasing use of biologics in disease areas such as cancer, auto-immunity and orphan diseases, in addition to healthcare cost containment, has driven this growth.

Novartis (Sandoz) leads the global biosimilars market with a market share of 4.1% and sales of $23m in 1H 2008. The company is expanding its portfolio to exploit the opportunities arising from branded biologics going off-patent in the US and EU.

An estimated $25bn worth of biologics will lose patent protection by 2016, creating a significant market opportunity for biosimilars. Monoclonal Antibodies (mAb) such as Herceptin and Rituxan/Mabthera are among a number of major biologics going off-patent during this period.

Teva is the third largest company in the global biosimilars market, with a share of 2.1% based on sales of $12m in 1H 2008. The company is investing in R&D and manufacturing capabilities to accelerate biosimilar development. The 2008 acquisition of Barr has substantially strengthened its market position, having provided access to Barr’s substantial expertise in the field.

Use this report to
•Compare the performances of the top 10 players in the global biosimilars market with this report’s analysis of marketed product sales for Biocon, Bioton, Emcure (Gennova), Hospira, Intas Biopharma, LG Life Sciences, Novartis (Sandoz), Ranbaxy, Teva, Wockhardt.

•Identify the market dynamics of the global biosimilars industry over the 2006-07 period, examine the drivers and resistors to industrial growth and understand the key trends that are shaping the future of the biosimilars market.

• Assess the future prospects of the top 10 biosimilars companies with this report’s analysis of each firm’s strengths, weaknesses, opportunities and threats, in addition to an examination of their product pipelines and growth strategies.

• Measure the progress of other leading biosimilars companies by evaluating the financial performances, marketed products and pipelines of 3SBio, Bharat Biotech, Dr Reddy’s, MJ Biopharm, Panacea Biotech, Pharmaclon, Shantha Biotech, Shenzhen Neptunus Interlong, Shreya Life Sciences and Stada.
Explore issues including

The safety and efficacy of biosimilars. Technological and manufacturing complexities make it difficult to produce exact replicas of biologics, raising concerns over the safety/efficacy of biosimilars. Such perceptions, combined with an unwillingness to switch from sophisticated branded biologics, mean that the market acceptance of biosimilars is likely to be slow.

The erosion of biosimilar price differentials. The cost of biosimilar development is rising due to regulatory agencies seeking additional clinical studies to ensure patient safety. This is reducing the price advantage of biosimilars against their reference drug. Price discounts are subsequently expected to amount to only 25%-35% initially, due to high costs and limited competition.

Significant regulatory hurdles to overcome. The complex structure of biosimilars demands stringent regulation to ensure patient safety. Europe was the first among regulated pharma markets to create a biosimilars approval pathway in 2006. This legislation provides 10 years of patent protection to biologics against biosimilars and hybrids, and calls for extensive testing to ensure safety. The difference between a similar biological medicinal product and the reference product must be justified with appropriate studies and clinical trials on a case-by-case basis, in addition to post-marketing monitoring.

Discover
• Which major trends are currently shaping the global biosimilars market?
• Who are the top 10 players in the market?
• What is the market share of each of the global leaders by company?
• What are the key growth strategies of leading companies?
• What are the strengths and weaknesses of the industry’s top players?
• Which factors are considered when creating biosimilar regulations across Europe, the US, Canada, India and China?
• How are the dynamics of the biosimilars market different from generics?

Table of Contents
• The Top 10 Biosimilar Players

Executive Summary 15
• Industry overview 15
• Novartis (Sandoz) 16
• Bioton 16
• Teva 17
• LG Life Sciences 17
• Wockhardt 18
• Biocon 18
• Intas (Intas Biopharma) 19
• Emcure (Gennova) 19
• Hospira 20
• Ranbaxy 20

Chapter 1 Introduction 24
• Scope of the report 24
• Methodology 24

Chapter 2 Industry overview 28
• Summary 28
• Introduction 29
• The emerging biosimilar landscape 29
• Industry characteristics 31
• Different market dynamics from standard generics 31
• High R&D spend requires greater clinical investment 33
• Intellectual property issues 33
• Regulations of biosimilars 33
• Regulated markets 34
• Semi-regulated markets 39
• Market Dynamics 41
• Global biosimilars market: size and growth 41
• Global positioning of the top 10 biosimilar companies 42
• Positioning of the top 10 biosimilar companies across off-patent biologic
• categories 44
• Product pipeline of the top 10 biosimilar companies 45
• Growth drivers and inhibitors 46
• Key trends in the industry 48
• Big pharmaceutical companies eyeing biosimilars 48
• Role of biosimilars in controlling healthcare expenditure 49
• Biosimilars of mAbs represent sizeable market opportunity 51
• Payors' acceptance of biosimilars as a means to reduce expenditure is
• expected to drive uptake 51
• Leading generics players with established market presence are spearheading
• biosimilar development 52
• Emergence of Indian biosimilar players to aid in market expansion 53
• Outlook 54

Chapter 3 Novartis (Sandoz) 56
• Summary 56
• Company overview 57
• Recent financial performance 57
• Marketed products 58
• Product pipeline 58
• Growth strategies 59
• Focus on expanding biosimilar product portfolio 59
• Acquisitions and divestments 59
• Partnerships and alliances 59
• SWOT analysis 60
• Strengths 60
• Strongly positioned in the European biosimilars market 60
• Strong R&D platform 61
• Weaknesses 61
• Development set-backs for enoxaparin 61
• Opportunities 61
• Developing cost-effective drugs 61
• Threats 62
• FDA warnings on EPO products 62

Chapter 4 Bioton 64
• Summary 64
• Company overview 65
• Recent financial performance 65
• Marketed products 66
• Product pipeline 67
• Growth strategies 67
• Expansion of biosimilars portfolio in drug categories other than insulin 67
• Acquisitions and divestments 68
• Partnerships and alliances 68
• SWOT analysis 69
• Strengths 69
• Strong distribution network in the semi-regulated markets 69
• Technical and regulatory experience 70
• Weaknesses 70
• Lacks brand equity 70
• Opportunities 70
• Entry in new markets 70
• Initiatives in Asia 71
• Threats 71
• Threat from analogue insulin 71

Chapter 5 Teva 74
• Summary 74
• Company overview 75
• Recent financial performance 75
• Marketed products 76
• Growth strategies 77
• Investing in R&D and manufacturing capabilities 77
• Acquisitions and divestments 77
• Partnership and alliances 78
• SWOT analysis 79
• Strengths 79
• Global capabilities 79
• Weaknesses 80
• Rising debt burden 80
• Opportunities 80
• Growth through acquisitions 80
• Joint-Venture with Lonza 80
• Approval for marketing TevaGrastim in the EU 81
• Threats 81
Competition from companies in cost-effective locations 81

Chapter 6 LG Life Sciences 84
• Summary 84
• Company overview 85
• Recent financial performance 85
• Marketed products 86
• Product pipeline 86
• Growth strategies 87
• Shifting focus from independent R&D to strategic partnerships 87
• Acquisitions and divestments 87
• Partnerships and alliances 88
• SWOT analysis 89
• Strengths 89
• Robust product portfolio 89
• Research expertise 90
• Weaknesses 90
• Relatively small size 90
• Opportunities 91
• Launch of Declage 91
• Targeting the antibody treatment segment 91
• Threats 91
• Threat from large biotech companies 91

Chapter 7 Wockhardt 94
• Summary 94
• Company overview 95
• Recent financial performance 95
• Marketed products 96
• Product pipeline 96
• Growth strategies 97
• Developing marketing and regulatory infrastructure capabilities 97
• Acquisitions and divestments 97
• Partnerships and alliances 97
• SWOT analysis 98
• Strengths 98
• Robust manufacturing infrastructure 98
• Domination of the Indian EPO market 99
• Strong insulin portfolio in India 99
• Weaknesses 99
• High debt burden 99
• Opportunities 100
• Launch of Glaritus 100
• Threats 100
• High competition for EPO in regulated markets 100

Chapter 8 Biocon 102
• Summary 102
• Company overview 103
• Recent financial performance 103
• Marketed products 104
• Product pipeline 104
• Growth strategies 105
• Accessing competitive markets 105
• Acquisitions, divestments 105
• Partnership and alliances 106
• SWOT analysis 106
• Strengths 107
• Strong position in the insulin market 107
• Weaknesses 107
• Weaker geographic presence and scale 107
• Opportunities 107
• Expanding biosimilar footprint in Europe 107
• Threats 107
• Patent threat to biosimilars in India 107

Chapter 9 Intas (Intas Biopharma) 110
• Summary 110
• Company overview 111
• Recent financial performance 111
• Marketed products 112
• Product pipeline 112
• Growth strategies 112
• Expansion into semi-regulated markets 112
• Restructuring sales network 113
• Acquisitions and divestments 113
• Partnership and alliances 113
• SWOT analysis 114
• Strengths 114
• EU-GMP-certified manufacturing facilities 114
• Expertise in filgrastim products development 115
• Weaknesses 115
• Lack of direct distribution networks in regulated markets 115
• Opportunities 115
• Expansion in regulated markets 115
• Construction of mAb manufacturing facility 116
• Threats 116
• Low demand for cancer biosimilars in India 116

Chapter 10 Emcure (Gennova) 120
• Summary 120
• Company overview 121
• Recent financial performance 121
• Marketed products 122
• Product pipeline 122
• Growth strategies 122
• Expansion in semi-regulated markets 122
• Acquisitions and divestments 123
• Partnership and alliances 123
• SWOT analysis 124
• Strengths 124
• Strong R&D platform 124
• Weaknesses 125
• Lack of marketing experience in the US 125
• Opportunities 125
• Diversified product pipeline 125
• Threats 125
• Patent approval for biosimilars in India 125

Chapter 11 Hospira 128
• Summary 128
• Company overview 129
• Recent financial performance 129
• Marketed products 129
• Product pipeline 130
• Growth strategies 130
• Expansion into regulated markets 130
• Acquisitions and divestments 131
• Partnerships and alliances 131
• SWOT analysis 132
• Strengths 132
• Strong presence in Europe 132
• Weaknesses 133
• Large debt burden 133
• Opportunities 133
• Ability to leverage its strong distribution network in the US 133
• Threats 134
• Overdependence on alliances 134

Chapter 12 Ranbaxy 136
• Summary 136
• Company overview 137
• Recent financial performance 137
• Marketed products 138
• Product pipeline 138
• Growth strategies 139
• Focus on alliances and in-licensing agreements 139
• Acquisitions and divestments 139
• Partnership and alliances 139
• SWOT analysis 140
• Strengths 140
• Strong business model 140
• Weaknesses 141
• High debt burden 141
• Opportunities 141
• Penetrating market for osteoporosis 141
• Threats 141
• Ban on Ranbaxy’s products 141
• Chapter 13 Other major players 144
• Stada (Bioceuticals) 144
• Company overview 144
• Recent financial performance 144
• Marketed products 145
• Product pipeline 145
• Shreya Life Sciences 146
• Company overview 146

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