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Published by: Business Insights
Published: Apr. 20, 2009 - 167 Pages
Table of Contents
- The Top 10 Biosimilar Players
- Executive Summary
- Industry overview
- Novartis (Sandoz)
- Bioton
- Teva
- LG Life Sciences
- Wockhardt
- Biocon
- Intas (Intas Biopharma)
- Emcure (Gennova)
- Hospira
- Ranbaxy
- Chapter 1 Introduction
- Scope of the report
- Methodology
- Chapter 2 Industry overview
- Summary
- Introduction
- The emerging biosimilar landscape
- Industry characteristics
- Different market dynamics from standard generics
- High R&D spend requires greater clinical investment
- Intellectual property issues
- Regulations of biosimilars
- Regulated markets
- Semi-regulated markets
- Market Dynamics
- Global biosimilars market: size and growth
- Global positioning of the top 10 biosimilar companies
- Positioning of the top 10 biosimilar companies across off-patent biologic
- categories
- Product pipeline of the top 10 biosimilar companies
- Growth drivers and inhibitors
- Key trends in the industry
- Big pharmaceutical companies eyeing biosimilars
- Role of biosimilars in controlling healthcare expenditure
- Biosimilars of mAbs represent sizeable market opportunity
- Payors' acceptance of biosimilars as a means to reduce expenditure is
- expected to drive uptake
- Leading generics players with established market presence are spearheading
- biosimilar development
- Emergence of Indian biosimilar players to aid in market expansion
- Outlook
- Chapter 3 Novartis (Sandoz)
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Focus on expanding biosimilar product portfolio
- Acquisitions and divestments
- Partnerships and alliances
- SWOT analysis
- Strengths
- Strongly positioned in the European biosimilars market
- Strong R&D platform
- Weaknesses
- Development set-backs for enoxaparin
- Opportunities
- Developing cost-effective drugs
- Threats
- FDA warnings on EPO products
- Chapter 4 Bioton
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Expansion of biosimilars portfolio in drug categories other than insulin
- Acquisitions and divestments
- Partnerships and alliances
- SWOT analysis
- Strengths
- Strong distribution network in the semi-regulated markets
- Technical and regulatory experience
- Weaknesses
- Lacks brand equity
- Opportunities
- Entry in new markets
- Initiatives in Asia
- Threats
- Threat from analogue insulin
- Chapter 5 Teva
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Growth strategies
- Investing in R&D and manufacturing capabilities
- Acquisitions and divestments
- Partnership and alliances
- SWOT analysis
- Strengths
- Global capabilities
- Weaknesses
- Rising debt burden
- Opportunities
- Growth through acquisitions
- Joint-Venture with Lonza
- Approval for marketing TevaGrastim in the EU
- Threats
- Competition from companies in cost-effective locations
- Chapter 6 LG Life Sciences
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Shifting focus from independent R&D to strategic partnerships
- Acquisitions and divestments
- Partnerships and alliances
- SWOT analysis
- Strengths
- Robust product portfolio
- Research expertise
- Weaknesses
- Relatively small size
- Opportunities
- Launch of Declage
- Targeting the antibody treatment segment
- Threats
- Threat from large biotech companies
- Chapter 7 Wockhardt
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Developing marketing and regulatory infrastructure capabilities
- Acquisitions and divestments
- Partnerships and alliances
- SWOT analysis
- Strengths
- Robust manufacturing infrastructure
- Domination of the Indian EPO market
- Strong insulin portfolio in India
- Weaknesses
- High debt burden
- Opportunities
- Launch of Glaritus
- Threats
- High competition for EPO in regulated markets
- Chapter 8 Biocon
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Accessing competitive markets
- Acquisitions, divestments
- Partnership and alliances
- SWOT analysis
- Strengths
- Strong position in the insulin market
- Weaknesses
- Weaker geographic presence and scale
- Opportunities
- Expanding biosimilar footprint in Europe
- Threats
- Patent threat to biosimilars in India
- Chapter 9 Intas (Intas Biopharma)
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Expansion into semi-regulated markets
- Restructuring sales network
- Acquisitions and divestments
- Partnership and alliances
- SWOT analysis
- Strengths
- EU-GMP-certified manufacturing facilities
- Expertise in filgrastim products development
- Weaknesses
- Lack of direct distribution networks in regulated markets
- Opportunities
- Expansion in regulated markets
- Construction of mAb manufacturing facility
- Threats
- Low demand for cancer biosimilars in India
- Chapter 10 Emcure (Gennova)
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Expansion in semi-regulated markets
- Acquisitions and divestments
- Partnership and alliances
- SWOT analysis
- Strengths
- Strong R&D platform
- Weaknesses
- Lack of marketing experience in the US
- Opportunities
- Diversified product pipeline
- Threats
- Patent approval for biosimilars in India
- Chapter 11 Hospira
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Expansion into regulated markets
- Acquisitions and divestments
- Partnerships and alliances
- SWOT analysis
- Strengths
- Strong presence in Europe
- Weaknesses
- Large debt burden
- Opportunities
- Ability to leverage its strong distribution network in the US
- Threats
- Overdependence on alliances
- Chapter 12 Ranbaxy
- Summary
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Growth strategies
- Focus on alliances and in-licensing agreements
- Acquisitions and divestments
- Partnership and alliances
- SWOT analysis
- Strengths
- Strong business model
- Weaknesses
- High debt burden
- Opportunities
- Penetrating market for osteoporosis
- Threats
- Ban on Ranbaxy’s products
- Chapter 13 Other major players
- Stada (Bioceuticals)
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Shreya Life Sciences
- Company overview
- Recent financial performance
- Marketed products
- Dr Reddy’s
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Shantha Biotech
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- MJ Biopharm
- Company overview
- Recent financial performance
- Marketed products
- Shenzhen Neptunus Interlong
- Company overview
- Recent financial performance
- Marketed products
- 3SBio
- Company overview
- Recent financial performance
- Marketed products
- Product pipeline
- Bharat Biotech
- Company overview
- Recent financial performance
- Marketed products
- Pharmaclon
- Company overview
- Recent financial performance
- Marketed products
- Panacea Biotech
- Company overview
- Recent financial performance
- Marketed products
- Chapter 14 Appendix
- Glossary
- Index
- List of Figures
- Figure 2.1: The emerging biosimilar landscape
- Figure 2.2: Proposed approval pathway in the US
- Figure 2.3: Top 10 biosimilar companies’ global market share, 1H08
- Figure 2.4: Product pipeline of the top 10 biosimilar companies
- Figure 2.5: Drivers and resistors
- Figure 2.6: Cost savings across drug categories in the US, 2017
- Figure 3.7: Novartis (Sandoz) SWOT analysis
- Figure 4.8: Bioton SWOT analysis
- Figure 5.9: Teva SWOT analysis
- Figure 6.10: LG Life Sciences SWOT analysis
- Figure 7.11: Wockhardt SWOT analysis
- Figure 8.12: Biocon SWOT analysis
- Figure 9.13: Intas (Intas Biopharma) SWOT analysis
- Figure 10.14: Emcure (Gennova) SWOT analysis
- Figure 11.15: Hospira SWOT analysis
- Figure 12.16: Ranbaxy SWOT analysis
- List of Tables
- Table 2.1: Comparison between generics and biosimilars
- Table 2.2: Biosimilars approved by the EMEA
- Table 2.3: Biosimilars approved in India
- Table 2.4: Patent expiries of key biologics
- Table 2.5: Top 10 biosimilar companies’ revenues ($m), 2006-1H08
- Table 2.6: Players in major biosimilar categories
- Table 2.7: Cost savings across drug categories in the US, 2017
- Table 3.8: Novartis (Sandoz) snapshot
- Table 3.9: Novartis (Sandoz) biosimilars financial performance ($m), 2006-1H08
- Table 3.10: Novartis (Sandoz) marketed products sales ($’000), 2006-1H08
- Table 4.11: Bioton snapshot
- Table 4.12: Bioton biosimilars financial performance ($m), 2006-1H08
- Table 4.13: Bioton marketed products sales ($’000), 2006-1H08
- Table 4.14: Bioton biosimilars pipeline
- Table 5.15: Teva snapshot
- Table 5.16: Teva biosimilars financial performance ($m), 2006-1H08
- Table 5.17: Teva marketed products sales ($’000), 2006-1H08
- Table 6.18: LG Life Sciences snapshot
- Table 6.19: LG Life Sciences biosimilars financial performance ($m), 2006-1H08
- Table 6.20: LG Life Sciences marketed products sales ($’000), 2006-1H08
- Table 6.21: LG Life Sciences biosimilars pipeline
- Table 7.22: Wockhardt snapshot
- Table 7.23: Wockhardt biosimilars financial performance ($m), 2006-1H08
- Table 7.24: Wockhardt marketed products sales ($’000), 2006-1H08
- Table 8.25: Biocon snapshot
- Table 8.26: Biocon biosimilars financial performance ($m), 2006-1H08
- Table 8.27: Biocon marketed products sales ($’000), 2006-1H08
- Table 8.28: Biocon biosimilars pipeline
- Table 9.29: Intas (Intas Biopharma) snapshot
- Table 9.30: Intas (Intas Biopharma) biosimilars financial performance ($m), 2006-1H08
- Table 9.31: Intas (Intas Biopharma) marketed products sales ($’000), 2006-1H08
- Table 10.32: Emcure (Gennova) snapshot
- Table 10.33: Emcure (Gennova) biosimilars financial performance ($m), 2006-1H08
- Table 10.34: Emcure (Gennova) marketed products sales ($,000s), 2006-1H08
- Table 11.35: Hospira snapshot
- Table 11.36: Hospira biosimilars financial performance ($m), 2006-1H08
- Table 11.37: Hospira marketed products sales ($’000), 2006-1H08
- Table 12.38: Ranbaxy snapshot
- Table 12.39: Ranbaxy biosimilars financial performance ($m), 2006-1H08
- Table 12.40: Ranbaxy marketed products sales ($’000), 2006-1H08
- Table 13.41: Stada (Bioceuticals) snapshot
- Table 13.42: Stada (Bioceuticals) biosimilars financial performance ($m), 2006-1H08
- Table 13.43: Stada (Bioceuticals) marketed products sales ($’000), 2006-1H08
- Table 13.44: Shreya Life Sciences snapshot
- Table 13.45: Shreya Life Sciences biosimilars financial performance ($m), 2006-1H08
- Table 13.46: Shreya Life Sciences marketed products sales ($’000), 2006-1H08
- Table 13.47: Dr Reddy’s snapshot
- Table 13.48: Dr Reddy’s biosimilars financial performance ($m), 2006-1H08
- Table 13.49: Dr Reddy’s marketed products sales ($’000), 2006-1H08
- Table 13.50: Shantha Biotech snapshot
- Table 13.51: Shantha Biotech biosimilars financial performance ($m), 2006-1H08
- Table 13.52: Shantha Biotech marketed products sales ($’000), 2006-1H08
- Table 13.53: MJ Biopharm snapshot
- Table 13.54: MJ Biopharm biosimilars financial performance ($m), 2006-1H08
- Table 13.55: MJ Biopharm marketed products sales ($’000), 2006-1H08
- Table 13.56: Shenzhen Neptunus Interlong snapshot
- Table 13.57: Shenzhen Neptunus Interlong biosimilars financial performance ($m), 2006-1H08
- Table 13.58: Shenzhen Neptunus Interlong marketed products sales ($’000), 2006-1H08
- Table 13.59: 3SBio snapshot
- Table 13.60: 3SBio biosimilars financial performance ($m), 2006-1H08
- Table 13.61: 3SBio marketed products sales ($’000), 2006-1H08
- Table 13.62: 3SBio biosimilars product pipeline
- Table 13.63: Bharat Biotech snapshot
- Table 13.64: Bharat Biotech biosimilars financial performance ($m), 2006-1H08
- Table 13.65: Bharat Biotech marketed products sales ($’000), 2006-1H08
- Table 13.66: Pharmaclon snapshot
- Table 13.67: Pharmaclon biosimilars financial performance ($m), 2006-1H08
- Table 13.68: Pharmaclon biosimilar product sales ($’000), 2006-1H08
- Table 13.69: Panacea Biotech snapshot
- Table 13.70: Panacea Biotech biosimilars financial performance ($m), 2006-1H08
- Table 13.71: Panacea Biotech biosimilars products sales ($’000), 2006-1H08
AbstractBiologics continue to outperform the global pharma 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?
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