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【关键词】Biogenerics 2005: A New Level of Complexity
【报告格式】 印刷版/电子版
【交付方式】 特快专递/E-MAIL
【释放日期】 2006年5月
【报告页数】 页
【报告字数】 字
【图表数量】 个
【报告价格】 印刷版：23000元 电子版：23000元 印刷＋电子：25000元
【其它信息】
【订购热线】 010-58613285 58613275 网上订购 邮件订购
Introduction
Biogenerics (or biosimilars, or follow-on proteins) could now enter the EU market in a matter of months, and the US by 2009. The prize awaiting biogeneric
manufacturers such as Sandoz, Teva, and BioPartners is a global market worth $20 billion. Market fragmentation, product-specific constraints and new challenges in biotechnology, drug delivery and marketing will present major barriers to entry.
Scope
In-depth analysis of product types and brands under threat, their suitability for biogenerics, and the forecast impact of biogenerics
Coverage of 25 biogenerics companies, their portfolios, partnerships and strategy, and analysis of improved, proprietary 'superbiogenerics'
Outline of regulatory progress, likely approval routes for biogenerics, and conflicting market pressures
Analysis of branded companies' franchises under threat, their strategies to deal with biogenerics, and their likely success
Highlights
The EU regulatory pathway has progressed rapidly over the last two years, and Datamonitor expects the first biogeneric to be approved by 2006. In the US immediate progress depends on the FDA's use of the controversial 505(b)(2) pathway for insulin and growth hormone. Datamonitor nevertheless expects biogenerics to launch in the US by 2009.
Biogenerics will require an entirely new development and marketing strategy: marketing and patient support will be much more important, and this will favour companies with strong financial resources and commercial experience. Further in the future, the development of 'superbiogenerics' (second-generation biogenerics), will be a vital opportunity.
Different product types will differ greatly in their suitability as targets for biogenerics. Market size and patent expiry are not the only two considerations, as proven by the minimal interest in insulin. Epoetin, CSFs and human growth hormone are expected to account for the majority of the $2.2 billion in forecast biogeneric sales by 2010.
Reasons to Purchase
Identify key potential partners and competitors in the emerging biogenerics industry and examine their products and strategies
Discover the advantages and drawbacks of key biogeneric product types, and learn the forecast levels of biogeneric competition within each class
Analyze and benchmark branded companies' strategies to maintain market share and their likely success
CHAPTER 1 EXECUTIVE SUMMARY
Scope
Datamonitor's opinion on the future of the biogenerics market
Biogenerics could be on the market sooner than many might think. The EU regulatory pathway has progressed rapidly over the last two years, and Datamonitor expects the first biogeneric to be approved by 2006. In the US, the situation is less clear, and immediate progress depends on the FDA's use of the controversial 505(b)(2) pathway for insulin and growth hormones. Datamonitor nevertheless expects biogenerics to launch in the US by 2009.
Biogenerics will require an entirely new development and marketing strategy from traditional generics. Companies need to differentiate their biogenerics: marketing and patient support will be much more important, and this will favor companies with strong financial resources and broad commercial experience. Further in the future, the development of 'superbiogenerics', or second-generation versions of biogenerics, will be a vital new growth opportunity.
Different product types will differ greatly in their suitability as targets for biogenerics. Market size and patent expiry are not the only two considerations, as proven by the minimal interest in developing biogeneric insulin. Nevertheless, epoetin, colony stimulating factors and human growth hormone are expected to account for the majority of the $2.2 billion in forecast biogeneric sales by 2010.
CHAPTER 2 OVERVIEW
Definition of biogenerics
Lack of regulatory pathways for approval is the limiting factor
Why biogenerics are now an issue
Wave of patent expiries makes biogenerics a priority
High cost of biologics increases the importance of biogenerics
Technological advances allow smaller companies to make good biological copies
Market forces: drivers and resistors to biogeneric entry
Key Industry Organizations
GPhA
Biotechnology Industry Organization (BIO)
PhRMA
Commercial factors driving biogeneric approval and uptake
High healthcare costs
Enabling greater patient coverage
Biotech players need to maintain a positive public reputation
Driving innovation
Commercial factors resisting biogeneric approval and uptake
Branded companies' defense of their franchises
Resistance from consumers/physicians to substitution
Gaining public confidence: adequate clinical testing required
Process is the product
Proving equivalence of the protein
Glycosylation
Proving equivalence of the end product
Differences in formulation
Branded view
Scientific argument
Legal and regulatory arguments
Generics view
Scientific argument
Legal and regulatory arguments
Conclusion
How to demonstrate therapeutic equivalence
Analytical techniques
ExSAR: characterizing 3-D protein structure
Momenta and Procognia: analyzing glycosylation patterns
Preclinical and clinical methods
Pricing of biogenerics - low enough to make an impact?
Cost of product development
Clinical data requirements
Manufacturing costs
Cost of marketing
Pricing strategy of biogenerics
Example of typical gross margins achievable
Would this kind of discount change physician prescribing?
Conclusion
CHAPTER 3 REGULATORY ISSUES IN EUROPE
EU regulatory overview
Timeline
Key current documents
European Commission: creating a legal framework
2001: EC starts review of pharmaceutical legislation
Directive 2003/63/EC, including Annex I
Directive 2004/27/EC
EMEA: development of a regulatory framework
Overarching guidelines
Comparability guidelines
Quality issues
Non-clinical and clinical issues
Product-specific guidelines
Future developments
Outlook
CHAPTER 4 REGULATORY ISSUES IN THE US
US regulatory overview
A history of delays...
FDA points to legal obstructions
...but at least some progress is being made
Timeline
Key chronological events
June 2003: Transfer of protein drugs from CBER to CDER
April 2004: Branded opposition intensifies
June 2004: US Senate hearings on follow-on biologics
September 2004: First FDA workshop
February 2005: Second FDA workshop
May 2005: USP monograph ignites debate on comparability
July 2005: FDA guidance is imminent
July 2005: PhRMA members disagree over new legal argument
Future developments
FDA draft guidance
Legal opposition to 505(b)(2)
New legislation from Congress
Likely approval routes
505(b)(2)
Doubts raised by Pfizer's Norvasc victory over Dr. Reddy's
Sandoz's Omnitrope adds to the uncertainty
New legislation enabling FDA guidelines
Outlook
CHAPTER 5 PRODUCT TYPES AND THEIR SUITABILITY FOR BIOGENERICS
Market opportunity - size of the global biologics markets
Which biologics are suitable targets for biogenerics?
Patent expiries
Market sizes
Comparison of products most at risk from biogenerics
Second wave of biogeneric products
Monoclonal antibodies and fusion proteins
Analysis and forecasts of products likely to face the 'first wave' of biogenerics
EPOs
Overview
Market size and competitors
Second-generation epoetins
Renal failure-induced versus chemotherapy-induced anemias
Patent situation
Suitability for biogenerics
Regulatory situation
Testing requirements for biogeneric epoetins
Biogeneric epoetins marketed or in development
Epoetin market forecast
Conclusion
Insulins
Overview
Market size and competitors
Insulin analogs
Future market development
Patent situation
Suitability for biogenerics
Regulatory situation
Testing requirements for biogeneric insulin
Biogeneric insulin marketed or in development
Insulin market forecast
Conclusion
Human growth hormone
Overview
Market size and competitors
Patent situation
Suitability for biogenerics
Regulatory situation
Sandoz's Omnitrope: landmark negotiations
Testing requirements for biogeneric somatropin
Biogeneric somatropin marketed or in development
Human growth hormone market forecast
Conclusion
Colony stimulating factors (CSFs)
Overview
Market size and competitors
Patent situation
Suitability for biogenerics
Regulatory situation
Testing requirements for biogeneric G-CSF
Biogeneric CSFs marketed or in development
Colony stimulating factor market forecast
Conclusion
Interferon alpha
Overview
Market size and competitors
Future market entrants
Patent situation
Suitability for biogenerics
Regulatory situation
Biogeneric interferon alpha marketed or in development
Interferon alpha market forecast
Conclusion
Interferon beta
Overview
Market size and competitors
Patent situation
Regulatory situation
Suitability for biogenerics
Biogeneric interferon beta marketed or in development
Interferon beta market forecast
Conclusion
Other proteins
Cerezyme (imiglucerase)
Factor VIII
Interferon gamma
Urokinase
Alteplase
Streptokinase
Hepatitis B vaccines
Interleukins
Second-wave biogenerics
Other biologics not immediately amenable to biogenerics
Blood or plasma-derived products and their recombinant alternatives
Other complex biologic products
Vaccines
Antibodies
Heparins: not classified as biogenerics
Forecast sales of biogenerics
CHAPTER 6 COMPANIES WITH THE CAPABILITIES TO ENTER THE BIOGENERICS MARKET
Barriers to biogeneric market entry
The key factor is higher development costs for biogenerics
Clinical trials: can (or will) generics companies get involved?
Development costs will primarily discourage late market entrants
Marketing: a new type of generic business model
Biotechnology expertise
Cell lines
Pharmacovigilance monitoring
Regulatory expertise and compliance
Complex patent situation: legal expertise required
Case study: Dynepo
Controlling manufacturing cost
Acquisition/partnership
Outsourcing
Build own facility
Strategies for success: remaining competitive in a dynamic market
Low cost base
Differentiation of biogenerics against competitors
Effective marketing and strong brand reputation
Line extensions, novel formulations
Superbiogenerics - the next level
Superbiogeneric products under development
Neose Technologies: PEGylated interferon alpha and several other partnered projects
BioGeneriX: PEGylated G-CSF and other undisclosed protein
Maxygen: various pegylated interferons, CSF and Factor VII
BioPartners: various slow-release products
Phage Biotechnology: various PEGylated products
Inhaled insulins: Nektar Therapeutics'/Pfizer's Exubera, Aradigm/Novo Nordisk's AERx and MannKind's Technosphere Insulin System
Cangene: long-acting human growth hormone
Dragon Pharmaceutical: slow-release EPO
Biosimilar or "me-too" stand-alone development approach
Key biogenerics companies profiled
Teva (and its subsidiary SICOR)
Overview
Biogeneric product portfolio and pipeline
Partners
Strategy
Outlook
Sandoz
Overview
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
BioPartners
Overview
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
BioGeneriX (ratiopharm group)
Overview
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
Stada (through Bioceuticals)
Overview
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
Pliva
Overview
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
Cangene
Overview
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
GeneMedix
Overview
Financial position
Products
Manufacturing
Technology
Partners
Strategy
Outlook
Phage Biotechnology
Overview
Technology
Biogeneric product portfolio/pipeline
Partners
Strategy
Outlook
Dragon Pharmaceutical
Overview
Biogeneric product portfolio/pipeline
Strategy
Partners
Outlook
Indian biogenerics players
Wockhardt
Biocon
Bharat Biotech
Shantha Biotech
Dr. Reddy's
Chinese biogenerics players
Other biogenerics companies
Barr Pharmaceuticals: Duramed Research
Neose Technologies
Microbix Biosystems
Aceto
CJ Corporation
CHAPTER 7 COMPANIES WITH PRODUCTS AT RISK - STRATEGIES AND CASE STUDIES
Strategies to maintain market share
Patent protection
Pegylation
Nektar Therapeutics
Neose Technologies
BiopolyMed
Other pegylation technologies
Limitations of pegylation as a lifecycle management strategy
Novel delivery systems
Pricing strategy
Case studies-companies at risk
Roche
Roferon-A
NeoRecormon
Amgen
Epogen
Neupogen
Johnson & Johnson
Procrit/Eprex
Eli Lilly
Humulin
Humatrope
Novo Nordisk
Novolin
Norditropin
Serono
Serostim/Saizen
Rebif
Biogen Idec
Avonex
Sanofi Aventis
Insuman
Schering-Plough
Intron A
Pfizer
Genotropin
CHAPTER 8 APPENDIX : SUPPORTING DATA
Financial data
Exchange rates
Methodology of sales data collection and forecasting
Forecasting methodology
List of Tables
Table 1: Production systems used for different biological product types
Table 2: Sales of biologics and total pharmaceuticals by 56 leading pharmaceutical companies, 2001-2010
Table 3: Patent expiries of selected key biologic pharmaceuticals
Table 4: Global combined market sizes** for sales of key first-generation biologic product types (assuming no biogenerics), 2003-10
Table 5: Analysis of classes most at risk from biogeneric competition
Table 6: Sales of leading epoetin products worldwide
Table 7: Biogeneric epoetin products
Table 8: Biogeneric epoetin is forecast strong uptake in the five major EU markets between 2006 and 2010
Table 9: Sales of leading human insulin products worldwide
Table 10: Sales of leading insulin analog products worldwide
Table 11: Biogeneric insulin products
Table 12: Biogeneric insulin is expected to have minimal impact on sales of insulin products in the five major EU markets, 2004-10 ($m)
Table 13: Sales of leading somatropin products worldwide
Table 14: Biogeneric somatropin products
Table 15: Biogeneric human growth hormone is expected to capture just under half of the branded market size in the five major EU markets by 2010 ($m)
Table 16: Biogeneric human growth hormone is expected to capture just under half of the branded market size in the five major EU markets by 2010 ($m)
Table 17: Sales of leading CSF products worldwide
Table 18: Biogeneric colony stimulating factors marketed or in development
Table 19: Sales of biogeneric G-CSF are expected to exceed branded G-CSF sales in the five major EU markets by 2010 ($m)
Table 20: Sales of leading interferon alpha products worldwide
Table 21: Biogeneric interferon alpha marketed or in development
Table 22: Sales of biogeneric interferon alpha are expected to almost eradicate branded interferon alpha sales in the five major EU markets by 2010 ($m)
Table 23: Currently marketed interferon beta products
Table 24: Sales of leading interferon beta (IFN beta) products worldwide
Table 25: Key patents covering interferon beta
Table 26: Biogeneric interferon beta marketed or in development
Table 27: Sales of biogeneric interferon beta are expected to have little impact in the five major EU markets by 2010 ($m)
Table 28: Teva's biogeneric product portfolio and pipeline
Table 29: Sandoz' biogeneric product portfolio and pipeline
Table 30: BioPartners' biogeneric product portfolio and pipeline
Table 31: BioGeneriX's biogeneric product portfolio and pipeline
Table 32: Bioceuticals' biogeneric product portfolio and pipeline
Table 33: Pliva's biogeneric product portfolio and pipeline
Table 34: Cangene's biogeneric product portfolio and pipeline
Table 35: GeneMedix's biogeneric product portfolio and pipeline
Table 36: Phage Biotechnology's biogeneric product portfolio and pipeline
Table 37: Dragon Pharmaceutical's biogeneric product portfolio and pipeline
Table 38: Biogeneric products already marketed in India
Table 39: Marketed products from Chinese biogenerics manufacturers
Table 40: Superbiogeneric products developed by Neose Technologies
Table 41: Key products using Nektar Therapeutics' technology
Table 42: Companies with key products at risk from biogenerics
Table 43: Exchange rates*, 2004
List of Figures
Figure 1: Datamonitor expects the initial market leaders to be those with the greatest financial backing and commercial expertise
Figure 2: Global combined market sizes for key first-generation biologic product types (assuming no biogenerics), 2003-10
Figure 3: Comparison of numbers of biogeneric products in development shows that CSFs and epoetin are the two most popular classes
Figure 4: Forecast sales of the six major classes of biogenerics in Western markets, 2005-2010
Figure 5: Timelines of legal and regulatory progress towards a biogeneric approval pathway in the EU
Figure 6: Global sales of biologics and total pharmaceuticals by 56 leading pharmaceutical companies, 2001-2010
Figure 7: Global combined market sizes for key first-generation biologic product types (assuming no biogenerics), 2003-10
Figure 8: Biogeneric epoetin is forecast strong uptake in the five major EU markets between 2006 and 2010
Figure 9: Biogeneric insulin is expected to have minimal impact on sales of insulin products in the five major EU markets, 2004-10 ($m)
Figure 10: Sales of biogeneric G-CSF are expected to exceed branded G-CSF sales in the five major EU markets by 2010 ($m)
Figure 11: Sales of biogeneric interferon alpha are expected to almost eradicate branded interferon alpha sales in the five major EU markets by 2010 ($m)
Figure 12: Sales of biogeneric interferon beta are expected to have little impact in the five major EU markets by 2010 ($m)
Figure 13: Comparison of numbers of biogeneric products in development shows that CSFs and epoetin are the two most popular classes
Figure 14: Forecast sales of the six major classes of biogenerics in Western markets, 2005-2010
Figure 15: Barriers to entry of biogenerics
Figure 16: Datamonitor expects the initial market leaders to be those with the greatest financial backing and commercial expertise
Figure 17: Schering-Plough sharply increased the price of Intron A after the launch of its second-generation Peg-Intron, in order to encourage patient switching
Figure 18: Sales growth of Amgen's G-CSF franchise, 2001-2010 |
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