Significant barriers to entry into the biosimilars market exist. High up-front investment and the need for specific expertise favor big players. Understanding of the marketplace is critical for success acceptance by key stakeholders is crucial for market uptake of biosimilars and achieving preferential reimbursement status through constant review of the pricing strategy is desirable.
Scope of this report
In-depth analysis of factors influencing market uptake of biosimilars
Analysis of the pricing and reimbursement environment for biosimilars
Detailed analysis of barriers to entry and strategies for success in the biosimilar market
Overview of strategies for originators' market share protection
Research and analysis highlights
Lack of automatic substitution with biosimilars means that intense promotion strategies need to be employed. Market uptake of biosimilars is highly dependent on acceptance by all key stakeholders especially physicians. All stakeholders need to be informed about biosimilars and various channels can be used.
Payers' reaction to biosimilars is not known, but it is expected they will embrace them after a lag period. Standard incentives used to encourage generics use may not be applicable to biosimilars distributed in hospitals and alternative approaches need to be used.
Barriers to entry remain high: high development and marketing costs compounded with the need for specialist expertise favor big players with strong financial backing and experience in branded generics industry. However smaller specialist players are well positioned to enter this market through co-development and co-marketing agreements.
Key reasons to read this report
Identify key stakeholders than need to be targeted in order to achieve high uptake of biosimilars
Understand the pricing and reimbursement environment of biosimilars, barriers to entry and key strategies for success in the biosimilars market
Gain insight into strategies employed by innovative pharmaceutical and biotechnology companies in order to maintain their market share
Table of Contents
CHAPTER 1 EXECUTIVE SUMMARY
Scope of the report
Key findings
Key definitions
CHAPTER 2 INTRODUCTION TO THE BIOSIMILARS MARKET
Drivers and resistors of growth in the biosimilars market
Drivers of biosimilars market growth
Biologics market growth
Advances in analytical techniques used to characterize biologics
Cost-containment pressures are driving the need for biosimilars
Resistors of biosimilars market growth
Lack of a regulatory pathway in the US
Opposition from the innovators
Cost and complexity of development
Europe as a testing ground
Five biosimilars have been approved in Europe so far
Outcome of US legislation - market exclusivity and difficulty
CHAPTER 3 FACTORS INFLUENCING MARKET UPTAKE OF BIOSIMILARS
Uptake is critical for market success
Patient switching is harder than with small molecule generics
Automatic substitution may be governed by legislation
Multiple stakeholders need to be targeted to ensure high uptake
Pharmacists have a role in the uptake of biosimilars
Patients' role in uptake
Physician uptake is critical
Informing physicians about biosimilars
CHAPTER 4 PRICING AND REIMBURSEMENT OF BIOSIMILARS
Pricing of biosimilars
Reimbursement of biosimilars
Payers perspective
EU payers are influenced by physicians and pharmacists
Retail biosimilars can lead to modest savings
Standard strategies for promoting generic uptake may not work for
biosimilars dispensed in hospitals
US payers may introduce reimbursement incentives
Tiered formularies are used by MCOs and PBMs
MCOs and PBMs are stressing the need for biosimilars
Discounts, rebates and patient co-pay will influence the use of
biosimilars
Product class analysis
HGH market is hard to penetrate
Price may be the key factor affecting biosimilar epoetin uptake
Restrictions on epoetin use in the US will impact the overall market
size
Launch of first biosimilar epoetin alpha in Europe is imminent
Interferon alpha market is dominated by second-generation products
Interferon beta market is growing but competition from improved
products exists
Insulin market is not an attractive target for biosimilars
Granulocyte colony-stimulating factor has attracted many biosimilar
companies
Biosimilar Enbrel presents a very lucrative opportunity
Monoclonal antibodies will not be targets for biosimilars in the near
future
CHAPTER 5 BIOSIMILARS MARKET ENTRY
Barriers to entry are high but not insurmountable
The development of biosimilars is more complex and costly than that of
small molecule generics
Lack of specific expertise
Complex patent protection of biologics is another barrier
High promotional costs
Expensive to exit
Competitive landscape less crowded than for small molecule drug generics
Smaller number of entrants
Early entry brings advantage but is risky
Contract manufacturing organizations will enter the biosimilars market
Big players will remain
Biosimilars manufacturers in the emerging markets
Low cost base is an advantage...
...but gaining regulatory approval is difficult
Confidence is important for acceptance
Case Study: Omnitrope - the story so far
Omnitrope' s EU approval was not smooth
US approval for Omnitrope was granted only after a law suit
Pricing and launch strategy for Omnitrope
Omnitrope' s branding strategy
Omnitrope sales to date
Line extension - liquid Omnitrope formulation
Case Study: Sandoz' s biosimilar epoetin alpha
CHAPTER 6 KEY RECOMMENDATIONS FOR SUCCESS
Making biosimilar products
Acquire biopharmaceutical expertise, facilities or pipelines
Marketing of biosimilar products
Achieving profitability in the biosimilars market
Low-cost manufacturing
Choice of reference product is important
Early entrants are rewarded
Enter strategic partnerships
Positioning of biosimilars - biosimilar or full submission route
Second-generation biosimilars
SWOT analysis of biosimilars manufacturers
CHAPTER 7 ORIGINATORS' STRATEGIES FOR MARKET SHARE PROTECTION
Communication with decision makers is crucial
Lobbying regulatory bodies
Automatic substitution should not be allowed for biosimilars
Labels should clearly state if a product is a biosimilar
Biosimilars should have different names
Informing physicians and patients about proven safety
Informing payers about quality and cost of service
Patent protection
Pricing strategies
Lifecycle management strategies for biologics
Authorized biosimilars
Licensing agreements with biosimilar manufacturers
Line extension
Innovative delivery systems
Innovation, innovation, innovation
Will branded pharma and biotech enter the biosimilars market?
CHAPTER 8 BIBLIOGRAPHY
Publications and online articles
Conference literature
Datamonitor resources
Suggested reading
GLOSSARY
List of Tables
Table 1: Aspects of biosimilars that influence acceptance by
pharmacists
Table 2: Companies taking part in the South London epoetin tender
Table 3: Development and approval processes of biosimilars and small
molecule generics
Table 4: Omnitrope sales by country, H2 2006-H1 2007 in USD
List of Figures
Figure 1: Multiple stakeholders need to be targeted
Figure 2: Stakeholder influence on the final dispensing decision
depends on the setting
Figure 3: Adoption process is different for hospital and retail
biosimilars
Figure 4: Tiered formularies are used in the US
Figure 5: Competencies required for the development and marketing of
biosimilars
Figure 6: Barriers to biosimilars market entry
Figure 7: Biosimilars development and marketing is a long and costly
process
Figure 8: Key challenges and strategies for success in the biosimilars
market
Figure 9: The 4Ps of marketing biosimilars
Figure 10: Characteristics of a successful biosimilars company
Figure 11: SWOT analysis of biosimilars manufacturers
医薬品
その他のカテゴリ
FAQ