Biosimilars Series: Strategic Issues - Potential Remains Uncertain : Market Research Report

Biosimilars Series: Strategic Issues - Potential Remains Uncertain

Published by: Datamonitor

Published: Oct. 3, 2007 - 104 Pages

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

Abstract

Introduction

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

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

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.

Reasons to Purchase

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

Please Note: This product is delivered as a zip file.

Get Full Details About This Report >>

US: 800.298.5699

Int'l: +1.240.747.3093

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.

Biosimilars Series: Strategic Issues - Potential Remains Uncertain

Table of Contents

Abstract