Coagulation Factors 2009: Target Pipeline and Competitor Benchmark Analysis

Abstract

The “Coagulation Factors 2009: Target Pipeline and Corporate Benchmark Analysis” report is the most complete and up-to-date evaluation and assessment of the recombinant and plasma-derived coagulation factor pipelines. The authors analyze and assess the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation business are evaluated and the strengths, weaknesses, opportunities and threats (SWOT) in their R&D pipeline benchmarked in the respective peer group. Technologies used for creation of next generation coagulation factors are discussed and assessed. The report identifies strategies to overcome weaknesses in the portfolio and suggests development strategies

Background

The market size of recombinant and plasma-derived coagulation factor products exceeded US$ 7.5 bln in 2008, the majority (US$ 5.5 bln) generated by recombinant proteins. Replacement of plasma-derived coagulation factors by marketed recombinant molecules is ongoing and will further increase by new recombinant coagulation factors in development. In light of ongoing expiration of substance patents, about 40 new recombinant coagulation factor projects are in the pipeline indicating a changing marketplace over the next decade. New players are competing and will challenge established manufacturers and marketers of coagulation factor products.

Scope of the report

• R&D pipeline overview;
• In depth profiles of most promising coagulation factors in the pipeline
• pipeline analysis for each coagulation factor ;
• evaluation and assessment of protein engineering and drug delivery technologies
• overview and analysis of marketed coagulation factors;
• profiles of more than 50 companies active in this business;
• corporate product portfolios and R&D pipelines
• benchmark and SWOT analysis of corporate competitors within peer group;

Ongoing patent expirations and failed life cycle management efforts leave the established companies vulnerable regarding the future growth perspective of their recombinant coagulation factor business, but at the same time opens the door to potential new market entrants.

The recombinant factor VIII pipeline consists of more than ten novel molecules, four of them already in clinical stages, some are wild-type constructs, but many are longer acting variants of factor VIII. The recombinant factor IX pipeline even counts 15 developments with three in clinical phases. In the recombinant factor VIIa pipeline, all projects except one are modified versions, either short-acting or longer acting with four projects in the clinic and two more shortly to follow.

All of the next generation molecules need systemic intravenous administration, attempts to allow subcutaneous or even non-injectable administration regimes so far have not succeeded and leave space for future optimization.

SWOT analysis revealed Novo Nordisk as well positioned in contrast to market leader Baxter.

• Understand your position in a highly competitive environment
• Avoid costly mistakes
• Learn from your competitors
• Challenge your strategy with a view from outside the organization
• Revise weaknesses of your molecule and development plan
• Identify threats to your business plan
• Realize new opportunities suggested by the report
• Reassure and build upon your strengths
• Find applications for your technology

• Project, product and portfolio managers
• Business development & licensing
• Research & development
• Technology evaluation
• Financial analysts
• Investment fund/venture capital managers
• Plasma fractionation companies with coagulation factor business
• Drug delivery companies
• Protein engineering companies
• Companies with surgery and wound healing business
• Companies interested in biosimilars/biogenerics