ANALYZING AND FORECASTING THE FUSION PROTEIN MARKET AND PIPELINE - Fusion Protein Technologies for Biopharmaceuticals: Applications and Challenges - page 24

ANALYZING AND FORECASTING THE FUSION PROTEIN
MARKET AND PIPELINE

M ARK B ELSEY 1 AND G ILES S OMERS 2
1 WestLB, London, UK
2 Datamonitor, London, UK

2.1 Introduction
2.2 Market sales dynamics of the FP market
2.3 Individual drug sales analysis
2.4 Database analysis
References

companies. Our analysis leads us to conclude that FPs are
unlikely to be viewed as a homologous technology with a
single best-in-class technology platform that Big Pharma/Big
Biotech companies aim to gain exposure to—instead, FP
candidates are selected on a drug-by-drug basis on factors
such as their individual efficacy and safety profiles, and
disease target. Last, based on our analysis, we think the
primary drivers for potential FP in-licensing by multinational
companies are (1) to capitalize on already established sales
and marketing networks, or (2) to lineup replacement drugs
following the loss of exclusivity for marketed drugs, or
replace other pipeline drugs they are developing if data are
less robust for these other pipeline drugs.
We define FPs as non-native proteins produced from a
genetic fusion of sequences encoding two or more protein
components (unless specified otherwise, protein component
relates to a whole protein, protein fragment, or peptide). As
such, all FP components must be combined in gene expres-
sion, as opposed to being chemically joined at a later time. A
linker or spacer peptide can also be included to aid folding of
the proteins and/or biologic activity.

2.1 INTRODUCTION

In this chapter, we look at the evolution of the fusion protein
(FP) market from the launch of Enbrel 1 in 1998, through to
the end of 2010 where there are seven sales-generating FPs
on at least one major western pharmaceutical market. Sub-
sequently, we carry out a market analysis, which indicates
that the fusion market could be worth $10.1 billion in our
view by 2016. This chapter also provides an in-depth market
analysis of the six drugs that we forecast will account for
93.5% of the estimated $10.1 billion FP market by 2016 (on
a risk-adjusted basis): Enbrel, Orencia 1 , Nplate 1 , dulaglu-
tide, albiglutide, and VEGF trap-Eye. Last, we provide an
analysis of the FP market pipeline, which has led to the
identification of 43 FPs in Phase II development and above.
From this analysis, we note that the most common targeted
therapy area is oncology, followed by autoimmune diseases:
a not uncommon finding for a biotech market. We also find
that many Big Pharma/Big Biotech companies have at least
one FP in Phase II development and above; however, few
have more than two, even though we believe FPs represent
attractive

2.2 MARKET SALES DYNAMICS
OF THE FP MARKET

In this section, we discuss the evolution of the FPmarket, what
we estimate total FP market sales are currently (as of the end
of 2010), and what we think the market will grow to in the
future (by 2016), together with discussing themain factors we
think will drive or restrict market growth going forward.

licensing targets for these multinational