ANALYZING AND FORECASTING THE FUSION PROTEIN MARKET AND PIPELINE - Fusion Protein Technologies for Biopharmaceuticals: Applications and Challenges - page 26

sales CAGR of 0.5%). The comparatively low growth of the

FP market masks an estimated 3.2% CAGR decline in sales of
the key FP drug, Enbrel over this period. Similar to other
biotech market (e.g., mAbs or nucleic acid therapeutics), the
FP market is dominated by a small number of high-selling
drugs. In the FP market, Enbrel is currently the only block-
buster (a blockbuster is a drug generating at least $1 billion
annual sales) and is a leading drug in autoimmune diseases (in
particular in two major indications: RA and psoriasis). We
estimate Enbrel sales in 2010 accounted for 86% of the total
FP market; however, we forecast that this will fall to 56% by
2016, based on our assumptions of a ramp up in competition
facing Enbrel in the form of branded originators and bio-
similars (Figure 2.1).
Strippi ng out the impact of Enbrel, our 2010-16E FP
ex-En brel sal es CAGR is 26.3% (al though we flag that this
strong growth is partly the result of having a low base in
2010, togethe r with assumptio ns that a numb er of new FP
drugs will laun ch over this period) . We forecas t that six
drugs will accou nt for 93.5% of the estimat ed $10.1 billion
FP market by 2016, includi ng three-ma rketed drugs: Enbrel,
Orencia, and Nplat e; and thr ee late- stage pipe line drugs:
VEGF trap-Eye, dula glutide, and albigl utide. We forecast
that by 2016, auto immune 6 will rem ain the lea d therape utic
area in terms of sales, accou nting for 78% of total est imated
2016 FP sales. While a full market anal ysis of all indicat ions
targeted by marketed FPs and those in late- stage clini cal
developme nt is beyond the scope of this chapter, we have
provide d (1) a brief overview of what we think are factors
driving and restrictin g FP market growt h (note: this is a
focus for Chapter 3; the sectio n below serves to introdu ce
these topics) and (2) deta il o n wha t we consider are key
positive and negative factors shapi ng the sales growth under-
lying wha t we think will be the six key FPs (see Section 2.3).

introduced to treat autoimmune diseases such as RA. It is
currently the market leader in both RA [2] and psoriasis [3].
We estimate that it holds one-third of the RA market, and just
under one half of the psoriasis market. It is thought by
independent market analysts and by key opinion leader
physicians to be the most efficacious agent in treating RA
[2] and to be in the top-3 psoriasis drugs in terms of overall
clinical profile [3]. In 2008, Enbrel was Wyeth's second-
highest selling drug [4], and it was the sixth-highest selling
pharmaceutical in 2009 globally, according to IMS sales
data. 7 We estimate that 86% of the 2010 FP market came

from Enbrel; therefore, the future sales performance of this
drug has a substantial impact on the overall FP market growth.
For Enbrel, RA and psoriasis (together with psori atic
arthritis) are the key market s: we estimat e that 70% Enbrel
current sales are from rheumatol ogy (excluding psori atic
arthritis) , wherea s 30% came from psoriasis and psori atic

arthritis [5]. Th ese are siz eable markets with substantia l
growth pote ntial: inde penden t mar ket anal ysts have esti-
mated that the RA market gener ated $8.8 billion sales in
2009 in the seven major markets, 8 and fore cast it to rise to
$12 billion by 2019 [2], wherea s these analyst s estimat e that
the psorias is market gener ated $3.4 billion sal es in 20 09, and
forecas t it to rise to $6.8 billion by 2019 [6]. A rece nt
rheumatol ogist survey indi cated that while Enbrel remained
the most effica cious drug (43% ), com petition is incr easing:
Humira 1 is right behi nd Enbrel (42%), and a higher per-
centage of managed care organizations prefer Humira over
Enbrel [2]. En brel als o appea rs to be facing substantia l
compet ition in psorias is: although we think Enbrel is still
one of the top-selling drugs in this market, a rece nt derma-
tologist survey indicat ed that Enbrel is thoug ht to b e less
efficaci ous than compet itors: 32% voted Humira is the mos t
efficaci ous, 29% voted for Remicad e 1 , and only 23%
selected Enbrel [7]. Furtherm ore, in both indicat ions, it
seems possi ble that the drug will face com petition from
biosimilar s in the med ium term.
Despite this increas e in competition , we think specific
positive factor s will help drive Enbrel sales and prevent a
rapid, substantia l sales decline in the face of this compet ition
include (1) very strong promotional and marketing support,
given the length of time that the drug has spent on the
market and the number of patients treated, and because the
drug is marketed by Amgen, Pfizer, and Takeda: three
leading pharmaceutical companies with substantial experi-
ence in autoimmune disease promotion plus extensive key
opinion leader networks; (2) a very well-established safety
profile, with over 2 million patient years of postmarketing
exposure (according to Amgen); (3) the autoinjector pen

2.2.3 Growth Driver s and Res trictors that Impac t
the FP Marke t

Briefly, we believe that the key factor s driving and restrict-
ing mar ket growt h include effica cy, safety, cost , and adm in-
istration. These are discusse d in greater detail in Chapte r 3.

2.3 INDIVID UAL DR UG SALES ANALYS IS

2.3.1 Enbrel

Amgen/Pfizer/Takeda's Enbrel (etanercept), launched in the
United States in 1998 for moderate to severe RA, was the first
tissue necrosis factor (TNF)-targeting biologic drug to be

6 We include the following indications in autoimmune: rheumatoid arthritis,
psoriasis, psoriatic arthritis, juvenile rheumatoid arthritis, ankylosing spon-
dylitis, idiopathic thrombocytopenic purpura, cryopyrin-associated periodic
syndromes and Muckle-wells syndrome.

7 http://www.imshealth.com/deployedfiles/imshealth/Global/Content/
StaticFile/Top_Line_Data/Top%2015%20Global%20Products_2009.pdf
8 We define the seven major markets as the United States, Japan, France,
Germany, Italy, Spain, and the United Kingdom.