Steady and Sustained
Growth in the US and EU Acne Markets Expected Between 2012–2018
Publisher estimates the 2012 pharmacological therapy
sales for acne to total approximately $2.3 billion across the six major
pharmaceutical markets (6MM) covered within this report: the US, France,
Germany, Italy, Spain, and the UK. The US contributes 91% of these sales,
generating an estimated $2.1 billion in 2012. With $207.0m in sales from the
5EU, Germany was the largest market with an estimated $54.3m in sales in 2012.
By the end of the forecast period in 2018, acne sales are
forecast to reach over $2.8 billion, growing at a compound annual growth rate
(CAGR) of 3.9% over the six-year forecast period. The majority of sales will
come from the US, which will maintain its 2012 lead and command 93% of the
market in 2018. A substantial amount of growth in that market is attributed to
the rapid uptake of Galderma’s Epiduo (benzoyl peroxide and adapalene) for
moderate patients and the continued success of isotretinoin. The anticipated
launch of AndroScience’s androgen receptor degradation enhancer, ASC-J9, in
2017 will add a new molecular entity to the market for acne for the first time
in approximately 30 years. Photocure’s Visonac is also expected to launch in
2017, adding photodynamic therapies to the treatment options for acne patients.
Together, these products are expected to add approximately $200m in sales to
the acne market in 2018.
Major drivers of
growth in the acne market over the forecast period include:
- Launch of AndroScience’s ASC-J9 in 2017, a therapeutic
that is highly anticipated in the previously stagnant acne market and will make
hormonal therapies available to males with acne. Publisher expects that ASC-J9
will be subject to rapid uptake.
- Continued success and uptake of Galderma’s Epiduo, with
label expansion into the pediatric population and launch of the Epiduo TAP
program to improve patient compliance.
- Launch of Photocure’s Visonac in 2017; potentially the
first photodynamic therapy for use in acne.
Major barriers to the growth of the acne market during
the forecast period include:
- Increasing emphasis for acne therapies to demonstrate
cost-effectiveness, particularly in a number of 5EU countries. Austerity
measures in Europe will pose a challenge for pharmaceutical companies trying to
justify high prices of novel therapies and reformulations when compared with
the cost-effective generic drugs that have a long history of use in acne.
- Pharmaceutical companies are not inclined to invest in
acne research, viewing R&D in this area as a poor return on investment.
This is especially true when compared with therapies such as biologic agents
that are used in other dermatology indications such as psoriasis and garner
lucrative sales. Increased regulatory rigidness has put pressure on the need
for longer clinical trials to reflect the chronic nature of acne.
Pharmaceutical Giants
Revisiting the Acne Arena, Deploying Notable R&D Strategies to Attain
Market Share
Despite its considerable patient population (estimated at
103.9 million in 2012 across the US and 5EU), the acne market has often been
overlooked and has remained stagnant for the past few decades, with no novel
drugs entering the arena. The lack of dedicated research programs has been
attributed to pharmaceutical companies viewing topicals, the mainstay of acne
therapy, as being inexpensive with a poor return on investment. Instead, the
market has shifted towards reformulations of existing products and/or
fixed-dose combination therapies. Examples of the latter include combination
products by key dermatology players, such as Galderma’s Epiduo (adapalene and
benzoyl peroxide), GlaxoSmithKline’s (GSK) Duac (benzoyl peroxide and
clindamycin phosphate), and Astellas’ Zineryt (zinc acetate and erythromycin).
By simplifying treatment, studies have demonstrated that compliance, and
therefore efficacy, can be improved by the synergistic effect of combining two
active ingredients. Meanwhile, novel formulations include microsponges,
liposomes, nanoemulsions, aerosol foams, subantimicrobial-dose doxycycline and
extended-release minocycline. Reformulations are a low-risk strategy for Big
Pharma, compared with investments into new molecular entities for acne.
Label expansions in acne have also been explored as a
lifecycle management strategy, as exhibited by Galderma’s entry into the large
and untapped pediatric market. In February 2013, Galderma obtained a label
expansion for children under 12 years of age for its lead product, Epiduo. The
need for an acne treatment for children younger than 12 years of age had
previously been overlooked due to safety concerns, the sensitive nature of skin
in young individuals, and the rarity of the condition in children. However,
recent evidence suggests that acne is more prevalent in younger individuals
than it once was, potentially due to the decreasing age of onset for puberty.
Targeting the previously untapped pediatric market is a strategy that Publisher
expects will be followed by other dermatology companies during the coming
decade.
Another corporate trend is the strategic acquisition of
key dermatology products by Big Pharma. A notable event in 2009 involved the
acquisition of Stiefel, a leading dermatology company, by GSK for $3.6 billion.
Innovative Products
in Acne Should Focus on Cost-Effectiveness, Potential to Improve Compliance
The biggest unmet needs in acne include the need for new
and innovative products, for improved compliance, and for less expensive
products relative to existing therapies. Historically, pharmaceutical companies
have been reluctant to enter the acne market due to the poor return on
investment in this competitive landscape. This attitude has inhibited progress
toward developing disease-modifying agents, and agents with more long-lasting
effects. However, the acne landscape is expected to change in the near- to
long-term, with the launch of AndroScience’s ASC-J9 and Photocure’s Visonac,
and additional companies involved in research for innovative acne products.
Although low-cost products are available for acne, these
typically contain a single active ingredient that is not very effective for
acne, especially in more severe cases. Use of two or more topical treatment options
for acne is challenging and adherence to these treatments is often very poor.
This is more pronounced in adolescent sufferers, who often struggle to
incorporate the various treatment regimens into their daily routine, viewing
them as time-consuming, inconvenient and messy. Pharmaceutical companies have
responded by combining two active ingredients into specially formulated
combination products; however, the costs of these treatments are prohibitive.
As such, there remains a need for a cost-effective combination product that
will allow better patient compliance.
Acne Market to
Experience a Period of Investment in Research
A continued unmet need for acne is the need for new and
innovative products to treat the underlying condition. Also necessary is further
investment of time and resources into understanding the disease
pathophysiology. The goal of these investigations would be to develop molecules
that can specifically target critical pathways in the acne pathophysiology.
There is a move in the acne field towards treatment with biologics,
particularly in targeted monoclonal antibodies (mAbs), with two mAbs under
development, XBiotech’s Phase II mAb against interleukin (IL)-1α, and Xoma’s
Phase II mAb against IL-1β. The targeted approach offered by biologics could
allow superior specificity for the treatment of acne compared with other
therapy options.
Focusing on small molecules, hormonal antagonists such as
androgen- and estrogen-based molecules are also being investigated. Given the
acne market’s substantial patient pool and increasing understanding of the
disease’s pathophysiology, Publisher expects continued interest in the acne
market from biotechs and pharmaceutical companies over the coming decade.
AndroScience’s ASC-J9
to Renew Hope for More Disease-Modifying Therapies That Can Further Challenge
the Established Acne Landscape
There is considerable excitement around the potential of
AndroScience’s ASC-J9 in the acne market. ASC-J9 not only represents a novel
mechanism of action, but also its entry to the market will be a much-needed
addition to a stagnant market. ASC-J9 functions to target the principal hormone
receptor associated with acne, the androgen receptor, a cause of acne in both
men and women. In addition to use in female patients with moderate to severe
acne, ASC-J9 will allow penetration into the male acne market, something not
achieved with currently available hormonal treatments. Furthermore, due to its
topical formulation, systemic side effects are likely to be reduced, if not altogether
ameliorated. When compared with isotretinoin, the current standard for patients
with severe acne, ASC-J9 has a better safety profile and is not teratogenic,
which poses a major barrier for isotretinoin. ASC-J9 is expected to become a
major product for the treatment of patients with severe acne and is forecast to
experience rapid uptake.
Spanning over 177 pages, “OpportunityAnalyzer:
Acne Vulgaris - Opportunity Analysis and Forecasts to 2018”
report covering the Disease Overview, Epidemiology, Current Treatment Options,
Unmet Needs Assessment and Opportunity Analysis, R&D Strategies, Pipeline
Assessment, Pipeline Valuation Analysis, Appendix.
