Acne Vulgaris - Opportunity Analysis and Forecasts to 2018, New Report Launched

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.

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