Acne - Pipeline Assessment and Market Forecasts to 2017

22 Jul 2010 • by Natalie Aster

GlobalData, the industry analysis specialist, has released a new report, “Acne - Pipeline Assessment and Market Forecasts to 2017”. The report is an essential source of information and analysis on the global acne therapeutics market. The report identifies the key trends shaping and driving the global acne therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the existing market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global acne therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

GlobalData’s research suggests that the global acne therapeutics market was worth $2.9 billion in 2009. It is estimated to reach revenues of $3.1 billion by 2017 at a Compound Annual Growth Rate (CAGR) of 0.7%. The moderate increase in revenues is attributed to the overcrowding of the market with generics and the increased acceptance of alternative therapies such as photodynamic therapy and Ultraviolet (UV)/blue light therapy. The current market has several products which treat acne by targeting different etiologic factors involved in the development of acne. Solodyn (minocycline hydrochloride) currently dominates the acne therapeutics market, followed by Doryx (doxycycline). The acne therapeutics market is witnessing a shift towards combination products, using two or more effective acne treatments. The currently marketed combination products such as Duac and Ziana are projected to steadily increase their revenues.

The Acne Therapeutics Market is Forecast to Show Moderate Growth in Revenues until 2017

GlobalData’s research suggests that the global acne therapeutics market was worth $2.9 billion in 2009. It is estimated to reach revenues of $3.1 billion by 2017 at a Compound Annual Growth Rate (CAGR) of 0.7%. The moderate increase in revenues is attributed to the overcrowding of the market with generics and the increased acceptance of alternative therapies such as photodynamic therapy and Ultraviolet (UV)/blue light therapy. The current market has several products which treat acne by targeting different etiologic factors involved in the development of acne. Solodyn (minocycline hydrochloride) currently dominates the acne therapeutics market, followed by Doryx (doxycycline). The acne therapeutics market is witnessing a shift towards combination products, using two or more effective acne treatments. The currently marketed combination products such as Duac and Ziana are projected to steadily increase their revenues.

The acne therapeutics market is largely genericized and is moderately served by the currently marketed drugs. The majority of the pipeline products of large pharmaceutical companies consist of combination products and there are very few first-in-class molecules. With emerging me-too combination products in the pipeline that are not significantly different from the current monotherapies, the acne therapeutics market awaits a blockbuster drug. Increases in the population in general and an increase in the prescription rate are expected to sustain the acne therapeutics market in the future.

With the recent characterization of acne as a chronic disease, Research and Development (R&D) in acne therapeutics requires, if not effective new launches, then the immediate prioritization of research on the pathology of this seemingly simple but actually complex disease.

Current Competition in the Acne Therapeutics Market is Strong

GlobalData assessed the current competitive landscape for acne drugs and found the competition to be strong. The market has several therapeutics for the treatment of mild, moderate and severe acne, which include antibacterial (P. acnes protein synthesis inhibitors), anti-inflammatory drugs and excessive sebum production inhibitors. Also included are drugs with selective affinity for nuclear retinoic acid receptors. Largely, treatments are based on attempts to decrease inflammatory responses, suppress bacterial growth and lower new comedone formation.

The top selling acne therapeutics have similar efficacy (~ 50%) and safety profiles with marginal differences. This has further intensified the competition in the market. Since the patents for the top selling drugs, Solodyn and Doryx, are set to expire in 2018 and 2022, respectively, the acne therapeutics market’s revenues are expected to steadily increase until 2017. The revenues from combination products such as Ziana and Duac are also predicted to contribute to the moderate growth in the acne therapeutics market. New entrants into the market will be forced to match or exceed the efficacy and safety profiles of the currently marketed products.

Me-too Molecules Dominating the Pipeline Leaves the Acne Pipeline Weak

GlobalData has found the pipeline in the acne therapeutics market to be weak. Although there are significant levels of Phase III research into the disease, very few molecules have shown promising results. Of the 15 molecules in Phase III, Allergan’s Dapsone gel 5% in combination with adapalene 0.1% benzoyl peroxide 4% gel and Stiefel’s Veltin have shown promising results thus far. The majority of the molecules in Phase III are me-too products, with one product-extension and no first-in-class molecules.

Following reliable Phase III results, Stiefel submitted Veltin for FDA approval. The acne pipeline has some first-in-class molecules, such as Cosmo Pharama’s CB-03-01, York Pharma’s YP 005 and Helix Biomedix’s HB 64 in the Phase II, preclinical and early stages, respectively. Getting reliable study results for the aforementioned molecules is likely to take time and they are unlikely to be approved before 2017.

Lack in Safety and Efficacy of Drugs account for Huge Unmet Need in Acne Therapeutics Market

The acne therapeutics market has huge unmet needs in terms of efficacy and safety. The presently marketed drugs are not capable of curing the disease completely – they only reduce lesions by approximately 50% and do not suppress their re-occurrence. In addition to this, the drugs do not target all the factors involved in the disease pathology.

The acne therapeutics market can be divided into two sectors – topical treatments and oral medication. Safety concerns associated with both oral and topical treatments significantly contribute to the high unmet need in the acne therapeutics market. Topical applications (gels and foams) result in skin dryness, irritation, stinging, redness and burning. Oral medications (such as antibiotics and retinoid) have been reported to cause hepatotoxicity, gastrointestinal complications and suicidal tendencies, in addition to the local cutaneous reactions mentioned above. These adverse reactions indicate that none of the products offer a completely safe profile. The development and subsequent launch of drugs with novel mechanisms of action to target acne, with relatively high safety and efficacy profiles, is essential to overcome the high unmet need in the acne therapeutics market.

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