Acne - Drug Pipeline Analysis and Market Forecasts to 2016

28 May 2010 • by Natalie Aster

GlobalData, the industry analysis specialist’s new report, “Acne - Drug Pipeline Analysis and Market Forecasts to 2016” is an essential source of information and analysis on the global acne market. The report identifies the key trends shaping and driving the global acne market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global acne 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.

The Acne Therapeutics Market is Forecast to Show Moderate Growth in Revenues till 2016

Globaldata research suggests that the global acne market was worth $2.8 billion in 2009. It is estimated to reach revenues of $3.02 billion by 2016 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 act on acne by targeting different etiologic factors involved in the development of acne. Solodyn (minocycline hydrochloride) currently rules the acne market, followed by Doryx (doxycycline). The acne therapeutics market is witnessing a shift towards combination products, using two or more effective acne treatments. Currently marketed combination products such as Duac and Ziana are estimated to steadily increase revenues.

The acne market is primarily genericised and is moderately served by the currently marketed drugs. The majority of the pipeline products of large pharmaceutical companies also consist of combination products with 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 market awaits a blockbuster drug. Increases in the population in general and an increase in the prescription rate are estimated to sustain the acne 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, immediate prioritization of research on the pathology of this seemingly simple but actually complex disease.

Current Competition in the Acne 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 antibacterials (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 formations.

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, acne market revenues are estimated to steadily increase until 2016. Revenues from combination products such as Ziana and Duac are also predicted to contribute to the moderate growth in the acne market. New entrants into the market will be forced to match or exceed the efficacy and safety profiles of the currently marketed products.

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

The acne 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 medications. Safety concerns associated with both oral and topical treatments significantly contribute to the high unmet need in the acne market. Topical applications (gels and foams) result in skin dryness, irritation, stinging, redness and burning. Oral medications (such as antibiotics and retinoids) have been reported to cause hepatotoxicity, gastrointestinal complications and suicidal tendencies, in addition to 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 a novel mechanism of action to target acne, with relatively high safety and efficacy profiles, is essential to overcome the high unmet need posed by the existing market.

Me-Too molecules dominating the pipeline leaves the Acne Pipeline Weak

GlobalData identified the pipeline in the acne market to be weak. Although research into the disease market is at a prominent level in Phase III, very few molecules have shown promising results. Of the 12 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 two product-extensions 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 Pharamaceutical’s CB-03-01, York Pharma’s YP 005, Helix Biomedix’s HB 64 in the Phase II, preclinical and early stages, respectively. A reliable study result for the aforementioned molecules is likely to take time and their approval seems unattainable before 2016.

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