Acne vulgaris, also known as acne, is a common, chronic, inflammatory disease of the glands that produce sebum (sebaceous follicles). This disease results in the formation of inflamed elevations (papules, pustules, nodules, and cysts), comedones (blackheads and whiteheads), and scars on the skin. Acne is one of the most common disorders treated by dermatologists and other healthcare providers. More than 90 percent of world population is affected by acne at some point in their life. Although acne is a skin disease, it can lead to prominent emotional and psychological issues. Several studies have confirmed that acne can affect a person’s quality of life, self-esteem, and mood adversely. Acne is a chronic, inflammatory skin condition with a multi-factorial pathogenesis. The source is hormonal changes during puberty and it is then further exacerbated by genetic and other factors.
Apart from the belief that acne results from sebaceous gland hyperplasia, abnormal follicular differentiation with increased keratinization, microbial hyper-colonization of the follicular canal, and increased inflammation primarily through activation of the adaptive immune system may also be contributors. There are various types of acne, such as acne vulgaris, acne rosacea, acne cosmetica, acne fulminans, and acne mechanica. Among them all, acne vulgaris is the most common, with prevalence in 99 percent of the acne cases. Acne vulgaris is a common inflammatory skin disease characterized by inflammatory or non-inflammatory lesions.
The prevalence of acne vulgaris globally was 681.2 million in 2016. This was an increase of 10 percent from 612 million in 2006. In 2010, acne ranked 8thin the list of most prevalent diseases in the world, with a global prevalence of 645 million. Approximately 80 percent of people are affected by acne between the onset of puberty and 30 years of age.
By the end of 2026, the number of people affected by acne in India is estimated to reach 23 million at a compound annual growth rate (compound average growth rate) of 0.5 percent. Females are more prone to acne as compared to males in India. In India, change in annual years of healthy life lost since 1990 to 2013 due to acne is -0.2 percent.
Dermatologic problems can result in psychosocial effects that drastically affect patient’s lives. More than a cosmetic nuisance, skin disease can produce anxiety, depression, and other psychological problems that affect patient’s lives in ways comparable to arthritis or other disabling illnesses. Even though antibiotics play a key role in acne management, the increase in acnes resistance is a matter of concern. The issue of antibiotic resistance also impacts the prescribing patterns and treatment algorithms.
The standard of care for the treatment of mild-to-moderate acne is topical therapy. There are two treatment guidelines for treatment available by the American Academy of Dermatology and European Union Group. The currently available therapeutic options for acne include several treatment approaches such as retinoids, antibacterial washes, antibiotic pills, lasers, pulsed-light therapies, photodynamic therapy, and systemic isotretinoin. There are multiple new breakthroughs we may see in the near future, which may include molecules with novel mechanisms and more effective dosage forms. The acne vulgaris product pipeline comprises the diverse set of molecules with the majority of products in early-stage development. The global acne product pipeline comprises a total of 64 programs at various stages of clinical development. 41 percent of products are in the preclinical and discovery stage. There are multiple promising molecules in clinical development that may potentially change the acne treatment approach in future.
Despite the size of the acne patient population, innovation in the acne therapy has remained limited over the past 20 years. Most of the innovation in acne therapy has involved reformulation of drugs with improved vehicles or development of a combination of approved products. Poor adherence is one of the critical and negatively impacting factors affecting acne treatment outcomes. Moreover, limited patient education and awareness about acne treatment is also a roadblock to successful treatment.
Topical formulations are perhaps among the most challenging products to develop regarding delivery of a drug to a target site. Also, foams, micro lipid carriers (such as liposomes), microsphere, colloidal delivery systems, porous materials, and combination therapy options are also explored by the companies to come up with new drug delivery solutions to enhance the efficacy of the treatment.
The acne therapy market is moving from mono therapy towards combination therapy options. The most likely reason is higher efficacy of combinations that consider the multi-factorial pathogenesis of acne, reduced resistance levels, and the ease of single product use versus two separate mono therapies.
This report provides in-depth market analysis of the global dermatology market, OTC dermatology product market and acne market. The market size for dermatology therapeutics is expected to grow considerably, from USD19.8billion in 2016 to USD41.2billion in 2026, at a compound average growth rate of 8 percent. The global OTC dermatology products market was worth USD114billion in 2016. Acne treatments take a considerable share of dermatology OTC product market. Also, increasingly various prescription acne treatments are becoming qualified as OTC products due to their history of long-term safety and efficacy. Products such as Benzoyl peroxide, Salicylic acid, and their combinations are largely moving into the OTC space. Accutane has been top-selling product in the acne prescription market with sales of USD 1.2 billion in 2016.
The Indian dermatology market grew from USD608 million in 2012 to USD1100 million in 2016, with five years compound average growth rate of 12.59 percent. The acne market has grown from USD48 million in 2012 to USD78.5 million in 2016. Over the course of 5 years, the acne prescription market grew at compound average growth rate of 10.34 percent. In line with the global market trend, the Indian market is also dominated by topical products for the treatment of acne vulgaris. The Indian acne market is expected to grow from USD78.5 million in 2016 to USD164 million by 2026 with a compound average growth rate of 7.65 percent. In 2016 topical products hold 72 percent (USD57 million) of market share by value vs. oral products holding 28 percent (USD21 million) market share. Combination products hold more than 35 percent market share by value, and it is expected to grow further reaching to 48 percent by 2026
In the Indian acne market, the top 10 companies hold more than 55 percent of the market by value. The market is crowded, with more than 50 pharmaceutical companies actively marketing their products in the acne therapy segment. Even though the market is largely dominated by local pharmaceuticals companies, multinational pharmaceuticals companies, such as Galderma, Janssen, Abbott, GSK and, Menarini together hold a considerable market share by value (12 percent) and are among the top 20 companies in acne therapy space.
The top assignee is Nestle, with 133 patents, followed by Allergan with 70 patents. Most of Nestlé’s patents belong to its subsidiary, Galderma, which is a Switzerland-based pharmaceutical subsidiary specializing in research and development (R&D) and marketing of dermatological solutions. The patent with the maximum impact factor (maximum number of citations) is focused on oleaginous pharmaceutical and cosmetic foam for the treatment of acne this patent was cited by 91 patents. Among the top assignees provided by Market research, Nestle (Galderma), Allergan, Dow Chemical (DowDuPont), GlaxoSmithKline, and Sun Pharma appear as top assignees in the intellectual property (patent) search as well. The inventors with the maximum number of fillings are Donella, John E, and Mallard Claire. Donella. John E is the most active inventor of Allergan, and Mallard Claire has been the most active inventor for Nestle.
Companies profiled in this report include Vyome Biosciences, Sun Pharma, Hegde and Hegde Pharma, Mankind Pharmaceuticals, Cipla Pharmaceuticals and Glenmark Pharmaceuticals.
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