Vitiligo Therapeutics - Pipeline Assessment and Market Forecasts to 2019

The Vitiligo Therapeutics Market is Expected to Show Moderate Growth up to 2019

GlobalData estimated the global vitiligo therapeutics market to be worth $1.4 billion in 2011. It is expected to grow to $2.7 billion by 2019 at a Compound Annual Growth Rate (CAGR) of 8.8%. This growth can be primarily attributed to the rise in the number of patients undergoing treatment for vitiligo and the launch of Scenesse (afamelanotide) in 2014. The vitiligo therapeutics market will witness only one new drug approval in the forecast period. The new introduction in the market will be positioned as a novel therapy among moderately efficacious generics and is expected to be launched at a premium price, thus limiting its market penetration in initial years. The market will be characterized with the dominance of generic products as only one new product is scheduled to be launched in the forecast period.

The prominence of generics in the market and the new drug introduction will lead to steady growth in the vitiligo therapeutics market over the forecast period. The market is expected to witness moderate growth with generics playing a major role in the forecast period, which is similar to the present market scenario.

Generics will Continue to Dominate the Vitiligo Therapeutics Market in the Forecast Period

GlobalData found that the treatment options currently available in the vitiligo therapeutics market are generics. Only Scenesse from Clinuvel Pharmaceuticals is expected to be launched in the forecast period. The vitiligo therapeutics pipeline is deprived of drug candidates in the late stage of clinical development.

Vitiligo Therapeutics Market

Published: February 2012
No. of Pages: 63
Price : Single User License - US$3995          Corporate User License - US$11985

                                       

Current Competition in the Vitiligo Therapeutics Market is Weak

GlobalData assessed the current competitive landscape for vitiligo drugs and found that competition is weak. All the available treatment options are moderately successful in meeting the market demand. Although the market has various treatment options available, none are able to manage vitiligo adequately. The products currently available in the market are associated with average efficacy and safety profiles. While current treatment options are capable of inducing some degree of repigmentation in the affected areas, they lack in ceasing disease progression and to impart satisfactory levels of repigmentation.

As the products currently in the market do not serve the unmet need, the market continues to offer opportunities for products in the pipeline with novel mechanism of action and disease modifying characteristics. The unmet need in the vitiligo therapeutics market is considered to be significant and can be fulfilled by technologically advanced products with improved safety and efficacy profiles.

Weak Pipeline Lacking in Effective Therapeutic Options in Late Phase of Clinical Development

GlobalData’s research indicates that the vitiligo therapeutics market pipeline is weak as the pipeline has few therapeutic treatment options. There are seven potential treatment options in the pipeline across various phases of clinical development. Out of the seven pipeline candidates, three are melanocytes transplantation therapies and the remaining four are therapeutic treatments. None of the therapeutic treatment options in the pipeline is in the late stage of development. In Phase III there are three melanocytes transplantation therapies, which will improve the disease management through surgical treatment options. In terms of therapeutic treatment options all of the molecules in the pipeline are first-in-class. The only first-in-class molecule in Phase II, Scenesse (afamelanotide) from Clinuvel Pharmaceuticals, acts by stimulating alpha-melanocytes. Of the three first-in-class molecules from the preclinical phase, DRM02 of Dermira, is a topical kinase inhibitor whereas two molecules from Switch Biotech, SWT05104 and SWT05105 are melanocytes formation stimulators. Scenesse is an analogue of alpha melanocytes stimulating hormone and mimics its action. Treatment of vitiligo patients with Scenesse is expected to facilitate repigmentation by enhancing the growth of melanocytes, assisting in their migration to depigmented areas of skin and activating pigment production within these regions.

Global Biosimilars: A return to optimism?

Examining the market for companies
The need for a settled market environment is essential if the growing numbers of biologic products losing patent protection in the next 5-10 years is to be exploited. However, progress is painfully slow and critical issues driving the market dynamic include:

Industry investment: a sign of confidence?
This report provides a detailed analysis of 50 companies active in the biosimilars field, many of which have declared their interest in 2011. The move may reflect a growing confidence that as regulatory provision for biosimilars increases, and as the pipeline of prospective products matures, then the prospect of actually being able to launch products grows more realistic.

The US continues to disappoint; Europe forges ahead
Despite President Obama's health reform bill being passed in 2010, very little has happened. And the FDA's cautious approach suggests little will happen in the immediate future. The much anticipated Guidance, expected in 2011 has failed to appear, and in May 2011 FDA published details for User Fees - a scheme that will not come into effect (assuming it is passed by Congress) until 2013. Given that an untried regulatory system will not operate at the fastest speed then prospects of a US market for advanced biosimilars seem remote before 2015. In contrast, European regulators are revising their widely-adopted regulations in the light of experience, with a view to issuing revisions and guidance in 2012.

Developing markets may offer a profitable alternative
Developing markets with rising disposable incomes may present the medium-term prospect for biosimilars, since they combine a large target population with reduced operating costs. Many countries are following the EU model of regulation. Markets such as India and China have plenty of home-grown production capacity. Some companies have sought to turn this capacity to their advantage, and have signed deals with Chinese/Indian producers for the development of products to be sold around the world.

Global Biosimilars Market

Published:January 2012
No. of Pages: 200




The Challenge for Industry
The development of a biosimilar presents a series of challenges to traditional generic drug manufacturers seeking to enter the sector. To succeed, a company must have good financial backing. Small companies will be able to do the science, but the cost of product development and approval will generally exceed the resources of most chemical generic organisations. After this, there is the cost of marketing and post-market surveillance. There is little prospect in the EU and USA of biosimilars being sold unbranded and biosimilar developers will have to pay for the branding and the marketing of the products; a task for which many lack the funds, sales force and experience.

Corporate manoeuvring is seeing the competitive landscape change
Despite the challenges there has been an upsurge in company activity, most notably from the branded industry and from companies who have no current significant pharmaceutical interests. With the regulatory situation generally favourable to the branded industry, why are they interested?

There are three broad reasons why an originator would wish to become involved with biosimilars. Firstly, it would create a more diversified portfolio, an important consideration in an era of near-dry pipelines. Secondly, it would potentially allow for the development of expertise in the biologic area for companies which traditionally have limited involvement in biologics. Thirdly, it could potentially act as a "spoiler" operation by making the market environment more difficult for smaller biosimilar developers.

Men's Health Therapeutics Market to 2017 – Availability of Generic Sildenafil from 2012 to Restrain Market Growth

GBI Research, the leading business intelligence provider, has released its latest research Men's Health Therapeutics Market to 2017 – Availability of Generic Sildenafil from 2012 to Restrain Market Growth. The report provides in-depth analysis of drivers and barriers that impact the global men’s health therapeutics market. The report analyzes the markets for men’s health in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Treatment usage patterns, market revenue, and the annual cost of treatment (ACT) are forecast until 2017 for the key geographies, as well as the leading therapeutic segments. Furthermore, the report provides profiles of the leading companies, and analyzes the mergers and acquisitions (M&As) and licensing agreements that shape the global markets. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts. GBI Research finds that the men’s health therapeutics market will continue to grow only moderately.

Men's Health Therapeutics Market

Published:January 2012
No. of Pages: 130

GBI Research finds that the men’s health therapeutics market will continue to grow only moderately. The principal reason for this stagnancy will be the first patent expiry of a top selling blockbuster, Viagra. The overall men’s health market is driven by the launch of late-stage pipeline candidates and the steady increase in the diseased and treated population. The erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) markets constitute a major portion of the men’s health market. In 2010, these markets accounted for more than 80% of the total men’s health therapeutics market. Male hypogonadism accounted for 8.6% of the total market size. The premature ejaculation market represents a small portion of the total men’s health market. The premature ejaculation market does not have any FDA approved products in the major market geographies.

Scope

• Annualized market data for the men’s health therapeutics market from 2002 to 2010 and forecast to 2017.
• Analysis of the leading therapeutic segments, including erectile dysfunction, male hypogonadism, premature ejaculation and benign prostatic hyperplasia.
• Analysis of the men’s health therapeutics market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain and Japan.
• Market characterization of the men’s health therapeutics market, including market size, revenue analysis by top seven geographies, generic share, annual cost of treatment, a treatment flow algorithm and treatment usage patterns.
• Key drivers and restraints that have a significant impact on the market.
• Coverage of pipeline molecules in various phases of drug development.
• Competitive benchmarking of leading companies. The key companies studied in this report are Pfizer Inc., Eli Lilly and Company, GlaxoSmithKline Inc., Bayer Healthcare AG, Abbott Laboratories, Endo Pharmaceuticals Holding Inc., Johnson and Johnson, VIVUS Inc. and Auxilium Pharmaceuticals, Inc.
• Key M&A activities and licensing agreements, that have taken place in the period 2004–2011 in the global men’s health therapeutics market.

Reasons to Buy

• Align your product portfolio to the markets with the highest growth potential.
• Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth.
• Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with more efficiency and better safety.
• Develop key strategic initiatives by understanding the key focus areas of leading companies.