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Cytomegalovirus (CMV) Infections - Pipeline Assessment and Market Forecasts to 2019

3830.62

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Market

Healthcare and Medical

Report Type

Market Research

Country

Global

Published

25 January 2013

Number of Pages

93

Report Delivery

Email

Delivery Lead Time

1-3 hours, 24 hour max

Publisher

GlobalData

File Format

PDF

Global cytomegalovirus market: $1.1 billion industry by 2019

The global Cytomegalovirus (CMV) infections market, comprising the markets of the US, the UK, France, Germany, Italy, Spain and Japan, was worth $685.50m in 2011 and will grow at a Compound Annual Growth Rate (CAGR) of 6.29% over the next eight years to reach $1.12 billion by 2019.

The CMV prophylactic market was estimated to be worth around $423.74m in 2011 and is forecast to grow at a CAGR of 7.79% to $772.01m in 2019. The CMV therapeutic market was estimated to be worth $261.76m in 2011 and is forecast to grow at a CAGR of 3.51% to reach $344.98m in 2019. The key events that are expected to impact the market during the forecast period are:

• The genericization of Valcyte in 2013 in the US and its patent expiry in 2015 in Europe in the prophylactic and therapeutic markets
• The expiry of Vistide's patent in Europe in 2012 in the therapeutic market
• The expected launch of Cytotect (CMV hyperimmunoglobulin) in 2015 in Europe in the therapeutic market
• The expected launch of TransVax in the US and Europe in 2016 in the prophylactic market

Additional factors that will contribute to growth are the increase of the patient pool, the expected launch of a vaccine due to its novelty and premium price and the increase in the number of Bone Marrow Transplant (BMT) and Solid Organ Transplant (SOT) patients.

New Companies Poised to Enter the CMV Prophylactic Market

Roche has a strong presence in the CMV market with Valcyte, which is the only branded product for the treatment of CMV infections. The company is likely to maintain its competitive position until the genericization of Valcyte in 2013 in the US and its patent expiry in 2015 in Europe. During the forecast period the market will experience the launch of a promising vaccine, TransVax, which has shown improved clinical safety and efficacy (Vical, press release, September 13, 2010). The CMV market will see the entrance of new companies that focus on three important strategies: first, companies focusing on novel mechanisms of action beyond DNA polymerase inhibitors; second, companies targeting transplant patients; and third, companies developing prophylactic products (40% of the pipeline products are being developed for CMV prophylaxis).

These strategies are expected to provide a distinct opportunity for pharmaceutical companies to build up their commercial presence in the CMV infections market.

Strong Pipeline Candidates with Novel Mechanisms are Expected to Intensify Future Competition

GlobalData's analysis shows that the CMV development pipeline is strong, with 49 molecules in various stages of clinical development. The late-stage pipeline consists of one First-In-Class (FIC) vaccine, TransVax. TransVax is expected to enter the market within the forecast period and GlobalData expects TransVax to have a significant impact on the market landscape. TransVax is the first plasmid DNA vaccine being developed for CMV prophylaxis in both the US and Europe, and has also received orphan drug designation from the US Food and Drug Administration (FDA). It is expected to raise the barrier to entry for new marketed products, while providing a stiff competitive advantage over those currently on the market.

According to the Key Opinion Leaders (KOLs) interviewed for this report, the pipeline molecules have better efficacy and safety profiles than those currently used and their entrance into the market has the potential to change the current treatment algorithm by addressing existing safety and efficacy needs.

Untapped Market Opportunity with Weak Competition

GlobalData's analysis shows that current market competition in the CMV market is weak, as Valcyte is the only branded drug for the treatment of CMV. Valcyte is a prodrug of ganciclovir with improved bioavailability, and is considered to be efficacious and safe for the treatment of CMV patients.

Aside from Valcyte, the market is completely dominated by generics, such as ganciclovir and foscarnet. Another drug, CMV-IG, is a biologic that has been available in the US since 1992. Other drugs, such as acyclovir and valacyclovir, are used off-label for CMV infections. All these drugs have low efficacy and safety profiles, leaving an untapped opportunity for companies able to provide better drugs than the existing branded products and generics.

Unmet Need Continues to Challenge the Pipeline Drugs

GlobalData's analysis indicates that the unmet need in the CMV prophylactics and therapeutics markets is significant, as the currently used treatment options are associated with adverse events such as myelosuppression and renal toxicity. They also have black-box warnings on their labels. Therefore, safety is a major concern in both the prophylactic and therapeutic markets. Efficacy is an unmet need, primarily in the prophylactic market, and viral resistance to the current drugs is a limitation for the therapeutic markets. There remains ample opportunity for new molecules with novel mechanisms of action and new entrants targeting transplant patients as they are at a high risk of developing CMV. This analysis is represented below for the prophylactic and therapeutic markets in below mentioned figures respectively.

Report Overview

This report is an essential source of information and analysis on the global Cytomegalovirus (CMV) Infections Therapeutics market. The report identifies the key trends shaping and driving the global Cytomegalovirus (CMV) Infections 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 current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global Cytomegalovirus (CMV) Infections Therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by our team of industry experts.

Scope

- Annualized seven key markets (US, France, Germany, Italy, Spain, UK and Japan) Cytomegalovirus (CMV) Infections Therapeutics market revenues data from 2006 to 2011, forecast for eight years to 2019.
- Pipeline analysis data providing a split across the different phases, mechanisms of action being developed and emerging trends by seven key markets. Pipeline candidates fall under major therapeutic classes.
- Analysis of the current and future competition in the seven key countries Cytomegalovirus (CMV) Infections Therapeutics market.
- Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide a qualitative analysis of its implications.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs and the implications for the Cytomegalovirus (CMV) Infections Therapeutics market.
- Analysis of key recent licensing and partnership agreements in Cytomegalovirus (CMV) Infections Therapeutics market.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global Cytomegalovirus (CMV) Infections Therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments and companies likely to impact the global Cytomegalovirus (CMV) Infections Therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- What's the next big thing in the global Cytomegalovirus (CMV) Infections Therapeutics market landscape? Identify, understand and capitalize.

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Select License Type

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Electronic License

An electronic version (mostly PDF, but can be Excel or PPT), which is either available for immediate download or will be sent via email by the Publisher of the report. The licencing for an electronic version is for use by the purchaser ONLY.

Site License

Site License

An electronic version (mostly PDF, but can be Excel or PPT). Where the report(s) is intended for use by more than one individual, across for example, a site, an office, or a division or country.

Corporate License

Corporate License

An electronic version (mostly PDF, but can be Excel or PPT). Where the report(s) is/are intended for use by an organisation in its entirety. For example, if reports are put on an Intranet or if they are distributed or used by more than one office, division, or country operation, then a Corporate Licence is required.

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