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December 01, 2009 (Vol. 29, No. 21)

H1N1 Boosts Development in Pharma Sector

Many Factors, Chief Among Them a Potential Pandemic, Are Fueling Vaccine Resurgence

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    Rod Raynovich

    The potential H1N1 pandemic has drawn renewed interest in vaccines. Over the last 100-plus years, vaccines have been one of the most important agents for controlling infectious disease. From a commercial standpoint, however, vaccines have been a low growth business due to safety risks, low prices, and ancient technology that is prone to frequent failure. The production difficulties have become more apparent with the current pandemic flu emergency and widespread shortages of H1N1 vaccine.

    It is widely believed that vaccines are one of the most effective public health interventions. The Bill and Melinda Gates Foundation has been funding vaccine research since 1998 and has committed $2 billion through 2009. The foundation focuses on malaria, tuberculosis (TB), and HIV and has a goal of preventing four million deaths per year. More than 200 million children have been immunized since the foundation’s inception.

    Several bullish vaccine forecasts have been published recently. According to a report from Kalorama in June, global sales of $9.9 billion were recorded in 2008 for pediatric vaccines with growth forecasted at 16.3% annually through 2013, when the market is expected to reach $21.1 billion. Among the new pediatric products that will drive sales growth are hepatitis, MMR, combination, and pneumococcal vaccines.

    The worldwide market for adult vaccines was $9.2 billion in 2008, it is growing at 14% and is anticipated to reach $17.8 billion in 2013. New product growth is expected to come from HPV, influenza, pneumococcal, and hepatitis vaccines. While Kalorama believes in the growth model it has lingering concerns about product safety, supply shortages, and consumers’ reluctance to immunize.

    Seasonal flu sales for 2008/2009 are expected to be in the $2.8 billion range,  growing to around $5 billion by 2018/2019. According to VisionGain, the period of 2008–2013 will be one of the fastest growing times for the pharmaceutical market.

    Scienta Advisors forecasts 12% annual growth from 2008 through 2014, with growth of 8% in the viral vaccine sector and 10% growth in the pediatric bacterial vaccine sector. Scienta cites new trends in the market such as fewer competitors and product innovation that translates to higher volume and margins for leaders.

  • Major Players

    GlaxoSmithKline (GSK), Novartis, and AstraZeneca have all recently made major investments in vaccine products and technology. The Wall Street Journal reported that GSK has invested more than $3.2 billion in R&D, acquisitions, and manufacturing. GSK is also the leading developer of adjuvants. The company markets over 25 vaccines worldwide and has a broad pipeline that contains over 20 vaccines for pediatric and adult diseases.

    AstraZeneca bought vaccine innovator MedImmune two years ago and is now selling FluMist® nasal spray products for seasonal flu A+B. MedImmune also markets a respiratory syncytial virus (RSV) vaccine. In addition, AstraZeneca has a number of collaborations with smaller companies. 

    Novartis has a contract to supply 90 million doses of H1N1 vaccine to the U.S. government. It recently switched from multidose to single-dose vials due to U.S. consumer concern about the use of trace amounts of thimerosal. Novartis is aggressively moving to cell-based manufacturing technology for future vaccines and is forecasting over $500 million in sales for the fourth quarter.

    Sanofi-aventis expects H1N1 sales of about $500 million in the fourth quarter and believes that its product can be effectively delivered in just one dose.

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