Wayne Pisano of sanofi-aventis' vaccines division explains to IMS his views on the potential of the reinvigorated vaccines market...
In April 2007, IMS Companies interviewed Wayne Pisano, Senior VP Commercial Operations & Corporate Strategy, sanofi pasteur (the vaccines division of sanofi-aventis). He discusses the general outlook for the vaccines industry amid renewed interest in the area thanks to the launch of innovative new vaccines and continuing concerns about a possible flu pandemic.
IMS: What do you see as being the main drivers of vaccines market growth?
Wayne Pisano: "I expect the vaccines market to double or even triple over the next 10 years due to a number of factors, notably: the introduction of new vaccines such as the cervical cancer vaccines – at maturity, these vaccines should have combined peak annual sales of $2.5-4 billion; a tripling in size of the flu market worldwide – the flu market in the US alone will double in size; and the third area of growth will come from meningitis vaccines – Menactra reported sales of $300 million in the USA alone during 2006 – it is currently indicated in the USA for people between the ages of 11 and 55 and we expect an approval for the 2–10 year age group during the second half of 2007. sanofi pasteur is building a new manufacturing plant in the USA to meet the demand for Menactra which should be operational between 2009–2010.
"Regarding the flu market in the USA, the market has been restricted because of lack of capacity. The CDC has broad immunization objectives to immunize 45-55% of the population by 2010 as part of their 'Healthy People 2010' campaign. While the industry cannot fulfil this objective today, it will have the production capacity by 2010 to meet this goal. The growth of flu immunisation will also be tremendous in Latin America – for example we anticipate the market in Mexico to grow three-fold by 2012, and we are making the investments in our production capacity to satisfy this market.
"So, to recap, Menactra will potentially be a $1 billion+ vaccine within the 2010–2012 timeframe as will also sanofi pasteur's flu business (Fluzone/Vaxigrip)."
IMS: Are there any other factors that might be responsible for vaccine growth?
WP: "Increasing immunization uptake in Asia Pacific/Latin America. In developed countries for example the flu immunization rate is about 25-35% of the population and the paediatric immunization rates are approaching 90% of the population. In much of Asia Pacific/Latin America immunization rates are considerably less. The growth of the latter regions will drive the industry. The vaccines business will also be driven by the increase in manufacturing capacity to meet the increase in growth – sanofi pasteur is very focused on expanding manufacturing capacity."
IMS: During the sanofi-aventis results meeting in Paris in February 2007, you mentioned that less than 2% of the Chinese population is vaccinated for influenza. Over what period of time do you see that figure increasing and to what magnitude?
WP: "We expect flu vaccine penetration in China to increase from the current 2%, to 15-20%, equivalent to 200 million people, over the next 10 years. sanofi pasteur is committed to building a manufacturing capacity in China and we have already initiated plans to build a bulk manufacturing plant for flu vaccine in Shenzhen. This new facility will allow sanofi pasteur to produce approximately 25% of the future flu vaccine demand projected for China."
IMS: The big companies would appear to be focusing on a narrow spectrum of diseases, whereas the most significant infectious diseases, notably malaria, tuberculosis and HIV/AIDS, would appear to receive very little focus – your response?
WP: "The reason we do not have vaccines for HIV, TB and malaria is that today's technology simply does not work in preventing these diseases – they will require a scientific breakthrough – this won't happen with today's technology. The 'big five' [sanofi pasteur, GlaxoSmithKline, Merck & Co, Wyeth and Novartis] are all working with universities and scientific institutions with the goal of developing the technology that will result in vaccines for these three major diseases."
IMS: Do you think government attitudes to vaccines are changing in a positive way that might foster innovation?
WP: "Trying to get appropriate reimbursement has historically been very difficult. As governments are increasingly struggling however with healthcare costs, they are viewing prevention as a good solution to spiralling expenditures. A good example is Adacel. This is an adolescent and adult booster containing three vaccines: diphtheria, tetanus and acellular pertussis. Adacel was launched in the USA in 2005, as it was recognised that the majority of pertussis in newborns is the result of direct contact with infected adults. By immunizing adolescents and adults we are preventing transmission to newborns and saving infant lives and healthcare costs. We are now witnessing increasing reimbursement for vaccines and this, together with funding from NGOs, is fuelling growth in the vaccine industry.
"In the area of meningitis, there is an increasing awareness of the vulnerability of newborns and those infants aged up to two years of age to this infection and of the likelihood of a resurgence in adolescents aged 16-18. Better awareness of the disease, coupled with pharmaco-economic analysis, has helped in raising reimbursement rates. Governments have also been alerted to the vulnerability of children and adolescents to flu and have begun expanding the recommendations and reimbursement for influenza immunisation as well.
"With reimbursement improving, there still remains a big challenge to motivate healthy adults to be immunised. Healthy adults tend not be overly worried about illness and often have such busy lives that finding time to see a healthcare provider is a challenge. It will require a huge investment in sales and marketing efforts to motivate this group to be immunised."
IMS: Might the US go the way of Europe in terms of offering a 'quick-fix' regulatory approach akin to Article 58 (whereby products are licensed for export only and not for use inside the EU, thus speeding vaccine availability in developing countries)?
WP: "The FDA has actually increased its requirements for licensure – the numbers of patients required for safety studies has increased about 10-20 fold over the past decade. The FDA licenses products for use solely in the USA, whereas in Europe, products can be licensed for export only. sanofi pasteur however maintains a standardised approach to producing vaccines to the highest quality worldwide, regardless of whether they are intended for the developing countries, or within the EU and North America."
IMS: Would you agree with the opinion that because the US is the single largest market for vaccines, insurance and Medicare vaccine reimbursement policies in the USA can define vaccine availability for the rest of the world?
WP: "High reimbursement in the USA has certainly helped determine what products are developed. However, access to vaccines is also strongly linked into production capacity – manufacturing capacity and the inherent production challenges associated with biologics are the biggest hurdles to vaccine development currently. Hand-in-hand with manufacturing capacity in terms of deciding vaccine availability, is an individual government's willingness to acknowledge the epidemiology of a disease and then the willingness to pay to prevent the disease – governments in the USA and Europe acknowledge a broader range of diseases than those in developing countries, and have the means to pay for prevention."
IMS: In order for governments to purchase a vaccine, its effect on the burden of a specific disease must be accurately estimated. Has sanofi pasteur any policies in place to attempt this with respect to its flu/polio vaccines?
WP: "In terms of flu, our models all support the cost effectiveness theory, especially in high risk groups such as the elderly and the paediatric population. With respect to polio, the move has been from oral to the more effective and safer inactivated polio vaccine (IPV). The latter however is more expensive than the oral version – one shot of IPV costs $2-3 versus 10-20 cents for oral polio. In an effort to keep prices down, in particular administration costs, the move has been towards combination vaccines – Pentaxim for example combines Hib, IPV, acellular pertussis, diphtheria and tetanus into one vaccine. Mexico is the first country outside of North America/Europe to move to a combined acellular pertussis/IPV product. Pentaxim represents a big shift in terms of vaccine acceptance and strategy for the Mexican government."
IMS: What is the sanofi pasteur business model? Is it akin for example to the GlaxoSmithKline one, whereby the vaccine unit is relatively small and autonomous from the rest of the group?
WP: "sanofi pasteur has strong linkages into sanofi-aventis, but in terms of R&D and commercial operations, sanofi pasteur has autonomy. Being part of sanofi-aventis has been very good for sanofi pasteur, especially from the manufacturing aspect. sanofi-aventis has made a huge commitment to reinvest in sanofi pasteur's manufacturing capacity. Infrastructure costs tend to be huge in this area – it is a challenge to build facilities while simultaneously meeting the current GMP requirements with the older facilities. sanofi pasteur is moving towards dedicated manufacturing facilities, whereby only one type of vaccine is produced per facility which virtually eliminates any cross contamination fears."
The full transcript of this interview will be available in the May 2007 IMS Company Profile on sanofi-aventis, where Wayne Pisano also discusses with IMS’ Executive Editor Dr Nora McCarthy the prospects for Gardasil, the cervical cancer vaccine that is being marketed in Europe by sanofi pasteur's joint venture with Merck & Co.
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Copyright IMS Health, 30th April 2007