Vaccine boom seen in last decade, finds WHO report
This article was originally published in Scrip
The last 10 years have been the most productive in the history of vaccine development, with the vaccine market tripling since 2000, reaching more than $17 billion in global revenues by mid-2008, says a new World Health Organisation report. In addition, more infants are being immunised today than ever before.
A record 106 million children were immunised before their first birthday in 2008, however around 24 million children (almost 20% of children born each year) are still not being reached with vaccines, finds the report, State of the world's vaccines and immunisation. At least an additional $1 billion per year will be needed to ensure that new and existing vaccines will be delivered to all children in the world's 72 poorest countries.
"The vaccine industry is experiencing a new, more dynamic period," says the report. Most of the expansion comes from sales in rich countries for newer, more costly vaccines, which make up more than half of the total value of global vaccine sales.
The report attributes the surge in vaccine development to the use of innovative manufacturing technology, growing support from public-private product development partnerships, and new funding resources and mechanisms (see table 1).
move to vaccine suppliers from poorer countries
Over the last decade, there has also been an unprecedented growth in the capacity of manufacturers in developing countries (such as in India) producing traditional childhood vaccines (such as measles, pertussis, tetanus and diphtheria), with these firms now meeting 86% of the global supply in volume terms (14% in value in terms).
In contrast, in value terms, vaccine supplies are dominated by five major pharmaceutical firms (includes GSK and Sanofi-Pasteur), which make up more than 80% of global vaccine revenues, with the remainder divided by more than 40 firms in developing countries.
"The striking disparity between revenue and volume reflects the large volume of low-cost, mainly traditional vaccines produced by these developing countries suppliers, primarily for use in their own or in other low- and middle-income countries – a market that represents 84% of the world's population," the report says.
UNICEF – a signatory to the report and one of the largest procurers of vaccines in the world which bought 2.6 billion vaccine doses (at $633 million) in 2008, reaching 56% of world's children – had three Indian firms in the top six firms it procured vaccines for 2008.
The top six firms were: GlaxoSmithKline Biologicals (Belgium), followed by Berna Biotech (Switzerland), Panacea (India), Sanofi-Pasteur (France), Serum Institute of India (India) and Shantha (India), a spokesperson told Scrip.
The growth in the capacity of vaccine suppliers in developing countries in the last decade has been partly driven by purchases from UNICEF (includes purchases for the GAVI Alliance) and the Pan American Health Organization. In 2000, 39% of vaccine doses purchased by these agencies came from developing country suppliers, but by 2007 this had risen to 60%.
Over the past decade, vaccination programmes had added new and underused vaccines to the original six – diphtheria, tetanus, pertussis, measles, polio and tuberculosis – given to young children. They include vaccines against hepatitis B, Haemophilus influenza type b disease, mumps, pneumococcal disease, rotavirus, rubella, and in countries where needed, yellow fever and Japanese encephalitis.
The report notes the addition of new vaccines and new formulations since 2000, including the first conjugate vaccine against pneumococcus (which causes more than 800,000 deaths per year in children aged under five and high rates of meningitis), two new vaccines against rotavirus (which kills some 527,000 children a year as it causes severe diarrhoea), two new vaccines against HPV (believed to be a cause of cervical cancer) and the first DTP combination vaccines formulated for adolescents and adults.
More than 80 candidate vaccines are in the late stages of clinical development, with about 30 of these aimed at major diseases for which no licensed vaccines exist, such as malaria and dengue. The report also notes the difficulties in developing an HIV/AIDS vaccine, as the virus has more than a dozen genetic subtypes and up to 24 different recombinant forms.
"Big Pharma" firms involved in vaccine development do not invest in in-house basic research (this is mainly conducted by academic bodies), and are only minor players in the applied research area. "Their main role is in vaccine evaluation. They are powerful engines for the development, industrialization, registration, and marketing of vaccines, but are increasingly outsourcing some of these functions," the report says.
factors for low pricing evaporate?
The report also notes that the vaccine market has changed over the last decade, noting that "three factors conducive to low vaccine prices have evaporated" for developing countries.
In the past, rich and poor countries had been using much the same vaccines, so that firms could charge developing countries lower prices (recoup costs in differential pricing); firms tended to keep an excess production capacity for many traditional vaccines; and up to the 1980s, there were enough vaccine suppliers to sustain competition among them, which kept prices low.
However, now, no longer do rich and poor countries use the same vaccines (industrialised countries are favouring new, second-generation or new vaccine combinations, such as MMR); no longer do firms maintain excess production as newer vaccines are too costly; and there are now far fewer players in industrialised countries.
Some product development partnerships (involved in vaccine development or introduction) ? International AIDS Vaccine Initiative ? Global HIV Vaccine Enterprise ? Aeras Global TB vaccine Foundation ? European Malaria Vaccine Initiative ? GAVI-funded pneumococcal accelerated development and introduction plan ? Rotavirus Accelerated Development and Introduction Plan (RotaADIP) ? Hib Initiative ? Meningitis Vaccine Project |
New financing mechanisms ? International Finance Facility for Immunisation ($5.3 billion over a 20-year period) ? Advance Market Commitment (first pilot targets pneumococcal disease) |