Snapshot H1N1 (swine influenza) – the post-pandemic pipeline

Few modern pandemics created as much global furore as the H1N1 swine flu outbreak which struck in 2008. The scale and spread of the outbreak created a very real sense of fear about mutating virus strains and created a boom for a new pipeline of vaccines and antivirals. Using detailed market data, we find out what the future holds for the industry in this post-pandemic period.


In August 2010, World Health Organisation (WHO) Director-General Dr Margaret Chan announced that the H1N1 influenza virus had moved into the post-pandemic period.

The Director-General was quick to point out, however, that as we enter the post-pandemic period, it does not mean the H1N1 virus has gone away.

Based on experience with past pandemics, the WHO expects the H1N1 virus to take on the behaviour of seasonal influenza viruses and continue to circulate for years to come.

The virus, which had never before resulted in human infection, was first reported in Mexico in April 2009 and has, by official estimates, claimed the lives of 18,000 people worldwide.

The new influenza virus spread rapidly around the world and by the time the WHO declared a pandemic in June 2009, a total of 74 countries and territories had reported laboratory confirmed infections. To date, most countries in the world have confirmed infections from the new virus.

While reactions to the virus - labelled as excessive to the point of scare mongering by some sections of society - will be assessed for some time, plaudits have been given for the rapid deployment of antivirals and vaccines, most notably in the US and UK.

Using detailed data from the GlobalData report H1N1 (Swine Influenza) - Pipeline Assessment and Market Forecasts to 2017, we discover just how likely the drug pipeline is to develop in the post-pandemic period.

The nature of H1N1 virus strains

"The virus, which had never before resulted in human infection, was first reported in Mexico in April 2009."

Influenza (flu) is caused by RNA (ribonucleic acid) viruses that infect the respiratory tract. Compared to most other respiratory infections, such as common colds, influenza often causes more severe illnesses.

Typical symptoms for influenza include fever and respiratory symptoms such as coughing, a sore throat, a runny or stuffy nose, headaches, muscle aches and extreme fatigue.

Most people who get flu recover completely in one or two weeks, but some people develop serious and potentially life-threatening medical complications, such as pneumonia.

Flu-related complications can occur at any age; however, the elderly and people with chronic health problems are more likely to develop serious complications from flu than younger, healthier people.

There are two types of influenza based on the epidemiology, seasonal and pandemic. Regular outbreaks of seasonal influenza are associated with winter and autumn seasons in temperate regions of the world.

In some tropical countries, seasonal influenza viruses circulate throughout the year, with one or two peaks during rainy seasons. In contrast, pandemic influenza outbreaks are irregular and on a global level.

H1N1 (swine influenza), also called swine flu, is caused by the type A influenza virus. It is a respiratory disease in pigs but it can be transmitted from pigs to humans who are in close contact with the animals. The incidence of swine flu was quite low until January 2009 with only 11 confirmed cases of the illness in the US, but in March 2009 an outbreak occurred in Mexico which spread to parts of the US and Europe. As the virus spread from one country to another, the World Health Organization (WHO) raised the pandemic alert from phase five to six.

Various antivirals have been recommended for the treatment or chemoprophylaxis of influenza. The major ones are relenza (zanamivir) and tamiflu (oseltamivir), which are effective against influenza A and influenza B.

These influenza antivirals reduce the risk of influenza-related complications, the major one being death. These antivirals have a high level of safety and efficacy and because of this are the most prescribed antivirals for H1N1 virus infection.

H1N1 (swine influenza) therapeutics markets are forecast to decline until 2017

GlobalData estimated the H1N1 (swine influenza) therapeutics market was worth $6,777m in 2010 and grew at a CAGR of 19% from 2005 to 2010. The growth was due to the pandemic (H1N1) in April 2009, a type of influenza that spread rapidly among humans after its emergence.

The virus has genes from bird, pig and human influenza viruses. GlobalData expects the H1N1 (swine influenza) therapeutics market to decline at a Compound Annual Growth Rate (CAGR) of 4% from $6,777m in 2010 to $4,960m in 2017.

"There are two types of influenza based on the epidemiology, seasonal and pandemic."

The negative growth is primarily due to the fact that the pandemic has moved into the post-pandemic stage. In addition, the expiration of major drug patents, namely relenza in 2013 and tamiflu in 2016, are also going to have a negative impact on the growth of this market.

The global H1N1 (swine influenza) therapeutics market is primarily based on the various vaccines and antivirals available. There are two major antivirals that are being prescribed for swine influenza, which are tamiflu (oseltamivir) and relenza (zanamivir).

There are a number of vaccines also available such as fluzone, fluvirin, flumist and afluria.

The US is the largest market for H1N1 therapeutics. The US H1N1 (swine influenza) therapeutics market was valued at $4,207m in 2010. Between 2005 and 2010, the US H1N1 (swine influenza) therapeutics market grew at a CAGR of 26%.

Current vaccination and antiviral options are highly successful

GlobalData found that products currently on the market are highly efficacious in providing protection against the disease with few side-effects. All of the marketed products provide high seroprotection rates and seroconversion rates against the disease.

The key products like fluzone, fluvirin, afluria and flumist are able to satisfy the demand in the H1N1 swine influenza vaccines market. The key products, tamiflu (oseltamivir) and relenza (zanamivir), are also able to satisfy the demand in the H1N1 swine influenza market.

Unmet needs in the H1N1 are moderate

The H1N1 swine influenza therapeutics market has moderate unmet needs as the market is well served by current prophylactic and therapeutic product options. This leaves scope for new entrants to capture value from under-served segments. The new products have to aim at gaining market share by providing unique offerings. The likely untapped area is the availability of products with novel mechanisms of action.

Weak pipeline candidates significantly impact the H1N1 therapeutics market

GlobalData analysis shows the H1N1 (swine influenza) therapeutics market pipeline is weak, with approximately 22 molecules in various phases of clinical development, including five first-in-class (FIC) molecules. These FIC molecules are in the early stages of clinical development, so their impact on the current market will be later in the future. In the case of vaccines, most of the late stage pipeline vaccines do not have novel mechanisms of action except for a single molecule which is in the early stage of development. As a result, the pipeline for the H1N1 (swine influenza) therapeutics market is weak.


For more details on the full GlobalData report click here:

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