Asthma drug market

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Dan Pan

Asthma is a respiratory condition in which the airways become inflammed and constrict, usually in response to one or more environmental triggers. As a serious and potentially fatal condition if left untreated, asthma can be managed by avoiding triggers and with drug therapy.

Over 300 million people suffer from asthma, which translates to a drug market worth over $15 billion. While drugs to manage asthma have existed for several decades, pharmaceutical companies have developed faster acting and more effective products over the years. GlaxoSmithKline's Advair and AstraZeneca's Symbicort are the latest generation of asthma drugs, and are poised to take over the market as older products go generic.^[1]

According to a new report published by Transparency Market Research (http://www.transparencymarketresearch.com/asthma-and-copd-market.html) In the overall Asthma and COPD market, Advair remained the market leader with USD 7,802 million in 2011 and is expected to reach USD xxxx million in 2014. Singulair is the second largest drug in terms of revenue at UD 5479 million in 2011. The patent that provides U.S. market exclusivity for Singulair will expire in August 2012. It is expected that within 2-3 years following patent expiration, it will lose substantially all U.S. sales of Singulair, with most of those declines coming in the first full year following patent expiration.

Drugmakers win from expanding market

The asthma market is currently $15 billion and is projected to reach $17 billion by 2010.^[1] The major players are:

Source: ^[2][3][4]

• GlaxoSmithKline - Advair (fluticasone/salmeterol) is the dominant drug in the market, with 2007 sales of US$6.9 billion^[2], and will likely remain the market leader in the current generation of asthma medication. It is a combination drug consisting of a corticosteroid and a long-acting beta antagonist (ICS/LABA).

• AstraZeneca - Symbicort (budesonide/formoterol) is a new asthma drug that launched in the US in mid-2007, with 2007 sales of $1.6 billion.^[3] It is also a combination drug that belongs to the same drug family as Advair (ICS/LABA), but with slightly faster action. The drug is expected to overtake Singular as the second most popular asthma drug in the next 5 years.

• Merck - Singulair (montelukast) is a leukotriene receptor antagonist that inhibits a specific inflammatory pathway. While it is less effective than ICSs, which inhibit many pathways, Merck has been able to market it in the US successfully by playing up fears of corticosteroids and promoting Singulair for use in children. Singulair is used to help maintain chronic asthma symptoms and cannot be used to treat acute asthma attacks. It is also the last branded drug for allergic rhinitis (hay fever). The drug is Merck's best-selling product, with 2007 sales of $4.3 billion, representing 18 percent of company total sales. ^[4]

Older single-therapy drugs include:

• ICSs (inhaled corticosteroids) reduce airway hyper-responsiveness and bronchial mucosal inflammation, making them useful for prophylactic therapy. Sales have stagnated with the launch of more effective combination products. ICSs that have not gone generic include AstraZeneca's Pulmicort, GlaxoSmithKline's Flovent, and Schering-Plough's Asmanex.

• LABAs (long-acting beta-2 agonists) rapidly reduces bronchoconstriction, providing fast asthma relief during an attack. However, sales have declined steadily with the arrival of more effective combination drugs such as Advair and Symbicort.

• SABAs (short-acting beta-2 agonists) are among the oldest asthma drugs that are similar to LABAs, but have shorter durations. The market is now generic. ^[1]

Health insurance companies lose from reimbursements

Health insurance companies such as Aetna (AET), UnitedHealth Group (UNH), WellPoint Health Networks (WLP), and AFLAC (AFL) may be hurt by the increased incidence of asthma because reimbursement costs will increase.

What is asthma?

Asthma describes the narrowing of airways in the lungs. Environmental triggers vary from person to person, but can include smoke, exercise, cold air, and other allergens such as dust mites, pollen, and infections. Symptoms of asthma include breathlessness, coughing, and wheezing. Over 300 million people summer from asthma, which translates to a drug market worth over $15 billion.^[1]

Why is the asthma market growing?

• Triggers - Depending on the patient, asthma may be triggered by smoke, exercise, cold air, and other allergens such as dust mites, pollen, and infections. Management of the condition centers around avoiding those triggers. Smoking and automobile emssions can greatly aggravate asthma.^[5][1] Various air filters may be used to help clean the air.

• Pollution and air quality - However, sometimes triggers cannot be avoided, such as the general air quality. There is a higher incidence of asthma in low-income populations. While it is impossible to draw a direct causal relationship, this correlation may be because low-income and ethnic populations are more likely to live near industrial areas.^[6]

• Heredity - Over 100 genes are associated with asthma, suggesting a hereditary component. However, asthma is a complex condition that cannot be determined by genetics alone.^[7]

• Maternal smoking increases asthma risk in children.^[8]

Upcoming treatments

Once-a-day combination products

Following the success of Advair and Symbicort, several new respiratory products are combination drugs. GSK and Novartis are developing new once-a-day combination products that are longer acting than drugs current on the market. The new drugs would be more convenient for patients because they only need to be taken once a day, rather than several times a day with current drugs.

• GSK is collaborating with Theravance to develop a new combination called Beyond Advair that would produce 24-hour bronchodilation with minimal side-effects. The drug has entered phase II trials, and if successful, is scheduled to take over Advair sales once its patent expires in 2011.

• Novartis is collaborating with Schering-Plough on another once-daily product that will compete directly with GSK's Beyond Advair. It is also in phase II trials, but is less developed than GSK.

Monoclonal antibodies

Monoclonal antibodies are a new class of drugs that use antibodies to bind to asthma-inducing allergens, asthma-inducing antibodies, or components of the immune system that contribute to asthma pathogenesis. Novartis and Genentech's Xolair, which targets IgE antibodies, is currently the first and only monoclonal antibody on the market. It is used to treat severe asthma, which although representing only 0.5 percent of the market, has disproportionately high costs. 2007 sales of Xolair was $472 million. Other monoclonal antibodies in development target cytokines or cytokine receptors such as IL-4, IL-5, IL-9, and IL-13.

References

1. ↑ ^{1.0 1.1 1.2 1.3} Mathon, Daniel (18 June 2007). "Asthma & COPD - Clearing the air". ING Analyst Report. 
2. ↑ ^{2.0 2.1} GSK 2007 20-F pg. 11  
3. ↑ ^{3.0 3.1} AZN 2007 20-F pg. 1  
4. ↑ ^{4.0 4.1} MRK 2007 10-K pg. 4  
5. ↑ Thomson NC, Spears M (2005). "The influence of smoking on the treatment response in patients with asthma". Curr Opin Allergy Clin Immunol 5 (1): 57–63. PMID 15643345. 
6. ↑ Patient/Public Education: Fast Facts - Asthma Demographics/Statistics. American Academy of Allergy Asthma & Immunology. Retrieved on 2006-05-02.
7. ↑ Ober C,Hoffjan S (2006). "Asthma genetics 2006: the long and winding road to gene discovery". Genes Immun 7 (2): 95-100. PMID 16395390. 
8. ↑ In Utero Exposure to Maternal Smoking Increases Asthma. Respiratory Reviews. Retrieved on 2008-06-09.

6. Asthma And COPD Drug Market http://www.transparencymarketresearch.com/asthma-and-copd-market.html