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European Biopharmaceutical Review

Biologics in Autoimmune Diseases: Strategies for Success

Outstripped only by oncology, this growth is driven by the increasing use of currently available biologic products across multiple disease indications and the launch of new biologics on the market (see Figure 1) (see Notes).

The treatment of autoimmune diseases has historically involved a blanket suppression of the immune system coupled with steroids to reduce inflammation. However, since autoimmune diseases persist throughout an individual’s life, these treatments can result in damaging long-term consequences. Innovators therefore developed biologic products targeting single mechanisms within the immune system and inflammatory cascade, such as tumour necrosis factor (TNF) and B-cell receptors. The term ‘biologic’ reflects the protein-based nature of these products, and applies to both therapeutic proteins and monoclonal antibodies.

The targeted approach has been very effective for several autoimmune diseases. A decade ago multiple sclerosis (MS) and rheumatoid arthritis (RA) were poorly controlled, but disease modification is now possible. The growth in the number of available biologic treatments for autoimmune diseases, combined with their high price has led to a profitable market – Datamonitor expects total sales to reach almost $18 billion in 2008 across the seven major markets (see Notes).

This article focuses on launch and marketing strategies used in the biologic autoimmune market, including increasing target populations, differentiation from competitors, and innovation.

INCREASE PATIENT POPULATION IN THREE KEY DIRECTIONS

Once a drug has an initial approval in any autoimmune disease, there are several ways to increase the targeted patient population. In the biologic autoimmune market, companies often pursue additional approvals for early disease stages, different subsets of a disease, or completely new autoimmune disease indications.


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Lisette Oversteegen joined Datamonitor in October 2005 and has since focused on the field of infectious and respiratory diseases, including HIV, respiratory syncytial virus, asthma, COPD, allergic rhinitis and cystic fibrosis. She is now a Senior Analyst in the infectious diseases and respiratory team, and authors market analyses in other fields as well. Prior to Datamonitor, Lisette completed a Master’s in Public Health at Maastricht University, The Netherlands, specialising in work and health, and a BA in Occupational Therapy at Amsterdam University, The Netherlands.

Clare Davies is a Lead Analyst at Datamonitor, overseeing the immunology and inflammation disease portfolio, and has worked in this area for five years. Clare has knowledge of a range of inflammatory diseases, covering dermatology, rheumatology and gastroenterology, allowing effective commercial analysis of treatments covering multiple indications. Her projects have included key autoimmune disease areas such as RA and psoriasis, and she has presented at industry conferences. Clare has a Masters degree in Biochemical Engineering from University College London.

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Lisette Oversteegen
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Clare Davies
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