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Blog
MIDAS Sales by Disease Insight Series #6
Respiratory treatment landscape overview
Alexandra Smith, Senior Consultant, European Thought Leadership
Oct 22, 2021
  • Blogs
  • MIDAS Sales by Disease Insight Series #6

Introduction

Broadly defined as treatments for the two major respiratory indications, asthma and chronic obstructive pulmonary disease (COPD), the respiratory market is one of largest therapy areas in the world, ranking fourth across the top 7 developed markets (US, Japan, EU4+UK) and valued at over $39 Billion dollars . Traditionally, these diseases have predominantly been treated with small molecule agents, delivered through inhalation. More recently though, the entrance of biologic agents to treat respiratory conditions has spurred a wave of innovation and novel agents entering the market.

As prescriptions for asthma and COPD tend to go through the same doctors, one key question that companies operating in this space have is how their products are used across the different indications and, importantly, which indications are driving their performance. Figure 1, below, uses IQVIA’s MIDAS Sales by Disease data to show how these trends have evolved in recent years for both small molecule agents and biologic molecules.

In the small molecule space, we see that since 2018, the share of sales derived from COPD has grown and as of 2021, asthma and COPD contribute equally to total sales in value terms. The contributions from two other respiratory indications treated by inhaled small molecule agents, bronchospasm and seasonal allergic rhinitis, are negligible.

For biologic molecules, the vast majority of sales come from asthma, with two smaller indications, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis, contribute a small but growing share of sales. This is a direct result of the indications in which these molecules are approved – while several biologics are under investigation for the treatment of COPD, none have been approved as yet.

Small molecules

The treatment of respiratory conditions typically relies on two main types of medication:

  • Long-acting agents taken at regular intervals to control chronic conditions and prevent attacks – these include bronchodilators such as long-acting beta agonists (LABA) or long-acting muscarinic antagonists (LAMA – also known as anticholinergics), as well as inhaled corticosteroids (ICS).
  • Short-acting agents taken as needed for short-term, rapid relief of symptoms – these include short-acting beta agonists (SABA) and short-acting muscarinic antagonists (SAMA).

Since the introduction of so-called “ultra-LABAs” around a decade ago (these need only be taken once a day, as opposed to every 12 hours), there has been little innovation in the way of new classes of small molecule agents. The majority of the innovation in this space has been focused on the development of fixed-dose combination therapies for long-acting agents, combining either two types of molecules (most commonly LABA + ICS or LABA + LAMA), or more recently all three (commonly referred to as triple therapies).

As shown in Figure 2, these recently launched triple therapies are rapidly gaining share, and now contribute 10% of sales and almost all value growth. Overall growth for respiratory small molecules has been relatively flat however, as older molecules contend with loss of exclusivity and monotherapies and dual combinations are replaced with newer classes and triple combinations.

Different classes and types of combinations are used differently to treat asthma and COPD. Plain Inhaled corticosteroids are predominantly used for asthma, as are dual ICS+LABA combinations (Figure 3). Anticholinergics (or LAMA) on the other had are mostly used for COPD, both in monotherapies and in combinations. Again, approvals play a role in this distribution; while several triple therapies have now been approved for asthma as well as COPD, this has only been the case since 2020.

This distribution accounts for the growing value share of COPD seen in Figure 1, the newest, most innovative triple therapies having been approved only for COPD until recently.

Biologics

Biologic agents represent the most significant step change in the treatment of respiratory conditions in recent years. The first of these to launch was Xolair (omalizumab), an anti-IgE antibody which came to market in 2003. Over 10 years later, a new generation of respiratory biologics have entered the market, the IL (interleukin) inhibitors.

There are currently four IL inhibitors on the market for respiratory indications: GSK’s Nucala (launched 2015), Teva’s Cinqair (launched 2016), AZ’s Fasenra (launched 2017), and Sanofi’s Dupixent (launched 2018 for asthma). The first 3 of these (Nucala, Cinqair, Fasenra) are monoclonal antibodies targeting IL-5 which plays a crucial role in the development and release of eosinophils from the bone marrow, and in their activation, while Dupixent targets the IL-4/13 signalling pathway.

An indication-level breakdown of sales is particularly important when looking at the sales of respiratory biologics as 3 of the 5 products approved for respiratory indication are also approved for the treatment of certain autoimmune conditions. Dupixent is approved for atopic dermatitis, Xolair for chronic urticaria, and Nucala for hypereosinophilic syndrome. As seen in Figure 4, in the case of Dupixent and Xolair, these non-respiratory indications contribute a significant share of sales.

Within the respiratory indications, sales are predominantly driven by asthma. Dupixent and Nucala are the notable exceptions, with ~30% of their volume use coming from chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis respectively. Xolair was also approved by the FDA for chronic rhinosinusitis with nasal polyps at the end of 2020. As yet, less than 1% of Xolair volume sales come from this indication but it is likely this will grow in the coming years.

Due to their mechanism of action, IL-inhibitors lend themselves to a broad range of conditions and so all of those currently marketed for respiratory indications are under investigation for additional indications (both respiratory and auto-immune). Importantly, most of these are in late-stage development for COPD which, if successful, will open up a large and currently un-tapped segment of the respiratory market to biologics.

However, as COPD is typically a result of lung-damage caused by smoking, it is possible that these immunosuppressive therapies will not impact as broadly as they have in asthma.

Nevertheless, one this is certain: the treatment landscape in respiratory will only become more complex going forward and understanding disease dynamics within these different classes of therapeutics will be more important than ever.

To learn more about IQVIA MIDAS Sales by Disease, Click here.

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