Therapeutic bronchoscopy is now expanding its reach to address the needs of vast and previously untapped patient populations—the millions suffering from emphysema and asthma—via new devices both on the market and currently under development. Once they become widely available, these devices have the potential to generate high market revenues; the start-up companies launching these innovative devices may thus prove attractive as acquisition or expansion targets for larger endoscopy companies. Because the number of trained bronchoscopists in the US is small, demand for these procedures will initially outstrip their availability. Nevertheless, with growing numbers of medical students specializing in interventional pulmonology, access to procedures will grow in the long term.

Two devices expected to impact market revenues include white light bronchoscopes and endomicroscopy lung probe systems. Although negatively impacted by the 2009 economic downturn, white-light bronchoscopes unit sales are expected to recover in 2010 and will grow with rising demand for interventional bronchoscopy treatments, which in turn is growing due to the expansion of the over-65 population in the US. Even during the 2008/2009 recession, the market generated more than $35 million in sales; this number will grow to almost $50 million by 2013. In the coming years, increased types and volumes of diagnostic and therapeutic applications will make use of flexible bronchoscopes, including the placement of metal stents, biopsies, foreign body removals, endomicroscopy, hemostasis procedures, and the deployment of emerging technologies used to treat a range of conditions, including emphysema. New technologies such as Mauna Kea’s Cellvizio LUNG probe system, launched in 2006, enable real-time diagnosis of lesions at the cellular level; this device can be used in any flexible bronchoscope and is appropriate for use in many indications. As the only device of its kind on the market, the Cellvizio LUNG probe system will have an early advantage as more therapeutic devices enter the market and diagnoses and treatments can occur in the same procedure. 

Disease-specific therapeutic devices are the newest addition to bronchoscopists’ portfolios. In particular, devices designed to treat lung conditions such as emphysema and asthma will be a key focus in the next five to seven years. Currently, there are only two treatment options for emphysema: oxygen therapy, which is inconvenient as patients must be attached to an oxygen tank; and open surgical procedures such as lung volume reduction surgery and lung transplants, both of which are risky and highly invasive. Over 3 million emphysema sufferers in the US could benefit from treatment, inspiring a number of companies to develop minimally invasive alternatives that will fuel patient demand. Among the new technologies currently under development are Broncus Technologies’ Exhale Stent, Spiration’s IBV Valve System, Aeris Therapeutics’ AeriSeal System for Lung Volume Reduction, Pulmonx’ Chartis endobronchial catheter system (used in the diagnosis of emphysema), and Uptake Medical’s Bronchoscopic Thermal Vapor Ablation System. Of the five, Broncus’ and Spiration’s devices are at the most advanced stage of development (phase III clinical trials). Broncus Technologies’s Exhale Stent is a drug-eluting stent designed to be placed in the walls of the bronchi to allow trapped air to exit via the bronchial tree. Spiration’s IBV Valve System’s one-way valves fit in the bronchi and block air from entering diseased areas of lungs, while allowing secretions and trapped air to exit peripheral lung tissue; the valves are designed to be easily removed if necessary. Once on the market, these devices will be the only available minimally invasive emphysema treatments, and as such, they have the potential to garner significant sales.

In 2008, there were almost 13 million diagnosed asthma cases in the US, according to Decision Resources’ Pharmacor. Currently, only pharmaceutical treatments and lifestyle adjustments are used to control asthma symptoms. Asthmatx’s Alair Bronchial Thermoplasty System, which was recommended for approval (with conditions) by the FDA in October 2009, reduces the asthma spasm-prone smooth muscle in a patient’s airway using a radiofrequency probe. Data from clinical trials so far find statistically significant improvements in breathing, reductions in medication, and higher qualities of life for asthmatics who received this treatment. The substantial patient base amenable to treatment with the Alair will prove lucrative for Asthmatx given that the company has the only device of its kind on the market.

Although therapeutic bronchoscopy looks set to expand rapidly, a lack of physician training will dampen growth somewhat. In the coming years, the number of physicians skilled in bronchoscopy will increase, but it will not be enough to meet growing patient demand. Procedures employing rigid bronchoscopy, such as stent placement, as well as image-guided surgery in the lungs, will be particularly limited by the shortage of trained physicians, since these techniques are complex and require intensive training and specialized equipment. Nevertheless, as patient demand grows and technological innovations are released, physicians will become increasingly familiar with new bronchoscopy procedures through greater residency training, workshops, and marketing efforts on the part of device manufacturers. IQ