Respiratory market opportunity
Respiratory disease affects a significant portion of the population globally. Asthma and COPD alone affect over 480m patients1,2. Further, specialist disease segments with smaller populations often have high unmet needs for new therapeutic treatments. There are high barriers to entry for companies focused on delivering molecules to the lungs. However, Vectura’s capabilities, expertise and experience position the Company to have a significant impact on patients’ lives with new, reformulated or generic therapies.
Asthma affects over 230m people worldwide1 but despite being such a common disease, there are still areas of high unmet need that are the focus of future research:
- Children have few approved treatment options compared to adults. Our VR647 (US) programme has the potential to provide a new therapeutic option in this patient population.
- Many patients with moderate/severe asthma cannot be controlled with current therapy and new approaches are needed. QVM149 in Phase III trials for asthma may help meet this need.
- Compliance with existing therapies remains a significant challenge and the need for easier to use and more convenient devices is high. Vectura’s device expertise can make a significant contribution to meeting this need.
Chronic obstructive pulmonary disease (COPD) affects over 250m people worldwide2 but currently does not have therapeutic options that treat the underlying disease. Unmet needs driving new research in COPD include:
- Improving the management of symptoms to allow patients to continue with their day-to-day lives; and
- As with asthma, improving convenience of devices to drive better compliance, where Vectura’s device expertise can have a real impact.
There are a significant number of clinical inhalation programmes ongoing, with >220 projects in inhalable medicines in the pipeline globally. This reflects the steady demand for new therapies to address growing unmet medical need. It is predominantly small- and medium‑sized pharmaceutical companies (~80%) driving this innovation, even beyond the pre-clinical phase.
In the major therapeutic classes, LABA/ICS combination treatments continue to be a mainstay of treatment with significant volumes globally. Volumes continue to grow, even as generics and competition impact the total market value.
Vectura products: flutiform® (Mundipharma Int., Kyorin)
Dual LABA/LAMA bronchodilators like Novartis’ Ultibro®/Utibron™ continue to drive significant growth in the COPD market. The LAMA class meanwhile is seeing some erosion as its use is replaced by combination therapies.
Vectura products: Ultibro®/Utibron™ and Seebri® (Novartis)
Following approvals in COPD and strong initial growth for the class, triple combinations of LABA/LAMA/ICS are expected to enter the asthma market over the next 12–24 months.
Vectura pipeline products: QVM149 (Novartis)
Biologic therapies remain a small but valuable class of treatments for certain subsets of patients and this class is expected to continue to grow.
In the US, inhaled generic prescription share is only 21%, compared to 87% in other delivery formulations, given the complexity of developing substitutable inhaled products. While price competition has had some impact on branded products in the US, prices are still much higher compared to Europe.
Vectura is well positioned to take advantage of this with VR315 partnered with Hikma, and there are few competitors like us with the proven inhalation capabilities to target this significant and largely untapped market.
Vectura pipeline products: VR315 (Hikma), VR2081 (Sandoz), generic GSK Ellipta® programme in development with Hikma.
In Europe and the rest of the world, generics and analogue products are an important therapeutic option. Demographic trends in the rest of the world in particular are a strong driver for future opportunity.
Vectura products: AirFluSal® Forspiro® (Sandoz).
While the ICS/LABA class is key to medium-term growth in generics, there is significant longer-term potential in LAMA, LABA/LAMA and triple therapies. Our partnership programme with Hikma, announced this year, will position Vectura to participate in these valuable markets.
Vectura pipeline products: generic GSK Ellipta® programme in development with Hikma.
2017 US generic prescription share %
- All other formulas - 87%
- Inhalants - 21%
While the ICS/LABA class is key to medium-term growth in generics, there is significant longer-term potential in LAMA, LABA/LAMA and triple therapies.
People with rare, orphan and specialist respiratory diseases have high unmet needs and often few therapeutic options. Specialist markets are expected to grow significantly as disease understanding improves and new treatments are developed.
Although patient populations are smaller compared with asthma and COPD, competition may be less intense, and there is significant commercial opportunity for effective therapies. A global market worth $10bn in 2018 is expected to grow considerably in the years ahead, reaching $20bn by 2027.
The specialist disease segment is well suited to nebulised therapy to better target the lung and avoid unwanted systemic effects and drug/drug interactions. The nebuliser device market is currently worth c.$730m.
Asthma is a chronic lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath, and coughing.
The total asthma market is projected to grow from $17.6bn in 2018 to $20.5bn in 2027
COPD describes progressive lung diseases, including emphysema and chronic bronchitis, which cause increasing breathlessness and severely impacts people’s lives.
There is significant room for improvement in diagnosis and treatment in both developed and developing markets.
The total COPD market is projected to grow from $16.9bn in 2018 to $22.0bn in 2027
Cystic fibrosis (CF) is a rare, progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time.
In people with CF, mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene cause the CFTR protein to become dysfunctional. The CFTR protein controls the movement of salt ions across the epithelium of cells.
In the lungs, the defective ion transport causes accumulation of thick mucus and an inability to clear the secretions. This leads to inflammation, airway obstruction and chronic infection, ultimately leading to destruction of the lung tissue.
There are a range of treatments currently available, targeting different aspects of the disease, to help loosen and clear the mucus in the lungs, improve absorption of nutrients and fight lung infection, as well as target underlying defects in the CFTR protein.
However, new treatments are still needed to improve lung function, reduce exacerbations and prolong life.
More than half of people with CF are over 18 years of age.
Major-market sales of key CF therapies will grow at a 13% compound annual growth rate (CAGR) to over $10bn by 2027
Pulmonary arterial hypertension (PAH) is a rare, progressive, fatal disease that affects the arteries in the lungs and the right side of the heart.
PAH has an annual mortality rate of 15% and a five-year survival of approximately 50%.
PAH affects approximately 100,000 people worldwide.Source: Decision Resources, 2018.
PAH severely impacts people’s quality of life - amongst other symptoms, it causes shortness of breath, fatigue and weakness, and can make exercise increasingly difficult for patients. At later stages of the disease, patients may find themselves short of breath even while at rest.
In 2017, Vectura’s partner Bayer launched Breelib™ for use with Ventavis, a well-established inhaled treatment for patients with PAH. Breelib™ is a small, handheld, battery-powered breath-activated vibrating mesh inhalation system developed by Vectura. This smart nebuliser utilises the FOX®’s flow rate and volume control technology. It provides patients with an easier to use device and a faster time of delivery for patients.
Immunocompromised patients are potentially susceptible to infection from many different micro‑organisms. Infections that are typically innocuous may cause significant disease states in immunocompromised hosts.
Patient groups include organ transplant or haematopoietic stem cell transplant recipients – their susceptibility to pathogens (bacteria, fungi, viruses and parasites) depends upon the nature of the underlying immune defects.
Globally, there are approximately 5,000 lung transplants each year, with over 175,000 stem cell and other solid organ transplants. Following lung transplant, infections are common and are associated with high morbidity and mortality.
Existing treatment options include systemic antiinfectives but these may have significant side-effects and drug/drug interactions which limit use. Inhaled anti-infectives may offer an effective, user-friendly alternative.