Novel Drugs and Smart Devices for Respiratory Disorders, 2018 - 2030

LONDON, June 26, 2018 /PRNewswire/ -- INTRODUCTION
According to the Forum of International Respiratory Societies, around 4 million individuals die each year due to chronic respiratory diseases. The World Health Organization (WHO) estimates the global prevalence of two of the most common chronic respiratory diseases, namely asthma and chronic obstructive pulmonary disease (COPD), to be around 335 million and 400 million patients respectively.

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Specifically, COPD is currently known to be the fourth leading cause of death worldwide. According to the data provided by the WHO, more than 3 million people die annually from COPD; this represents a total of 6% of the global annual deaths.

Around 90% of these deaths occur in low and middle-income countries. Asthma, on the other hand, is more common in pediatric population. Asthma alone results in more than 30% of pediatric hospitalizations. Moreover, it is responsible for around 180,000 annual deaths worldwide.

In addition to asthma and COPD, other chronic respiratory disorders are also associated with high unmet needs. Specifically, the patients suffering from cystic fibrosis, which is known to have a global prevalence of 70,000, have reported median lifespan of less than 30 years. In addition, the patients suffering from cystic fibrosis are at a relatively higher risk of acquiring life threatening lung infections.

The high prevalence, high rate of hospitalization and high cost of treatment for these disorders places a huge burden on the society in terms of direct healthcare costs and the loss of productivity associated with disability and premature mortality of the patients.

Although these diseases cannot be cured, several government agencies and big pharma companies have made significant investments in R&D to improve disease management and address the unmet needs. These investments and development initiatives have led to the approval of several therapies, such as LAMA / LABA fixed dose combinations, ICS / LAMA / LABA fixed combinations, CFTR modulators, and novel biologics and antibiotics, which have helped improve the quality of life of patients.

The industry is gradually transitioning towards the development of more targeted therapies. This shift is facilitating a scenario, wherein therapeutic strategies are changing from broad spectrum remedies to those that target individual patient segments.

The 'Novel Drugs and Smart Devices for Respiratory Disorders, 2018-2030' report provides a comprehensive study on the current landscape of novel therapies and smart devices being evaluated for the treatment of asthma, COPD and cystic fibrosis. The field has captured the interest of several drug developers, both small and large companies. With several novel drug candidates in development, we anticipate the market to witness continued growth over the next 5-10 years.

Amongst other elements, the report features:
• A discussion on the novel therapies under development for the treatment of asthma, COPD and cystic fibrosis. The report provides information on the developers, phase of development of candidate drugs / therapies, mechanism of action, route of administration, type of molecule, type of formulation and the dose frequency of the various therapies.
• An analysis highlighting the key unmet needs across asthma, COPD and cystic fibrosis. The study presents insights generated from real-time data on unmet needs identified from social media posts, recent publications, patient blogs and discussions of key opinion leaders.
• An extensive review of the development portfolio and key initiatives undertaken by established players (players with approved / late-stage drug candidates). This section also provides an overview of the companies, their financial performance, recent collaborations and a comprehensive future outlook.
• Elaborate profiles of marketed and phase III drugs; each profile features an overview of the drug, its mechanism of action, dosage information, details on the cost and sales (wherever available), clinical development plan, and key clinical trial results.
• An assessment of the key players involved in the development of smart inhalers. It provides information on the development status of the inhalers, type of inhalers and the key collaborators. In addition, the report provides a comparative assessment of the various smart inhalers on the basis of several parameters, such as availability of Bluetooth, USB connection, reminder function and rechargeable options.
• A discussion on the regulatory landscape for the approval of combination products (drugs and inhalers), as well as smart inhalers in different countries.
• Detailed analysis of the key trends (for instance, relative start-up activity) in the development of novel therapies across asthma, COPD and cystic fibrosis.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. The research, analysis and insights presented in this report include potential sales of novel therapies, as well as smart inhalers that are currently marketed or are in the late stages of development. To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were influenced by discussions with senior stakeholders in the industry. These include Antonio Anzueto (Pulmonologist, University of Texas Health Science Center), Richard Moss (Pediatric Pulmonologist, Lucile Packard Children's Hospital, Stanford University), Alex Stenzler (Founder and President, Novoteris), Dinesh Srinivasan (Director, Anthera Pharmaceuticals) and Dinu Sen (CEO, CURx Pharmaceuticals). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

1.1. RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

1.1. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the respiratory disorders market, specific to asthma, COPD and cystic fibrosis, in the short-mid and long term.

Chapter 3 provides a general introduction to asthma, COPD and cystic fibrosis. In this section, we have discussed, in detail, the healthcare burden associated with the three indications. In addition, we have provided information on the diseases, including details on the key triggers, types and symptoms, statistics, regional prevalence, current treatment options and the treatment guidelines set by regulatory authorities.

Chapter 4 provides a comprehensive overview of the market landscape of novel therapies that are approved or are being developed in clinical and preclinical stages for the treatment of patients with asthma, COPD and cystic fibrosis. This chapter includes information on the developers of these candidates, along with details on the mechanism of action, route of administration, type of molecule, type of formulation, and dose frequency of the therapies.

Chapter 5 highlights the key unmet needs associated with the management and treatment of asthma, COPD and cystic fibrosis. For each of these indications, the chapter provides detailed analysis of unmet needs that were identified from views expressed by patients / experts across different platforms, such as social media posts, recent publications and patient blogs, and the discussions of key opinion leaders at conferences / symposiums. We have analyzed the information in the form of an insightful sentiment analysis and word cloud analysis to better understand the opinions expressed across the public portals.

Chapter 6 includes detailed profiles of the players that have received approval for their novel therapies targeting asthma, COPD or cystic fibrosis. Each profile provides a brief overview of the company, its financial performance, product portfolio, recent collaborations and future outlook. In addition, each profile includes a detailed brand positioning matrix for the player covering several aspects such as pipeline strength / diversity, likely time to market, trial results, recent collaborations, accelerated designations, reimbursement agreements, and the overall market positioning of the players.

Chapter 7 contains detailed profiles of drugs that are marketed or are in phase III of development. Each profile features an overview of the drug, and provides information on the mechanism of action, dosage, cost and sales, clinical development plan, and results of the key clinical trials.

Chapter 8 features an overview of the market landscape of the key players involved in the development of smart inhalers. It provides information on the development status of the inhalers, type of inhalers and the key collaborators. In addition, the chapter presents a comparative product competitiveness analysis of the various smart inhalers on the basis of different parameters, such as availability of Bluetooth, USB connection, reminder function and rechargeable options.

Chapter 9 presents detailed analysis of the key trends observed in the development of novel therapies for asthma, COPD and cystic fibrosis. The chapter presents the landscape of various players involved in the development of therapies for respiratory disorders. Additionally, it presents four-dimensional grid analysis (based on the phase of development / mechanism of action / type of molecule / mode of administration) of the pipeline candidates against asthma, COPD and cystic fibrosis.

Chapter 10 provides information on the regulatory environment related to the grant of marketing authorizations for combination products (inhaler and drug) across different countries. It highlights the role of regulatory bodies in the approval of smart inhalers in North America, Europe, Latin America, Asia Pacific and the Middle East.

Chapter 11 presents an assessment of the market opportunity for smart inhalers. It provides detailed projections of the sales of such inhalers. The sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition and the likely price of these inhalers. The chapter also presents segmentation of the smart inhalers market on the basis of the indications (asthma, COPD and cystic fibrosis), severity (early-stage, moderate and severe) of the disease and the geographies.

Chapter 12 provides a comprehensive forecast analysis, highlighting the future potential of the respiratory disorders market, specific to asthma, COPD and cystic fibrosis, till the year 2030. It includes future sales projections of the drugs that are either marketed or are being evaluated in advanced stages of clinical development. The sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of the products. The chapter also presents a detailed market segmentation on the basis of the indications, geographies, drug classes, route of administration, and type of molecule.

Chapter 13 summarizes the overall report. The chapter provides a list of the key takeaways and presents our independent opinion on the respiratory disorders market, specific to asthma, COPD and cystic fibrosis, based on the research and analysis described in the previous chapters.

Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Antonio Anzueto (Pulmonologist, University of Texas Health Science Center), Richard Moss (Pediatric Pulmonologist, Lucile Packard Children's Hospital, Stanford University), Alex Stenzler (Founder and President, Novoteris), Dinesh Srinivasan (Director, Anthera Pharmaceuticals) and Dinu Sen (CEO, CURx Pharmaceuticals).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Around 135 novel drug candidates are being evaluated across various stages of development for the treatment of patients suffering from asthma, COPD and cystic fibrosis. Of these, around 15 drugs have received approval / market authorization, and 72% and 17% of the candidates are being developed in clinical and preclinical stages, respectively.
2. Majority of the novel drugs (38%) are being developed for the treatment of patients with asthma, while around 30% of the candidates are being developed to target COPD. Rest of the drugs are being evaluated for the treatment of cystic fibrosis. Further, 11% of the therapies target more than one of these diseases.
3. The development landscape comprises of around 90 companies and universities. Of these, around 37% of the players are small-sized companies (less than 50 employees), close to 30% of the players are mid-sized companies (51-200 employees) and around 33% are large-size players / universities (more than 200 employees).
4. Of the big pharma companies, several players have recently received approval for their novel product(s) being developed for asthma, COPD and cystic fibrosis; examples of these companies are (in alphabetical order, no selection criteria) AstraZeneca, Boehringer Ingelheim, Chiesi Pharmaceuticals, Gilead Sciences, GSK, Novartis, Teva Pharmaceutical and Vertex Pharmaceuticals.
5. Specifically for asthma, the industry focus is gradually shifting towards development of therapies for the treatment of patients with moderate to severe disease. In fact, in last few years, around four biologics have been approved for the treatment of severe form of asthma. These include (in decreasing order of approval year) FASENRA™ (2017), CINQAIR™ (2016), XOLAIR® (2016, for pediatric patients) and NUCALA® (2015).
6. For the treatment of COPD, most of the approved novel therapies are combinations of long-acting beta-agonist (LABA) and long-acting muscarinic receptor antagonist (LAMA) drugs. Some of the marketed dual fixed dose combinations include (in decreasing order of approval year) ANORO ELLIPTA™ (2017), BEVESPI AEROSPHERE® / PT003 (2016), Utibron™ Neohaler® (2015), STIOLTO™ RESPIMAT® (2015), Duaklir® Genuair® / Brimica Genuair (2014) and Ultibro® Breezhaler® (2013).
7. Across cystic fibrosis, the launch of KALYDECO® in 2012 and ORKAMBI® in 2015 by Vertex Pharmaceuticals has revolutionized the treatment landscape. Several novel combinations or drug classes are being evaluated in late stages of clinical development. Emerging targeted approaches, such as gene therapy and gene editing, are also being explored.
8. A detailed analysis of the opinions expressed on patient blogs, social media posts and published literature, and by KOLs highlights significant unmet needs across asthma, COPD and cystic fibrosis. High rate of non-adherence, delayed / mis-diagnosis and lack of personalized therapies are amongst the pressing unmet needs.
9. To overcome the unmet needs associated with drug adherence, the industry is promoting the use of connected devices, such as smart inhalers, that enable the patient / healthcare providers to track drug intake. In fact, we identified more than 20 companies involved in the development of smart inhalers; examples include (in alphabetical order) 3M, Adherium, Aerobit, Cohero Health, FindAir, Gecko Health Innovations, H&T Presspart, Inspiro Medical, OPKO Health, Propeller Health, Qualcomm Life, and Vectura.
10. With several approved drugs and late stage clinical (phase II and above) candidates, the market for novel therapeutics is anticipated to grow at a steady pace between 2018 and 2030. By 2030, a number of LABA / LAMA, as well as ICS / LABA / LAMA fixed dose combinations are likely to attain blockbuster status. Examples include, ANORO ELLIPTA™, Utibron™ Neohaler® / Ultibro® Breezhaler®, FASENRA™ and ORKAMBI®.

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