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

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    Report

  • 420 Pages
  • February 2018
  • Region: Global
  • Roots Analysis
  • ID: 4473077
Description Jump to:

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. 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, 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.

Example Highlights


  • 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.
  • 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. 11% of the therapies target more than one of these diseases.
  • 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).
  • 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.
  • 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 the last few years, four biologics have been approved for the treatment of severe form of asthma. These are FASENRA™ (2017), CINQAIR™ (2016), XOLAIR® (2016, for pediatric patients) and NUCALA® (2015).
  • 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. Examples of marketed dual fixed dose combinations include ANORO ELLIPTA™ (2017), BEVESPI AEROSPHERE® / PT003 (2016), Utibron™ Neohaler® (2015), STIOLTO™ RESPIMAT® (2015), Duaklir® Genuair® / Brimica Genuair (2014) and Ultibro® Breezhaler® (2013).
  • 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.
  • 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.
  • 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.
  • 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®.

Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Respiratory Disorders and the Healthcare Burden
3.2. Type of Respiratory Disorders
3.3. Prevalence of Respiratory Disorders
3.4. Respiratory Disorders with High Unmet Need
3.4.1. Asthma
3.4.1.1. Introduction
3.4.1.2. Key Triggers
3.4.1.3. Types and Symptoms
3.4.1.4. Disease Statistics
3.4.1.5. Treatment Options
3.4.1.6. Economic Burden
3.4.2. Chronic Obstructive Pulmonary Disease (COPD)
3.4.2.1. Introduction
3.4.2.2. Key Triggers
3.4.2.3. Types and Symptoms
3.4.2.4. Disease Statistics
3.4.2.5. Treatment Options
3.4.2.6. Economic Burden
3.4.3. Cystic Fibrosis
3.4.3.1. Introduction
3.4.3.2. Key Triggers
3.4.3.3. Types and Symptoms
3.4.3.4. Disease Statistics
3.4.3.5. Treatment Options
3.4.3.6. Economic Burden
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Respiratory Disorders Pipeline: Distribution by Indication
4.2.1. Asthma Pipeline
4.2.1.1. Distribution by Phase of Development
4.2.1.2. Distribution by Mechanism of Action
4.2.1.3. Distribution by Type of Molecule
4.2.1.4. Distribution by Mode of Administration
4.2.1.5. Distribution by Dose Frequency
4.2.1.6. Distribution by Key Players
4.2.2. COPD Pipeline
4.2.2.1. Distribution by Phase of Development
4.2.2.2. Distribution by Mechanism of Action
4.2.2.3. Distribution by Type of Molecule
4.2.2.4. Distribution by Mode of Administration
4.2.2.5. Distribution by Dose Frequency
4.2.2.6. Distribution by Key Players
4.2.3. Cystic Fibrosis Pipeline
4.2.3.1. Distribution by Phase of Development
4.2.3.2. Distribution by Mechanism of Action
4.2.3.3. Distribution by Type OF Molecule
4.2.3.4. Distribution by Mode of Administration
4.2.3.5. Distribution by Dose Frequency
4.2.3.6. Distribution by Key Players
5. UNMET NEED ANALYSIS
5.1. Chapter Overview
5.2. Unmet Need Analysis in Asthma
5.2.1. Introduction
5.2.2. Patient Blogs
5.2.2.1. Methodology
5.2.2.2. Key Insights
5.2.3. Published Literature
5.2.3.1. Methodology
5.2.3.2. Key Insights
5.2.4. Social Media Platforms
5.2.4.1. Methodology
5.2.4.2. Key Insights
5.2.5. Expert Opinions (Source: Public Portals)
5.2.5.1. Nicola Hanania, Associate Professor of Medicine, Baylor College of Medicine, US
5.2.5.2. Ian Adcock, Professor of Respiratory Cell and Molecular Biology, National Heart and Lung Institute, Imperial College London, UK
5.2.5.3. Nikolaos Papadopoulos, Professor of Allergy and Pediatric Allergy, Institute of Human Development, UK
5.2.5.4. Antonio Spanevello, Director of the Post Graduate School in Respiratory Diseases, University of Insubria, Italy
5.2.5.5. Sally Wenzel, MD, Director, University of Pittsburgh Medical Center (UPMC) Asthma Institute, US
5.2.6. Summary: Key Unmet Needs in Asthma
5.3. Unmet Need Analysis in COPD
5.3.1. Introduction
5.3.2. Patient Blogs
5.3.2.1. Methodology
5.3.2.2. Key Insights
5.3.3. Published Literature
5.3.3.1. Methodology
5.3.3.2. Key Insights
5.3.4. Social Media Platforms
5.3.4.1. Methodology
5.3.4.2. Key Insights
5.3.5. Expert Opinions (Source: Public Portals)
5.3.5.1. Nicholas Hart, Clinical Director, King’s College London, UK
5.3.5.2. Peter Barnes, Professor and Head of Respiratory Medicine, Imperial College London, UK
5.3.5.3. Mario Cazzola, Director, Post Graduate School of Respiratory Medicine, University of Rome, Italy
5.3.5.4. Brian Carlin, Pulmonologist, US
5.3.5.5. Nikolaos Papadopoulos, Professor of Allergy and Pediatric Allergy, Institute of Human Development, UK
5.3.6. Summary: Key Unmet Needs in COPD
5.4. Unmet Need Analysis in Cystic Fibrosis
5.4.1. Introduction
5.4.2. Patient Blogs
5.4.2.1. Methodology
5.4.2.2. Key Insights
5.4.3. Published Literature
5.4.3.1. Methodology
5.4.3.2. Key Insights
5.4.4. Social Media Platforms
5.4.4.1. Methodology
5.4.4.2. Key Insights
5.4.5. Key Expert Opinions (Source: Public Portals)
5.4.5.1. Randall Rosenblatt, MD, Chief of Pulmonary Medicine, Baylor University Medical Center, US
5.4.5.2. Multiple Speakers
5.4.5.3. Kenneth Olivier, Staff Clinician, National Institute of Allergy and Infectious Diseases in Bethesda, US
5.4.5.4. Kevin Southern, Pediatric Respiratory Consultant, Alder Hey Children’s Hospital, UK
5.4.6. Summary: Key Unmet Needs in Cystic Fibrosis
6. COMPANY PROFILES
6.1. Chapter Overview
6.2. AbbVie
6.2.1. Company Overview
6.2.2. Financial Performance
6.2.3. Respiratory Disorders: Development Portfolio
6.2.4. Recent Collaborations
6.2.5. Future Outlook
6.2.6. Brand Positioning Matrix
6.3. AstraZeneca
6.3.1. Company Overview
6.3.2. Financial Performance
6.3.3. Respiratory Disorders: Development Portfolio
6.3.4. Recent Collaborations
6.3.5. Future Outlook
6.3.6. Brand Positioning Matrix
6.4. Boehringer Ingelheim
6.4.1. Company Overview
6.4.2. Financial Performance
6.4.3. Respiratory Disorders: Development Portfolio
6.4.4. Recent Collaborations
6.4.5. Future Outlook
6.4.6. Brand Positioning Matrix
6.5. Chiesi Pharmaceuticals
6.5.1. Company Overview
6.5.2. Financial Performance
6.5.3. Respiratory Disorders: Development Portfolio
6.5.4. Recent Collaborations
6.5.5. Future Outlook
6.5.6. Brand Positioning Matrix
6.6. GlaxoSmithKline
6.6.1. Company Overview
6.6.2. Financial Performance
6.6.3. Respiratory Disorders: Development Portfolio
6.6.4. Recent Collaborations
6.6.5. Future Outlook
6.6.6. Brand Positioning Matrix
6.7. Novartis
6.7.1. Company Overview
6.7.2. Financial Performance
6.7.3. Respiratory Disorders: Development Portfolio
6.7.4. Recent Collaborations
6.7.5. Future Outlook
6.7.6. Brand Positioning Matrix
6.8. Teva Pharmaceutical
6.8.1. Company Overview
6.8.2. Financial Performance
6.8.3. Respiratory Disorders: Development Portfolio
6.8.4. Recent Collaborations
6.8.5. Future Outlook
6.8.6. Brand Positioning Matrix
6.9. Vertex Pharmaceuticals
6.9.1. Company Overview
6.9.2. Financial Performance
6.9.3. Respiratory Disorders: Development Portfolio
6.9.4. Recent Collaborations
6.9.5. Future Outlook
6.9.6. Brand Positioning Matrix
6.10. CURx Pharmaceuticals
6.10.1. Company Overview
6.10.2. Financial Performance
6.10.3. Respiratory Disorders: Development Portfolio
6.10.4. Recent Collaborations
6.10.5. Future Outlook
6.10.6. Brand Positioning Matrix
6.11. Laurent Pharmaceuticals
6.11.1. Company Overview
6.11.2. Financial Performance
6.11.3. Respiratory Disorders: Development Portfolio
6.11.4. Recent Collaborations
6.11.5. Future Outlook
6.11.6. Brand Positioning Matrix
6.12. Sanofi
6.12.1. Company Overview
6.12.2. Financial Performance
6.12.3. Respiratory Disorders: Development Portfolio
6.12.4. Recent Collaborations
6.12.5. Future Outlook
6.12.6. Brand Positioning Matrix
6.13. Gilead Sciences
6.13.1. Company Overview
6.13.2. Financial Performance
6.13.3. Respiratory Disorders: Development Portfolio
6.13.4. Recent Collaborations
6.13.5. Future Outlook
6.13.6. Brand Positioning Matrix
6.14. AB Science
6.14.1. Company Overview
6.14.2. Financial Performance
6.14.3. Respiratory Disorders: Development Portfolio
6.14.4. Recent Collaborations
6.14.5. Future Outlook
6.14.6. Brand Positioning Matrix
7. DRUG PROFILES
7.1. Chapter Overview
7.2. Marketed/Approved Drugs
7.2.1 LAMA/LABA Combinations
7.2.1.1 ANORO™ ELLIPTA®
7.2.1.1.1 Drug Overview
7.2.1.1.2 Mechanism of Action
7.2.1.1.3. Cost, Dosage and Sales
7.2.1.1.4. Clinical Development
7.2.1.1.5. Key Clinical Trial Results
7.2.1.2. BEVESPI AEROSPHERE®
7.2.1.2.1. Drug Overview
7.2.1.2.2. Mechanism of Action
7.2.1.2.3. Cost, Dosage and Sales
7.2.1.2.4. Clinical Development
7.2.1.2.5. Key Clinical Trial Results
7.2.1.3. Duaklir® Genuair®
7.2.1.3.1. Drug Overview
7.2.1.3.2. Mechanism of Action
7.2.1.3.3. Cost, Dosage and Sales
7.2.1.3.4. Clinical Development
7.2.1.3.5. Key Clinical Trial Results
7.2.1.4. STIOLTO™ RESPIMAT®
7.2.1.4.1. Drug Overview
7.2.1.4.2. Mechanism of Action
7.2.1.4.3. Cost, Dosage and Sales
7.2.1.4.4. Clinical Development
7.2.1.4.5. Key Clinical Trial Results
7.2.1.5. Ultibro® Breezhaler®/Utibron® Neohaler®
7.2.1.5.1. Drug Overview
7.2.1.5.2. Mechanism of Action
7.2.1.5.3. Cost, Dosage and Sales
7.2.1.5.4. Clinical Development
7.2.1.5.5. Key Clinical Trial Results
7.2.2. ICS/LAMA/LABA Combinations
7.2.2.1. Trelegy Ellipta
7.2.2.1.1. Drug Overview
7.2.2.1.2. Mechanism of Action
7.2.2.1.3. Cost, Dosage and Sales
7.2.2.1.4. Clinical Development
7.2.2.1.5. Key Clinical Trial Results
7.2.2.2. Trimbow™
7.2.2.2.1. Drug Overview
7.2.2.2.2. Mechanism of Action
7.2.2.2.3. Cost, Dosage and Sales
7.2.2.2.4. Clinical Development
7.2.2.2.5. Key Clinical Trial Results
7.2.3. IL-5 Inhibitors/IgE Receptor Antagonists
7.2.3.1. CINQAIR®
7.2.3.1.1. Drug Overview
7.2.3.1.2. Mechanism of Action
7.2.3.1.3. Cost, Dosage and Sales
7.2.3.1.4. Clinical Development
7.2.3.1.5. Key Clinical Trial Results
7.2.3.2. FASENRA™
7.2.3.2.1. Drug Overview
7.2.3.2.2. Mechanism of Action
7.2.3.2.3. Cost, Dosage and Sales
7.2.3.2.4. Clinical Development
7.2.3.2.5. Key Clinical Trial Results
7.2.3.3. NUCALA®
7.2.3.3.1. Drug Overview
7.2.3.3.2. Mechanism of Action
7.2.3.3.3. Cost, Dosage and Sales
7.2.3.3.4. Clinical Development
7.2.3.3.5. Key Clinical Trial Results
7.2.3.4. XOLAIR®
7.2.3.4.1. Drug Overview
7.2.3.4.2. Mechanism of Action
7.2.3.4.3. Cost, Dosage and Sales
7.2.3.4.4. Clinical Development
7.2.3.4.5. Key Clinical Trial Results
7.2.4. CFTR Modulators/Novel Antibiotics
7.2.4.1. Bronchitol®
7.2.4.1.1. Drug Overview
7.2.4.1.2. Mechanism of Action
7.2.4.1.3. Cost, Dosage and Sales
7.2.4.1.3. Clinical Development
7.2.4.1.4. Key Clinical Trial Results
7.2.4.1. KALYDECO®
7.2.4.1.1. Drug Overview
7.2.5.1.2. Mechanism of Action
7.2.5.1.3. Cost, Dosage and Sales
7.2.5.1.4. Clinical Development
7.2.5.1.5. Key Clinical Trial Results
7.2.4.2. ORKAMBI®
7.2.4.2.1. Drug Overview
7.2.4.2.2. Mechanism of Action
7.2.4.2.3. Cost, Dosage and Sales
7.2.4.2.4. Clinical Development
7.2.4.2.5. Key Clinical Trial Results
7.3. Late Stage Drug Candidates
7.3.1. QVM149
7.3.2. Masitinib
7.3.3. PT010
7.3.4. QAW039
7.3.5. SAR231893/REGN668
7.3.6. Spirivia (for Cystic Fibrosis)
7.3.7. Timapiprant
7.3.8. VX-661 and Ivacaftor Combination
8. KEY INSIGHTS
8.1. Chapter Overview
8.2. Asthma, COPD and Cystic Fibrosis: Pipeline Analysis by Size of Players
8.3. Asthma: Pipeline Analysis by Phase of Development, Drug Class, Type of Molecule and Mode of Administration
8.4. COPD: Pipeline Analysis by Phase of Development, Drug Class, Type of Molecule and Mode of Administration
8.5. Cystic Fibrosis: Pipeline Analysis by Phase of Development, Drug Class, Type of Molecule and Mode of Administration
9. SMART INHALERS: INTRODUCTION AND DEVELOPER LANDSCAPE
9.1. Chapter Overview
9.2. Internet of Things (IoT)
9.3. Evolution of Inhalers
9.4. Inhalers and The Cost of Non-Adherence
9.5. Smart Inhalers
9.5.1. Introduction
9.5.2. Market Landscape
9.5.3. Distribution by Key Parameters
9.5.3.1. Bluetooth
9.5.3.2. Reminders
9.5.3.3. Inhaler Type
9.5.3.4. Status of Development
9.5.4. Smart Inhaler Developer: Brand Positioning Matrix
9.5.5 Recent Collaborations
9.5.6. Business Models
9.5.7. Ideal Smart Inhaler
9.5.7.1. Connectivity
9.5.7.2. Storage
9.5.7.3. Design
9.5.7.4. Interface and Patient Interaction
9.5.7.5. Reminders and Dose Recording
9.5.7.6. Other Features
10. REGULATORY LANDSCAPE FOR SMART INHALERS
10.1. Chapter Overview
10.2. Rise of Connected Devices
10.3. Regulatory Approval of Combination Products in the US
10.3.1. Overview
10.3.2. Historical Background
10.3.3. Regulatory Bodies and their Role in Product Approval
10.3.4. Regulatory Approval Pathway for Smart Inhalers
10.4. Regulatory Approval of Combination Products in Europe
10.4.1. Overview
10.4.2. Regulatory Bodies and their Role in Product Approval
10.4.3. Regulatory Approval Pathway for Smart Inhalers
10.5. Regulatory Approval of Combination Products in Canada
10.5.1. Overview
10.5.2. Regulatory Bodies and their Role in Product Approval
10.5.3. Regulatory Approval Pathway for Smart Inhalers
10.6. Regulatory Approval of Combination Products in Brazil
10.6.1. Overview
10.6.2. Regulatory Bodies and their Role in Product Approval
10.6.3. Regulatory Approval Pathway of Smart Inhalers
10.7. Regulatory Approval of Combination Products in Mexico
10.7.1. Overview
10.7.2. Regulatory Bodies and their Role in Product Approval
10.7.3. Regulatory Approval Pathway for Smart Inhalers
10.8. Regulations of Combination Products in Argentina
10.8.1. Overview
10.8.2. Regulatory Bodies and their Role in Product Approval
10.8.3. Regulatory Approval Pathway for Smart Inhalers
10.9. Regulatory Approval of Combination Products in Australia
10.9.1. Overview
10.9.2. Regulatory Bodies and their Role in Product Approval
10.9.3. Regulatory Approval Pathway for Smart Inhalers
10.10. Regulatory Approval of Combination Products in Japan
10.10.1. Overview
10.10.2. Regulatory Bodies and their Role in Product Approval
10.10.3. Regulatory Approval Pathway for Smart Inhalers
10.11. Regulatory Approval of Combination Products in China
10.11.1. Overview
10.11.2. Regulatory Bodies and their Role in Product Approval
10.11.3. Regulatory Approval Pathway for Smart Inhalers
10.12. Regulations of Combination Products in India
10.12.1. Overview
10.12.2. Regulatory Bodies and their Role in Product Approval
10.12.3. Regulatory Approval Pathway for Smart Inhalers
10.13. Regulation of Combination Products in South Korea
10.13.1. Overview
10.13.2. Regulatory Bodies and their Role in Product Approval
10.13.3. Regulatory Approval Pathway for Smart Inhalers
10.14. Regulation of Combination Products in Saudi Arabia
10.14.1. Overview
10.14.2. Regulatory Bodies and their Role in Product Approval
10.14.3. Regulatory Approval Pathway for Smart Inhalers
10.15. Regulation of Combination Products in United Arab Emirates (UAE)
10.15.1. Overview
10.15.2. Regulatory Bodies and their Role in Product Approval
10.15.3. Regulatory Approval Pathway for Smart Inhalers
10.16. Smart Inhalers: Demonstrating Safety, Effectiveness and Performance
11. SMART INHALERS: MARKET SIZE AND OPPORTUNITY ANALYSIS
11.1. Chapter Overview
11.2. Forecast Methodology and Key Assumptions
11.3. Overall Smart Inhalers Market, 2018-2030
11.3.1 Overall Smart Inhalers Market: Distribution by Indication
11.4.1. Smart Inhalers Market: Asthma
11.4.2. Smart Inhalers Market: COPD
11.5. Overall Smart Inhalers Market: Distribution by Disease Severity
11.5.1. Smart Inhalers Market: Mild Asthma/COPD
11.5.2. Smart Inhalers Market: Moderate Asthma/COPD
11.5.3. Smart Inhalers Market: Severe Asthma/COPD
11.4. Overall Smart Inhalers Market: Distribution by Geography
12. RESPIRATORY DISORDERS: NOVEL THERAPEUTICS, MARKET SIZE AND OPPORTUNITY ANALYSIS
12.1. Chapter Overview
12.2. Forecast Methodology and Key Assumptions
12.3. Respiratory Disorders: Overall Novel Therapeutics Market, 2018-2030
12.4. Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Indication
12.4.1. Asthma
12.4.2. COPD
12.4.3. Cystic Fibrosis
12.5. Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Drug Class
12.5.1. LABA/LAMA Combinations
12.5.2. ICS/LABA/LAMA Combinations
12.5.3. IL-5 Inhibitors
12.5.4. CRTh2 Antagonists
12.5.5. CFTR Modulators
12.5.6. Other Drug Classes
12.6. Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Key Players
12.7. Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Type of Molecule
12.8. Respiratory Disorders: Overall Novel Therapeutics Market: Distribution by Route of Administration
12.9. Respiratory Disorders: Overall Novel Therapeutics Market: Distribution by Geography
13. CONCLUSION
13.1. With High Prevalence and Lack of Efficient Treatment Options, Asthma, COPD and Cystic Fibrosis Continue to Pose Enormous Burden on the Healthcare System
13.2. To Improve Disease Management, Several Stakeholders, including Well Established Pharma Players, are Exploring Novel Opportunities
13.3. LABA/LAMA and ICS/LAMA/LABA Fixed Dose Combinations are Redefining Treatment Options for COPD; Biologics are Expected to Become Popular for Asthma
13.4. High Success of CFTR Modulators Has Offered Hope in the Cystic Fibrosis Segment; Combination Therapies are Likely to Emerge in the Near Future
13.5. Despite These Advancements, High Rate of Non-adherence, Delayed/Mis-Diagnosis and Lack of Personalized Therapies are amongst the pressing Unmet Needs
13.6. With Various Companies Adopting Digital Solutions to Overcome Specific Patient Needs, Smart Inhalers are Likely to Offer Significant Opportunities
13.7. As the Recently Approved Therapies Provide More Evidence of their Benefits, the Overall Market is Anticipated to Grow at a Steady Pace
14. INTERVIEW TRANSCRIPTS
14.1. Chapter Overview
14.2. Alex Stenzler, Founder and President, Novoteris
14.3 Dinu Sen, CEO, CURx Pharmaceuticals
14.4 Antonio Anzueto, Pulmonologist, University of Texas Health Science Center
14.5 Richard Moss, Pediatric Pulmonologist, Lucile Packard Children’s Hospital, Stanford University
14.6 Dinesh Srinivasan, Director, Anthera Pharmaceuticals
15. APPENDIX 1: TABULATED DATA16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
LIST OF FIGURES
Figure 3.1 Respiratory Disorders: Classification
Figure 3.2 Respiratory Disorders: Key Statistics
Figure 3.3 Asthma: Key Triggers
Figure 3.4 Asthma: Global Prevalence
Figure 3.5 Asthma: Treatment Options
Figure 3.6 Asthma: Treatment Guidelines, Global Initiative for Asthma (GINA) 2017
Figure 3.7 Asthma: Treatment Guidelines for Adults, UK
Figure 3.8 Asthma: Treatment Guidelines for Children, UK
Figure 3.9 Asthma: Distribution of Patients by Disease Severity
Figure 3.10 Asthma: Distribution of Annual Treatment Cost by Disease Severity
Figure 3.11 COPD: Key Statistics
Figure 3.12 COPD: Key Triggers
Figure 3.13 COPD: ABCD Assessment Framework
Figure 3.14 COPD: Global Prevalence
Figure 3.15 COPD: Distribution by Disease Severity
Figure 3.16 COPD: Treatment Guidelines
Figure 3.17 COPD: Distribution of Annual Treatment Cost by Type of Payer
Figure 3.18 COPD: Distribution of Direct Treatment Cost
Figure 3.19 Cystic Fibrosis: Genetic Relationship
Figure 3.20 Cystic Fibrosis: US Prevalence
Figure 3.21 Cystic Fibrosis: Global Prevalence
Figure 3.22 Cystic Fibrosis: Distribution by Type of Mutation
Figure 3.23 Cystic Fibrosis: Distribution by Type of Therapy (Children)
Figure 3.24 Cystic Fibrosis: Distribution by Primary Airway Clearance Techniques
Figure 3.25 Cystic Fibrosis: Distribution of Annual Treatment Cost by Disease Severity
Figure 3.26 Cystic Fibrosis: Distribution of Annual Treatment Cost by Type of Treatment
Figure 3.27 Cystic Fibrosis: Distribution of Patients by Disease Severity and Insurance Provider
Figure 4.1 Respiratory Disorders Pipeline: Distribution by Indication
Figure 4.2 Asthma Pipeline: Distribution by Phase of Development
Figure 4.3 Asthma Pipeline: Distribution by Mechanism of Action
Figure 4.4 Asthma Pipeline: Distribution by Type of Molecule
Figure 4.5 Asthma Pipeline: Distribution by Mode of Administration
Figure 4.6 Asthma Pipeline: Distribution by Dose Frequency
Figure 4.7 Asthma Pipeline: Distribution by Key Players
Figure 4.8 COPD Pipeline: Distribution by Phase of Development
Figure 4.9 COPD Pipeline: Distribution by Mechanism of Action
Figure 4.10 COPD Pipeline: Distribution by Type of Molecule
Figure 4.11 COPD Pipeline: Distribution by Mode of Administration
Figure 4.12 COPD Pipeline: Distribution by Dose Frequency
Figure 4.13 COPD Pipeline: Distribution by Key Players
Figure 4.14 Cystic Fibrosis: Distribution by Phase of Development
Figure 4.15 Cystic Fibrosis: Distribution by Mechanism of Action
Figure 4.16 Cystic Fibrosis: Distribution by Type of Molecule
Figure 4.17 Cystic Fibrosis: Distribution by Mode of Administration
Figure 4.18 Cystic Fibrosis: Distribution by Dose Frequency
Figure 4.19 Cystic Fibrosis: Distribution by Key Players
Figure 5.1 Unmet Need Analysis: Methodology Overview
Figure 5.2 Unmet Needs in Asthma: Word Cloud Analysis of Patient Blogs
Figure 5.3 Unmet Needs in Asthma: Cumulative Number of Publications, Year-wise Trend
Figure 5.4 Unmet Needs in Asthma: Social Media Platforms, Sentiment Analysis
Figure 5.5 Unmet Needs in Asthma: Social Media Analysis, Word Cloud
Figure 5.6 Unmet Needs in Asthma: Social Media Analysis: Negative Tweets
Figure 5.7 Key Unmet Needs in Asthma
Figure 5.8 Unmet Needs in COPD: Word Cloud Analysis of Patient Blogs
Figure 5.9 Unmet Needs in COPD: Cumulative Number of Publications, Year-wise Trend
Figure 5.10 Unmet Needs in COPD: Social Media Platforms, Sentiment Analysis
Figure 5.11 Unmet Needs in COPD: Social Media Analysis, Word Cloud
Figure 5.12 Unmet Needs in COPD: Social Media Analysis: Negative Tweets
Figure 5.13 Key Unmet Needs in COPD
Figure 5.14 Unmet Needs in Cystic Fibrosis: Word Cloud Analysis of Patient Blogs
Figure 5.15 Unmet Needs in Cystic Fibrosis: Cumulative Number of Publications, Year-wise Trend
Figure 5.16 Unmet Needs in Cystic Fibrosis: Social Media Platforms, Sentiment Analysis
Figure 5.17 Unmet Needs in Cystic Fibrosis: Social Media Analysis, Word Cloud
Figure 5.18 Unmet Needs in Cystic Fibrosis: Social Media Analysis, Negative Tweets
Figure 5.19 Key Unmet Needs in Cystic Fibrosis
Figure 6.1 AbbVie: Revenues, 2012- 2017 (USD Billion)
Figure 6.2 AbbVie: Brand Positioning Matrix
Figure 6.3 AstraZeneca: Revenues, 2012- 2017 (USD Billion)
Figure 6.4 AstraZeneca: Brand Positioning Matrix
Figure 6.5 Boehringer Ingelheim: Revenues, 2012- 2017 (EUR Billion)
Figure 6.6 Boehringer Ingelheim: Brand Positioning Matrix
Figure 6.7 Chiesi Pharmaceuticals: Revenues, 2012-2016 (EUR Billion)
Figure 6.8 Chiesi Pharmaceuticals: Brand Positioning Matrix
Figure 6.9 GSK: Revenues, 2012- 2017 (GBP Billion)
Figure 6.10 GSK: Segment-Wise Revenues, 2016 (GBP Billion)
Figure 6.11 GSK: Brand Positioning Matrix
Figure 6.12 Novartis: Revenues, 2012- 2017 (USD Billion)
Figure 6.13 Novartis: Brand Positioning Matrix
Figure 6.14 Teva Pharmaceutical: Revenues, 2012- 2017 (USD Billion)
Figure 6.15 Teva Pharmaceutical: Brand Positioning Matrix
Figure 6.16 Vertex Pharmaceuticals: Revenues, 2012- 2017 (USD Billion)
Figure 6.17 Vertex Pharmaceuticals: Brand Positioning Matrix
Figure 6.18 CURx Pharmaceuticals: Brand Positioning Matrix
Figure 6.19 Laurent Pharmaceuticals: Brand Positioning Matrix
Figure 6.20 Sanofi: Revenues, 2012- 2017 (EUR Billion)
Figure 6.21 Sanofi: Brand Positioning Matrix
Figure 6.22 Gilead Sciences: Revenues, 2012- 2017 (USD Billion)
Figure 6.23 Gilead Sciences: Brand Positioning Matrix
Figure 6.24 AB Science: Revenues, 2012- 2017 (EUR Million)
Figure 6.25 AB Science: Brand Positioning Matrix
Figure 7.1 ANORO™ ELLIPTA®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.2 BEVESPI AEROSPHERE®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.3 Duaklir®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.4 STIOLTO™ RESPIMAT®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.5 Ultibro® Breezhaler®: Annual Sales (2014- 2017, USD Million)
Figure 7.6 Ultibro® Breezhaler®/Utibron® Neohaler®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.7 Trelegy Ellipta: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.8 Trimbow™: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.9 CINQAIR®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.10 FASENRA™: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.11 NUCALA®: Annual Sales (2012-2017, GBP Million)
Figure 7.12 NUCALA®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.13 XOLAIR®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.14 Bronchitol®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.16 KALYDECO®: Annual Sales (2012- 2017, USD Million)
Figure 7.17 KALYDECO®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 7.18 ORKAMBI®: Annual Sales (2012- 2017, USD Million)
Figure 7.19 ORKAMBI®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Figure 8.1 Internet of Things: Framework
Figure 8.2 Internet of Things: Applications in Healthcare
Figure 8.3 Inhalers: Evolutionary Landscape
Figure 8.4 Smart Inhalers: Design and Functioning
Figure 8.5 Smart Inhalers: Potential Applications
Figure 8.6 Smart Inhalers: Distribution by Bluetooth Option
Figure 8.7 Smart Inhalers: Distribution by Reminder Option
Figure 8.8 Smart Inhalers: Distribution by Type of Inhaler
Figure 8.9 Smart Inhalers: Distribution by Status of Development
Figure 8.10 Smart Inhalers: Brand Positioning Matrix
Figure 8.11 Smart Inhalers: Recent Collaborations
Figure 8.12 Smart Inhalers: Market Opportunity
Figure 8.13 Ideal Smart Inhaler: Key Features
Figure 9.1 Asthma, COPD and Cystic Fibrosis: Pipeline Analysis by Size of Players
Figure 9.2 Asthma: Pipeline Analysis by Phase of Development, Drug Class, Type of Molecule and Mode of Administration
Figure 9.3 COPD: Pipeline Analysis by Phase of Development, Drug Class, Type of Molecule and Mode of Administration
Figure 9.4 Cystic Fibrosis: Pipeline Analysis by Phase of Development, Drug Class, Type of Molecule and Mode of Administration
Figure 10.1 Global Regulations Related to Smart Inhalers
Figure 10.2 Smart Inhalers: Business Models
Figure 10.3 Regulatory Approval Pathway for Combination Products in the US
Figure 10.4 Regulatory Approval Pathway for Combination Products in Canada
Figure 10.5 Regulatory Approval Pathway of Combination Products in China
Figure 11.1 Overall Smart Inhalers Market, 2018-2030, Conservative Scenario, Base Scenario and Optimistic Scenario (USD Billion)
Figure 11.2 Smart Inhalers Market: Asthma, 2018-2030, Conservative Scenario, Base Scenario and Optimistic Scenario (USD Billion)
Figure 11.3 Smart Inhalers Market: COPD, 2018-2030, Conservative Scenario, Base Scenario and Optimistic Scenario (USD Billion)
Figure 11.4 Smart Inhalers Market: Distribution by Asthma Severity, Base Scenario, 2018, 2025 and 2030 (USD Billion)
Figure 11.5 Smart Inhalers Market: Distribution by COPD Severity, Base Scenario, 2018, 2025 and 2030 (USD Billion)
Figure 11.6 Smart Inhalers Market: Distribution by Geography, Base Scenario, 2018, 2025 and 2030 (USD Billion)
Figure 12.1 Respiratory Disorders: Overall Novel Therapeutics Market, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.2 Respiratory Disorders: Novel Therapeutics Market, Asthma, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.3 Respiratory Disorders: Novel Therapeutics Market, COPD, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.4 Respiratory Disorders: Novel Therapeutics Market, Cystic Fibrosis, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.5 Respiratory Disorders: Overall Novel Therapeutics Market, Market Attractiveness Analysis by Drug Class, 2018-2030 (USD Billion)
Figure 12.6 Respiratory Disorders: Novel Therapeutics Market, LABA/LAMA, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.7 Respiratory Disorders: Novel Therapeutics Market, ICS/LABA/LAMA, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.8 Respiratory Disorders: Novel Therapeutics Market, IL-5 Inhibitors, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.9 Respiratory Disorders: Novel Therapeutics Market, CRTh2 Antagonists, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.10 Respiratory Disorders: Novel Therapeutics Market, CFTR Modulators, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.11 Respiratory Disorders: Novel Therapeutics Market, Other Drug Classes, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Figure 12.12 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Key Players, 2018, 2025 and 2030
Figure 12.13 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Type of Molecule, 2018, 2025 and 2030
Figure 12.14 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Route of Administration, 2018, 2025 and 2030
Figure 12.15 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Geography, 2018, 2025 and 2030
Figure 13.1 Respiratory Disorders: Overall Novel Therapeutics Market, Conservative, Base and Optimistic Forecast Scenarios, 2018, 2025 and 2030 (USD Billion)
LIST OF TABLES
Table 4.1 Asthma: Development Pipeline
Table 4.2 Asthma: Development Pipeline (Information on Type of Molecule, Dosage and Administration)
Table 4.3 COPD: Development Pipeline
Table 4.4 COPD: Development Pipeline (Information on Type of Molecule, Dosage and Administration)
Table 4.5 Cystic Fibrosis: Development Pipeline
Table 4.6 Cystic Fibrosis: Development Pipeline (Information on Type of Molecule, Dosage and Administration)
Table 6.1 AbbVie: Respiratory Disorders, Development Portfolio
Table 6.2 AstraZeneca: Respiratory Disorders, Development Portfolio
Table 6.3 Boehringer Ingelheim: Respiratory Disorders, Development Portfolio
Table 6.4 Chiesi Pharmaceuticals: Respiratory Disorders, Development Portfolio
Table 6.5 GlaxoSmithKline: Respiratory Disorders, Development Portfolio
Table 6.6 Novartis: Respiratory Disorders, Development Portfolio
Table 6.7 Teva Pharmaceutical: Respiratory Disorders, Development Portfolio
Table 6.8 Teva Pharmaceutical: Smart Inhaler Collaborations
Table 6.9 Vertex Pharmaceuticals: Respiratory Disorders, Development Portfolio
Table 6.10 CURx Pharmaceuticals: Respiratory Disorders, Development Portfolio
Table 6.11 Laurent Pharmaceuticals: Respiratory Disorders, Development Portfolio
Table 6.12 Sanofi: Respiratory Disorders, Development Portfolio
Table 6.13 Gilead Sciences: Respiratory Disorders, Development Portfolio
Table 6.14 AB Science: Respiratory Disorders, Development Portfolio
Table 7.1 List of Drugs: Detailed Profiles
Table 7.2 List of Drugs: Brief Profiles
Table 7.3 ANORO ELLIPTA™: Registered Clinical Trials
Table 7.4 BEVESPI AEROSPHERE®: Registered Clinical Trials
Table 7.5 Duaklir®: Registered Clinical Trials
Table 7.6 STIOLTO™ RESPIMAT®: Registered Clinical Trials
Table 7.7 Ultibro® Breezhaler®// Utibron® Neohaler®: Registered Clinical Trials
Table 7.8 Trelegy Ellipta: Registered Clinical Trials
Table 7.9 Trimbow™: Registered Clinical Trials
Table 7.10 CINQAIR®: Registered Clinical Trials
Table 7.11 FASENRA™: Registered Clinical Trials
Table 7.12 NUCALA®: Registered Clinical Trials
Table 7.13 XOLAIR®: Dosage Regimen Every Four Weeks (Patients > 12 Years of Age)
Table 7.14 XOLAIR®: Dosage Regimen Every Two Weeks (Patients > 12 Years of Age)
Table 7.15 XOLAIR®: Dosage Regimen Every Two/Four Weeks (Patients 6-12 Years of Age)
Table 7.16 XOLAIR®: Registered Clinical Trials
Table 7.17 Bronchitol®: Registered Clinical Trials
Table 7.18 KALYDECO®: Registered Clinical Trials
Table 7.19 ORKAMBI®: Registered Clinical Trials
Table 7.20 Drug Profile: HCP 1202
Table 7.21 Drug Profile: Masitinib
Table 7.22 Drug Profile: PT-010
Table 7.23 Drug Profile: QVM149
Table 7.24 Drug Profile: QAW039
Table 7.25 Drug Profile: SAR231893/REGN668
Table 7.26 Drug Profile: Spiriva
Table 7.27 Drug Profile: Timapiprant
Table 7.28 Drug Profile: VX-661 and Ivacaftor combination
Table 8.1 Asthma and COPD: Type of Inhalers
Table 8.2 Smart Inhalers: Developer Landscape
Table 8.3 Smart Inhalers: Information on Features
Table 8.4 USFDA Centers for Drugs and Device Approval
Table 8.5 USFDA: Review Timelines
Table 8.6 Regulatory Bodies in EU5 Countries
Table 8.7 Saudi Arabia: Regulatory Review Timeline
Table 15.1 Asthma: Global Prevalence
Table 15.2 Asthma: Distribution of Patients by Disease Severity
Table 15.3 Asthma: Distribution of Annual Treatment Cost by Disease Severity
Table 15.4 COPD: Global Prevalence
Table 15.5 COPD: Distribution by Disease Severity
Table 15.6 COPD: Distribution of Annual Treatment Cost by Type of Payer
Table 15.7 COPD: Distribution of Direct Cost
Table 15.8 Cystic Fibrosis: US Prevalence
Table 15.9 Cystic Fibrosis: Distribution by Type of Mutation, UK
Table 15.10 Cystic Fibrosis: Distribution by Type of Therapy (Children)
Table 15.11 Cystic Fibrosis: Distribution by Primary Airway Clearance Techniques
Table 15.12 Cystic Fibrosis: Distribution of Annual Treatment Cost by Disease Severity
Table 15.13 Cystic Fibrosis: Distribution of Annual Treatment Cost by Type of Treatment
Table 15.14 Cystic Fibrosis: Distribution of Patients by Disease Severity and Insurance Provider
Table 15.15 Respiratory Disorders Pipeline: Distribution by Indication
Table 15.16 Asthma Pipeline: Distribution by Phase of Development
Table 15.17 Asthma Pipeline: Distribution by Mechanism of Action
Table 15.18 Asthma Pipeline: Distribution by Type of Molecule
Table 15.19 Asthma Pipeline: Distribution by Mode of Administration
Table 15.20 Asthma Pipeline: Distribution by Dose frequency
Table 15.21 Asthma Pipeline: Distribution by Key Players
Table 15.22 COPD Pipeline: Distribution by Phase of Development
Table 15.23 COPD Pipeline: Distribution by Mechanism of Action
Table 15.24 COPD Pipeline: Distribution by Type of Molecule
Table 15.25 COPD Pipeline: Distribution by Mode of Administration
Table 15.26 COPD Pipeline: Distribution by Dose frequency
Table 15.27 COPD Pipeline: Distribution by Key Players
Table 15.28 Cystic Fibrosis Pipeline: Distribution by Phase of Development
Table 15.29 Cystic Fibrosis Pipeline: Distribution by Mechanism of Action
Table 15.30 Cystic Fibrosis Pipeline: Distribution by Type of Molecule
Table 15.31 Cystic Fibrosis Pipeline: Distribution by Mode of Administration
Table 15.32 Cystic Fibrosis Pipeline: Distribution by Dose frequency
Table 15.33 Cystic Fibrosis Pipeline: Distribution by Key Players
Table 15.34 Asthma Unmet Needs: Cumulative Number of Publications, Year-wise Trend
Table 15.35 COPD Unmet Needs: Cumulative Number of Publications, Year-wise Trend
Table 15.36 Cystic Fibrosis Unmet Needs: Cumulative Number of Publications, Year-wise Trend
Table 15.37 AbbVie: Revenues, 2012- 2017 (USD Billion)
Table 15.38 AstraZeneca: Revenues, 2012- 2017 (USD Billion)
Table 15.39 Boehringer Ingelheim: Revenues, 2012- 2017 (EUR Billion)
Table 15.40 Chiesi Pharmaceuticals: Revenues, 2012- 2016 (EUR Billion)
Table 15.41 GSK: Revenues, 2012- 2017 (GBP Billion)
Table 15.42 GSK: Segment-Wise Revenues, 2016 (GBP Billion)
Table 15.43 Novartis: Revenues, 2012- 2017 (USD Billion)
Table 15.44 Teva Pharmaceutical: Revenues, 2012- 2017 (USD Billion)
Table 15.45 Vertex Pharmaceuticals: Revenues, 2012- 2017 (USD Billion)
Table 15.46 Sanofi: Revenues, 2012- 2017 (EUR Billion)
Table 15.47 Gilead Sciences: Revenues, 2012 -2017 (USD Billion)
Table 15.48 AB Science: Revenues, 2012 -2017 (EUR Million)
Table 15.49 ANORO™ ELLIPTA®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.50 BEVESPI AEROSPHERE®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.51 Duaklir®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.52 STIOLTO™ RESPIMAT®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.53 Ultibro® Breezhaler®: Annual Sales (2014- 2017, USD Million)
Table 15.54 Ultibro® Breezhaler®/Utibron® Neohaler®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.55 Trelegy Ellipta: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.56 Trimbow™: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.57 CINQAIR®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.58 FASENRA™: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.59 NUCALA®: Annual Sales (2012- 2017, GBP Million)
Table 15.60 NUCALA®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.61 XOLAIR®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.62 Bronchitol®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.63 KALYDECO®: Annual Sales (2012- 2017, USD Million)
Table 15.64 KALYDECO®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.65 ORKAMBI®: Annual Sales (2012- 2017, USD Million)
Table 15.66 ORKAMBI®: Distribution of Clinical Trials by Phase of Development and Recruitment Status
Table 15.67 Smart Inhalers: Distribution by Bluetooth Option
Table 15.68 Smart Inhalers: Distribution by Reminders Option
Table 15.69 Smart Inhalers: Distribution by Type of Inhaler
Table 15.70 Smart Inhalers: Distribution by Status of Development
Table 15.71 Asthma: Four-Dimensional Grid Analysis
Table 15.72 COPD: Four-Dimensional Grid Analysis
Table 15.73 Cystic Fibrosis: Four-Dimensional Grid Analysis
Table 15.74 Overall Smart Inhalers Market, 2018-2030, Conservative Scenario, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.75 Smart Inhalers Market: Asthma, 2018-2030, Conservative Scenario, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.76 Smart Inhalers Market: COPD, 2018-2030, Conservative Scenario, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.77 Smart Inhalers Market: Distribution by Asthma Severity, Base Scenario, 2018, 2025 and 2030 (USD Billion)
Table 15.78 Smart Inhalers Market: Distribution by COPD Severity, Base Scenario, 2018, 2025 and 2030 (USD Billion)
Table 15.79 Smart Inhalers Market: Distribution by Geography, Base Scenario, 2018, 2025 and 2030 (USD Billion)
Table 15.80 Respiratory Disorders: Overall Novel Therapeutics Market, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.81 Respiratory Disorders: Novel Therapeutics Market, Asthma, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.82 Respiratory Disorders: Novel Therapeutics Market, COPD, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.83 Respiratory Disorders: Novel Therapeutics Market, Cystic Fibrosis, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.84 Respiratory Disorders: Overall Novel Therapeutics Market, Market Attractiveness Analysis by Drug Class, 2018-2030 (USD Billion)
Table 15.85 Respiratory Disorders: Novel Therapeutics Market, LABA/LAMA, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.86 Respiratory Disorders: Novel Therapeutics Market, ICS/LABA/LAMA, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.87 Respiratory Disorders: Novel Therapeutics Market, IL-5 Inhibitors, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.88 Respiratory Disorders: Novel Therapeutics Market, CRTh2 Antagonists, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.89 Respiratory Disorders: Novel Therapeutics Market, CFTR Modulators, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.90 Respiratory Disorders: Novel Therapeutics Market, Other Drug Classes, 2018-2030, Conservative Scenarios, Base Scenario and Optimistic Scenario (USD Billion)
Table 15.91 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Key Players, 2018, 2025 and 2030
Table 15.92 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Type of Molecule, 2018, 2025 and 2030
Table 15.93 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Route of Administration, 2018, 2025 and 2030
Table 15.94 Respiratory Disorders: Overall Novel Therapeutics Market, Distribution by Geography, 2018, 2025 and 2030
Table 15.95 Respiratory Disorders: Overall Novel Therapeutics Market, Conservative, Base and Optimistic Forecast Scenarios, 2018, 2025 and 2030 (USD Billion)

Executive Summary

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.

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.

Companies Mentioned

  • 3M
  • AB Science
  • AbbVie
  • Abeome
  • Ablynx
  • Adherium
  • Aerobit
  • Afimmune
  • Airnest
  • AlgiPharma
  • Almirall
  • Alphabet
  • American College of Chest Physicians
  • American Thoracic Society
  • Amgen
  • Amiko
  • AnaptysBio
  • Anthem
  • Anthera
  • Aptar Pharma
  • Aridis Pharmaceuticals
  • Ario Pharma
  • Array BioPharma
  • Artax Biopharma
  • ASLAN Pharmaceuticals
  • Asthma UK
  • AstraZeneca
  • Atopix Therapeutics
  • Australian Advisory Committee on Prescription Medicines
  • Axikin Pharmaceuticals
  • Bayer
  • BIOCORP
  • Biomarck Pharmaceuticals
  • BioMed X
  • Boehringer Ingelheim
  • British Lung Foundation
  • Celtaxsys
  • Chiesi Pharmaceuticals
  • Cipla
  • Circassia Pharmaceuticals
  • Cohero Health
  • Concert Pharmaceuticals
  • Corbus Pharmaceuticals
  • CRISPR Therapeutics
  • Crux Product Design
  • CURx Pharmaceuticals
  • Cystic Fibrosis Foundation
  • Dermira
  • DS Biopharma
  • Duke-NUS Academic Medical Centre
  • Dynavax
  • Editas Medicine
  • Eleventa
  • Ethris
  • Eularis
  • European Respiratory Society
  • EURRUS Biotech
  • Express Scripts
  • FindAir
  • Five Prime Therapeutics
  • Flatley Discovery Lab
  • Folium Optics
  • Foresee Pharmaceuticals
  • Forum of International Respiratory Societies
  • Galapagos
  • Gecko Health Innovations
  • Geisinger
  • Genzyme
  • Gilead Sciences
  • GlaxoSmithKline (GSK)
  • Glenmark Pharmaceuticals
  • Global Initiative for Asthma (GINA)
  • Global Initiative for Chronic Obstructive Lung Disease
  • Grifols
  • Guangzhou Medical University
  • H&T Presspart
  • Hanmi Pharmaceutical
  • Health Care Originals
  • Health Factors
  • HealthCore
  • Hewlett Packard Labs
  • Hikma Pharmaceuticals
  • Hydra Biosciences
  • IBM
  • ID Pharma
  • Imperial College London
  • Innoviva
  • Insmed
  • Inspiro Medical
  • International Federation of Pharmaceutical Manufacturers and Associations
  • Inventiva
  • Ivax
  • Janssen Biotech
  • Japanese Ministry of Health, Labour and Welfare
  • Jvion
  • KBP Biosciences
  • Koronis BioMedical Technologies
  • Laurent Pharmaceuticals
  • Ligand Pharmaceuticals
  • Mariposa Health
  • MedImmune
  • Merck
  • MicroDose Therapeutx
  • Moderna Therapeutics
  • MorphoSys
  • Mylan
  • National Health Service (NHS)
  • NIHR Manchester Biomedical Research Centre
  • Novartis
  • Novimmune
  • Novoclem Therapeutics
  • Novoteris
  • Ono Pharmaceuticals
  • OPKO Health
  • Orexo
  • Palobiofarma
  • Panmira Pharmaceuticals
  • Paranta Biosciences
  • Parion Sciences
  • Pearl Therapeutics
  • Pfizer
  • Pharmaxis
  • Pieris Pharmaceuticals
  • Polyphor
  • Propeller Health
  • ProQR Therapeutics
  • Proteostasis Therapeutics
  • Pulmagen Therapeutics
  • Pulmatrix
  • Qualcomm
  • Reata Pharmaceuticals
  • Regeneron Pharmaceuticals
  • Resolve Digital Health
  • RespiVert
  • REX Medical
  • Rigel Pharmaceuticals
  • Roche
  • Sanofi
  • Savara Pharmaceuticals
  • Singapore Health Services (SingHealth)
  • Southern Research
  • Spyryx Biosciences
  • Sterna Biologicals
  • Sunovion
  • Sunrise Labs
  • Synairgen
  • Syqe Medical
  • Teijin Pharma
  • Teva Pharmaceutical
  • Therapeutics Good Administration (TGA)
  • University of California Berkeley (UCB)
  • University of Iowa
  • US Food and Drug Administration
  • Vectura
  • Verona Pharma
  • Vertex Pharmaceuticals
  • Weill Cornell Medicine
  • World Health Organization
  • Xencor
  • YUNGJIN Pharmaceutical

Methodology

 

 

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