Chronic Obstructive Pulmonary Disease Forecast and Market Analysis to 2026
Author: Pammy Spicer
Publisher: Datamonitor Healthcare
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Disease Overview
Chronic obstructive pulmonary disease (COPD) is defined by persistent airflow limitation (reduction in the ability to exhale at a normal rate and volume). While chronic and progressive dyspnea (shortness of breath) is a key symptom, patients may also present with productive cough. Significant exposure to noxious particles or gases, namely tobacco smoke, is the primary cause of the underlying alveolar and airway abnormalities that result in the airflow limitation and respiratory symptoms that characterize the disease. However, other environmental and occupational exposures or genetic abnormalities may also contribute to symptoms.
Latest key takeaways
- Datamonitor Healthcare estimates that in 2018, there were approximately 307.0 million prevalent cases of chronic obstructive pulmonary disease (COPD) worldwide, and forecasts that number to increase to 328.9 million prevalent cases by 2027.
- The “ABCD” GOLD treatment guidelines focus on exacerbation risk and patient-reported outcomes to determine pharmacological treatment strategies, independent of spirometric value.
- Dual bronchodilator combinations are being considered as the new gold standard over long-acting muscarinic antagonist (LAMA) Spiriva in the treatment of more severe COPD.
- Triple inhaled corticosteroid/long-acting beta 2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) fixed-dose combination therapies delivered through a single inhaler bring convenience to more severe patients. For Breztri Aerosphere’s FDA submission, AstraZeneca included data from the KRONOS study, but the ETHOS trial did not complete primary endpoints until mid-2019. As such, the FDA issued a complete response letter to AstraZeneca, benefitting rival GlaxoSmithKline’s marketed Trelegy Ellipta with a longer time as the only triple on the US market. More recently, Breztri has gained approval in the US, and a European opinion is expected during 2020.
- IL-5 inhibitors have disappointed in the broader population of more severe COPD patients. However, ongoing studies are evaluating AstraZeneca’s Fasenra (benralizumab) and GlaxoSmithKline’s Nucala (mepolizumab) in individuals with high eosinophils. Top-line results from Fasenra’s RESOLUTE and Nucala’s MATINEE trials are expected in the coming years, while Phase III results from Sanofi and Regeneron’s dual IL-4 and IL-13 inhibitor Dupixent (dupilumab) are expected in 2023.
- Nebulizers are limited by convenience and often are being developed by smaller companies that lack the commercial resources of large pharma.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Disease definition
8 Diagnosis
8 Patient segmentation
11 GOLD treatment recommendations
13 TREATMENT
13 Maintenance treatment
15 Oral therapies for maintenance treatment
15 Non-pharmacological management of COPD
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
28 PIPELINE DRUGS
36 KEY REGULATORY EVENTS
36 Cipla Files ANDA For Advair Rival; FDA Will Now Consider Indian Firm’s Version Alongside Hikma
36 Can Glenmark’s Triple Therapy Combo Move COPD Treatment Needle?
36 String Of Positives For Lupin Lifts Outlook
36 Cipla Granted Approval For First US Proventil Rival
37 Mylan Launches Advair Rival In Canada
37 Canada Explains Studies Needed For Subsequent-Entry Orally Inhaled Products
37 Perrigo Rolls Out US ProAir Rival
37 FDA Eyes Adverse Events For Mylan’s Wixela Inhub
38 Lupin US Launches On Track But Albuterol ‘Clarity’ Awaited
38 Blow To AZ As FDA Rejects COPD Contender
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 Iconovo And Amneal Collaborate On Symbicort Rival
40 Circassia Ends AZ Deal To Dig Itself Out Of Debt Hole
40 Chiesi Tackles Carbon Footprint Of Inhalers
40 Lupin-Aptar Launch India’s First Smart Device For MDIs At $22 Apiece
41 Sanofi Strikes Deal To Develop Respiratory Health App
41 Lannett Strikes Deal For Respirent’s US Advair Rival
42 CLINICAL TRIAL LANDSCAPE
43 Sponsors by status
44 Sponsors by phase
45 Recent events
49 DRUG ASSESSMENT MODEL
49 LAMAs
49 LABAs
50 LABA/LAMAs
50 ICS/LABAs
50 ICS/LABA/LAMAs
51 Biologics
51 PDE3/4 inhibitor
53 MARKET DYNAMICS
54 FUTURE TRENDS
54 Triple therapies will drive modest growth of the COPD market
54 The impact of nebulized treatment is limited
54 Biologics present an opportunity that is limited to certain patient subsets
56 CONSENSUS FORECASTS
63 RECENT EVENTS AND ANALYST OPINION
63 Breztri Aerosphere for COPD (June 24, 2020)
64 RPL554 (Inhaled) for COPD (March 31, 2020)
66 Breztri Aerosphere for COPD (October 1, 2019)
67 Breztri Aerosphere for COPD (August 28, 2019)
70 Multiple Drugs for COPD (June 25, 2019)
72 KEY UPCOMING EVENTS
73 UNMET NEEDS
73 Characterizing patient subpopulations
73 Developing more effective means of managing exacerbations
73 Improving inhaler technique and compliance
74 BIBLIOGRAPHY
74 Prescription information
76 APPENDIX
LIST OF FIGURES
18 Figure 1: Trends in prevalent cases of COPD, 2018–27
28 Figure 2: Overview of pipeline drugs for COPD in the US
28 Figure 3: Pipeline drugs for COPD, by company
29 Figure 4: Pipeline drugs for COPD, by drug type
29 Figure 5: Pipeline drugs for COPD, by classification
39 Figure 6: Probability of success in the COPD pipeline
42 Figure 7: Clinical trials in COPD
42 Figure 8: Top 10 drugs for clinical trials in COPD
43 Figure 9: Top 10 companies for clinical trials in COPD
43 Figure 10: Trial locations in COPD
44 Figure 11: COPD trials status
45 Figure 12: COPD trials sponsors, by phase
49 Figure 13: Datamonitor Healthcare’s drug assessment summary for COPD
53 Figure 14: Market dynamics in COPD
54 Figure 15: Future trends in COPD
64 Figure 16: Breztri Aerosphere for COPD (June 24, 2020): Phase III – ETHOS
66 Figure 17: RPL554 (Inhaled) for COPD (March 31, 2020): Phase II – Metered-Dose Inhaler (MDI) Formulation
70 Figure 18: Breztri Aerosphere for COPD (August 28, 2019): Phase III – ETHOS
72 Figure 19: Key upcoming events in COPD
LIST OF TABLES
9 Table 1: Modified British Medical Research Council (mMRC) Questionnaire
10 Table 2: COPD Assessment Test (CAT)
11 Table 3: COPD assessment, by spirometric grade
12 Table 4: The “ABCD” assessment tool
13 Table 5: Inhaled bronchodilators
14 Table 6: Combination therapies
17 Table 7: Prevalent cases of COPD, 2018–27
20 Table 8: Marketed drugs for COPD
30 Table 9: Pipeline drugs for COPD
57 Table 10: Historical global sales, by drug ($m), 2015–19
61 Table 11: Forecasted global sales, by drug ($m), 2020–24
63 Table 12: Breztri Aerosphere for COPD (June 24, 2020)
65 Table 13: RPL554 (Inhaled) for COPD (March 31, 2020)
66 Table 14: Breztri Aerosphere for COPD (October 1, 2019)
68 Table 15: Breztri Aerosphere for COPD (August 28, 2019)
70 Table 16: Multiple Drugs for COPD (June 25, 2019)
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