drug delivery: inhalation devices report extract/media/informa...drivers of the inhalation drug...

Drug Delivery: Inhalation Devices Report ExtractUS, 5EU Markets, and Japan

REPORT EXTRACT

2 / October 2019 © Informa UK Ltd 2019 (Unauthorized photocopying prohibited.)

©2019 Meddevicetracker i #MDT19016

Drug Delivery: Inhalation Devices Table of Contents

Executive Summary .................................................................................. ES-1

i. Respiratory disease prevalence ........................................................................................ ES-1

ii. Inhalation drug delivery devices market .......................................................................... ES-1

a. Geographic market analysis ................................................................................ ES-2

iii. Market drivers and limiters ............................................................................................. ES-3

iv. Market leaders ................................................................................................................ ES-4

v. Methodology .................................................................................................................... ES-4

Exhibit ES-1: Inhalation drug delivery devices, market forecast, by product segment ($m),

2018-23 .................................................................................................................... ES-2

Exhibit ES-2: Inhalation drug delivery devices, market forecast, by region ($m),

2018-23 .................................................................................................................... ES-3

1. Inhalation Drug Delivery Technology ...................................................... 1-1

1.1 Technology ...................................................................................................................... 1-1

1.1.1 Metered dose inhalers .................................................................................... 1-1

1.1.2 Dry powder inhalers ........................................................................................ 1-2

1.1.3 Nebulizers ....................................................................................................... 1-2

2. Inhalation Devices for Asthma................................................................ 2-1

2.1 Epidemiology ................................................................................................................... 2-1

2.2 Products .......................................................................................................................... 2-2

2.2.1 Regulatory guidelines ...................................................................................... 2-2

2.2.2 AstraZeneca .................................................................................................... 2-3

2.2.3 Boehringer Ingelheim...................................................................................... 2-3

2.2.4 GlaxoSmithKline .............................................................................................. 2-3

2.2.5 Merck & Co ..................................................................................................... 2-4

2.2.6 SkyePharma/Vectura ...................................................................................... 2-4

2.2.7 Emerging products .......................................................................................... 2-5

2.3 Market analysis ............................................................................................................... 2-5

2.3.1 Advair and Breo............................................................................................... 2-7

2.3.2 Dulera .............................................................................................................. 2-7

2.3.3 Flutiform ......................................................................................................... 2-7

2.3.4 Spiriva .............................................................................................................. 2-8

2.3.5 Symbicort ........................................................................................................ 2-8

2.3.6 Combined market forecast ............................................................................. 2-8


©2019 Meddevicetracker ii #MDT19016


2.3.7 US market forecast ......................................................................................... 2-9

2.3.8 5EU market forecast ..................................................................................... 2-11

2.3.9 Japan market forecast ................................................................................... 2-14

2.4 Bibliography .................................................................................................................. 2-16

Exhibit 2-1: Asthma, epidemiology by region (millions), 2016-36 ........................................ 2-2

Exhibit 2-2: Selected inhaled asthma treatment products, 2019 ......................................... 2-4

Exhibit 2-3: Asthma market, forecasting methodology ........................................................ 2-6

Exhibit 2-4: Inhaled asthma treatment products, combined market forecast ($m),

2018-23 ..................................................................................................................... 2-9

Exhibit 2-5: Inhaled asthma treatment products, US market forecast ($m), 2018-23 ....... 2-11

Exhibit 2-6: Inhaled asthma treatment products, 5EU market forecast ($m), 2018-23 ..... 2-13

Exhibit 2-7: Inhaled asthma treatment products, Japan market forecast ($m), 2018-23 .. 2-15

3. Inhalation Devices for Chronic Obstructive Pulmonary Disease .............. 3-1

3.1 Epidemiology ................................................................................................................... 3-1

3.2 Products .......................................................................................................................... 3-2

3.2.1 AstraZeneca .................................................................................................... 3-2

3.2.2 Boehringer Ingelheim...................................................................................... 3-3

3.2.3 Chiesi Farmaceutici ......................................................................................... 3-3

3.2.4 GlaxoSmithKline .............................................................................................. 3-3

3.2.5 Novartis ........................................................................................................... 3-4

3.2.6 Emerging products .......................................................................................... 3-4

3.3 Market analysis ............................................................................................................... 3-6

3.3.1 Bevespi, Duaklir, PT010, Symbicort, and Tudorza .......................................... 3-6

3.3.2 Spiriva, Stiolto, and Striverdi ........................................................................... 3-7

3.3.3 Trimbow .......................................................................................................... 3-8

3.3.4 Advair, Breo, Anoro, Trelegy, and Incruse ...................................................... 3-8

3.3.5 Arcapta, Seebri, Utibron ................................................................................. 3-9

3.3.6 Combined market forecast ............................................................................. 3-9

3.3.7 US market forecast ....................................................................................... 3-10

3.3.8 5EU market forecast ..................................................................................... 3-13

3.3.9 Japan market forecast ................................................................................... 3-15

3.4 Bibliography .................................................................................................................. 3-17

Exhibit 3-1: COPD, epidemiology (millions), 2018-38 ........................................................... 3-2


©2019 Meddevicetracker iii #MDT19016


Exhibit 3-2: Selected inhaled COPD treatment products, 2019 ............................................ 3-5

Exhibit 3-3: COPD market, forecasting methodology ........................................................... 3-6

Exhibit 3-4: Inhaled COPD treatment products, combined market forecast ($m),

2018-23 ................................................................................................................... 3-10

Exhibit 3-5: Inhaled COPD treatment products, US market forecast ($m), 2018-23 .......... 3-12

Exhibit 3-6: Inhaled COPD treatment products, 5EU market forecast ($m), 2018-23 ........ 3-14

Exhibit 3-7: Inhaled COPD treatment products, Japan market forecast ($m), 2018-23 ..... 3-16

Appendix: Company Listing ........................................................................ A-1


©2019 Meddevicetracker ES-1 #MDT19016

Drug Delivery: Inhalation Devices Executive Summary

Executive Summary This comprehensive market and medical technology report provides an overview of the inhalation-based devices used in the management of asthma and chronic obstructive pulmonary disease (COPD), and includes an in-depth, product-specific market analysis. Countries covered by this report comprise the US, the five major EU markets (France, Germany, Italy, Spain, and the UK), and Japan. This report provides the following useful information:

• respiratory disease treatment overview • key epidemiology data on the prevalence of asthma and COPD in major world regions • related product portfolios offered by leading manufacturers • top selling inhalation drug delivery devices, as well as emerging products under development • in-depth market and competitive analyses.

Medical devices covered by this analysis include metered dose inhalers (MDIs) and dry powder inhalers (DPIs) for the treatment of asthma (discussed in Chapter 2) and COPD (discussed in Chapter 3). Nebulizers are also used to administer medications via inhalation for these respiratory diseases; however, their usage is limited to a small percentage of total treated caseloads, and as a result they are excluded from the scope of this analysis. i. Respiratory disease prevalence According to Datamonitor Healthcare, the 2018 combined prevalence of asthma and COPD in the countries covered by this analysis was approximately 111.6 million, with COPD accounting for 53.6% and asthma accounting for the remaining 46.4%. Over the next two decades, the numbers of total prevalent cases of asthma and COPD are expected to increase at absolute rates of 7.0% and 23.1%, respectively, as a result of the increasing and aging population. ii. Inhalation drug delivery devices market In 2018, combined sales of inhaled asthma and COPD devices in the countries covered by this analysis totaled approximately $10.4bn. Of this, asthma devices accounted for 52.5% and COPD devices accounted for 47.5%. Over the forecast period covered by this analysis, total sales are expected to increase at a compound annual growth rate (CAGR) of 3.0%, reaching an estimated $12.1bn in 2023 and combining 4.2% growth in the COPD segment and 1.9% growth in the asthma segment. By the end of the forecast period, COPD devices will account for the majority of sales, with 50.3%. Exhibit ES-1 presents the market forecast, by product segment, for inhalation drug delivery devices for 2018-23.




Exhibit ES-1: Inhalation drug delivery devices, market forecast, by product segment ($m), 2018-23

Device type 2018 2019 2020 2021 2022 2023 CAGR %

(2018-23)

Asthma devices 5,464.2 5,618.4 5,735.8 5,836.7 5,918.9 5,987.9 1.9

COPD devices 4,942.7 5,182.1 5,443.2 5,663.4 5,868.6 6,063.1 4.2

Total sales 10,406.9 10,800.5 11,179.0 11,500.1 11,787.5 12,051.0 3.0

Notes: Includes sales of inhaled Advair (GlaxoSmithKline), Breo Ellipta (GlaxoSmithKline), Dulera (Merck & Co), Flutiform (Vectura), Spiriva (Boehringer Ingelheim), and Symbicort (AstraZeneca) for asthma indications, and sales of inhaled drug/device combinations from AstraZeneca (Bevespi Aerosphere, Duaklir Pressair, Symbicort, and Tudorza Pressair), Boehringer Ingelheim (Spiriva Respimat and HandiHaler, Stiolto Respimat, and Striverdi Respimat), Chiesi Farmaceutici (Trimbow), GlaxoSmithKline (Advair, Anoro Ellipta, Breo Ellipta, Incruse Ellipta, and Trelegy Ellipta), and Novartis (Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler) for COPD indications.

Source: Datamonitor Healthcare a. Geographic market analysis In terms of geographic sales data, the US accounted for 66.7% of sales of inhaled asthma and COPD devices in 2018, followed by the five major EU markets with 21.8% and Japan with the remaining 11.5%. Over the forecast period covered by this analysis, US sales are expected to increase at a CAGR of 4.5%, with sales in the five major EU markets and Japan declining at rates of -0.1% and -0.9%, respectively. Exhibit ES-2 presents the inhalation drug delivery devices market forecast, by region, for 2018-23.




Exhibit ES-2: Inhalation drug delivery devices, market forecast, by region ($m), 2018-23

Country/region 2018 2019 2020 2021 2022 2023 CAGR %

(2018-23) US 6,944.9 7,349.9 7,736.9 8,065.7 8,366.3 8,651.3 4.5

5EU 2,265.5 2,253.4 2,249.9 2,255.0 2,258.0 2,255.5 -0.1

Japan 1,196.5 1,197.2 1,192.2 1,179.4 1,163.2 1,144.2 -0.9

Total sales 10,406.9 10,800.5 11,179.0 11,500.1 11,787.5 12,051.0 3.0

Notes: Includes sales of inhaled Advair (GlaxoSmithKline), Breo Ellipta (GlaxoSmithKline), Dulera (Merck & Co), Flutiform (Vectura), Spiriva (Boehringer Ingelheim), and Symbicort (AstraZeneca) for asthma indications, and sales of inhaled drug/device combinations from AstraZeneca (Bevespi Aerosphere, Duaklir Pressair, Symbicort, and Tudorza Pressair), Boehringer Ingelheim (Spiriva Respimat and HandiHaler, Stiolto Respimat, and Striverdi Respimat), Chiesi Farmaceutici (Trimbow), GlaxoSmithKline (Advair, Anoro Ellipta, Breo Ellipta, Incruse Ellipta, and Trelegy Ellipta), and Novartis (Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler) for COPD indications.

Source: Datamonitor Healthcare iii. Market drivers and limiters Drivers of the inhalation drug delivery devices market include:

• the increasing prevalence of asthma and COPD due to the growing population and the aging of the population

• low price discounts for generics due to the complexity of developing the drugs and associated devices, causing some patients to continue using a branded product rather than switching to a generic option

• the introduction of triple-combination therapies, which eliminate the need for patients to use multiple devices for disease control.




Limiters of the inhalation drug delivery devices market include: • generic competition for blockbuster drug/device combos such as Advair and

Symbicort • for ICS and LAMA monotherapies, a trend toward combination therapies • a downward trend in cigarette smoking is expected to contribute to a decrease

in the incidence of COPD; however, prevalence is expected to continue to rise, as the disease is highly related to aging.

iv. Market leaders The three leading competitors in the inhalation drug delivery devices market, accounting for 89.1% of overall sales, are:

• GlaxoSmithKline – With a 45.4% share of the overall inhaled drug delivery devices market as defined by this analysis, including 56.2% of the asthma devices market (where the company is the market leader) and 33.5% of the COPD devices market based on sales of its Advair, Anoro Ellipta, Breo Ellipta, Incruse Ellipta, and Trelegy Ellipta products.

• AstraZeneca – With a 22.0% share of the total market, including 31.1% of the asthma devices market and 12.0% of the COPD devices market based on sales of its Bevespi Aerosphere, Duaklir Pressair, Symbicort, and Tudorza Pressair products.

• Boehringer Ingelheim – With a 21.7% share of the total market, including 5.4% of the asthma devices market and 39.7% of the COPD devices market (where the company is the market leader). Boehringer Ingelheim competes via its Spiriva, Stiolto Respimat, and Striverdi Respimat devices.

v. Methodology Multiple qualitative and quantitative techniques were used to develop the market segment forecasts in this analysis, allowing estimates to be crosschecked to ensure accuracy. All of Meddevicetracker’s forecasts are reviewed and verified by a team of medical device industry analysts and are benchmarked against vendors’ own data, where possible. This analysis primarily utilized data from Datamonitor Healthcare’s Forecast: Asthma and Forecast: COPD reports. Meddevicetracker analysts also have exclusive access to content from leading proprietary medtech/healthcare intelligence services and the industry analysts who produce them. These services include Meddevicetracker, Biomedtracker, Medtech Insight, In Vivo, Citeline, Medtrack, and Strategic Transactions. Links to these products are listed at the end of this methodology statement. Market forecasts A combination of regression and cause-and-effect analysis of the data (of different growth drivers and resistors) was used to provide the forecasts for market sizing.




Prices used in projections of market revenues are average prices paid by the end user for the products, and are derived via supplier and user quotations or estimates based on typical industry discounts from list prices. Data concerning unit shipments, market values, growth rates, and market share were incorporated into Meddevicetracker’s forecasting and market share analysis models, which were used to derive market estimates for future years. A rate factor is utilized to determine the speed with which the market develops, which is similar to that observed for markets for other medical products and is adjusted to match historical data for the market under analysis. Primary research Datamonitor Healthcare’s 2017 primary research was used to calculate the diagnosed asthma and COPD populations, the number of patients seeking maintenance treatment, as well as drug-treated patient rates. Each of these rates was applied by severity, by country. Brand penetration for each disease severity was based on 2017 primary research data. For select brands, formulation-specific rates were applied. Secondary research Numerous secondary sources for statistical and technological information used in this analysis include organizations such as the American Lung Association, the European Respiratory Society, National Institutes of Health, the US Food and Drug Administration, the World Health Organization, and publications in the scientific and trade literature. While these are believed to be the best secondary sources of data on disease incidence and prevalence, the estimation of trends from these data is complicated by periodic changes in reporting and classification methods. Figures cited are for the most recent years publicly available. In addition to the use of corporate annual and quarterly reports, financial information for this analysis was obtained from company prospectuses and press releases, Forms 10-K and 10-Q, investment analysts’ reports, product catalogs, and price lists. Other Informa Pharma Intelligence products used in the preparation of this analysis include: Meddevicetracker: www.meddevicetracker.com Biomedtracker: www.biomedtracker.com Medtech Insight: https://medtech.pharmamedtechbi.com In Vivo: https://invivo.pharmamedtechbi.com Datamonitor Healthcare: www.datamonitorhealthcare.com Citeline: https://citeline.com Medtrack: www.medtrack.com Strategic Transactions: www.pharmamedtechbi.com/deals


©2019 Meddevicetracker A-1 #MDT19016

Company Listing Appendix

Appendix: Company Listing AstraZeneca PLC www.astrazeneca.com Boehringer Ingelheim Group/ CH Boehringer Sogn AG & Ko KG www.boehringer-ingelheim.com Chiesi Farmaceutici SpA www.chiesi.com GlaxoSmithKline PLC www.gsk.com Merck & Co, Inc. www.merck.com Novartis AG www.novartis.com Vectura Group PLC www.vectura.com

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