allergic rhinitis: allergen-specific immunotherapy – opportunity analysis … · reference code...

REFERENCE CODE GDHC023POA | PUBLICAT ION DATE SEPTEMBER 2014

ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY –

OPPORTUNITY ANALYSIS AND FORECAST TO 2018

Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018

Executive Summary

AR Immunotherapies: Key Metrics in the Seven Major Markets, 2013–2018 2013 Prevalent AR Cases Number of Cases of AR 147,561,088 Immunotherapy-Treated Population 3,802,729

2013 Market Sales US $172.5m 5EU $840.9m Japan $3.3m Total $1.02bn

Key Events (2013–2018) Level of Impact

SAIL Short Ragweed Sublingual Liquid Approval in the US in 2016 ↑↑

Merck HDM AIT Approval in the US in 2016 ↑↑↑ ALK HDM AIT Approval in the 5EU in 2015 ↑↑

Stallergenes HDM AIT Approval in the 5EU in 2015 ↑↑↑

Allergy Therapeutics – Pollinex Quattro Grasses in the 5EU in 2015 ↑↑↑

Cedartolen Added to Price Listing on the NHI Reimbursement List in Japan in 2014 ↑↑↑

HDM Subcutaneous Immunotherapy (SCIT) Approval in Japan in 2015 ↑↑

HDM AIT Approval (Torii via a licensing agreement with ALK-Abello) in Japan in 2016 ↑↑

HDM AIT Approval (Shionogi via a licensing agreement with Stallergenes) in Japan in 2016

↑↑

Japanese Cedar Pollen AIT Approval (Torii via a licensing agreement with ALK-Abello) in Japan in 2017

↑↑

2018 Prevalent AR Cases Number of Cases of AR 151,107,117 Immunotherapy-Treated Population 4,151,488 2018 Market Sales US $688.2m 5EU $879.9m Japan $47.1m Total $1.62bn Source: GlobalData 5EU = France, Germany, Italy, Spain, and UK; 7MM = US, 5EU, and Japan AIT: allergen immunotherapy tablet; AR: allergic rhinitis; HDM: house dust mite; NHI = National Health Insurance

The table above presents the key metrics for

allergic rhinitis (AR) in the seven major

pharmaceutical markets covered in this report (US,

France, Germany, Italy, Spain, UK, and Japan)

during the forecast period from 2013–2018.

Rapid Growth of the AR Market is Expected from 2013 to 2018

GlobalData estimates the 2013 sales for AR was

approximately $1.02 billion across the seven major

markets (7MM.) the 5EU (France, Germany, Italy,

Spain, and UK) contributed the majority of these

sales, generating an estimated $840.9m. By the

end of the forecast period, AR immunotherapy

sales will grow to approximately $1.62 billion, at a

Compound Annual Growth Rate (CAGR) of 9.7%

over the five-year period. The majority of sales will

continue to come from the 5EU, which will

represent more than 54% of the market (based on

the 7MM) in 2018.

Major drivers to the growth of the AR

immunotherapies market over the forecast period

will include:

The introduction of several allergen

immunotherapy tablets (AITs): Merck’s Grastek

(grass), Ragwitek (ragweed), and Mitizax

(HDM) tablets, as well as Greer’s Oralair

(grass) in the US. These new products

overcome the inconvenience of conventional

subcutaneous immunotherapies (SCIT).



Executive Summary

The launch of new sublingual immunotherapies

(SLIT) in Japan by both Torii and Shionogi.

Shionogi represents a new market entrant with

brand power that will lead to increased

awareness of SLITs in general and subsequent

market growth. In addition, to prescribe Torii’s

newly approved SLIT, Cedartolen, physicians

must undergo a compulsory online training

course. This will aid education of Japanese

physicians regarding this new generation of

specific immunotherapies (SIT), which will

likewise serve to drive the market.

The introduction of a new regulation by the

German health authorities has required

allergen manufacturers to acquire full

marketing authorization (MA) for products

containing several of the most prevalent

allergens. Following registration of these

products, the process of prescribing SIT,

including paperwork, should be become

simpler. Furthermore, as part of the

registration, products will need to demonstrate

clinical efficacy in randomized controlled

clinical trials. This is expected to improve

attitudes surrounding SIT and allow evidence-

based prescribing.

In the US, the higher profit margins associated

with AIT compared with SCIT will boost the US

market size, even if uptake is minimal.

Major barriers to the growth of the AR

immunotherapies market will include:

The introduction of new regulations by the

German health authorities will impact several

of the smaller allergen immunotherapy

manufacturers, for whom it will not be

economically viable to evaluate their products

in clinical studies.

Due to the high cost of AIT (which is

administered at home), the US market is

expected to grow rapidly following their launch.

However, US physicians will be financially

disincentivized to prescribe AIT, due to a lack

of revenue from physician visits.

European austerity measures will continue to

restrict healthcare spending, particularly in

southern Europe, tempering allergy vaccine

sales.



Executive Summary

The figure below illustrates the AR immunotherapy

sales for the 7MM during the forecast period.

Sales of AR SITs, 2013–2018

17%

83%

0%

US

5 EU

Japan

2013Total: $1.02bn

43%

54%

3%

2018Total: $1.62bn

Source: GlobalData 5EU = France, Germany, Italy, Spain, UK

Restricted Healthcare Spending in Europe Has Incentivized Partnerships to Deliver AITs to Underserved Markets

The slow recovery from the global economic

downturn in 2008 has impacted European health

expenditure. Subsequently, the imposed austerity

measures have caused a perceptible decline in the

allergen extract market, particularly in the 5EU,

which comprises a substantial proportion of the

worldwide immunotherapy market. Over the

forecast period, tempered growth in Europe is

expected. ALK-Abello and Stallergenes, the global

market leaders in allergen immunotherapy, have

begun to explore new underserved markets. By

partnering with companies in the US and Japan—

ALK with Merck and Torii, and Stallergenes with

Greer and Shionogi—both companies hope to

expand and deliver their AIT portfolios outside of

Europe.

Changes in German Legislation on Marketing Approval Will Increase Clinical Evidence of SIT Efficacy and Safety

Changes in German legislation require companies

to produce a national marketing application

containing documentation that supports the

efficacy and safety of their products that contain

the most prevalent allergen extracts. As Germany

represents the largest immunotherapy market

worldwide, this requirement will see companies

streamlining their portfolios and focusing their

efforts on evaluating their most profitable allergens

in randomized control trials by the imposed 2017

deadline. This will serve to legitimize SIT as a valid

causative therapy for AR and will provide a

standardized route to prescribe this therapy, as

currently it is often unlicensed and prescribed on a

named patient basis.



Executive Summary

AITs Will Be Launched in the US

The US market has conventionally been served by

a small group of FDA-licensed allergen

manufacturers who distribute extracts for

subcutaneous delivery. In 2014, ALK and

Stallergenes partnered with Merck and Greer,

respectively, to launch AIT in the US. AIT is

expected to have several advantages in the US

market; for example, in the US, SCIT is prescribed

by US allergists and requires patients to visit the

physician’s office frequently over three to five

years, and to remain under observation in the

physician’s office for 30 minutes post-

administration. In contrast, AIT can be

administered at home, dramatically increasing the

convenience of SIT. Furthermore, allergen extracts

in the US are currently inexpensive, with the bulk

of the cost of therapy coming from the physician’s

time. AIT has a much higher profit margin than

SCIT and therefore, even if patient uptake is

modest, there will be a large increase in the size of

the US market. This growth in the US market, with

a CAGR of 31.9%, will drive the increase in the

allergen immunotherapy market across the 7MM in

2018.

Launch of Clinically-Evaluated Allergen Immunotherapy in Japan Set to Bolster SIT-Treated Population

The Japanese immunotherapy market is currently

non-existent. Despite having a large population

with AR, fewer than 6,000 patients were treated

with SIT in 2013. Cedartolen, a sublingual liquid

containing the standardized Japanese cedar pollen

allergen, was evaluated in randomized controlled

trials and subsequently approved in 2014. As a

condition of approval, prescribing physicians must

undergo an online training course. This will

increase physician awareness of novel

developments in allergen immunotherapies, an

unmet need in the field of allergen immunotherapy.

The approval of SITs with clinically proven efficacy

will bolster the credibility of this therapy type in

Japan, which has seen a rapid decline in previous

decades, due to the advent of more convenient

symptomatic therapies with a rapid onset of action.

Within the five-year forecast period, three tablet

formulations for Japanese cedar pollen and HDM

will be launched in Japan. Torii has been the sole

player in this market since SIT became available in

Japan in the 1960s. However, Shionogi, in

partnership with Stallergenes, is set to enter the

SIT market in Japan. Their brand power and

extensive marketing base in Japan will place them

strongly in this field. Taken together, the extremely

small SIT-treated population is set to increase ten-

fold in the period between 2013 and 2018.

What Do Physicians Think?

The key opinion leaders (KOLs) interviewed for this

report highlighted a fundamental issue regarding

AR treatment and diagnosis: the various barriers to

patients’ initiation of SIT.



Executive Summary

“I think that both types of rhinitis – seasonal and

perennial – are increasing and the reasons are

different … For pollens, polysensitization is quite

relevant, because today 8 out of 10 patients are

polysensitized.”

EU Key Opinion Leader

“Of course it is easier to spend money on

antihistamines and nasal steroids. But the problem

is in the future, if this kind of patient with severe

allergic rhinitis increases, it is possible that this

kind of treatment is not sufficient and cannot satisfy

the patient. For this reason, immunotherapy and

the use of immunotherapy can in a way increase.”


“The problem of GPs is very relevant because,

unfortunately, they are not updated in the

development of immunotherapy. The majority of

[GPs] consider immunotherapy like many years

ago in the past, when they were administered just

by injection. This is a very critical problem, it is very

difficult to change the GP’s idea of immunotherapy

… It is very long-term work, currently this work is in

progress.”


“The problem is that [allergen immunotherapy] is

not affordable for many patients because it is quite

expensive. For this reason, we have to separate

from a clinical point of view as it is influenced by

economic crisis problem. For this reason, we are

forced to reduce the number of patients treated

with both sublingual and subcutaneous

immunotherapy.”


“The vast majority of immunotherapy, and the only

[immunotherapy] that has been approved in the

United States until a couple of weeks ago, has

been subcutaneous. And that has to be given

periodically and always in a physician’s office, so it

is inconvenient. Also, when you are dealing with

the pediatric population, there is a large group that

doesn’t want to go on injections.”

US Key Opinion Leader

“The most important thing to understand is the

allergy community in the United States that does

subcutaneous immunotherapy, economically it

makes up anywhere from as low as 10% to 50% of

their income every year. And there is a big financial

disincentive for doctors to recommend any of these

other treatments if it is going to cut into the

subcutaneous immunotherapy buy.’




Executive Summary

“I think that obviously the approval of tablets will

help [the number of patients taking SIT] because

they can again be administered at home, so I think

you know that will help at least in some groups and

may help … as far as needle phobia. So I think it

will increase the numbers that start

immunotherapy.”


“It is no longer so attractive to treat patients with

immunotherapy, since the reimbursement that has

been clearly reduced and that is why from

economic point of view it does not make sense for

a doctor to offer immunotherapy as a treatment.”


“To diagnose allergy adequately, to supply

subcutaneous immunotherapy, [physicians are] not

adequately reimbursed. So the skin prick test, the

blood sampling for specific IgE, the injections, that

is not reimbursed in an adequate way. … There

are initiatives to change that [reimbursement] in

some regions of Germany, we already see that

these initiatives have led to better reimbursement,

so there’s a lot of hope on the side of the

specialists that the situation will improve and this

will stop the decline in the use of the

immunotherapy.”


“Tablets are better for Japanese allergic patients.

Patients will prefer tablets to SCIT. If tablets are

available, SCIT will be out of sight. Japanese

people hate injections due to the needle pain.”

Japan Key Opinion Leader

“The most important thing is we can use the tablets

for children. That is very important. If you use the

tablet for children, maybe the number of patients

with allergic rhinitis taking [SIT] will increase by 10,

maybe even 20%.”

Japan Key Opinion Leader


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 8

1.1 List of Tables .................................................................................................................... 12

1.2 List of Figures ................................................................................................................... 13

2 Introduction ............................................................................................................................... 15

2.1 Catalyst ............................................................................................................................. 15

2.2 Related Reports ................................................................................................................ 16

2.3 Upcoming Related Reports ............................................................................................... 16

3 Disease Overview ..................................................................................................................... 17

3.1 Etiology and Pathophysiology ........................................................................................... 17

3.2 Classification ..................................................................................................................... 20

3.2.1 Seasonal and Perennial AR .......................................................................................... 20

3.2.2 ARIA Classification of AR .............................................................................................. 20

3.3 Diagnosis .......................................................................................................................... 21

3.4 Quality of Life .................................................................................................................... 22

3.5 Symptoms ......................................................................................................................... 23

4 Epidemiology ............................................................................................................................ 24

4.1 Disease Background ......................................................................................................... 24

4.2 Risk Factors and Comorbidities ........................................................................................ 25

4.2.1 Family history of allergic rhinitis is a strong predictor for allergic rhinitis in children and adults ........................................................................................................................... 26

4.2.2 Exposure to allergens in the environment increases the risk for allergic rhinitis ............. 27

4.2.3 Urban living elevates the risk of allergic rhinitis ............................................................. 27

4.2.4 Comorbidities ................................................................................................................ 28

4.3 Global and Historical Trends ............................................................................................. 29

4.3.1 US ................................................................................................................................. 30

4.3.2 5EU ............................................................................................................................... 31


Table of Contents


4.3.3 Japan ............................................................................................................................ 32

4.4 Forecast Methodology ....................................................................................................... 33

4.4.1 Sources Used................................................................................................................ 35

4.4.2 Sources Not Used ......................................................................................................... 38

4.4.3 Forecast Assumptions and Methods ............................................................................. 39

4.5 Epidemiological Forecast of Allergic Rhinitis (2013–2023) ................................................ 43

4.5.1 Total Prevalent Cases of Allergic Rhinitis ...................................................................... 43

4.5.2 Age-Specific Total Prevalent Cases of Allergic Rhinitis ................................................. 44

4.5.3 Sex-Specific Total Prevalent Cases of Allergic Rhinitis ................................................. 46

4.5.4 Age-Standardized Total Prevalence of Allergic Rhinitis ................................................. 48

4.5.5 Distribution of Total Prevalent Cases of Allergic Rhinitis by Severity ............................. 49

4.5.6 Distribution of Total Prevalent Cases of Allergic Rhinitis by Type .................................. 50

4.5.7 Allergic Rhinitis Total Prevalent Cases Sensitized to Specific Allergens ........................ 51

4.6 Discussion ........................................................................................................................ 52

4.6.1 Epidemiological Forecast Insight ................................................................................... 52

4.6.2 Limitations of the Analysis ............................................................................................. 53

4.6.3 Strengths of the Analysis ............................................................................................... 54

5 Competitive Assessment .......................................................................................................... 55

5.1 Overview ........................................................................................................................... 55

5.2 Treatment Algorithm.......................................................................................................... 55

5.2.1 First- and Second-Line Treatment: OTC and Prescription Antihistamines, Nasal Corticosteroids, and Minor Therapeutic Classes ........................................................... 57

5.2.2 Third-Line Treatment: Immunotherapy .......................................................................... 59

5.2.3 Types of SIT Marketing Approval .................................................................................. 64

5.3 Leading Immunotherapy Manufacturers ............................................................................ 66

5.3.1 ALK-Abello .................................................................................................................... 66

5.3.2 Stallergenes .................................................................................................................. 79

5.3.3 Allergy Therapeutics...................................................................................................... 90


Table of Contents


5.3.4 Allergopharma GmbH & Co. KG .................................................................................... 99

5.3.5 HAL Allergy Group ...................................................................................................... 106

5.3.6 Torii Pharmaceutical.................................................................................................... 111

5.4 US Market ....................................................................................................................... 117

5.4.1 Current Licensed US Allergen Extract Suppliers ......................................................... 121

6 Unmet Needs Assessment and Opportunity Analysis ............................................................. 124

6.1 Overview ......................................................................................................................... 124

6.2 Unmet Needs Analysis .................................................................................................... 126

6.2.1 Affordable Specific Immunotherapies in Countries Without Full Reimbursement ......... 126

6.2.2 A New Generation Tablet Formulation for Every Allergen............................................ 128

6.2.3 Increased Physician Referral to Specialists for Diagnosis and Immunotherapy Initiation ................................................................................................................................... 130

6.2.4 Increased Compliance to SIT ...................................................................................... 133

6.2.5 Clinical Evidence for the Use of SIT in Polysensitized Patients ................................... 134

6.2.6 Standardized Allergen Extracts in Japan ..................................................................... 135

6.3 Opportunity Analysis ....................................................................................................... 136

6.3.1 A Test to Determine Lifetime Immunity to an Allergen ................................................. 136

6.3.2 A Single-Dose Vaccine Course ................................................................................... 136

6.3.3 SIT Prescribed by a Range of Specialists .................................................................... 137

6.3.4 Label Expansion to Prophylactically Treat Asthma and to Reduce Asthma Exacerbations ................................................................................................................................... 138

7 Research and Development Strategies ................................................................................... 139

7.1 Overview ......................................................................................................................... 139

7.1.1 SCIT Allergen Modifications ........................................................................................ 139

7.1.2 Alternative Routes of Administration ............................................................................ 145

7.1.3 Allergen Immunotherapy in the Treatment of Asthma .................................................. 147

7.2 Clinical Trial Design ........................................................................................................ 150

7.2.1 Current Clinical Trial Design ........................................................................................ 150


Table of Contents


7.2.2 Selection of Clinically Relevant Trial Endpoints ........................................................... 151

7.2.3 Controlling Allergen Exposure: Environmental Exposure Chambers ........................... 154

8 Market Outlook ....................................................................................................................... 157

8.1 Top-Line, Five-Year Forecast .......................................................................................... 157

8.1.1 US ............................................................................................................................... 160

8.1.2 5EU ............................................................................................................................. 163

8.1.3 Japan .......................................................................................................................... 164

9 Appendix................................................................................................................................. 167

9.1 Bibliography .................................................................................................................... 167

9.2 Abbreviations .................................................................................................................. 182

9.3 Methodology ................................................................................................................... 188

9.4 Forecast Methodology ..................................................................................................... 188

9.4.1 Pediatric Allergic Rhinitis Population ........................................................................... 188

9.4.2 Specific Immunotherapy Drug-Treated Population ...................................................... 194

9.4.3 Companies Profiled ..................................................................................................... 194

9.4.4 Launch Dates .............................................................................................................. 195

9.4.5 General Pricing Assumptions ...................................................................................... 196

9.4.6 Individual Drug Class Assumptions ............................................................................. 197

9.4.7 Company-Level Forecast Assumptions ....................................................................... 201

9.5 Physicians and Specialists Included in This Study .......................................................... 205

9.6 About the Authors ........................................................................................................... 206

9.6.1 Analyst, Cardiovascular and Metabolic Disorders ........................................................ 206

9.6.2 Therapy Director – CVMD and Acting Director of Epidemiology .................................. 206

9.6.3 Global Head of Healthcare .......................................................................................... 207

9.6.4 Epidemiologist ............................................................................................................. 207

9.7 About GlobalData ............................................................................................................ 208

9.8 Disclaimer ....................................................................................................................... 208


Table of Contents


1.1 List of Tables

Table 1: Types of AR-Causing Allergens ................................................................................................... 17

Table 2: Common Symptoms of AR .......................................................................................................... 23

Table 3: Classification of Allergic Rhinitis .................................................................................................. 25

Table 4: Risk Factors and Comorbidities for Allergic Rhinitis ..................................................................... 26

Table 5: Prevalence of Most Frequently Occurring Comorbidities in People with Allergic Rhinitis ............... 29

Table 6: Age-Specific Prevalence of Hay Fever from the NHIS Survey in 2011.......................................... 31

Table 7: Age- and Sex-Standardized Self-Reported Total Prevalence (%) of Allergic Rhinitis, Ages 20–44

Years, 5EU.................................................................................................................................. 31

Table 8: Total Prevalence (%) of Allergic Rhinitis in the EU, Ages 6–14 Years........................................... 32

Table 9: 7MM, Sources of Data Used for the Total Prevalence and the Segmentations for Allergic Rhinitis 34

Table 10: 7MM, Sources Excluded for the Epidemiological Forecast of Total Prevalent Cases of Allergic

Rhinitis ........................................................................................................................................ 39

Table 11: 7MM, Total Prevalent Cases of Allergic Rhinitis, Both Sexes, Ages ≥18 Years, N, 2013–2023 ..... 43

Table 12: 7MM, Age-Specific Total Prevalent Cases of Allergic Rhinitis, Both Sexes, N (Row %), 2013 ...... 45

Table 13: 7MM, Sex-Specific Total Prevalent Cases of Allergic Rhinitis, Ages ≥18 Years, N (Row %), 2013 47

Table 14: 7MM, Distribution of Total Prevalent Cases of Allergic Rhinitis by Severity, Both Sexes, N (Row

%), 2013 ..................................................................................................................................... 50

Table 15: 7MM, Distribution of Total Prevalent Cases of Allergic Rhinitis by Type, Both Sexes, N (Row %),

2013............................................................................................................................................ 51

Table 16: 7MM, Proportion of Allergic Rhinitis Total Prevalent Cases Sensitized to Specific Allergens, Both

Sexes, %, 2013 ........................................................................................................................... 52

Table 17: AR Treatment Guidelines Available ............................................................................................. 56

Table 18: Product Profile – Grazax ............................................................................................................. 74

Table 19: ALK-Abello SWOT Analysis ......................................................................................................... 76

Table 20: Product Profile – Oralair .............................................................................................................. 86


Table of Contents


Table 21: Stallergenes SWOT Analysis ....................................................................................................... 88

Table 22: Product Profile – Pollinex Quattro Grass ...................................................................................... 96

Table 23: Allergy Therapuetics’ SWOT Analysis .......................................................................................... 98

Table 24: Product Profile – Allergovit ........................................................................................................ 103

Table 25: Allergopharma SWOT Analysis ................................................................................................. 105

Table 26: Product Profile – Purethal .......................................................................................................... 109

Table 27: HAL’s SWOT Analysis ............................................................................................................... 110

Table 28: Product Profile – Cedartolen ...................................................................................................... 114

Table 29: Torii SWOT Analysis ................................................................................................................. 116

Table 30: Overall Unmet Needs – Current Level of Attainment .................................................................. 126

Table 31: Top-Line Sales Forecasts ($m) for AR , Specific Immunotherapies 2013–2018 .......................... 158

Table 32: Key Events Impacting Sales for AR, Specific Immunotherapies 2013–2018 ............................... 160

Table 33: AR Market – Drivers and Barriers, 2013–2018 ........................................................................... 166

1.2 List of Figures

Figure 1: AR: Mechanisms of Allergic Response ........................................................................................ 19

Figure 2: ARIA Classification of AR Symptoms ........................................................................................... 21

Figure 3: 7MM, Total Prevalent Cases of Allergic Rhinitis, Both Sexes, Ages ≥18 Years, N, 2013–2023 ..... 44

Figure 4: 7MM, Age-Specific Total Prevalent Cases of Allergic Rhinitis, Both Sexes, N, 2013 ..................... 46

Figure 5: 7MM, Sex-Specific Total Prevalent Cases of Allergic Rhinitis, Ages ≥18 Years, N, 2013 .............. 48

Figure 6: 7MM, Age-Standardized Total Prevalence (%) of Allergic Rhinitis, Ages ≥18 Years, by Sex, 2013 ...

................................................................................................................................................... 49

Figure 7: ARIA Guidelines for the Treatment of AR..................................................................................... 57

Figure 8: ALK-Abello Product Pipeline ........................................................................................................ 72


Table of Contents


Figure 9: Stallergenes’ Product Pipeline ..................................................................................................... 83

Figure 10: Allergy Therapeutics’ Product Pipeline ......................................................................................... 93

Figure 11: Allergopharma’s Product Pipeline .............................................................................................. 101

Figure 12: HAL Allergy Group’s Product Pipeline ........................................................................................ 107

Figure 13: Torii’s Product Pipeline .............................................................................................................. 114

Figure 14: Sales of AR, Specific Immunotherapies 2013–2018 ................................................................... 159



Introduction

2 Introduction

2.1 Catalyst

The global specific immunotherapy (SIT) market for allergic rhinitis (AR) is highly fragmented, with

the US, Europe, and Japan having different SIT formulations available, under different regulatory

restrictions, with almost no historical company crossover between markets. Europe has the most

developed market, with subcutaneous immunotherapy (SCIT), sublingual immunotherapy (SLIT),

and allergen immunotherapy tablets (AITs) all being available. However, economy-driven

healthcare expenditure restrictions have led to negative growth in European SIT sales for many

companies, and now previously European-centric allergen extract manufacturers are partnering

with US and Japanese pharmaceutical companies to distribute their therapies in the previously

underdeveloped markets. This has been in conjunction with the introduction of national regulations

in Germany that require immunotherapies that treat allergies to the most prevalent allergens to gain

full marketing approval by demonstrating clinical efficacy and safety delivered in the appropriate

documentation. Due to the high cost of this process, allergen manufacturers in Europe are

streamlining their medical portfolios and conducting large-scale randomized clinical trials to assess

their products containing the most prevalent allergens. As Germany represents the largest allergen

immunotherapy market, meeting these requirements is essential to maintain revenue for many

allergen manufacturers reliant on this market. Prior to the introduction of the Regulation on

Therapeutic Allergens (Therapie-Allergene-Verordnung, TAV) in 2008, more than 6,000 different

allergen combinations were commercially available; however, according to the Paul Ehrlich Institute

(PEI), most of these have been withdrawn from the market (Brehler et al., 2013). This process has

the potential to consolidate the highly fragmented European SIT market by reducing the number of

smaller private allergen manufacturers and increasing the dominance of the major players.

Following Germany’s lead, Spain and Italy have also drafted therapy allergen ordinance and are

likely to introduce their own marketing restrictions; However, other countries’ legislation is unlikely

to significantly impact the SIT market, as companies will be able to apply for a European Union

Mutual Recognition Procedure (MRP) based on their national approval in Germany.

In the US, the introduction of AITs will drive growth in the AR immunotherapies market, due to their

high cost relative to standard subcutaneous allergen extracts. There are several barriers to SLITs’

market entry, but they will offer an option to patients who refuse SCIT. KOLs interviewed by

The global specific immunotherapy (SIT) market for allergic rhinitis (AR) is highly fragmented, with the US, Europe, and Japan having different SIT formulations available, under different regulatory restrictions, with almost no historical company crossover between markets.



Introduction

GlobalData suggest that around 50% of patients offered SCIT reject treatment, suggesting that

there is a large potential market for alternatives such as SLIT and AIT.

A further advancement in the SIT market is the clinical development of a new generation of tablet

formulations, moving away from the standard SCIT injections and SLIT drops. Tablet formulations

that have been evaluated according to a standardized stepwise algorithm, with dose-finding studies

and double-blind placebo-controlled efficacy trials, have gained marketing authorization (MA) via

the traditional routes. These products will continue to add legitimacy to immunotherapy as an

important treatment option for patients with AR. ALK-Abello and Stallergenes will lead this by

introducing their relevant allergens in tablet form into the Japanese and US markets through

licensing partners.

Japan, a market previously not widely treated with SIT, is set to see a new range of standardized,

clinically-evaluated products containing the two most prevalent allergens, house dust mite (HDM)

and Japanese cedar pollen. Available options will include AIT formulations previously unavailable

in the market. This will be key in a market where crude allergen extracts containing a range of

antigens were previously available. Advancements in SIT, particularly the advent of tablet

formulations, will increase the use of immunotherapy amongst the pediatric population. In a market

previously dominated by a sole allergen extract manufacturer, the introduction of a new entrant,

Shionogi, with its marketing power and reputation, is set increase awareness of allergen

immunotherapies. KOLs interviewed by GlobalData predicted that these factors will see a dramatic

increase in the immunotherapy-treated AR population in Japan.

2.2 Related Reports

GlobalData (2014). Asthma – Global Drug Forecast and Market Analysis to 2023, August 2014,

GDHC83PIDR.

GlobalData (2014). Allergic Conjunctivitis – Global Drug Forecast and Market Analysis to 2023,

August 2014.

2.3 Upcoming Related Reports

GlobalData (2014). Allergic Rhinitis – Global Drug Forecast and Market Analysis to 2023,

December 2014.


Appendix


9.7 About GlobalData

GlobalData is a leading global provider of business intelligence in the healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports, and

forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,

Singapore, and Australia.

9.8 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior

permission of the publisher, GlobalData.

allergic rhinitis: allergen-specific immunotherapy – opportunity analysis … · reference code...

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