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).
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 3 © 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
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.
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 4 © 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
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.
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 5 © 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
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.
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 6 © 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
“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.”
EU Key Opinion Leader
“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.”
EU Key Opinion Leader
“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.”
EU Key Opinion Leader
“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.’
US Key Opinion Leader
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 7 © 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
“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.”
US Key Opinion Leader
“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.”
EU Key Opinion Leader
“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.”
EU Key Opinion Leader
“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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 13 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 14 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 15 © 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
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.
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 16 © 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
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.
Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecast to 2018 208 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Appendix
ALLERGIC RHINITIS: ALLERGEN-SPECIFIC IMMUNOTHERAPY – OPPORTUNITY ANALYSIS AND FORECAST TO 2018
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.