`
`REF ERENCE COOE GBHC1TSPIOR| PUBLICATION DATE SEPTEMBER 2015
`
`GlobalData »
`PharmaPoint
`
`
`
`-ALLERGIC RHINITIS es
`GLOBAL DRUGFORECAST =~ MARKETANALYSIS —
`|
`TO 2024
`
`
`
`
`
`MEDA_APTX03503458
`CIP2053
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`PTX0397-00001
`
`CIPLA LTD. EXHIBIT 2026 PAGE1
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`

`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`Executive Summary
`Markets, 2014-2024
`UI ciae emaCmeee hl(ele
`
`
`155,237,386
`Numberofcases ofAR
`Drug-treated population
`35,877,112
`
`The table above presents the key metrics for
`
`allergic
`
`rhinitis
`
`(AR)
`
`in
`
`the
`
`seven major
`
`pharmaceutical markets
`
`(7MM)
`
`(US, France,
`
`Germany, Italy, Spain, UK, and Japan) during the
`
`
`
`us
`BU“_‘(‘(aCC;'t
`
`Japan
`Total
`
`$2.8bn
`$2.5bn
`— $4.88br
`$7.18bn
`
`Number of drugs in Phase IIb—lil
`Number of first-in-class drugs
`
`forecast period from 2014-2024.
`
`Allergic Rhinitis Market Will Grow to $7.3
`
`Billion by 2024
`
`GlobalData
`
`astimated
`
`the
`
`sales
`
`for
`
`AR
`
`(prescription drugs only) in 2014, the base year of
`
`the forecast period, at approximately $7.20 billion
`
`across the seven markets covered in this report.
`
`The US contributed 38% of these sales, generating
`
`Nasonex patent expiry in 2014
`bit
`Patanase patent expiry in 2014
`L
`Astepro patent expiry in 2014
`4
`Singulair patent expiry in Japan in2016
`Wa
`“Veramystgeneric entryin2016
`a
`HP-3060 drug launch in 2017
`tT
`§-565739 launch in the US and Japar in
`+
`2017
`in the 7MM are forecast
`to remain stagnant to
`
`
`2024PrevalentARCases
`$7.27 billion at a Compound Annual Growth Rate
`Number of cases of AR
`187 426,939
`
`"Drug-treated:popuiation 36,430,1 7
`(CAGR) of 0.1% over the 10-year period. The
`second-generation Ht
`receptor antagonists and
`
`an estimated $2.8 billion. This was mainly due to
`
`the much higher prices of AR medications in the
`
`US,
`
`and the jack of over-the-counter
`
`(OTC}
`
`intranasal corticosteroids (INCS)
`
`for AR in this
`
`market in the base year.
`
`By the end of the forecast period in 2024, AR sales
`
`us
`
`SEU
`
`$2.74br
`$2.57 bn
`
`Japan
`Total
`
`‘Source;GlobalData
`“SEU = France,Germany, aly,Spainpand UK
`
`$1,96br,
`$7.27bn
`
`INCS are the leading drug classes in terms of
`
`market value. The INCS currently capture almost
`half tne total AR market; however,
`their market
`
`share
`
`will
`
`shrink
`
`to
`
`34% as_
`
`allergen
`
`the treatment of
`for
`(AITs)
`immunotherapies
`moderate-to-severe AR enter the market over the
`
`forecast period and start dominating this space,
`
`growing from 14% to 26% of the total AR sales.
`
`The uptake of these nove! drugs will be a major
`
`driver of AR market growth, and will offset the dip
`
`Allergic Rhinitis - Global DrugForecast and Market Analysis to2024
`@ GtobalDate. This report isa licensed product and is-not to be copied, reproduced, shared or reseldjn-any forn
`
`MEDA_APTX03503459
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`

`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`
`*
`
`Increasing
`
`pressure
`
`for
`
`cost-effectiveness
`
`across all markets, which will limit the pricing of
`
`new products, and in some cases, prevent
`their reimbursement.
`
`The figure below illustrates the sales for AR in the
`
`US, SEU, and Japan during the forecast period.
`
`Sales for AR by Region, 2014-2024
`2014
`Total: $7,181.3m
`
`mg France
`
`These overcome—thenew products
`
`
`
`mGermany
`inconvenience of conventional subcutaneous
`
`in
`sales caused by Nésonex’s
`(mometasone
`furoate) 2014 patent expiry. The US market size
`
`will shrink slightly compared to the other markets
`
`— at a negative CAGR of 0.1% — due to the
`
`expected surge in generic and OTC competition in
`
`this market, driven by the first approvals cf OTC
`
`INCS.
`
`In 2024, the US will retain its AR market
`
`share, representing 38% of the total market.
`
`The major drivers of the growth of the AR market
`
`over the forecast period include:
`
`e
`
`The intreduction of several AIT tablets: Merck's
`
`Grastek {grass), Ragwitek (ragweed), and
`
`Mitizax (house dust mite (HDM))
`
`tablets, as
`
`well as Greer's Oralair
`
`(grass)
`
`in the US.
`
`immunatherapies (SCITs).
`
`*
`
`The increasing global prevalence of AR.
`
`The major barriers to the growth of the AR market
`inctude:
`
`» Generic erosion of the leading brands for AR
`
`treatment,
`
`such
`
`as Nasonex, Astepro
`
`{azelastine
`
`hydrochloride},
`
`and
`
`Singulair
`
`{montelukast sodium) in (Japan).
`
`»
`
`The increasing push for patients to seif-
`
`medicate using OTC drugs will decrease the
`
`prescription AR drug marketsize.
`
`58.4% aUS
`6.5% 6.9%
`
`13.4%
`
`Italy
`
`2024
`Total: $7,265.3m
`
`wSpain
`a@UK
`
`27.0%
`
`37.7%
`
` mdapan
`
`14% ‘oe
`
`i
`
`13.5%
`
`7.4%
`
`Source: GlobalData
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`i Globalbata. This reportis alicensed product and is:not to be copied, reproduced, shared or resold-in any-form.
`
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`

`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`Companies are Diverting Their AR Portfolios to
`the OTC Market
`
`Historically, the AR market has been very large,
`
`with several companies
`
`launching drugs
`
`that
`
`gained blockbuster status.
`
`In particular, Merck &
`
`Co. has had a very strong presence,
`
`leading the
`
`AR market with its three franchises, Nasonex,
`
`singulair,
`
`and Clarinex (desloratadine). Other
`
`the US. This is set to have a large impact on the
`
`prescription drug treatment rate, as patients are
`
`incentivized to self-diagnose and self-medicate
`
`using the growing number of OTC options. Direct-
`
`to-consumer
`
`(DTC)
`
`advertising,
`
`increased co-
`
`payments on prescription AR drugs, and stretched
`
`healthcare resources, as well as the increasingly
`
`competitive cast of OTC-equivalent options, will all
`
`
`
`
`
`
`
`further the progressively increasing trend for AR
`players AR market=includedefining the
`patients to seek treaiment independently.
`
`GlaxoSmithKline
`
`(GSK),
`
`Sanofi,
`
`and
`
`Teva.
`
`However, over the past decade, almost all the key
`
`GlobalData expects
`
`the large pharmaceutical
`
`drugs for the treatment of AR symptoms havelost
`
`companies with a previously strang foothold in the
`
`patent
`
`protection,
`
`including
`
`Sanofi’s Allegra
`
`AR market, such as GSK, to be increasingly less
`
`(fexofenadine hydrochloride), Pfizer(UCB Pharma’s
`
`focused on AR drugs. Instead, the major players
`
`are investing in research and development (R&D)
`fer
`respiratory indications, but
`for asthma anc
`
`chronic obstructive pulmonary disease (COPD),
`rather than for AR.
`
`Zyrtec (cetirizine hydrochloride) and two of Merck's
`
`blockbuster drugs, Singulair and Nasonex. As a
`
`result, AR, which was once a blockbuster-status
`
`therapy area,
`
`is
`
`now highly
`
`saturated and
`
`genericized, with companies seeing large declines
`
`in the sales of their respiratory portfolios due to
`
`generic erosion.
`
`In an attempt
`
`to retain a revenue stream from
`
`branded generics,
`
`companies have sought a
`
`successful strategy to convert their AR prescription
`
`drugs to OTC status, known as the Rx-tc-OTC
`
`switch,
`
`transferring
`
`these
`
`products
`
`to
`
`their
`
`respective consumer care units. The most recent
`
`examples
`
`of
`
`this
`
`are
`
`the Food
`
`and Drug
`
`Administration's (FDA's) approval of OTC status
`
`for Sanofi’s Nasacort Allergy 24HR (triamcinolone
`
`intranasal)
`
`and GSK’s
`
`Flonase
`
`(fluticasone
`
`propionate), the first INCS to be available OTC in
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`i Globalbata. This reportis alicensed product and is:not to be copied, reproduced, shared or resold-in any-form.
`
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`
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`

`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`The figure befow provides an analysis of
`
`the
`
`Japanese pollen counts have grown five fold over
`
`company porticlio gap in AR during the forecast
`
`the past three decades. A primary cause of the
`
`period.
`
`Company Portfolio Gap Analysis in AR, 2014-2024
`
`High
`
`&.
`wh
`SANOFI
`
`Products Low
`StrengthofMarketed
`
`rising pollen levels is the afforestation policy of
`
`cedar,
`
`cypress,
`
`and birch
`
`trees, which was
`
`inttoduced during the post-World War | era (1949-
`
`#954)
`
`to provide a steady supply of domestic
`
`lumber. Today, there are an estimated 4.5 billion
`
`cedar trees in Japan. In addition to the increasingly
`
`prevafent Japanese tree pollen, Asian dust events
`
`eccur, where smog laden with fine particles less
`
`than 2.5 micrometers
`
`in diameter, known as
`
`PM2.5, enters Japan through from inland China —
`
`for example,
`
`from the Gobi Desert, where the
`
`yellow dust picks up dirt and pollen and carries it to
`
`South Korea and Japan via the westerly winds.
`
`Increasing pollution from this region is contributing
`
`ta the AR problem in Japan.
`
`Furthermore, studies have shown ihat pollen tevets
`
`are rising in tandem with global warming. Glabal
`
`climate change is evidenced by the increasing
`
`average
`
`earth
`
`temperature,
`
`increasing
`
`anthropogenic (caused by humans) greenhouse
`
`gas levels, and elevated pollen levels. Pollutants of
`
`interest include carbon dioxide (CO2}, ozone (Os),
`
`and nitrous oxide (NO2), because they can
`
`enhance the allergic
`
`response
`
`and
`
`lead
`
`to
`
`increased
`
`symotams
`
`of
`
`allergic
`
`respiratory
`
`diseases, Heightened CO, levels stimulate pollen
`
`production
`
`via
`
`photosynthesis
`
`and
`
`increased
`
`growth in muitiple investigated plant species (Lin
`
`and Zacharek, 2012), Allergen patterns are also
`
`changing in response to climate change, and air
`
`Strength of Pipeline
`Source: GiobalData
`
`There is a Growing Prevalence of AR Patients
`
`AR is
`
`becoming
`
`an
`
`increasingly
`
`prevalent
`
`condition, with the most commen form being
`
`moderate to severe in nature (Baena-Cagqnani et
`
`al,, 2015). According to the European Academy of
`
`Allergy and Clinical Immunology (EAACI), 50% of
`
`Europeans will suffer fram an allergy by 2027
`
`(Papadopoulos
`
`ef
`
`al.,
`
`2012}. A GlobalData
`
`epidemiological study estimated that about one in
`
`seven people in the US have been diagnosed with
`
`AR at some point in their life, or about 43 million
`
`people. This rate appears to be on the rise, and is
`
`expected to reach over 46 million by 2024.
`
`Allergic Rninitis — Global Drug Forecast and Market Analysis to 2024
`© GlobalDats. This report is-a licensed product and is not to be copied, reproduced, shared or resold in any form
`
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`

`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`poliution can modify the allergenic potential of
`
`antihistamines (AHs),
`
`INCS, and orai
`
`leukotriene
`
`poliens,
`
`especially
`
`under
`
`specific weather
`
`conditions. The prevalence of asthma and alfergic
`
`receptor antagonists (LRAs), which are also xnown
`as leukotriene inhibitors and antileukotnenes. INCS
`
`diseases has increased dramatically during the
`
`and AHs are the gold-standard,first-line therapies
`
`past few decades (D'Amato et al., 2013). This
`
`for AR patients. However, despite
`
`receiving
`
`notion
`
`is
`
`supported by
`
`the
`
`change in
`
`the
`
`maximum doses of evidence-based therapy as
`
`prevalence of AR in the US population, from 10%
`
`directed by the ARIA (Allergic Rhinitis and its
`
`in 1979 to 30% in 2000, It has been postulated that
`
`Impact
`
`on Asthma)
`
`guidelines,
`
`a
`
`significant
`
`the changing environment, particularly the trend of
`
`percentage (approximately 20%) of patients with
`
`global warming, may lead to increased pollen
`
`AR, particularly moderate to severe AR, have
`
`exposure and expanded environments for
`
`the
`
`inadequately controlled symptoms (Bousquetet al.,
`
`growth of numerous plant species. An increase in
`
`2010). Refractory patients are often diagnosed with
`
`the growing season, with earlier flowering and
`
`severe chronic upper airway disease (SCUAD),
`
`possibly increased airborne pollen counts, could be
`
`and represent a therapeutic challenge clinically.
`
`the consequences of the projected rise in the
`
`Furthermore, AR is often undiagnosed; in Eurepe,
`
`earth's temperature.
`
`as many as 25-60% of patients with AR aré not
`
`diagnosed
`
`(Bauchau
`
`and Durham,
`
`2004).
`
`Pollen seasons are set
`
`to last
`
`longer and to
`
`become
`
`increasingly more
`
`intense.
`
`[f pollen
`
`seasons are going to overlap more frequently, the
`
`severity
`
`of
`
`symptoms
`
`experienced
`
`by
`
`polysensitized patients is set
`
`to increase. This
`
`increase in the AR prevalence will be a strong
`
`driver of the growth of this market, as the AR
`
`patient pool will
`
`increase,
`
`leading to higher
`
`consumption of medications used to treat
`disease.
`
`the
`
`There is a Large Unmet Need for the Treatment
`
`of Severe, Persistent AR That is Refractory to
`
`the Standard Therapies
`
`AR symptoms can be controlled in the majority of
`
`pattents using the current standard therapies,
`
`which are based mainly on combinations of
`
`there are considerably high unmet
`Therefore,
`needs within the indication, which are both clinical
`
`and environmental in nature. Overail, these needs
`
`mainly reflect the primary care culture, which often
`
`dismisses AR as a minor condition, despite the
`
`huge
`
`socioeconomic
`
`and morbidity
`
`costs
`
`associated with the disease. This leads to poor
`
`diagnosis,
`
`lack of patient compliance with the
`
`standard therapies,
`related ireatment.
`
`and inadequate symptom-
`
`The level of environmental unmet need in AR is
`
`high. Patients and primary care physicians (PCPs)
`
`alike have a fow awareness of the impact of AR.
`
`This directly impacts the drug treatment rate, with
`
`many AR patients
`
`not
`
`taking
`
`any
`
`therapy.
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`i Globalbata. This reportis alicensed product and is:not to be copied, reproduced, shared or resold-in any-form.
`
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`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`Physicians also often show an underappreciation
`
`There is little room for new entrants, as the market
`
`for the prevalence of mixed rhinitis, which consists
`
`is well-served
`
`by
`
`a wealth of
`
`symptomatic
`
`of a combination of altergic and non-allergic rhinitis
`
`therapies. Since the competition is increasing, the
`
`(NAR}, and the challenges involved in its diagnosis
`
`market for AR therapies is becoming increasingly
`
`and treatment. Multiple patient-derived factors,
`
`less
`
`jucrative. Also,
`
`there are
`
`currently
`
`combined with
`
`inadequate treatment options,
`
`breakthrough symptomatic therapy products
`
`no
`
`in
`
`means that thé majority of AR patients continue to
`
`clinical development. The remaining clinical unmet
`
`experience symptoms, even though they have
`
`needs in this market include the requirement for
`
`received
`
`treatment
`
`directed
`
`by
`
`the ARIA
`
`more efficacious products, and the underserved
`
`guidelines. Patients are often highly dissatisfied
`
`area
`
`of
`
`causative
`
`therapies,
`
`such
`
`as
`
`with their treatment options, are non-compliant,
`
`and often aliernate their prescription medications
`
`with OTC products due to a lack of adequate
`
`efficacy of a perceived reduction in efficacy over
`
`time. Patients often try several medications, with
`
`approximately 75% of patients taking more than
`
`immunotherapies, which target
`cause of the disease.
`
`the underlying
`
`Clinical trials evatuating novel AR treatmenris are
`
`complicated by several factors,
`
`including variable
`
`allergy testing methods,
`
`fluctuations
`
`in pollen
`
`counts, and the timing and intensity of additional
`
`one symptomatic therapy simultaneously in search
`
`of a medication that actually “works” {(Demoly et al.,
`
`2002).
`
`seasonal allergens. This is further complicated
`
`when
`
`assessing
`
`immunotherapies,
`
`as
`
`the
`
`treatment must be initiated prior to the onset of the
`
`Novel Symptomatic Products Will Struggle to
`
`following pollen season. Therefore, subjects are
`
`Enter This Large Genericized Market
`
`enrolled into trials based on their symptoms during
`
`The AR treatment paradigm is well-defined, and
`
`the AR market is mature and highly genericized,
`
`with numerous drug classes that target a number
`
`of nasal symptoms associated with AR. Following
`
`the
`
`high-profile
`
`patent
`
`expirles
`
`of
`
`several
`
`blockbuster drugs marketed
`
`by
`
`the
`
`Jeading
`
`the previous poflen season, which may vary over
`
`consecutive years and pollen seasons. Vanable
`
`weather paiterns, and hence fluctuating pollen
`
`counts, have thwarted the efforts of several drug
`
`manufacturers that are developing new treatments
`for AR.
`
`manufacturers in this area, a wealth of inexpensive
`
`Environmental exposure chambers (EECs) create
`
`generic
`
`options
`
`became
`
`available,
`
`both
`
`by
`
`stable and reproducible allergen exposure under
`
`prescription and OTC. As the market
`
`is very
`
`highly standardized environmental conditions, and
`
`saturated,
`
`the average daily cost of therapy is
`
`have been used to assess several AR drugs,
`
`exceedingly low forall the drug classes.
`
`including AHs
`
`such as Allegra
`
`and Claritin
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`i Globalbata. This reportis alicensed product and is:not to be copied, reproduced, shared or resold-in any-form.
`
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`

`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`(loratadine). However,
`
`this method has been
`
`and Stallergenes wili lead the way by introducing
`
`criticized, as it doesn't
`
`reflect
`
`the “real-world”
`
`their
`
`relevant ailergens in tablet
`
`form into the
`
`experience of patients with AR. Further validation
`
`Japanese and US markets
`
`through licensing
`
`of this study methed will be required before it gains
`
`pariners. Japan, a market previously not widely
`
`acceptance by the European Medicines Agency
`
`treaied with SIT,
`
`is set to see a new range of
`
`(EMA) and the FDA as a sufficient method to
`
`standardized,
`
`clinically-evaluated
`
`products
`
`assess AR drug efficacy and safety.
`
`containing the two most prevalent allergens: HDM
`
`The challenges involved in evaluating novel AT
`
`pipeline agents using the current gold-standard
`
`clinical practices will affect the launch of new AR
`
`drugs, which could ultimately discourage drug
`
`companies from pursuing the development of
`
`pipeline candidates in this space.
`
`The
`
`Market
`
`Entry
`
`of
`
`Approved
`
`Immunotherapies Will Improve the Treatment
`
`Landscape
`
`for
`
`the Difficult-to-Treat AR
`
`Population
`
`One of the few remaining unmet needs in the AR
`
`market is for a causative therapy that is capable of
`
`providing
`
`long-term relief of
`
`symptoms, The
`
`aliergen-specific immunotherapy (SIT) market
`
`is
`
`the clinical development of a new generation of
`
`tabiet formulations, moving away from the standard
`
`SCIT injections and sublingual
`
`immunotherapy
`
`(SLIT) drops. Tablet formulations that have been
`
`evaluated according to a standardized stepwise
`
`algorithm in 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 impertant
`
`treatment option for patients with AR. ALK-Abello
`
`and Japanese cedar pollen. These treatment
`
`options will
`
`include AIT formulations that were
`
`previously
`
`unavailable
`
`in
`
`the
`
`market.
`
`Advancements in SIT, particularly the advent of
`tablet
`formulations, will
`increase the use of
`
`immunotherapy among the pediatric population.
`
`The intreduction of AITs will drive growth in the AR
`
`market, due to their high cost
`
`relative to the
`
`standard subcutaneous (SC) allergen extracts,
`
`thereby decreasing the negative impact of
`
`the
`
`growing genericized market.
`
`What De Physicians Think?
`
`The key opinion leaders (KOLS)
`
`interviewed by
`
`GlobalData for this report highlighted the need for
`an increase in awareness of the evidence-based
`
`AR treatment
`
`guidelines
`
`among
`
`healthcare
`
`professionals, pharmacists, and patients, which
`
`would ideally lead to an increase in the number of
`
`patients with adequate symptomatic control. The
`current standard medications, such as AH and
`
`INCS therapies, tackle only the symptoms; KCLs
`
`said they do not expect that novel drugs in these
`
`classes will fulfill this need. The immunotherapies
`
`in development will address these issues to some
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`i Globalbata. This reportis alicensed product and is:not to be copied, reproduced, shared or resold-in any-form.
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`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`‘! think fthe US-based practice parameters, and
`also.
`the
`ARIA
`
`guidelines}
`
`are
`
`pretty
`
`degree, but only in a very small proportion of AR
`
`sufferers, and they will be very costly.
`
`“There are quite a fot unmet needs fin AR}. First of
`
`all, if you look at — actually, the quality oflife of
`
`these patients — there’s still a debate.
`
`in reality,
`
`optimal quality of life is reached by no more than
`
`one third of [AR] patients. No more than one third
`
`of our patients. This means that two third/s] — they
`
`don't have the optimal quality of iffe. There is stil
`
`roam for improvement. And they recently did a
`
`survey of many societies, and in reality,
`
`the
`
`patients,
`
`independently of the prescription of the
`
`GP jgeneral practitioner} or whatever,
`
`the vast
`
`majority are using two ar three different treatments
`
`fat the same time] for the allergic rhinitis. This
`
`means that there fs a lot to investigate, and a fot of
`
`froom for} improvement for treatment.”
`
`comprehensive, and /
`
`think they are largely,
`
`heavily evidence-based, which makes it very useful
`
`for me.
`
`ft fhave] found them fio be} very good:
`
`think they are useful i don't think they are widely
`
`distributed. But personally, when |
`
`teach about
`
`allergic rhinitis or research, or give patient care,
`refer fo them and use them.”
`
`|
`
`US Key Opinion Leader
`
`‘in
`
`the United States,
`
`ihe
`
`primary
`
`care
`
`doctors...see many, many patients in a day. They
`
`have very little time fo get educated on jthej
`
`guidelines for [the] multitudes of diseases that they
`
`manage. And for a disease like allergic rhinitis, the
`
`chances are fthat]
`
`they are not up on {the
`
`guidelines or the guideline-driven care for it, so
`
`EU Key Opinion Leader
`
`overall,
`
`in my opinion,
`
`they do a bad job at
`
`managing} if.”
`
`US Key Opinion Leader
`
`“One of the ways in which we can help patients
`
`with rhinitis is to promuigate the guidelines. We're
`
`just re-doing the evidence-based guidelines. | think
`
`the promufgation — getting them down ta patients,
`
`to GPs, jana] fo practice nurses in a way that fhey
`
`can use them will be very helpiul to patients.”
`
`EU Key Opinion Leader
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`i Globalbata. This reportis alicensed product and is:not to be copied, reproduced, shared or resold-in any-form.
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`

`GlobalData»
`
`ALLERGIC RHINITIS —
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
` Executive Summary
`
`
`“Vell, fin] the [AR] patient population,
`
`in general,
`
`“Of course,
`
`it
`
`is easier fo spend money on
`
`there’s a very significant [percentage] — perhaps
`
`antihistamines and nasal steroids. But the problem
`
`40% of patients seen will have mixed rhinitis, That
`
`is fthadj in the future,
`
`if ffhe number off this kind of
`
`is,
`
`they will have positive allergy skin tests, some
`
`patient with severe allergic rhinitis increases,
`
`if is
`
`of which are clinically significant, but the pathology
`
`possible that this kind of treatment is not sufficient
`
`underlying their disease is not limifed to allergy.
`
`and cannot safisfy the patient. For this reason,
`
`Alfhough we classify them as having allergic
`
`immunotherapy and the use of immunotherapy
`
`rhinitis, they're really mixed. So, [this méans] that
`
`can, in a way, inerease.”
`
`they’ have underlying triggers which are irritants,
`
`such as cigarette smoke, paint
`
`fumes,
`
`fand]
`
`weaiher conditions,
`
`as well These
`
`are
`
`the
`
`ffreaiment-j resistant poputation; it's not the purely
`
`seascnal allergic rhinitis. A person who comes into
`
`this office with tree and grass poffen allergy limited
`
`to fhe springtime is really a piece of cake. They're
`
`very easy fo treat. They respond almost universally
`
`fo therapy, and they're not resistant. [However,} it’s
`
`a patient who comes into the office that has
`
`positive skin fests, and they also have seasonal
`
`allergic rhinitis, Out
`
`they have an underlying
`
`pathology related io non-allergic triggers as well;
`
`they're the resistant ones.”
`
`EU Key Opinion Leader
`
`“We know thaf about over half the patients with
`
`nasal allergies never go see a physician; finsiead,}
`
`they treat it fusing producis sold] over the counter.”
`
`US Key Opinion Leader
`
`As |! mentioned,
`
`the [AR patient] flow is,
`
`they
`
`usually go first to pharmacists, the second step is
`
`the GP, and the third step is the specialist. Usuaily,
`
`when they come fio the specialist}, fits because]
`
`there’s a special reasons [sic], or jif’s] because
`
`they have already got the disease. And, of course,
`
`it’s} because with the usual treatments, they dont
`
`gel
`
`fhe
`
`sufficient benefif,
`
`or because
`
`they
`
`US Key Opinion Leader
`
`specifically want
`
`to have immunotherapy,
`
`for
`
`instance, and this is the fiurning] point for them.
`
`EU Key Opinion Leader
`
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`

`GlobalData »
`
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`ALLERGIC RHINITIS —
`
` Executive Summary
`
`“Clearly,
`
`if family doctors cured [AR] patients
`
`enough, fallergy] specialists would not exist.
`
`[Yet]
`
`we exist still This fact suggests they're flamily
`
`doctors} incompetent when prescribing fallergy]
`
`treatments, fand] are not following any guidelines.”
`
`Japanese Key Opinion Leader
`
`Allergic Rhinitis —Global Drug Forécast and Market Analysis to 2024
`(6 GlobalData: This report is adicensed product and is:not to be copied, reproduced, shared or resold. in any-form!
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`

`GlobalData »
`
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`ALLERGIC RHINITIS —
`
`Table of Contents
`
`1
`
`Table of Contents
`
`
`
`
`
` See
`1.1
`
`
`
`1.2
`
`List Of FIQUPES oooec cere e rete renter eet nae re cage eee pnnaeeseecoeemavercasessneesecneeneeeesneaneesaaees 22
`
`Bigorate
`2.4
`CatalSt... ccccccccessceeccecenccsseecesneeecssanaueevseueeeeccsreeeecssseeseuessseneeesesceuseesccssnesssssseseensssensaas 23
`
`2.2.
`
`Related Reports oo... oc... ec ccceccceecccnecececestee eee bocce ee scdsenuessseaeeasseadeenessseceauecnseseeeeesseeeenes 24
`
`2.3
`Upcoming Related Reports oo... cece cece cee cce cence cece ecceeeeeeneesesaeaeeeeceeceescneeeneseneeoseeaaes 24
`
`3.4
`Etiologyatand Pathophysiology csbeseeceeeosstssseveteaseeees beeessseeeeesee
`
`B22
`
`3.3
`
`SYMPTOMSeee cect cece cee ee cette eee nee cceaeeeaeceeeesegaccaeaaeeeneesecaaeceneeesenseesaeeeeneeess28
`
`Cla SSifRCARIONee eecer cent tence treeeascuaerevesenateneetieeeeetnnesriepaeesniesacepeaetunvaraveraatonsentenents 29
`
`3.3.1
`
`Seasonal and Perennial AR ooo... eee cece ceece cee ceeeeeeee eee eveeeeeeteneesecneueeenneeeneeceeeees 29
`
`3.3.2
`
`ARIA Classification of ARoie cc ccnne scence ceceeecenee ca ereecenegeneegeaysceneeseeeesepeeesoeeeses 29
`
`3.4
`
`DIAQMOSIS 00... cece ce cece cee c cena erence er cee ree ee een eee Fete REd EF eenEt Sten dtd ped Obed doneca densa sas eeaaaaeesaneeearreaeaaas
`
`3.6
`
`Quality Of Life oo. ccc cece eceesccceeneaeseebecasaeseseeseeseessaneaesceedcaessaesaeetetenseassseetterssiataaease 32
`
`
`
`4.4
`
`4.2
`
`Dis@ase Background... cccsccecseeceseeeseeeceneeesensaee eee enneeeeneeescrinnaseesenateseataessescesensinnasaseenas 33
`
`Risk Factors and Comorbidities 000... ecccssstssseenerceeaseaeasaeserarneessnaassneneasarsseonetesssteseas 34
`
`4.2.1.
`
`A family history of AR is a strong predictor for AR in children and adults... 35
`
`4.2.2
`
`Exposure to allergens in the environment increases the risk for AR ..........0. eee 36
`
`4.2.3
`
`Urban living elevates the riSk for AR. ccc cece ccc ceeceeeeeecesseeeeeeesseeneeeeeeceeens 36
`
`Allergic Rhinitis ~Global Drug Forécast and Market Analysis to2024
`© GlobalData: This report is a licensed product and is not to be copied, reproduced, shared or resold:in any form
`
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`GlobalData »
`
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`ALLERGIC RHINITIS —
`
`fi
`Table of Contents
`
`4.24
`
`COMmOrbidities 2.0. cee eer ene et renner i rennet renee neee rote runt eenieeeecirenniecsinenieeescieree 37
`
`4.3
`
`Global and Historical Trends...nee eee nee cee enadeeeeeesnaaeaecneeaeecnneaeenseceenas 39
`
`FBT
`
`US eee eee eneceesteentestencestensaeteescsseaetaessevaeeescspecessereesiaediisanecsapaeeaesneecsepeesecertnentiriecats 39
`
`AB Bec ceccc tener cee en er eeeeteeeceneeetaenaevee snes ccaeeetarceensaeetenisecespaetaeneercttesesaeeuetpaseeneseets 40
`
`ABB JADA cece cee cece ness eee eeeeeeeeeeesssseneececeeeeeeeessnaeceeceeeeeeeesssanseeeeeseeneasssemtees 44
`
`4.4
`
`Forecast Methodology...............e..ccec cece cece eceeee ee ceee certs ee ecaeeceeeceacgeeeceeeccsgesaeeeeeeaseeseneees 42
`
`4.4.1
`
`Sources USS... ee ceeeecseessscccssssneesssseeecsaessseneassaeeeraseuecseeeceucsereveesecceeenscscersccensncrenss
`
`4.4.2
`
`Sources Not Usedocc cece sees cc ceneeceeceeceeeesrssaaeeseeceesaaeeseeestecesaeeceteseneae 47
`
`44.3
`
`Forecast Assumptions and Methods 2000.00 ccccceccsssecceccceeeeeeeesseeeeeesesemeeeeeu eens 47
`
`4.5
`
`Epidemiological Forecast for AR (2013-2023) ooo cece cern ee etneeneeeneaeetenaeeenas 50
`
`4.5.1
`
`Total Prevalent Cases of AR occ ieee seer senna nine snenciaecnisteaeterenneeeersonsean 50
`
`4.5.2 Age-Specific Total Prevalent Cases of AR .......cccccsccecssssssssrseeesseesssseessrseessseeenenteneaureeaes 52
`
`4.5.3
`
`Sex-Specific Total Prevalent Cases of AR.........cccccscecceccssescceersserersssenssseeeesseractensareeaaes 54
`
`4.5.4 Age-Standardized Total Prevalence of AR ..........0.....cccccsccccceeeseceeecnnneceerescpecceceneesceanes 56
`
`4.5.5
`
`Distribution of Total Prevalent Cases of AR by Severity .............cccceeccsseeersseerenersssreeees 58
`
`4.5.6
`
`Distribution of Total Prevalent Cases of AR by Type ........ 2.0 ccccccetccceenceeeeeceetes 59
`
`4.5.7
`
`Distribution of Total Prevalent Cases of AR Sensitized to Specific Alfergens................. 60
`
`4.5
`
`DISCUSSION 0... eeecccecteenrceneen en ere ee nee e EE EE EEEEEEEL ED DEEEEEEE EERO PTELEDEOLEE ECOL SPROUE SHEEP ELEOUEEEREE OLS EE EEN 61
`
`4.6.1
`
`Epidemiological Forecast Insigitt.........0 cceessccceaseseeeeeeeersccteseeeeeneesseescceeaeaa 61
`
`4.6.2
`
`Limitations of the Amalysis ..............cceccssessrsesrsccsenecseeeeeeeescussensnseeescsennnecseearepenaeaneseneeeags 61
`
`Strengths of the Analysis... ec... cee scecacseee cc gees ceneeeceecacsceeseeeesseeegesnegepesecsepepseneeepesen Oe
`4.6.3
`
`
`
`Be
`EDGE ED
`EgeLa:
`Lee GE EOiene
`ELE
`
`5.1
`
`Diagnosis and Treatment OVerVieW 2... cece cena e ca sueeneeanecsneenssesseeeeeecsteaeeseeeneeeas 63
`
`Allergic Rhinitis — Global Drug Forécast and Market Analysis to 2024
`feGlobalData. This reportis a licensed product andis-not to be copied, reproduced, shared or resold:in any-form
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`GlobalData »
`
`GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2024
`
`ALLERGIC RHINITIS —
`
`fi
`Table of Contents
`
`5.1.1
`
`DAQNOSIS «00... eee cece cceencesceeeceeesssreeseeereceeeussseeusecseeuaeeeesssedcsneneeeesassseauetesesesnuessaneress 63
`
`5.1.2
`
`Treatment Guidelines and Leading Prescribed Drugs 2.000 64
`
`5.1.3
`
`Climical Practice... ice einen een ere deen e enor ned erecta rene teenie iiteaeas 67
`
`5.2 Seeee ER eR ee ERROR AEE ade edad cnn dade dene 76
`
`ons
`
`FRANCE ooo. cece eee cecee eee ceee eer tne ee ennse enae teats tinea e