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  • REFERENCE CODE GDHC343DFR| PUBLICATION DATE FEBRUARY 2014

    XELJANZ (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

  • Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

    XELJANZ (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

    Executive Summary

    Table below provides a summary of the key

    metrics for Xeljanz in the 8MM Ulcerative Colitis

    (UC) markets in 2022:

    Xeljanz: Key Metrics in the 8MM UC Market in 2022 Key Events (2012–2022) Level of Impact

    Xeljanz entering the US and EU in 2017 ↑↑↑

    2022 Market Sales

    US $70.8m

    5EU $3.8m

    Japan $9.3m

    Canada $17.2m

    Global* $101.1m Global = US, France, Germany, Italy, Spain, UK, Japan, Canada, China, and India 5EU = France, Germany, Italy, Spain, and UK; 8MM = US, 5EU, Japan, and Canada Source: GlobalData

    Sales for Xeljanz in Global Ulcerative Colitis Market, 2022

    Pfizer will launch Xeljanz in the US market in 2017.

    In its first year, sales of Xeljanz in the Ulcerative

    Colitis market are projected to reach $9.66 million.

    By 2022, we project its sales to increase upto

    $101.1 million in the Ulcerative Colitis market. Key

    factors affecting the sales of Xeljanz will include.

    Major growth drivers for Xeljanz in the UC market

    over the forecast period include:

     Oral administration

     Pfizer’s strong reputation for strategic

    commercialization

    Conversely, major barriers to the growth of the

    Xeljanz sales in UC market include:

     Severe adverse effects

     Rejected twice by the EMA for the treatment of

    RA in April and July 2013.

    Figure below illustrates the global Xeljanz sales by

    region in 2022:

    Sales for Xeljanz by Region, 2022

    70.08%

    3.74%

    9.21%

    16.96%

    2022 Total: $101.1m

    US

    5EU

    Japan

    Canada

    Source: GlobalData

  • Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

    XELJANZ (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

    Executive Summary

    What Do Physicians Think?

    Physicians interviewed by GlobalData expressed

    doubts about the use of Inflectra (an infliximab

    biosimilar) following its approval in Europe in

    September 2013.

    “I do not comprehend what the EMA based the

    label extrapolation upon. I would like to see data

    from a clinical trial of Inflectra done on UC patients.

    I’m afraid, though, that we [physicians] might

    receive pressure to prescribe this biosimilar

    treatment because of the healthcare funding cuts”

    [EU] key opinion leader, October, 2013

    The physicians also underscored the need for a

    curative treatment for UC.

    “Essentially, there is no adequate treatment for

    severe UC patients. AZA [azathioprine] has an

    unpredictable array of adverse effects and no

    guaranteed efficacy. The biologics only work in

    40% of the severe UC patients, and in most cases,

    they are underdosed. We need a curative

    treatment.”

    [EU] key opinion leader, October 2013

    Some KOLs expressed the opinion that UC

    patients should be referred to a specialist before

    they develop bloody diarrhea, as well as the desire

    for companies to develop disease severity

    prediction tests, which could allow for the earlier

    detection of UC.

    “Patients usually go to their primary care

    physicians and complain about chronic diarrhea,

    some sort of uveitis, poor quality of life, etcetera. If

    colonoscopy is considered necessary, and a heavy

    colonic inflammatory burden is observed, then the

    patient undergoes regular monitoring. This doesn’t

    happen with everyone, though, and in 90% of the

    cases, UC is diagnosed upon the presence of

    bloody diarrhea. But, I think we can catch it sooner.

    We need a [disease] severity prediction test.”

    [US] key opinion leader, November, 2013

    The physicians also commented on the clinical

    positioning that they would choose for Takeda’s

    pipeline therapy, Entyvio.

    “I think if vedolizumab is as good as it looks, it will

    be [a] first- or second-line treatment in place of

    azathioprine. If you have a UC patient relapsing

    frequently, despite the use of mesalazine,

    vedolizumab will be an ideal candidate. I regard it

    as safer than azathioprine and more effective [for

    UC]. [However,] I would carry on using anti-TNFs

    for the treatment of CD.”

    [EU] key opinion leader, September 2013

    The physicians also shared their thoughts on the

    high risk of colorectal cancer in inflammatory

    bowel.

  • Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

    Table of Contents

    XELJANZ (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

    1 Table of Contents

    1 Table of Contents ....................................................................................................................... 4

    1.1 List of Tables ...................................................................................................................... 7

    1.2 List of Figures ..................................................................................................................... 8

    2 Introduction ................................................................................................................................. 9

    2.1 Catalyst ............................................................................................................................... 9

    2.2 Related Reports .................................................................................................................. 9

    2.3 Upcoming Related Reports ............................................................................................... 11

    3 Disease Overview ..................................................................................................................... 12

    3.1 Etiology and Pathophysiology ........................................................................................... 12

    3.1.1 Etiology ......................................................................................................................... 12

    3.1.2 Pathophysiology ............................................................................................................ 14

    3.2 Symptoms ......................................................................................................................... 16

    3.2.1 Quality of Life ................................................................................................................ 16

    4 Disease Management ............................................................................................................... 18

    4.1 Diagnosis and Treatment Overview .................................................................................. 18

    4.1.1 Diagnosis ...................................................................................................................... 18

    4.1.2 Treatment Guidelines and Leading Prescribed Drugs ................................................... 21

    4.1.3 Clinical Practice ............................................................................................................. 23

    5 Competitive Assessment .......................................................................................................... 27

    5.1 Overview ........................................................................................................................... 27

    5.2 Strategic Competitor Assessment ..................................................................................... 28

  • Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

    Table of Contents

    XELJANZ (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

    6 Opportunity and Unmet Need ................................................................................................... 30

    6.1 Overview ........................................................................................................................... 30

    6.2 Unmet Needs .................................................................................................................... 31

    6.2.1 Curative Therapy for Severe UC Patients ...................................................................... 31

    6.2.2 Diagnostic Markers for Disease Severity ....................................................................... 31

    6.2.3 Personalized Therapy ....................................................................

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