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REFERENCE CODE GDHC345DFR | PUBLICAT ION DATE FEBRUARY 2014

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

Remicade (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.

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

Executive Summary

Table below provides a summary of the key

metrics for Remicade in the 10MM Ulcerative

Colitis (UC) markets during the forecast period

from 20122022

Remicade: Key Metrics in the 10MM UC Markets, 20122022

2012 Market Sales

US $899.4m

5EU $762.3m

Japan $39.4m

Canada $142.4m

China and India $178.8m

Total $2.0bn

Key Events (20122022) Level of Impact

Approval of first infliximab biosimilar in September 2013

Remicade (infliximab) losing patent 2018 (US), 2015 (EU)

2022 Market Sales

US $616.2m

5EU $369.9m

Japan $90.4m

Canada $160.4m

China and India $301.6m

Global* 1.5bn 10MM= US, France, Germany, Italy, Spain, UK, Japan, Canada, China, and India 5EU = France, Germany, Italy, Spain, and UK *For the purposes of this report, Global = US, France, Germany, Italy, Spain, UK, Japan, Canada, China, and India; N/A= Not Available Source: GlobalData

Sales for Remicade in Global UC Market, 20122022

Remicade sales are expected to decrease from

$2.0 billion in 2012 to $1.5 billion in 2022 with a

negative Compound Annual Growth Rate (CAGR)

of 2.7%.

Major growth drivers in the UC market over the

forecast period include:

The most established and trusted anti-TNF-

treatment in the IBD market today; the gold-

standard UC biologic.

Easier for patients to adhere to treatment, as it

is repeated every eight weeks in a medical

facility.

Gastroenterologists use it as a reference drug

in terms of efficacy in comparison with new

therapies.

Marketed by strong companies with

experienced marketing and sales forces.

Conversely, major barriers to the growth of the UC

market include:

Serious adverse effects that are mostly related

to susceptibility to infections, lymphomas, other

neoplastic disease, and liver toxicity.

IV administration is unpleasant for patients.

Exhibits cross-reactivity with other anti-TNF-

treatments.

Remicade (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.

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

Executive Summary

The murine component of the infliximab protein

induces the production of antibodies against it,

which leads to loss of response to the drug.

As with all anti-TNF treatments, patients need

to be screened for hepatitis viruses, TB, and

similar diseases before beginning treatment

with Remicade. If the test results are positive,

these patients cannot be treated with the

biologic. Even if the results are negative,

patients may become susceptible to these

infections at a later stage during Remicade

treatment.

Figure below illustrates the global Remicade sales

by region during the forecast period.

Sales for Remicade by Region, 20122022

44.47%

37.69%

1.95%

7.04%

8.84%

2012Total: $2.0bn

US

5EU

Japan

Canada

China and India

40.05%

24.05%

5.87%

10.43%

19.61%

2022 Total: $1.5bn

Source: GlobalData

Remicade (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.

REMICADE (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.

Im 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 doesnt

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 Takedas

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

Remicade (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.

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

Executive Summary

The physicians also shared their thoughts on the

high risk of colorectal cancer in inflammatory bowel

disease (IBD) sufferers, which includes those with

UC.

Colorectal cancer is a huge risk in UC

patients.Pharmaceutical intervention is not

designed to prevent this risk. The use of

immunosuppressants does not help.

[EU] key opinion leader, September 2013

Remicade (Ulcerative Colitis) - Forecast and Market Analysis to 2022 6 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

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

1 Table of Contents

1 Table of Contents ....................................................................................................................... 6

1.1 List of Tables ...................................................................................................................... 8

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 ............................................................................................................ 15

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

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

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