crohn’s disease – india drug forecast and market analysis ...cd therapies, coupled with many...

REFERENCE CODE GDHC213CFR | PUBLICAT ION DATE JANUARY 2014

CROHN’S DISEASE – INDIA DRUG FORECAST AND MARKET ANALYSIS TO

2022

Crohn’s Disease – India Drug 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.

CROHN’S DISEASE – INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

The below mentioned table presents the key

metrics for Crohn’s disease (CD) in the India:

Crohn’s Disease: Key Metrics in India Markets

2012 Market Sales

Anti-TNF $89.8m

5-ASAs $52.8m

Total $142.6m

2022 Market Sales

Anti-TNF $179.7m

Integrin inhibitors $54.8m

Total $234.5m Source: GlobalData

Sales for CD in the India in 2012–2022:

The India CD market was worth approximately

$142.6 million in 2012, with a projected compound

annual growth rate (CAGR) of 5.1% due to an

increase in total sales to $234.5 million in 2022.

Major growth drivers in the India CD market over

the forecast period include:

Continued investment in the national

healthcare system and services

Sizeable CD patient population that will

increase over the coming decade

Conversely, major barriers to the growth of the CD

market include:

Loose intellectual property policies present a

major challenge for developers with novel

drugs

Limited access to and the high price point of

CD therapies, coupled with many Indians’

belief in traditional medicine, negatively

impacts branded drug sales

Downward pricing pressure limits drug sales

growth

Below mentioned figure illustrates the sales for CD

in India by therapeutic class during the 10-year

forecast period.

CD: India Sales by Therapeutic Class, 2012–2022

63%

37%

2012Total: $142.6m

77%

23%

2022Total: $234.5m

Anti-TNFs

5-ASAs

Source: GlobalData



Table of Contents

What Do Physicians Think?

Following the approval of Hospira/Celltrion’s

Inflectra, a biosimilar of the market-leading

biologic, Remicade, in September 2013 for the

multiple autoimmune indications for which

Remicade is approved, some KOLs highlighted

that they would await data from a CD- or an IBD-

specific trial before prescribing Inflectra for their

CD or UC patients. This, in turn, could limit the

initial uptake of Inflectra.

“I am not interested in [using] Inflectra in [my] IBD

[patients] unless it is tested in IBD[-specific] clinical

trials.”

[EU] key opinion leader

KOLs stressed that predicting the course of CD

remains the most challenging aspect of managing

their CD patients.

“I think the most challenging aspect is to, first of all,

risk-stratify as to what patients are going to do

badly in the long run, and trying to tailor an

effective therapy for them.”

[Outside-US] key opinion leader

Having biomarkers included in their diagnostic

tools is important to gastroenterologists, as it could

allow them to effectively predict the course of CD

in a given patient and allow them to offer a

personalized treatment approach.

“I think we need a more biomarker-based

approach….I think we are falsely diagnosing early

disease. With Crohn’s, two days of endoscopic

techniques and two days of radiological

assessments are precise enough to allow you to

see the morphological damage, but in pre-stage

patients at risk of developing the disease, we do

have difficulties in properly assessing the disease.”


KOLs stressed their desire for new drug therapies

to treat the anti-TNF refractory patient segment.

“We are learning that the anti-TNF therapies have

a limited lifespan….We are going to run into a

problem where we have a lot of people losing

response to anti-TNF therapy early on in their

disease course, and then they don’t have an option

later on.”

[US] key opinion leader

“All these drugs [anti-TNFs] have a finite natural

history, as we rapidly move from one drug to

another, and five years down the road, someone

with a history of Crohn’s is going to be with no

treatment options.”

[US] key opinion leader



Table of Contents

KOLs validated that emerging therapies with novel

MOAs will form the basis of their treatment

paradigm.

“In the future, what we will do is either switching of

anti-TNF therapies, or we will switch to alternative

mechanisms, and we will soon have [the]

alpha4beta7, vedolizumab.”


According to KOLs, anti-IL-6 therapies, which are

currently in early clinical development, hold

promise.

“There are so many companies out there with anti-

IL-6 agents that I feel there could be a new

paradigm coming up, which could add to the value

of innovation…not just to the molecule, but also to

the way we use it.”




Table of Contents

1 Table of Contents

1 Table of Contents ....................................................................................................................... 5

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

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

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

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

2.2 Related Reports ................................................................................................................ 10

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 ............................................................................................................ 12

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

3.3 Prognosis .......................................................................................................................... 17

3.4 Quality of Life .................................................................................................................... 18

4 Disease Management ............................................................................................................... 19

4.1 Treatment Overview .......................................................................................................... 20

4.2 India .................................................................................................................................. 25

4.2.1 Diagnosis ...................................................................................................................... 25

4.2.2 Clinical Practice ............................................................................................................. 25

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

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

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

5.3 Product Profiles – Major Brands ....................................................................................... 29

5.3.1 Remicade (infliximab) .................................................................................................... 29

5.3.2 Other Marketed Products .............................................................................................. 35

6 Opportunity and Unmet Need ................................................................................................... 36


Table of Contents


6.1 Overview ........................................................................................................................... 36

6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach ......... 37

6.3 More Therapies for Anti-TNF-Refractory Patients ............................................................. 38

6.4 Unmet Needs Gap Analysis .............................................................................................. 39

6.5 Targeted Therapies ........................................................................................................... 40

6.6 Predictive Tools for Early Diagnosis and Treatment .......................................................... 41

7 Pipeline Assessment................................................................................................................. 42

7.1 Overview ........................................................................................................................... 42

7.2 Promising Drugs in Clinical Development .......................................................................... 42

7.3 Other Late-Stage Pipeline Products .................................................................................. 44

7.3.1 Cx601............................................................................................................................ 44

7.3.2 RHB-104 (clarithromycin + clofazimine + rifabutin) ........................................................ 46

8 Market Outlook ......................................................................................................................... 51

8.1 Global Markets .................................................................................................................. 51

8.1.1 Drivers and Barriers – Global Issues ............................................................................. 51

9 India .......................................................................................................................................... 56

9.1 Forecast ............................................................................................................................ 56

9.2 Key Events ........................................................................................................................ 58

9.3 Drivers and Barriers .......................................................................................................... 59

9.3.1 Driver: Continued investment in the national healthcare system and services ............... 59

9.3.2 Driver: Sizeable CD patient population that will increase over the coming decade ........ 59

9.3.3 Barrier: Loose intellectual property policies present a major challenge for developers with novel drugs ........................................................................................................... 60

9.3.4 Barrier: Limited access to and the high price point of CD therapies, coupled with many Indians’ belief in traditional medicine, negatively impacts branded drug sales .............. 60

9.3.5 Barrier: Downward pricing pressure limits drug sales growth ......................................... 61

10 Appendix................................................................................................................................... 62

10.1 Bibliography ...................................................................................................................... 62


Table of Contents


10.2 Abbreviations .................................................................................................................... 68

10.3 Methodology ..................................................................................................................... 72

10.4 Forecasting Methodology .................................................................................................. 72

10.4.1 Diagnosed CD Patients ................................................................................................. 72

10.4.2 Percent Drug-Treated Patients ...................................................................................... 73

10.4.3 Drugs Included in Each Therapeutic Class .................................................................... 73

10.4.4 General Pricing Assumptions ........................................................................................ 73

10.4.5 Individual Drug Assumptions ......................................................................................... 75

10.4.6 Generic Erosion ............................................................................................................ 75

10.5 Physicians and Specialists Included in This Study ............................................................ 76

10.6 Primary Research – Prescriber Survey ............................................................................. 77

10.7 About the Authors ............................................................................................................. 78

10.7.1 Author/Reviewer ............................................................................................................ 78

10.7.2 Global Head of Healthcare ............................................................................................ 78

10.8 About GlobalData .............................................................................................................. 79

10.9 Disclaimer ......................................................................................................................... 79

1.1 List of Tables

Table 1: Symptoms of CD .............................................................................................................................. 17

Table 2: Treatment Guidelines for CD ............................................................................................................ 21

Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 ............. 23

Table 4: Leading Branded Drugs Used to Treat CD ....................................................................................... 29

Table 5: Product Profile – Remicade .............................................................................................................. 31

Table 6: Remicade SWOT Analysis, 2013 ..................................................................................................... 34

Table 7: Summary of the Minor Therapeutic Classes in CD, 2013 .................................................................. 35

Table 8: Overall Unmet Needs in CD – Current Level of Attainment ............................................................... 37


Table of Contents


Table 9: Clinical Unmet Needs in CD – Gap Analysis, 2013 ........................................................................... 40

Table 10: Promising Drugs in Clinical Development for CD – Pipeline Phase, 2013........................................ 42

Table 11: Comparison of Therapeutic Classes in Development for CD, 2013 ................................................. 43

Table 12: Product Profile - Cx601 .................................................................................................................. 45

Table 13: Cx601 SWOT Analysis, 2013 ......................................................................................................... 46

Table 14: Product Profile – RHB-104 ............................................................................................................. 48

Table 15: RHB-104 SWOT Analysis, 2013 ..................................................................................................... 50

Table 16: Global CD Market – Drivers and Barriers, 2012–2022 .................................................................... 51

Table 17: Sales Forecasts ($) for CD in India, 2012–2022.............................................................................. 57

Table 18: Key Events Impacting Sales for CD in India, 2012–2022 ................................................................ 58

Table 19: CD Market in India – Drivers and Barriers, 2012–2022 ................................................................... 59

Table 20: Physicians Surveyed, By Country ................................................................................................... 77

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) ............................ 13

Figure 2: Potential Biologic Drug Targets for CD ............................................................................................ 16

Figure 3: Patient Care Path for CD ................................................................................................................ 22

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012–2022 ..................................... 43

Figure 5: Sales for CD in India by Drug Class, 2012–2022 ............................................................................. 58



Introduction

2 Introduction

2.1 Catalyst

The Crohn’s disease (CD) market is currently very dynamic, with novel biologic therapies on the

horizon, such as:

Takeda’s alpha4beta7 inhibitor, Entyvio (vedolizumab)

Johnson & Johnson’s (J&J’s) interleukin (IL)-12/23 inhibitor, Stelara (ustekinumab)

These compounds will challenge the current biologics in an attempt to dislodge the stronghold of

the TNF inhibitors, as they aim to tap into the lucrative portion of the CD therapeutics market. If

their promising safety and efficacy profiles translate to clinical practice once they enter the market,

their launch will be to the detriment of the existing market leaders, Remicade (infliximab) and

Humira (adalimumab).

The loss of patent protection of the anti-TNF marketed brands will allow for the emergence of

biosimilars, such as Hospira’s Inflectra (infliximab) a Remicade biosimilar. Patent expiries begin in

2015 for the current market leaders:

J&J’s Remicade

AbbVie’s Humira

Focusing on country dynamics, Canada and the emerging markets of China and India will also play

a key role in driving growth in the long term, with each market forecast to post positive Compound

Annual Growth Rates (CAGRs) from 2012 to 2022, primarily due to the anticipated strong uptake of

Remicade over the forecast period.

Exciting times lay ahead for the CD marketplace, as the market events noted above are due to

occur against the backdrop of a steadily rising global CD prevalent population. With the clinical

unmet need for better diagnostic tools and treatment options for the anti-TNF-refractory population,

CD represents an attractive autoimmune disease for drug developers. This, in turn should fuel

commercial interest in this subtype of IBD.



Introduction

2.2 Related Reports

GlobalData (2013). PharmaPoint: Psoriasis – Global Drug Forecast and Market Analysis to

2022, May 2013, GDHC48PIDR

GlobalData (2013). PharmaPoint: Rheumatoid Arthritis – Global Drug Forecast and Market

Analysis Event-Driven Update, July 2013, GDHC60PIDR

GlobalData (2014). PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market

Analysis to 2022, January 2014, GDHC77PIDR

GlobalData (2014). Crohn’s Disease – US Drug Forecast and Market Analysis to 2022,

January 2014, GDHC208CFR

GlobalData (2014). Crohn’s Disease – 5EU Drug Forecast and Market Analysis to 2022,


GlobalData (2014). Crohn’s Disease – Japan Drug Forecast and Market Analysis to 2022,


GlobalData (2014). Crohn’s Disease – Canada Drug Forecast and Market Analysis to 2022,


GlobalData (2014). Crohn’s Disease – China Drug Forecast and Market Analysis to 2022,


GlobalData (2014). Cimzia (Crohn’s Disease) – Forecast and Market Analysis to 2022, January

2014, GDHC323DFR

GlobalData (2014). Entyvio (Crohn’s Disease) – Forecast and Market Analysis to 2022,

January 2014, GDHC324DFR

GlobalData (2014). Humira (Crohn’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Prochymal (Crohn’s Disease)– Forecast and Market Analysis to 2022,


GlobalData (2014). Remicade (Crohn’s Disease) – Forecast and Market Analysis to 2022,




Introduction

GlobalData (2014). Stelara (Crohn’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Tysabri (Crohn’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Vercirnon (Crohn’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Crohn’s Disease – Current and Future Players, January 2014,

GDHC1027FPR

2.3 Upcoming Related Reports

GlobalData (2014). PharmaPoint: Ulcerative Colitis – Global Drug Forecast and Market

Analysis to 2022


Appendix


10.8 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.

10.9 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.

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