JSB Market Research: PharmaPoint: Crohn's Disease - Global Drug Forecast and Market Analysis to 2022


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)

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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 (infliximab)
- AbbVie's Humira (adalimumab)

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.


Key Questions Answered

- How will the Crohn's disease market (sales and patient numbers) evolve over the 10-year forecast period from 2012 to 2022?
- Which brands and specific drug classes did physicians select for their CD patients in 2012 and how do they foresee their prescribing behavior evolving over the next five years?
- How will the launch of late-stage pipeline therapies such as Entyvio and Stelara shape the future treatment landscape?
- What are the remaining unmet needs and opportunities for drug developers within the CD market?

Key Findings

- The main drivers of growth in the CD market during the coming decade include the anticipated launch of the first non-anti-tumor necrosis factor (TNF) biologics, Entyvio and Stelara; the uptake of infliximab and adalimumab biosimilars; and the increasing prevalent cases of CD.
- Companies striving to enter the CD market appear most focused on the anti-TNF refractory population, as this remains the most underserved group. However, competition within this patient segment is set to intensify from 2014 on, following new product launches. Therefore, companies with early-phase products targeting this patient group may struggle to gain a foothold in the future CD market.
- The level of unmet need in the CD marketplace is moderate, with clinical unmet needs being the main driver for research into this autoimmune disease. The most pressing clinical unmet need is for reliable disease diagnostic tools, such as biomarkers, as these could aid physicians to tailor their treatment approach.
- Although GlobalData forecasts four new product launches (Entyvio, Stelara, vercirnon, and Prochymal [remestemcel-L]) during the 2012-2022 forecast period, growth within the 10 CD healthcare markets covered in this report will largely be driven by the strong uptake of Entyvio and Stelara.


- Overview of CD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Annualized CD therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the CD therapeutics markets.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-to-late stage pipeline drugs.
- Analysis of the current and future market competition in the global CD therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global CD therapeutics markets.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CD therapeutics markets in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global CD therapeutics markets from 2012-2022.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Content:

2 Introduction 23
2.1 Catalyst 23
 2.2 Related Reports 24
 2.3 Upcoming Related Reports 24
 3 Disease Overview 25
 3.1 Etiology and Pathophysiology 25
 3.1.1 Etiology 25
 3.1.2 Pathophysiology 25
 3.2 Symptoms 29
 3.3 Prognosis 30
 3.4 Quality of Life 31
 4 Epidemiology 32
 4.1 Risk Factors and Comorbidities 32
 4.1.1 Up to 60% of CD patients experience reduced bone density 33
 4.1.2 One third of patients with CD suffer from psychiatric illness 33
 4.1.3 Arthritis affects 25% of CD Patients 33
 4.1.4 Gastrointestinal complications often occur as part of CD 34
 4.2 Global Trends 34
 4.2.1 US 35
 4.2.2 5EU 36
 4.2.3 Japan 37
 4.2.4 Canada 38
 4.2.5 China 38
 4.2.6 India 39
 4.3 Forecast Methodology 39
 4.4 Sources Used 42
 4.4.1 US 42
 4.4.2 France 42
 4.4.3 Germany 43
 4.4.4 Italy 43
 4.4.5 Spain 44
 4.4.6 UK 45
 4.4.7 Japan 45
 4.4.8 Canada 46
 4.4.9 China 46
 4.4.10 India 47
 4.5 Forecast Assumptions and Methods 47
 4.5.1 Incident Cases 47
 4.5.2 Prevalent Cases 50
 4.5.3 Sources Not Used 53
 4.6 Epidemiological Forecast for CD 54
 4.6.1 Incident Cases of CD 54
 4.6.2 Prevalent Cases of CD 59
 4.7 Discussion 66
 4.8 Limitations of the Analysis 68
 4.9 Strengths of the Analysis 68
 5 Disease Management 69
 5.1 Treatment Overview 70
 5.2 US 75
 5.2.1 Diagnosis 75
 5.2.2 Clinical Practice 75
 5.3 France 77
 5.3.1 Diagnosis 77
 5.3.2 Clinical Practice 78
 5.4 Germany 79
 5.4.1 Diagnosis 79
 5.4.2 Clinical Practice 79
 5.5 Italy 81
 5.5.1 Diagnosis 81
 5.5.2 Clinical Practice 81
 5.6 Spain 83
 5.6.1 Diagnosis 83
 5.6.2 Clinical Practice 83
 5.7 UK 85
 5.7.1 Diagnosis 85
 5.7.2 Clinical Practice 85
 5.8 Japan 87
 5.8.1 Diagnosis 87
 5.8.2 Clinical Practice 87
 5.9 Canada 89
 5.9.1 Diagnosis 89
 5.9.2 Clinical Practice 89
 5.10 China 90
 5.10.1 Diagnosis 90
 5.10.2 Clinical Practice 90
 5.11 India 91
 5.11.1 Diagnosis 91
 5.11.2 Clinical Practice 92

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