During the forecast period from 2012–2022, the growth of the UC market will be driven largely by the entry of Johnson & Johnson’s (J&J’s) Simponi and Takeda’s Entyvio, which will lead to an increase in the overall number of patients being treated with biologics in the US, 5EU, Japan, and Canada.
Another key event affecting the UC market is the anticipated launch of biosimilars, given that the patent expiry of the UC blockbusters, Remicade and Humira are set to expire in the US in 2018 and 2016, respectively.
Overall, major barriers to the growth of the UC market include:
Remicade and Humira losing patent protection in the mid-forecast
Austerity measures favoring generic prescribing
Biosimilars are predicted to face low uptake due to the lack of regulatory guidelines in some markets, such as the US
In 2012, GlobalData estimates that the global UC market reached $4.2 billion across the 10 healthcare markets covered in our forecast: the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, and India. By the end of the forecast period, in 2022, sales across these markets will grow steadily to reach $6.6 billion, representing a Compound Annual Growth Rate (CAGR) of 4.8% over the 10-year timeframe .
Overview of UC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
Annualized UC 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 UC therapeutics markets.
Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late stage pipeline drugs.
Analysis of the current and future market competition in the global UC therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Market Model Features
An interactive excel forecast model based on primary research interviews and surveys with KOLs and high-prescribing physicians is included in this report*. This patient based model provides diagnosis rates, patient segmentation, treatment rates, annual costs of therapy , and indication-specific drug sales for the 10 year forecast period. The forecast model is robust, fully transparent, and easy to navigate. Moreover, our models support data presented in the reports and the complete methodology is outlined in the report and the model.
*Model only available with site and global license purchases.
The UC market has predominantly been driven by two TNF blockers, namely J&J’s Remicade and AbbVie’s Humira. Although these TNF blockers have monopolized the UC market for almost a decade, the balance is about to be tipped, with Takeda’s Entyvio imminently entering the market in 2014 and J&J’s Simponi launching in 2014 as well, stealing market share from Humira and Remicade.
Remicade and Humira will also be hit by their respective loss of patent protection in 2018 (US), 2015 (EU) and 2016 (US), 2018 (EU). Europe has already approved a biosimilar to Remicade, Celltrion’s Remsima, which will be marketed by Hospira under the brand name Inflectra in the EU. Due to lack of regulatory guidelines and the current debate about indication extrapolation for biosimilars based on a clinical trial in one indication, initial biosimilar uptake will be low, but by the end of the forecast period, in 2022 infliximab, adalimumab and golimumab biosimilars are forecast to become an established part of the UC market.
During the coming decade, Europe is expecting the approval and launch of a UC colectomy rescue therapy, InDex Pharmaceuticals’ Kappaproct. Kappaproct is targeting a small patient population group, but due to the involvement of key gastroenterologists in the development of this therapy, it will likely be welcomed for use in this new treatment setting, which has never been addressed before by a pharmaceutical product. In addition, Pfizer’s Xeljanz is expected to face low uptake post its estimated launch in 2017, owing to the controversy surrounding its rejection by the EMA for its primary indication, rheumatoid arthritis.
Key Questions Answered in this Report
How will the UC 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 UC 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 Kappaproct shape the future treatment landscape?
What are the remaining unmet needs and opportunities for drug developers within the UC market?
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 UC therapeutics markets.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global UC 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 UC 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.
Report at a Glance
Number of Pages – 328
Number of Tables – 144
Number of Figures – 30
Number of Companies Mentioned – 9
Number of Marketed and Pipeline Products Mentioned – 14
Number of KOL interviews – 9
Major Pipeline Products Mentioned – 3 Phase III/Filed products
Markets Covered – US, France, Germany, Italy, Spain, UK, Japan, Canada, China, India
List Of Tables
Table 1: Ulcerative Colitis: Key Metrics in the 10 Major Pharmaceutical Markets, 2012–2022 16
Table 2: Genetic Factors That Confer a Predisposition to UC 30
Table 3: Typical Symptoms of UC 32
Table 4: Strongest Putative Risk Factors for UC 36
Table 5: Prevalence of UC in the US 41
Table 6: Incidence of UC in the 5EU 42
Table 7: Prevalence of UC in the 5EU 43
Table 8: 10MM, Sources of UC Incidence Data Used in the Epidemiological Forecast 50
Table 9: 10MM, Sources of UC Prevalence Data Used in the Epidemiological Forecast 51
Table 10: 10MM, Incident Cases of UC, Ages =10 Years, Both Sexes, N, Select Years, 2012–2022 65
Table 11: 10MM, Incident Cases of UC, By Age, Both Sexes, N (Row %), 2012 67
Table 12: 10MM, Incident Cases of UC, By Sex, Ages =10 Years, N (Row %), 2012 69
Table 13: 10MM, Prevalent Cases of UC, Ages =10 Years, Both Sexes, N, Select Years, 2012–2022 72
Table 14: 10MM, Prevalent Cases of UC, By Age, Both Sexes, N (Row %), 2012 74
Table 15: 10MM, Prevalent Cases of UC, By Sex, Ages =10 Years, N (Row %), 2012 76
Table 16: Truelove and Witts UC Severity Index 83
Table 17: UCDAI 84
Table 18: Treatment Guidelines for UC Used in the 10MM 85
Table 19: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 86
Table 20: UC Management Country Profile – US 92
Table 21: UC Management Country Profile – France 94
Table 22: UC Management Country Profile – Germany 97
Table 23: UC Management Country Profile – Italy 100
Table 24: UC Management Country Profile – Spain 102
Table 25: UC Management Country Profile – UK 105
Table 26: UC Management Country Profile – Japan 107
Table 27: Country Profile – Canada 110
Table 28: UC Management Country Profile – China 112
Table 29: UC Management Country Profile – India 115
Table 30: Leading Treatments for UC, 2014 118
Table 31: Product Profile – Remicade 121
Table 32: Remicade SWOT Analysis, 2014 125
Table 33: Global Sales Forecasts ($m) for Remicade, 2012–2022 126
Table 34: Product Profile – Humira 128
Table 35: Humira Efficacy in the ULTRA 2 Trial 129
Table 36: Product Efficacy Comparison – Humira vs. Remicade 129
Table 37: Humira SWOT Analysis, 2014 131
Table 38: Global Sales Forecasts ($m) for Humira, 2012–2022 132
Table 39: Product Profile – Simponi 134
Table 40: Simponi SWOT Analysis, 2014 136
Table 41: Global Sales Forecasts ($m) for Simponi, 2012–2022 137
Table 42: Product Profile – Apriso 139
Table 43: Apriso SWOT Analysis, 2014 141
Table 44: Global Sales Forecasts ($m) for Apriso, 2012–2022 142
Table 45: Product Profile – Asacol HD 144
Table 46: Asacol HD SWOT Analysis, 2014 147
Table 47: Global Sales Forecasts ($m) for Asacol HD, 2012–2022 148
Table 48: Product Profile – Lialda 149
Table 49: Lialda SWOT Analysis, 2014 151
Table 50: Global Sales Forecasts ($m) for Lialda, 2012–2022 152
Table 51: Product Profile – Pentasa 153
Table 52: Pentasa SWOT Analysis, 2014 155
Table 53: Global Sales Forecasts ($m) for Pentasa, 2012–2022 156
Table 54: Product Profile – Colazal 157
Table 55: Colazal SWOT Analysis, 2014 159
Table 56: Global Sales Forecasts ($m) for Colazal, 2012–2022 160
Table 57: Product Profile – Giazo 161
Table 58: Giazo SWOT Analysis, 2014 163
Table 59: Global Sales Forecasts ($m) for Giazo, 2012–2022 164
Table 60: Product Profile – sfRowasa 165
Table 61: sfRowasa SWOT Analysis, 2014 166
Table 62: Global Sales Forecasts ($m) for sfRowasa, 2012–2022 167
Table 63: Product Profile – Uceris 168
Table 64: Uceris SWOT Analysis, 2014 170
Table 65: Global Sales Forecasts ($m) for Uceris, 2012–2022 171
Table 66: Summary of Other Immunomodulators for UC, 2013 172
Table 67: Biosimilars Pipeline, 2013 174
Table 68: Global Sales Forecasts ($m) for Infliximab Biosimilars, 2012–2022 177
Table 69: Global Sales Forecasts ($m) for Adalimumab Biosimilars, 2012–2022 177
Table 70: Global Sales Forecasts ($m) for Golimumab Biosimilars, 2012–2022 178
Table 71: Overall Unmet Needs – Current Level of Attainment 179
Table 72: Corticosteroid Long-Term Side Effects 182
Table 73: Clinical Unmet Needs in UC – Gap Analysis, 2013 185
Table 74: Prognostic Markers in UC 186
Table 75: UC – Clinical Trials by Phase and Status, 2014 189
Table 76: UC – Pre-Registration and Phase III Pipeline, 2014 189
Table 77: Comparison of Therapeutic Classes in Development for UC, 2014 190
Table 78: Product Profile – Entyvio 193
Table 79: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 194
Table 80: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 195
Table 81: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 196
Table 82: Entyvio SWOT Analysis, 2014 199
Table 83: Global Sales Forecasts ($m) for Entyvio, 2012–2022 201
Table 84: Product Profile – Xeljanz 202
Table 85: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 203
Table 86: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 205
Table 87: Xeljanz SWOT Analysis, 2014 207
Table 88: Global Sales Forecasts ($m) for Xeljanz, 2012–2022 208
Table 89: Product Profile – Kappaproct 209
Table 90: Results of Phase IIb Trial of Kappaproct in the Induction of Remission in UC 210
Table 91: Kappaproct SWOT Analysis, 2014 212
Table 92: Global Sales Forecasts ($m) for Kappaproct, 2012–2022 213
Table 93: Key Companies in the UC Market, 2012–2022 215
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