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REFERENCE CODE GDHC93PIDR | PUBLICATION DATE DECEM BER 2014

RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS

TO 2023

RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

The table below summarizes the key metrics for Launch of sirukumab (10MM) ↑↑ rheumatoid arthritis (RA) in the seven major Launch of (10MM) ↑↑ pharmaceutical markets analyzed in this report: the Launch of (US, 5EU) ↑↑ 2023 Market Sales US, France, Germany, Italy, Spain, the UK, and US $12.6bn Japan. Additional markets covered in this report 5EU $3.6bn include Australia, China, and India, for a total of 10 Japan $1.2bn major markets (10MM) during the forecast period Australia $613.8m from 2013–2023. China $588.9m India $780.0m Rheumatoid Arthritis: Key Metrics in the 10 Major Total $19.3bn Pharmaceutical Markets Source: GlobalData 2013 Epidemiology 10MM = US, France, Germany, Italy, Spain, UK, Japan, Australia, China, and India Prevalent Population 12.9 million 5EU = France, Germany, Italy, Spain, and UK Diagnosed Prevalence Population 7.3 million

Treated Population 5.3 million 2013 Market Sales Steady Growth in the RA Market Expected from US $10.4bn 2013 to 2023 5EU $2.9bn Japan $969.7m The RA market in the 10MM (US, France, Italy, Australia $476.9m Germany, Spain, UK, Australia, China, and India) China $325.8m is expected to grow at a Compound Annual Growth India $529.7m Rate (CAGR) of 2.1% during the forecast period, Total $15.6bn Pipeline Assessment from 2013 sales of $15.6 billion to sales of $19.3 Number of drugs in Phase IIa 43 billion in 2023. Number of drugs in Phase IIb–III (late-stage 13 development) The major drivers of growth in the global RA Number of first-in-class drugs (late-stage market during the forecast period are: 5 development) Peak-Year  Most Promising Pipeline Drugs An increase in the prevalent cases of RA in all Sales the markets, in part, due to an aging population Adalimumab biosimilars $1,978.2m Infliximab biosimilars $815.3m Mavrilimumab $366.3m Sirukumab $212.3m Baricitinib $112.5m Level of Key Events (2013–2023) Impact Launch of biosimilars for several ↓↓↓ established brands (10MM)

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

 The anticipated introduction of interleukin (IL)-6 The figure below shows the sales for RA in the inhibitors (Sanofi/Regeneron’s sarilumab, 10MM by region during the forecast period. Johnson & Johnson/GlaxoSmithKline’s Sales for RA by Region, 2013–2023 [J&J/GSK’s] sirukumab, Alder’s clazakizumab), 2013 novel biologics (Novartis’ Cosentyx, Total: $15.6bn

AstraZeneca/MedImmune’s mavrilimumab, 2% 3% 3% AbbVie/Biotest’s tregalizumab, and 6%

Amgen/Daiichi Sankyo’s denosumab), small 4% molecules (four [JAK] inhibitors: 3% 2% Eli Lilly/Incyte’s baricitinib, Astellas’ , Vertex’s , AbbVie/Galapagos’ 8% ; and one c-Kit inhibitor: AB Science’s 2% 67% masitinib), which will expand options to treat RA patients and contribute to overall market

growth 2023 Total: $19.3bn  The early diagnosis and treatment of patients 3% 4% with RA to limit disease progression 3% 6%  The market entry of biosimilars, which will 4%

make RA treatments more accessible 3% 2% The major barriers to the growth of the global RA market during the forecast period are: 8% 65% 2%  The high cost of biologics, which will limit their uptake, especially in cost-conscious markets

that are facing austerity measures US France Germany Italy Spain UK Japan Australia China India  The lack of regulatory guidance on biosimilars Source: GlobalData

 The market entry of biosimilars, which will provide a less expensive alternative and will challenge the established brands

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

The RA Market is Dominated by Big Pharma, there were no oral disease-modifying anti- Biologics, and High Price Tags rheumatic drugs (DMARDs) on the market to compete with the biologics, so Pfizer priced its The RA market is dominated by Big Pharma, and small molecule close to that of a biologic agent. all of the compounds in late-stage development are backed by a major pharmaceutical company. The Since the pathophysiology of RA overlaps with that major players in the RA market have extensive of other inflammatory diseases, most RA drugs will portfolios, and may enter into Phase I buyouts and undergo label expansions into additional partnerships at very early stages. It is especially indications, such as ankylosing spondylitis, common for these companies to form an early psoriasis, psoriatic arthritis, systemic lupus partnership for development in the Japanese erythematosus, and ulcerative colitis. However, the market: for example, AstraZeneca/MedImmune’s major brands for RA will soon face patent partnership with Daiichi Sankyo on the Phase I expiration, and biosimilars will be available in all 10 biologic known as AMP-110. Increasingly, due to markets covered in this report by the conclusion of the fragmented and increasingly competitive the forecast period in 2023. Biosimilars alone are landscape, companies are favoring collaborations forecast at $4.6 billion for the 2023 RA market, with in order to overcome both R&D and commercial adalimumab biosimilars accounting for nearly half barriers, reducing both their risk and costs in the that number at $2 billion. process. For example, Regeneron has partnered Meanwhile, a strategy being utilized by Roche, with Sanofi for the Phase III IL-6 inhibitor, another key player in the RA market, is to sarilumab. It is also common for Big Pharma to strengthen its brand, and the company is currently team up together and leverage their positions in running several post-marketing trials for Actemra the global markets, as is the case with sirukumab, (tocilizumab) to establish the drug’s position within an IL-6 inhibitor backed by both J&J and GSK. the treatment paradigm. Several Big Pharma While the development of biologics is both a companies, such as Pfizer and , have difficult and expensive endeavor, pharmaceutical realized the potential of biosimilars in the RA companies have used it to their advantage. The market and have launched programs to develop pricing for these RA drugs is upwards of $30,000 biosimilars of their own. per year, and although the market is crowded, a small patient share often translates into big earnings. Pfizer used this pricing strategy to its advantage when Xeljanz () launched in the US in 2012 and in Japan in 2013. At that time,

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

The figure below provides an analysis of the biomarkers will one day be available to determine company portfolio gap in RA during the forecast the best course of action to take for each patient. period. At the same time, it is recognized that RA may be a heterogeneous group of diseases, and that each Company Portfolio Gap Analysis in RA, 2013–2023 subtype may have a predominant pathway that is pathologically altered.

A key concern is that the prohibitive cost of the

High biologics means that some patients are unable to afford these medications, or that governments Current and Current Players Future Players must limit the number of patients who are Future Players approved for them. With biosimilars priced at 70% the cost of the originator brand, the addition of

Strength of Marketed ProductsMarketedof Strength these therapies to the RA market will certainly Low make treatment more accessible. However, KOLs interviewed by GlobalData believe that the lower Low High cost of biosimilars will not completely address the Strength of Pipeline need for less expensive treatment options. Source: GlobalData Pipeline Drugs Will Only Partially Address the

Remaining Unmet Needs in RA Biomarkers and Biosimilars Hold Hope in Addressing Unmet Needs in RA The unmet needs in RA are not expected to be directly addressed by the pipeline agents. The The biologic agents available to treat RA are disease is effectively treated by the currently reasonably effective at managing the symptoms available options, and upon launch, the pipeline and preventing progression of the disease. agents will compete for the same patient However, the challenges in treating the disease lie populations. Although drugs with novel in the unpredictable responses of each patient. mechanisms of action are welcome additions to the Many patients become frustrated as they cycle market, the real challenge will be to determine through multiple biologic agents before finding one where these drugs fit into the treatment paradigm. that is effective at managing their disease. Key The unmet needs are likely to be met through opinion leaders (KOLs) interviewed by GlobalData initiatives and research efforts to understand the hope that research on RA moves towards pathophysiology of RA, and through the individualized medicine, and that predictive development of diagnostic and prognostic

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

biomarkers for the disease. These efforts are likely pathways, and include three anti-IL6 therapies to expand the RA market through the diagnosis of (Sanofi/Regeneron’s sarilumab, J&J/GSK’s patients as early as possible, and by targeting the sirukumab, Alder’s clazakizumab), an anti-IL17 correct therapy to each patient. While research in (Novartis’ Cosentyx), and two drugs with novel this area is underway, it is expected that mechanisms of action that target immune cells individualized medicine will still be in its beginning (AstraZeneca-MedImmune’s mavrilimumab and stages by the end of the forecast period in 2023. AbbVie/Biotest’s tregalizumab). Additionally, Amgen/Daiichi Sankyo’s denosumab, which is a Due to the competitive nature of the RA market, marketed drug for disorders that targets pipeline agents must meet a number of criteria. receptor activator nuclear factor kappa-B ligand The drugs must be both safe and effective, and (RANKL), a molecule in the TNF family that ideally, be provided at a lower cost than the controls , is expected to gain label currently available therapies. Pfizer’s Xeljanz, the expansion for RA in Japan. There are also two first oral therapy to compete with the biologics in classes of oral therapies in the late-stage RA the RA market, which launched in the US in 2012 pipeline, including four JAK inhibitors (Eli and in Japan in 2013, is priced higher than most Lilly/Incyte’s baricitinib, AbbVie/Galapagos’ oral medications, as the current market allows for filgotinib, Astellas’ peficitinib, and Vertex’s high prices. This scenario will likely change by decernotinib), and one c-Kit inhibitor (AB Science’s 2021, when Xeljanz loses its patent protection masitinib). expiration in the US, and the first JAK inhibitor is offered as a generic. However, the situation will be The key products that are expected to have the different from the patent expiration of biologics, largest impact on the global RA market include: where biosimilars must go through an expensive  J&J and GSK’s sirukumab, which is in Phase development program, including Phase I and III of development and is expected to launch in Phase III testing, and as a result, these products all the markets in 2018, with the exception of are likely to be priced high. China, where it will launch in 2022. Although Biologics and Small Molecules with Novel sirukumab is considered to have a safety and Mechanisms of Action are Welcome Additions efficacy similar to sarilumab, and will launch in to the RA Market the same year, it is expected to become available in all the markets and have higher The late-stage pipeline for RA contains both non- sales. Sirukumab is expected to reach annual anti- (TNF) biologics and sales of $212.3m in 2023, and will primarily novel oral therapies for RA. Of the seven current late-stage biologics, most target inflammatory

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

compete with Roche’s IL-6 inhibitor, Actemra  Biotest and AbbVie’s tregalizumab is a Phase (SC). IIb mAb directed at the CD4 receptor on regulatory T cells (Tregs), and activates this  Eli Lilly and Incyte’s baricitinib is a Phase III cell type, limiting inflammation. Like oral JAK inhibitor. Although it will face mavrilimumab, this drug will be a first-in-class competition in the US and Japan, baricitinib is agent, with no other drugs in the pipeline expected to be the first available JAK inhibitor having the same mechanism of action, and will in the 5EU, Australia, China, and India, with its likely be used in a similar clinical setting, as it launch forecast to occur in 2017, with the will be reserved as a second-line biologic exception of China, where it will launch in therapy, or beyond. Tregalizumab is expected 2021. Still, this assumption is based on the to launch in 2022, with sales reaching current unclear status and future of Pfizer’s approximately $161.6m the following year. Xeljanz in the 5EU, following a negative recommendation from the European Medicine The figure below provides a competitive Agency’s (EMA’s) Committee for Medicinal assessment of the most promising late-stage Products for Use (CHMP) for the drug pipeline agents for RA during the forecast period. in 2013. Sales of baricitinib are forecast at Competitive Assessment of the Late-Stage Pipeline $112.5m in 2023, and the drug will cover more Agents for RA, 2013–2023

Astellas’s Lilly/Incyte’s J&J/GSK’s sirukumab markets than the other JAK inhibitors in the pef icitinib baricitinib pipeline. Sanofi/Regeneron’s Novartis’s Galapagos/AbbVie’s filgotinib sarilumab Cosentyx  AstraZeneca/MedImmune’s Phase IIb drug, High Alder’s clazakizumab Biotest/AbbVie’s mavrilimumab, is a (mAb) Vertex’s tregalizumab Amgen/Daiichi decernotinib Sankyo’s targeted against the granulocyte macrophage denosumab AstraZeneca’s mavrilimumab colony-stimulating factor (GM-CSF) receptor

AB Science’s masitinib and reduces inflammation in the joints. IRBP’s RAVAX Commercial Attributes Commercial Although mavrilimumab will likely be reserved Low at least as a second line of biologic therapy, it is highly anticipated as the first drug of its Low High Clinical Attributes class, with no drugs in the pipeline of the same Source: GlobalData class. Mavrilimumab is expected to launch in

2020, and is anticipated to reach annual sales of $366.3m in 2023.

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

What Do Physicians Think? “Unless we can upfront identify a group in whom it’s [a pipeline agent] going to be effective…, [or] The RA market is very competitive, and the new unless it’s marketed at a significantly lower cost entrants are expected to be met with some than its competitors, what will happen is that the resistance and experience slow uptake, as the [new] drug will be used fourth or fifth line, etcetera. market is currently dominated by the anti-TNFs, Because if it costs the same as a currently and rheumatologists feel comfortable with the long- available biologic, the currently available biologics term safety and efficacy of this class of drugs. have got a stronger history, [a] longer history of “We at least have a reasonably good handle on maybe safety and efficacy data, [so] why would what the long-term or relatively long-term safety you choose to use the new one unless you’d profile of [the] anti-TNFs is. They’re not perfect, but actually tried and failed [with] the old ones? The at least we know what the issues are, and there problem with that, of course, for the new ones, is are concerns, I think, with the [the] long-term safety that they end up being tried on often the most profiles of some of the new agents that have come difficult rheumatoid [arthritis] patients, and so, often through. And so, given that we rheumatologists they don’t work.” feel more comfortable with the anti-TNFs…, we know what to look out for. Then, for any new [EU] KOL players…, it can be difficult to compete because One of the greatest challenges with the the concern is always, well, maybe the new drug introduction of new biologics in the RA market will might have long-term side effects, and so we better be to target these drugs to the right patients. Many use the ones that we’ve got more — [that] we’re rheumatologists believe that the future of RA is in more familiar with.” individualized medicine, where biomarkers determine the best course of action for each [EU] KOL patient.

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

“I think the patients find the whole process [of One of the greatest unmet needs in RA is the finding an effective therapy to be] very difficult. affordability of drugs, as the biologics cost upwards They often lose faith in our approach to treat their of $30,000 per year in the US. Biosimilars are disease well. It may have an impact on their expected to launch over the forecast period from adherence to medication in the future. We kind of 2013–2023 in all 10 markets covered in this report, keep dropping and changing between one thing changing the market dynamics and offering a less and another thing. How do they know that the fifth expensive alternative to the branded biologics. thing is going to work when the first four haven’t? “If a biosimilar is only half as expensive [as the Actually, adherence to drugs is a big issue in originator brand] — which it’s probably not, [as people with long-term conditions [such as RA], and that’s] probably overly optimistic — it’s still way out the fact that it can take us a long time to find of the reach of most patients if they have [health something that works, I think, is a big issue in the insurance] coverage problems. Yes, it will help the context of that for the patients as well.” overall system, but [it will] probably not help the [UK] KOL individual patient very much. [I would prescribe biosimilars when they are available] sure, “I think it will be very difficult for rheumatologists to absolutely….You would potentially replace the manage this huge number of different drugs that innovative product with a biosimilar whenever you are available without us having some kind of have that option. The only reason you do that, strategy for establishing which groups of patients obviously, is cost. In most cases, it’s not going to each particular drug would be most effective in, be my decision; it’s going to be the decision of and so that kind of takes us down to [the] whoever is paying for it….It will be helpful, but it’s personalized medicine route, and I think that’s not going to be a big game-changer….Two thirds what companies need to be looking at as they’re of [what is already] a heck of a lot of money is still developing these new agents….We need to work almost a heck of a lot of money, and most people out who to treat with what — who to treat with what don’t have that.” drug, based on identifying biomarkers that predict [the patient’s] response, which could be ones that [US] KOL you measure in the blood or [the] ones that you

measure from the joint, but I think that will have to

be the direction of travel.”

[EU] KOL

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

1 Table of Contents

1 Table of Contents ...... 10 1.1 List of Tables ...... 17 1.2 List of Figures ...... 25 2 Introduction ...... 28 2.1 Catalyst ...... 28 2.2 Related Reports ...... 29 2.3 Upcoming Related Reports ...... 29 3 Disease Overview ...... 30 3.1 Etiology and Pathophysiology ...... 30 3.1.1 Etiology ...... 30 3.1.2 Pathophysiology ...... 30 3.2 Symptoms ...... 35 3.3 Prognosis ...... 35 3.4 Quality of Life ...... 36 4 Epidemiology ...... 37 4.1 Disease Background ...... 37 4.2 Risk Factors and Comorbidities ...... 37 4.3 Global Trends ...... 39 4.3.1 US ...... 39 4.3.2 5EU ...... 40 4.3.3 Japan ...... 41 4.3.4 Australia ...... 41 4.3.5 China ...... 42 4.3.6 India ...... 42 4.4 Forecast Methodology ...... 42 4.4.1 Sources Used...... 45

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

4.4.2 Sources Not Used ...... 49 4.4.3 Forecast Assumptions and Methods – Total Prevalent Cases of RA ...... 50 4.4.4 Forecast Assumptions and Methods – Diagnosed Prevalent Cases of RA ...... 54 4.5 Epidemiological Forecast for RA (2013–2023) ...... 55 4.5.1 Total Prevalent Cases of RA ...... 55 4.5.2 Age-Specific Total Prevalent Cases of RA ...... 57 4.5.3 Sex-Specific Total Prevalent Cases of RA ...... 59 4.5.4 Diagnosed Prevalent Cases of RA ...... 61 4.5.5 Age-Standardized Diagnosed Prevalence of RA ...... 63 4.6 Discussion ...... 64 4.6.1 Epidemiological Forecast Insight ...... 64 4.6.2 Limitations of the Analysis ...... 65 4.6.3 Strengths of the Analysis ...... 66 5 Disease Management ...... 67 5.1 Diagnosis and Treatment Overview ...... 67 5.1.1 Diagnosis ...... 67 5.1.2 Treatment Guidelines ...... 69 5.1.3 Leading Prescribed Drugs for the Treatment of RA ...... 78 5.1.4 Clinical Practice ...... 79 5.2 US...... 84 5.3 France ...... 88 5.4 Germany ...... 89 5.5 Italy ...... 92 5.6 Spain ...... 94 5.7 UK...... 95 5.8 Japan ...... 99 5.9 Australia ...... 101

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

5.10 China ...... 103 5.11 India ...... 105 6 Competitive Assessment ...... 108 6.1 Overview ...... 108 6.2 Product Profiles – Major Brands ...... 109 6.2.1 Enbrel (etanercept)...... 109 6.2.2 Humira (adalimumab) ...... 116 6.2.3 Remicade (infliximab) ...... 120 6.2.4 Simponi (golimumab) ...... 126 6.2.5 Cimzia (certolizumab pegol) ...... 132 6.2.6 Orencia (abatacept)...... 136 6.2.7 Actemra/RoActemra (tocilizumab) ...... 142 6.2.8 Rituxan/MabThera (rituximab) ...... 150 6.2.9 Inflectra/Remsima (infliximab biosimilar) ...... 155 6.2.10 Xeljanz (tofacitinib) ...... 158 6.2.11 Iguratimod/T-614 ...... 165 6.2.12 Methotrexate (Numerous Brands) ...... 168 6.3 Biosimilars ...... 172 6.3.1 Introduction ...... 172 6.3.2 Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases ...... 174 6.3.3 Biosimilars in the Immunology Community ...... 174 6.3.4 By the Numbers: Biosimilars in Development ...... 175 6.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry ...... 179 6.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market ...... 180 6.3.7 Biosimilars’ Forecast ...... 183 6.4 Other Therapies ...... 191 7 Unmet Need and Opportunity ...... 193

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

7.1 Overview ...... 193 7.2 Development of Cost-Effective Therapies ...... 194 7.2.1 Unmet Need ...... 194 7.2.2 Gap Analysis ...... 195 7.2.3 Opportunity ...... 195 7.3 Biomarkers to Predict Responsiveness to Therapy ...... 195 7.3.1 Unmet Need ...... 195 7.3.2 Gap Analysis ...... 197 7.3.3 Opportunity ...... 198 7.4 Early Diagnosis of RA ...... 198 7.4.1 Unmet Need ...... 198 7.4.2 Gap Analysis ...... 199 7.4.3 Opportunity ...... 200 7.5 Personalized Treatment Approach ...... 201 7.5.1 Unmet Need ...... 201 7.5.2 Gap Analysis ...... 201 7.5.3 Opportunity ...... 203 8 Pipeline Assessment...... 205 8.1 Overview ...... 205 8.2 Mapping ...... 205 8.2.1 Clinical Trials by Class ...... 205 8.3 Promising Drugs in Clinical Development ...... 207 8.3.1 Sarilumab ...... 214 8.3.2 Sirukumab ...... 222 8.3.3 Clazakizumab...... 229 8.3.4 Cosentyx (secukinumab) ...... 235 8.3.5 Tregalizumab ...... 241

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

8.3.6 Mavrilimumab ...... 247 8.3.7 Denosumab (Prolia/Xgeva) ...... 252 8.3.8 Baricitinib ...... 258 8.3.9 Peficitinib ...... 268 8.3.10 Decernotinib ...... 274 8.3.11 Filgotinib ...... 280 8.3.12 Masitinib ...... 286 8.3.13 RAVAX ...... 293 8.4 Other Drugs in Development ...... 298 9 Current and Future Players ...... 301 9.1 Trends in Corporate Strategy ...... 304 9.2 Company Profiles ...... 305 9.2.1 AbbVie ...... 305 9.2.2 Pfizer ...... 307 9.2.3 Amgen...... 310 9.2.4 Johnson & Johnson ...... 313 9.2.5 Eli Lilly ...... 315 9.2.6 Bristol-Myers Squibb ...... 317 9.2.7 UCB ...... 319 9.2.8 Roche...... 320 9.2.9 GlaxoSmithKline ...... 322 9.2.10 Novartis ...... 324 9.2.11 Sanofi ...... 326 9.2.12 AstraZeneca- MedImmune ...... 328 9.2.13 Astellas ...... 330 9.2.14 Vertex...... 332 9.2.15 Daiichi Sankyo ...... 334

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

10 Market Outlook ...... 337 10.1 Global Markets ...... 337 10.1.1 Forecast ...... 337 10.1.2 Drivers and Barriers – Global Issues ...... 342 10.2 United States ...... 344 10.2.1 Forecast ...... 344 10.2.2 Key Events ...... 350 10.2.3 Drivers and Barriers ...... 351 10.3 France ...... 353 10.3.1 Forecast ...... 353 10.3.2 Key Events ...... 358 10.3.3 Drivers and Barriers ...... 358 10.4 Germany ...... 361 10.4.1 Forecast ...... 361 10.4.2 Key Events ...... 366 10.4.3 Drivers and Barriers ...... 367 10.5 Italy ...... 370 10.5.1 Forecast ...... 370 10.5.2 Key Events ...... 375 10.5.3 Drivers and Barriers ...... 375 10.6 Spain ...... 377 10.6.1 Forecast ...... 377 10.6.2 Key Events ...... 383 10.6.3 Drivers and Barriers ...... 384 10.7 United Kingdom ...... 386 10.7.1 Forecast ...... 386 10.7.2 Key Events ...... 392

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

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10.7.3 Drivers and Barriers ...... 392 10.8 Japan ...... 395 10.8.1 Forecast ...... 395 10.8.2 Key Events ...... 400 10.8.3 Drivers and Barriers ...... 400 10.9 Australia ...... 403 10.9.1 Forecast ...... 403 10.9.2 Key Events ...... 408 10.9.3 10.9.3 Drivers and Barriers...... 408 10.10 China ...... 410 10.10.1 Forecast ...... 410 10.10.2 Key Events ...... 415 10.10.3 Drivers and Barriers ...... 415 10.11 India ...... 417 10.11.1 Forecast ...... 417 10.11.2 Key Events ...... 422 10.11.3 Drivers and Barriers ...... 422 11 Appendix...... 425 11.1 Bibliography ...... 425 11.2 Abbreviations ...... 451 11.3 Methodology ...... 458 11.4 Forecasting Methodology ...... 458 11.4.1 Diagnosed RA Patients ...... 458 11.4.2 Percentage of Drug-Treated Patients ...... 459 11.4.3 Drugs Included in Each Therapeutic Class ...... 459 11.4.4 Launch and Patent Expiry Dates ...... 460 11.4.5 General Pricing Assumptions ...... 461

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

11.4.6 Individual Drug Assumptions ...... 463 11.4.7 Generic and Biosimilar Erosion ...... 475 11.4.8 Pricing of Pipeline Agents...... 475 11.5 Primary Research – KOLs Interviewed for This Report ...... 478 11.6 Primary Research – Prescriber Survey ...... 480 11.7 About the Authors ...... 480 11.7.1 Analyst ...... 480 11.7.2 Reviewer ...... 481 11.7.3 Therapy Area Director ...... 481 11.7.4 Epidemiologist ...... 482 11.7.5 Global Head of Healthcare ...... 483 11.8 About GlobalData ...... 484 11.9 Disclaimer ...... 484

1.1 List of Tables

Table 1: Symptoms of RA ...... 35

Table 2: Risk Factors and Comorbidities for RA ...... 39

Table 3: 1987 ACR Diagnostic Criteria for RA ...... 43

Table 4: 10MM, Sources of RA Prevalence Data ...... 44

Table 5: 8MM, Total Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2013–2023 .... 56

Table 6: 8MM, Age-Specific Total Prevalent Cases of RA, Both Sexes, N (Row %), 2013 ...... 58

Table 7: 8MM, Sex-Specific Total Prevalent Cases of RA, Ages ≥18 Years, N (Row %), 2013 ...... 60

Table 8: 10MM, Diagnosed Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, Selected Years 2013– 2023...... 62

Table 9: 1987 ACR Diagnostic Criteria for RA ...... 68

Table 10: 2010 ACR/EULAR Diagnostic Criteria for RA ...... 69

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Table 11: Treatment Guidelines for RA Used by Each Country in the 10MM ...... 71

Table 12: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity ...... 74

Table 13: EULAR 2013 Criteria for RA Remission ...... 75

Table 14: Most Prescribed Biologics for RA (After csDMARDs) in the Global Markets, 2014 ...... 79

Table 15: RA Treatment Country Profile – US ...... 87

Table 16: RA Treatment Country Profile – France ...... 89

Table 17: RA Treatment Country Profile – Germany ...... 91

Table 18: RA Treatment Country Profile – Italy ...... 93

Table 19: RA Treatment Country Profile – Spain ...... 95

Table 20: RA Treatment Country Profile – UK ...... 98

Table 21: RA Treatment Country Profile – Japan ...... 100

Table 22: RA Treatment Country Profile – Australia ...... 103

Table 23: RA Treatment Country Profile – China ...... 105

Table 24: RA Treatment Country Profile – India ...... 107

Table 25: Leading Branded Treatments for RA 2014 ...... 109

Table 26: Product Profile – Enbrel ...... 111

Table 27: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers ...... 112

Table 28: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results ...... 113

Table 29: Enbrel SWOT Analysis, 2014 ...... 114

Table 30: Global Sales Forecasts ($m) for Enbrel, 2013–2023 ...... 115

Table 31: Product Profile – Humira ...... 117

Table 32: Humira SWOT Analysis, 2014 ...... 119

Table 33: Global Sales Forecasts ($m) for Humira, 2013–2023 ...... 120

Table 34: Product Profile – Remicade ...... 122

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Table 35: Remicade SWOT Analysis, 2014...... 125

Table 36: Global Sales Forecasts ($m) for Remicade, 2013–2023 ...... 126

Table 37: Product Profile – Simponi ...... 128

Table 38: Simponi SWOT Analysis, 2014 ...... 130

Table 39: Global Sales Forecasts ($m) for Simponi, 2013–2023 ...... 131

Table 40: Product Profile – Cimzia ...... 133

Table 41: Cimzia SWOT Analysis, 2014...... 135

Table 42: Global Sales Forecasts ($m) for Cimzia, 2013–2023 ...... 136

Table 43: Product Profile – Orencia ...... 138

Table 44: Orencia SWOT Analysis, 2014 ...... 141

Table 45: Global Sales Forecasts ($m) for Orencia, 2013–2023 ...... 142

Table 46: Product Profile – Actemra...... 146

Table 47: Actemra SWOT Analysis, 2014 ...... 148

Table 48: Global Sales Forecasts ($m) for Actemra, 2013–2023 ...... 149

Table 49: Product Profile – Rituxan ...... 152

Table 50: Rituxan SWOT Analysis, 2014 ...... 153

Table 51: Global Sales Forecasts ($m) for Rituxan, 2013–2023 ...... 154

Table 52: Product Profile – Inflectra/Remsima ...... 156

Table 53: Inflectra/Remsima SWOT Analysis, 2014 ...... 157

Table 54: Product Profile – Xeljanz ...... 161

Table 55: ORAL Standard ACR20 Responses for Tofacitinib vs. Humira and Placebo at Month 6 ...... 162

Table 56: ORAL Step ACR20, 50, and 70 Responses for Xeljanz vs. Placebo at Month 6 ...... 162

Table 57: Xeljanz SWOT Analysis, 2014 ...... 164

Table 58: Global Sales Forecasts ($m) for Xeljanz, 2013–2023 ...... 165

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Table 59: Product Profile – Iguratimod ...... 166

Table 60: Iguratimod SWOT Analysis, 2014 ...... 167

Table 61: Global Sales Forecasts ($m) for Iguratimod, 2013–2023 ...... 168

Table 62: Product Profile – MTX ...... 170

Table 63: MTX SWOT Analysis, 2014 ...... 171

Table 64: Global Sales Forecasts ($m) for MTX, 2013–2023 ...... 172

Table 65: Biosimilars Pipeline for RA, 2013...... 176

Table 66: Physician Uptake of Biosimilar Products for RA Across the 10MM, 2014 ...... 183

Table 67: Global Sales Forecasts ($m) for Etanercept Biosimilars, 2013–2023 ...... 183

Table 68: Global Sales Forecasts ($m) for Adalimumab Biosimilars, 2013–2023 ...... 184

Table 69: Global Sales Forecasts ($m) for Infliximab Biosimilars, 2013–2023 ...... 186

Table 70: Global Sales Forecasts ($m) for Certolizumab Pegol Biosimilars, 2013–2023 ...... 187

Table 71: Global Sales Forecasts ($m) for Abatacept Biosimilars, 2013–2023 ...... 188

Table 72: Global Sales Forecasts ($m) for Tocilizumab Biosimilars, 2013–2023...... 189

Table 73: Global Sales Forecasts ($m) for Rituximab Biosimilars, 2013–2023 ...... 190

Table 74: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 ...... 192

Table 75: Unmet Need and Opportunity in RA, 2014 ...... 194

Table 76: Comparison of Therapeutic Drug Classes in Development for RA, 2014 ...... 214

Table 77: Product Profile – Sarilumab ...... 216

Table 78: MOBILITY Study Part, A, Results for Sarilumab at Week 12 ...... 217

Table 79: MOBILITY Study, Part B, Results for Sarilumab at Week 52 ...... 217

Table 80: Sarilumab SWOT Analysis, 2014...... 221

Table 81: Global Sales Forecasts ($m) for Sarilumab, 2013–2023 ...... 222

Table 82: Product Profile – Sirukumab ...... 223

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Table 83: Sirukumab SWOT Analysis, 2014 ...... 227

Table 84: Global Sales Forecasts ($m) for Sirukumab, 2013–2023 ...... 228

Table 85: Product Profile – Clazakizumab ...... 230

Table 86: Phase IIb Study of Clazakizumab: ACR Responses After 12 Weeks ...... 231

Table 87: Phase IIb Study of Clazakizumab: ACR Responses After 24 Weeks ...... 231

Table 88: Clazakizumab SWOT Analysis, 2014 ...... 234

Table 89: Global Sales Forecasts ($m) for Clazakizumab, 2013–2023 ...... 235

Table 90: Product Profile – Cosentyx ...... 237

Table 91: Cosentyx SWOT Analysis, 2014 ...... 240

Table 92: Global Sales Forecasts ($m) for Cosentyx, 2013–2023 ...... 241

Table 93: Product Profile – Tregalizumab ...... 243

Table 94: Tregalizumab SWOT Analysis, 2014 ...... 246

Table 95: Global Sales Forecasts ($m) for Tregalizumab, 2013–2023 ...... 246

Table 96: Product Profile – Mavrilimumab ...... 248

Table 97: Mavrilimumab SWOT Analysis, 2014...... 251

Table 98: Global Sales Forecasts ($m) for Mavrilimumab, 2013–2023 ...... 252

Table 99: Product Profile – Denosumab ...... 254

Table 100: Denosumab SWOT Analysis, 2014...... 257

Table 101: Global Sales Forecasts ($m) for denosumab in RA, 2013–2023 ...... 258

Table 102: Product Profile – Baricitinib ...... 260

Table 103: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 ...... 261

Table 104: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 ...... 261

Table 105: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 ...... 263

Table 106: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12...... 263

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Table 107: Baricitinib SWOT Analysis, 2014 ...... 266

Table 108: Global Sales Forecasts ($m) for Baricitinib, 2013–2023 ...... 267

Table 109: Product Profile – Peficitinib ...... 269

Table 110: Peficitinib SWOT Analysis, 2014 ...... 273

Table 111: Global Sales Forecasts ($m) for Peficitinib, 2013–2023 ...... 274

Table 112: Product Profile – Decernotinib ...... 275

Table 113: Phase IIb tudy of Decernotinib: ACR Responses at Week 24...... 276

Table 114: Decernotinib SWOT Analysis, 2014 ...... 279

Table 115: Global Sales Forecasts ($m) for Decernotinib, 2013–2023 ...... 280

Table 116: Product Profile – Filgotinib ...... 281

Table 117: Filgotinib SWOT Analysis, 2014 ...... 285

Table 118: Global Sales Forecasts ($m) for Filgotinib, 2013–2023 ...... 286

Table 119: Product Profile – Masitinib ...... 288

Table 120: ACR Response to Masitinib in RA (12 Weeks)...... 289

Table 121: ACR Responses for Masitinib in the Phase IIa ITT Population (12–82 Weeks) ...... 289

Table 122: Masitinib SWOT Analysis, 2014...... 292

Table 123: Global Sales Forecasts ($m) for Masitinib, 2013–2023 ...... 293

Table 124: Product Profile – RAVAX ...... 294

Table 125: RAVAX SWOT Analysis, 2014 ...... 297

Table 126: Drugs in Phase II of Development for RA, 2014 ...... 299

Table 127: Key Companies in the RA Market, 2014 ...... 303

Table 128: AbbVie’s RA Portfolio Assessment, 2014 ...... 306

Table 129: Pfizers’s RA Portfolio Assessment, 2014 ...... 309

Table 130: Amgen’s RA Portfolio Assessment, 2014 ...... 312

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Table 131: J&J’s RA Portfolio Assessment, 2014 ...... 314

Table 132: Eli Lilly’s RA Portfolio Assessment, 2014 ...... 316

Table 133: BMS’ RA Portfolio Assessment, 2014 ...... 318

Table 134: UCB’s RA Portfolio Assessment, 2014 ...... 319

Table 135: Roche’s RA Portfolio Assessment, 2014 ...... 321

Table 136: GSK’s RA Portfolio Assessment, 2014 ...... 323

Table 137: Novartis’ RA Portfolio Assessment, 2014 ...... 325

Table 138: Sanofi’s RA Portfolio Assessment, 2014 ...... 327

Table 139: AstraZeneca -MedImmune’s RA Portfolio Assessment, 2014...... 329

Table 140: Astellas’s RA Portfolio Assessment, 2014 ...... 331

Table 141: Vertex’s RA Portfolio Assessment, 2014 ...... 333

Table 142: Daiichi Sankyo’s RA Portfolio Assessment, 2014 ...... 335

Table 143: Global Sales Forecasts ($m) for RA, 2013–2023 ...... 339

Table 144: Global RA Market – Drivers and Barriers, 2013–2023 ...... 342

Table 145: Sales Forecasts ($m) for RA in the United States, 2013–2023 ...... 347

Table 146: Key Events Impacting Sales for RA in the US, 2013–2023 ...... 350

Table 147: RA Market in the US – Drivers and Barriers, 2013–2023...... 351

Table 148: Sales Forecasts ($m) for RA in France, 2013–2023 ...... 355

Table 149: Key Events Impacting Sales for RA in France, 2013–2023 ...... 358

Table 150: RA Market in France – Drivers and Barriers, 2013–2023 ...... 358

Table 151: Sales Forecasts ($m) for RA in Germany, 2013–2023 ...... 363

Table 152: Key Events Impacting Sales for RA in Germany, 2013–2023 ...... 366

Table 153: RA Market in Germany – Drivers and Barriers, 2013–2023 ...... 367

Table 154: Sales Forecasts ($m) for RA in Italy, 2013–2023 ...... 372

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Table of Contents

Table 155: Key Events Impacting Sales for RA in Italy, 2013–2023 ...... 375

Table 156: RA Market in Italy – Drivers and Barriers, 2013–2023 ...... 375

Table 157: Sales Forecasts ($m) for RA in Spain, 2013–2023...... 380

Table 158: Key Events Impacting Sales for RA in Spain, 2013–2023 ...... 383

Table 159: RA Market in Spain – Drivers and Barriers, 2013–2023 ...... 384

Table 160: Sales Forecasts ($m) for RA in the UK, 2013–2023 ...... 389

Table 161: Key Events Impacting Sales for RA in the UK, 2013–2023 ...... 392

Table 162: RA Market in the UK – Drivers and Barriers, 2013–2023...... 392

Table 163: Sales Forecasts ($m) for RA in Japan, 2013–2023 ...... 397

Table 164: Key Events Impacting Sales for RA in Japan, 2013–2023 ...... 400

Table 165: RA Market in Japan – Drivers and Barriers, 2013–2023 ...... 400

Table 166: Sales Forecasts ($m) for RA in Australia, 2013–2023 ...... 405

Table 167: Key Events Impacting Sales for RA in Australia, 2013–2023 ...... 408

Table 168: RA Market in Australia – Drivers and Barriers, 2013–2023...... 408

Table 169: Sales Forecasts ($) for RA in China, 2013–2023 ...... 412

Table 170: Key Events Impacting Sales for RA in China, 2013–2023 ...... 415

Table 171: RA Market in China – Drivers and Barriers, 2013–2023 ...... 415

Table 172: Sales Forecasts ($m) for RA in India, 2013–2023 ...... 419

Table 173: Key Events Impacting Sales for RA in India, 2013–2023 ...... 422

Table 174: RA Market in India – Drivers and Barriers, 2013–2023 ...... 422

Table 175: Key Launch Dates of RA Products in the 10MM ...... 460

Table 176: Key Patent Expiries ...... 461

Table 177: High-Prescribing Physicians (non-KOLs) Surveyed, By Country ...... 480

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Table of Contents

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA ...... 31

Figure 2: Cellular and Cytokine Targets for the Current RA Drugs ...... 34

Figure 3: 8MM, Total Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, 2013–2023 ...... 57

Figure 4: 8MM, Age-Specific Total Prevalent Cases of RA, Both Sexes, N, 2013 ...... 59

Figure 5: 8MM, Sex-Specific Total Prevalent Cases of RA, Ages ≥18 Years, N, 2013 ...... 61

Figure 6: 10MM, Diagnosed Prevalent Cases of RA, Ages ≥18 Years, Both Sexes, N, 2013–2023 ...... 63

Figure 7: 10MM, Age-Standardized Prevalence of RA (%), Ages ≥18 Years, 2013 ...... 64

Figure 8: Disease Management Flowchart for Early RA – ACR 2012...... 75

Figure 9: Disease Management Flowchart for Established RA – ACR 2012...... 76

Figure 10: Flowchart for the Management of RA – EULAR 2013 ...... 77

Figure 11: Biosimilar Prescribing Habits in RA Across the 10MM, 2014 ...... 182

Figure 12: Global Sales Forecasts ($m) for Enbrel vs. Etanercept Biosimilars, 2013–2023 ...... 184

Figure 13: Global Sales Forecasts ($m) for Humira vs. Adalimumab Biosimilars, 2013–2023 ...... 185

Figure 14: Global Sales Forecasts ($m) for Remicade vs. Infliximab Biosimilars, 2013–2023 ...... 187

Figure 15: Global Sales Forecasts ($m) for Cimzia vs. Certolizumab Pegol Biosimilars, 2013–2023 ...... 188

Figure 16: Global Sales of Orencia vs. Abatacept (IV) Biosimilars, 2013–2023 ...... 189

Figure 17: Global Sales of Actemra vs. Tocilizumab (IV) Biosimilars, 2013–2023 ...... 190

Figure 18: Global Sales of Rituxan vs. Rituximab Biosimilars, 2013–2023 ...... 191

Figure 19: RA Clinical Trials – By Drug Class, 2014 ...... 207

Figure 20: RA – Phase II–III Pipeline, 2014 ...... 209

Figure 21: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013–2023 ...... 213

Figure 22: Clinical and Commercial Positioning of Sarilumab ...... 220

Figure 23: Clinical and Commercial Positioning of Sirukumab ...... 227

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Table of Contents

Figure 24: Clinical and Commercial Positioning of Clazakizumab ...... 234

Figure 25: Clinical and Commercial Positioning of Cosentyx ...... 239

Figure 26: Clinical and Commercial Positioning of Tregalizumab ...... 245

Figure 27: Clinical and Commercial Positioning of Mavrilimumab ...... 251

Figure 28: Clinical and Commercial Positioning of denosumab in RA ...... 257

Figure 29: Clinical and Commercial Positioning of Baricitinib ...... 266

Figure 30: Clinical and Commercial Positioning of Peficitinib ...... 272

Figure 31: Clinical and Commercial Positioning of Decernotinib ...... 278

Figure 32: Clinical and Commercial Positioning of Filgotinib ...... 284

Figure 33: Clinical and Commercial Positioning of Masitinib ...... 291

Figure 34: Clinical and Commercial Positioning of RAVAX ...... 297

Figure 35: Company Portfolio Gap Analysis in RA, 2013–2023 ...... 304

Figure 36: AbbVie SWOT Analysis in RA, 2013–2023 ...... 307

Figure 37: Pfizer SWOT Analysis in RA, 2013–2023 ...... 310

Figure 38: Amgen SWOT Analysis in RA, 2013–2023 ...... 312

Figure 39: J&J SWOT Analysis in RA, 2013–2023 ...... 315

Figure 40: Eli Lilly SWOT Analysis in RA, 2013–2023 ...... 317

Figure 41: BMS SWOT Analysis in RA, 2013–2023 ...... 318

Figure 42: UCB SWOT Analysis in RA, 2013–2023 ...... 320

Figure 43: Roche SWOT Analysis in RA, 2013–2023 ...... 322

Figure 44: GSK SWOT Analysis in RA, 2013–2023 ...... 324

Figure 45: Novartis SWOT Analysis in RA, 2013–2023 ...... 326

Figure 46: Sanofi SWOT Analysis in RA, 2013–2023 ...... 328

Figure 47: AstraZeneca/MedImmune SWOT Analysis in RA, 2013–2023 ...... 330

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Table of Contents

Figure 48: Astellas SWOT Analysis in RA, 2013–2023 ...... 332

Figure 49: Vertex SWOT Analysis in RA, 2013–2023 ...... 334

Figure 50: Daiichi Sankyo SWOT Analysis in RA, 2013–2023 ...... 336

Figure 51: Global Sales for RA by Region, 2013–2023...... 341

Figure 52: Sales for RA in the United States by Drug Class, 2013–2023 ...... 349

Figure 53: Sales for RA in France by Drug Class, 2013–2023 ...... 357

Figure 54: Sales for RA in Germany by Drug Class, 2013–2023 ...... 365

Figure 55: Sales for RA in Italy by Drug Class, 2013–2023 ...... 374

Figure 56: Sales for RA in Spain by Drug Class, 2013–2023 ...... 382

Figure 57: Sales for RA in the UK by Drug Class, 2013–2023 ...... 391

Figure 58: Sales for RA in Japan by Drug Class, 2013–2023 ...... 399

Figure 59: Sales for RA in Australia by Drug Class, 2013–2023 ...... 407

Figure 60: Sales for RA in China by Drug Class, 2013–2023 ...... 414

Figure 61: Sales for RA in India by Drug Class, 2013–2023 ...... 421

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Introduction

2 Introduction

2.1 Catalyst

The Rheumatoid Arthritis (RA) market will grow over the 2013–2023 forecast period, driven by a number of new product launches, such as:

 Novel biologics

 Anti-interleukin (IL)-6 biologics

 Small molecules, including janus kinase (JAK) inhibitors

Other factors that will drive market expansion are growth in the emerging markets of China, India, and Australia, where product launches extend product lifecycles. In addition, there will be an increase in the prevalence of RA across the 10 major markets (10MM) covered in this report.

The loss of patent protection for the anti-tumor necrosis factor (TNF) marketed brands will allow for the emergence of biosimilars, such as Celltrion’s Remsima (infliximab)/Hospira’s Inflectra (infliximab), which is a Remicade biosimilar. The patent expiries begin in 2015 and 2016, respectively, for the current market leaders:

 J&J’s Remicade

 AbbVie’s Humira

The catalysts and objectives for this report are to:

 Determine the impact that biosimilars will have on the RA market

 Assess the uptake of JAK inhibitors, including Pfizer’s Xeljanz (tofacitinib) and other pipeline agents

 Identify the unmet needs in the RA market

 Determine the remaining opportunities in the RA market

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Introduction

2.2 Related Reports

 GlobalData (2014). PharmaPoint: Ulcerative Colitis – Global Drug Forecast and Market Analysis to 2022, Event-Driven Update, September 2014, GDHC005EPIDR

 GlobalData (2014). PharmaPoint: Crohn's Disease – Global Drug Forecast and Market Analysis to 2022, January 2014, GDHC77PIDR

 GlobalData (2014). PharmaPoint: Atopic – Global Drug Forecast and Market Analysis to 2022, November 2013, GDHC66PIDR

 GlobalData (2014). PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis – Global Drug Forecast and Market Analysis to 2022, October 2013, GDHC65PIDR

 GlobalData (2014). PharmaPoint: Psoriasis – Global Drug Forecast and Market Analysis to 2022, May 2013, GDHC48PIDR

2.3 Upcoming Related Reports

 GlobalData (2015). Opportunity Analyzer: Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis – Global Drug Forecast and Market Analysis to 2023, to be published in March 2015

 GlobalData (2015). PharmaPoint: Atopic Dermatitis – Global Drug Forecast and Market Analysis to 2022, Event-Driven Update, to be published in January 2015

 GlobalData (2015). PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis – Global Drug Forecast and Market Analysis to 2022, Event-Driven Update, to be published in January 2015

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RHEUMATOID ARTHRITIS – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023

Appendix

11.8 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.

11.9 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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