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Advances in the Rheumatoid Arthritis Market
Rheumatoid arthritis (RA) is a chronic disorder for which there is currently no cure. It affects around 23.5 million adults in the world (WHO, 2013) and
approximately 294,000 children under the age of 18 are affected by pediatric arthritis and other rheumatologic conditions (PhRMA, 2013).
In 2012, immunology drugs generated global sales of around US$36.6bn of which two thirds were associated with the management rheumatology related
conditions (US$24.5bn), the remainder of sales were split evenly between the treatment of dermatological and gastroenterology related conditions. Revenues
growth has been driven by improvements in diagnosis and early, more aggressive treatment of RA, the approval of new disease modifying anti rheumatic drugs
(DMARDs), new formulations/devices and line extensions. By 2018, we forecast the immunology market will be worth over US$38.5bn as leading players focus
on growing their RA franchises in the emerging markets, launch innovative targeted synthetic DMARDs and biologic DMARDs to address unmet clinical needs
and biosimilars emerge in the European market to carve out US$3bn share of revenues.
The market is on the cusp of change as the first orally active biologic Xeljanz (tofacitimib) from Pfizer/Takeda entered the US market at the end of 2012; several
new synthetic and biological DMARDs are in late stage clinical development and Europe approved the first biosimilar generic infliximab (Remicade) from
Celltrion/Egis and Hospira in September 2013. Generic entanercept (Enbrel) is not far behind from Baxter/Cogerus and several manufacturers have begun to
make copycat versions of Humira which goes off patent in the US in 2016.
This report examines in more detail the recent developments that have occurred in the RA market, including the expansion of approved products for new
indications, formulations and new market launches and analyses the progression of pipeline products. It assesses how the new American College of
Rheumatology (ACR) and European League against Rheumatism (EULAR) guidelines will impact product uptake and discusses the potential impact of
biosimilars on the global RA market.
table Of Content

scope Of The Report.2

catalyst .3

about The Author .4

section 1: Why Is Rheumatoid Athritis Important, Why Now? .5
introduction –where Are We Now?.5
around A Half Of Patients Stop Responding To Dmards Within 5 Years .7
2012 Acr Guidelines Recommend More Aggressive, Early Treatment Of Ra.7
2013 Eular Guidelines Include The Use Of Pfizer New Oral Agent Xeljanz .9
what Synthetic Dmards Lead The Field In The Treatment Of Rheumatoid Arthritis? .11
mtx Is The Preferred Sdmard For First Line Therapy In Early And Active Disease.12
pfizer’s Xeljanz Is The First Targeted Sdmard To Reach The Market.13
will Pfizer’s Xeljanz Be Able To Compete In Psoriasis? .14
will Pfizer’s Xeljanz Be Able To Compete On Price?.14
eisai/toyama’s Careram A New Dmard For The Japanese Market.15
how Do Bdmards Compare With One Another?.15
humira, Enbrel And Remicade Are The Most Prescribed Bdmards Across The Globe.18
comparative Effectiveness Studies With Bdmards Are Limited.20
head To Head Study Orencia Comparable To Humira.20
head To Head Study Show Actemra Superior To Humira.20
new Formulations And Devices Help Drive Patient Compliance And Product Acceptance .21
oral Agents May Cause A New Shift In Ra Treatment Paradigms .21
subcutaneous Formulations Remain The Mainstay For Biological Dmards .21
new Infusion Formulations Add Value.22
new Indications Stimulate Sales Growth In Bdmards.23
humira’s New Indications “will Add Roughly Us$1.5bn In Incremental Global Sales .25
janssen To Seek Several New Line Extension For Simponi And Stelara Before 2017 .25
cimzia Sales Growth Stimulated By New Indications And New Markets .26
companies Turn To Japan And The Emerging Markets To Grow Dmard Sales .26
abbvie Set Sights On Bric Economies To Drive Humira Franchise Forward .27
amgen Expanding Capabilities In Japan To Commercialize Its Product Pipeline.27
bms Partnered With Simcere To Maximize Orencia Penetration In The Emerging Markers .27
pricing And Reimbursement.28
us Reimbursement Of Dmards Mainly Through Private Insurance Programs .28
in Europe Dmards Reimbursed Based On Clinical And Economic Data And Price Referencing.28
reimbursement Of Japanese Drugs Set Chuikyo.29
patient’s Face High Out-of-pockets Expenses In The Emerging Economies.30
chinese Government Has Accelerated And Expanded Patient Access To Dmards.31
russian Federation Has Expand Access To Innovative Biologics.31
Advances in the Rheumatoid Arthritis Market
high Out Of Pocket Expenses Curb Bdmard Use India.31
what Impact Will Biosimilars Have On The Treatment Of Ra?.32
biosimilar Etanercept.33
biosimilar Etanercept Available In China And India.33
etanercept Biosimilars Are Under Clinical Development In Europe And The Us .33
biosimilar Adalimumab.34
biosimilar Infliximab .36
the First Infliximab Biosimilar Now Approved In Europe .36
several Infliximab Biosimilars Are Under Development For The Developed Markets .37
biosimilar Rituximab.38
rituximab Biosimilars Available In India Since 2007.38
several Rituximab Biosimilars Under Development In The Emerging Economies .38

table Of Contents Advances In The Rheumatoid Arthritis Market

anti-rheumatoid Arthritis Disease Modifying Drugs - Market Forecasts 40

new Strategies In The Management Of Rheumatoid Arthritis . 43
new Regulatory Guidance To Fuel Ra Development.44

new Drugs On The Block . 45

approach 1: Targeted Sdmards . 46
drug Type 1: Oral Kinase Inhibitors. 46
ones To Watch.47
baricitinib (eli Lilly/incyte). 47
vx-509 (vertex) .48
waiting In The Wings . 49
asp015k (janssen/astellas Pharma). 49
incb039110 (incyte). 49
glpg0634 (abbvie/galapagos).50
long Shots.51
ipi-145 (infinity Pharmaceuticals). 51

approach 1: Targeted Sdmards Drug Type 2: Non-kinase Agents . 52

waiting In The Wings . 53
apremilast (celgene). 53
ccx354 (chemocentry/gsk). 53
long Shots. 55
lx2931 (lexicon Pharmaceuticals). 55
plx5622 (plexxikon/ Daiichi Sankyo Company) . 55
conclusions On Sdmard Developments – Forecasts . 56

approach 2: Biological Agents. 57

drug Type 2: Anti-interleukin Inhibitors. 58

ones To Watch. 59
sirukumab (janssen/glaxosmithkline). 59
sarilumab (sanofi/regeneron).60
secukinumab (novartis). 62
waiting In The Wings . 64
clazakizumab (bms/alder Pharmaceuticals).64
long Shots. 65
alx-0061(abbvie/ablynx). 65
guselkumab (janssen Biotech/morphosys) . 65
ixekizumab (eli Lilly). 65
Advances in the Rheumatoid Arthritis Market
olokizumab (eli Lilly).66

approach 2: Biological Agents.67

drug Type 2: Non Anti-interleukin Strategies .67
waiting In The Wings . 68
mavrilimumab (medimmune).68
mor103 (glaxosmithkline/morphosys).68
long Shots. 70
amp-110 (amplimmune). 70
biib 023 (biogen Idec) . 70
dekavil (pfizer/philogen Spa). 70
otelixizumab (glaxosmithkline/tolerx). 70
prtx-100 (protalex). 70
tnf-kinoid (neovacs). 71

conclusions On Bdmard Developments – Forecasts. 72

appendix 1. 73
clinical Endpoints To Assess Disease Activity And Response To Treatment . 73

methodology .74
primary Research. 74
secondary Research. 74

acronyms .75

references.76

endnotes. 79

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research needs spanning across industry verticals with our huge collection of market research reports. We provide our services to all sizes of organizations and
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Advances in the Rheumatoid Arthritis Market

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Advances in the Rheumatoid Arthritis Market: Market Research Report by Researchmoz.us

  • 1. Advances in the Rheumatoid Arthritis Market Rheumatoid arthritis (RA) is a chronic disorder for which there is currently no cure. It affects around 23.5 million adults in the world (WHO, 2013) and approximately 294,000 children under the age of 18 are affected by pediatric arthritis and other rheumatologic conditions (PhRMA, 2013). In 2012, immunology drugs generated global sales of around US$36.6bn of which two thirds were associated with the management rheumatology related conditions (US$24.5bn), the remainder of sales were split evenly between the treatment of dermatological and gastroenterology related conditions. Revenues growth has been driven by improvements in diagnosis and early, more aggressive treatment of RA, the approval of new disease modifying anti rheumatic drugs (DMARDs), new formulations/devices and line extensions. By 2018, we forecast the immunology market will be worth over US$38.5bn as leading players focus on growing their RA franchises in the emerging markets, launch innovative targeted synthetic DMARDs and biologic DMARDs to address unmet clinical needs and biosimilars emerge in the European market to carve out US$3bn share of revenues. The market is on the cusp of change as the first orally active biologic Xeljanz (tofacitimib) from Pfizer/Takeda entered the US market at the end of 2012; several new synthetic and biological DMARDs are in late stage clinical development and Europe approved the first biosimilar generic infliximab (Remicade) from Celltrion/Egis and Hospira in September 2013. Generic entanercept (Enbrel) is not far behind from Baxter/Cogerus and several manufacturers have begun to make copycat versions of Humira which goes off patent in the US in 2016. This report examines in more detail the recent developments that have occurred in the RA market, including the expansion of approved products for new indications, formulations and new market launches and analyses the progression of pipeline products. It assesses how the new American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) guidelines will impact product uptake and discusses the potential impact of biosimilars on the global RA market. table Of Content scope Of The Report.2 catalyst .3 about The Author .4 section 1: Why Is Rheumatoid Athritis Important, Why Now? .5 introduction –where Are We Now?.5 around A Half Of Patients Stop Responding To Dmards Within 5 Years .7 2012 Acr Guidelines Recommend More Aggressive, Early Treatment Of Ra.7 2013 Eular Guidelines Include The Use Of Pfizer New Oral Agent Xeljanz .9 what Synthetic Dmards Lead The Field In The Treatment Of Rheumatoid Arthritis? .11 mtx Is The Preferred Sdmard For First Line Therapy In Early And Active Disease.12 pfizer’s Xeljanz Is The First Targeted Sdmard To Reach The Market.13 will Pfizer’s Xeljanz Be Able To Compete In Psoriasis? .14 will Pfizer’s Xeljanz Be Able To Compete On Price?.14 eisai/toyama’s Careram A New Dmard For The Japanese Market.15 how Do Bdmards Compare With One Another?.15 humira, Enbrel And Remicade Are The Most Prescribed Bdmards Across The Globe.18 comparative Effectiveness Studies With Bdmards Are Limited.20 head To Head Study Orencia Comparable To Humira.20 head To Head Study Show Actemra Superior To Humira.20 new Formulations And Devices Help Drive Patient Compliance And Product Acceptance .21 oral Agents May Cause A New Shift In Ra Treatment Paradigms .21 subcutaneous Formulations Remain The Mainstay For Biological Dmards .21 new Infusion Formulations Add Value.22 new Indications Stimulate Sales Growth In Bdmards.23 humira’s New Indications “will Add Roughly Us$1.5bn In Incremental Global Sales .25 janssen To Seek Several New Line Extension For Simponi And Stelara Before 2017 .25 cimzia Sales Growth Stimulated By New Indications And New Markets .26 companies Turn To Japan And The Emerging Markets To Grow Dmard Sales .26 abbvie Set Sights On Bric Economies To Drive Humira Franchise Forward .27 amgen Expanding Capabilities In Japan To Commercialize Its Product Pipeline.27 bms Partnered With Simcere To Maximize Orencia Penetration In The Emerging Markers .27 pricing And Reimbursement.28 us Reimbursement Of Dmards Mainly Through Private Insurance Programs .28 in Europe Dmards Reimbursed Based On Clinical And Economic Data And Price Referencing.28 reimbursement Of Japanese Drugs Set Chuikyo.29 patient’s Face High Out-of-pockets Expenses In The Emerging Economies.30 chinese Government Has Accelerated And Expanded Patient Access To Dmards.31 russian Federation Has Expand Access To Innovative Biologics.31 Advances in the Rheumatoid Arthritis Market
  • 2. high Out Of Pocket Expenses Curb Bdmard Use India.31 what Impact Will Biosimilars Have On The Treatment Of Ra?.32 biosimilar Etanercept.33 biosimilar Etanercept Available In China And India.33 etanercept Biosimilars Are Under Clinical Development In Europe And The Us .33 biosimilar Adalimumab.34 biosimilar Infliximab .36 the First Infliximab Biosimilar Now Approved In Europe .36 several Infliximab Biosimilars Are Under Development For The Developed Markets .37 biosimilar Rituximab.38 rituximab Biosimilars Available In India Since 2007.38 several Rituximab Biosimilars Under Development In The Emerging Economies .38 table Of Contents Advances In The Rheumatoid Arthritis Market anti-rheumatoid Arthritis Disease Modifying Drugs - Market Forecasts 40 new Strategies In The Management Of Rheumatoid Arthritis . 43 new Regulatory Guidance To Fuel Ra Development.44 new Drugs On The Block . 45 approach 1: Targeted Sdmards . 46 drug Type 1: Oral Kinase Inhibitors. 46 ones To Watch.47 baricitinib (eli Lilly/incyte). 47 vx-509 (vertex) .48 waiting In The Wings . 49 asp015k (janssen/astellas Pharma). 49 incb039110 (incyte). 49 glpg0634 (abbvie/galapagos).50 long Shots.51 ipi-145 (infinity Pharmaceuticals). 51 approach 1: Targeted Sdmards Drug Type 2: Non-kinase Agents . 52 waiting In The Wings . 53 apremilast (celgene). 53 ccx354 (chemocentry/gsk). 53 long Shots. 55 lx2931 (lexicon Pharmaceuticals). 55 plx5622 (plexxikon/ Daiichi Sankyo Company) . 55 conclusions On Sdmard Developments – Forecasts . 56 approach 2: Biological Agents. 57 drug Type 2: Anti-interleukin Inhibitors. 58 ones To Watch. 59 sirukumab (janssen/glaxosmithkline). 59 sarilumab (sanofi/regeneron).60 secukinumab (novartis). 62 waiting In The Wings . 64 clazakizumab (bms/alder Pharmaceuticals).64 long Shots. 65 alx-0061(abbvie/ablynx). 65 guselkumab (janssen Biotech/morphosys) . 65 ixekizumab (eli Lilly). 65 Advances in the Rheumatoid Arthritis Market
  • 3. olokizumab (eli Lilly).66 approach 2: Biological Agents.67 drug Type 2: Non Anti-interleukin Strategies .67 waiting In The Wings . 68 mavrilimumab (medimmune).68 mor103 (glaxosmithkline/morphosys).68 long Shots. 70 amp-110 (amplimmune). 70 biib 023 (biogen Idec) . 70 dekavil (pfizer/philogen Spa). 70 otelixizumab (glaxosmithkline/tolerx). 70 prtx-100 (protalex). 70 tnf-kinoid (neovacs). 71 conclusions On Bdmard Developments – Forecasts. 72 appendix 1. 73 clinical Endpoints To Assess Disease Activity And Response To Treatment . 73 methodology .74 primary Research. 74 secondary Research. 74 acronyms .75 references.76 endnotes. 79 ResearchMoz(http://www.researchmoz.us/) is the one stop online destination to find and buy market research reports & Industry Analysis. We fulfill all your research needs spanning across industry verticals with our huge collection of market research reports. We provide our services to all sizes of organizations and across all industry verticals and markets. Our Research Coordinators have in-depth knowledge of reports as well as publishers and will assist you in making an informed decision by giving you unbiased and deep insights on which reports will satisfy your needs at the best price. Contact: M/s Sheela, 90 State Street, Suite 700, Albany NY - 12207 United States Tel: +1-518-618-1030 USA - Canada Toll Free 866-997-4948 Email: sales@researchmoz.us Website: http://www.researchmoz.us/ Advances in the Rheumatoid Arthritis Market