Advanced in the Rheumatoid Arthritis Market

Advanced in the Rheumatoid Arthritis Market

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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 Contents

About the Author
Introduction -where are we now?
Around a half of patients stop responding to DMARDs within 5 years
2012 ACR guidelines recommend more aggressive, early treatment of RA
2013 EULAR guidelines include the use of Pfizer new oral agent Xeljanz
What synthetic DMARDs lead the field in the treatment of rheumatoid arthritis?
MTX is the preferred sDMARD for first line therapy in early and active disease
Pfizer's Xeljanz is the first targeted sDMARD to reach the market
Will Pfizer's Xeljanz be able to compete in psoriasis?
Will Pfizer's Xeljanz be able to compete on price?
Eisai/Toyama's Careram a new DMARD for the Japanese market
How do bDMARDs compare with one another?
Humira, Enbrel and Remicade are the most prescribed bDMARDs across the globe
Comparative effectiveness studies with bDMARDs are limited
Head to head study Orencia comparable to Humira
Head to head study show Actemra superior to Humira
New formulations and devices help drive patient compliance and product acceptance
Oral agents may cause a new shift in RA treatment paradigms
Subcutaneous formulations remain the mainstay for biological DMARDs
New Infusion formulations add value
New indications stimulate sales growth in bDMARDs
Humira's new indications "will add roughly US$15bn in incremental global sales
Janssen to seek several new line extension for Simponi and Stelara before 2017
Cimzia sales growth stimulated by new indications and new markets
Companies turn to Japan and the emerging markets to grow DMARD sales
AbbVie set sights on BRIC economies to drive Humira franchise forward
Amgen expanding capabilities in Japan to commercialize its product pipeline
BMS partnered with Simcere to maximize Orencia penetration in the emerging markers
Pricing and reimbursement
US reimbursement of DMARDS mainly through private insurance programs
In Europe DMARDs reimbursed based on clinical and economic data and price referencing
Reimbursement of Japanese drugs set Chuikyo
Patient's face high out-of-pockets expenses in the emerging economies
Chinese government has accelerated and expanded patient access to DMARDs
Russian Federation has expand access to innovative biologics
High out of pocket expenses curb bDMARD use India
What impact will biosimilars have on the treatment of RA?
Biosimilar etanercept
Biosimilar etanercept available in China and India
Etanercept biosimilars are under clinical development in Europe and the US
Biosimilar adalimumab
Biosimilar infliximab
The first infliximab biosimilar now approved in Europe
Several infliximab biosimilars are under development for the developed markets
Biosimilar rituximab
Rituximab biosimilars available in India since
Several Rituximab biosimilars under development in the emerging economies
Anti -rhe umatoid arthritis disease modifyin g dr ugs - Mar ket forecasts
New regulatory guidance to fuel RA development
New dr ugs on the bloc k
Approach 1: Tar geted sDMARDs
Drug type 1: Oral kinase inhi bitors
Ones to watch
Baricitinib (Eli Lilly/Incyte)
VX-509 (Vertex)
Waitin g in the win gs
ASP015K (Janssen/Astellas Pharma)
INCB039110 (Incyte)
GLPG0634 (AbbVie/Galapagos)
Long shots
IPI-145 (Infinity Pharmaceuticals)
Approach 1: Tar geted sDMARDs Drug type 2: Non -kinase agents
Waitin g in the win gs
Apremilast (Celgene)
CCX354 (ChemoCentry/GSK)
Long shots
LX2931 (Lexicon Pharmaceuticals)
PLX5622 (Plexxikon/ Daiichi Sankyo Company)
Concl usions on sDMARD developments - forecasts
Approach 2: Biolo gical agents
Drug type 2: Anti -interle ukin inhi bitors
Ones to watch
Sirukumab (Janssen/GlaxoSmithKline)
Sarilumab (Sanofi/Regeneron)
Secukinumab (Novartis)
Waitin g in the win gs
Clazakizumab (BMS/Alder Pharmaceuticals)
Long shots
Guselkumab (Janssen Biotech/MorphoSys)
Ixekizumab (Eli Lilly)
Olokizumab (Eli Lilly)
Approach 2: Biolo gical agents
Drug type 2: Non anti -interle ukin strate gies
Waitin g in the win gs
Mavrilimumab (MedImmune)
MOR103 (GlaxoSmithKline/MorphoSys)
Tregalizumab (AbbVie/Biotest GA)
Long shots
AMP-110 (Amplimmune)
BIIB 023 (Biogen Idec)
Dekavil (Pfizer/Philogen SpA)
Otelixizumab (GlaxoSmithKline/Tolerx)