Global Rheumatology Market to 2024

Market Overview, Key in-line Products, Market Share Distribution, Competitive Dynamics, Regulatory Outlook, Pipeline Development, Growth Catalysts & Challenges, Leading Market & R&D Trends, Partnership & Deals Analyses, Global Sales forecast of in-line and pipeline products, Fast Growing Private Companies, Management Perspectives, Commentaries, Market Outlook & Summary Conclusions

Global rheumatology market was valued at $31bn in 2015 and is forecast to grow at a modest 4.0% CAGR between 2015 and 2024 to reach 2024 global sales of $46bn.

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Rheumatology encompasses numerous musculoskeletal and autoimmune diseases that cause systemic manifestations including joint pain, inflammation and destruction. Worldwide, over 470 million people suffer from rheumatologic diseases. Rheumatology represents a significant disease burden with annual costs associated with rheumatologic diseases estimated at $250bn in the U.S.

The four most prevalent rheumatologic diseases are rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), gout, and osteoarthritis (OA).

More than 2 million people in the U.S. are afflicted with RA, a serious and potentially disabling autoimmune disease that is characterized by joint inflammation.

Systemic Lupus Erythematosis (SLE) is an idiopathic relapsing and remitting autoimmune disorder that predominantly affects women affecting roughly one million Americans.

Gout is a systemic inflammatory condition that afflicts 3-5 million people in the U.S. Prevalence is increasing, with recent estimates suggesting the number could be as high as 8 million in the U.S.

Osteoarthritis (OA) is a degenerative joint disease occurring primarily in the hip, knee, and spine, afflict 20 million people in the U.S.
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“Oral RA drugs approved and in development”

“Treatment Algorithm for Rheumatology”

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Rheumatoid arthritis (RA) represents the largest segment within the rheumatology category. Initial therapy in RA includes NSAIDs, methotrexate with physicians turning to TNF-inhibitors to those who are refractory to these treatments. The leading brands within TNF inhibitors include Amgen/Pfizer’s Enbrel, AbbVie’s Humira, J&J’s Remicade J&J/Merck’s Simponi and UCB’s Cimzia.

With the first EU TNF-inhibitors biosimilar approval of Inflectra (Remicade biosimilar) and Erelzi (Novartis’ Enbrel biosimilar) this year, the anti-TNF class may see increased competition.

Patients who do not respond well to TNF-inhibitors, they are switched to a different drug class represented by Orencia (Bristol Myers), Actemra (Roche), Rituxan (Biogen/Roche), or to Xeljanz (Pfizer), a JAK inhibitor. Approval of Xeljanz, the newest class of oral RA therapy represents a revolutionary approach of DMARD (Disease modifying anti rheumatic drugs) but adoption of the drug has been constrained by reimbursement and safety concerns.

Currently, no disease modifying treatments for OA are, available. Patients are given both prescription and OTC medications (chiefly NSAIDs including Cox-2 inhibitors, naproxen, and ibuprofen to relieve their pain.

"AbbVie, Amgen, Pfizer, J&J, Merck, Bristol Myers and Roche are some of the key players for rheumatology treatment market"

Key players include Amgen, Pfizer, J&J, Merck, Bristol Myers and Roche among others.

TNF-inhibitors from AbbVie (Humira), Amgen/Pfizer (Enbrel) and J&J’s Remicade led the rheumatology category during 2015. Bristol Myer’s Orencia, Roche’s Actemra, and Biogen/Roche’s Rituxan are used in RA patients’ refractory to TNF-inhibitors. This may represent a small patient population yet constitutes a multi-billion dollar market.

Pfizer’s JAK inhibitor Xeljanz (tofacitinib) was FDA approved in 2012 as the first oral drug for RA. However, physician hesitance and payor policies tend to restrict Xeljanz’s initial use to TNF-failure patients.

“Product innovations in rheumatology”

In RA, Eli Lilly/Incyte’s baricitinib that was NDA filed appears to be the best-in class JAK, but it is expected that it will be given the JAK class boxed warning for infections. Galapagos’s JAK1 inhibitor, filgotinib is partnered with Gilead and Phase III studies are expected to start by in 2017. Abbvie’s JAK1 inhibitor, ABT 494, is currently in Phase III studies.

In OA, Anti-NGF1 therapies, most notably Pfizer’s tanezumab and Regeneron’s fasinumab, have shown impressive efficacy in controlling OA pain and both the antibodies are in Phase III programs. Other treatments in development include Ampio Pharma’s Ampion, an intra-articular (IA) injection and Flexion’s Zilretta, a sustained-release triamcinolone for IA use.

“Reimbursement insights”

Given ongoing payor pressures, physician consultants are enthusiastic about the prospect of lower priced TNF-inhibitors. Biogen/Samsung’s Enbrel biosimilar (Benepali) was launched in February 2016. In EU, Remicade biosimilar Inflectra (Pfizer) was approved in April 2016 and in August 2016, the FDA approved Erelzi (Novartis), an Enbrel biosimilar. In the absence of switch studies data, only newly diagnosed patients are appropriate for treatment with anti-TNFs biosimilars. Therefore the initial impact on the well-established TNF-inhibitors franchises is expected to be modest.

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This release was published on openPR.