Example Highlights
Although the DMARDs market is currently dominated by TNF inhibitors, non-TNF inhibitors, such as IL-6 inhibitors/IL-6R antagonists, IL-1 inhibitors, T-cell costimulation inhibitors, B-cell inhibitors and JAK inhibitors, have emerged as viable drug classes for the treatment of patients suffering from RA.
We came across over 80 drugs/therapies in the non-TNF inhibitors development pipeline; of these, 6% represent marketed molecules, while 11% of the pipeline molecules are either under review by the FDA or in phase III of clinical development. Over 30% of the molecules are in the preclinical/discovery stage.
JAK inhibitors and anti-ILs are the most popular drug classes in terms of the number of pipeline molecules that are in higher phases of development (pre-registration and phase III). Xeljanz® is the only JAK inhibitor that is currently commercially available; however, one such drug (baricitinib) is currently in the pre-registration stage, while three other JAK inhibitors (filgotinib, peficitinib and upadacitinib) are in phase III of clinical development. On the other hand, anti-ILs consist of two marketed (Actemra® and Kineret®) molecules, two in the pre-registration stage (sarilumab and sirukumab), six phase II product candidates (bimekizumab, clazakizumab, CNTO 6785, Dekavil, vobarilizumab and gerilimzumab) and four preclinical candidates.
Big biopharmaceutical players, namely Amgen, BMS, Roche/Genentech and Pfizer, currently hold the major share in the overall market with the maximum number of marketed drugs in this domain. There are several mid-sized and large firms, including (in alphabetical order) AbbVie, Amgen, Astellas Pharma, Daiichi Sankyo, Eli Lilly, Galapagos, Gilead Sciences, GSK, Incyte Corporation, Janssen, Regeneron Pharmaceuticals and Sanofi-Aventis, which have RA therapies in late stages of clinical development. Additionally, there are small-sized players that have captured a significant portion of the preclinical/discovery pipeline. Some of these players include (in alphabetical order) Acetylon Pharmaceuticals, Aegera Therapeutics, Arrien Pharmaceuticals, Asana BioSciences, Atlantic Bio Sci, Avexxin, CASI Pharmaceuticals, CJ HealthCare, Immune Response Biopharma, Oscotec, Peptinov, Principia Biopharma, RedHill Biopharma, SBI Biotech, TechnoPhage and Toleranzia.
A number of stakeholders in the non-TNF RA drugs market have entered into collaborations with other players. We came across close to 50 deals that have been signed over the last decade for various purposes, including product development and/or commercialization (70%), research (16%), manufacturing (6%), technology licensing (4%), acquisition (2%) and product distribution (2%). There are instances where a company has entered into more than one collaboration; examples of such players include (in alphabetical order) AbbVie, Ablynx, Bird Rock Bio, Can-Fite Biopharma, Chugai Pharmaceuticals, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Merck-Serono, MorphoSys and Roche.
In order to address the growing concerns related to patient compliance, drug developers have shifted their focus towards the development of orally administrable drugs. Of all pipeline molecules, over 50% are being developed as oral therapies.
The use of existing drugs as combination/add-on therapies has been shown to be associated with better outcomes and treatment effects compared to their use as monotherapies. In fact, 38% of the drugs in the clinical pipeline are being tested as add-on therapy/combination therapies. MTX is the preferred add-on/combination drug in most such clinical trials.
It is necessary to highlight that key patents protecting multiple approved drugs are set to expire in the coming years. This is likely to have a significant impact on the market’s growth in the mid-long term. However, we believe that the emergence of novel treatment options and the approval of late stage molecules is likely to balance the aforementioned decline. JAK inhibitors and non-TNF biologics are anticipated to capture the major share of the anti-TNFs market. Specifically, the JAK inhibitors market is expected to grow at a CAGR of 23.5% over the next decade.