Tumor necrosis factor (TNF, cachexin or cachectin formerly known as tumor necrosis factor alpha or TNF-α) is an adipokine and a cytokine. TNF is a member of the TNF superfamily, which consists of various transmembrane proteins with a homologous TNF domain. As an adipokine, TNF promotes insulin resistance and is associated with obesity-induced type 2 diabetes. As a cytokine, TNF is used by the immune system for cell signaling. If macrophages (certain white blood cells) detect an infection, they release TNF to alert other immune system cells as part of an inflammatory response. There are two receptors for TNF, namely TNF receptor 1 (TNFR-1, p55 receptor) and TNFR-2 (p75 receptor). TNFR-1 is ubiquitously expressed while TNFR-2 is mainly expressed in immune cells. The mechanism of action (MOA) of the TNF inhibitors is binding to soluble TNF or inhibiting the interaction between TNF and its receptors. This binding prevents TNF from exerting its pro-inflammatory effects and reduces the inflammatory response in the body.
TNF inhibitors are used in the treatment of digestive system diseases, autoimmune diseases, intestinal diseases, connective tissue diseases, skin diseases, bone diseases, spondylitis, psoriasis, urologic diseases, kidney diseases, metabolic diseases, neoplasms, etc. Increased prevalence of inflammatory conditions, such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, inflammatory bowel disease, and the rise in the aging population, etc. are the key drivers for the TNF inhibitor market. For instance, according to the Centers for Disease Control and Prevention, an estimated 1.3% of US adults (3 million) reported being diagnosed with IBD, either Crohn's disease or ulcerative colitis. The introduction of newer products by market players may look for opportunities that have a big impact on comprehensive research and development in TNF inhibitors. For instance, Janssen Biotech’s Tecvayli (Teclistamab) was launched for the treatment of multiple myeloma. Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instance, Pfizer’s Elranatamab (PF-06863135) for the indication of multiple myeloma is under the various stages of clinical studies.
TNF Market Key Developments:
- In February 2021, AbbVie received FDA approval for its Humira (Adalimumab) for the additional indication to treat ulcerative colitis in pediatric patients 5 years of age and older.
- In October 2022, Janssen Biotech received FDA approval for its Tecvayli (Teclistamab) injection for the treatment of relapsed or refractory multiple myeloma.
Approved Drug Molecules and Brand Names for TNF:
- Humira (Adalimumab)
- Remicade (Infliximab)
- Enbrel (Etanercept)
- Cimzia (Certolizumab Pegol)
- Simponi (Golimumab)
- Tecvayli (Teclistamab)
Drugs under the Pipeline for TNF:
- Inflectra (Infliximab-Dyyb)
- Eyevinal (Ibudilast)
- Amjevita (Adalimumab-Atto)
- Humira SC (Adalimumab
- Hyrimoz (Adalimumab-Adaz)
- Renflexis (Infliximab-Abda)
- Elranatamab (PF-06863135)
- Remsima SC (Infliximab Biosimilar SC)
- Orismilast Oral (LEO 32731)
- Riviciclib (P27600)
- Cyltezo (Adalimumab-Adbm)
- Fibromun (Onfekafusp Alfa)
- Apocept (Asunercept)
- Hadlima (Adalimumab-Bwwd)
- Careram (Iguratimod)
- DLX105
- Iremod (Iguratimod)
- Yisaipu (Etanercept Biosimilar)
- Hulio (Adalimumab-Fkjp)
- Saccovid (Efprezimod Alfa)
- Tnferade (Golnerminogene Pradenovec)
- Eticovo (Etanercept-Ykro)
- Idacio (Adalimumab-Aacf)
- Nanozora (Ozoralizumab)
- RVT-3101
- Linvoseltamab (REGN5458)
- Avsola (Infliximab-Axxq)
- Hukyndra (Adalimumab Biosimilar)
- INB03
- Shinbaro (GCSB-5)
- Tnfcept (Etanercept Biosimilar)
- Yuflyma (Adalimumab-Aaty)
- Bacillus Calmette-Guerin (BCG)
- Placulumab (CEP-37247)
- Tanfanercept (HL036)
- ABBV-383
- Abrilada (Adalimumab-Afzb)
- Altebrel (Etanercept Biosimilar)
- Galepa (Daleuton Topical)
- HMPL-004
- Ixifi (Infliximab-Qbtx)
- MK-7240
- Nidlegy (Darleukin
- Solymbic (Adalimumab Biosimilar)
- Xpro (Pegipanermin)
- Dexanabinol (ETS2101)
- Golimumab
- Remtolumab (ABT-122)
- Semapimod (AXD-455)
- Tadekinig Alfa (IL-18BP)
- Davictrel (Etanercept Biosimilar)
- Erelzi (Etanercept-Szzs)
- NI-071 (Infliximab Biosimilar)
- RLS-0071
- TNF-α Kinoid
- Isomyosamine (MYMD-1)
- Onercept (R-Htbp)
- Recombinant Ectodysplasin A1 (APO200)
- Anbainuo (Etanercept Biosimilar)
- BAT2506 (Golimumab Biosimilar)
- BCD-055 (Infliximab Biosimilar)
- CHS-0214 (Etanercept Biosimilar)
- CMAB008 (Infliximab Biosimilar)
- DRM02
- Hemay007
- Infimab (Infliximab Biosimilar)
- M923 (Adalimumab Biosimilar)
- MBS2320
- Qletli (Adalimumab Biosimilar)
- REGN5459
- Rotundine (Levo-Tetrahydropalmatine)
- SAR441566
- TT-301
- Tunex (Etanercept Biosimilar)
- V565
- Licaminlimab (OCS-02)
- Pavurutamab (AMG 701)
- AD-35
- AMAP-102
- AVT05 (Golimumab Biosimilar)
- Adalimumab BS MA (Adalimumab Biosimilar)
- Anjiarun (Adalimumab Biosimilar)
- Aurimune (CYT-6091)
- Cinnora (Adalimumab Biosimilar)
- DMT210
- DTRM-555
- Dalibra (Adalimumab Biosimilar)
- Enerceptan (Etanercept Biosimilar)
- GSK1995057
- GSK2862277
- Handayuan (Adalimumab Biosimilar)
- IA-14069
- LMY-920
- Lipocurc (Liposomal Curcumin)
- MYL-1401A (Adalimumab Biosimilar)
- PTX-35
- SEA-BCMA
- XTMAB-16
- Ensereptide (PXL01)
- Hitanercept (T0001)
- Pacanalotamab (AMG 420)
- Tgaac94 Gene Therapy
- Tulinercept (OPRX-106)
- AC-701
- AN-0128
- AN2898
- AVX-470
- BCMA CAR-NK
- BCMA CAR-NK 92 Cells
- BCMA CAR-NK Cell Therapy
- BI-1808
- BLX-1002
- CC-92328
- CM336
- Cadalimab (Adalimumab Biosimilar)
- DMB-3113 (Adalimumab Biosimilar)
- DWP422 (Etanercept Biosimilar)
- Descartes-25
- EMB-06
- FT576
- GSK2800528
- HFB200301
- HOT-3010 (Adalimumab Biosimilar)
- HPN-217
- IPH6401
- ISB 2001
- JNJ-61178104
- Jiayujian (Infliximab Biosimilar)
- LMW Heparin MMX (Low Molecular Weight Heparin)
- LUCAR-B68
- Nepexto (Etanercept Biosimilar)
- PBP1502 (Adalimumab Biosimilar)
- PF-05230905
- PF-07261271
- PRA023 SC
- PRA052
- Qiangke (Etanercept Biosimilar)
- Quellor (DN-TNF)
- RO7297089
- SAR442970
- SFA-002
- SYN060 (Adalimumab Biosimilar)
- Sulinno (Adalimumab Biosimilar)
- TQB2934
- TUR01 (Adalimumab Biosimilar)
- Tinefcon (NPS31807)
- Virulizin (Bovine Bile Tissue Extract)
- WVT078
- YHB1411-2
- Yusimry (Adalimumab-Aqvh)
- Adalimumab Biobetter (ZB002)
- Alnuctamab (CC-93269)
- Anti-TNF
- Belantamab (GSK2857914)
- Dersalazine (UR 12746)
- Hypochlorous Acid (PR022)
- Lenalidomide Subcutaneous Prolonged-Release (NEX-20A)
- Meclocycline (SNX-1012)
- Orismilast Topical (LEO 32731 Topical)
Clinical Activity and Developments of TNF:
Up until July 2023, there will be about 40 companies with over 330 compounds that focus on various forms of rheumatoid arthritis, psoriasis, and ankylosing spondylitis. For these molecules, more than 3,000 clinical trials are being conducted and the majority are in phase-2, and phase-3 clinical trials by the players across the globe. For instance,
- In February 2023, Pfizer conducted phase 2, open-label, multicenter, non-randomized study of Elranatamab (PF-06863135) monotherapy in participants with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one ANTI-CD38 antibody.
- In January 2023, Sandoz completed phase 1, a pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF
|
Molecule Name |
Number of Studies |
|
Hyrimoz (Adalimumab-Adaz) |
14 |
|
Renflexis (Infliximab-Abda) |
13 |
|
Elranatamab (PF-06863135) |
15 |
|
Remsima SC (Infliximab Biosimilar SC) |
12 |
|
Orismilast Oral (LEO 32731) |
12 |
Target Indication Analysis of Tumor Necrosis Factor Inhibitor Market
The molecules such as Humira (Adalimumab) developed by AbbVie for the line of treatment for the treatment of ulcerative colitis in patients 5 years of age and older, moderate to severe hidradenitis suppurative (HS) in patients 12 years and older, uveitis in patients 2 years of age and older, symptoms of active arthritis in patients with psoriatic arthritis, active ankylosing spondylitis, etc. Moreover, Janssen Biotech’s Tecvayli (Teclistamab) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Regional Analysis
Tumor Necrosis Factor Inhibitor Market
Total sales of AbbVie’s Humira (Adalimumab) for the full year ended were US$58 billion in FY 2022 globally. Shows a 2.6% increase in the same period 2021. While the US experienced a 7.4% increase in sales annually and internationally, revenue decreased 22.2%, attributed to biosimilar competition. To date, Humira has pulled in sales of $214.2 billion for AbbVie (and previously Abbott) since its launch in 2003, making it the bestselling drug ever. However, In January 2023, Amgen became the first company to eye a slice of Humira’s American presence with the launch of the first Adalimumab biosimilar, Amjevita. While Amgen has the advantage of being first to market through a 2017 settlement with AbbVie, there are nine other players with approved biosimilars lined up - Alvotech, Amgen, Boehringer Ingelheim, Coherus, Fresenius Kabi, Mylan, Pfizer, Organon, Sandoz, Viatris. Increase incidence of inflammatory diseases like arthritis and ankylosing spondylitis seems to create lucrative opportunities for the TNF inhibitor market for the forecasted period.
Latin America
Europe
Asia Pacific
Middle East
North America
Key Features of the Reports
- The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
- The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
- The report tracks recent innovations, key developments, and start-up details that are actively working in the market
- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
Frequently Asked Questions
Humira (Adalimumab), Tecvayli (Teclistamab),Remicade (Infliximab), Enbrel (Etanercept), etc are the few FDA approved TNF Inhibitors.
Total sales of AbbVie’s Humira (Adalimumab) for the full year ended were US$ 58 billion in FY 2022 in globally.
Eisai, AbbVie, Merck (MSD), J&J, Pfizer, Amgen, etc. are a few leading market players in the TNF market.
digestive system diseases, autoimmune diseases, intestinal diseases, connective tissue diseases, skin diseases, bone diseases, spondylitis, psoriasis, etc. are the major indications of TNF inhibitors.
There are a total of 159 molecules that are in Phase-1, Phase-2, and Phase-3 clinical development.
- Eisai
- AbbVie
- Merck (MSD)
- J&J
- Pfizer
- Amgen
- Astellas
- UCB
- MediciNova
- Genmab
- Daiichi Sankyo
- Novartis
- Biogen
- Celltrion
- UNION Therap
- Boehringer Ingelheim
- Philogen
- Apogenix
- Cipla
- Abbott
- Biocon
- Sanofi
- Cipla
- Hikma
- Teva
- AbbVie
- INmune Bio
- Ferring
- Coherus Biosci
- Eli Lilly
- Sun Pharma
- Reliance Life Sci
- Lupin
- GSK