RANK Ligand Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Receptor activator of nuclear factor kappa-Β ligand (RANKL), also known as tumor necrosis factor ligand superfamily member 11 (TNFSF11), TNF-related activation-induced cytokine (TRANCE), osteoprotegerin ligand (OPGL), and osteoclast differentiation factor (ODF), is a protein that in humans is encoded by the TNFSF11 gene. RANKL is known as a type II membrane protein and is a member of the tumor necrosis factor (TNF) superfamily. RANKL is expressed in several tissues and organs including skeletal muscle, thymus, liver, colon, small intestine, adrenal gland, osteoblast, mammary gland epithelial cells, prostate, and pancreas. The mechanism of action (MOA) of RANK ligand Inhibitor is by binding it triggers a signaling cascade that leads to the differentiation, activation, and survival of osteoclasts.

Osteoclasts are specialized cells involved in bone resorption, a process where old or damaged bone tissue is broken down and replaced with new bone thereby preventing the activation of osteoclasts and reducing bone resorption. RANK ligand Inhibitors are used for the treatment of adenocarcinoma, arthralgia, autoimmune disorders, blood coagulation disorders, bone diseases, breast neoplasms, cardiovascular abnormalities, arthritis, digestive system diseases, and connective tissue diseases, among others. Increased prevalence of autoimmune disorders, osteoarthritis, and the aging population, etc are the key drivers for the RANK ligand Inhibitor market. For instance, according to the Centers for Disease Control and Prevention 2021, around there were 32.5 million adults affected with osteoarthritis in the US. The launch of newer products by the market players could seek opportunities that influence extensive research and development in RANK ligand inhibitors. For instance, Amgen’s Prolia (Denosumab) is launched for the treatment of osteoporosis and bone loss in men and women. Moreover, the development of novel molecules by market players is coming up to overcome challenges in therapy. For instance, Luye Pharma’s LY01011 (Denosumab Biosimilar) for the indication of osteoporosis is under the various stages of clinical studies.

Key Market Developments:

In March 2018, Amgen received FDA approval for Denosumab for expanded indication in the prevention of skeletal-related events (SRES) in patients with multiple myeloma (MM).

Approved Drug Molecules and Brand Names for RANK ligand Inhibitor:

• Prolia (Denosumab)
• Xgeva (Denosumab)

Drugs under the Pipeline for RANK ligand Inhibitor:

• Narlumosbart (JMT103)
• LY01011 (Denosumab Biosimilar)
• QL1206 (Denosumab Biosimilar)
• AVT03 (Denosumab Biosimilar)
• Denub (Denosumab Biosimilar)
• HS-20090 (Denosumab Biosimilar)
• Bmab 1000 (Denosumab Biosimilar)
• CMAB807 (Denosumab Biosimilar)
• CT-P41 (Denosumab Biosimilar)
• HLX14 (Denosumab Biosimilar)
• MB09 (Denosumab Biosimilar)
• SB16 (Denosumab Biosimilar)
• FKS518 (Denosumab Biosimilar)
• GB223
• GP2411 (Denosumab Biosimilar)
• RGB-14-P (Denosumab Biosimilar)

Clinical Activity and Developments of RANK ligand Inhibitor:

Till July 2023, more than 22 companies have approximately 18 molecules targeting 123 diseases. For these molecules, more than 120 clinical trials are being conducted and the majority are in phase-2, and phase-3 clinical trials by players across the globe. For instance,

• In October 2022, Shanghai Jinmante Biotechnology has conducted a phase Ib/II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of JMT103 (Narlumosbart ) in surgically unsalvageable or refractory giant cell tumor of bone.
• In October 2022, Luye Pharma Group completed phase 1, a randomized, double-blind, single-dose, parallel-controlled, biosimilar drug comparison trial for comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of LY01011(Denosumab Biosimilar) and Xgeva in Chinese healthy subjects.