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Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....
Complement C5 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023
Complement component 5 is a part of the complement system in humans and is coded by the C5 gene. It is the initiator of the effector terminal phase of the complement system. It consists of 2 units- Alpha and Beta, which are linked by disulfide bonds. C5 convertase enzyme cleaves it into C5a and C5b. C5a is a potent inflammatory mediator with many functions like vasodilation, inducing contraction of smooth muscles, and increasing the permeability of small blood vessels. It can also stimulate histamine release from basophils leading to allergic and inflammatory responses. Therefore, the complement system is essential in controlling homeostasis and inflammation and providing defense from pathogens. Activation of C5 leads to inflammation and cell damage. Complement C5 Inhibitors are being tried for many diseases, but the primary use for which it is approved by the USFDA is in the treatment of Paroxysmal Nocturnal Haemoglobinuria (PNH). PNH is a rare and life-threatening disease of blood in which destruction of RBC takes place, blood clots form, and the function of bone marrow is impaired. Companies are trying to find new and novel molecules to prevent and cure these diseases. The development and launch of newer products by the market players will significantly enhance the revenue of the Complement C5 Inhibitors market over the forecast years. For instance, according to the National Organization for Rare Disorders, in 2023, the USA has a prevalence of PNH of about 0.5 – 1.5 per million people.
Several of these inhibitors are on the market, while many are in ongoing clinical trials. 23 companies have various products in their pipelines, with 20 products in various stages of clinical trials. 2 products are in Phase 4, 11 products are in Phase 3, 4 products are in Phase 2, and 3 products are in Phase 1 of the clinical trials.
Key Developments of Complement C5 Inhibitors
Approved molecules
Drugs in Pipeline
Clinical Activity and Developments of Complement C5 Inhibitors
As of June 2023, 23 companies have approximately 20 products for 89 diseases. For these diseases, about 75 trials are being conducted by players globally. For instance,
Molecule name |
Number of studies |
Soliris (eculizumab) |
114 |
Ultomiris IV (ravulizumab-cwvz IV) |
34 |
Gohibic (vilobelimab) |
18 |
pozelimab (REGN3918) |
14 |
zilucoplan (RA101495) |
14 |
Drugs like Soliris (eculizumab) by AstraZeneca and Ultomiris (ravulizumab-cwvz) by AstraZeneca are approved for various indications by various regulatory agencies around the globe. These drugs are authorized to be used to treat Paroxysmal Nocturnal Haemoglobinuria (PNH), Generalized Myasthenia Gravis, and Atypical Hemolytic Uremic Syndrome (aHUS). Currently, the molecule is under investigation for many indications, and clinical trials are being conducted across the globe to evaluate the Complement C5 Inhibitors for indications like Hemolytic anemia, Bone marrow disorders, Blood platelet disorders, Leukemia, Lymphoma, Haemoglobinuria, and others. As the prevalence rates of the diseases have been rising for many years, it is a good opportunity for the market players.
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Soliris (eculizumab) and Ultomiris IV (ravulizumab-cwvz IV) are approved by the FDA and other regulatory agencies across the globe for various indications.
These are used in various indications like Paroxysmal Nocturnal Haemoglobinuria (PNH), Generalized Myasthenia Gravis, and Atypical Hemolytic Uremic Syndrome (aHUS). These are under clinical trials for other indications.
AstraZeneca (USA), Staidson Biopharma Inc. (USA), InflaRx (USA), Regeneron Pharmaceuticals (USA), and UCB S.A. (Belgium) are some of the major market players for Complement C5 Inhibitors.
Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and changing lifestyles are the key opportunities for Complement C5 Inhibitors in the market.
Key Market Players