The tumor necrosis factor alpha (TNF-a) inhibitors represent one of the major treatment methods for inflammatory diseases. Globally, this drug class is known to be the most successful drugs in the overall pharmaceutical industry. Several conditions such as inflammations, rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and seronegative spondyloarthropathies, can be treated with the help of these drugs. The total sales of the top three blockbuster TNF-alpha inhibitors namely Remicade, Enbrel, and Humira had surpassed USD 32 billion in 2016.
Xalud’s lead product XT-150 harnesses the power of the body’s potent anti-inflammatory protein IL-10 to treat inflammatory diseases of the central nervous system (CNS) and joints. XT-150 is in the stage of the preclinical trials for multiple sclerosis, neuropathic pain, and osteoarthritis. In leading rodent model study for neuropathic pain XT-150 has been highly efficacious. Single injection delivers it into the fluid surrounding the spinal cord ensuring that the therapy reaches its target.
In the present scenario, developing countries have stringent regulatory requirements for approval of a new drug. It is a difficult task for marketing authorization application to get single regulatory for a new drug product which belongs to various categories of drugs such as NCE, biologicals, controlled drugs, etc. Therefore, the knowledge of precise and detailed regulatory requirements for market authorization application of different categories of drugs should be known to establish a suitable regulatory strategy. There is a need for pronounce and a fine balance between the persistence of gaining market access to pharmaceuticals, to protect the public health and facilitate healthy growth of pharmaceutical manufacturers.
The global tumor necrosis factor alpha inhibitors market is expected to grow at a CAGR of approximately 7.1% during the forecast period 2017-2023..
Segmentation
The global tumor necrosis factor alpha inhibitors market is segmented on the basis of the drug, disorder type, route of administration, stage of clinical trials, and application.
On the basis of the drug, the global tumor necrosis factor alpha inhibitors market is segmented into Humira, Enbrel, Remicade, and others
On the basis of the disease type, the global tumor necrosis factor alpha inhibitors market is segmented into Alzheimer's diseases, Parkinson's diseases, ischemic stroke, multiple sclerosis, and others.
By the route of administration, the global tumor necrosis factor alpha inhibitors market is segmented into oral, subcutaneous, intravenous, and others.
On the basis of the stage of clinical trials, the global tumor necrosis factor alpha inhibitors market is segmented into the preclinical trial, phase 1 clinical trial, phase 2 clinical trial, phase 3 clinical trial, and phase 4 clinical trial.
On the basis of the application, the global tumor necrosis factor alpha inhibitors market is segmented into medicine, scientific research, and others.
Key Players
In May 2016, Pfizer acquires Anacor for its inflammatory & immunology portfolio. Anacor is a biopharmaceutical company focused on small molecule therapeutics from its boron chemistry platform, and its asset Crisaborole is in FDA review if approved will be a first-line treatment option for patients with atopic dermatitis. They have entered into a definitive merger agreement under which Pfizer will acquire Anacor for approximately $5.2 billion which assumes the conversion of Anacor’s outstanding convertible notes. Anacor will be a strong fit with Pfizer’s innovative business due to the strategic focus on inflammation and immunology and is expected to enhance near-term revenue growth for the innovative business.
Some of key the players in the global tumor necrosis factor alpha inhibitors market are AbbVie Inc. (U.S.), Ablynx (Belgium), Apogenix GmBH (Germany), AryoGen Biopharma (U.S.), Bionovis (Brazil), CASI Pharmaceuticals (U.S.), Celltrion Healthcare (South Korea.), Celgene Corporation (U.S.), Delenex Therapeutics (Switzerland), Dexa Medica (Indonesia), EPIRUS Biopharmaceuticals (U.S.), Janssen Biotech (U.S.), GlaxoSmithKline Inc. (U.S.), HanAll Biopharma (South Korea.), Intas Pharmaceuticals (India), LEO Pharma (Denmark), LG Life Sciences (U.S.), MedImmune (U.S.), Momenta Pharmaceuticals (U.S.), Novartis AG (Switzerland), Sanofi-Aventis (France), Zydus Cadila (India), and others.