Autoimmune hepatitis (AIH) is a chronic liver disease that occurs when the body's immune system attacks liver cells, causing inflammation and damage. AIH can progress to cirrhosis and liver failure if left untreated. The exact cause of AIH is unknown, but it is believed to be triggered by a combination of genetic and environmental factors. AIH is a rare disease, with a prevalence of 10-40 cases per 100,000 individuals in North America and Europe. It is more common in women than men and can occur at any age, although it is most commonly diagnosed in individuals between the ages of 15 and 40. AIH is also more prevalent in certain ethnic groups, including individuals of Northern European and Middle Eastern descent.
Several drugs are currently in development for the treatment of autoimmune hepatitis. One promising drug is B-701, a monoclonal antibody that targets a specific protein on B cells, a type of immune cell that plays a role in autoimmune diseases. B-701 has shown promising results in early clinical trials, with a favorable safety profile and the potential to improve outcomes for patients with autoimmune hepatitis. Another drug in development is EYP001, a small molecule inhibitor of the Janus kinase (JAK) pathway. The JAK pathway is involved in immune cell signaling and has been implicated in autoimmune diseases such as rheumatoid arthritis and ulcerative colitis. EYP001 has shown promising results in preclinical studies and is currently in early-stage clinical trials for the treatment of autoimmune hepatitis.
Furthermore, in recent years, the autoimmune hepatitis (AIH) drug market has seen significant developments in the development of new treatments, including novel immunosuppressive agents and combination therapies. These treatments are increasing the options available to clinicians and improving patient outcomes. One example of a novel immunosuppressive agent is mycophenolate mofetil (MMF). MMF has been shown to be effective in inducing and maintaining remission in AIH patients who do not respond to or cannot tolerate traditional treatment with corticosteroids. It works by inhibiting the proliferation of lymphocytes and reducing the production of antibodies, which are the hallmarks of autoimmune disease.
Another combination therapy is the combination of MMF and corticosteroids. This therapy has been shown to be effective in inducing remission in AIH patients who do not respond to traditional treatment, and it may have fewer side effects than traditional treatment with corticosteroids alone. Overall, these developments in new treatments and combination therapies are improving the options available to clinicians and the outcomes for AIH patients. However, further research is needed to optimize these treatments and identify new targets for therapy in AIH.
New product launches to flourish in the market
There have been several new product launches in the AIH drug market in recent years: Imraldi (adalimumab): In October 2018, Samsung Bioepis launched Imraldi, a biosimilar version of Humira (adalimumab), for the treatment of various autoimmune diseases, including AIH; Maviret (glecaprevir/pibrentasvir): In August 2018, AbbVie launched Maviret, a combination therapy for the treatment of chronic hepatitis C, including in patients with AIH; Zeposia (ozanimod): In March 2020, Bristol-Myers Squibb launched Zeposia, a sphingosine 1-phosphate receptor modulator, for the treatment of relapsing forms of multiple sclerosis. While not specifically approved for AIH, it is being studied for its potential use in the disease; Lupkynis (voclosporin): In January 2021, Aurinia Pharmaceuticals launched Lupkynis, an oral calcineurin inhibitor, for the treatment of lupus nephritis. While not specifically approved for AIH, it is being studied for its potential use in the disease.
By Drug Class: The autoimmune hepatitis drug market is divided into Oral antivirals and Immune modulators. Oral antivirals may be used as adjunctive therapy in some cases, such as when a patient with AIH also has a viral infection such as hepatitis B or C. In such cases, antivirals can be used to treat the viral infection and help prevent further liver damage. Examples of oral antivirals that may be used in combination with other medications for AIH treatment include: Entecavir (Baraclude), Tenofovir (Viread) and Sofosbuvir (Sovaldi). Moreover, immune modulators are a class of drugs used in the treatment of autoimmune hepatitis (AIH) to suppress the immune system and reduce inflammation in the liver. These drugs work by targeting specific components of the immune system involved in the autoimmune response, such as T-cells and B-cells.
By Distribution Channel: The autoimmune hepatitis drug market is divided into hospital pharmacies, drug stores & retail pharmacies, and online providers. Autoimmune hepatitis drugs are typically prescription medications that are used to treat autoimmune hepatitis, a chronic inflammatory liver disease. These drugs are typically available through hospital pharmacies, drug stores and retail pharmacies, and online providers. Hospital pharmacies are typically the primary source of these drugs for patients who are receiving treatment in a hospital setting. Drug stores and retail pharmacies, such as CVS and Walgreens, are also common providers of autoimmune hepatitis drugs for patients who are receiving treatment on an outpatient basis. Patients can obtain their prescriptions from their healthcare providers and then fill them at a local pharmacy.
In recent years, online providers have become increasingly popular as a source of prescription medications, including autoimmune hepatitis drugs. Online providers may offer the convenience of home delivery and the ability to order refills online. However, patients should exercise caution when ordering prescription medications online and ensure that they are purchasing from a reputable and licensed provider.
By Region: The Asia-Pacific autoimmune hepatitis drug market is one of the fastest-growing markets globally, driven by a combination of factors such as increasing incidence of autoimmune hepatitis, rising awareness about the disease, improving healthcare infrastructure, and growing government initiatives to provide better healthcare facilities. Some of the examples of autoimmune hepatitis drugs that are gaining traction in the region include: Prednisone and Azathioprine, which is widely used as a first-line treatment for autoimmune hepatitis. The drug combination is effective in controlling inflammation and preventing liver damage. In addition, Mycophenolate mofetil is an immunosuppressive drug and is gaining popularity in the region as a second-line treatment option for autoimmune hepatitis. Mycophenolate mofetil is effective in controlling inflammation and reducing the need for high-dose steroid therapy.
Furthermore, Tacrolimus drug is another immunosuppressive agent that is used to treat autoimmune hepatitis in the region. Tacrolimus is generally used as a salvage therapy for patients who do not respond to standard treatment. Budesonide is an alternative to prednisone and is effective in reducing inflammation in the liver. It is particularly useful for patients with mild to moderate autoimmune hepatitis. Overall, the Asia-Pacific autoimmune hepatitis drug market is expected to grow rapidly in the coming years, driven by increasing awareness and better treatment options for this chronic inflammatory liver disease.
Competitive analysis and profiles of the major players in the autoimmune hepatitis drug market, such as AbbVie Inc., Bristol Myers & Squibb, Cipla Ltd, Gilead Sciences, GlaxoSmithKline plc, F. Hoffmann-La Roche AG, Lupin, Merck & Co. Inc., Teva Pharmaceutical Industries Limited and Zydus Wellness Ltd are provided in the report. Major players have adopted product launch and acquisition as key developmental strategies to improve the product portfolio of the autoimmune hepatitis drug market.
Autoimmune Hepatitis Drug Market Report Highlights
By Drug Class
By Distribution Channel
Key Market Players
Merck & Co. Inc., AbbVie Inc., Zydus Wellness Ltd, Teva Pharmaceutical Industries Limited, GlaxoSmithKline plc, Gilead Sciences, Bristol Myers & Squibb, Lupin, F. Hoffmann-La Roche AG, Cipla Ltd