According to the most recent analysis by Emergen Research, the global Alagille Syndrome market had a value of USD 361.89 million in 2021 and is predicted to grow at a rate of 5.8% during the projected period.
According to the most recent analysis by Emergen Research, the global Alagille Syndrome market had a value of USD 361.89 million in 2021 and is predicted to grow at a rate of 5.8% during the projected period. The introduction of novel and enhanced diagnostic platforms for early diagnosis, rising prevalence of alagille syndrome, and rising number of clinical studies and trials in the area of alagille syndrome-based treatments are key factors propelling market revenue growth.
An important element driving the market is the increase in R&D activities and clinical trials, along with increased investment and funding received by major market players for the R&D of novel medications for the treatment of Alagille syndrome. The creation of fresh medications for the treatment of Alagille syndrome is the attention of several significant actors. Clinical trials for these substances are currently under place, and the USFDA is anticipated to approve them soon.
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For instance, Mirum Pharmaceuticals, Inc. stated in 2020 that the first part of its rolling New Drug Application (NDA) for maralixibat had been submitted to the U.S. Food and Drug Administration (FDA). Patients with Alagille syndrome are testing the effectiveness of maralixibat, a new, minimally absorbed, oral apical sodium-dependent bile acid transporter (ASBT) inhibitor, to treat cholestatic pruritus (ALGS). As a result, it is projected that the market would grow thanks to the strong pipeline of medications for the treatment of Alagille syndrome.
Similar to other types of liver illness typically observed in newborns and young children, Alagille syndrome is a genetically inherited ailment. The National Institute of Diabetes and Digestive and Kidney Diseases estimates that one in every 30,000 live babies suffers with Alagille Syndrome. Clinically, Alagille Syndrome manifests as a number of phenotypes, although it is typically identified by five specific symptoms: poor bile flow, congenital heart disease, bone problems, thickening of the eyelid crease, and distinctive facial features. Genetic testing can be used to support the diagnoses. A multisystem illness, ALGS might present with preclinical symptoms, mildly abnormal liver enzymes, a heart condition, butterfly vertebrae, and posterior embryotoxicity. Clinical diagnosis of Alagille syndrome requires evidence of a lysosomal acid alpha-glucosidase enzyme deficiency, which can be verified in dried blood spots or liquid blood samples, in addition to supporting biomarker tests and molecular genetic analyses.
Eye examinations, spine x-rays to look for distinctive changes like butterfly vertebrae, abdominal ultrasounds of the hepatobiliary tree (including the liver, pancreas, gall bladder, and spleen) to look for abnormalities or rule out other conditions, and blood tests to evaluate liver function and find fat-soluble vitamin deficiencies are additional tests that may be used to diagnose Alagille syndrome in addition to a liver biopsy. An early diagnosis and start to treatment can arise from personalised molecular screening and genetic testing of people who are at risk, potentially improving the clinical outcomes of Alagille syndrome patients.
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Alagille syndrome research and development projects have sparked major efforts for its translation into the therapeutic field as a result of rapid scientific developments. ClinicalTrials.gov currently lists 4 clinical research trials for the treatment of alagille syndrome, 3 of which are in the Phase II stage and 1 of which is in the Phase III stage. Numerous potential therapies for alagille syndrome have started the preclinical and clinical stages of development recently and are currently in late-stage clinical trials. The genetic illness alagille syndrome is a topic of continuing research in the global pharmaceutical business.
However, the slow clinical identification of Alagille Syndrome, which can take months or even years, together with inadequate funding for such rare disorders are impeding the development of this industry. Traditional screening techniques also have a variety of disadvantages, such as delayed findings and false-positive tests, to name a couple. These are a few of the things preventing market expansion.
Some Key Highlights From the Report
- In 2021, the genetic testing market contributed a sizeable portion of total revenue. Alagille syndrome (ALGS), which is caused by genetic abnormalities in the Jagged 1 (JAG1), Notch 2 (NOTCH2), or 20p12 chromosomal deletion, is best diagnosed by genetic testing. Accurate genetic testing identifies over 95% of patients with clinical symptoms and an ALGS-related mutation. Using cellular DNA extraction and analysis, a medical professional performs this process in a lab setting to look for genetic anomalies that could be the cause of the disease. By locating gene variants linked to ALGS, genetic testing can aid in predicting patient outcomes, recurrence risk, and medical therapy. If one or both parents have ALGS, prenatal genetic testing (DNA samples obtained during pregnancy) or preimplantation genetic testing (DNA samples taken from embryos made through in vitro fertilisation) may help in the early discovery of the disorder in a foetus. These are the main elements influencing this segment's growth.
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- In 2021, the hospitals market contributed a sizeable portion of total revenue. Alagille syndrome can be promptly transferred from patients with minor symptoms to specialist facilities because to the innovative and enhanced methods being developed by several hospitals to aid in early detection of the condition. In order to adequately evaluate and diagnose patients and enable them to start therapy as soon as possible. All varieties of alagille syndrome are treated individually by hospital doctors and medical professionals, who also administer additional supportive medications to treat the condition's symptoms and complications.
- In 2021, the Europe market contributed a modest portion of total sales. An increasing number of experimental medications created for Alagille syndrome have been approved in recent years. For instance, Mirum Pharmaceuticals, Inc. disclosed the validation status for the company's Marketing Authorization Application (MAA) for its investigational drug maralixibat on November 30, 2020. This drug is intended to treat patients with progressive familial intrahepatic cholestasis type 2 (PFIC2), also known as bile salt export pump (BSEP) deficiency. The biopharmaceutical firm is committed to the creation and marketing of cutting-edge therapies for debilitating liver illnesses (EMA). These are the main elements influencing income development in this area.
- Albireo Pharma, Inc., Bioarray S.L., Mirum Pharmaceuticals, Inc., AbbVie Inc., CANbridge Life Sciences Ltd., Teva Pharmaceutical Industries Ltd., Takeda Pharmaceutical Company Limited., Endo International plc., Mylan N.V., Novartis AG, Amneal Pharmaceuticals LLC., and Epic Pharma, LLC. are a few of the significant companies mentioned in the global market report.
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Emergen Research has segmented the global alagille syndrome market based on diagnostic method, treatment type, treatment centers, and region:
- Diagnostic Method Outlook (Revenue, USD Million; 2019-2030)
- Genetic Testing
- Liver Biopsy
- Heart and Blood Vessel Tests
- X-ray Imaging
- Abdominal Ultrasound
- Kidney Function Tests
- Treatment Type Outlook (Revenue, USD Million; 2019-2030)
- Drug Medications
- Ileal Bile Acid Transporter (IBAT) inhibitors
- Ursodeoxycholic Acid
- Cholestyramine
- Rifampicin
- Late Stage Pipeline Drugs
- Others
- Surgery
- Liver Transplantation
- Kidney Surgery
- Others
- Drug Medications
- Treatment Centers Outlook (Revenue, USD Million; 2019-2030)
- Hospitals
- Diagnostic Centers
- Others
- Regional Outlook (Revenue, USD Million; 2019-2030)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Benelux
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Rest of LATAM
- Middle East & Africa
- Saudi Arabia
- UAE
- South Africa
- Turkey
- Rest of Middle East & Africa
- North America
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