Global Urea Cycle Disorders Treatment Market, by Treatment Type (Amino Acid Supplements, Sodium Phenylbutyrate, Glycerol Phenylbutyrate, Sodium Benzoate, and Others (Low Protein Diet, Carglumic acid, etc.), By Enzyme Deficiency Type (OTC – Ornithine Transcarbamylase, AS – Argininosuccinate Synthetase (citrullinemia), AG – Arginase, AL – Argininosuccinate Lyase, CPS1 – Carbamoyl Phosphate Synthase, and NAGS – N-acetylglutamate Synthase), By Route of Administration (Oral and Injectable), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa), is estimated to be valued at US$ 1,188.9 million in 2020 and is expected to exhibit a CAGR of 3.5% during the forecast period (2020-2027), as highlighted in a new report published by Coherent Market Insights.
The increasing number of pipeline products for the treatment of urea cycle disorders is expected to fuel growth of the global urea cycle disorders treatment market in the near future.
For instance, in September 17, 2019, Kaleido Biosciences, a clinical-stage healthcare company, initiated phase 2 clinical trial study to evaluate the efficacy and safety of KB195 in subjects with urea cycle disorder with severe symptoms. The study is estimated to be completed on November 2021.
Global Urea Cycle Disorders Treatment Market – Impact of Coronavirus (COVID-19)
- The COVID-19 pandemic caused major disruptions in the execution of clinical trials in the U.S., impacting key stakeholders across the urea cycle disorder treatment drugs market. During the pandemic, investigative site capabilities experienced upheaval, which was driven by staff furloughs, social-distancing protocols, financial losses, and concerns over patient safety. Sponsors, CROs, and other organizations that support drug development shifted to remote working environments. An estimated 80% of non-COVID-19 trials were stopped or interrupted as a result of the COVID-19 pandemic.
- An April 2020 study suggested that investigative sites demonstrated flexibility and ingenuity in adopting new approaches in order to cope with challenges presented by the COVID, with over half of investigative sites transitioning to virtual approaches to interact with their patients. A few follow-up studies were performed on COVID-19, in August 2020 has identified persistent impact of COVID on clinical trials, over 60% reported of an average or greater level of impact of COVID on the ongoing clinical trials as well as in the initiation of new trials. Respondents specifically highlighted the challenges in patient enrollment and recruitment due to the COVID-19 pandemic.
- Recently, the U.S. FDA guidance (March 2020 and updated July 2020) acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits. Therefore, now there are more opportunities for using remote healthcare including conducting virtual or decentralized trials, site-less clinical trials, and use of other non-traditional approaches that do not involve in-person visits.
- Moreover, various research institutes are focusing on understanding the impact of COVID-19 on patients suffering from inherited metabolic diseases (IMD) such as urea cycle disorder. For instance, in January 2021, University Hospital, Lille, initiated an observational study on the impact of COVID-19 on the equilibrium of hereditary metabolic disease in patients with COVID-19 infection. The study is estimated to be completed by January 2023.