Jersey City, NJ, May 10, 2023 (GLOBE NEWSWIRE) -- InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Rare Disease Clinical Trials Market Size, Share & Trends Analysis Report By Therapeutic Area (Oncology, Cardiovascular Disorders, Neurological Disorders, Infectious Disease, Genetic Disorders, Autoimmune and Inflammation, Hematologic Disorders, Musculoskeletal Disorders), Phase (Phase I, II, III, and IV), And Sponsor (Pharmaceutical & Biopharmaceutical Companies, Non-profit Organizations)- Market Outlook And Industry Analysis 2031"
The Global Rare Disease Clinical Trials Market is estimated to reach over USD 24.74 billion by 2031, exhibiting a CAGR of 9.31% during the forecast period.
The worldwide cancellation of elective treatments, including treatment and diagnostic procedures, caused by the COVID-19 pandemic significantly influenced the market for treating uncommon diseases. For instance, a review article detailing the difficulties individuals with uncommon disorders faced was published in the Frontiers in Public Health Journal in April 2021. The article's conclusion found regular clinical care, counseling, and therapies utterly insufficient. Due to the COVID-19 pandemic's suspension of research projects and clinical trials for uncommon and genetic diseases, clinicians, researchers, and scientists who work on these diseases, have experienced additional problems due to the pandemic. But, once the limits were removed, the market began to rebound. Throughout the projection period, the market is anticipated to increase steadily.
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Additionally, rising R&D activities for novel therapeutics and drugs, an increase in the number of new drug launches, an increase in the number of rare disease cases and initiatives favoring vaccinations, as well as an expansion in the number of new drug launches and favorable government policies, are all actively influencing the growth of the market under study.
Recent Developments:
• In January 2023, Genethon, an R&D company, began a crucial clinical trial for the use of gene therapy to treat Crigler-Najjar Syndrome. Crigler-Najjar syndrome is a rare genetic liver disease marked by abnormally elevated bilirubin levels in the blood. (hyperbilirubinemia).
• In November 2022, The Biologics License Application (BLA) for PRX-102 (pegunigalsidasealfa) for the treatment of adult patients with Fabry disease was re-submitted to the US Food and Drug Administration (FDA) by ProtalixBiotherapeutics Inc. and Chiesi Global Rare Diseases.
List of Prominent Players in the Rare Disease Clinical Trials Market:
• Takeda Pharmaceutical Company;
• F. Hoffmann-La Roche Ltd.;
• Pfizer, Inc.;
• AstraZeneca;
• Novartis AG;
• LabCorp;
• IQVIA, Inc.;
• Charles River Laboratories;
• Icon PLC;
• Parexel International Corporation
Rare Disease Clinical Trials Market Report Scope
| Report Attribute | Specifications |
| Market size value in 2022 | USD 11.30 Bn |
| Revenue forecast in 2031 | USD 24.74 Bn |
| Growth rate CAGR | CAGR of 9.31% from 2023 to 2031 |
| Quantitative units | Representation of revenue in US$ Billion, and CAGR from 2023 to 2031 |
| Historic Year | 2019 to 2022 |
| Forecast Year | 2023-2031 |
| Report coverage | The forecast of revenue, the position of the company, the competitive market statistics, growth prospects, and trends |
| Segments covered | Therapeutic Area, Phase, And Sponsor |
| Regional scope | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Country scope | U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; Southeast Asia |
Market Dynamics:
Drivers-
Treatment innovation, rising product approvals, collaborations and acquisitions by major companies all contribute to the market's expansion. For instance, xenpozyme (olipudasealfa), a medicine for the treatment of non-central nervous system (CNS) aspects of Acid Sphingomyelinase Deficiency (ASMD), a rare and progressive genetic condition, was authorised by the European Medicines Agency (EMA) in May 2022. According to EMA, acid sphingomyelinase (ASM), a patient's deficient or malfunctioning enzyme, was replaced with xenpozyme, making it the first ASMD-specific medication created in the EU. This replacement enzyme helps patients reduce fat buildup inside cells and alleviates various ASMD symptoms. These approvals are anticipated to accelerate market growth over the course of the forecast.
Challenges:
Even in phase I and II studies, many clinical trials for uncommon diseases must be multicentre and frequently international to ensure adequate patient recruitment. This may put the synchronisation of procedure, ethical review, indemnity, clinical service organisation, standards of care, and cultural diversity at risk. However, the burden of the disease that patients already live with is increased by the trial's requirements, which include taking additional medicine, keeping diaries, and noting symptoms or adverse effects.
Regional Trends:
Due to the high prevalence of rare diseases in the region, such as Huntington's disease, spina bifida, fragile X syndrome, Guillain-Barré syndrome, Crohn's disease, cystic fibrosis, and Duchenne muscular dystrophy, high awareness of these diseases, and the presence of a strong healthcare system for the diagnosis and treatment of rare diseases, the North American region is expected to maintain a significant share in the global market for rare disease treatments.
In May 2022, the Genetic and Rare Diseases (GARD) Information Center reported that there are about 7,000 identified rare diseases and that one in ten Americans (or 30 million people) suffer from one. Also, according to the Canadian Organization for Rare Disorders (CORD) Report 2021, roughly 1 in 12 Canadians experience a rare disease each year, with genetic alterations accounting for 80% of these disorders' causes. Thus, due to the high prevalence of uncommon diseases in the area, the market is anticipated to grow significantly over the next few years.
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Segmentation of Rare Disease Clinical Trials Market:
By Therapeutic area-
• Oncology
• Cardiovascular Disorders
• Neurological Disorders
• Infectious Disease
• Genetic Disorders
• Autoimmune and Inflammation
• Hematologic Disorders
• Musculoskeletal Disorders
• Others
By Phase-
• Phase I
• Phase II
• Phase III
• Phase IV
By Sponsor-
• Pharmaceutical & Biopharmaceutical Companies
• Non-profit Organizations
• Others
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of Middle East and Africa
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