Rare Disease Clinical Trials : Market Size, Share & Trends Analysis Report, Prominent Players, Market Dynamics Drivers, Challenges, Regional Trends, Recent Developments, Segmentation Forecasts, 2023-2031

The global Rare Disease Clinical Trials market is anticipated to exceed USD 24.74 billion by 2031, with a compound annual growth rate CAGR of 9.31% during the forecast period.

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The market for treating uncommon diseases was substantially impacted by the worldwide cancellation of elective treatments, including diagnostic procedures and treatment, due to the COVID-19 pandemic. For example, in April 2021, the Frontiers in Public Health Journal published a review article that outlined the challenges that individuals with uncommon disorders encountered. The article concluded that conventional clinical care, counselling, and therapies were entirely inadequate. Clinicians, researchers, and scientists who specialize in rare and genetic diseases have encountered additional challenges as a consequence of the COVID-19 pandemic's suspension of clinical trials and research projects. However, the market experienced a recovery after the restrictions were lifted. It is anticipated that the market will experience a consistent increase throughout the projection period.

Furthermore, the market under investigation is being actively influenced by an increase in the number of new drug launches, an increase in the number of rare disease cases, initiatives that favour vaccinations, and an expansion in the number of new drug launches, all of which are contributing to the market's growth.

List of Prominent Players in the Rare Disease Clinical Trials Market:

• Charles River Laboratories
• F. Hoffmann-La Roche Ltd.
• Takeda Pharmaceutical Company
• Pfizer, Inc
• AstraZeneca
• Novartis AG
• LabCorp
• Parexel International Corporation
• IQVIA, Inc
• Icon PLC

Market Dynamics:

Drivers-

The market is expanding due to the increasing number of product approvals, collaborations, acquisitions, and treatment innovations by significant companies. For example, the European Medicines Agency (EMA) authorized the enzyme (olipudasealfa) in May 2022 as a medication for the treatment of non-central nervous system (CNS) aspects of Acid Sphingomyelinase Deficiency (ASMD), a rare and progressive genetic condition. The first ASMD-specific medication to be developed in the EU was an enzyme, which replaced acid sphingomyelinase (ASM), a deficient or malfunctioning enzyme in a patient. This was confirmed by the European Medicines Agency (EMA). This replacement enzyme assists patients in the reduction of fat accumulation within cells and the alleviation of a variety of symptoms associated with ASMD. It is anticipated that these approvals will expedite market growth throughout the forecast period.

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Challenges:

Many clinical trials for uncommon diseases must be multicentre and frequently international to assure adequate patient recruitment, even in phase I and II studies. This may jeopardize the synchronization of procedure, ethical review, indemnity, clinical service organization, standards of care, and cultural diversity. Nevertheless, the trial's demands, such as the necessity of taking additional medication, maintaining diaries, and documenting symptoms or adverse effects, exacerbate the disease burden that patients already endure.
Regional Trends:

The North American region is anticipated to maintain a substantial share in the global market for rare disease treatments, in part due to the high prevalence of rare diseases in the area, including Huntington's disease, spina bifida, fragile X syndrome, Guillain-Barré syndrome, Crohn's disease, cystic fibrosis, and Duchenne muscular dystrophy. Additionally, the region has a robust healthcare system capable of diagnosing and treating these diseases. The Genetic and Rare Diseases (GARD) Information Center reported in May 2022 that approximately 7,000 rare diseases have been identified and that one in ten Americans (or 30 million individuals) are affected by one. Additionally, the Canadian Organization for Rare Disorders (CORD) Report 2021 indicates that approximately one in twelve Canadians are affected by a rare disease annually, with genetic mutations accounting for eighty per cent of the aetiology of these conditions. Consequently, the market is expected to experience substantial growth in the coming years due to the high prevalence of uncommon diseases in the region.

Recent Developments:

• In January 2023, Genethon, a research and development business, initiated a pivotal clinical trial to investigate the efficacy of gene therapy in the treatment of Crigler-Najjar Syndrome.Crigler-Najjar syndrome is an uncommon hereditary liver disorder characterized by unusually high levels of bilirubin in the bloodstream. Hyperbilirubinemia.
• In November 2022, ProtalixBiotherapeutics Inc. and Chiesi Global Rare Diseases resubmitted the Biologics License Application (BLA) for PRX-102 (pegunigalsidasealfa) to the US Food and Drug Administration (FDA). The purpose of the application is to seek approval for the treatment of adult patients with Fabry disease.

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Segmentation of Rare Disease Clinical Trials Market-

By Therapeutic area-
• Musculoskeletal Disorders
• Cardiovascular Disorders
• Oncology
• Neurological Disorders
• Infectious Disease
• Autoimmune and Inflammation
• Genetic Disorders
• Hematologic Disorders
• Others

By Phase-
• Phase I
• Phase II
• Phase III
• Phase IV

By Sponsor-
• Non-profit Organizations
• Pharmaceutical & Biopharmaceutical Companies
• Others

By Region-

North America-
• Canada
• The US
• Mexico

Europe-
• Italy
• Rest of Europe
• Germany
• The UK
• France
• Spain

Asia-Pacific-
• South East Asia
• Japan
• China
• India
• South Korea
• Rest of Asia Pacific

Latin America-
• Argentina
• Brazil
• Rest of Latin America

Middle East & Africa-
• South Africa
• GCC Countries
• Rest of Middle East and Africa

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