San Francisco, 23 December 2024: The Report Rare Disease Clinical Trialss Market Size, Share & Trends Analysis Report By Therapeutic Area (Autoimmune & Inflammation, Hematologic Disorders), By Phase (Phase I, Phase II), By Sponsor, By Region, And Segment Forecasts, 2023 - 2030
The global Rare Disease Clinical Trialss market size is expected to reach USD 24.25 billion by 2030, expanding at 9.7% CAGR from 2023 to 2030, according to a new report by Grand View Research, Inc. The main driving factors of the Rare Disease Clinical Trials industry are the high burden of rare diseases worldwide, which has led to rising demand for research. Furthermore, intermittent launches and a large number of products in the pipeline also propel growth. Government initiatives that encourage product development, such as the Orphan Drug Act, are further expected to assist industry growth.
According to the National Institutes of Health (NIH), there are more than 7,000 rare diseases worldwide. These diseases affect nearly 30 million Americans, or 1 in every 10 people. Eurodis states that 72% of rare diseases are genetic, while others are caused by infections, allergies, and environmental causes. The growing awareness among people regarding rare diseases and growing interest in developing potential treatments for treating rare diseases are expected to support market growth.
Pharmaceutical companies and non-profit organizations are actively providing funding for rare disease clinical research. For instance, in February 2022, the Health Research Board funded USD 1.1 million to support Rare Disease Clinical Trialss. Similar initiatives in the future are expected to support the market during the forecast period.
Orphan drug sales have been steadily increasing in recent years. For instance, according to Evaluate Pharma, orphan drug sales accounted for USD 138 billion in 2020, and by 2022, they accounted for USD 172 billion. It is estimated that orphan drug sales will reach USD 268 billion by 2026. The rise in the sales of orphan drugs is expected to generate interest among researchers in developing new treatments in the area of rare diseases and thus support the market in the post-pandemic period.
This growth can be attributed to several factors, including the less number of drugs available for treating rare diseases, improvements in personalized medicine, and cell and gene therapies, which are opening up new avenues for the development of new treatments for rare diseases. Moreover, an increase in the number of funding from pharmaceutical and biotech companies and non-profit organizations for Rare Disease Clinical Trialss is further supporting market growth.
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The COVID-19 pandemic had a significant impact on the ability to conduct clinical trials. Due to the pandemic, various clinical trials of rare diseases were halted and delayed, and participant enrollment was postponed. This resulted in the delayed arrival of new treatments and drugs developed for the treatment of rare diseases. However, clinical trials for rare diseases resumed by the second half of 2020, and the trials are now initiated, which is expected to support the market in the post-pandemic period.
Rare Disease Clinical Trialss Market Report Highlights
• The phase III segment is expected to grow at the fastest CAGR of 10.3% during the forecast period. The segment’s growth is supported by the high cost of phase III Rare Disease Clinical Trialss due to the requirement for a large number of volunteers • The oncology segment held the largest market revenue share of 33.9% in 2022. The growing interest of researchers in the development of new potential treatments for treating rare cancers is supporting the growth of the segment • Based on the sponsor, the nonprofit organization segment is expected to grow at a CAGR of 9.9% over the forecast period owing to the significant funding offered by these organizations to support rare disease clinical research • North America dominated the market and accounted for a revenue share of 49.3% in 2022. The high burden of rare diseases in North America and the presence of a large number of players in clinical trials are some of the key reasons for its high market share
The Orphan Drug Act (ODA) of 1983 introduced significant incentives for businesses to develop treatments for rare diseases. As per this act, the sponsors of clinical trials are not required to pay the Prescription Drug User Fee Amendments (PDUFA). The ODA provides clinical research grants, an R&D tax credit for 25% of qualified clinical trial costs for orphan drugs, and market exclusivity for seven years. All these factors are likely to support the market's growth.
Rare Disease Clinical Trials Market Report Scope
Report Attribute Details Market size value in 2023 USD 12.65 billion Revenue forecast in 2030 USD 24.25 billion Growth rate CAGR of 9.7% from 2023 to 2030 Base year for estimation 2022 Actual estimates/Historical data 2018 - 2021 Forecast period 2023 - 2030
Biopharmaceutical researchers have developed groundbreaking treatments for several rare diseases by utilizing new technology and the expanding body of knowledge on numerous rare diseases. Orphan medications for uncommon diseases accounted for more than half (55%) of unique new drug and biological approvals in 2020. In the same year, medicines licensed to treat orphan diseases included a therapy that targets von Hippel-Landau disease, a genetic disease that affects 10,000 people in the U.S. and causes tumors and/or cysts in various sections of the body. Such research is likely to support the market.
