The rare disease clinical trials market size is projected to be valued at USD 12,566.14 million in 2023 and is expected to rise to USD 31,715.25 million by 2033. The sales of rare disease clinical trials are expected to record a significant CAGR of 9.7% during the forecast period.
Various Factors Propelling the Demand for Rare Disease Clinical Trials
The rare disease clinical trials market refers to the development of drugs and therapies for the treatment of rare diseases. These diseases, by definition, affect a small percentage of the population. Consequently, there is often limited research and development in this area.
Clinical trials for rare diseases can be challenging due to the small patient population, limited natural history data, and a lack of standardized endpoints. However, the market is growing due to increased funding and attention to the development of treatments for these diseases.
For example, The Orphan Drug Act was passed in the United States in 1983. The act was enacted to offer financial incentives to pharmaceutical companies to develop treatments for rare diseases.
The advancement in technology and genomics allows for more targeted treatments and personalized medicine. Additionally, there has been increased collaboration between patient advocacy groups, researchers, and the industry. This collaboration has helped to overcome some challenges of conducting clinical trials in rare diseases.
Overall, the market represents an important area of research and development. As it offers hope for patients with conditions that may have previously been considered untreatable.
Attribute | Details |
---|---|
Rare Disease Clinical Trials Market Estimated Size (2023) | USD 12,566.14 million |
Rare Disease Clinical Trials Market CAGR (2023 to 2033) | 9.7% |
Rare Disease Clinical Trials Market Forecasted Size (2033) | USD 31,715.25 million |
The rare disease clinical trials market was valued at USD 11,455.0 million in 2022 with a substantial growth trajectory of 8.9% between the analysis period of 2018 to 2022.
Future Market Insights expects the rare disease clinical trials market to expand at a CAGR of 9.7% during the forecast period of 2023 to 2033. The growth can be attributed to the following reasons
Considering the above-mentioned factors, FMI opines, the rare disease clinical trials market is likely to witness a market value of USD 31,715.25 million by the end of 2033.
In 2022, the oncology segment held a notable share of 33.9%. A few of the key factors fueling the segment growth are
For example, in January 2023, the USFDA approved atezolizumab (Tecentriq), an immunotherapy drug for advanced alveolar soft part sarcoma patients (ASPS).
During the forecast period, the infectious disease segment is expected to expand at an exponential rate of 10.6%. Acanthamoeba keratitis, Q fever, Marburg virus, and other rare infectious diseases are examples. As these rare diseases are fatal, researchers are hugely interested in developing treatments and vaccines for them.
Contact lens wearers are likely to develop Acanthamoeba keratitis. Over 85% of people in the United States wear contact lenses. This increases the risk of disease and fuels the demand for treatment. These factors are assisting segment growth.
In 2022, Phase II had a notable share of 42.6%. Phase II studies are divided into two parts: the first part includes dose range exploration as well as efficacy studies, while the second part includes dose finalization. Over 100-300 participants are recruited for Phase II clinical trials.
The phase II segment had the most registered clinical studies as of November 2022. The ClinicalTrial.gov portal had 72,522 studies registered as of November 2022. The high amount of Phase II clinical trials is driving the segment's growth.
The United States has a well-established regulatory framework for rare disease clinical trials, with the Orphan Drug Act of 1983. It provides incentives for the development of drugs for rare diseases. The FDA's Breakthrough Therapy Designation program has also facilitated the development of drugs for rare diseases. Additionally, the National Institutes of Health (NIH) has established a Rare Diseases Clinical Research Network (RDCRN) to facilitate the conduct of clinical trials for rare diseases.
Europe is a significant market for rare disease clinical trials, with countries like Germany, France, and the United Kingdom accounting for a significant share of the market. The European Medicines Agency (EMA) has been proactive in offering regulatory support for rare disease drug development. Therefore, the support from several agencies has increased the clinical trials in Europe.
Asia Pacific is a significantly growing market for rare disease clinical trials, with countries like China, Japan, and India emerging as key players. The region offers a substantial patient population and low trial costs compared to Western countries. Making it an attractive destination for colossal clinical trials. However, the regulatory environment in some countries can be challenging, and there is a need for great awareness and education about rare diseases.
Latin America is an emerging market for rare disease clinical trials, with countries like Brazil and Mexico. The region offers a diverse patient population and low trial costs compared to North America and Europe. However, there are challenges in terms of regulatory compliance and infrastructure, which can limit the growth of the market.
The Middle East and Africa region is a small but growing market for rare disease clinical trials. Countries like South Africa and Israel are emerging as key players due to their advanced healthcare infrastructure and supportive regulatory environment. However, there are challenges related to political instability, low awareness about rare diseases, and limited healthcare resources in some parts of the region.
The rare disease clinical trials market is highly competitive, with several global players operating in the space. Some key players in the market include
In addition to these companies, there are many other small CROs and specialized service providers operating in the rare disease clinical trials market. As the market continues to grow, competition among these companies is expected to increase. These players are competing on factors such as service quality, expertise, and pricing.
Attribute | Details |
---|---|
Growth Rate | CAGR of 9.7% from 2023 to 2033 |
Base Year of Estimation | 2022 |
Historical Data | 2018 to 2022 |
Forecast Period | 2023 to 2033 |
Quantitative Units | Revenue in USD million and Volume in Units and F-CAGR from 2023 to 2033 |
Report Coverage | Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, growth factors, Trends, and Pricing Analysis |
Key Segments Covered | By Therapeutic Area, By Sponsor, By Phases, By Region |
Regions Covered | North America; Latin America; Europe; East Asia; South Asia; The Middle East & Africa;Oceania |
Key Countries Profiled | The United States, Canada, Brazil, Mexico, Germany, Italy, France, The United Kingdom, Spain, Russia, China, Japan, India, GCC Countries, Australia |
Key Companies Profiled | Takeda Pharmaceutical Company; F. Hoffmann-La Roche Ltd.; Pfizer, Inc.; AstraZeneca; Novartis AG; LabCorp; IQVIA, Inc.; Charles River Laboratories; Icon PLC; Parexel International Corporation |
Customization & Pricing | Available upon Request |
Table 1: Global Market Value (US$ Million) Forecast by Region, 2018 to 2033
Table 2: Global Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 3: Global Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 4: Global Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 5: North America Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 6: North America Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 7: North America Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 8: North America Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 9: Latin America Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 10: Latin America Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 11: Latin America Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 12: Latin America Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 13: Europe Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 14: Europe Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 15: Europe Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 16: Europe Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 17: South Asia Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 18: South Asia Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 19: South Asia Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 20: South Asia Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 21: East Asia Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 22: East Asia Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 23: East Asia Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 24: East Asia Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 25: Oceania Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 26: Oceania Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 27: Oceania Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 28: Oceania Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Table 29: MEA Market Value (US$ Million) Forecast by Country, 2018 to 2033
Table 30: MEA Market Value (US$ Million) Forecast by Therapeutic Area, 2018 to 2033
Table 31: MEA Market Value (US$ Million) Forecast by Phase, 2018 to 2033
Table 32: MEA Market Value (US$ Million) Forecast by Sponsor, 2018 to 2033
Figure 1: Global Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 2: Global Market Value (US$ Million) by Phase, 2023 to 2033
Figure 3: Global Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 4: Global Market Value (US$ Million) by Region, 2023 to 2033
Figure 5: Global Market Value (US$ Million) Analysis by Region, 2018 to 2033
Figure 6: Global Market Value Share (%) and BPS Analysis by Region, 2023 to 2033
Figure 7: Global Market Y-o-Y Growth (%) Projections by Region, 2023 to 2033
Figure 8: Global Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 9: Global Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 10: Global Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 11: Global Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 12: Global Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 13: Global Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 14: Global Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 15: Global Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 16: Global Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 17: Global Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 18: Global Market Attractiveness by Phase, 2023 to 2033
Figure 19: Global Market Attractiveness by Sponsor, 2023 to 2033
Figure 20: Global Market Attractiveness by Region, 2023 to 2033
Figure 21: North America Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 22: North America Market Value (US$ Million) by Phase, 2023 to 2033
Figure 23: North America Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 24: North America Market Value (US$ Million) by Country, 2023 to 2033
Figure 25: North America Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 26: North America Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 27: North America Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 28: North America Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 29: North America Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 30: North America Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 31: North America Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 32: North America Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 33: North America Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 34: North America Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 35: North America Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 36: North America Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 37: North America Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 38: North America Market Attractiveness by Phase, 2023 to 2033
Figure 39: North America Market Attractiveness by Sponsor, 2023 to 2033
Figure 40: North America Market Attractiveness by Country, 2023 to 2033
Figure 41: Latin America Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 42: Latin America Market Value (US$ Million) by Phase, 2023 to 2033
Figure 43: Latin America Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 44: Latin America Market Value (US$ Million) by Country, 2023 to 2033
Figure 45: Latin America Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 46: Latin America Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 47: Latin America Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 48: Latin America Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 49: Latin America Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 50: Latin America Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 51: Latin America Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 52: Latin America Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 53: Latin America Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 54: Latin America Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 55: Latin America Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 56: Latin America Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 57: Latin America Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 58: Latin America Market Attractiveness by Phase, 2023 to 2033
Figure 59: Latin America Market Attractiveness by Sponsor, 2023 to 2033
Figure 60: Latin America Market Attractiveness by Country, 2023 to 2033
Figure 61: Europe Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 62: Europe Market Value (US$ Million) by Phase, 2023 to 2033
Figure 63: Europe Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 64: Europe Market Value (US$ Million) by Country, 2023 to 2033
Figure 65: Europe Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 66: Europe Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 67: Europe Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 68: Europe Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 69: Europe Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 70: Europe Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 71: Europe Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 72: Europe Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 73: Europe Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 74: Europe Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 75: Europe Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 76: Europe Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 77: Europe Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 78: Europe Market Attractiveness by Phase, 2023 to 2033
Figure 79: Europe Market Attractiveness by Sponsor, 2023 to 2033
Figure 80: Europe Market Attractiveness by Country, 2023 to 2033
Figure 81: South Asia Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 82: South Asia Market Value (US$ Million) by Phase, 2023 to 2033
Figure 83: South Asia Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 84: South Asia Market Value (US$ Million) by Country, 2023 to 2033
Figure 85: South Asia Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 86: South Asia Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 87: South Asia Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 88: South Asia Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 89: South Asia Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 90: South Asia Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 91: South Asia Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 92: South Asia Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 93: South Asia Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 94: South Asia Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 95: South Asia Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 96: South Asia Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 97: South Asia Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 98: South Asia Market Attractiveness by Phase, 2023 to 2033
Figure 99: South Asia Market Attractiveness by Sponsor, 2023 to 2033
Figure 100: South Asia Market Attractiveness by Country, 2023 to 2033
Figure 101: East Asia Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 102: East Asia Market Value (US$ Million) by Phase, 2023 to 2033
Figure 103: East Asia Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 104: East Asia Market Value (US$ Million) by Country, 2023 to 2033
Figure 105: East Asia Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 106: East Asia Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 107: East Asia Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 108: East Asia Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 109: East Asia Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 110: East Asia Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 111: East Asia Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 112: East Asia Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 113: East Asia Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 114: East Asia Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 115: East Asia Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 116: East Asia Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 117: East Asia Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 118: East Asia Market Attractiveness by Phase, 2023 to 2033
Figure 119: East Asia Market Attractiveness by Sponsor, 2023 to 2033
Figure 120: East Asia Market Attractiveness by Country, 2023 to 2033
Figure 121: Oceania Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 122: Oceania Market Value (US$ Million) by Phase, 2023 to 2033
Figure 123: Oceania Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 124: Oceania Market Value (US$ Million) by Country, 2023 to 2033
Figure 125: Oceania Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 126: Oceania Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 127: Oceania Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 128: Oceania Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 129: Oceania Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 130: Oceania Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 131: Oceania Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 132: Oceania Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 133: Oceania Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 134: Oceania Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 135: Oceania Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 136: Oceania Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 137: Oceania Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 138: Oceania Market Attractiveness by Phase, 2023 to 2033
Figure 139: Oceania Market Attractiveness by Sponsor, 2023 to 2033
Figure 140: Oceania Market Attractiveness by Country, 2023 to 2033
Figure 141: MEA Market Value (US$ Million) by Therapeutic Area, 2023 to 2033
Figure 142: MEA Market Value (US$ Million) by Phase, 2023 to 2033
Figure 143: MEA Market Value (US$ Million) by Sponsor, 2023 to 2033
Figure 144: MEA Market Value (US$ Million) by Country, 2023 to 2033
Figure 145: MEA Market Value (US$ Million) Analysis by Country, 2018 to 2033
Figure 146: MEA Market Value Share (%) and BPS Analysis by Country, 2023 to 2033
Figure 147: MEA Market Y-o-Y Growth (%) Projections by Country, 2023 to 2033
Figure 148: MEA Market Value (US$ Million) Analysis by Therapeutic Area, 2018 to 2033
Figure 149: MEA Market Value Share (%) and BPS Analysis by Therapeutic Area, 2023 to 2033
Figure 150: MEA Market Y-o-Y Growth (%) Projections by Therapeutic Area, 2023 to 2033
Figure 151: MEA Market Value (US$ Million) Analysis by Phase, 2018 to 2033
Figure 152: MEA Market Value Share (%) and BPS Analysis by Phase, 2023 to 2033
Figure 153: MEA Market Y-o-Y Growth (%) Projections by Phase, 2023 to 2033
Figure 154: MEA Market Value (US$ Million) Analysis by Sponsor, 2018 to 2033
Figure 155: MEA Market Value Share (%) and BPS Analysis by Sponsor, 2023 to 2033
Figure 156: MEA Market Y-o-Y Growth (%) Projections by Sponsor, 2023 to 2033
Figure 157: MEA Market Attractiveness by Therapeutic Area, 2023 to 2033
Figure 158: MEA Market Attractiveness by Phase, 2023 to 2033
Figure 159: MEA Market Attractiveness by Sponsor, 2023 to 2033
Figure 160: MEA Market Attractiveness by Country, 2023 to 2033
The market is valued at USD 12.5 billion in 2023.
Pfizer, Inc., AstraZeneca, and Novartis AG are the top market players.
The market held a CAGR of 8.9% from 2018 to 2022.
Advancements in personalized medicine to boost market growth.
Phase II segment is likely to remain preferred through 2033.
Explore Similar Insights
Thank you!
You will receive an email from our Business Development Manager. Please be sure to check your SPAM/JUNK folder too.