In 2023, the market size for neurology clinical trials is projected to expand at a compound annual growth rate (CAGR) of 5.5% during the forecast period of 2024 and 2032. Increasing neurological diseases, such as dementia, stroke, and peripheral neuropathy, and rising R&D expenditures in neurological research are largely responsible for this trend. The "SGT-53 in Children with Recurrent or Progressive CNS Malignancies" study, for example, was initiated in June 2023. A study entitled "GB5121 in Adult Patients with Relapsed/Refractory CNS Lymphoma" was initiated in May of 2023. After the pandemic, it is anticipated that an increase in the number of studies will stimulate market expansion.
The high prevalence of neurological diseases around the world has piqued the interest of sponsors and investors in funding neurological clinical studies. Over the years, neuroscientific research has received substantial funding. In March 2023, researchers from Brown University, New York University, and the University of Rochester received USD 16.0 million from the NIH for Alzheimer's disease research. It is anticipated that future initiatives of this nature will foster segment market expansion.
The global elderly population has grown substantially over time. According to the World Health Organization, this number is anticipated to reach 2.1 billion by 2050. (WHO). By 2050, the number of people aged 60 and older is projected to reach 2.1 billion, up from 1,4 billion in 2020. Neurological disorders such as Alzheimer's disease, stroke, and Parkinson's disease are largely caused by the population's aging. Alzheimer's disease is one of the most prevalent neurological diseases in 2019, affecting more than 50 million individuals worldwide. Parkinson's disease affects 10 million people globally. It is anticipated that the high prevalence of these diseases will increase demand for research, which will stimulate market expansion.
In order to facilitate clinical trials for patients, a substantial number of neurological trials are decentralized at present. In August 2020, Firma Clinical Research and C2N Diagnostics launched a decentralized Alzheimer's disease diagnostic clinical trial. Increasing adoption of such trials is anticipated to increase participant interest in clinical studies, thereby significantly expanding the market.
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With a 45 % revenue share in 2023, the phase II clinical trials segment dominated the neurology clinical trials market. Based on phase, the market is divided into Phase I, Phase II, Phase III, and Phase IV. The increasing number of industry-sponsored and non-industry-sponsored phase II clinical trials, the increasing complexity of phase II clinical trials, and the globalization of clinical trials all contribute to the expansion of this market segment. A significant number of phase I drugs have been approved in recent years. In May 2021, for example, PharmaTher Holdings Ltd. announced that the U.S. Food and Drug Administration (FDA) had approved the company's Investigational New Drug (IND) application to advance the company's ketamine drug to phase II clinical trial, to study the drug's safety, efficacy, and pharmacokinetics in Parkinson's patients. These approvals are anticipated to further stimulate segment expansion.
Phase III is anticipated to experience the highest growth rate over the forecast period, at 5.6% CAGR. This growth may be due to the fact that phase III clinical trials are the most expensive and involve the most participants. To determine the treatment's safety and efficacy, clinical trial market participants are aggressively initiating phase III trials. Pfizer, for instance, announced in April 2023 that it intends to open clinical trial sites in order to conduct phase III trials of its investigational mini-dystrophin gene therapy, which is used to treat patients with Duchenne muscular dystrophy. These initiatives by market participants are likely to spur segment growth.
The Huntington's disease segment is anticipated to record the highest growth rate during the forecast period, at 6.2%. Epilepsy, Parkinson's disease (PD), Huntington's disease, stroke, traumatic brain injury (TBI), amyotrophic lateral sclerosis (ALS), and other indications segment the market. Due to the lack of treatment for Huntington's disease, novel medications are in high demand. The majority of cases are caused by inheritance or mutation. As of June 2023, there were only 222 studies registered for HD, with the majority in phases I and II and only three in phase IV. It is expected that the low number of phase IV studies and the relative lack of medications for the diseases will increase the demand for research, which will have a positive impact on the market.
In 2023, epilepsy constituted the largest proportion, 22%. Epilepsy is one of the most prevalent neurological diseases, affecting over 65 million people worldwide, according to the World Health Organization. Eighty percent of all epilepsy cases occur in countries with a low or middle income. ClinicalTrials.gov lists 1,755 epilepsy-related studies as of June 2023. Epilepsy awareness and demand for innovative treatments for the condition are expected to drive the segment's market.
With a 96% revenue share in 2023, the interventional segment dominated the neurology clinical trials market. Based on the study design, the market is divided into interventional, observational, and expanded access segments. A large number of interventional studies for Central Nervous System (CNS) disorders are being conducted worldwide, which explains the growth. ClinicalTrials.gov lists over 23,000 interventional studies related to CNS disorders as of June 2023. In April 2023, for instance, participants were recruited for a feasibility study titled Feasibility of Acquiring Hyperpolarized Imaging in Patients with Primary CNS Lymphoma. These factors all contribute to the segment market.
During the forecast period, the observational segment is anticipated to expand by 5.8% per year. Observational studies are routinely used to evaluate treatment effects in a variety of circumstances, including post-marketing drug safety assessments and when clinical trials are impractical. In addition, more than 7,900 of the total CNS condition studies listed on ClinicalTrials.gov as of June 2023 are observational. The observational study titled "The Use of Biomarkers to Predict CNS Involvement in Diffuse Large B-Cell Lymphoma: A Danish Nationwide Registry Study" was completed in January 2023. The aforementioned factors support the segment market.
In 2023, the market for neurology clinical trials was dominated by North America, which accounted for 45.0% of its total revenue. The market for neurology clinical trials in the region is propelled by the increasing prevalence of neurological disorders and the presence of a large number of clinical trial participants. As the population ages and life expectancy rises, the prevalence of Alzheimer's disease and other forms of dementia will increase, with an estimated 8.4 million Americans 65 and older suffering from Alzheimer's disease or another form of dementia by 2030. In the United States, there are a large number of neurological patients, which increases the need for expanding clinical trials. In 2020, 5.8 million Americans were diagnosed with Alzheimer's disease. This number is projected to triple to 14 million by 2060.
In the United States, companies like Biogen and IQVIA have made consistent progress in the development of new drugs and FDA approvals for neurological disorders. In an effort to reduce the prevalence of neurological disorders in the United States, government agencies such as the National Institute of Neurological Disorders and Strokes fund clinical trials and a number of research programs. Between 2023 and 2032, it is anticipated that the dollar opportunity growth will reach $1.8 billion.
Asia-Pacific is expected to grow at a rate of 6% annually over the forecast period, the highest of any region. As a result of the investments of numerous developed nations in the Asia-Pacific region, this market has the highest growth rate. In comparison to North America and Europe, clinical trial enrollment is increasing in Asia. This is the case due to the large patient pool and low trial costs. Additionally, neuroscientists in the region are actively developing new treatments. In February 2021, for example, scientists at the Jawaharlal Nehru Centre for Advanced Scientific Research in India developed a small molecule known as TGR 63, which had the ability to disrupt the mechanism by which neurons in Alzheimer's disease become non-functional. These research efforts are likely to contribute to the expansion of the regional market.
There are a large number of multinational corporations on the global market. The majority of these businesses prioritize regional expansion, partnerships, collaborations, and mergers and acquisitions as their primary strategies. Labcorp, the parent company of Covance, expanded its cell & gene therapy research capabilities through a partnership with Xcell Biosciences, a developer of cell and gene therapy technologies, in April 2023. Labcorp and Xcellbio will collaborate to enhance the effectiveness and safety of cell and gene therapies for Parkinson's disease, cancer, and other conditions. Novartis, Covance, Med pace, Charles River Laboratories, Syneous Health, Icon Plc, GlaxoSmithKline, Aurora healthcare, Biogen, IQVIA and Others.
The following are recent developments by leading providers of neurology clinical trials:
