Mild Cognitive Impairment Market is Predicted to Advance at a CAGR of 11.6% by 2034 | DelveInsight
According to DelveInsight's analysis, the mild cognitive impairment market is anticipated to increase during the forecast period (2024-2034), owing to the rise in the launch of emerging therapies and healthcare spending globally.
LAS VEGAS, Jan. 8, 2025 /PRNewswire/ -- DelveInsight's Mild Cognitive Impairment Market Insights report includes a comprehensive understanding of current treatment practices, mild cognitive impairment emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
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Key Takeaways from the Mild Cognitive Impairment Market Report
-- According to DelveInsight's analysis, the market size for mild cognitive
impairment was found to be USD 2.8 billion in the 7MM in 2023.
-- The United States accounted for the highest market size of MCI,
approximately 52% of the total market size in 7MM in 2023, in comparison
to the other major markets, i.e., EU4 countries (Germany, France, Italy,
and Spain), and the United Kingdom, and Japan.
-- In 2023, among the 7MM, the US accounted for the highest diagnosed
prevalent cases of MCI, representing 42% of the total cases. Analysis by
DelveInsight's experts indicates that the overall diagnosed prevalent
cases of MCI are expected to rise in the coming years.
-- Leading mild cognitive impairment companies such as Alzheon, AriBio, Eli
Lilly, Novo Nordisk, AgeneBio, Anavex Life Sciences, TauRx Therapeutics,
AC Immune, Johnson & Johnson, and others are developing novel mild
cognitive impairment drugs that can be available in the mild cognitive
impairment market in the coming years.
-- The promising mild cognitive impairment therapies in the pipeline
include Valiltramiprosate (ALZ-801), Mirodenafil (AR1001), Remternetug
(LY3372993), Semaglutide (NN6535), Levetiracetam (AGB101), Blarcamesine
(ANAVEX2-73), Hydromethylthionine Mesylate (HMTM)/TRx0237,
ACI-35.030/JNJ-2056, and others.
-- In July 2024, the US FDA approved KISUNLA (donanemab-azbt, 350 mg/20
mL), an Alzheimer's therapy developed by Eli Lilly for adults with early
symptomatic Alzheimer's disease, including MCI and mild dementia with
confirmed amyloid pathology.
-- In October 2024, AgeneBio announced that its Phase 2B trial of AGB101
demonstrated a 40% reduction in clinical decline and significant slowing
of entorhinal cortex atrophy in non-carriers of the ApoE-4 allele with
mild cognitive impairment due to Alzheimer's disease, compared to
placebo. Results of the HOPE4MCI trial to date provide strong support
for further testing of AGB101 in patients with MCI due to AD who are
non-carriers of ApoE-4. AgeneBio is currently completing an extension of
this study in the United States (NCT05986721).
-- In December 2024, Blarcamesine (ANAVEX2-73) received EMA filing
acceptance for treatment of Alzheimer's Disease. The Submission was
based on favorable ANAVEX2-73-AD-004 trial results in patients with
early Alzheimer's disease.
-- As of December 2024, TauRx continues to liaise with both the Medicines
and Healthcare products Regulatory Agency (MHRA) and National Institute
for Health and Care Excellence (NICE) regarding the company's UK
Marketing Authorisation Application (MAA) for hydromethylthionine
mesylate (HMTM), a 4 mg oral tablet for the treatment of mild cognitive
impairment (MCI-AD) and mild to moderate Alzheimer's disease.
Discover which therapies are expected to grab the major mild cognitive impairment market share @ Mild Cognitive Impairment Market Report
Mild Cognitive Impairment Overview
Mild cognitive impairment (MCI) refers to a noticeable decline in cognitive abilities, such as memory and thinking, that is more severe than expected for a person's age but not severe enough to interfere significantly with daily activities. MCI can be a precursor to more serious conditions, such as Alzheimer's disease, but not everyone with MCI will develop dementia.
The causes of MCI vary, with potential factors including aging, genetics, brain injury, or conditions like diabetes, high blood pressure, or depression. The symptoms of MCI often involve frequent memory lapses, such as forgetting names, appointments, or recent events. Individuals may also experience difficulty with tasks that require planning and organization.
Diagnosis typically involves a thorough evaluation that includes medical history, cognitive tests, neuroimaging (like MRI or CT scans), and sometimes biomarkers to rule out other conditions. Neuropsychological testing can help assess the extent of cognitive decline and differentiate MCI from normal age-related changes.
Mild Cognitive Impairment Epidemiology Segmentation
The mild cognitive impairment epidemiology section provides insights into the historical and current mild cognitive impairment patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The mild cognitive impairment market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
-- Total Diagnosed Prevalent Cases of Parkinson's Disease
-- Total Diagnosed Prevalent Cases of Alzheimer's Disease
-- Total Diagnosed Prevalent Cases of MCI
Mild Cognitive Impairment Treatment Market
Currently, there is scarcity of approved treatment specifically for mild cognitive impairment, and the focus is on symptom management and addressing risk factors. Recommendations typically include lifestyle changes such as regular exercise, a healthy diet, cognitive activities, and social interaction, which can help maintain cognitive function and possibly slow decline. Some medications used for Alzheimer's disease may be prescribed off-label for MCI, though evidence supporting their effectiveness in this group is limited.
Despite these efforts, there are notable gaps in MCI management. A major challenge is the absence of clear diagnostic biomarkers, which causes variability in diagnosis and complicates the development of targeted therapies. There is also a need for interventions that can delay or prevent the progression to dementia, along with personalized treatment plans that account for the diverse MCI subtypes and underlying conditions. Furthermore, there is a lack of specialized support services for individuals with MCI and their caregivers, including access to cognitive rehabilitation and community-based resources.
Sometimes, doctors prescribe cholinesterase inhibitors to MCI patients primarily experiencing memory loss. These drugs, approved for Alzheimer's disease, have shown mixed results in clinical trials for MCI. Looking forward, there are promising opportunities to address the unmet needs in MCI management, though more research and development are needed. Advancements in neuroimaging and biomarker discovery could improve early detection and tracking of disease progression.
Approved by the US FDA in January 2023, LEQEMBI (lecanemab) from Biogen and Eisai targets amyloid beta-protein in MCI treatment. This IV-administered monoclonal antibody secured Breakthrough Therapy and Fast Track designations in 2021. It also received priority review status in the US, underscoring its clinical relevance. KISUNLA (donanemab-azbt), developed by Eli Lilly, is an anti-amyloid monoclonal antibody that received FDA approval in July 2024 for treating early Alzheimer's, including individuals with MCI or mild dementia due to Alzheimer's. Administered via intravenous infusion, the drug specifically targets amyloid plaques, aiming to slow disease progression. KISUNLA initially received US FDA BTD in 2021, highlighting its potential to address unmet needs in MCI.
The treatment landscape for MCI presents a notable gap, underscoring a critical need for innovative therapeutic approaches. Existing therapies primarily focus on alleviating symptoms rather than targeting the root causes, highlighting the demand for more specific and effective treatments. Advancing new therapies is crucial for enhancing patient outcomes and offering sustainable management solutions for individuals impacted by MCI. This urgency is reflected in the strong pipeline of MCI's therapies and the competition among various companies to bring their products to market.
Ongoing drug development efforts are focusing on novel therapeutic targets and disease-modifying treatments to help maintain cognitive function. Additionally, digital health technologies, including mobile apps and wearable devices, present possibilities for remote monitoring and tailored interventions in MCI care. Collaborative efforts among academia, industry, and regulatory bodies are essential to push research forward, foster innovation, and apply scientific discoveries to clinical practice.
To know more about mild cognitive impairment treatment guidelines, visit @ Mild Cognitive Impairment Management
Mild Cognitive Impairment Pipeline Therapies and Key Companies
-- Valiltramiprosate (ALZ-801): Alzheon
-- Mirodenafil (AR1001): AriBio
-- Remternetug (LY3372993): Eli Lilly
-- Semaglutide (NN6535): Novo Nordisk
-- Levetiracetam (AGB101): AgeneBio
-- Blarcamesine (ANAVEX2-73): Anavex Life Sciences
-- Hydromethylthionine Mesylate (HMTM)/TRx0237: TauRx Therapeutics
-- ACI-35.030/JNJ-2056: AC Immune SA/Johnson & Johnson
Discover more about mild cognitive impairment drugs in development @ Mild Cognitive Impairment Clinical Trials
Mild Cognitive Impairment Market Dynamics
The mild cognitive impairment market dynamics are expected to change in the coming years. As the global population ages, the incidence of MCI, which often serves as a precursor to conditions like Alzheimer's disease, is on the rise, creating a greater demand for early diagnosis and intervention. Technological advancements in imaging and biomarkers are improving diagnostic accuracy, enabling healthcare providers to detect MCI at earlier stages.
Additionally, increasing awareness of MCI and its potential progression to more severe cognitive disorders is driving the adoption of treatments aimed at slowing its progression. Research and development in pharmacological therapies, coupled with a focus on personalized medicine, are also fueling market growth. Lastly, government initiatives and funding for research on cognitive disorders and dementia are further contributing to the expansion of the MCI market.
Furthermore, potential therapies are being investigated for the treatment of mild cognitive impairment, and it is safe to predict that the treatment space will significantly impact the mild cognitive impairment market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the mild cognitive impairment market in the 7MM.
However, several factors may impede the growth of the mild cognitive impairment market. One of the key challenges is the difficulty in early diagnosis and differentiation between MCI and other neurodegenerative conditions, such as Alzheimer's disease, which can delay treatment and intervention. Additionally, there is a lack of standardized diagnostic criteria and biomarkers, making it harder for healthcare providers to accurately identify and manage MCI.
The mild cognitive impairment market is also constrained by limited treatment options, with most interventions focusing on symptom management rather than disease modification. This creates a gap in patient expectations and a lack of physician confidence in available therapies. Furthermore, reimbursement issues and the high costs of innovative treatments add financial pressures, limiting patient access to care. Lastly, stigma and awareness issues surrounding cognitive decline can result in patients being reluctant to seek early medical attention, further complicating the market landscape.
These barriers highlight the need for improved diagnostic tools, targeted therapies, and broader patient education to advance the MCI market.
Mild Cognitive Impairment Market Report Metrics
Details
Study Period
2020-2034
Coverage 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Mild Cognitive Impairment Market CAGR 11.6 %
Mild Cognitive Impairment Market Size in 2023
USD 2.8 Billion
Key Mild Cognitive Impairment Companies Alzheon, AriBio, Eli Lilly, Novo Nordisk, AgeneBio, Anavex Life Sciences, TauRx Therapeutics, Araclon
Biotech, AC Immune, Johnson & Johnson, and others
Key Pipeline Mild Cognitive Impairment Therapies Valiltramiprosate (ALZ-801), Mirodenafil (AR1001), Remternetug (LY3372993), Semaglutide (NN6535),
Levetiracetam (AGB101), Blarcamesine (ANAVEX2-73), Hydromethylthionine Mesylate (HMTM)/TRx0237,
ABvac40, ACI-35.030/JNJ-2056, and others
Scope of the Mild Cognitive Impairment Market Report
-- Therapeutic Assessment: Mild Cognitive Impairment current marketed and
emerging therapies
-- Mild Cognitive Impairment Market Dynamics: Key Market Forecast
Assumptions of Emerging Mild Cognitive Impairment Drugs and Market
Outlook
-- Competitive Intelligence Analysis: SWOT analysis and Market entry
strategies
-- Unmet Needs, KOL's views, Analyst's views, Mild Cognitive Impairment
Market Access and Reimbursement
Download the report to understand which factors are driving mild cognitive impairment market trends @ Mild Cognitive Impairment Market Trends
Table of Contents
1
Key Insights
2
Report Introduction
3
Mild Cognitive Impairment (MCI) Market Overview at a Glance
3.1
Market Share (%) Distribution of Mild Cognitive Impairment (MCI) in 2020
3.2
Market Share (%) Distribution of Mild Cognitive Impairment (MCI) in 2034
4
Methodology of Mild Cognitive Impairment (MCI) Epidemiology and Market
5
Executive Summary
6
Key Events
7
Disease Background and Overview
7.1
Introduction to Mild Cognitive Impairment (MCI)
7.2
Classification of MCI
7.3
Signs and Symptoms
7.4
Risk Factors
7.5
Pathophysiology
7.6
Diagnosis
7.6.1
Diagnostic Algorithm
7.6.2
Diagnostic Guidelines
7.6.2.1
Practice Guideline Update Summary: MCI by American Academy of Neurology
7.6.2.2
MCI: The Manchester Consensus
7.6.2.3 German Society of Neurology Guidelines for the Diagnosis and Treatment of Cognitive Impairment and Affective Disorders in
People with Parkinson's Disease: New Spotlights on Diagnostic Procedures and Non-Pharmacological Interventions
7.6.2.4
The Italian Guideline "Diagnosis and treatment of Dementia and MCI"
7.6.2.5
The Japanese MCI Screen for Early Detection of Alzheimer's Disease and Related Disorders
7.7
Treatment and Management
7.7.1.1
Pharmacologic Treatments for MCI
7.7.1.2
Non-Pharmacologic Interventions
7.7.1.3
Lifestyle Modifications for MCI
7.7.2
Treatment Algorithm
7.7.3
Treatment Guidelines
7.7.3.1
American Academy of Neurology (AAN) Guideline on Mild Cognitive Impairment (MCI)
7.7.3.2
British Association for Psychopharmacology (BAP) 2006 Guideline
8
Patient Journey
9
Epidemiology and Patient Population
9.1
Key Findings
9.2
Assumptions and Rationale: 7MM
9.2.1
Diagnosed prevalent cases of Parkinson's Disease
9.2.2
Diagnosed Prevalent Cases of Alzheimer's Disease
9.2.3
Diagnosed Prevalent Cases of MCI
9.2.3.1
Diagnosed Prevalent Cases of MCI due to Parkinson's Disease
9.2.3.2
Diagnosed Prevalent Cases of MCI due to Alzheimer's Disease
9.3
Total Diagnosed Prevalent Cases of MCI in the 7MM
9.4
The United States
9.4.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in the US
9.4.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in the US
9.4.3
Total Diagnosed Prevalent Cases of MCI in the US
9.5
EU4 and the UK
9.5.1
Germany
9.5.1.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in Germany
9.5.1.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in Germany
9.5.1.3
Total Diagnosed Prevalent Cases of MCI in Germany
9.5.2
France
9.5.2.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in France
9.5.2.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in France
9.5.2.3
Total Diagnosed Prevalent Cases of MCI in France
9.5.3
Italy
9.5.3.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in Italy
9.5.3.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in Italy
9.5.3.3
Total Diagnosed Prevalent Cases of MCI in Italy
9.5.4
Spain
9.5.4.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in Spain
9.5.4.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in Spain
9.5.4.3
Total Diagnosed Prevalent Cases of MCI in Spain
9.5.5.
The UK
9.5.5.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in the UK
9.5.5.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in the UK
9.5.5.3
Total Diagnosed Prevalent Cases of MCI in the UK
9.6
Japan
9.6.1
Total Diagnosed Prevalent Cases of Parkinson's Disease in Japan
9.6.2
Total Diagnosed Prevalent Cases of Alzheimer's Disease in Japan
9.6.3
Total Diagnosed Prevalent Cases of MCI in Japan
10
Marketed Drugs
10.1
Key Cross Competition of Marketed Drugs
10.2
LEQEMBI (lecanemab): Biogen Inc./Eisai Co., Ltd.
10.2.1
Product Description
10.2.2
Regulatory Milestones
10.2.3
Other Developmental Activities
10.2.4
Clinical Trials Information
10.2.5
Safety and Efficacy
10.3
KISUNLA (Donanemab): Eli Lilly and Company
10.3.1
Product Description
10.3.2
Regulatory Milestones
10.3.3
Other Developmental Activities
10.3.4
Clinical Trials Information
10.3.5
Safety and Efficacy
11
Emerging Drug Profiles
11.1
Key Cross Competition of Emerging Drugs
11.2
Valiltramiprosate (ALZ-801): Alzheon Inc.
11.2.1
Product Description
11.2.2
Other Developmental Activities
11.2.3
Clinical Trials Information
11.2.4
Safety and Efficacy
11.2.5
Analyst Views
11.3
Mirodenafil (AR1001): AriBio Co., Ltd.
11.3.1
Product Description
11.3.2
Other Developmental Activities
11.3.3
Clinical Trials Information
11.3.4
Safety and Efficacy
11.3.5
Analyst Views
11.4
Remternetug (LY3372993): Eli Lilly
11.4.1
Product Description
11.4.2
Clinical Trial Information
11.4.3
Safety and Efficacy
11.4.4
Analyst Views
11.5
Semaglutide (NN6535): Novo Nordisk
11.5.1
Product Description
11.5.2
Clinical Trial Information
11.5.3
Safety and Efficacy
11.5.4
Analyst Views
11.6
Levetiracetam (AGB101): AgeneBio, Inc.
11.6.1
Product Description
11.6.2
Other Developmental Activities
11.6.3
Clinical Trials Information
11.6.4
Safety and Efficacy
11.6.5
Analyst Views
11.7
Blarcamesine (ANAVEX2-73): Anavex Life Sciences Corp.
11.7.1
Product Description
11.7.2
Other Developmental Activities
11.7.3
Clinical Trials Information
11.7.4
Safety and Efficacy
11.7.5
Analyst Views
11.8
Hydromethylthionine Mesylate (HMTM)/TRx0237: TauRx Therapeutics
11.8.1
Product Description
11.8.2
Other Developmental Activity
11.8.3
Clinical Trials Information
11.8.4
Safety and Efficacy
11.8.5
Analyst's Views
11.9
ABvac40: Araclon Biotech S.L.
11.9.1
Product Description
11.9.2
Other Development Activities
11.9.3
Clinical Trials Information
11.9.4
Safety and Efficacy
11.9.5
Analyst Views
11.10
ACI-35.030/JNJ-2056: AC Immune SA/Johnson & Johnson
11.10.1
Product Description
11.10.2
Other Developmental Activities
11.10.3
Clinical Trials Information
11.10.4
Safety and Efficacy
11.10.5
Analysts' Views
12
Mild Cognitive Impairment (MCI): Market Analysis
12.1
Key Findings
12.2
Key Market Forecast Assumptions
12.3
Market Outlook
12.4
Conjoint Analysis
12.5
Total Market Size of MCI in the 7MM
12.6
Market Size of MCI by Therapies in the 7MM
12.7
Market Size of MCI in the United States
12.7.1
Total Market Size of MCI
12.7.2
Market Size of MCI by Therapies in the United States
12.8
Market Size of MCI in EU4 and the UK
12.8.1
Market Size of MCI in Germany
12.8.1.1
Total Market Size of MCI
12.8.1.2
Market Size of MCI by Therapies in Germany
12.8.2
Market Size of MCI in France
12.8.2.1
Total Market Size of MCI
12.8.2.2
Market Size of MCI by Therapies in France
12.8.3
Market Size of MCI in Italy
12.8.3.1
Total Market Size of MCI
12.8.3.2
Market Size of MCI by Therapies in Italy
12.8.4
Market Size of MCI in Spain
12.8.4.1
Total Market Size of MCI
12.8.4.2
Market Size of MCI by Therapies in Spain
12.8.5
Market Size of MCI in the UK
12.8.5.1
Total Market Size of MCI
12.8.5.2
Market Size of MCI by Therapies in the UK
12.9
Market Size of MCI in Japan
12.9.1
Total Market Size of MCI
12.9.2
Market Size of MCI by Therapies in Japan
13
Key Opinion Leaders' Views
14
SWOT Analysis
15
Unmet Needs
16
Market Access and Reimbursement
16.1
The United States
16.1.1
Center for Medicare and Medicaid Services (CMS)
16.2
In EU4 and the UK
16.2.1
Germany
16.2.2
France
16.2.3
Italy
16.2.4
Spain
16.2.5
The United Kingdom
16.3
Japan
16.3.1
MHLW
17
Appendix
17.1
Bibliography
17.2
Acronyms and Abbreviations
17.3
Report Methodology
18
DelveInsight Capabilities
19
Disclaimer
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