Blood-Based Testing in Neurodegenerative Diseases Competitive Intelligence Report

We conducted an in-depth analysis of current and expected future use of testing across 47 clinicians, spanning Primary Care, Neurologists, and Geriatricians. 

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Survey Findings

• What percentage (%) of your pre-diagnosis patient population presenting with concerns related to cognitive impairment or suspected neurodegenerative disease (e.g., Alzheimer's, Parkinson's, FTD, ALS, MS) did you order a blood-based biomarker test for over the past 12 months?
• Within the blood-based biomarker tests you ordered over the past 12 months for pre-diagnosis patients presenting with concerns related to cognitive impairment or suspected neurodegenerative disease, what percentage (%) of tests were ordered for each of the following diseases: AD, PD, FTD, ALS, MS, other
• What percentage (%) of your post-diagnosis patient population presenting with cognitive impairment or neurodegenerative disease (e.g., Alzheimer's, Parkinson's, FTD, ALS, MS) did you order a blood-based biomarker test for over the past 12 months?
• Within the blood-based biomarker tests you ordered over the past 12 months for post-diagnosis patients presenting with cognitive impairment or neurodegenerative disease, what percentage (%) of tests were ordered for each of the following diseases: AD, PD, FTD, ALS, MS, other?

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Alzheimer’s Disease

• How familiar are you with each of the following blood-based biomarkers for Alzheimer's? 
• In the past 12 months, how many blood-based biomarker tests have you ordered to aid in the assessment or diagnosis of Alzheimer's Disease?
• What share (%) of your testing in the past 12 months consisted of the following blood-based AD biomarker tests?
• What is your familiarity with each of the following vendors regarding their blood-based Alzheimer's biomarker tests?
• What share (%) of your blood-based Alzheimer's biomarker testing was performed using each of the following vendors over the past 12 months? 
• For what primary purpose(s) have you ordered, or would you consider ordering, blood-based AD biomarker tests? 
• In your opinion, what is the clinical utility of currently available blood-based AD biomarker tests?

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Multiple Sclerosis

• How familiar are you with blood-based biomarkers for Multiple Sclerosis (MS)?
• In the past 12 months, how many blood-based biomarker tests have you ordered to aid in the assessment or diagnosis of MS?
• What share (%) of your testing in the past 12 months consisted of the following blood-based MS biomarker tests? 
• What is your familiarity with each of the following vendors regarding their blood-based Multiple Sclerosis biomarker tests?
• For what primary purpose(s) do you typically order these blood-based biomarkers for MS? 

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Parkinson’s Disease

• How familiar are you with blood-based biomarkers for Parkinson's Disease or other synucleinopathies?
• In the past 12 months, how many blood-based biomarker tests have you ordered to aid in the assessment or diagnosis of PD / synucleinopathies?
• What share (%) of your testing in the past 12 months consisted of the following blood-based PD / synucleinopathy biomarker tests?
• What is your familiarity with each of the following vendors regarding their blood-based PD / synucleinopathy biomarker tests?
• What share (%) of your blood-based biomarker testing for PD / synucleinopathies was performed using each of the following vendors over the past 12 months?
• For what primary purpose(s) do you typically order these blood-based biomarkers for PD/synucleinopathies? 

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Frontotemporal Dementia

• How familiar are you with blood-based biomarkers for frontotemporal dementia (FTD)?
• In the past 12 months, how many blood-based biomarker tests have you ordered to aid in the assessment or diagnosis of FTD?
• What share (%) of your testing in the past 12 months consisted of the following blood-based FTD biomarker tests?
• What is your familiarity with each of the following vendors regarding their blood-based FTD biomarker tests?
• What share (%) of your blood-based biomarker testing for FTD was performed using each of the following vendors over the past 12 months?
• For what primary purpose(s) do you typically order these blood-based biomarkers for FTD? 

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Amyotrophic Lateral Sclerosis

• How familiar are you with blood-based biomarkers for Amyotrophic Lateral Sclerosis (ALS)?
• In the past 12 months, how many blood-based biomarker tests have you ordered to aid in the assessment or diagnosis of ALS?
• What share (%) of your testing in the past 12 months consisted of the following blood-based ALS biomarker tests?
• What is your familiarity with each of the following vendors regarding their blood-based ALS biomarker tests?
• What share (%) of your blood-based biomarker testing for ALS was performed using each of the following vendors over the past 12 months?
• For what primary purpose(s) do you typically order these blood-based biomarkers for ALS? 

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Future Testing

• How likely are you to increase your use of blood-based neurodegenerative disease biomarkers in your practice over the next 12 months?
• For which indications do you expect to increase your use of blood-based biomarker testing over the next 12 months?
• What do you perceive as the biggest barriers to wider adoption of blood-based biomarkers for neurological diseases in clinical practice today?

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We conducted an in-depth analysis of current and expected future use of testing across 20 biopharma stakeholders (large and small)

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Survey Findings

• How many blood-based biomarker tests did your organization run in 2024 and how many do you expect to run in 2025 within your company's neurodegenerative disease portfolio across basic/discovery research, translational research and clinical trials?
• Of the blood-based biomarker tests run within your company's neurodegenerative disease portfolio, what percent (%) will be used for the following phases of R&D?
• What percent (%) of your company's blood-based biomarker testing was performed across the following neurodegenerative diseases?
• What percent (%) of your company's blood-based neurodegenerative disease biomarker testing assessed the following analytes?
• What percent (%) of your company's blood-based neurodegenerative disease biomarker testing utilized the following modalities/technology types?
• What is your familiarity with each of the following vendors regarding their blood-based neurodegenerative disease biomarker tests?
• Overall, how would you characterize your organization's current level of integration of blood-based biomarker testing into its neurodegenerative disease clinical trial programs?
• Please indicate the extent to which blood-based biomarker testing is utilized for neurodegenerative diseases.
• How impactful is the data derived from blood-based biomarkers on key go/no-go decisions for your company's neurodegenerative drug candidates at various stages of development?

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Biomarker Applications

• For what primary purposes are blood-based biomarkers currently being used in your neurodegenerative disease clinical trials? 
• Which specific blood-based biomarkers are currently incorporated into your company's neurodegenerative clinical trials?
• For each selected biomarker, please specify the primary disease focus (e.g., AD, PD, MS, ALS, FTD, etc.).
• How would you rate your organization's current confidence in the clinical utility and actionability of the following established blood-based biomarkers for neurological diseases?
• What are the key criteria your organization uses when selecting a laboratory vendor for blood-based biomarker analysis in clinical trials? 

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Companion Diagnostics

• Is your organization actively developing or planning to develop companion diagnostics (CDx) based on blood-based biomarkers for any of your neurodegenerative disease drug candidates?
• For which therapeutic areas/mechanisms of action is CDx development being prioritized? 
• What is your company's preferred model for developing CDx assays for neurodegenerative disease blood-based biomarkers?
• What are the key regulatory challenges your organization perceives or has experienced in the development of neurodegenerative disease drugs and blood-based CDx's? 
• What are the key reimbursement challenges your organization anticipates or has experienced for blood-based CDx in neurodegenerative diseases in major markets (e.g., US, EU5)?
• What is your organization's general perception of the typical timeline from initiating development of a novel blood-based neurodegenerative disease CDx to achieving market authorization (e.g., FDA approval/clearance)?

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Future Outlook

• Looking ahead 5 years, which emerging blood-based biomarker analyte types do you believe hold the most promise for advancing neurodegenerative disease drug development?
• Looking ahead 5 years, which emerging blood-based biomarker technology types do you believe hold the most promise for advancing neurodegenerative disease drug development?
• What is the current trend regarding your organization's investment (financial and human resources) in novel neurodegenerative disease blood-based biomarker discovery and validation efforts?
• To what extent does your organization rely on internal capabilities versus external collaborations/partnerships for novel neurological biomarker discovery and validation?
• Beyond Alzheimer's Disease, in which other neurodegenerative disease areas do you see the next significant opportunity for impactful blood-based biomarker development and integration into drug trials? 
• How significantly do you expect the availability of robust, validated blood-based biomarkers to accelerate the overall timeline for neurological drug development in the next 5-10 years?
• What is the biggest unmet need or scientific/technical hurdle your organization faces in discovering, validating, and implementing novel blood-based biomarkers for neurological diseases?

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