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. 2022 Mar;18(3):469-477.
doi: 10.1002/alz.12450. Epub 2021 Sep 28.

The costs of developing treatments for Alzheimer's disease: A retrospective exploration

Jeffrey L Cummings  1 , Dana P Goldman  2 , Nicholas R Simmons-Stern  3 , Eric Ponton  3
Affiliations

The costs of developing treatments for Alzheimer's disease: A retrospective exploration

Jeffrey L Cummings et al. Alzheimers Dement. 2022 Mar.

Abstract

Introduction: With the exception of the recent accelerated approval of aducanumab, in over 26 years of research and development (R&D) investment in Alzheimer's disease (AD), only five novel drugs-all for symptomatic treatment only-have reached FDA approval. Here, we estimate the costs of AD drug development during this period in the private sector.

Methods: To estimate private R&D funding, we collected information on AD clinical trials (n = 1099; phases 1-4) conducted between January 1, 1995 and June 21, 2021 from various databases. Costs were derived using previously published methodologies and adjusted for inflation.

Results: Since 1995, cumulative private expenditures on clinical stage AD R&D were estimated at $42.5 billion, with the greatest costs (57%; $24,065 million) incurred during phase 3; approximately 184,000 participants were registered or are currently enrolled in clinical trials.

Discussion: Measures to reduce expenditures while moving toward disease-modifying therapies that alleviate the rising burden of AD require continued investment from industry, government, and academia.

Keywords: Alzheimer's disease; clinical trials; funding; industry; research and development.

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Conflict of interest statement

J. L. Cummings has provided consultation to Acadia, Alkahest, Alzheon, AriBio, Avanir, Axsome, Behren Therapeutics, Biogen, Cassava, Cerecin, Cortexyme, EIP Pharma, Eisai, Foresight, GemVax, Genentech, Green Valley, Grifols, Janssen, Karuna, Merck, Novo Nordisk, Ono, Otsuka, ReMYND, Resverlogix, Roche, Signant Health, Sunovion, Suven, and United Neuroscience pharmaceutical and assessment companies. He has stock options in ADAMAS, AnnovisBio, MedAvante, and BiOasis. He owns the copyright of the Neuropsychiatric Inventory. He is supported by NIGMS grant P20GM109025, NINDS grant U01NS093334, NIA grant R01AG053798, NIA grant P20AG068053, and NIA grant R35AG71476. D. P. Goldman has received research support, speaker fees, travel assistance, or consulting income from the following sources: ACADIA Pharmaceuticals, Amgen, The Aspen Institute, Biogen, Blue Cross Blue Shield of Arizona, Bristol Myers Squibb, Cedars‐Sinai Health System, Celgene, Edwards Lifesciences, Gates Ventures, Genentech, Gilead Sciences, GRAIL, Johnson & Johnson, Kaiser Family Foundation, National Institutes of Health, Novartis, Pfizer, Precision Health Economics, Roche, and Walgreens Boots Alliance. N. Simmons‐Stern is an employee of Biogen. E. Ponton was an employee of Biogen at the time of this study.

Figures

FIGURE 1
FIGURE 1
PRISMA flowchart of trial records included in the estimates. aInitial list of agents derived from those listed on Alzforum in June of 2021. These agents included those with potential mechanisms in key areas of study in AD: amyloid pathway, tau pathway, inflammation, and neurotransmitters. Agents with mechanisms that were not pursued by larger organizations or where dollar investment may be insignificant were excluded
FIGURE 2
FIGURE 2
The collective cost of AD drug development since 1995. The graph illustrates the year‐over‐year cumulative estimated cost of drug development for agents in phases 1, 2, 3, and 4. R&D, research and development
FIGURE 3
FIGURE 3
Agents in clinical development by key disease targets. The chart summarizes the highest development phase for each agent (n) in clinical development for Alzheimer's disease, categorized by the key disease targets as defined by the Common Alzheimer's Disease and Related Dementias Ontology
FIGURE 4
FIGURE 4
Highest clinical trial phase reached for agents in clinical development for Alzheimer's disease (AD). The chart summarizes agents (n) in clinical development for AD from 1995 to 2021, categorized by the highest clinical trial phase reached for discontinued (red) and ongoing (green) agents
FIGURE 5
FIGURE 5
Drug development cost by clinical trial phase. The chart illustrates the estimated cost of AD drug development from 1995 to 2021 for agents in phases 1, 2, and 3
See this image and copyright information in PMC

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