The evolving Alzheimer’s landscape: Unmet needs and implications for pharma and biotech
Yasasvi Popuri and Howard Deutsch
According to the Alzheimer’s Association, an estimated 6.9 million Americans aged 65 and older are living with Alzheimer’s dementia as of 2023. This number is projected to grow to 13.8 million by 2060 as the population ages in the absence of breakthrough treatments that could slow or cure Alzheimer’s disease. It is also estimated that an additional 5–7 million Americans aged 65 and older are living with mild cognitive impairment (MCI) due to Alzheimer’s as of 2023. Individuals with MCI have an increased risk of progressing to Alzheimer’s or another type of dementia over time.
These conditions not only impact the lives of those diagnosed, but also place a significant burden on their families, caregivers, and the healthcare system at large. The Alzheimer’s Association estimates that over 11 million family members have provided over 18 billion hours of unpaid care to patients with Alzheimer’s dementia in 2023, valued at a staggering $347 billion. As the population continues to age, addressing the growing Alzheimer’s and MCI cases remains a critical public health priority in the United States.
The treatment landscape: Slow but steady progress
The Alzheimer’s treatment landscape has undergone a significant transformation since the turn of the century. In the early 2000s, the focus was primarily on symptomatic treatments, with medications like cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine) and memantine providing modest improvements in cognitive and functional abilities for patients. These drugs, while helpful in managing symptoms, did not address the underlying pathology of the disease.
The past decade, however, has witnessed the emergence of disease-modifying therapies that aim to slow the progression of Alzheimer’s. In 2021, the FDA approved Aduhelm (aducanumab), the first disease-modifying drug for Alzheimer’s, which targets the amyloid-beta protein, a key hallmark of the disease. The approval, while controversial, opened the door for other drugs, most notably, Leqembi (lecanemab), which demonstrated a statistically significant, albeit modest, slowing of cognitive decline in early-stage Alzheimer’s patients. Most recently, an FDA advisory panel unanimously recommended the approval of donanemab, another disease-modifying therapy targeting the amyloid-beta protein. These developments have ignited renewed hope and investment in the development of more effective disease-modifying treatments. Additionally, novel therapeutic approaches targeting different clinical pathways, such as tau-targeted therapies and neuroinflammation modulators, have shown promising results in clinical trials, offering alternative mechanisms of action to address the complex pathophysiology of Alzheimer’s.
Alongside the advancements in pharmacological interventions, the role of digital health technologies has become increasingly prominent in the Alzheimer’s landscape. Digital biomarkers, such as those derived from smartphone-based assessments of cognitive function, have shown promise in early detection and monitoring of the disease. Additionally, digital therapeutics, including cognitive training apps and virtual reality-based interventions, are being explored as complementary tools to support patients and caregivers in managing the symptoms of Alzheimer’s. These digital innovations have the potential to revolutionize the way Alzheimer’s is diagnosed, treated, and managed, offering personalized and scalable solutions to address the diverse needs of those affected by the disease.
Persistent unmet needs
Despite the advancements in Alzheimer’s treatment, significant unmet needs persist from the patient’s perspective. The lack of effective treatments that can halt or reverse the disease course remains a major concern. Many individuals living with Alzheimer’s continue to face the devastating cognitive and functional decline, profoundly impacting their quality of life. Even treatment with currently approved amyloid-beta protein immunomodulators, only slows cognitive decline by about 20%-30%.
Caregivers, who often bear the brunt of the disease’s burden, also face persistent challenges. The emotional, physical, and financial toll of caring for a loved one with Alzheimer’s can be overwhelming, with limited support systems in place. Data from the Alzheimer’s Association suggests that almost 60% of caregivers report high stress due to the demands of caregiving. As the US population ages, the number of individuals requiring caregiver support is expected to rise, underscoring the urgent need for comprehensive caregiver resources and respite services.
The most recent Facts and Figures report by the Alzheimer’s Association indicates that nearly 85% of people with dementia were diagnosed by providers who don’t specialize in dementia, most notably, primary care physicians. The lack of reliable and accessible biomarkers for early-stage Alzheimer’s makes it difficult for primary care providers to accurately diagnose the condition, leading to delayed interventions and suboptimal patient outcomes. A survey conducted by the Alzheimer’s Association in 2019 found that nearly 40% of primary care physicians reported being never or “only sometimes” comfortable in their ability to diagnose Alzheimer’s, underscoring the need for improved diagnostic tools and training.
Neurologists and geriatricians are essential for the comprehensive management of Alzheimer’s patients. However, the shortage of specialized Alzheimer’s care providers, particularly in underserved communities, hinders timely and equitable access to care. Nearly twenty US states are projected to have as few as 10 neurologists per 10,000 dementia patients in 2025. This lack of access can lead to delayed diagnoses, fragmented care, and suboptimal treatment outcomes for Alzheimer’s patients.
As the U.S. population continues to grow and age, the shortage of Alzheimer’s specialists is projected to become increasingly acute in the years ahead. While the number of Americans living with Alzheimer’s dementia is expected to double by 2060, the ranks of practicing neurologists are anticipated to remain relatively stagnant. Given the progressive nature of this disease, longer wait times to access expert care will become intolerable. Both today’s patients and those of the future will require solutions that empower a broader population of healthcare providers to effectively diagnose and treat Alzheimer’s disease.
Direct care professionals, such as personal care aides, occupational therapists, speech-language pathologists, and social workers, play a vital role in supporting Alzheimer’s patients and their caregivers. Yet, these professions see high turnover owing to poor training and certification, job conditions and persistently low compensation. These challenges are limiting their ability to deliver the full range of interventions that could improve the quality of life for those affected by the disease.
Bridging the gaps: How pharma can elevate Alzheimer’s care
The Alzheimer’s landscape is in a state of flux, marked by both progress and persistent challenges. One of the primary unmet needs is the development of more effective disease-modifying treatments. With over 120 drugs currently in development for addressing various aspects of Alzheimer’s, this unmet need appears to be acknowledged and addressed.
Innovative approaches to early detection and diagnosis could also be a game-changer. The lack of reliable biomarkers and the heterogeneity of Alzheimer’s make accurate diagnosis a significant challenge, leading to delayed interventions and suboptimal care. Pharmaceutical companies can collaborate with diagnostic partners to integrate advanced imaging techniques, digital biomarkers, and AI technologies into the clinical workflow, enabling earlier identification of the disease and personalized treatment planning.
Addressing the needs of caregivers is another critical area where the pharmaceutical industry can make a meaningful impact. The emotional, physical, and financial toll of caregiving is immense, and the limited support systems in place often leave caregivers feeling isolated and overwhelmed. Pharmaceutical companies can leverage their expertise and resources to develop comprehensive caregiver support programs, including educational resources, respite services, and digital tools to help manage the day-to-day challenges of caring for a loved one with Alzheimer’s.
Moreover, the industry can play a pivotal role in improving access to specialized Alzheimer’s care, particularly in underserved communities. By sponsoring geriatric neurology specializations and developing certification programs, pharmaceutical companies can play an integral role in expanding the base of providers specializing in Alzheimer’s care. By partnering with healthcare providers, policymakers, and patient advocacy groups, pharmaceutical companies can help expand the reach of specialized memory clinics, train more Alzheimer’s care specialists, and ensure that all individuals affected by the disease have equitable access to the resources and support they need.
The responsibility to address the unmet needs of patients, caregivers, and healthcare providers is not just a moral imperative, but also a strategic opportunity for pharma manufacturers to cement their position as true partners in the fight against Alzheimer’s. By embracing a holistic approach that goes beyond drug development, the industry can help transform the lives of those affected by cognitive impairment and Alzheimer’s, paving the way for a future where this formidable disease is no longer a daunting challenge, but a manageable condition that allows individuals to maintain their dignity and quality of life.
