Alzheimer's Disease

Alzheimer's Disease Market Redefinition: Where Approaches Meet Achievement

"Revolutionizing the market growth for Alzheimer's disease using data-driven analysis."

Alzheimer? How do we turn it into a distant memory? Let’s deep dive into the field of Alzheimer’s Disease diagnosis and therapy analysed by DiseaseLandscape Insights, where new advancements and technologies are reshaping the business environment.

Alzheimer's disease is one of the most detrimental brain disorders which is poorly treated and under-recognized, and it is becoming a serious public health issue. The most common cause of dementia is Alzheimer’s Disease, and it affects around 50 million individuals worldwide and cases are rising to 5 million per year. According to NIH, around 60 to 80% cases of dementia are due to Alzheimer’s Disease and about 5 to 10% of people with dementia face vascular dementia.

In Latin America and Western Europe, predominance of Alzheimer's Disease is 4.6%, followed by China and the Western Pacific with 4.0%, while 1.6% cases of Alzheimer's Disease. Moreover, death cases due to Alzheimer’s Disease are increasing worldwide due to change in lifestyle and less early detection cases. Below graph shows the region wise death cases of Alzheimer’s disease. 

Representation of Alzheimer’s Disease Death Rate Worldwide

As shown above, countries like Japan and Middle East & North Africa measure highest death cases which count to 28% and 25%, respectively, followed by East Asia & Pacific, Western Pacific and China which account for 24%, 24% and 23% of death ratio, respectively. Comparatively, South Asia and India have shown less cases compared to other countries which is 18%. However, in the US Official death certificates reported were 1,21,499 making Alzheimer's the sixthleading cause of death.

Alzheimer’s Disease also known as Sporadic Alzheimer’s Disease as it most frequently affects the people over the age of 65. Also, at least one APOE4 allele is present in 40 to 80% of people with sporadic Alzheimer’s Disease.

Additionally, as per DLI studies, up to 10% of familial Alzheimer’s Disease, a mostly rare hereditary illness, are early-onset cases that affect adults in their 30s to mid-60s due to mutations in genes. Those include presenilin’s PSEN1 and PSEN2, the amyloid-beta precursor protein gene and tau protein abnormalities.

There are several risk elements known to raise the chances of getting Alzheimer’s Disease. According to the CDC reports, following are the risk factors for Alzheimer’s Disease.

As shown in the above pie chart, high blood pressure is the major risk factor for Alzheimer’s Disease which accounts for 32% followed by obesity, diabetes and depression which constitute 22%, 12% and 11%, respectively. The least contributing factors include cigarette smoking, hearing loss, and binge drinking which measures 9%, 7% and 7%, respectively.

An innovation in the diagnostic and treatment field has been considered as an essential part of increasing the opportunities on a worldwide scale for the market players.

DiseaseLandscape Insights here aids in making educated decisions in the field of medical technology, therapies, and diagnostics, where diverse technologies and spectacular developments will modify the landscape, resulting in greater growth.

Alzheimer’s Disease is growing worldwide, causing a drastic shift in individual outcomes and quality of life. Changing the current circumstances of Alzheimer’s Disease would thus push the companies in the right direction and impart new prospects for a variety of market participants in the domain of Disease Landscape.

DiseaseLandscape Insights is ready to facilitate the strategic decisions in the Diagnostic, Treatment, and Medical Device Landscapes.

Alzheimer’s Disease Diagnostic Analysis: -

"Diagnostic Revolution in Alzheimer's Disease: Optimizing Individuals' Health"

Diagnosis of Alzheimer’s is challenging but desirable. Unfortunately, there is no single test that can definitively diagnose Alzheimer’s Disease.  It can be diagnosed once all other possible causes of the symptoms have been ruled out. A diagnosis is made by complying with an in-depth assessment which includes:

1. Clinical diagnosis

   - This diagnosis includes a medical history and physical examination, blood, and urine tests, along with cognitive tests, medical imaging, and cerebrospinal fluid analysis. Clinical diagnosis yielded sensitivity for Alzheimer’s Disease varying from 70.9 to 82.7% and specificity from 54.5 to 70.8% when compared to autopsy. At autopsy, 17% of patients who clinically showed Alzheimer's disease did not exhibit dementia-related pathology.

• Medical History and Physical Examination-

  Medical history and physical examinations reveal the health conditions that are source of dementia symptoms in the patients. Observations on behaviour and family history can also help in diagnosing the symptoms of Alzheimer’s Disease.

• Blood and Urine Tests-

  The blood and urine tests are considered to be a significant aspect to evaluate and diagnose Alzheimer's disease which include complete blood count (CBC), complete metabolic panel (CMP), and B12. Blood tests are performed to check the accumulation of plaques of amyloid beta proteins. Studies have proven, these tests show 97% specificity and 91% sensitivity.

• Cognitive Tests-

  Memory, reasoning, and basic problem-solving skills are assessed using cognitive, functional, and behavioural tests, which can also be used to quickly gauge changes in behaviour and symptoms.

2. Medical Imaging-

• Structural Imaging-

  This test includes magnetic resonance imaging and computed tomography. These examinations are largely performed to rule out other illnesses that might be present with symptoms like Alzheimer's but need different therapies.

• Brain Imaging -

  Brain imaging technologies are used to determine whether the individual has high levels of beta-amyloid, a characteristic of Alzheimer's. Amyloid PET and tau PET, fMRI, and SPECT functional brain imaging techniques are being utilized to map alterations in the dysfunction of smaller brain areas in the medial temporal and parietal lobes.

• PET Amyloid Imaging

  - By 16–78%, PET amyloid imaging boosts clinician confidence in diagnosis. This technique is designed to make an early diagnosis of Alzheimer’s Disease and has 100% sensitivity and 82% specificity.

• Cerebrospinal Fluid Analysis -

  According to research, the early stages of Alzheimer’s Disease may produce changes in CSF levels of numerous indicators such as tau and beta-amyloid, two markers that create abnormal brain tangles that are closely related to Alzheimer's.

3. Brain Biopsy-

   The only absolute diagnostic test is a brain biopsy, which is rarely acquired in practice. The side effect associated with brain biopsy is haemorrhage.

Diagnostic tests are frequently carried out in public or private laboratories that are equipped with the appropriate and occasionally pricey equipment. The market for Alzheimer's diagnostics is extremely crowded and has many major players with a global presence.

The below table provides names of the market competitors who are transforming healthcare with their advanced diagnostic breakthroughs globally:

Alzheimer’s Disease Treatment Analysis: -

The number of cases of Alzheimer’s disease is increasing promptly. This has generated an immense surge in research for finding novel drugs to treat the disease. Despite all scientific efforts, there are currently no effective treatments available for Alzheimer’s but have some alternative therapy to prevent and minimize the symptoms of the disease. Following are the temporary medications given to patients:

1. Medications that temporarily reduce the disease's symptoms

• Anti-amyloid Treatments

  - It helps in removing the beta-amyloid protein accumulated in the brain. Amyloid-related imaging abnormalities (ARIA), infusion-related reactions, headaches, and falls are some of the side effects of this treatment. It includes-

• Aducanumab-

  It is an anti-amyloid antibody given monthly through intravenous to the patient diagnosed with elevated beta-amyloid in the brain. It is approved by the FDA in June 2021. Roughly 100 patients got the medication by September 2021.

• Lecanemab-

  It is an anti-amyloid antibody given to the patient diagnosed with elevated beta-amyloid in the brain every two weeks through intravenous. It is approved by the FDA in 2023. It helps to slow the cognitive decline by 27% in phase III clinical trials.

2. Medications that slowdown the Alzheimer’s Disease's progression

These drugs are used to treat symptoms of memory and thinking. While these medications cannot reverse the damage done to brain cells by Alzheimer's, they may help to alleviate or stabilize symptoms for a brief time by influencing molecules involved in the exchange of signals between brain nerve cells.

Cholinesterase inhibitors and glutamate regulators are the medications currently licensed to treat cognitive problems.

3. Drugs for the treatment of non-cognitive symptoms

Non-cognitive symptoms include sleep changes and agitation. Before adding drugs, it is important to consider non-drug techniques to manage non-cognitive symptoms.

• Suvorexant

  It blocks the activity of chemical messenger required in the sleep-wake cycle. Suvorexant was the first drug authorized by the FDA for the treatment of sleep problems in Alzheimer’s Disease in February 2020.

• Brexpiprazole

  It is the only FDA-approved atypical antipsychotic drug available in the market for the treatment of agitation due to dementia.

• Serotonin reuptake inhibitors-

  (SSRIs: fluoxetine, sertraline, paroxetine, citalopram, fluvoxamine) are widely regarded as the most effective antidepressants for the treatment of comorbid depression in Alzheimer’s Disease dementia stated by NIH.

New Therapies in Development-

Immunotherapy-

Most pharmaceutical companies are researching both active immunization and passive immunization as a strategy for the treatment of Alzheimer’s Disease. Because of the prevalence of encephalitis, new vaccines are in development.  

In addition, preclinical data from mouse studies suggest that innovative immunotherapeutic approaches such as DNA epitope vaccines, antibodies against the -secretase cleavage site of the APP, and mucosal immunization could be used as safe and effective ways for Alzheimer’s Disease therapy.

To explore and grow in the treatment field, market players can choose the market research and consulting services of DiseaseLandscape Insights. We guide you to stay stronger and ahead of the competition through our detailed analysis of treatment options, new products, and technologies. DLI offers extensive support in arranging, carrying out, and evaluating clinical studies for new drug development.

The global Alzheimer’s Disease market is highly competitive and owing a large market player with a global presence. The below table gives information on drug names, the drug indicated, and the common side effects of the drug.

Services Offered for the Patients Suffering from Alzheimer’s Disease

The business element of Alzheimer's disease focuses on a variety of services and goods, ranging from management and prevention to further therapy and research. The following are the services provided to begin the process of removing the epidemic.

• To stop the spread of Alzheimer's disease, the Indian government is offering a wide range of healthcare services. For doctors and caretaker staff in Indian Country, IHS began Project ECHO (Extension for Community Healthcare Outcomes) in 2021 in collaboration with the Northwest Portland Area Indian Health Board (NPAIHB).
• To make people aware of Alzheimer’s Disease, various organizations have been developed. “Addressing Dementia in Indian Country: Models of Care” is published by IHS in 2022, to announce the availability of $5 million to target resources directly to tribes, to combat AD/ADRD inside tribal areas, Tribal organizations, and IHS direct service facilities.

Regulatory Framework for Alzheimer’s Disease

"Protecting Public Health: Building a Stable Regulatory Framework for Alzheimer's Disease"

DiseaseLandscape Insights has significantly simplified the regulatory structure for key players who have a presence in Alzheimer’s Disease Landscape. DLI helps the stakeholder to understand the import/export laws, surveillance, and regulatory design of different countries. Key players can adequately mitigate, handle and respond to the epidemics of Alzheimer’s Disease by considering the well-being of the affected population.

However, ongoing regulatory approvals and EUAs encourage the development of markets. The Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for treating Alzheimer’s Disease under its accelerated approval program on June 7th, 2021. Aducanumab is the first suspected disease-modifying drug (DMT) licensed for the treatment of Alzheimer’s Disease, with a high clinical benefit potential compared to current symptomatic treatments.

In addition, the Peripheral and Central Nervous System Drugs Advisory Committee announced the use of LEQEMBI (lecanemab) solution for intravenous infusion to treat Alzheimer’s Disease on June 9, 2023. Lecanemab, a monoclonal antibody that targets amyloid plaques for the treatment of Alzheimer's, was created by American biopharmaceutical Biogen and Japanese pharmaceutical Eisai. It is approved by The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) to treat early-stage Alzheimer's.

Competitive Analysis

"Emancipating Economic Opportunities: Study the Competitive Landscape of the Alzheimer's Disease Market."

Major worldwide competitors have been working on launching new techniques for detection and novel products for the treatment of AD to boost their competitive edge. In addition, they are expanding their networks through various collaborations and extending their range of the products in the market.

Moreover, a key player Coya Therapeutics (US), is creating a COYA 301, which is an interleukin 2 (IL2) therapy, to treat mild to moderate Alzheimer’s Disease by increasing the body’s Treg cell function. According to Coya Therapeutics, increasing the number of Treg cells halt an inflammatory cascade and hence improves the disease.

Along with Coya Therapeutics, competitors like Rensselaer Polytechnic Institute in New York have studied the interactions between apolipoprotein E (ApoE) with heparan sulfate (HS). They also constructed a 3D structural model of ApoE-HS and evaluated their interaction in cell cultures and animal models to understand the therapeutic target of Alzheimer’s Disease.  

Moreover, for discovering new drugs, BenevolentAI and the partners AstraZeneca and Novartis have developed the Al platform to treat Alzheimer’s Disease.

Research and developments of the competitors have increased the awareness of disease and the therapy product in the public. These achievements also increased the overall revenue of the companies along with various collaborations.    

Market Trends Analysis

"Utilize the Changing Patterns of the Alzheimer's Disease Market to Ensure Long-Term Success."

The market is expanding because of the development of various drugs for the treatment of Alzheimer’s Disease; however, the disease cannot be completely cured. In-depth research is required to come up with a complete curative medicine for Alzheimer’s Disease. Market players have various opportunities in the diagnostic as well as treatment fields. Research on monoclonal antibodies and immunotherapy helps the market player to grow globally.

To promote patient health and as part of the National Plan to Address Alzheimer’s Disease, the NIA increased its efforts to identify realistic, proactive measures to assist researchers in recruiting and retaining diverse volunteers for an increasing number of Alzheimer's and related dementia clinical studies. These plans helped the market players to expand their business across the globe.

The National Institute on Aging (NIA) promotes 33 Alzheimer’s Disease Research Centres (ADRCs) by providing funds to major medical institutions across the country. These centres’ researchers are aiming to transform research advancements into better diagnosis and care for people with Alzheimer’s Disease, as well as to develop therapy or a strategy to prevent Alzheimer's. Increased research has given tremendous output for the keyholders to grow.

Furthermore, the usage of the LEQEMBI (lecanemab) solution as an off-label product for the treatment of Alzheimer’s Disease and rising R&D spending are further factors that are projected to boost the global market.

However, a slew of AI technologies is transforming practically every stage of the new Alzheimer's drugs process, with significant potential to reshape the industry's pace and cost.

Clinical Data Assessment:

The increasing emphasis on comparative effectiveness the government emphasizes the importance of clinical trials in the practice of evidence-based medicine and healthcare reform. Clinical data helps the market players to properly compare medical therapy and achieve one of the primaries aims in healthcare reform.

The study titles of the currently active clinical trials, as well as the phases in which they are being conducted, are included in the table below.

Why DLI-

DiseaseLandscape Insights guides the industry players to develop new products and techniques for management and detection of Alzheimer’s Disease epidemics. Moreover, due to greater understanding of disease dynamics, there is a growing demand for diagnostic tools, novel treatments like immunotherapy, and clinical assessment. 

Services offered by DLI help the market players to carry out clinical trials for novel medications and therapies easily. Also, it supports in patient recruitment, regulatory compliance, and other activities. DLI also provides detailed information about market competitors, growth of market and new regulations and rules across the globe to industry players. DLI assists all market participants in gaining a stronger foothold in the Alzheimer’s Disease sector.