アルツハイマー病 - 市場考察、疫学、市場予測（2032年）

主なハイライト

• アルツハイマー病の有病率は、老年人口の増加と疾患認知度の向上により、日本で増加傾向にあります。
• 認知度の向上と病態生理学の包括的な理解の進歩により、新規シグナル伝達経路が発見され、その結果、さまざまな診断ツールが開発され、疾患の診断に革命的な変化をもたらしています。
• 現在の治療法はほとんどが対症療法であり、疾患の進行を遅らせ、生活の質を改善するのに役立っています。しかし根治的なものではなく、非薬物療法と薬物療法が混在しています。
• 非薬物療法には認知刺激、身体運動、社会参加などが含まれます。介護者の支援と教育は、アルツハイマー病に関連する課題を管理するために極めて重要です。
• アルツハイマー病市場を理解する上で懸念されるのは、パイプラインが非常に充実しているにもかかわらず、gantenerumab、dabigatran、verubecestatのような潜在的な治療薬の多くが試験フェーズを通過できなかったように、失敗率が高いために市場参入の可能性を評価することが難しいことです。
• 日本では、2023年9月にBiogen/Eisai/BioArcticのアミロイドβたんぱく阻害剤LEQEMBI（lecanemab）が承認され、従来の対症療法から大きく改善され、疾患修飾療法への渇望が癒されました。これは大きな節目であり、早期アルツハイマー病患者のアンメットニーズに応えるための前向きな一歩です。これはまた、基礎となる病態を標的とする他の生物学的製剤や薬剤への道を開くものでもあります。
• 2022年、日本におけるアルツハイマー病の市場規模は約8億6,410万米ドルでした。2032年までに増加すると予測されています。

アルツハイマー病市場の見通し

• 日本のアルツハイマー病の総市場規模は、2022年に約9億1,450万米ドルであり、予測期間（2023年～2032年）に増加すると予測されています。
• 日本では2022年にコリンエステラーゼ阻害薬（donepezil、rivastigmine、Galantamine）が8億6,980万米ドル、NMDA受容体拮抗薬（memantine）が2,190万米ドルを占めています。コリンエステラーゼ阻害薬の中では、donepezilがもっともシェアが高く（全治療法の中で）、このクラスの総売上の約67％を占め、rivastigmineは2022年に6,760万米ドルを生み出しました。
• 2023年9月に厚生労働省から承認を取得したBiogenとEisaiのLEQEMBIは、予測期間に大きく成長し、2032年までに日本のアルツハイマー病市場全体の約2.8%の収益を獲得すると予測されています。
• Anavex Life SciencesのANAVEX2-73（blarcamesine）、AlzheonのALZ-801（valiltramiprosate）、Athira Pharmaのfosgonimeton（ATH-1017）、Annovis Bioのbuntanetap、Eli Lillyのdonanemab（LY3002813）、BioVieのNE3107、Cassava Sciencesのsimufilam（PTI-125）などのさまざまな治療薬があり、中でもTauRx Therapeuticsのメシル酸ヒドロメチルチオニン（TRx0237）が予測期間に市場に参入する見込みです。

当レポートでは、日本のアルツハイマー病市場について調査分析し、市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 アルツハイマー病市場の概要

• アルツハイマー病の市場シェア分布（2019年）
• アルツハイマー病の市場シェア分布（2032年）

第4章 アルツハイマー病の疫学の調査手法と市場

第5章 アルツハイマー病のエグゼクティブサマリー

第6章 主な出来事

第7章 疾患の背景と概要

• アルツハイマー病のイントロダクション
• 兆候と症状
• アルツハイマー病の分類
• 危険因子
• アルツハイマー病の重症度
• 病態生理学
• 診断
• 治療
• 治療アルゴリズム

第8章 ペイシェントジャーニー

第9章 疫学と患者数

• 主な調査結果
• 前提条件と根拠：日本
• 日本

第10章 上市済み薬品

• 主な競合
• LEQEMBI (lecanemab): Biogen/Eisai/BioArctic

第11章 新薬

• 主な競合
• ADUHELM (aducanumab): Biogen/Eisai
• NE3107: BioVie
• Masitinib (AB1010): AB Science
• Donanemab (LY3002813): Eli Lilly and Company
• Simufilam (PTI-125): Cassava Sciences
• Hydromethylthionine mesylate (HMTM)/TRx0237: TauRx Therapeutics
• Semaglutide (NN6535): Novo Nordisk
• KFRX01 (nilotinib BE): KeifeRx
• Remternetug (LY3372993): Eli Lilly
• AR1001: AriBio
• Tricaprilin (CER-0001): Cerecin
• ALZ-801 (valiltramiprosate): Alzheon
• Piromelatine (Neu-P11): Neurim Pharmaceuticals
• Fosgonimeton (ATH-1017): Athira Pharma
• Buntanetap: Annovis Bio
• ANAVEX2-73 (blarcamesine): Anavex Life Sciences
• AGB101: AgeneBio
• E2814: Eisai
• Masupirdine (SUVN-502): Suven Life Sciences

第12章 アルツハイマー病：市場の分析

• 主な調査結果
• 主な市場予測の前提条件
• 市場見通し
• コンジョイント分析
• 日本のアルツハイマー病の総市場規模
  • アルツハイマー病の総市場規模
  • アルツハイマー病の市場規模：治療法別

第13章 KOLの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場参入と償還

• 日本
  • 厚生労働省

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Market and Epidemiology (2019-2032)
• Table 2: Key Events for Alzheimer's Disease
• Table 3: DSM-5 Diagnostic Criteria for Diagnosing Alzheimer's Disease
• Table 4: IWG-2 Criteria for Alzheimer's Disease
• Table 5: Interpreting the Results Using MMSE Scoring Chart
• Table 6: Japanese Clinical Practice Guideline for Alzheimer's Disease Dementia 2017
• Table 7: Diagnosed Prevalent Cases of Alzheimer's Disease in Japan, in thousands (2019-2032)
• Table 8: Gender-specific Cases of Alzheimer's Disease in Japan, in thousands (2019-2032)
• Table 9: Age-specific Cases of Alzheimer's Disease in Japan, in thousands (2019-2032)
• Table 10: Severity-specific Cases of Alzheimer's Disease in Japan, in thousands (2019-2032)
• Table 11: Key Cross Of Marketed Drugs
• Table 12: LEQEMBI (lecanemab), Clinical Trial Description, 2023
• Table 13: Comparison of Emerging Drugs for Treatment
• Table 14: ADUHELM (aducanumab), Clinical Trial Description, 2023
• Table 15: NE3107, Clinical Trial Description, 2023
• Table 16: Masitinib, Clinical Trial Description, 2023
• Table 17: Donanemab, Clinical Trial Description, 2023
• Table 18: Simufilam (PTI-125), Clinical Trial Description, 2023
• Table 19: Hydromethylthionine mesylate (HMTM)/TRx0237 Clinical Trial Description, 2023
• Table 20: Semaglutide (NN6535), Clinical Trial Description, 2023
• Table 21: KFRX01 (nilotinib BE), Clinical Trial Description, 2023
• Table 22: Remternetug (LY3372993), Clinical Trial Description, 2023
• Table 23: AR1001, Clinical Trial Description, 2023
• Table 24: Tricaprilin (CER-0001), Clinical Trial Description, 2023
• Table 25: ALZ-801 (valiltramiprosate), Clinical Trial Description, 2023
• Table 26: Piromelatine (Neu-P11), Clinical Trial Description, 2023
• Table 27: Fosgonimeton (ATH-1017), Clinical Trial Description, 2023
• Table 28: Buntanetap, Clinical Trial Description, 2023
• Table 29: ANAVEX2-73, Clinical Trial Description, 2023
• Table 30: AGB101, Clinical Trial Description, 2023
• Table 31: E2814, Clinical Trial Description, 2023
• Table 32: Masupirdine, Clinical Trial Description, 2023
• Table 33: Key Market Forecast Assumptions for ADUHELM (aducanumab)
• Table 34: Key Market Forecast Assumptions for NE3107
• Table 35: Key Market Forecast Assumptions for Masitinib (AB1010)
• Table 36: Key Market Forecast Assumptions for Donanemab (LY3002813)
• Table 37: Key Market Forecast Assumptions for Simufilam (PTI-125)
• Table 38: Key Market Forecast Assumptions for Hydromethylthionine mesylate (TRx0237)
• Table 39: Key Market Forecast Assumptions for Semaglutide (NN6535)
• Table 40: Key Market Forecast Assumptions for KFRX01 (nilotinib BE)
• Table 41: Key Market Forecast Assumptions for Remternetug (LY3372993)
• Table 42: Key Market Forecast Assumptions for AR1001
• Table 43: Key Market Forecast Assumptions for Tricaprilin (CER-0001)
• Table 44: Key Market Forecast Assumptions for ALZ-801 (valiltramiprosate)
• Table 45: Key Market Forecast Assumptions for Piromelatine (Neu-P11)
• Table 46: Key Market Forecast Assumptions for Fosgonimeton (ATH-1017)
• Table 47: Key Market Forecast Assumptions for Buntanetap (ANVS401/posiphen)
• Table 48: Key Market Forecast Assumptions for ANAVEX2-73 (blarcamesine)
• Table 49: Key Market Forecast Assumptions for AGB101 (ER formulation of levetiracetam)
• Table 50: Key Market Forecast Assumptions for E2814
• Table 51: Total Market Size of Alzheimer's Disease in Japan, in USD million (2019-2032)
• Table 52: The Market Size of Alzheimer's Disease by Therapies in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: Symptoms of Alzheimer's Disease
• Figure 2: Classification of Alzheimer's Disease
• Figure 3: Risk Factors of Alzheimer's Disease
• Figure 4: Stages of Alzheimer's Disease
• Figure 5: Pathophysiology of Alzheimer's Disease
• Figure 6: Treatment Algorithm for Management of Alzheimer's Disease in Japan
• Figure 7: Patient Journey of Alzheimer's Disease
• Figure 8: Diagnosed Prevalent Cases of Alzheimer's Disease in Japan (2019-2032)
• Figure 9: Gender-specific Cases of Alzheimer's Disease in Japan (2019-2032)
• Figure 10: Age-specific Cases of Alzheimer's Disease in Japan (2019-2032)
• Figure 11: Severity-specific Cases of Alzheimer's Disease in Japan (2019-2032)
• Figure 12: Total Market Size of Alzheimer's Disease in Japan, in USD million (2019-2032)
• Figure 13: The Market Size of Alzheimer's Disease by Therapies in Japan, in USD million (2019-2032)
• Figure 14: SWOT Analysis of Alzheimer's Disease
• Figure 15: Unmet Needs of Alzheimer's Disease
• Figure 16: Health Technology Assessment
• Figure 17: Reimbursement Process in Japan

Key Highlights:

• The diagnosed prevalence of Alzheimer's disease has been increasing in Japan due to the increasing geriatric population and disease awareness.
• Increased awareness and advancements in a comprehensive understanding of the disease pathophysiology have led to the discovery of novel signaling pathways, due to which various diagnostic tools have evolved that have revolutionized disease diagnosis.
• The current treatment regime is mostly symptomatic, slows disease progression, and helps improve quality of life. It is not curative and is a mix of nonpharmacological and pharmacological approaches.
• Nonpharmacological therapies include cognitive stimulation, physical exercise, and social engagement. Caregiver support and education are crucial for managing the challenges associated with Alzheimer's.
• The major concern in understanding the market for Alzheimer's disease is that despite an extremely vibrant pipeline, assessing drugs' potential to enter the market is difficult due to high failure rates, as many potential therapies like gantenerumab, dabigatran, and verubecestat were unable to move past the trial phase.
• In Japan, the approval of Biogen/Eisai/BioArctic's LEQEMBI (lecanemab) in September 2023, an amyloid beta-protein inhibitor, has led to significant improvements from the traditional symptomatic treatment regime and quenched the thirst for disease-modifying therapy. This marks a major milestone and is a forward-looking step in addressing the unmet needs of patients with early Alzheimer's. This also paves the way for other biologics and drugs targeting the underlying disease pathology.
• In 2022, the market size of Alzheimer's disease in Japan accounted for approximately USD 864.1 million. It is expected to increase by 2032.

DelveInsight's "Alzheimer's Disease - Market Insights, Epidemiology, and Market Forecast - 2032" report delivers an in-depth understanding of Alzheimer's disease historical and forecasted epidemiology and the market trends in Japan.

The Alzheimer's disease market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted Japan Alzheimer's disease market size from 2019 to 2032. The report also covers current Alzheimer's disease treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• Japan

Study Period: 2019-2032.

Alzheimer's Disease Understanding and Treatment Algorithm

Alzheimer's Disease Overview

Alzheimer's disease, the most common type of dementia, is a progressive neurodegenerative disorder with a multifactorial pathogenesis. It is characterized by the gradual decline in cognitive and functional abilities, with individuals eventually losing the ability to undertake everyday tasks and function independently. Symptoms, for most people, first appear in their mid-60s. However, early disease may manifest in quadragenarians as well.

Although the symptoms vary widely, they develop slowly and worsen over time. Early signs may include forgetfulness, difficulty with problem-solving or completing familiar tasks, confusion, disorientation, and changes in mood or behavior. As the disease progresses, individuals may experience severe memory loss, language problems, impaired judgment, personality changes, and a decline in overall cognitive abilities.

Improved disease understanding demonstrates that the disease is characterized by two microscopic features, amyloid plaques and neurofibrillary agglomerates. The exact cause is mostly unknown, but research indicates that progressive cognitive decline is associated with the accumulation of amyloid-beta (AB) and tau proteins. These deposits form amyloid protein plaques outside the brain cells and tangles of tau protein within the brain cells.

These plaques and tangles disrupt normal communication between brain cells, leading to progressive degeneration, memory deterioration, and death. Increasing age and family history are important risk factors.

Alzheimer's Disease Diagnosis

The pathogenesis is multifactorial, and due to the continuous discovery of novel signaling pathways, various diagnostic tools have revolutionized and improved disease diagnosis, making it more personalized. This has helped me understand the various possibilities of tau and amyloid deposition, neurodegeneration, and symptom manifestation.

Diagnosing Alzheimer's disease involves a comprehensive evaluation of medical history, cognitive tests, neurological exams, and assessment of behavioral and functional changes. There is no single test for the diagnosis. Clinical practice typically diagnoses it through a multidisciplinary workup based on patient history, clinical symptoms, and neuropsychiatric, physical, and functional assessments. Imaging (computed tomography, magnetic resonance imaging (MRI), positron emission tomography (PET) assessments, and blood tests are particularly important to rule out certain other causes of dementia. PET scans, especially amyloid scans, fluorodeoxyglucose imaging, and tau imaging, besides CSF biomarkers and blood-biomarker-based diagnosis, have improved the diagnosis manifold

Further details related to country-based variations are provided in the report…

Alzheimer's Disease Treatment

There is no cure for Alzheimer's disease, and the available treatments offer relatively small symptomatic benefits but remain palliative. The treatment is divided into pharmaceutical, psychosocial, and caregiving.

Psychosocial interventions are adjuncts to pharmaceutical treatment and are classified within behavior, emotion, cognition, or stimulation-oriented approaches. Cognitive stimulation therapy (CST), cognitive rehabilitation, simulated presence therapy, and music therapy effectively reduce behavioral and psychological symptoms.

Environment and lifestyle modifications, diet, and behavioral interventions are also important to improve the quality of life.

The drugs currently available to treat many symptoms associated with dementia are working by increasing activity levels of some brain neurotransmitters, such as acetylcholine, serotonin, and noradrenaline, or by reducing the activity of other neurotransmitters, such as glutamate and dopamine.

Pharmacological therapies for symptomatic treatment, such as acetylcholinesterase inhibitors (AChEIs) and NMDA receptor antagonists, memantine, have been available for over a decade. Recently, more targeted monoclonal antibodies that target amyloid beta-proteins have entered the Alzheimer's market space.

Donepezil, rivastigmine transdermal patch, and galantamine are three AChEIs approved for treating Alzheimer's disease. These are recommended to treat mild-to-advanced stages of Alzheimer's disease, yet their benefit-risk ratio is still being debated, with many countries not allowing their reimbursement.

Besides these, the NMDA receptor antagonist, memantine, has also been approved for treating Alzheimer's disease, but it is limited to moderate and severe cases and mostly in cases where cholinesterases have not been effective. Atypical antipsychotics, though not approved, are even commonly used to treat behavioral symptoms associated with Alzheimer's disease.

Alzheimer's Disease Epidemiology

As the market is derived using a patient-based model, the Alzheimer's disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of Alzheimer's disease, age-specific cases of Alzheimer's disease, gender-specific cases of Alzheimer's disease, and severity-specific cases of Alzheimer's disease in Japan from 2019 to 2032.

• In 2022, the total diagnosed prevalent cases of Alzheimer's disease in Japan were estimated to be approximately 3,954,710. These cases are projected to increase during the forecast period.
• As per DelveInsight's estimates, Alzheimer's disease is more common in females than males. In 2022, the gender-specific diagnosed prevalent cases of Alzheimer's disease accounted for around 64% of females and 36% of males in Japan.

In 2022, the age-specific distribution of the disease suggests that the age cohort of 75-84 years accounted for the majority, nearly 51% of the cases, followed by =85 accounting for 32% of the cases, followed by others in Japan. These cases of Alzheimer's disease are expected to increase during the forecast period.

• According to estimates based on DelveInsight's epidemiology model for Alzheimer's disease, in Japan, in 2022, there were approximately 2,324,183 cases of MCI, 826,139 cases of mild dementia, 517,671 cases of moderate dementia, and 286,716 cases of severe dementia, which are expected to increase during the study period.

Alzheimer's Disease Drug Chapters

The drug chapter segment of the Alzheimer's disease report encloses a detailed analysis of Alzheimer's disease - currently used drugs and mid-stage (Phase II and Phase I) pipeline drugs. It also helps understand the Alzheimer's disease clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

LEQEMBI (lecanemab): Biogen/Eisai/ BioArctic

LEQEMBI (lecanemab) is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of AB. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. LEQEMBI reduces amyloid beta plaques and is indicated for treating mild cognitive impairment or mild dementia stage of Alzheimer's disease. The US FDA has granted the drugs breakthrough therapy designation and FTD.

The recommended dosage of LEQEMBI is 10 mg/kg, diluted and then administered via IV infusion for approximately 1 h, once every 2 weeks, to eligible patients with confirmed presence of AB pathology before initiating treatment. Enhanced clinical vigilance for amyloid-related imaging abnormalities (ARIA) is recommended during the first 14 weeks of treatment with LEQEMBI.

In September 2023, Japan's MHLW approved Biogen, Eisai, and BioArctic's LEQEMBI (lecanemab) as a treatment for slowing the progression of MCI and mild dementia due to Alzheimer's disease. In July 2023, the US FDA converted accelerated approval to traditional approval following a determination that a confirmatory trial verified clinical benefit. LEQEMBI is the first amyloid beta-directed antibody targeting the disease process to be converted from accelerated approval to traditional approval.

Biogen and Eisai have submitted an application to the European Medicines Agency (EMA) for approval of lecanemab in the EU and further aim to submit a Biologics License Application (BLA) with the US FDA for LEQEMBI SC formulation by March 2024 and are conducting trials for the same.

Emerging Drugs

ADUHELM (aducanumab): Biogen/Eisai

ADUHELM is a human IgG1 mAb directed against amyloid beta (AB) protein, one of the hallmarks of Alzheimer's disease. It exerts its mechanism of action by crossing the blood-brain barrier and selectively targeting and binding aggregated soluble oligomers and insoluble fibril conformations of AB plaques in the brain.

The drug is approved by the US FDA for use in Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of the disease. The recommended maintenance dosage is 10 mg/kg administered as an IV over approximately 1 h every 4 weeks. ADUHELM is administered as an IV infusion over approximately 1 h every 4 weeks and at least 21 days apart. The most common side effects of ADUHELM include swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain, amyloid-related imaging abnormalities (ARIA), and headache.

In April 2022, Biogen withdrew its marketing authorization application (MAA) for ADUHELM from the EMA. In December 2021, Biogen and Eisai faced a refusal to approve ADUHELM from the Japanese regulators due to insufficient data.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

Alzheimer's disease, the most common type of dementia, is a progressive neurodegenerative disorder with a multifactorial pathogenesis. It is characterized by a gradual decline in cognitive and functional abilities, with individuals eventually losing the ability to undertake everyday tasks and function independently. Symptoms of Alzheimer's disease, for most people, first appear in their mid-60s. However, early disease may manifest in quadragenarians as well. Early diagnosis becomes difficult with the exact cause mostly unknown and limited early manifestation. The multifactorial nature of the disease further compounds this. Earlier diagnosis is important for enabling symptomatic therapies, treating behavioral symptoms, and adopting lifestyle changes.

The current treatment regime is mostly symptomatic, slows disease progression, and helps improve quality of life. It is not curative and is a mix of nonpharmacological and pharmacological approaches. Most drugs to treat symptoms work by increasing activity levels of some brain neurotransmitters, such as acetylcholine, serotonin, and noradrenaline, or by reducing the activity of other neurotransmitters, such as glutamate and dopamine.

Pharmacological therapies for symptomatic treatment, such as acetylcholinesterase inhibitors (AChEIs) and NMDA receptor antagonist memantine, have been available for over a decade. Recently, more targeted monoclonal antibodies that target amyloid beta-proteins have entered the Alzheimer's market space.

The three AChEIs, donepezil, rivastigmine, and Galantamine, are approved with comparable therapeutic effects. These are recommended to treat mild-to-advanced stages of Alzheimer's disease, yet their benefit-risk ratio is still being debated. They work by inhibiting the activity of acetylcholinesterase, an enzyme that breaks down acetylcholine, a neurotransmitter involved in memory and cognitive function. By inhibiting acetylcholinesterase, these medications increase the levels of acetylcholine in the brain, potentially improving cognitive symptoms in Alzheimer's disease.

Alzheimer's Disease Market Outlook

The drugs currently available to treat many symptoms associated with dementia are working by increasing activity levels of some brain neurotransmitters, such as acetylcholine, serotonin, and noradrenaline, or by reducing the activity of other neurotransmitters, such as glutamate and dopamine. Due to associated side effects, it is also important to personalize dementia symptomatic therapeutics considering patients' comorbidities and their respective therapies. Effects on cardiac function, drug elimination, and other interactions should be assessed case by case.

There are three approved AChEIs, donepezil, rivastigmine, and Galantamine are used in more than 60 countries to treat mild-to-advanced stages of Alzheimer's disease. These are donepezil, rivastigmine transdermal patch, and galantamine. The therapeutic effects of donepezil, rivastigmine, and galantamine are fairly comparable. Their effectiveness is considered modest and temporary and needs to be regularly re-evaluated. Though these have demonstrated symptomatic benefits in rigorous double-blind, placebo-controlled randomized clinical trials, there are also associated side effects. However, their benefit-risk ratio is still being debated, due to which some countries, notably France, have chosen not to allow their reimbursement by the public health sector.

The NMDA antagonist, memantine, works in another brain cell communication network and slows the progression of symptoms in individuals with moderate to severe Alzheimer's disease. It can be given as monotherapy or combined with a cholinesterase inhibitor.

The current market has been covered by the symptomatic treatment that includes different pharmacological agents used in Japan, which presents minor variations in the overall prescription pattern. LEQEMBI (lecanemab), galantamine, rivastigmine, donepezil, memantine, and a combination of memantine and acetylcholinesterase inhibitors are the major drugs considered for symptomatic treatment in the forecast model.

Key players Anavex Life Sciences, Alzheon, Athira Pharma, Annovis Bio, Eli Lilly, BioVie, AB Science, Novo Nordisk, Cassava Sciences, TauRx Therapeutics, KeifeRx, AriBio, Cerecin, Eisai, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of Alzheimer's Disease.

• The total market size of Alzheimer's disease in Japan was approximately USD 914.5 million in 2022 and is projected to increase during the forecast period (2023-2032).
• As per DelveInsight's estimates, in Japan, cholinesterase inhibitors (donepezil, rivastigmine, and Galantamine) and NMDA receptor antagonist (memantine) accounted for USD 869.8 million and USD 21.9 million in 2022. Among cholinesterase inhibitors, donepezil had the highest share (of all the therapies), with nearly 67% of the total revenue in the class, while rivastigmine generated USD 67.6 million in 2022.
• According to DelveInsight's estimates, Biogen and Eisai's LEQEMBI, which received approval from MHLW in September 2023, is projected to grow substantially during the forecast period and revenue capture around 2.8% of the total Japanese Alzheimer's disease market by 2032.
• Various therapies like Anavex Life Sciences's ANAVEX2-73 (blarcamesine), Alzheon's ALZ-801 (valiltramiprosate), Athira Pharma's fosgonimeton (ATH-1017), Annovis Bio's buntanetap, Eli Lilly's donanemab (LY3002813), BioVie's NE3107, Cassava Sciences' simufilam (PTI-125), and TauRx Therapeutics' hydromethylthionine mesylate (TRx0237) among others are anticipated to enter the market during the forecast period.
• Eli Lilly's donanemab (LY3002813) is projected to be the first emerging therapy to enter the market by 2024. It is an amyloid B protein inhibitor that will compete with Biogen/Eisai/BioArctic's LEQEMBI. With one of the best efficacy results, wherein the therapy led to a 39% lower risk of progressing to the next stage of the disease, the drug is projected to have a slow-medium uptake. High costs will translate to higher revenue, and it will attain its peak share by the seventh year. Despite product-related safety concerns, the drug will perform well during the forecast period, capturing nearly 26.1% of the total Alzheimer's market by 2032.
• Another Eli Lilly product, remternetug (LY3372993), a mAb that targets toxic amyloid plaques linked to the onset of Alzheimer's disease, is being investigated in IV and SC forms. The candidate is projected to capture around 0.1% of Japan's Alzheimer's disease market in its launch year 2029.
• TauRx Therapeutics' Hydromethylthionine mesylate (HMTM)/TRx0237, an orally administered therapy for early Alzheimer's, has reported no safety issues. It is the first novel target drug that is not biological and has the potential to be one of the best performers.
• BioVie's NE3107, Cassava Sciences' simufilam (PTI-125), Anavex Life Sciences' ANAVEX2-73 (blarcamesine), Alzheon's ALZ-801 (valiltramiprosate) are next in line with projected entry by 2027. Alzheon's ALZ-801, another FDA-designated product, is an orally administered amyloid beta-protein and oligomer formation inhibitor. The drug has demonstrated excellent efficacy in its trial, but high doses and long treatment duration may affect its potential. With a slow-medium uptake, it will attain its peak share by the eighth year.
• Anavex Life Sciences' ANAVEX2-73 (blarcamesine), a SIGMAR1 activator and muscarinic receptor modulator for treating early Alzheimer's patients, has the potential to establish itself in the crowded market space. The trials have demonstrated that about 84% of the treated patients have improved cognition. A low-dose regime might ensure better compliance. All these factors point to the drug performing well in the Alzheimer's market. The drug will peak by the seventh year with a medium uptake.
• Athira Pharma's fosgonimeton (ATH-1017), a hepatocyte growth factor and MET receptor stimulant, has demonstrated excellent improvements in cognitive score in its trial. A low dose favorable safety profile places the drug in a strong position, which is anticipated to have a medium uptake.

Alzheimer's Disease Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, Annovis Bio's buntanetap, a translational inhibitor of neurotoxic aggregating proteins, with an anticipated entry by 2029 in the US, is predicted to have a slow-medium uptake during the forecast period.

Further detailed analysis of emerging therapies drug uptake in the report…

Alzheimer's Disease Pipeline Development Activities

The report provides insights into therapeutic candidates in late-stage development, including Phase III and Phase II/III. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Alzheimer's disease.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the Alzheimer's disease evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in Japan. Centers like the National Institute of Infectious Diseases, Kyoto University, Japanese Society of Psychiatry and Neurology, Yokohama Brain and Spine Center, and Japan Society for Dementia Research were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Alzheimer's disease market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

According to the primary research analysis, LEQEMBI's approval will change the treatment regime and market dynamics for Alzheimer's. Though not curative, this is the first approved disease-modifying therapy in Japan for early Alzheimer's patients, as it delays the progression. Though the drug has potential, there are certain hurdles, like testing requirements on the drug's prescribing label and risk warning, which push one to keep caution. The results in delaying disease progression have done well, and awareness needs to be generated to ensure drug usage.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based upon change from baseline in the ADCS-ADL scale, ADAS-Cog scale, and Clinical Dementia Rating (CDR) - global score results, among others. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The therapies' safety is evaluated wherein treatment-related adverse events along with serious adverse events were majorly observed, besides the occurrence of amyloid-related imaging abnormalities (ARIA). It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The National Health Insurance Drug List of the Japanese Ministry of Health, Labor and Welfare has enlisted donepezil (1,190,012), memantine (1,190,018), galantamine (1,190,019), and rivastigmine (1,190,700).

In September 2023, LEQEMBI (lecanemab), a humanized anti-soluble aggregated amyloid-beta (AB) monoclonal antibody, was approved in Japan as a treatment for slowing the progression of MCI and mild dementia due to Alzheimer's disease. Following the approval, the drug reimbursement policy has been debated. Considering its large patient population, the Central Social Insurance Medical Council (Chuikyo) discussed how best to finance the drug. A key focus of the first discussion was if LEQEMBI was priced similarly in Japan to its price in the US, it would be eligible for the new "mega-seller" rule.

The Central Social Insurance Medical Council (Chuikyo) General Meeting Discussion from November revealed that drug prices were calculated using the usual calculation method (similar drug efficacy comparison method or cost calculation method), and the drug prices of LEQEMBI intravenous injection 200 mg and LEQEMBI intravenous injection 500 mg were announced. Further, the drug pricing organization will create a pricing proposal, and based on that, the Chuikyo general meeting will decide whether the drug will be included in the drug price standards (insurance coverage) by 24th December 2023 at the latest.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, descriptive overview of Alzheimer's disease, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Alzheimer's disease market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report, covering the Japan drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the Japanese Alzheimer's disease market.

Alzheimer's Disease Report Insights

• Patient Population
• Therapeutic Approaches
• Alzheimer's Disease Pipeline Analysis
• Alzheimer's Disease Market Size and Trends
• Existing and Future Market Opportunity

Alzheimer's Disease Report Key Strengths

• Ten Years Forecast
• Japan Coverage
• Alzheimer's Disease Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Alzheimer's Disease Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Market Insights

• What was the total market size of Alzheimer's disease, the market size of Alzheimer's disease by therapies, market share (%) distribution in 2019, and what would it look like by 2032? What are the contributing factors for this growth?
• How will donanemab (LY3002813), hydromethylthionine mesylate (HMIM)/TRx0237, ALZ-801 (valiltramiprosate), fosgonimeton (ATH-1017), and others affect the treatment paradigm of Alzheimer's disease?
• How will LEQEMBI (lecanemab) compete with other off-label symptomatic and emerging treatments?
• Which drug is going to be the largest contributor by 2032?
• What are the prices of different therapies in Japan?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Alzheimer's disease? What will be the growth opportunities in Japan with respect to the patient population pertaining to Alzheimer's disease?
• What is the historical and forecasted patient pool of Alzheimer's disease in Japan?
• What patient population is affected by different severity stages of Alzheimer's disease in Japan?
• What factors are contributing to the growth of Alzheimer's disease cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Alzheimer's disease?
• How many companies are developing therapies for the treatment of Alzheimer's disease?
• How many emerging therapies are in the mid-stage and early stage of development for treating Alzheimer's disease?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in Japan?
• What is Japan's historical and forecasted market for Alzheimer's disease?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Alzheimer's disease market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunity in Japan and the growth potential over the coming years.
• Historical and current patient share distribution is based on real-world prescription data in Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy

Table of Contents

1. Key Insights

2. Report Introduction

3. Alzheimer's Disease Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Alzheimer's Disease in 2019
• 3.2. Market Share (%) Distribution of Alzheimer's Disease in 2032

4. Methodology of Alzheimer's Disease Epidemiology and Market

5. Executive Summary of Alzheimer's Disease

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction to Alzheimer's Disease
• 7.2. Signs and Symptoms
• 7.3. Classification of Alzheimer's Disease
• 7.4. Risk Factors
• 7.5. Severity of Alzheimer's Disease
• 7.6. Pathophysiology
  • 7.6.1. Neurofibrillary Tangle Formation
  • 7.6.2. Cholinergic Neurotransmitter System Dysfunctioning
  • 7.6.3. Amyloid Beta (AB) Accumulation
  • 7.6.4. Mitochondrial Dysfunction
  • 7.6.5. Inflammation
• 7.7. Diagnosis
  • 7.7.1. National Institute on Aging and the Alzheimer's Association Criteria
  • 7.7.2. DSM-5 Criteria for Diagnosing Alzheimer's Disease
  • 7.7.3. IWG-2 Criteria for Alzheimer's Disease
  • 7.7.4. Techniques
  • 7.7.5. Mini-Mental State Exam (MMSE)
• 7.8. Treatment
  • 7.8.1. Psychosocial Approach
  • 7.8.2. Caregiving
  • 7.8.3. Diet
• 7.9. Treatment Algorithms
  • 7.9.1. Japanese Clinical Practice Guideline for Alzheimer's Disease Dementia 2017

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: Japan
  • 9.2.1. Diagnosed Prevalent Cases of Alzheimer's Disease
  • 9.2.2. Gender-specific Cases of Alzheimer's Disease
  • 9.2.3. Age-specific Cases of Alzheimer's Disease
  • 9.2.4. Severity-specific Cases of Alzheimer's Disease
• 9.3. Japan
  • 9.3.1. Diagnosed Prevalent Cases of Alzheimer's Disease in Japan
  • 9.3.2. Gender-specific Cases of Alzheimer's Disease in Japan
  • 9.3.3. Age-specific Cases of Alzheimer's Disease in Japan
  • 9.3.4. Severity-specific Cases of Alzheimer's Disease in Japan

10. Marketed Drugs

• 10.1. Key Cross Competition
• 10.2. LEQEMBI (lecanemab): Biogen/Eisai/BioArctic
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Development
  • 10.2.5. Clinical Trials Information
  • 10.2.6. Safety and efficacy
  • 10.2.7. Product Profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. ADUHELM (aducanumab): Biogen/Eisai
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Development Activities
  • 11.2.4. Clinical Development
  • 11.2.5. Clinical Trials Information
  • 11.2.6. Safety and Efficacy
  • 11.2.7. Product Profile
• 11.3. NE3107: BioVie
  • 11.3.1. Product Description
  • 11.3.2. Other Developmental Activity
  • 11.3.3. Clinical Development
  • 11.3.4. Clinical Trials Information
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Product Profile
  • 11.3.7. Analysts' Views
• 11.4. Masitinib (AB1010): AB Science
  • 11.4.1. Product Description
  • 11.4.2. Other Development Activity
  • 11.4.3. Clinical Development
  • 11.4.4. Clinical Trials Information
  • 11.4.5. Safety and Efficacy
  • 11.4.6. Product Profile
  • 11.4.7. Analysts' Views
• 11.5. Donanemab (LY3002813): Eli Lilly and Company
  • 11.5.1. Product Description
  • 11.5.2. Other Developmental Activity
  • 11.5.3. Clinical Development
  • 11.5.4. Clinical Trials Information
  • 11.5.5. Safety and Efficacy
  • 11.5.6. Product Profile
  • 11.5.7. Analysts' Views
• 11.6. Simufilam (PTI-125): Cassava Sciences
  • 11.6.1. Product Description
  • 11.6.2. Other Developmental Activity
  • 11.6.3. Clinical Development
  • 11.6.4. Clinical Trials Information
  • 11.6.5. Safety and Efficacy
  • 11.6.6. Product Profile
  • 11.6.7. Analysts' Views
• 11.7. Hydromethylthionine mesylate (HMTM)/TRx0237: TauRx Therapeutics
  • 11.7.1. Product Description
  • 11.7.2. Other Developmental Activity
  • 11.7.3. Clinical Development
  • 11.7.4. Clinical Trials Information
  • 11.7.5. Safety and Efficacy
  • 11.7.6. Product Profile
  • 11.7.7. Analyst's Views
• 11.8. Semaglutide (NN6535): Novo Nordisk
  • 11.8.1. Product Description
  • 11.8.2. Clinical Development
  • 11.8.3. Clinical Trial Information
  • 11.8.4. Safety and Efficacy
  • 11.8.5. Product Profile
  • 11.8.6. Analysts' Views
• 11.9. KFRX01 (nilotinib BE): KeifeRx
  • 11.9.1. Product Description
  • 11.9.2. Other Development Activities
  • 11.9.3. Clinical Development
  • 11.9.4. Clinical Trial Information
  • 11.9.5. Safety and Efficacy
  • 11.9.6. Product Profile
  • 11.9.7. Analysts' Views
• 11.10. Remternetug (LY3372993): Eli Lilly
  • 11.10.1. Product Description
  • 11.10.2. Clinical Development
  • 11.10.3. Clinical Trial Information
  • 11.10.4. Safety and Efficacy
  • 11.10.5. Product Profile
  • 11.10.6. Analysts' Views
• 11.11. AR1001: AriBio
  • 11.11.1. Product Description
  • 11.11.2. Other Developmental Activity
  • 11.11.3. Clinical Development
  • 11.11.4. Clinical Trials Information
  • 11.11.5. Safety and Efficacy
  • 11.11.6. Product Profile
  • 11.11.7. Analysts' Views
• 11.12. Tricaprilin (CER-0001): Cerecin
  • 11.12.1. Product Description
  • 11.12.2. Other Developmental Activity
  • 11.12.3. Clinical Development
  • 11.12.4. Clinical Trials Information
  • 11.12.5. Safety and Efficacy
  • 11.12.6. Product Profile
  • 11.12.7. Analysts' Views
• 11.13. ALZ-801 (valiltramiprosate): Alzheon
  • 11.13.1. Product Description
  • 11.13.2. Other Development Activity
  • 11.13.3. Clinical Development
  • 11.13.4. Clinical Trials Information
  • 11.13.5. Safety and Efficacy
  • 11.13.6. Product Profile
  • 11.13.7. Analysts' Views
• 11.14. Piromelatine (Neu-P11): Neurim Pharmaceuticals
  • 11.14.1. Product Description
  • 11.14.2. Clinical Development
  • 11.14.3. Clinical Trials Information
  • 11.14.4. Safety and Efficacy
  • 11.14.5. Product Profile
  • 11.14.6. Analysts' Views
• 11.15. Fosgonimeton (ATH-1017): Athira Pharma
  • 11.15.1. Product Description
  • 11.15.2. Other Development Activities
  • 11.15.3. Clinical Development
  • 11.15.4. Clinical Trial Information
  • 11.15.5. Safety and Efficacy
  • 11.15.6. Product Profile
  • 11.15.7. Analysts' Views
• 11.16. Buntanetap: Annovis Bio
  • 11.16.1. Product Description
  • 11.16.2. Other Developmental Activity
  • 11.16.3. Clinical Development
  • 11.16.4. Clinical Trials Information
  • 11.16.5. Safety and Efficacy
  • 11.16.6. Product Profile
  • 11.16.7. Analysts' Views
• 11.17. ANAVEX2-73 (blarcamesine): Anavex Life Sciences
  • 11.17.1. Product Description
  • 11.17.2. Other Development Activities
  • 11.17.3. Clinical Development
  • 11.17.4. Clinical Trial Information
  • 11.17.5. Safety and Efficacy
  • 11.17.6. Product Profile
  • 11.17.7. Analysts' Views
• 11.18. AGB101: AgeneBio
  • 11.18.1. Product Description
  • 11.18.2. Other Development Activities
  • 11.18.3. Clinical Development
  • 11.18.4. Clinical Trial Information
  • 11.18.5. Safety and Efficacy
  • 11.18.6. Product Profile
  • 11.18.7. Analysts' Views
• 11.19. E2814: Eisai
  • 11.19.1. Product Description
  • 11.19.2. Other Developmental Activity
  • 11.19.3. Clinical Development
  • 11.19.4. Clinical Trials Information
  • 11.19.5. Safety and Efficacy
  • 11.19.6. Product Profile
  • 11.19.7. Analysts' Views
• 11.20. Masupirdine (SUVN-502): Suven Life Sciences
  • 11.20.1. Product Description
  • 11.20.2. Other Development Activities
  • 11.20.3. Clinical Development
  • 11.20.4. Clinical Trial Information
  • 11.20.5. Safety and Efficacy
  • 11.20.6. Product Profile
  • 11.20.7. Analysts' Views

12. Alzheimer's Disease: 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 Alzheimer's Disease in Japan
  • 12.5.1. Total Market Size of Alzheimer's Disease
  • 12.5.2. The Market Size of Alzheimer's Disease by Therapies

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet needs

16. Market Access and Reimbursement

• 16.1. Japan
  • 16.1.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight