Alzheimer's Disease-Modifying Therapy: Leqembi and Kisunla Uptake | Diagnostics Market Intelligence

Description

List of Tables

Japan was the first country outside the United States to put disease-modifying Alzheimer's therapy into routine practice, and it has now accumulated the world's most instructive early experience. Leqembi has been reimbursed since late 2023 and Kisunla followed with a usefulness premium and its own Optimal Use Guidelines issued in November 2024. Two years in, the questions have shifted from whether the drugs work to whether the system around them works: infusion capacity, MRI monitoring schedules, amyloid confirmation pathways, and the economics of treating a large eligible population inside a tightly budgeted health system.

The tension is concrete. Treatment requires an infrastructure that Japan is still building: infusion chairs, radiology capacity for safety monitoring, and biomarker confirmation at scale. The subcutaneous autoinjector formulation filed in November 2025 could change home-dosing economics and relieve capacity pressure, but it also reopens pricing and delivery questions. Meanwhile the eligibility gate, confirming amyloid pathology before treatment, depends on PET imaging, CSF testing, or blood-based assays whose reimbursement pathway remains unresolved, making diagnostics the effective throttle on therapy uptake. Stakeholders disagree about how fast capacity should expand and who should pay for it.

This report examines uptake after two years as an operating system, not a headline. It reconstructs the regulatory and reimbursement pathway for lecanemab and donanemab in Japan, including NHI pricing mechanics and the premium structure; maps the treatment-delivery infrastructure by region and provider type; profiles the confirmation-testing landscape across PET, CSF, and blood biomarkers with Sysmex, Fujirebio, Roche, and Shimadzu platforms; and assesses the pipeline that will shape the next phase, including subcutaneous formulations, Roche's trontinemab, anti-tau programs, and prevention trials. Comparator chapters cover the US, EU5, and China, where approval and access trajectories differ sharply.

The report serves pharma commercial and market-access teams, infusion-center and clinic operators, diagnostics companies, hospital planners, and investors. It is organized so that each operational layer, eligibility, delivery, monitoring, payment, can be analyzed independently and benchmarked against international practice.

Scope and Coverage

The report covers lecanemab and donanemab regulatory status, reimbursement, and delivery infrastructure in Japan, with comparator analysis for the US, EU5, and China. It spans eligibility diagnostics, infusion and monitoring capacity, formulation development, and the next-wave pipeline. It describes system structure and coverage, not clinical efficacy results.

Report Highlights

Regulatory and NHI reimbursement pathway for Leqembi and Kisunla in Japan
Optimal Use Guidelines structure and prescriber requirements
Eligibility-confirmation landscape: PET, CSF, and blood-based biomarkers
Infusion and MRI-monitoring capacity mapping by region and provider
Subcutaneous formulation development and its delivery implications
Next-wave pipeline: trontinemab, anti-tau programs, and prevention trials

Product Code: JPH-006

Table of Content

1. Executive Summary

2. Alzheimer's Disease-Modifying Therapy: Technology and Test Landscape

3. Clinical Evidence and Guideline Context

4. Regulatory Status: PMDA, FDA, IVDR, and NMPA Pathways

5. Reimbursement and Price Formation with a Focus on Japan

6. Adoption, Channels, and Screening Infrastructure in Japan

7. Competitive Landscape: Companies and Platforms

8. Opportunities and Barriers for Market Participants

9. Appendix: Methodology and Sources

Companies Mentioned

Eisai (JP) - originator of lecanemab (Leqembi); Japan commercial lead; SC autoinjector filed 2025
Biogen (US) - Leqembi co-commercial partner with aducanumab legacy experience
Eli Lilly (US) - donanemab (Kisunla) launched in Japan with a usefulness premium
Roche (CH) - trontinemab Brainshuttle program and Elecsys AD diagnostics
AC Immune (CH) - anti-amyloid and anti-tau immunotherapy pipeline
Otsuka (JP) - brexpiprazole (Rexulti) for agitation in dementia; behavioral-symptom franchise
Green Valley Pharmaceutical (CN) - GV-971 sodium oligomannate, China-approved AD drug
Novo Nordisk (DK) - oral semaglutide EVOKE and EVOKE+ Phase 3 trials in early AD
Fujirebio (JP) - Lumipulse pTau217 and NfL assays gating DMT-eligibility testing
Sysmex (JP) - HISCL amyloid assays and the 2026 Fujirebio sales collaboration
Johnson & Johnson (US) - posdinemab anti-tau antibody in Phase 2
Shimadzu (JP) - MALDI mass-spectrometry blood amyloid technology

Product Code: JPH-006

List of Tables

Table 1. Alzheimer's disease-modifying therapy: mechanism taxonomy and amyloid-pathway background
Table 2. Lecanemab and donanemab: molecular profiles and development histories
Table 3. Clinical-program lineage: Clarity AD and TRAILBLAZER-ALZ 2 program structures
Table 4. Milestones in Japanese Alzheimer's treatment policy by year
Table 5. Early Alzheimer's disease populations: MCI due to AD and mild AD dementia frameworks
Table 6. Japanese dementia population structure and diagnostic settings
Table 7. Eligibility-confirmation requirements: amyloid PET, CSF, and blood-based options
Table 8. Exclusion and caution frameworks: ARIA risk factors, anticoagulation, and APOE considerations
Table 9. Regional distribution of diagnosis and treatment settings in Japan
Table 10. Leqembi (lecanemab) in Japan: approval pathway, label structure, and NHI listing
Table 11. Kisunla (donanemab) in Japan: approval pathway, usefulness premium, and label structure
Table 12. Optimal Use Guidelines for lecanemab and donanemab: requirements and compliance mechanics
Table 13. Infusion-delivery protocols and visit schedules under current labels
Table 14. MRI safety-monitoring schedules and ARIA management pathways
Table 15. Registry and post-marketing surveillance obligations for anti-amyloid therapy in Japan
Table 16. Subcutaneous lecanemab autoinjector: formulation development and November 2025 filing
Table 17. Maintenance-dosing and treatment-duration frameworks across programs
Table 18. Trontinemab (Roche Brainshuttle) program structure and transferrin-receptor targeting
Table 19. Anti-tau pipeline: posdinemab (J&J) and AC Immune immunotherapy programs
Table 20. Oral semaglutide EVOKE and EVOKE+ Phase 3 programs in early Alzheimer's disease
Table 21. GV-971 (Green Valley) and other international pipeline entries
Table 22. AHEAD 3-45 and prevention-trial frameworks for preclinical populations
Table 23. PMDA review pathway for lecanemab and donanemab: process reconstruction
Table 24. FDA and EMA pathway comparison for anti-amyloid antibodies
Table 25. China regulatory status and NMPA considerations for the class
Table 26. Biomarker-confirmation requirements as regulatory gatekeeping
Table 27. Subcutaneous formulation regulatory considerations
Table 28. NHI price-setting mechanics applied to Leqembi and Kisunla
Table 29. Usefulness-premium criteria and their application to donanemab
Table 30. Infusion and monitoring cost components within the Japanese reimbursement system
Table 31. US coverage framework: Medicare structures and registry requirements
Table 32. EU5 access environment and HTA positions for anti-amyloid therapy
Table 33. China access environment for Alzheimer's disease-modifying therapy
Table 34. PET imaging capacity and tracer availability in Japan
Table 35. CSF testing infrastructure and laboratory networks
Table 36. Blood-based biomarker platforms: Sysmex HISCL and Fujirebio Lumipulse systems
Table 37. Roche Elecsys and Shimadzu MALDI-MS assay positions in confirmation testing
Table 38. Eisai: lecanemab franchise structure and Japanese commercial lead
Table 39. Biogen: partnership role and aducanumab legacy
Table 40. Eli Lilly: donanemab launch structure in Japan
Table 41. Otsuka: brexpiprazole (Rexulti) and the behavioral-symptom franchise
Table 42. Infusion-center and clinic operator landscape for Alzheimer's therapy
Table 43. Diagnostics-channel participants: reference labs and hospital laboratories
Table 44. Delivery-capacity constraints and expansion options
Table 45. Eligibility-bottleneck analysis: confirmation testing as the system throttle
Table 46. Home-dosing transition scenarios under subcutaneous formulations
Table 47. Japan experience as a reference for other Asian health systems
Table 48. Monitoring and data infrastructure opportunities for vendors
Table 49. Report methodology: source hierarchy, interview base, and cut-off dates
Table 50. Glossary of mechanisms, programs, and regulatory terms

List of Figures

Figure 1. Amyloid-pathway mechanism map for disease-modifying therapy
Figure 2. Lecanemab and donanemab development timeline
Figure 3. Clarity AD and TRAILBLAZER-ALZ 2 program architecture
Figure 4. Japanese Alzheimer's treatment policy timeline
Figure 5. Early-AD population funnel: from cognition concerns to confirmed eligibility
Figure 6. Japanese dementia diagnosis pathway map
Figure 7. Eligibility-confirmation decision tree: PET, CSF, and blood biomarkers
Figure 8. Exclusion and caution framework schematic
Figure 9. Regional treatment-setting distribution map framework
Figure 10. Leqembi Japan pathway: from filing to NHI listing
Figure 11. Kisunla Japan pathway: approval, premium, and listing
Figure 12. Optimal Use Guidelines compliance structure
Figure 13. Infusion-visit schedule schematic
Figure 14. MRI monitoring and ARIA management pathway
Figure 15. Post-marketing surveillance architecture
Figure 16. Subcutaneous autoinjector development timeline
Figure 17. Maintenance-dosing framework comparison
Figure 18. Trontinemab Brainshuttle mechanism schematic
Figure 19. Anti-tau pipeline map
Figure 20. EVOKE and EVOKE+ program structure
Figure 21. International pipeline-entry map including GV-971
Figure 22. Prevention-trial framework: AHEAD 3-45 design schematic
Figure 23. PMDA review pathway reconstruction diagram
Figure 24. FDA and EMA pathway comparison flow
Figure 25. NMPA pathway considerations for the class
Figure 26. Biomarker gatekeeping structure in the treatment pathway
Figure 27. Subcutaneous formulation regulatory decision points
Figure 28. NHI price-setting flow for anti-amyloid antibodies
Figure 29. Usefulness-premium assessment framework
Figure 30. Infusion and monitoring cost-component map
Figure 31. US coverage architecture for Alzheimer's DMT
Figure 32. EU5 HTA landscape map for the class
Figure 33. China access environment map
Figure 34. PET imaging capacity framework in Japan
Figure 35. CSF laboratory network structure
Figure 36. Sysmex-Fujirebio blood-biomarker platform architecture
Figure 37. Roche Elecsys and Shimadzu MALDI-MS assay positioning
Figure 38. Eisai lecanemab franchise structure
Figure 39. Biogen partnership and legacy diagram
Figure 40. Lilly donanemab launch structure in Japan
Figure 41. Otsuka behavioral-symptom franchise map
Figure 42. Infusion-center operator landscape map
Figure 43. Diagnostics-channel structure: labs and hospitals
Figure 44. Delivery-capacity constraint map and expansion options
Figure 45. Eligibility-bottleneck schematic
Figure 46. Home-dosing transition scenario tree
Figure 47. Japan-to-Asia knowledge-transfer map
Figure 48. Vendor opportunity map in monitoring and data infrastructure
Figure 49. Methodology flow: sources, interviews, and cut-off dates
Figure 50. Data cut-off and update cadence schematic

Alzheimer's Disease-Modifying Therapy: Leqembi and Kisunla Uptake | Diagnostics Market Intelligence | US, EU5, Japan & China

Description

Table of Contents

List of Tables

Table of Content

1. Executive Summary

2. Alzheimer's Disease-Modifying Therapy: Technology and Test Landscape

3. Clinical Evidence and Guideline Context

4. Regulatory Status: PMDA, FDA, IVDR, and NMPA Pathways

5. Reimbursement and Price Formation with a Focus on Japan

6. Adoption, Channels, and Screening Infrastructure in Japan

7. Competitive Landscape: Companies and Platforms

8. Opportunities and Barriers for Market Participants

9. Appendix: Methodology and Sources

Companies Mentioned

List of Tables

List of Figures