高コレステロール血症治療ワクチン(PCSK9)の世界市場機会分析

◆英語タイトル:MarketVIEW: Cholesterol (PCSK9) vaccines : Global vaccine commercial opportunity assessment
◆商品コード:VZINE50201
◆発行会社(リサーチ会社):VacZine Analytics
◆発行日:2015年2月
◆ページ数:90
◆レポート形式:英語 / PDF、Excel
◆納品方法:Eメール
◆調査対象地域:グローバル
◆産業分野:製薬
◆販売価格オプション(消費税別)
Executive Summary (PDF)USD4,995 ⇒換算¥554,445見積依頼/購入/質問フォーム
Forecast Model (Excel)USD4,995 ⇒換算¥554,445見積依頼/購入/質問フォーム
PDF+ExcelUSD8,995 ⇒換算¥998,445見積依頼/購入/質問フォーム
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【レポートの概要】

Cardiovascular disease(s) (CVD) are prominent within the 10 leading causes of death in high-income countries. The most common manifestations of CVD are coronary heart disease (CHD), ischaemic stroke, and peripheral arterial disease (PAD). Raised low-density lipoprotein cholesterol (LDL-C), smoking, and uncontrolled hypertension are major risk factors the development of CVD. By 2030 almost 24.3M people/year globally are predicted to die from CVD.

Currently Statins (HMG-CoA reductase inhibitors) are the most effective drug class for reducing LDL-C but differ in their LDL-C lowering capacity. In addition, several novel therapies are in development to reduce LDL-C levels in patients with severe hypercholesterolemia. These include PCSK9 inhibitors (monoclonals) of which Sanofi’s SAR236553 (REGN727) PRALUENT and Amgen’s evolocumab RAPATHA have now been filed for registration in both the US and EU. Both monoclonals were shown to reduce LDL-C levels by 40 to 60% in combination with statins/ezetimibe in high-risk patients and those with homozygous familial hypercholesterolaemia. CVD outcomes studies are now ongoing.

Some companies (Pfizer and AFFiRiS AG) are also investigating the possibility of preclinical PCSK9 vaccines that could help reduce LDL-C levels in high-risk patients who cannot achieve guideline LDL-C treatment goals. Vaccines could have the added benefit of lower cost and less frequency of administration than monoclonals.

This MarketVIEW product contains a comprehensive MS Excel-based model + summary presentation which forecasts the potential commercial value of PCSK9 (cholesterol) vaccines + monoclonals across major Western markets until 2030. The model contains value ($ m) and volume (mio doses) predictions per product type along with timeframe, pricing and penetration estimates for all target populations. The product also includes an in depth review of latest epidemiological trends, lipid lowering treatments/guidelines and latest developments in R&D.

【レポートの目次】

****This product is composed of two forecast models and a summary presentation
※PAGES: ~90 MS PowerPoint slides, fully referenced/sourced. Available in .pdf form

Author’s note
Contents
Executive Summary
Commercial model: key model outputs
PCSK9 vaccines: predicted venues by scenario to 2030
PCSK9 vaccines: predicted revenues by region to 2030
PCSK9 vaccines: predicted volume to 2030
Patient numbers: PCSK9 vaccines versus anti-PCSK9 mAbs to 2030
Cardiovascular disease (CVD): background and epidemiology
Cardiovascular disease: a major cause of death
The economic burden of cardiovascular disease (US)
The economic burden of cardiovascular disease (EU)
Secondary causes of hyperlipidemia most commonly encountered in clinical practice
Managing CVD: EU and US lipid guidelines – background
Major changes in new US ATP IV guidelines
Focus on CVD risk groups
CVD risk groups: Heterozygous familial hypercholesterolemia (heFH)
LDL-C treatment goals
LDL-C treatment goals: comparing EU to US
LDL-C treatment goals: ESC/EAS LDL-C treatment targets
LDL-C treatment goals: intervention strategies by risk group/ LDL-C
LDL-C lowering treatments
Statins: lipid lowering intensity levels
Drivers of statin choice
Patient subgroups: statin benefits outweigh risks
Side effects of statins
LDL-C lowering treatment uptake: general
Hospitalized CVD patients discharged on statin therapy, 1996-2006, by EU country
LDL-C lowering treatment uptake: by risk group
LDL-C goal achievement in CVD patients
LDL-C goal achievement in heFH patients
Anti-PCSK9 monoclonal antibodies: Novel LDL-C lowering agents
Background to PCSK9 inhibitors
PCSK9 role in LDL cholesterol (LDL-C) metabolism
PCSK9 inhibition strategies
PCSK9 monoclonal antibodies: current status
Broad target populations for anti-PCSK9 mAbs
PCSK9 monoclonal antibodies: overview of competitor activity
Sanofi Aventis – alirocumab (SAR236553)
Sanofi Aventis – alirocumab: Phase II data
Sanofi Aventis – alirocumab: ODYSSEY program
Sanofi Aventis – alirocumab: Phase III – ODYSSEY results
Submissions of alirocumab (SAR236553) – PraluentTM
PraluentTM – market opportunity (US/EU5/Japan)
Amgen – evolocumab (REPATHATM)
Evolocumab: example Phase III data (TESLA Part B)
Evolocumab: market opportunity (US/EU5/Japan)
Pfizer – bococizumab
Summary of anti-PCSK9 mAbs: outcomes studies
PCSK9 – other targetted therapies
Concerns with anti-PCSK9 monoclonals
Other remaining questions regarding PCSK9 inhibitors
PCSK9 vaccines: background and overview of R&D
PCSK9 vaccine: key model assumptions
The role of a PCSK9 vaccine
PCSK9 vaccine: Target Product Profile (TPP)
PCSK9 vaccine development – AFFiRiS AG
PCSK9 vaccine development – Pfizer
PCSK9 vaccine development – Pfizer (preclinical data)
Pros and cons of PCSK9 vaccine approach
PCSK9 vaccine: modelling commercial potential
Key model inputs: countries & target populations
Key model inputs: vaccine market penetration
Key model inputs: vaccine dosing/pricing
Key model inputs: vaccine discontinuation rate
Key model inputs: summary table
Methodology: definition of risk groups
Modelling methodology
Risk groups modelled
CVD hospital discharges
Death rates CHD
Coronary revascularisation (TCA and CABG combined), hospital discharges
Transluminal coronary angioplasty (TCA) and coronary artery bypass graft (CABG) discharges
Methodology: stroke incidence
Appendix: Anti-PCSK9 monoclonals: List of major clinical trials
ODYSSEY program – overview of Phase III trials
Phase III trials of evolocumab
Phase III trials of bococizumab
Bibliography
About VacZine Analytics
Disclaimer

[Contents – Vaccine demand model TX vaccine (MS Excel-based)] ※Worksheets ~ 35 interconnected

Title sheet
CHARTS – VALUE
CHARTS – VOLUME
CHARTS – TREATED PATIENTS
Vaccine – Value
Vaccine – Volume
Patients – mAbs
Secondary prevention
Country worksheets 
US
Canada
France
Germany
Italy
Spain
UK
Other Europe
Australia
Source material 
Key inputs
Vaccine price summary
Coronary revascularisation
TCA
CABG
PAD
Stroke
US discharge trends
heFH
LDL-C goals
WHO
Statins in CVD patients
Clinical trials
Total population
Back pagenull



【レポートのキーワード】

PCSK9ワクチン(PCSK9阻害薬)、コレステロール、高コレステロール血症、心血管疾患(CVD)、LDL-C(LDLコレステロール)、ワクチン開発、市場機会、ビジネスモデル



【免責事項】
http://www.globalresearch.jp/disclaimer

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