Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast 2014-2024

Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast

2014-2024Opportunities for Leading Companies

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Contents

1.1 The Alzheimer’s Disease Therapeutics and Diagnostics Market Overview

1.2 Prostate Cancer Therapeutics Market Segmentation

1.3 Why You Should Read This Report

1.4 How This Report Delivers

1.5 Key Questions Answered by This Analytical Report

1.6 Who is This Report For?

1.7 Methodology

1.8 Frequently Asked Questions (FAQ)

1.9 Associated Reports

1.10 About Visiongain

2.1 Neurodegenerative Diseases

2.1.1 What is Alzheimer’s Disease?

2.1.2 What Causes Alzheimer’s Disease?

2.1.2.1 Alzheimer’s Disease: Type 3 Diabetes?

2.1.3 Management of Alzheimer’s Disease

2.1.4 The Socio-Economic Impact of Alzheimer’s Disease

2.1.5 Diagnosis of Alzheimer’s Disease

3.1 Alzheimer’s Disease Therapeutics and Diagnostics Market, 2013

3.2 Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-2024

3.2.1 The Market Has Been Left Exposed to Intensified Generic Competition

1. Report Overview

2. Alzheimer’s Disease: An Introduction

3. Alzheimer’s Disease Therapeutics and Diagnostics Market 2014-

2024

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Contents 3.2.2 Healthcare Costs for Alzheimer’s Disease Will Surpass All Other Medical Expenses

3.2.3 New Diagnostics and Drugs Regulatory Guidelines Will Lower the Barriers to Entry

3.3 Drivers and Restraints

4.1 Current Approaches and Unmet Needs in the Treatment of Alzheimer’s disease

4.2 The Alzheimer’s Disease Drugs Market, 2013

4.3 Changing Market Shares of the Leading Alzheimer’s Disease Drugs, 2014-2024

4.4 The Alzheimer’s Disease Drugs Market Forecast 2014-2024

4.5 Namenda

4.5.1 Namenda Sales Forecast, 2014-2024

4.6 Aricept

4.6.1 Aricept Sales Forecast, 2014-2024

4.7 Exelon

4.7.1 Exelon Sales Forecast, 2014-2024

4.8 Alzheimer’s Disease Drugs Pipeline, 2014

4.8.1 Recent High-Profile Failures of Clinical Trials for Alzheimer’s Disease Drug

Candidates

4.8.1.1 Solanezumab (Eli Lilly)

4.8.1.2 LY-2886721 (Eli Lilly)

4.8.1.3 GSK2647544 (GSK)

4.8.1.4 Bapineuzumab (Elan/J&J/Pfizer)

4.8.1.5 Gammagard (Baxter)

4.9 FDA to Relax Rules for the Approval of Alzheimer’s Drugs

4.10 Will Novel Drug Development Strategies Prove Successful?

4.11 Promising Therapies in the Alzheimer’s Disease Drugs Pipeline, 2013

4.11.1 Solanezumab (Eli Lilly)

4.11.1.1Solanezumab Sales Forecast 2014-2024

4. The Alzheimer’s Disease Drugs Market, 2014-2024

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Contents 4.11.2 Gantenerumab (Roche)

4.11.2.1The Gantenerumab Pipeline Forecast, 2014-2024

4.11.3 MK-8931 (Merck)

4.11.3.1 The MK-8931 Pipeline Forecast, 2014-2024

4.11.4 TTP488 (TransTechPharma)

4.11.5 LMTX (TauRx)

4.11.6 EVP-6124 (Forum Pharmaceuticals)

4.12 Deep Brain Stimulation (Functional Neuromodulation)

4.13 Leading Companies in the Alzheimer’s Disease Drugs Market, 2013

4.13.1 Pfizer, Inc

4.13.1.1Sales and Recent Performance Analysis, 2013

4.13.1.2 Pfizer: Aricept

4.13.1.3 Pfizer: R&D Capabilities and Alzheimer’s Disease Drug Candidates

4.13.2 Eisai

4.13.2.1 Sales and Recent Performance Analysis, 2013

4.13.2.2Eisai: Aricept

4.13.2.3 Eisai: R&D Capabilities and Alzheimer’s Disease Drug Candidates

4.13.2.4 Collaboration with Biogen

4.13.2.5 Partnership with GE Healthcare for Diagnostic Development

4.13.3 Forest Laboratories (Acquired by Actavis)

4.13.3.1Acquisition by Actavis

4.13.3.2 Forest: Namenda

4.13.3.3 Namenda’s Sales and Recent Performance Analysis, 2013

4.13.4 Lundbeck A/S


4.13.4.2 Lundbeck: R&D Capabilities

4.13.4.3Lundbeck’sAlzheimer’s Disease Drug Pipeline

4.13.4.4 Lundbeck: Ebixa

4.13.5 Daiichi Sankyo

4.13.5.1 Financial Sales and Recent Performance, 2013

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Contents 4.13.5.2 Daiichi Sankyo: Memary

4.13.6 Novartis AG


4.13.6.2 Novartis: Exelon

4.13.6.3 eHealth Programme Delivering Innovation

4.13.6.4 Novartis: Alzheimer’s Disease Drug Pipeline

4.13.7 TauRx

4.13.7.1Partnership with Bayer Schering Pharma AG

4.13.8 Transtech Pharma

4.13.8.1 TTP Translational Technology

4.13.8.2 TranstechPharma: Alzheimer’s Disease Pipeline Portfolio

5.1 There is Still a Strong Market Need for Effective Diagnosis

5.2 The Alzheimer’s Disease Diagnostics Market, 2013

5.3 Changing Market Shares of Leading Alzheimer’s Diagnostic Markets, 2014-2024

5.4 The Alzheimer’s Diagnostics Market, 2014-2024

5.5 New Criteria and Guidelines to Diagnose Alzheimer’s Disease

5.6 Biomarkers for Alzheimer’s Disease

5.6.1 Leading Companies Pursuing Novel Biomarker Development Strategies

5.7 Alzheimer’s Disease: Advances in Diagnostic Imaging Technologies

5.7.1 Structural Imaging

5.7.2 Functional Imaging

5.7.3 Molecular Imaging Technologies

5.7.3.1 Pittsburgh Compound B (PIB) (GE Healthcare)

5.7.3.2 Florbetapir F18 (18F-AV-45) (Eli Lilly)

5.7.3.3 Flutemetamol (GE Healthcare)

5.7.3.4 Florbetaben (Piramal Imaging)

5.8 Other Alzheimer’s Diagnostics in Development

5. The Alzheimer’s Disease Diagnostics Market, 2014-2024

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Contents 5.8.1 CSF Proteins

5.8.2 Blood Based Biomarkers for Alzheimer’s Disease

5.8.3 Genetic Risk Profiling

5.8.4 Eye Tests

5.9 Leading Companies in the Alzheimer’s Disease Diagnostics Market, 2014

5.9.1 Eli Lilly

5.9.1.1 Recent Performance and Sales Analysis, 2013

5.9.1.2 Alzheimer’s Disease Research Effort

5.9.1.3 Solanezumab

5.9.1.4 Amyvid (Florbetapir F18)

5.9.1.5 Amyvid Receives Marketing Authorization from the European

Commission

5.9.1.6 LY-2886721: Terminated Drug

5.9.1.7 N3pG-AB mAb:Phase I

5.9.1.8 Eli Lilly Acquires Novel Tau Tangle Diagnostic Programme

5.9.2 Amarantus BioScience Holdings, Inc.

5.9.2.1 Recent Performance and Sales Analysis, 2013

5.9.2.2 LymPro

5.9.2.3 Intellectual Property Acquisitions

5.9.3 Piramal Enterprises

5.9.3.1Piramal Imaging SA

5.9.3.2 U.S. and EMA Approval of Florbetaben

5.9.3.3 Manufacturing and Distribution Agreements

5.9.4 GE Healthcare

5.9.4.1 GE’s Commitment to Imaging Research in the Alzheimer’s Field

5.9.4.2 Regulatory Approval of Flutemetamol

5.9.4.3 Licensing Agreements for Flutemetamol

5.9.5 Navidea

5.9.5.1 NAV4694 (Fluorine-18)

5.9.5.2 Collaboration Agreements

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Contents 5.9.5.3 NAV4694 Clinical Development

5.9.6 Diagenic

5.9.6.1 Organisational Restructuring

6.1 Regional Breakdown of the Global Alzheimer’s Disease Therapeutics and Diagnostic Market,

2013

6.1.1 The US and Europe Represent More than 70% of the Total Market

6.2 The Global Alzheimer’s Disease Therapeutics and Diagnostics Market: Regional Forecast,

2014-2024

6.3 Changing Market Shares of Leading National Markets 2014-2024

6.4 The US Alzheimer’s Disease Therapeutics and Diagnostics Market, 2014-2024

6.4.1 One in Eight Over the Age of 65 has AD in the US

6.4.2 The US Will Remain the Largest Market Over the Forecast Period

6.5 The European Alzheimer’s Disease Therapeutics and Diagnostics Market, 2014-2024

6.5.1 The German Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast,

2014-2024

6.5.2 The French Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast,

2014-2024

6.5.3 The UK Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-

2024

6.5.4 The Spanish Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, #

2014-2024

6.5.5 The Italian Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast,

2014-2024

6.5.6 The Rest of Europe Alzheimer’s Disease Therapeutics and Diagnostics Market

Forecast, 2014-2024

6.6 The Japanese Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-

2024

6. The Leading National Markets, 2014-2024

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Contents 6.7 The Chinese Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-2024

6.8 The Indian Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-2024

6.9 The Brazilian Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-2024

6.10 The Russian Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-2024

6.11 The Rest of the World Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast,

2014-2024

7.1 SWOT Analysis

7.2 Strengths

7.2.1 Alzheimer’s Disease is a High Profile Disease

7.2.2 Expanding Patient Population

7.2.3 Strong R&D Pipeline in Both Sectors of the Market

7.3 Weaknesses

7.3.1 Current Drugs Only Treat the Symptoms of Alzheimer’s Disease

7.3.2 Recent Failures of Promising Drug Candidates in Clinical Trials

7.3.3 Poor Macroeconomic Conditions in Key Regions of the Market

7.4. Opportunities

7.4.1 Regulations Seeking Improved Standards of Alzheimer’s Disease Drug

Development

7.4.2 Neurodegenerative Diseases Have Strong R&D

7.4.3 Emerging Markets Will Help Drive the Market

7.4.4 Advances in Diagnostic Technologies Will Improve Drug Market Penetration

7.5 Threats

7.5.1 Patent Expiries Will Lead to Further Generic Competition

7.5.2 New AD Therapies Face Political, Commercial and Social Pressures

7.6 Porter’s Five Force Analysis

7. Qualitative Analysis of the Alzheimer’s Disease Therapeutics and

Diagnostics Market, 2014-2024

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Contents 7.6.1 Rivalry Among Competitors

7.6.2 Threats of New Entrants

7.6.3 Powers of Suppliers

7.6.4 Bargaining Power of Buyers

7.6.5 Threat of Substitutes

8.1 Dr Simon Ridley, Head of Research, Alzheimer’s Research UK

8.1.1 Alzheimer’s Treatment in Late Stage Development

8.1.2 The Benefits of Alzheimer’s Diagnosis: A Future Prospect

8.1.3 Alzheimer’s and its Relationship with Other Diseases

8.1.4 Strategies to Incentivise Alzheimer’s Research and Investment

8.2 David Hanlon, Director of Business Development and Strategic Collaborations, Quanterix

8.2.1 Ultra Sensitive Automated Immunoassay Platform for Alzheimer’s

8.2.2 Alzheimer’s Disease Blood-based Biomarkers

8.2.3 Research Based Setting of the Simoa Technology

8.2.4 Quanterix: Alzheimer’s Partners and Collaborations

8.3 Elizabeth Edgerly, Ph.D., Chief Program Officer, The Alzheimer’s Association Northern

California and Northern Nevada

8.3.1 Alzheimer’s Severe Under diagnosis

8.3.2 Novel Biomarkers: Critical for Alzheimer’s Diagnosis

8.3.3 Alzheimer’s Treatment Paradigm: Needs to be More Universally Effective

8.3.4 A Push to Improve the Success of Alzheimer’s Research

8.3.5 Alzheimer’s Treatment: The Greatest Challenge

#

9.1 Novel Diagnostic Technologies Will Emerge First and Then the Disease Modifying Drugs

9.2 Disease Modifying Drugs Will Transform the Declining Alzheimer’s Market

9. Conclusions

8. Expert Opinions

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Contents 9.3 Demographics Will Help Drive the Market Over the Forecast Period

9.4 Medicines and Diagnostic Tests for Alzheimer’s Disease Hold Great Potential from 2014 to

2024

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Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast 2014-2024: Opportunities for Leading Companies

condition. Separate analyses, and forecasts, for Pfizer’s Aricept and Eisai’s Aricept can be found in

sections 4.13.1.2 and 4.13.2.2, respectively.

Visiongain predicts total Aricept sales will exhibit a CAGR of -9% over the period 2013-2024. We

therefore we expect Aricept to generate a total of $0.4bn in sales by 2024. Even though sales are

poised to decline, we expect Aricept to remain one of the leading drugs throughout the forecast

period as it is a long established product and the most commonly prescribed in the market. Aricept

is therefore likely to be prescribed in combination with novel treatments throughout the analysis

period.

Table 4.5 Aricept: Sales Forecast ($bn), AGR (%), CAGR (%), 2013-2024

Figure 4.7 Aricept: Sales Forecast ($bn), AGR (%), 2013-2024

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Aricept ($bn) 1.0 0.9 0.8 0.7 0.6 0.6 0.5 0.5 0.4 0.4 0.4 0.4AGR (%) -16 -13 -10 -10 -9 -9 -8 -8 -7 -6 -6CAGR (%) 2013-2018CAGR (%) 2013-2024

2018-2024-9

-12 -7

-18

-16

-14

-12

-10

-8

-6

-4

-2

0

0.0

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0.4

0.6

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1.0

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AGR

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Reve

nue

($bn

)

Year

Revenue ($bn) AGR (%)

Source: visiongain 2014


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4.13.1.1Sales and Recent Performance Analysis, 2013 In 2013, Pfizer achieved net sales of $51.6bn (figure 4.12), which represented a decrease of -5.7%

compared to the previous fiscal year. Net income increased 50.7% over 2012, reaching $22.0bn.

The decline in revenues was reported to be primarily due to the loss of exclusivity of Lipitor in the

U.S., developed Europe and other markets. Pfizer estimate the loss due to the erosion of sales of

Lipitor to be approximately $5.6bn. Other losses of exclusivity include Geodon in March 2012 in the

US and other less revenue generating products.

In 2013, most of the revenues came from the established products and emerging markets

operating segment. This segment of the company achieved $19.7bn in revenue in 2013,

accounting for 38.1% of the company’s net sales.

Figure 4.12 Pfizer: Historical Revenues ($bn), Net Income ($bn) and Profit Margin (%), 2009-2013

49.3

67.1 67.4

54.7 51.6

8.6 8.3 10.0 14.6

22.0

051015202530354045

01020304050607080

Prof

it M

argi

n (%

)

US

Billi

ons

($)

Fiscal Year

Revenue ($bn) Net Income ($bn) Profit Margin (%)

Source: Pfizer 2014; visiongain 2014

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6.5.5 The Italian Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast, 2014-2024 The Italian AD therapeutics and diagnostics market was worth $0.2bn in 2013, and therefore

currently represents 8.4% of the total European market. Visiongain forecasts this market will

expand to $0.5bn by 2024. Similar to Spain, and other countries in Europe, Italy’s economy has

been severely affected by a debt crisis that has spurred unemployment in the country to

unprecedented levels.

Consequently, the Italian National Health Service has been underfinanced for many years as a

result of reduced government spending. Italy offers universal healthcare access, modeled originally

on the British NHS. An ageing population brings with it concomitant increases in chronic, long-term

conditions which are expensive to treat, including AD. In the case of Italy, the country as a whole

is more elderly than France, the UK, and Spain. Although Germany has, since 2008, a higher

percentage of its population aged 65 or over, Italian demography is still daunting in terms of its

implications for healthcare spending. Approximately 21% of Italians are aged 65 or over, and this

will rise to nearly 23% by 2023. Although Italian drug prices are lower than in France, Germany

Figure 6.16 The Spanish Alzheimer’s Disease Therapeutics and Diagnostics Market Forecast: Revenue ($bn), AGR (%),2013-2024

-10

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