Potentials and Trends in Biomimetics

Product Description

The purpose of this study was to take an in-depth look at the most important trends and the potentials of biomimetics as a basis of science and engineering development and innovation and to assess the standing of biomimetic research and development in Germany as compared internationally. Building on case studies; analyses of literature, patents, and research networks; and interviews and workshops, information and specific findings were compiled with respect to the status of biomimetics as a research and development field, the validity of the “biomimetic promise” of ecological adaptation and low-risk biomimetic solutions, the current trends in bionics, as well as the general setting, driving forces, and obstacles in the realization of its potential for innovation.

Buy from AMAZON Potentials and Trends in Biomimetics

Business Trends: Pharmaceuticals Technology Understanding Your Life Sciences Customer 2009 (Customer Focus)–Aarkstore Enterprise

Aarkstore announce a new report  ” Business Trends: Pharmaceuticals Technology Understanding Your Life Sciences Customer 2009 (Customer Focus) ” through its vast collection of market research report.

Introduction

This Ovum study examines top business challenges, IT budget outlook, and spending priorities among pharmaceutical and biotechnology companies in the US, Canada, the UK, France, Germany, Japan, China and India. It is based on the results of Ovum’s Business Trends primary research, conducted in Q3 and Q4 2009, with a total of 150 life sciences companies.

Scope

*In-depth interviews with 150 pharmaceutical and biotechnology companies

*Geographic coverage includes: US, Canada, UK, France, Germany, Japan, China and India

*The study focuses on business challenges, IT budget outlook, and adoption rate of data and knowledge management solutions

*Respondents include IT decision-makers such as CIOs and CTOs

Highlights

For the life sciences industry, regulatory compliance is and will always be at the heart of every IT investment strategy. Moving past this, executives are increasingly turning to IT to help optimize business processes. As the end of the recession nears, life sciences companies will focus on completing IT projects that were put on hold in 2009.

With the patent cliff on the horizon, life sciences companies must have robust product pipelines to maintain steady revenue streams. Small pharma and biotech companies are especially under great pressure to develop a successful drug as they are relying on funding primarily from investors, with little or no revenue coming in.

As generic competition increases, pharma companies aim to globalize their brand and increase their market share in the emerging markets. To increase their presence, there is increased M&A activity with local organizations. In addition, pharma companies are outsourcing key business processes as they cut costs and become leaner.

Reasons to Purchase

*Validate your market messaging and positioning in the life sciences industry

*Compare pharmaceutical and biotechnology IT purchasing plans across geographies

*Identify emerging areas of concern for pharmaceutical and biotechnology companies

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Special offer till 31th Dec 2009

Biochips – A Global Update Of Market Trends & Opportunities

The biochip industry is in the early stages of growth and hence, not only promises potential but also is susceptible to vagaries of market forces. Competition, patent disputes, knowledge constraints (in terms of skilled employees, technical know-how) and financial strength might be a few impediments for firms engaged in this industry. A promising market arises from three factors – an aging population, third party reimbursement and a growing number of individuals suffering from common chronic diseases. Biochips would certainly evolve in terms of physical, technical characteristics, and with focus on miniaturization of assays, they would turn smaller and more powerful with each generation. The industry is characterized by both intense rivalry and equally well-developed web of alliances.

These and other market data and trends are presented in “Biochips: A Global Update of Market Trends & Opportunities” by BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses.

Biotechnology Industry: Biochips – A Global Update of Market Trends & Opportunities
Company Profile, SWOT and Revenue Analysis!

1. METHODOLOGY 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Quantitative Techniques & Reporting Level 3

2. INDUSTRY OVERVIEW 4
Promising Biochips Promote Biological Research 4
Market Scenario across Products and Regions 4
DNA Chips Lead the Application Front 5
Probable Industry Directions 5
Biochip Technology Boosts Personalised Medicine 6
Biochip Technology Spreads beyond Pharma Industry 7
Protein Chips to Shape the Future 7
Proteomics “Chip” into Biochip Technology 8
Towards Increasing Minaturization 8
European Advancements Set Diagnostic Procedures 8
Competitive Scenario 8
Major Participants 8
Roche and Affymetrix Taste Success in the Diagnostics Market 10
Growing Partnerships between Pharma and Biotech Companies 10
Tech Giants Join the Biochip Fray 11

3. PRODUCT FACTS 12
A. DNA Chips 12
B. Protein Chips 13
C. Lab Chips 13

4. APPLICATIONS OF BIOCHIPS 13
Biochip Uses 14
Biochips and Pharmaceutical Investigation 14
Biochips and Medical Diagnostics 15
Advantages of Biosensor Chip Technology 15
Biochips and Forensics 16
Biochips and Transplantation Screening 16
Biochips and Identity Testing 16
Biochips and Water and Environmental Testing 16
Food Industry 16

5. TRENDS 17
Industry Characteristics 17
New Products and Players to Drive Market 17
Key Forces Boosting the Industry 17
Industry Structure 17
Industry Challenges 18
Price Dearness Pauses Biochips Growth 18
Current Approaches to Biochips 19
The Business of Biochips 19
Technological Trends 20
Sensitivity 20
Microfabrication 20
Density 20
Integrated Chips 21
Patent Trends 21
Patent Applications 21

6. NEXT GENERATION TECHNOLOGY 22
Microfluidics Using CD-ROM Technology 22

7. CORPORATE DEVELOPMENTS 23
Affymetrix Acquires USB 23
Illumina Announces Partnership with Genpathway for ChIP
Sequencing Services 23
Affymetrix and Avesthagen Enter into an Agreement 24
Roche NimbleGen and Affymetrix Announce Expansion of License
Agreement 24
GATC Biotech Establishes New Subsidiary 25
Affymetrix Introduces Complete Cytogenetic Solution 25
Sigma Launches ChIP Kit 25
US and Czech Scientists to Develop Biochips for Detecting Cancer 26
Roche Takes Over NimbleGen 26
GenTel BioSciences Acquires Protein Chip Platform Assets of GSK 27
Advanced Liquid Logic Acquires Nanolytics 27
Applied Microarrays Acquires Select GE Healthcare’s Assets 27
Affymetrix and Partners Healthcare Extend Collaboration 28
Agencourt, NuGEN and Affymetrix Clinical Services Collaborate 29
Affymetrix Inks Licensing Agreement with Empire Genomics 29
Caliper Enters into a Licensing Agreement with Monogram
Biosciences 30
Affymetrix and IPSOGEN Sign Agreement 30
bioMérieux and NuGEN Enter into Supply and Cross-License
Agreement 31
VWR and CapitalBio Enter into a Distribution Agreement 31
UCL Subsidiary and Roche Diagnostics Ink Licensing Deal 32
Affymetrix Establishes the European Cytogenetic Research
Initiative. 32
Roche Introduces Gene Expression Services and Arrays 32
Affymetrix Unveils Affymetrix GeneChip Command Console Software 33
Affymetrix Introduces GeneChip Mouse and Rat Gene 1.0 ST Arrays 33
Affymetrix Unveils Genome-Wide Human SNP Array 6.0 34
Caliper Life Sciences Launches High Throughput RNA Assay 35
Applied Biosystems Unveils DNA Tools 35
febit Launches Geniom RT Analyzer 35
Austrian Research Center Develops New Biochip Surface 36
Researchers Develop Biochips to Eliminate Animal Testing 36

8. MAJOR PLAYERS 37
Affymetrix (US) 37
Applied Biosystems Group (US) 37
Biomerieux (France) 37
Bio-Rad Laboratories, Inc. (US) 37
Caliper Life Sciences, Inc. (US) 37
Cepheid Inc. (US) 38
GE Healthcare Ltd (UK) 38
Takara Bio, Inc. (Japan) 38
Zyomyx (US) 38

9. MARKET ANALYTICS 39

10. THE UNITED STATES 43
Biochips Market Overview 43
Time Saving Biochips – All Set to Grow 43
Multiple Applications of Biochips Drive Sales 43
Biochip Market Faces Challenges 43

11. CANADA 45

12. JAPAN 46
DNA Chip Based on Printing Technology 46
DNA Chips to Reveal Links Among Genes 47
A Leading Japanese Biochip Player – Takara Shuzo 47
ICAN ™ Technology for Large-Scale Production of DNA Fragments 48

13. EUROPE 50

a. France 52

b. Germany 53

c. The United Kingdom 55

d. Rest of Europe 56

14. REST OF WORLD 57
China 58
Basic Environment and Commercial Development 58
Biochip Research 58
Status of Biochip Industry in China 59
Taiwan 59
Taiwan Pursues Promise of Biochip Sector 59
International Advantage Sought 60

EXHIBITS

Table 1: Market Shares of Biochips Patent Applications in the
World – 2003

Table 2: Global Biochips Market by Region for the Period
2007-2015 (Sales in US$ Million)

Table 3: Percentage Breakdown of Global Biochips Market by
Region for the Years 2008 & 2012

Table 4: Global DNA Chips Market by Region for the Period
2007-2015 (Sales in US$ Million)

Table 5: Percentage Breakdown of Global DNA Chips Market by
Region for the Years 2008 & 2012

Table 6: Global Protein Chips Market by Region for the Period
2007-2015 (Sales in US$ Million)

Table 7: Percentage Breakdown of Global Protein Chips Market
by Region for the Years 2008 & 2012

Table 8: Global Lab Chips Market by Region for the Period
2007-2015 (Sales in US$ Million)

Table 9: Percentage Breakdown of Global Lab Chips Market by
Region for the Years 2008 & 2012

Table 10: Biochips Market by Segment in the US: 2007-2015
(Sales in US$ Million)

Table 11: Percentage Breakdown of Biochips Market by Segment
in the US for the Years 2008 & 2012

Table 12: Biochips Market by Segment in Canada: 2007-2015
(Sales in US$ Million)

Table 13: Percentage Breakdown of Biochips Market by Segment
in Canada for the Years 2008 & 2012

Table 14: Biochips Market by Segment in Japan: 2007-2015
(Sales in US$ Million)

Table 15: Percentage Breakdown of Biochips Market by Segment
in Japan for the Years 2008 & 2012

Table 16: Biochips Market by Region in Europe: 2007-2015
(Sales in US$ Million)

Table 17: Percentage Breakdown of Biochips Market by Region in
Europe for the Years 2008 & 2012

Table 18: Biochips Market by Segment in Europe: 2007-2015
(Sales in US$ Million)

Table 19: Percentage Breakdown of Biochips Market by Segment
in Europe for the Years 2008 & 2012

Table 20: Biochips Market by Segment in France: 2007-2015
(Sales in US$ Million)

Table 21: Percentage Breakdown of Biochips Market by Segment
in France for the Years 2008 & 2012

Table 22: Biochips Market by Segment in Germany: 2007-2015
(Sales in US$ Million)

Table 23: Percentage Breakdown of Biochips Market by Segment
in Germany for the Years 2008 & 2012

Table 24: Biochips Market by Segment in the UK: 2007-2015
(Sales in US$ Million)

Table 25: Percentage Breakdown of Biochips Market by Segment
in the UK for the Years 2008 & 2012

Table 26: Biochips Market by Segment in Rest of Europe:
2007-2015 (Sales in US$ Million)

Table 27: Percentage Breakdown of Biochips Market by Segment
in Rest of Europe for the Years 2008 & 2012

Table 28: Biochips Market by Segment in Rest of World:
2007-2015 (Sales in US$ Million)

Table 29: Percentage Breakdown of Biochips Market by Segment
in Rest of World for the Years 2008 & 2012

The Future Of Virtualization: Emerging Trends And The Evolving Vendor Landscape-Aarkstore Enterprise

This report investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via fixed dose combinations. The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to provide a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world. An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.

This report explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs.

The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to give the reader a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world.

An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.

Key findings

Drug manufacturers must make the best strategic use of the patent-protected lifespan of a drug, or else risk losing the profit incentives they perceived at the start of the project. (Ch. 1)

In light of the increasing complexity of biopharmaceutical patenting, the ‘freedom to operate’, i.e. to commercialize the invention, is coming under increasing scrutiny. (Ch. 2)

The US Congress’ emerging stance on data exclusivity provisions for biologics will define the length of time a biotechnology company can keep out generic competition in new indications. The biotech industry’s stance is that the current provisions do not provide for enough time to profit from their post-approval R&D investments. (Ch. 2)

The potential for post-approval label expansion is much greater for biologics in comparison to small molecule pharmaceutical drugs. Most biologics on the market today can expect to add significant revenue streams via new indications, and potentially extend their commercial lifespan. (Ch 3)

Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.

If an FDC is launched close to the loss of exclusivity date of the constituent brand, it may be interpreted as a marketing tactic to limit post-LoE revenue losses. If launched early, it may show intent to cater to a genuine unmet need, or to legitimately maximize the potential of the parent molecule(s). (Ch. 4)

Scope of the report

In-depth case studies explore the real-world execution of the issues and challenges discussed in the report.

Analysis of historic drug approval data provides the reader with contextual reference points.

Case studies on Vytorin, Advair and BiDil illustrate the strategies employed by three leading FDC brands.

Brand histories of Yaz, Remicade and Seroquel show how label expansion is fundamental to successful lifecycle management.

Where applicable, these strategies are discussed with reference to specific therapeutic areas or geographies.

Issues related to biologics are highlighted to indicate where they differ from small molecule drugs.

Use this report to

Gain an understanding of legal provision for patent protection and data exclusivity. Understand their role in the context of product lifecycle management

Utilize the historical data on NDA approvals to identify trends and build assumptions into competitive landscape forecasts.

Understand the stance of key stakeholders and implications of off-label drug usage.

Understand the role of FDCs in optimizing the commercial potential of a product asset, and the main challenges in their commercialization

Juxtapose historic sales performance with the timing of indication expansion and FDC based strategies to assess the success or failure

 
 
 
  Table of Contents : 
 

Optimizing Lifecycle Management
Executive summary 8
Product lifecycle and management challenges 8
Influencing the commercial lifespan of the drug 9
Accessing broader patient populations 10
Fixed dose combinations 11
Chapter 1 Product lifecycle and management challenges 14
Summary 14
Introduction 15
The lifecycle of biopharmaceutical drugs 15
Development lifecycle 17
Commercial lifecycle 22
Managing the lifecycle 22
Longer development time 23
Slower product uptake via reimbursement hurdles 24
Peak sales potential is reduced by higher competition 25
Earlier lifecycle decline due to therapeutic substitution 26
Chapter 2 Influencing the commercial lifespan of a drug 30
Summary 30
Bargaining power of biopharmaceutical brands 31
Brand equity 31
Patent protection and “freedom to operate” 32
Strategic patenting 33
Patent prosecution superhighway 35
Patent protection for biologics 35
Data exclusivity 36
Difference between data exclusivity and patent protection 40
8+2+1 system in the EU 40
Data exclusivity in the US 42
Data exclusivity in Japan 43
Data exclusivity in the context of biologics 44
Chapter 3 Accessing broader patient populations 46
Summary 46
Drug labeling and market access 47
Off-label drug usage 47
Commercial incentives and disincentives 48
Payors stance on off-label reimbursement 49
Case study: Avastin and Lucentis 51
Expanding the label 53
Role in product lifecycle management 53
New indications 53
Pediatric extensions and special populations 54
Modified indications and expanded usage 54
Case study: Yaz 55
Case study: Remicade 58
Indication expansion 59
Choosing the primary indication 61
Related versus unrelated indications 63
Sequence of indication expansion 64
Timing of indication expansion 65
Launching early in commercial lifecycle 68
Launching late in commercial lifecycle 69
Seroquel: Using indication expansion and drug reformulation synergistically 70
Recent trends in indication expansion 72
Indication expansion for NDAs 72
Indication expansion for biologics 75
Chapter 4 Fixed dose combinations 80
Summary 80
Introduction 81
Clinical challenges in FDC development 81
FDC patents 82
Data exclusivity for FDCs 83
Role in product lifecycle maximization 83
Case study: Advair’s role in GSK’s asthma franchise 85
Case study: How Vytorin influenced Zocor’s patent expiry 88
Case study: BiDil’s value proposition reinvented 90
FDC uptake by geography 91
Case study: FDCs for hypertension 91
Clinical rationale 93
Synergistic efficacy or safety 94
Easier Rx management 95
Correlation between FDC usage and drug compliance 95
Correlation between drug compliance & improved clinical outcomes 96
FDC usage by therapy area 96
Key success factors and competitive hurdles 98
Endorsement by treatment guidelines 98
Perceived synergy effects over free combination 99
Compliance advantage over the free combination 99
Usage of mono compounds prior to FDC launch 99
Discount compared to cheapest free combination 100
Time-to-LOE of parent brand 101
Chapter 5 Appendix 103
Primary research methodology 103
Glossary 107
Index 111
List of Figures
Figure 1.1: Summary of lifecycle of medicinal drugs 17
Figure 1.2: Transition probabilities for clinical phases 18
Figure 1.3: Out-of-pocket and capitalized costs of developing a drug ($m) 19
Figure 1.4: Time taken for development of new pharma & biotech drugs 20
Figure 1.5: Approval timelines at CDER for priority NDAs, 1999-08 21
Figure 1.6: Approval timelines at CDER for standard NDAs, 1999-08 21
Figure 1.7: Imperatives of efficient lifecycle management 23
Figure 1.8: Increasing importance of payors as stakeholders 24
Figure 1.9: Tougher payor environments are slowing product uptake 25
Figure 1.10: Therapeutic substitution and formulary access 27
Figure 2.11: 8+2+1 data exclusivity system in Europe 41
Figure 2.12: Data exclusivity and patent protection in the US 43
Figure 3.13: On and off-label decision making by payors 50
Figure 3.14: Off-label usage of Avastin: a pharmacoeconomic model for wet AMD 52
Figure 3.15: Yaz: Label expansion & sales growth – US ($m), 2006-08 57
Figure 3.16: Remicade: Label expansion & sales growth – US ($m), 2001-08 59
Figure 3.17: Time between launch of original and new indications in the US (by ATC), 1999-08 66
Figure 3.18: Time between launch of original and new indications in the US (by ATC), 1999-08 (contd) 67
Figure 3.19: Considerations in launching new indications early in the lifecycle 69
Figure 3.20: Considerations in launching new indications late in the lifecycle 70
Figure 3.21: Lifecycle management: Seroquel and Seroquel XR 71
Figure 3.22: New indication approvals for NDAs, 1999-2008 73
Figure 3.23: New indication approvals for Orphan drugs, 1999-08 73
Figure 3.24: New indication approvals with priority reviews, 1999-08 74
Figure 3.25: Increasing clinical and commercial potential for Remicade 77
Figure 4.26: FDC approvals in the US, 1999-08 84
Figure 4.27: Advair: FDA approvals and patent protection 86
Figure 4.28: Advair-Serevent sales in the US: maintaining revenues post patent expiry of Flovent 87
Figure 4.29: Zocor-Vytorin-Zetia brand timeline 88
Figure 4.30: Cushioning the patent cliff: Zocor-Vytorin-Zetia sales in US ($m), 2001-08 89
Figure 4.31: FDC usage for hypertension across major markets 93
Figure 4.32: Drug classes with maximum FDC approvals in the US, 1999-08 97
List of Tables
Table 2.1: Data exclusivity periods by country 39
Table 3.2: Success drivers and barriers in indication expansion 61
Table 3.3: Unmet needs prevalent within an indication 62
Table 3.4: Commercial considerations in prioritizing new indications 62
Table 3.5: Disease areas and related sub-populations for hypertension and heart failure 63
Table 3.6: New indication approvals by drug class, 1999-08 75
Table 4.7: FDC case studies 81

 
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Pharmaceutical Key Trends 2010

Pharmaceutical Key Trends 2010
 
 Pharma faces a number of key resistors to growth including the impending 2011 patent cliff which is set to erode $78 billion in global branded sales from drugs facing patent expiry over the 201014 period (plus $32 billion from continued erosion of already expired brands). Price cuts, reimbursement restrictions and growing regulatory pressure are further set to limit sales growth going forward. ( http://www.bharatbook.com/detail.asp?id=134235&rt=Pharmaceutical-Key-Trends-2010.html )
 
 Scope
 
 * Overview of the key drivers and resistors facing Pharma, Biotech and generics players out to 2014
 * Analysis of recent regulatory changes in the US, EU and emerging markets and their impact on pricing and reimbursement, drug development and marketing
 * Examination of key global and country-specific issues facing both biosimilars and generics players
 * Assessment of the impact of the global economic downturn on the Pharma and Biotech sectors and their respective counter strategies
 
 Highlights
 
 Annual sales growth of pharmaceuticals in the emerging markets is already double-digit, providing a key opportunity for Pharma. Revenue streams in these markets can be derived from launching branded off-patent drugs, branded generics, and local brands owned or licensed by the acquiring pharma company.
 
 Pharma is moving away from the “”me-too”" and increasingly genericized primary care market towards more high value biologic therapies in secondary care as well as more niche markets; markets with little or no existing competition, and which despite their smaller size (in terms of patient numbers) are still commercially attractive.
 
 To maintain profitability in the face of slowing sales to 2014, pharma companies have implemented a number of cost-cutting measures (in addition to strategic repositioning and diversification strategies) in order to boost profitability going forward.
 
 Reasons to Purchase
 
 * Examine the combined prescription drug sales forecasts for the top 50 Pharma out to 2014 by molecule type, product source, geography and therapy area
 * Identify the key factors impacting Pharma’s R&D productivity as well as the solutions companies are implementing to strengthen their R&D efforts
 * Assess key drivers behind Pharma’s M&A activity and its role in boosting profits by opening up new access to new markets as well as cutting costs
 
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