With pharmaceutical companies increasingly looking for ways to extend the revenue-earning lifetime of their biggest products, drug delivery has become an important focus of the industry. Kalorama’s Drug Delivery Markets: Implantable / Injectable and Needle-Free Delivery Systems provides detail for business planners on the market for implantable / injectable delivery system markets.

Biopharmaceutical products are driving growth of needle-free systems; there will likely be significant increases in revenues in the vaccine arena. This report looks at that trend and reports current and forecasted revenues for the implantable/injectable drug delivery market, segmented into two main categories:

• Needle-free drug delivery

• Other Injectable/Implantable

Unique analysis offers segmentation of this market for:

• Drug Delivery Technology Revenues

• Pharmaceuticals Sold via Delivery Technology

This breakout makes the report relevant to business plans of either device technology companies or pharmaceutical concerns. (This market analysis does not include drug-eluding stents or prefilled or regular syringes. Kalorama considers these separate markets)

The report covers both pharmaceuticals sold through implantable/injectable delivery systems and the technologies themselves including:

• Detailed Profiles of Key Companies in Implantable/Injectable Delivery

• Brief Round-Up of Smaller Players

• Current Market Size and Forecasts to 2013

• Needle-Free Cost Savings, Protein-Coated Microcrystal Technology, Nanotechnology, and Other Trends and Developments

• Revenue Forecasts

• New Products in Development

Kalorama’s trusted information-gathering process provides most accurate study of the implantable/injectable delivery drug market available today. Information and analysis presented in this report is based on extensive interviews with senior management of top companies in the industry. While major research literature and government information is culled, information is corroborated and key market insights originate from interviews with industry leaders.

Companies Profiled in the report include:

• Alkermes, Inc.

• ALZA Corp.

• Antares Pharma, Inc.

• Bioject Medical Technologies, Inc.

• CyDex, Inc.

• MGI Pharma, Inc

• Nektar Therapeutics

• Pacira Pharmaceuticals, Inc.

• pSivida

• SurModics, Inc

• Zogenix Corporation

• AP Pharma

• Baxter BioPharma Solutions

• QLT USA, Inc

• Ypsomed Holding AG

Kalorama has also published Drug Delivery Markets: Oral Delivery, which details markets for oral technology enhancements which have increased drug product sales and extended patent life.

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The term “companion biomarker” means that a particular diagnostic test is specifically linked to a therapeutic drug either in drug development or in the clinic. Biomarkers of disease have long played an important role in diagnostic medicine as evidenced by the intense use of specific clinical laboratory tests in the diagnosis of disease. Biomarkers can be used in five very distinct ways in drug development: 1) companion biomarkers can be correlated with biological events during drug development in order to validate drug targets or to predict drug response; 2) biomarkers can be used as companion diagnostics in drug development to characterize patient populations in order to better understand the extent to which new drugs reach intended therapeutic targets can alter proposed therapeutic pathways and achieve successful clinical outcomes; 3) biomarkers can be used to stratify patient populations for drug response in primary prevention or disease-modification studies, particularly in specific clinical areas such as neuron degeneration and cancer; 4) clinically useful biomarkers are becoming increasingly useful to make proper therapeutic decisions regarding candidate drugs; and 5) clinically useful biomarkers are becoming increasingly required by the FDA and other outside authorities to make proper regulatory decisions regarding candidate drugs. This report describes new biomarker technology platforms developed for the analyses of drug targets that are connected to the effectiveness of therapeutic agents in a clinical setting. The emphasis is on those companies that are actively developing and marketing new companion diagnostic tests for performing biomarker tests during drug development, as opposed to the more routine and clinically accepted companion markers that are manufactured and marketed by large diagnostic companies for routine clinical use.

Table of Contents :   1. Overview 13
1.1 Statement of Report 13
1.2 About This Report 13
1.3 Scope of the Report 13
1.4 Objectives 13
1.5 Methodology 15
1.6 Executive Summary 16

2. Introduction: Companion Diagnostics in Drug Development 19
2.1 Companion Diagnostics as Biomarkers 20
2.1.1 Potential Benefits of Biomarkers as Companion Diagnostics 22
2.2 Biomarkers in Different Phases of Drug Development 22
2.2.1 Drug Discovery and Development Process 22
2.2.2 Biomarkers in Drug Development 24
2.3 Drug Targets 24
2.3.1 Target Discovery Using Functional Genomics 26
2.3.2 Functional Genomics 26
2.3.3 Target Validation 28
2.3.3.1 Target Discovery 28
2.3.3.2 Lead Identification 28
2.3.4 Target and Biomarker Discovery 29
2.3.4.1 Biomarker Validation 29
2.4 Biomarkers in Drug Discovery, Development and Clinical Diagnostics 29
2.4.1 Role of Biomarkers in Drug Discovery, Preclinical, Clinical Development and Diagnostics 29
2.4.2 The Pipeline Problem 31
2.4.3 Biomarkers in the Drug Discovery Process 32
2.4.4 Segmentation of Biomarker Usage 32
2.4.5 Efficacy of Biomarkers as Surrogate Endpoints 33
2.4.6 Biomarkers Used to Reduce the Cost of Drug Development 34
2.4.7 Biomarkers: Challenges and Opportunities 34
2.4.8 Biomarkers in Early Safety and Toxicity Assessment 35
2.4.9 Biomarkers in Determining Validation Parameters 35
2.4.10 Challenges in Development of Biomarkers 36
2.4.11 Using Biomarkers in Early Clinical Development 36
2.4.12 Translational Biomarkers 36
2.4.13 Use of Biomarkers in “Go”/No-Go” Decisions 37
2.4.14 Diagnostic Tests 37
2.4.15 Biomarkers in Deal Making 37
2.4.16 Payors Use Biomarkers in Decision-Making 37
2.5 World Pharmaceutical Markets 38
2.5.1 World Market Summary 38
2.5.2 Company Performance in this Segment 40
2.5.3 Forces Affecting the Structure of the Pharmaceutical Industry 41
2.5.3.1 Threats 41
2.5.3.2 Competitive Forces 42
2.6.1 Industry Overview 42
2.6.1.1 Pharmaceutical Industry Drug Pipeline 44
2.6.1.2 Asia-Pacific to Replace United States and Europe as Pharmaceutical Industry Center 54
2.6.1.3 The Changing Pharmaceutical Business Model 54
2.6.2 Benefits for Companion Diagnostic Tests in Drug Development 55
2.6.3 Strategies for the Creation of Partnerships – Predicting and Overcoming Challenges in Creating Drug Response Profiling Diagnostics 57
2.6.4 Options and Applications 57
2.6.4.1 Clinical Applications of Genomics: The Use of Evidence Based Frameworks by Decision-Makers 57
2.6.5 Challenges, Drivers and Trends 58
2.6.5.1 Macro Trends in Biomarkers 58
2.6.5.2 Biomarkers: Industry SWOT Analysis 61
2.6.6 Breakaway Technologies 62
2.6.7 Collaboration for Companion Diagnostics 63
2.6.8 Key Stake Holders in Companion Diagnostics 63
2.9 Future Developments 65

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Drug Device Combination – a High Growth Market

Drug-device combination is defined as the combination of drugs and medical devices that can be chemically or physically united or co-packaged as separate, cross labeled products. The commercialization cycle from R&D to product shows the immense potential of the bundled offering. Currently, the market has a potential of US$10.6 billion and has been experiencing a growth of 15% CAGR for the past two years. In the next five years, the market is expected to grow at a CAGR of 11.8%. A future view of the drug-device combination is that these products will make single component medical devices obsolete.

The drug-eluting stents (DES) market is the largest segment in the drug-device combination market. This is supported by the fact that cardiovascular applications constitute about 64% of the entire drug-device combination applications market. However, it is the relatively smaller market of antimicrobial catheter that offers the highest growth potential over the next five years in the overall market.

The DES market is further segmented into stent grafts, coronary stents and peripheral vascular stents. Though coronary stents has the highest market share, peripheral vascular stents is expected to have the highest growth rate till 2014. The fastest growing macro-market of antimicrobial catheter is segmented into micro-markets such as urological catheter, cardiovascular catheter, peripherally inserted central catheter, oximetry catheter, thermodilution catheter and wound drainage catheter. Closed loop glucose monitor and insulin pump is also expected to record a high growth rate for the period 2009 to 2014. The two major segments: steroid eluting electrodes and photodynamic therapy are estimated to see the slowest growth rate due to a slow development of new products in these markets.

The challenges crippling the growth of the market in the future are expected to be the issues involved in cross industry partnerships, jurisdiction issues, patient safety and interoperability issues.

The drug-device combination market is not fragmented and the key players in this market are Medtronic, Boston Scientific Corp., Edwards Life sciences Corp., Stryker Corp., QLT Inc. etc. The maximum number of new product developments is expected to take place in the bone graft substitutes, advanced wound care products and antimicrobial catheter markets. Our patent analysis indicates that E.U. has filed for the maximum number of patents followed by the U.S.

There is an immense scope of collaboration between the drugs and medical devices companies in the areas of closed loop glucose monitor and insulin pump, bone graft substitutes and advanced wound care products market. However, the antibiotic bone cements and advanced wound care market is expected to face stiff competition in the next five years to come.

The incremental benefits of these combination products over the regular medical devices are increased efficiency, reduction in overall cost of treatment along with the rising awareness. The market holds significant opportunity for the early movers albeit with extensive research to develop new and improved products at competitive prices. Successful strategic alliances between companies from the drugs and medical devices areas assist them in taking advantage of the existing technologies by avoiding capital expenditure in R&D and take the drug-device combination market to new heights.

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