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Drug Delivery Markets: Implantable / Injectable and Needle-Free
Delivery Systems

September 1, 2009


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

Kalorama's 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.



Additional Information

New York, September 10, 2009 - Many of the novel biopharmaceutical drugs
developed now can only be delivered by injection, and this has biologic manufacturers
seeking out the most patient-friendly options, including needle-free systems. According
to healthcare market research firm Kalorama Information, this trend has helped fuel a
$2.7 billon market for pharmaceutical products combined with needle-free technology.
In its report Drug Delivery Markets: Implantable / Injectable and Needle-Free
Systems, Kalorama says a recent convergence of synthetic materials and
computerized design software will propel the market for such product delivery systems
to 9.7% annual growth over the next five years.
“Three fourths of biopharmaceuticals cannot be delivered orally,” said Mary Ann
Crandall, Kalorama Information’s drug delivery analyst. “Using a needle-free injection
has been shown to reduce needlestick injuries, increase compliance and eliminate the
need for disposal, all advantages that will help sales.”

Most needle-free jet injectors use metal springs, compressed air, or CO2 gas to power
the injection. The device's nozzle is held against the patient's skin and, once activated,
injects a fine stream of the drug into the skin at a high pressure.

In the United States, more than a dozen needle-free jet injectors have been licensed by
the Food and Drug Administration and are on the market. The VitaJet, made by Bioject,
has long been used by diabetes patients. The Biojector 2000 is a popular system for
vaccine delivery, the SeroJet has been used for delivering hormone treatments for HIV-
associated wasting, and the PenJet has been used for multiple applications. Product
developer Antares Pharma and Teva Pharmaceutical announced recently a new
needle-free injector system called Tjet used to administer the growth hormone product
Tev-Tropin to children.

“Delivery is considered crucial to the marketing strategy of drugs,” Crandall said.
“Needle-free has been a part of insulin marketing for some time and now we are also
seeing it with vaccines and protein treatments.”

More information on needle-free systems can be found in Kalorama Information’s new
report Drug Delivery Markets: Implantable / Injectable and Needle-Free Systems,
which provides an in-depth breakdown of the global market for these devices. A market
summary includes a total market analysis, key product summary, forecasts and a
competitive analysis of leading companies.

About Kalorama Information
Kalorama Information supplies the latest in independent market research in the life
sciences, as well as a full range of custom research services.



TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY

       Market Drivers
       Market Size and Growth
       Total Implantable/Injectable Drug Delivery Marke
       The Implantable/Injectable Drug Delivery Only Market
       Competitor and Market Analysis

CHAPTER TWO: INTRODUCTION
Scope and Methodology
    Reasons for Injectable/Implantable Drug Delivery Systems
    History of Injectable/Implantable Drug Delivery
    Phases of Drug Action
    Needle-Free Drug Delivery
    Auto-injectors
    Pen Injectors
    Major Applications
    Safety Concerns
    Products
    Implantable Drug Delivery
    Mechanisms
    Applications
    Products
    Sustained-Release Drug Delivery
    Products
    Targeted Injection Drug Delivery
    Products
    Lipsome
    Niosome
    Microspheres and Nanoparticles
    Cyclodetrins
    Prodrug
    Polymeric Micelles
    PEGylation

CHAPTER THREE: TRENDS AND DEVELOPMENTS

    Drivers of the Implantable/Injectable Drug Delivery Market
       o Biologics
       o Cancer
    Pen Injectors
    Proprietary Product Development
    Delivery Systems Placement Trends
    Therapeutic Trends
    Incorporation of Technology
    Nanotechnology
    Drug Delivery Development
       o Microsphere Technology
       o Targeted Technology
       o MicroChip Technology
       o Protein-Coated Microcrystal Technology
       o Needle-Free Delivery Development
       o Selected Products in Development

CHAPTER FOUR: MARKET SIZE AND GROWTH
The Total Implantable/Injectable Drug Delivery Market
     Injectable/Implantable Delivery Technology Only Market

CHAPTER FIVE: COMPETITIVE AND MARKET ANALYSIS

     Competitive Landscape
     Market Analysis

CHAPTER SIX: COMPANY PROFILES

     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

COMPANIES IN BRIEF

     AP Pharma
     Baxter BioPharma Solutions
     QLT USA, Inc
     Ypsomed Holding AG

APPENDIX: COMPANY DIRECTORY
                        TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

     Figure 1-1 The Worldwide Market for Implantable/Injectable Drug Delivery
     Technology and Pharmaceuticals 2003-201

CHAPTER TWO: INTRODUCTION

     Table 2-1 Sequence of Drug Action
     Table 2-2 Marketed Products Using Liposomal Drug Delivery
     Table 2-3 Marketed Products Using Nanoparticle Drug Delivery

CHAPTER THREE: TRENDS AND DEVELOPMENTS

     Table 3-1 Select Products in Development by Drug Delivery Companies
CHAPTER FOUR: MARKET SIZE AND GROWTH

       Table 4-1 The Worldwide Market for Implantable/Injectable Drug Delivery
       Technology and Pharmaceuticals 2003-2013
       Figure 4-1 The Worldwide Market for Implantable/Injectable Drug Delivery
       Technology and Pharmaceuticals 2003-2013
       Table 4-2 The Worldwide Market for Pharmaceuticals Utilizing
       Injectable/Implantable Drug Delivery by Type 2003-2013
       Figure 4-2 The Worldwide Market for Pharmaceuticals Utilizing
       Injectable/Implantable Drug Delivery by Type 2003-2013
       Table 4-3 The Worldwide Market for Pharmaceuticals Utilizing
       Injectable/Implantable Drug Delivery Market Share by Type 2003-2013
       Figure 4-3 The Worldwide Market for Pharmaceuticals Utilizing
       Injectable/Implantable Drug Delivery Market Share by Type 2008
       Figure 4-4 The Worldwide Market for Pharmaceuticals Utilizing
       Injectable/Implantable Drug Delivery Market Share by Type 2013
       Table 4-4 The Worldwide Market for Injectable/Implantable Drug Delivery
       Systems by Pharmaceutical and Drug Delivery Component 2003-2013
       Table 4-5 The Worldwide Market for Injectable/Implantable Drug Delivery
       Systems Distribution of Revenue by Pharmaceutical and Drug Delivery
       Component 2003-2013
       Figure 4-5 The Worldwide Market for Injectable/Implantable Drug Delivery
       Systems Distribution of Revenue by Pharmaceutical and Drug Delivery
       Component 2008
       Figure 4-6 The Worldwide Market for Injectable/Implantable Drug Delivery
       Systems Distribution of Revenue by Pharmaceutical and Drug Delivery
       Component 2013

CHAPTER FIVE: COMPETITIVE AND MARKET ANALYSIS

       Table 5-1 Leading Suppliers of Implantable/Injectable Drug Delivery Technology
       Figure 5-1 Cost per Million Injections by Injector Type



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Drug Delivery Markets: Implantable / Injectable and Needle-Free Delivery Systems

  • 1. Get more info on this report! Drug Delivery Markets: Implantable / Injectable and Needle-Free Delivery Systems September 1, 2009 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 Kalorama's 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
  • 2. 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. Additional Information New York, September 10, 2009 - Many of the novel biopharmaceutical drugs developed now can only be delivered by injection, and this has biologic manufacturers seeking out the most patient-friendly options, including needle-free systems. According to healthcare market research firm Kalorama Information, this trend has helped fuel a $2.7 billon market for pharmaceutical products combined with needle-free technology. In its report Drug Delivery Markets: Implantable / Injectable and Needle-Free Systems, Kalorama says a recent convergence of synthetic materials and computerized design software will propel the market for such product delivery systems to 9.7% annual growth over the next five years.
  • 3. “Three fourths of biopharmaceuticals cannot be delivered orally,” said Mary Ann Crandall, Kalorama Information’s drug delivery analyst. “Using a needle-free injection has been shown to reduce needlestick injuries, increase compliance and eliminate the need for disposal, all advantages that will help sales.” Most needle-free jet injectors use metal springs, compressed air, or CO2 gas to power the injection. The device's nozzle is held against the patient's skin and, once activated, injects a fine stream of the drug into the skin at a high pressure. In the United States, more than a dozen needle-free jet injectors have been licensed by the Food and Drug Administration and are on the market. The VitaJet, made by Bioject, has long been used by diabetes patients. The Biojector 2000 is a popular system for vaccine delivery, the SeroJet has been used for delivering hormone treatments for HIV- associated wasting, and the PenJet has been used for multiple applications. Product developer Antares Pharma and Teva Pharmaceutical announced recently a new needle-free injector system called Tjet used to administer the growth hormone product Tev-Tropin to children. “Delivery is considered crucial to the marketing strategy of drugs,” Crandall said. “Needle-free has been a part of insulin marketing for some time and now we are also seeing it with vaccines and protein treatments.” More information on needle-free systems can be found in Kalorama Information’s new report Drug Delivery Markets: Implantable / Injectable and Needle-Free Systems, which provides an in-depth breakdown of the global market for these devices. A market summary includes a total market analysis, key product summary, forecasts and a competitive analysis of leading companies. About Kalorama Information Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services. TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY Market Drivers Market Size and Growth Total Implantable/Injectable Drug Delivery Marke The Implantable/Injectable Drug Delivery Only Market Competitor and Market Analysis CHAPTER TWO: INTRODUCTION
  • 4. Scope and Methodology Reasons for Injectable/Implantable Drug Delivery Systems History of Injectable/Implantable Drug Delivery Phases of Drug Action Needle-Free Drug Delivery Auto-injectors Pen Injectors Major Applications Safety Concerns Products Implantable Drug Delivery Mechanisms Applications Products Sustained-Release Drug Delivery Products Targeted Injection Drug Delivery Products Lipsome Niosome Microspheres and Nanoparticles Cyclodetrins Prodrug Polymeric Micelles PEGylation CHAPTER THREE: TRENDS AND DEVELOPMENTS Drivers of the Implantable/Injectable Drug Delivery Market o Biologics o Cancer Pen Injectors Proprietary Product Development Delivery Systems Placement Trends Therapeutic Trends Incorporation of Technology Nanotechnology Drug Delivery Development o Microsphere Technology o Targeted Technology o MicroChip Technology o Protein-Coated Microcrystal Technology o Needle-Free Delivery Development o Selected Products in Development CHAPTER FOUR: MARKET SIZE AND GROWTH
  • 5. The Total Implantable/Injectable Drug Delivery Market Injectable/Implantable Delivery Technology Only Market CHAPTER FIVE: COMPETITIVE AND MARKET ANALYSIS Competitive Landscape Market Analysis CHAPTER SIX: COMPANY PROFILES 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 COMPANIES IN BRIEF AP Pharma Baxter BioPharma Solutions QLT USA, Inc Ypsomed Holding AG APPENDIX: COMPANY DIRECTORY TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY Figure 1-1 The Worldwide Market for Implantable/Injectable Drug Delivery Technology and Pharmaceuticals 2003-201 CHAPTER TWO: INTRODUCTION Table 2-1 Sequence of Drug Action Table 2-2 Marketed Products Using Liposomal Drug Delivery Table 2-3 Marketed Products Using Nanoparticle Drug Delivery CHAPTER THREE: TRENDS AND DEVELOPMENTS Table 3-1 Select Products in Development by Drug Delivery Companies
  • 6. CHAPTER FOUR: MARKET SIZE AND GROWTH Table 4-1 The Worldwide Market for Implantable/Injectable Drug Delivery Technology and Pharmaceuticals 2003-2013 Figure 4-1 The Worldwide Market for Implantable/Injectable Drug Delivery Technology and Pharmaceuticals 2003-2013 Table 4-2 The Worldwide Market for Pharmaceuticals Utilizing Injectable/Implantable Drug Delivery by Type 2003-2013 Figure 4-2 The Worldwide Market for Pharmaceuticals Utilizing Injectable/Implantable Drug Delivery by Type 2003-2013 Table 4-3 The Worldwide Market for Pharmaceuticals Utilizing Injectable/Implantable Drug Delivery Market Share by Type 2003-2013 Figure 4-3 The Worldwide Market for Pharmaceuticals Utilizing Injectable/Implantable Drug Delivery Market Share by Type 2008 Figure 4-4 The Worldwide Market for Pharmaceuticals Utilizing Injectable/Implantable Drug Delivery Market Share by Type 2013 Table 4-4 The Worldwide Market for Injectable/Implantable Drug Delivery Systems by Pharmaceutical and Drug Delivery Component 2003-2013 Table 4-5 The Worldwide Market for Injectable/Implantable Drug Delivery Systems Distribution of Revenue by Pharmaceutical and Drug Delivery Component 2003-2013 Figure 4-5 The Worldwide Market for Injectable/Implantable Drug Delivery Systems Distribution of Revenue by Pharmaceutical and Drug Delivery Component 2008 Figure 4-6 The Worldwide Market for Injectable/Implantable Drug Delivery Systems Distribution of Revenue by Pharmaceutical and Drug Delivery Component 2013 CHAPTER FIVE: COMPETITIVE AND MARKET ANALYSIS Table 5-1 Leading Suppliers of Implantable/Injectable Drug Delivery Technology Figure 5-1 Cost per Million Injections by Injector Type Available immediately for Online Download at http://www.marketresearch.com/product/display.asp?productid=2422083 US: 800.298.5699 UK +44.207.256.3920