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Report Description
The injectable drug delivery market holds significant potential for the future. From the conventional syringes with vials and painful needles to the modern-day pre-filled syringes, pen-injectors, needle free injectors and auto-injectors, the injectable drug delivery devices market has come a long way. Taking the concept of self-injectors to a new stratum, ‘Bolus Injectors’ have surfaced recently. Also known as non-insulin patch pumps, these devices not only offer a range of benefits to the end users but also provide a number of additional benefits to other stakeholders in the industry.
One of the main drivers for the perceived growth of bolus injectors is the large number of biologics currently under development. A majority of these molecules are highly viscous and are required to be delivered in volumes of greater than 1 ml. The absence of devices which can safely administer these drugs is currently a big unmet need in the market. However, the early signs are encouraging. Despite the uncertainties related to the device development and approval, many companies are investing time, money and resources to develop novel devices.
This development is being led jointly by established firms such as Becton Dickinson, West Pharmaceuticals and emerging players such as Unilife, Ratio Drug Delivery and Sensile Medical, amongst others. It is widely anticipated that, once ready, such devices which will allow self-administration of high viscosity, large volume biologics and be readily adopted in the industry.
Scope of the Report
The “Bolus Injectors” report provides a comprehensive analysis of the current state of this market and the likely future evolution over the next ten years. Starting with the basic introduction to bolus injectors, their components, the report explains the advantages, usage mechanism and the current status of development of each of these devices. As these injectors are currently only available for investigational use, the investment being done in this area is geared towards tapping the significant future potential of this market. In fact, one of the primary objectives of this report is to estimate the size of this future promise offered by bolus injectors.
For the purposes of our analysis, we followed a top-down approach to estimate the size of this market. This included:
Where possible, we have added robustness to our forecasting model by conducting extensive primary research interviews with senior stakeholders in the industry. Owing to the uncertain nature of the market, we provide three scenarios for our market forecast. The conservative, base and optimistic scenarios are considered for the forecasting of each of the analysed drug-disease combinations and represent three different tracks of industry evolution.
Contents
Chapter 2 provides a general introduction to the market and the historical evolution of self-administration injection devices. The chapter also talks about needlestick injuries and the growing preference towards safe and easy-to-use devices.
Chapter 3 provides a detailed overview on wearable injectors and the various unmet needs which are fuelling the rise of these injectors. It not only provides a detailed introduction to bolus injectors but also highlights their key features and categorises the various bolus injectors (currently under development) by mode of operation, device usage and volume.
Chapter 4 highlights the various molecules which are likely to form the target market of bolus injectors. It also looks at the likely growth of biologics market over the next ten years; this is expected to be a significant driver for the bolus injectors which are likely to become the preferred device for delivery of high viscous, large volume biologics.
Chapter 5 includes detailed profiles of various bolus injectors, their applications, usage mechanism and current state of development.
Chapter 6 looks at the future state of bolus injectors market till 2024. It highlights the leading disease classes which will drive this growth and the relative market size of bolus injectors within each disease class, both in terms of the number of units and the value of the market.
Chapter 7 provides the SWOT analysis of bolus injectors market giving strategic insights to the major factors that are likely to contribute to the growth while also highlighting the weakness and threats that can negatively impact the growth.
Chapter 8 includes profiles of the key companies in the bolus injectors market. Each company profile includes information such as financial performance, marketed / pipeline products, recent developments and future growth plans.
Chapter 9 is a collection of transcripts of some of the interviews which were conducted while preparing this report.
Chapter 10 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in the previous chapters.
Chapter 11 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.
Chapter 12 is an appendix, which provides a list of companies and organisations mentioned in this report.
1. EXECUTIVE SUMMARY
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
1.4. Key Highlights
1.4.1. Most of the Bolus Injectors Being Developed are Electronic
1.4.2. The First Commercial Launch Likely to Happen in 2014/15
1.4.3. Drugs for Cancer will Remain the Focus Area
1.4.4. Opportunities Outweigh the Weaknesses
1.4.5. Market Potential is Huge and Will Be Rapidly Monetized
2. INTRODUCTION
2.1. Chapter Overview
2.2. Conventional Needle and Syringe Delivery
2.3. Self-administration of Drugs
2.3.1. Rising Burden of Chronic Diseases
2.3.2. Systems Available for Self-administration
2.4. Needlestick Injuries
2.4.1. Incidence and Cost Burden
2.4.2. Government Legislation for Needlestick Injury Prevention
2.5. Safety Options in Self Injectors
3. OVERVIEW AND MARKET BACKGROUND
3.1. Chapter Overview
3.2. What Are Wearable Injectors?
3.3. The Need For Wearable Injectors
3.3.1. Advancements in Drug Classes
3.3.2. Need for Better Patient Compliance
3.4. Types of Wearable Injectors
3.4.1. Insulin Pumps with Infusion Sets
3.4.2. Insulin Patch Pumps
3.4.3. Transdermal Patch
3.4.4. Bolus Injectors
3.5. Components of a Bolus Injector
3.6. Classification of Bolus Injectors
3.6.1. Mechanism Based Classification
3.6.2. Usage Based Classification
3.6.3. Drug Delivery Based Classification
3.7. Bolus Injectors Under Development
3.7.1. Distribution by Mode of Operation
3.7.2. Distribution by Device Usage
3.7.3. Distribution by Volume
3.8. Factors Driving the Bolus Injectors Market
3.8.1. Growth of Biologics and Biosimilars
3.8.2. Life Cycle Management Activities Driving Demand for Alternative Delivery Systems
3.8.3. Need for Brand Differentiation
3.8.4. Drive Towards Cheaper Healthcare Costs
3.8.5. Convenient Drug Reconstitution
4. TARGET DRUGS FOR BOLUS INJECTORS
4.1. Biologics Market
4.1.1. Biologics Market Forecast, 2013-2023
4.1.2. Biologics Market Trends
4.1.3. Biologics Under Consideration for Bolus Injectors
4.2. Case Study: Herceptin (Genentech/Roche)
4.2.1. Background and History of Development
4.2.2. Indications and Dosage Forms
4.2.3. Target Population
4.2.4. Sales, 1998 - 2012
4.2.5. Launch of Subcutaneous Formulation
4.2.5.1. ENHANZE ™: The Technology Behind Subcutaneous Formulation of Herceptin (Halozyme Therapeutics)
4.2.5.2. Advantages of Subcutaneous Form Over Intravenous
4.2.5.3. Herceptin to be the First Biologic to be Launched in Bolus Injector
5. PRODUCT PROFILES
5.1. Chapter Overview
5.2. MyDose (Roche)
5.2.1. Introduction
5.2.2. Product Description
5.2.3. Usage / Mechanism
5.2.4. Advantages
5.2.5. Manufacturing of MyDose
5.2.6. Current Status
5.3. BD™ Microinfusor Patch Injector (BD MEDICAL, A Segment Of Becton, Dickinson and Company)
5.3.1. Introduction
5.3.2. Product Description
5.3.3. Usage / Mechanism
5.3.4. Advantages
5.3.5. Current Status
5.4. SmartDose® Electronic Patch Injector System Platform Technology (West Pharmaceutical Services, Inc.)
5.4.1. Introduction
5.4.2. Product Description
5.4.3. Usage / Mechanism
5.4.4. Advantages
5.4.5. Current Status
5.5. Precision-TherapyTM and Flex-TherapyTM Wearable Injectors (Unilife Corporation)
5.5.1. Introduction
5.5.2. Product Description
5.5.3. Usage / Mechanism
5.5.4. Advantages
5.5.5. Current Status
5.6. PatchPump® (SteadyMed Therapeutics)
5.6.1. Introduction
5.6.2. Product Description
5.6.3. Usage / Mechanism
5.6.4. Advantages
5.6.5. Current Status
5.6.6. Drug Development Pipeline
5.7. SenseBolus and SensePatch Pumps (Sensile Medical AG)
5.7.1. Introduction
5.7.2. Product Description
5.7.3. SenseBolus SD
5.7.4. SensePatch (SD and FD)
5.7.5. Usage / Mechanism
5.7.6. Advantages
5.7.7. Current Status
5.8. NuPrivo-SC (Ratio, Inc.)
5.8.1. Introduction
5.8.2. Product Description
5.8.3. Advantages
5.8.4. Current Status
5.9. Rapid Infuser (Valeritas, Inc.)
5.9.1. Introduction
5.9.2. Product Description
5.9.3. Advantages
5.9.4. Current Status
6. MARKET SIZE AND FORECAST
6.1. Chapter Overview
6.2. Forecast Methodology
6.3. Overall Bolus Injectors Market, 2014 – 2024
6.4. Bolus Injectors for Cancer and Related Conditions, 2014 – 2024
6.5. Bolus Injectors for Autoimmune Diseases, 2014 – 2024
6.6. Bolus Injectors for Blood Disorders, 2014 – 2024
6.7. Bolus Injectors for Genetic Disorders, 2014 – 2024
6.8. Bolus Injectors for Infectious Diseases, 2014 – 2024
6.9. Bolus Injectors for Cardiovascular Diseases, 2014 – 2024
6.10. Bolus Injectors for Transplantation, 2014 – 2024
6.11. Bolus Injectors for Respiratory Disorders, 2014 – 2024
6.12. Bolus Injectors for Digestive Disorders, 2014 – 2024
6.13. Bolus Injectors for Musculoskeletal Disorders, 2014 – 2024
6.14. Bolus Injectors for Diabetes, 2014 – 2024
6.15. Bolus Injectors for Eye Conditions, 2014 – 2024
6.16. Bolus Injectors for Skin Diseases, 2014 – 2024
6.17. Bolus Injectors for Neurologic Disorders, 2014 – 2024
6.18. Bolus Injectors for Other Diseases, 2014 – 2024
7. SWOT ANALYSIS
7.1. Overview
7.2. Strengths
7.3. Weaknesses
7.4. Opportunities
7.5. Threats
8. COMPANY PROFILES
8.1. Unilife Corporation
8.1.1. Overview and Background
8.1.2. Financial Performance
8.1.3. Product Portfolio
8.1.3.1. Unifill Platform of Prefilled Syringes
8.1.3.2. EZMix Platform of Dual-Chamber Syringes (Drug Reconstitution Delivery Systems)
8.1.3.3. Auto-Injector Platform
8.1.3.4. Wearable Injector Platform
8.1.3.5. Ocular Delivery Systems
8.1.3.6. Novel Delivery Systems
8.1.4. Recent Developments
8.1.4.1. Partnership with Biodel
8.1.4.2. Partnership with Sanofi
8.1.5. Future Growth Plans
8.2. West Pharmaceuticals
8.2.1. Overview and Background
8.2.2. Financial Performance
8.2.3. Product Portfolio
8.2.3.1. Marketed Products
8.2.3.2. Pipeline Products
8.2.4. Recent Developments
8.2.4.1. New Manufacturing Facility in China
8.2.4.2. Agreement with Janssen Biotech
8.2.5. Future Growth Plans
8.3. BD Medical, A Segment Of Becton, Dickinson and Company
8.3.1. Overview and Background
8.3.2. Financial Performance
8.3.3. Product Portfolio
8.3.3.1. Marketed Products
8.3.3.2. Pipeline Products
8.3.4. Recent Developments
8.3.5. Future Growth Plans
8.4. Sensile Medical AG
8.4.1. Overview and Background
8.4.2. Product Portfolio
8.4.3. Technology Portfolio
8.4.4. Recent Developments
8.4.5. Future Growth Plans
8.5. SteadyMed Therapeutics
8.5.1. Overview and Background
8.5.2. Financial Performance
8.5.3. Product Portfolio
8.5.4. Technology Portfolio
8.5.5. Recent Developments
8.5.6. Future Growth Plans
8.6. Ratio, Inc.
8.6.1. Overview and Background
8.6.2. Financial Performance
8.6.3. Product Portfolio
8.6.4. Technology Portfolio
8.6.5. Recent Developments
8.6.6. Future Growth Plans
8.7. Valeritas Inc.
8.7.1. Overview and Background
8.7.2. Financial Performance
8.7.3. Product Portfolio
8.7.4. Technology Portfolio
8.7.4.1. h-Patch™
8.7.4.2. Mini-Ject™
8.7.4.3. Micro-Trans™
8.7.5. Recent Developments
9. INTERVIEW TRANSCRIPTS
10. CONCLUSION
10.1. An Emerging Market Ready to Explode
10.2. Venture Capital Interest Likely to Stay High
10.3. Key Driving Factors
10.4. Concluding Remarks
11. APPENDIX 1: TABLES
12. APPENDIX 2: LIST OF COMPANIES
Figure 2.1 Prevalence of Diabetes, 2012 - By Countries (MM, %)
Figure 3.1 Benefits of Bolus Injectors to Stakeholders
Figure 3.2 Bolus Injectors: Distribution by Modes of Operation
Figure 3.3 Bolus Injectors: Distribution by Device Usage
Figure 3.4 Bolus Injectors: Distribution by Volume
Figure 4.1 Total Drugs Market, 2012 - By Nature of Drug (USD BN, %)
Figure 4.2 Drugs Market Forecast, Short - Mid Term Forecast (2012-2018) - Split by Biologics and Pharmaceuticals (USD BN)
Figure 4.3 Drugs Market Forecast, Long Term Forecast (2018-2023) - Split by Biologics and Pharmaceuticals (USD BN)
Figure 4.4 Biologic Drugs in Development, 2012 - Number by Type of Molecule (%)
Figure 4.5 HER2 Expression in Breast Cancer Patients (%)
Figure 4.6 Herceptin Sales, 1998 - 2012 (USD Million)
Figure 6.1 Overall Bolus Injectors Market (# of Devices, MM), 2014 - 2024
Figure 6.2 Overall Bolus Injectors Market (USD BN), 2014 - 2024
Figure 6.3 Number of Molecules in Bolus Injectors for Cancer and Related Conditions (2014 - 2024)
Figure 6.4 Bolus Injectors Market for Cancer and Related Conditions (# of Devices, MM), 2014 - 2024
Figure 6.5 Number of Molecules in Bolus Injectors for Autoimmune Diseases (2014 - 2024)
Figure 6.6 Bolus Injectors Market for Autoimmune Diseases (# of Devices, MM), 2014 - 2024
Figure 6.7 Number of Molecules in Bolus Injectors for Blood Disorders (2014 - 2024)
Figure 6.8 Bolus Injectors Market for Blood Disorders (# of Devices, MM), 2014 - 2024
Figure 6.9 Number of Molecules in Bolus Injectors for Genetic Disorders (2014 - 2024)
Figure 6.10 Bolus Injectors Market for Genetic Disorders (# of Devices, MM), 2014 - 2024
Figure 6.11 Number of Molecules in Bolus Injectors for Infectious Diseases (2014 - 2024)
Figure 6.12 Bolus Injectors Market for Infectious Diseases (# of Devices, MM), 2014 - 2024
Figure 6.13 Number of Molecules in Bolus Injectors for Cardiovascular Diseases (2014 - 2024)
Figure 6.14 Bolus Injectors Market for Cardiovascular Diseases (# of Devices, MM), 2014 - 2024
Figure 6.15 Number of Molecules in Bolus Injectors for Transplantation (2014 - 2024)
Figure 6.16 Bolus Injectors Market for Transplantation (# of Devices, MM), 2014 - 2024
Figure 6.17 Number of Molecules in Bolus Injectors for Respiratory Disorders (2014 - 2024)
Figure 6.18 Bolus Injectors Market for Respiratory Disorders (# of Devices, MM), 2014 - 2024
Figure 6.19 Number of Molecules in Bolus Injectors for Digestive Disorders (2014 - 2024)
Figure 6.20 Bolus Injectors Market for Digestive Disorders (# of Devices, MM), 2014 - 2024
Figure 6.21 Number of Molecules in Bolus Injectors for Musculoskeletal Disorders (2014 - 2024)
Figure 6.22 Bolus Injectors Market for Musculoskeletal Disorders (# of Devices, MM), 2014 - 2024
Figure 6.23 Number of Molecules in Bolus Injectors for Diabetes (2014 - 2024)
Figure 6.24 Bolus Injectors Market for Diabetes (# of Devices, MM), 2014 - 2024
Figure 6.25 Number of Molecules in Bolus Injectors for Eye Conditions (2014 - 2024)
Figure 6.26 Bolus Injectors Market for Eye Conditions (# of Devices, MM), 2014 - 2024
Figure 6.27 Number of Molecules in Bolus Injectors for Skin Diseases (2014 - 2024)
Figure 6.28 Bolus Injectors Market for Skin Diseases (# of Devices, MM), 2014 - 2024
Figure 6.29 Number of Molecules in Bolus Injectors for Neurologic Disorders (2014 - 2024)
Figure 6.30 Bolus Injectors Market for Neurologic Disorders (# of Devices, MM), 2014 - 2024
Figure 6.31 Number of Molecules in Bolus Injectors for Other Diseases (2014 - 2024)
Figure 6.32 Bolus Injectors Market for Other Diseases (# of Devices, MM), 2014 - 2024
Figure 7.1 Number of Biologics Approved by the US FDA, 2009-2012
Figure 7.2 Biosimilars in Development, 2011 (%), By Development Stage
Figure 8.1 Revenues, Unilife Corporation, FY 2011 - FY 2013 (USD ‘000)
Figure 8.2 West Pharmaceutical Services, 2012 - Sales by Business Divisions (USD MM, %)
Figure 8.3 BD Medical, 2012 - Sales by Business Divisions (USD MM, %)
Figure 10.1 Bolus Injectors Market (# of Devices, MM): 2016, 2020, 2024
Figure 10.2 Bolus Injectors Market (USD MM): 2016, 2020, 2024
Table 3.1 Traditional Pump Devices vs. Bolus Injectors
Table 3.2 Bolus Injectors: Benefits v/s Perceived Issues
Table 3.3 Bolus Injectors Under Development
Table 4.1 Biologics Under Consideration for Bolus Injectors
Table 7.1 SWOT Analysis of the Bolus Injectors Market
Table 7.2 List of Available Autoinjectors, 2013
Table 7.3 Recall of Autoinjectors
Table 7.4 Recall of Prefilled Syringes
Table 8.1 Unilife Incorporation, Commercial Pipeline of Injection Pumps
Table 11.1 Prevalence of Diabetes, 2012 - By Countries (MM, %)
Table 11.2 Bolus Injectors: Distribution by Modes of Operation
Table 11.3 Bolus Injectors: Distribution by Device Usage
Table 11.4 Bolus Injectors: Distribution by Volume
Table 11.5 Total Drugs Market, 2012 - By Nature of Drug (USD BN, %)
Table 11.6 Drugs Market Forecast, Short - Mid Term Forecast (2012-2018) - Split by Biologics and Pharmaceuticals (USD BN)
Table 11.7 Drugs Market Forecast, Short - Long Term Forecast (2018-2023) - Split by Biologics and Pharmaceuticals (USD BN)
Table 11.8 Biologic Drugs in Development, 2012 - By Type of Molecule (%)
Table 11.9 Overall Bolus Injectors Market (# of Devices, MM), 2014 – 2024 – Base Scenario
Table 11.10 Overall Bolus Injectors Market (USD MM), 2014 – 2024 – Base Scenario
Table 11.11 Number of Molecules in Bolus Injectors for Cancer and Related Conditions, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.12 Bolus Injectors Market for Cancer and Related Conditions (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.13 Number of Molecules in Bolus Injectors for Autoimmune Diseases, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.14 Bolus Injectors Market for Autoimmune Diseases (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.15 Number of Molecules in Bolus Injectors for Blood Disorders, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.16 Bolus Injectors Market for Blood Disorders (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.17 Number of Molecules in Bolus Injectors for Genetic Disorders, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.18 Bolus Injectors Market for Genetic Disorders (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.19 Number of Molecules in Bolus Injectors for Infectious Diseases, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.20 Bolus Injectors Market for Infectious Diseases (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.21 Number of Molecules in Bolus Injectors for Cardiovascular Diseases, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.22 Bolus Injectors Market for Cardiovascular Diseases (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.23 Number of Molecules in Bolus Injectors for Transplantation, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.24 Bolus Injectors Market for Transplantation (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.25 Number of Molecules in Bolus Injectors for Respiratory Disorders, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.26 Bolus Injectors Market for Respiratory Disorders (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.27 Number of Molecules in Bolus Injectors for Digestive Disorders, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.28 Bolus Injectors Market for Digestive Disorders (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.29 Number of Molecules in Bolus Injectors for Musculoskeletal Disorders, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.30 Bolus Injectors Market for Musculoskeletal Disorders (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.31 Number of Molecules in Bolus Injectors for Diabetes, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.32 Bolus Injectors Market for Diabetes (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.33 Number of Molecules in Bolus Injectors for Eye Conditions, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.34 Bolus Injectors Market for Eye Conditions (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.35 Number of Molecules in Bolus Injectors for Skin Diseases, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.36 Bolus Injectors Market for Skin Diseases (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.37 Number of Molecules in Bolus Injectors for Neurologic Disorders, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.38 Bolus Injectors Market for Neurologic Disorders (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.39 Number of Molecules in Bolus Injectors for Other Diseases, 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
Table 11.40 Bolus Injectors Market for Other Diseases (# of Devices, MM), 2014 - 2024 (Conservative, Base, Optimistic Scenarios)
The following companies have been mentioned in this report.