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Report Description
In today’s pharmaceutical market, many drugs are supplied in powdered formulation because of their lower shelf life in liquid formulation. The drugs are formulated into powdered form by various processes such as lyophilisation or spray drying; these drugs are then reformulated into liquid form by mixing with a suitable diluent at the time of administration. The overall market of drug reconstitution systems is characterised by the presence of around 50 devices (both conventional and novel). The primary goal of these systems is to provide a hassle free reconstitution process in minimal number of steps. In addition, these systems also aim to provide an optimal protection from needlestick injuries to both the patients and healthcare providers.
Conventional drug reconstitution systems, including Vial Adaptors, Vial to Vial Systems, Direct Connection to Vial Systems and a few others, currently dominate the market. Some of these systems were developed nearly two decades ago and have gained a significant share of the market overtime. In addition, the use of traditional hypodermic needles for reconstituting the drug using a diluent vial is still widespread, especially in the developing countries. However, with new needlestick injuries prevention laws being implemented, along with rising approvals for biologic drugs, novel reconstitution systems such as Dual Chamber Systems are expected to be more popular and preferred option. A number of these novel systems make the process as easy as the push of a button in a much more safer and accurate manner.
Though the market for such novel devices is currently at nascent stage, there are several devices available for investigational use. The technology used in novel systems is likely to play an important part in enhancing the safety, patient compliance and ease of use. When ready, these devices are likely to have a significant impact on the overall market landscape.
Scope of the Report
The ‘Novel Drug Reconstitution Systems, 2014-2024 Market’ report provides a comprehensive study of the growing market of drug reconstitution systems. As mentioned earlier, this includes not only the conventional systems such as Vial Adaptors, Vial to Vial Systems but also novel systems such as Dual Chamber Systems. Due to an increasing number of biologics and the growing trend towards self-administration of drugs, novel drug reconstitution devices are becoming a key focus area for medical device manufacturers. The focus of this study is primarily to understand the governing trends and the likely future evolution of these devices over the next decade.
The report covers various aspects such as market developments, recent partnerships and our opinion on the likely drivers which will influence the industry’s evolution. In addition, we have provided a holistic view of the market landscape including detailed profiles of leading devices, key features and their comparative position vis-à-vis other devices. Innovations in design and advanced safety mechanisms will continue to present encouraging prospects to device manufacturers in the years ahead.
In addition to the key benefits and the likely market drivers, this study also highlights some of the challenges associated with the use and implementation of these devices. Regular modifications in design and incorporation of safety features present operational challenges to the manufacturers. Cost is another factor that can significantly restrain the market, especially in the case of novel reconstitution systems. However, with the entrance of more devices in the market, prices are expected to come down; this, in turn, will result in a higher uptake of such systems.
The report also includes a special case study on drugs and vaccines requiring reconstitution prior to administration. We have looked at the specific indications, therapeutic areas and mode of administration of these powdered formulations.
The study provides short-midterm and long term market forecasts for the period 2014 - 2019 and 2019 - 2024, respectively. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research.
Contents
Chapter 2 provides an executive summary of major highlights captured in the report. It offers a high level view on the likely future of drug reconstitution systems market.
Chapter 3 provides a general introduction to the drug reconstitution process. It covers the advantages of advanced reconstitution systems over conventional systems including likely benefits to both the patients and the manufacturers.
Chapter 4 provides a comprehensive analysis of the current market of drug reconstitution systems. It lists 50 devices that can be used to carry out reconstitution of powdered drugs, categorising them into the various sub-types (Vial Adaptors, Vial to Vial Systems, Direct Connection to Vial Systems, Dual Chamber Systems, Closed Systems and Needle Free Systems), mode of delivery and the nature of the device (disposable / reusable).
Chapter 5 provides detailed analysis on Dual Chamber Systems that are used for reconstitution of lyophilised drugs. We have presented a 2 X 2 matrix to compare the product competitiveness and supplier power of several devices belonging to this category. The chapter also provides detailed profiles of a number of Dual Chamber Systems which are currently available either commercially or for investigational use.
Chapter 6 focuses on other novel drug reconstitution systems. As in the last chapter, we have provided detailed profiles and highlighted key features of some of the upcoming devices in this category.
Chapter 7 focuses on Needle Free Reconstitution Systems. Most of these systems are used for infusion purposes. In addition to the detailed profiles of such systems, we have also included a special case study on ZetaJet TM , an advanced spring powered system that is designed to deliver vaccines and injectable medication either subcutaneously or intramuscularly.
Chapter 8 focuses on 24 conventional reconstitution systems which were identified during the course of this study. For these Vial Adaptors, Direct Connection to Vial Systems and Closed Systems, we have done a 2 X 2 matrix to compare the product competitiveness with respective supplier power. As in the earlier chapters, we have also profiled a number of these devices.
Chapter 9 highlights the likely future evolution of drug reconstitution systems market over the next ten years. We have done separate analysis for both conventional and novel reconstitution systems till the year 2024.
Chapter 10 provides information on FDA approved drugs and vaccines which are supplied in powdered formulation. We have analysed the product landscape highlighting the popular therapeutic areas and the mode of drug administration.
Chapter 11 includes the detailed profiles of some of the major players in the drug reconstitution systems market. For each company, we have covered details on financial performance, product portfolio, recent developments and future growth plans.
Chapter 12 captures the recent developments which have influenced the drug reconstitution systems market. It includes the agreements / partnerships that have been inked between different stakeholders. We have also provided a technology evolution roadmap clearly depicting the key milestones which have shaped the industry thus far.
Chapter 13 provides the SWOT analysis of drug reconstitution systems market giving strategic insights to the major factors that have contributed to the growth of this market. It also highlights the weaknesses and threats that can negatively impact the growth.
Chapter 14 is a collection of interview transcripts; for the purposes of this study, we held discussions with several experts to ascertain the key strategic initiatives and future roadmap of the industry.
Chapter 15 summarises 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 previous chapters.
Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.
Chapter 17 is an appendix, which provides a list of companies and organisations mentioned in this report.
1. PREFACE
1.1. Scope Of The Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Defining Drug Reconstitution
3.2. History
3.3. Human Factors Driving The Growth Of Advanced Reconstitution Devices
3.4. Traditional Method vs. Novel Reconstitution Methods
3.5. Challenges With Traditional Reconstitution Process
3.6. Benefits Of Advanced Reconstitution Systems For Patients
3.7. Benefits For Manufacturers
3.8. Factors To Be Considered By Manufacturers For Choosing The Right Reconstitution System
3.9. Common Reconstitution Systems
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Drug Reconstitution Systems
4.2.1. Novel Reconstitution Systems Are Gaining Ground
4.2.2. Most Of The Reconstitution Systems Are Disposable
4.2.3. Injectable Devices Continue To Dominate
4.3. Product Framework
5. DUAL CHAMBER SYSTEMS
5.1. Chapter Overview
5.2. Market Landscape: Product Competitiveness And Supplier Power
5.3. Product Profiles
5.4. Detailed Profiles
5.4.1. LyoTwist TM (Ypsomed)
5.4.1.1. Introduction
5.4.1.2. Specifications Of Devices Under LyoTwist TM Platform
5.4.1.3. Usage / Mechanism
5.4.1.4. Advantages / Features
5.4.1.5. Benefits To The End-user
5.4.1.6. Current Status
5.4.2. EZMix TM (Unilife)
5.4.2.1. Introduction
5.4.2.2. Usage / Mechanism
5.4.2.3. Advantages / Features
5.4.2.4. Benefits For Customers
5.4.2.5. Current Status
5.4.3. Airless DC TM (Duoject)
5.4.3.1. Introduction
5.4.3.2. Structure
5.4.3.3. Usage / Mechanism
5.4.3.4. Advantages / Features
5.4.4. SafeClick TM Lyo (Future Injection Technologies)
5.4.4.1. Introduction
5.4.4.2. Usage / Mechanism
5.4.4.3. Advantages / Features
5.4.4.4. Benefits To The End-user
5.5. Brief Product Profiles
5.5.1. Lyo-DCPS (Arte Corporation & ProJect Pharmaceutics)
5.5.2. BD™ Liquid / Dry Injector (Becton Dickinson)
5.5.3. Genotropin Miniquick (Vetter Pharma)
5.5.4. ChaSyr TM DDS (Global Holdings)
6. OTHER NOVEL SYSTEMS
6.1. Chapter Overview
6.2. Product Profiles
6.3. Detailed Profiles
6.3.1. SenseLyo (Sensile Medical)
6.3.1.1. Introduction
6.3.1.2. Usage / Mechanism
6.3.1.3. Advantages / Features
6.3.2. Flexi-Q DV (Elcam Medical)
6.3.2.1. Introduction
6.3.2.2. Parts Of Flexi-Q DV
6.3.2.3. Usage / Mechanism
6.3.2.4. Advantages / Features
6.3.2.5. Current Status
6.3.3. Pen-Prep TM EVO (Duoject)
6.3.3.1. Introduction
6.3.4. Usage / Mechanism
6.3.4.1. Advantages / Features
6.4. Brief Profiles
6.4.1. LyoTip TM (Integrity Bio)
6.4.2. VRx2 TM (Mystic Pharmaceuticals)
6.4.3. LyoKit (Recon Therapeutics)
6.4.4. Inter-Vial / Inter Vial Plus (Duoject)
6.4.5. PenJet (PenJet Corporation)
6.4.6. BD PhaSeal TM System (Becton Dickinson)
7. NEEDLE FREE SYSTEMS
7.1. Chapter Overview
7.2. Product Profiles
7.3. Detailed Profiles
7.3.1. Vial2Bag (West Pharmaceutical Services)
7.3.1.1. Introduction
7.3.1.2. Usage / Mechanism
7.3.1.3. Advantages / Features
7.3.1.4. Current Status
7.3.2. Mapset (Technoflex)
7.3.2.1. Introduction
7.3.2.2. Usage / Mechanism
7.3.2.3. Advantages / Features:
7.4. Brief Profiles
7.4.1. DianaTM (ICU Medical)
7.4.2. Macopharma
7.5. Case Study: ZetaJet (Bioject)
7.5.1.1. Introduction
7.5.1.2. Product Specifications
7.5.1.3. Usage / Mechanism
7.5.1.4. Advantages / Features
7.5.1.5. Convenience
7.5.1.6. Safety
7.5.1.7. Current Status
8. CONVENTIONAL RECONSTITUTION SYSTEMS
8.1. Chapter Overview
8.2. Market Landscape: Product Competitiveness And Supplier Power 8.3. Product Profiles
8.4. Detailed Profiles
8.4.1. Tevadaptor (Teva Medical)
8.4.1.1. Introduction
8.4.1.2. Components
8.4.1.3. Material Specifications
8.4.1.4. Usage / Mechanism
8.4.1.5. Advantages / Features
8.4.1.6. Current Status
8.4.2. Smart-Rod XR (Duoject)
8.4.2.1. Introduction
8.4.2.2. Usage / Mechanism
8.4.2.3. Advantages / Features
8.4.2.4. Current Status
8.4.3. SmartMix™ (Yukon Medical)
8.4.3.1. Introduction
8.4.3.2. Usage / Mechanism
8.4.3.3. Advantages / Features
8.4.3.4. Current Status
8.5. Brief Profiles
8.5.1. MixJect (West Pharmaceuticals)
8.5.2. FILLChoice™ Dose bag (Haemopharm)
8.5.3. Mix2Vial (West Pharmaceutical Services)
8.5.4. Bioject Drug Reconstitution System (Bioject)
8.5.5. CodanCyto (Codan)
8.5.6. Clip’n’Ject (West Pharmaceutical Services)
9. MARKET FORECAST
9.1. Chapter Overview
9.2. Forecast Methodology
9.3. Overall Drug Reconstitution Systems Market, 2014-2024
9.4. Conventional Reconstitution Systems Market, 2014-2024
9.5. Novel Reconstitution Systems Market 2014-2024
10. APPROVED DRUGS AND VACCINES
10.1. Chapter Overview
10.2. Drugs Approved By FDA In Powder For Reconstitution Formulation
10.2.1. Distribution By Year
10.2.2. Distribution By Therapeutic Areas
10.2.3. Distribution By Mode Of Administration
10.3. Vaccines Approved In Powdered Formulation
11. COMPANY PROFILES
11.1. Chapter Overview
11.2. Unilife Corporation
11.2.1. Overview And Background
11.2.2. Financial Performance
11.2.3. Product Portfolio
11.2.3.1. Unifill Platform Of Prefilled Syringes
11.2.3.2. EZMix Platform Of Dual-Chamber Syringes (Drug Reconstitution Delivery Systems)
11.2.3.3. Auto-Injector Platform
11.2.3.4. Wearable Injector Platform
11.2.3.5. Ocular Delivery Systems
11.2.3.6. Novel Delivery Systems
11.2.4. Recent Developments
11.2.5. Future Growth Plans
11.3. West Pharmaceutical Services
11.3.1. Overview And Background
11.3.2. Financial Performance
11.3.3. Product Portfolio
11.3.3.1. Marketed Products
11.3.3.2. Pipeline Products
11.3.4. Recent Developments
11.3.5. Future Growth Plans
11.4. BD Medical, A Segment Of Becton Dickinson And Company
11.4.1. Overview And Background
11.4.2. Financial Performance
11.4.3. Product Portfolio
11.4.3.1. Marketed Products
11.4.3.2. Pipeline Products
11.4.4. Recent Developments
11.4.5. Future Growth Plans
11.5. Sensile Medical AG
11.5.1. Overview And Background
11.5.2. Product Portfolio
11.5.3. Technology Portfolio
11.5.4. Recent Developments
11.5.5. Future Growth Plans
11.6. Ypsomed
11.6.1. Overview And Background
11.6.2. Financial Performance
11.6.3. Product Portfolio
11.6.4. Recent Developments
11.6.5. Future Growth Plans
11.7. Bioject Medical Technologies
11.7.1. Overview And Background
11.7.2. Product Portfolio
11.7.3. Technology Portfolio
11.7.4. Recent Developments
11.7.5. Future Growth Plans
11.8. Teva Pharmaceuticals
11.8.1. Overview And Background
11.8.2. Financial Performance
11.8.3. Product Portfolio
11.8.4. Recent Developments
11.8.5. Future Growth Plans
11.9. Vetter Pharma
11.9.1. Company Overview
11.9.2. Lyo-Ject Glass Prefilled Systems
11.9.3. Safety Systems: Add on Devices
11.9.4. Recent Developments
12. INDUSTRY PARTNERSHIPS AND TECHNOLOGICAL EVOLUTION
12.1. Chapter Overview
12.2. Partnerships: Key Industry Agreements
12.3. Technology: Mapping The Evolution
13. SWOT ANALYSIS
13.1. Chapter Overview
13.2. Strengths
13.3. Weaknesses
13.4. Opportunities
13.5. Threats
14. INTERVIEW TRANSCRIPTS
14.1. Chapter Overview
14.2. Interview 1: Michael Reilly, Vice President Business Development, Integrity Bio
14.3. Interview 2: Timothy Sullivan, President & CEO, Mystic Pharmaceuticals
15. CONCLUSION
15.1. The Transition From Conventional Systems To Novel Systems
15.2. Growth Of Novel Systems Will Be Driven By A Number Of Factors
15.3. Conventional Systems Likely To Continue Their Dominance In The Near Future
15.4. Over Time, Novel Systems Will Account For A Tangible Market Share
16. APPENDIX 1: TABULATED DATA
17. APPENDIX 2: LIST OF COMPANIES
Figure 4.1 Classification Of Reconstitution Systems
Figure 4.2 Drug Reconstitution Systems: Distribution by Usability
Figure 4.3 Drug Reconstitution Systems: Distribution By Mode Of Administration
Figure 4.4 Product Map Of 50 Drug Reconstitution Devices
Figure 5.1 Market Landscape Of Dual Chamber Systems: Product Competitiveness And Supplier Power
Figure 5.2 Dual Chamber Systems: Product Framework
Figure 6.1 Other Novel Systems: Product Framework
Figure 7.1 Needle Free Systems: Product Framework
Figure 8.1 Market Landscape Of Conventional Systems: Product Competitiveness And Supplier Power
Figure 8.2 Conventional Systems: Product Framework
Figure 9.1 Overall Drug Reconstitution Systems Market, Short-Midterm (2014-2019): Base Scenario (USD Billion)
Figure 9.2 Overall Drug Reconstitution Systems Market, Long Term (2019-2024): Base Scenario (USD Billion)
Figure 9.3 Conventional Reconstitution Systems Market, Short-Midterm (2014-2019): Base Scenario (USD Billion)
Figure 9.4 Conventional Reconstitution Systems Market, Long Term (2019-2024): Base Scenario (USD Billion)
Figure 9.5 Conventional Reconstitution Systems, 2014-2024: Distribution by Type of System
Figure 9.6 Novel Reconstitution Systems Market, Short-Midterm (2014-2019): Base Scenario (USD Billion)
Figure 9.7 Novel Reconstitution Systems Market, Long Term (2019-2024): Base Scenario (USD Billion)
Figure 9.8 Novel Reconstitution Systems, 2014-2024: Distribution By Type of System
Figure 10.1 Drugs In Powdered Formulation: Distribution By Year Of Approval
Figure 10.2 Drugs Approved In Powdered Formulation: Distribution By Therapeutic Area
Figure 10.3 Drugs Approved In Powdered Formulation: Distribution By Mode Of Administration
Figure 11.1 Unilife Corporation: Revenue, 2011 - 2013 (USD ‘000)
Figure 11.2 West Pharmaceutical Services: Revenue By Business Divisions, 2011-2013(USD Million)
Figure 11.3 BD Medical: Revenue By Business Divisions, 2011-2013 (USD Billion)
Figure 11.4 Ypsomed: Revenue By Business Divisions, 2011-2013 (CHF Million)
Figure 11.5 Teva Pharmaceuticals: Revenue By Business Divisions, 2011 – 2013 (USD Billion)
Figure 12.1 Drug Reconstitution Systems: Technological Evolution Map
Figure 15.1 Drug Reconstitution Systems Market: Comparative Market Evolution Scenarios, 2014, 2019 and 2024 (USD Billion)
Table 4.1 List Of Drug Reconstitution Systems
Table 5.1 LyoTwist TM : Key Features Of Variants
Table 8.1 Materials Used In Tevadaptor System
Table 9.1 Conventional Systems: Composition Of Subcategories
Table 10.1 List Of Drugs In ‘Powder For Reconstitution’ Formulation
Table 10.2 Vaccines In Powder Formulation
Table 11.1 Ypsomed: Marketed Products
Table 11.2 Bioject: Product Pipeline
Table 12.1 Recent Agreements
Table 13.1 SWOT Analysis
Table 16.1 Classification Of Reconstitution Systems
Table 16.2 Distribution Of The Reconstitution Systems On The basis Of Usability
Table 16.3 Distribution Of Drug Reconstitution Systems On The basis Of their use
Table 16.4 Overall Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Base Scenario)
Table 16.5 Overall Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Conservative Scenario)
Table 16.6 Overall Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Optimistic Scenario)
Table 16.7 Overall Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Base Scenario)
Table 16.8 Overall Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Conservative Scenario)
Table 16.9 Overall Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Optimistic Scenario)
Table 16.10 Conventional Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Base Scenario)
Table 16.11 Conventional Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Conservative Scenario)
Table 16.12 Conventional Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Optimistic Scenario)
Table 16.13 Conventional Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Base Scenario)
Table 16.14 Conventional Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Conservative Scenario)
Table 16.15 Conventional Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Optimistic Scenario)
Table 16.16 Novel Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Base Scenario)
Table 16.17 Novel Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Conservative Scenario)
Table 16.18 Novel Drug Reconstitution Systems Market (USD BN), Short-Mid Term Forecast: 2014 - 2019 (Optimistic Scenario)
Table 16.19 Novel Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Base Scenario)
Table 16.20 Novel Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Conservative Scenario)
Table 16.21 Novel Drug Reconstitution Systems Market (USD BN), Long Term Forecast: 2019 - 2024 (Optimistic Scenario)
Table 16.22 Year-wise Distribution Of Approved Drugs In Powdered Formulation, Since 2010
Table 16.23 Classification Of Approved Drugs Based On Therapeutic Area
Table 16.24 Distribution Of Approved Drugs By Mode Of Administration
Table 16.25 Revenues, Unilife Corporation, FY 2011-2013 (USD ‘000)
Table 16.26 West Pharmaceutical Services, 2011-2013, Sales By Business Divisions (USD Million, %)
Table 16.27 BD Medical, 2011-2013, Sales By Business Divisions (USD Billion)
Table 16.28 Ypsomed, 2011-2013, Sales By Business Divisions (CHF Million)
Table 16.29 Revenue Distribution In Different Segments Of Teva (USD Billion, 2011-2013)
Table 16.30 Drug Reconstitution Systems Market (USD Billion): Comparative Scenarios; 2014, 2019 and 2024
The following companies have been mentioned in this study:
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