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Report Description
Amongst various efforts to ensure efficient drug delivery, subcutaneous administration has emerged as one of the most promising approaches to deliver viscous biologic drugs in a patient friendly format. Owing to its numerous compelling advantages, the concept has gained huge traction in recent years. The flexibility and convenience of subcutaneous administration over other routes of delivery, along with the increasing trend of self-medication, are some of the key factors contributing to the expansion of this market.In addition, the plethora of self-administration devices created by device manufacturers to fulfil the demand for subcutaneous delivery systems is acting as a key enabler. Examples of such devices include prefilled syringes, auto-injectors, needle free injectors and bolus-injectors.
The market is characterized by the presence of a robust pipeline comprising various large molecules; these include proteins, peptides and antibodies in different phases of development being investigated for their subcutaneous use. Furthermore, the approved therapeutic products that are currently delivered intravenously are being developed as subcutaneous formulations to enhance their use and adoption.The upcoming trend is likely to create a positive impact on healthcare productivity and therapy adherence.
Though the market for biologics is considerably mature (with majority of existing biologic therapies being given intravenously), subcutaneous formulation and administration presents new opportunities for multiple stakeholders in the market.Providing a subcutaneous formulation of a particular drug in self-injectable format also helps a pharmaceutical company in achieving brand differentiation for that therapy against competitors within the same therapeutic category.
Scope of the Report
The ‘Subcutaneous Biologics: Products, Technologies and Delivery Systems’ report provides an extensive study of the rapidly growing market of subcutaneous biologic drugs. It is an emerging area that is gaining substantial attention from researchers and manufacturers across the globe. Subcutaneous delivery provides numerous advantages over other routes of delivery. Some of the major benefits include reduction in time spent in drug administration, reduced patient time at healthcare facilities, decreased healthcare costs and improved therapy compliance.The utility of viscous biologics in the treatment of chronic diseases, the increasing trend of self-medication and requirement of high concentration subcutaneous formulation of biologics are some of the driving factors behind the market’s evolution.
The study not only provides an in-depth analysis of pipeline and marketed subcutaneous biologic drug candidates but also includes a detailed discussion on the formulation and delivery aspects associated with such biological macromolecules. In addition, the advancing trend of transition from intravenous to subcutaneous and the fundamental challenge of formulation of biologics into subcutaneous format highlight the crucial role of technology developers in this field. The requirement of suitable delivery systems for subcutaneous administration also presents immense growth prospects for device manufacturing firms which are working aggressively to provide a diverse range of self-injection devices.
In fact, one of the key objectives of the report is to identify the future potential of the industry for these stakeholders. In addition to the market forecast for subcutaneous biologic drugs, we have also provided a ten year forecast of the subcutaneous delivery systems including prefilled syringes, drug reconstitution systems and bolus injectors. The base year for the report is 2014. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from primary and secondary research.
Contents
Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of subcutaneous biologics market.
Chapter 3 provides a general introduction on the subcutaneous route of administration, including its advantages and limitations. We have also covered, in detail, the concept of stabilization and formulation associated with subcutaneous administration of biological macromolecules.
Chapter 4 analyses the global subcutaneous biologics market. This chapter identifies the various marketed and pipeline candidates. In addition to the case studies of some of the leading subcutaneous biologics, the chapter provides an in-depth analysis of pipeline by phase of development.
Chapter 5 focuses on the formulation technologies that enable subcutaneous administration of biologic drugs. Each technology profile covers various aspects including technology description, advantages, drugs using the technology and related developments.
Chapter 6 provides details on the drug delivery systems available in the market that facilitate subcutaneous delivery of biologics.
Chapter 7 includes profiles of key technology developers in the subcutaneous biologics market. Each company profile includes information such as financial performance, pipeline overview, technology overview, recent developments and future outlook.
Chapter 8 presents a detailed ten year forecast for the subcutaneous biologics market and drug delivery systems. Due to the uncertainty surrounding some of the key assumptions, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.The chapter also provides a view on financial terms and conditions involved in technology licensing deals identified from various spheres of the pharmaceutical industry.
Chapter 9 provides the SWOT analysis of the subcutaneous biologics market giving strategic insights to the major factors that are likely to drive future growth while also highlighting the weaknesses and threats that can negatively impact the industry’s evolution.
Chapter 10 is a collection of transcripts of interviews conducted during the course of this study.
Chapter 11 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 previous chapters.
Chapter 12 is an appendix which provides tabulated data and numbers for all the figures provided in the report.
Chapter 13 is an appendix which provides a list of companies and organizations mentioned in the report.
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Context and Background
3.2. Instability in Therapeutic Products
3.3. Subcutaneous Administration
3.3.1. Formulation for Subcutaneous Drug Delivery
3.3.2. Method of Subcutaneous Administration
3.3.3. Advantages of Subcutaneous Route of Administration
3.3.4. Limitations of Subcutaneous Administration
3.3.5. Challenges in Subcutaneous Formulation
4. SUBCUTANEOUS BIOLOGICS MARKET
4.1. Chapter Overview
4.2. Biologics: An Overview
4.3. Subcutaneous Administration of Biologics: An Emerging Trend
4.4. Subcutaneous Biologics in the Market
4.5. Case Studies
4.5.1. Herceptin (Genentech/Roche; Chugai)
4.5.1.1. Background and History of Development
4.5.1.2. Indications and Dosage Forms
4.5.1.3. Target Population
4.5.1.4. Sales, 1999 - 2013
4.5.1.5. Launch of Subcutaneous Formulation
4.5.1.6. ENHANZE™: The Technology behind Subcutaneous Formulation of Herceptin (Halozyme Therapeutics)
4.5.1.7. Advantages of Subcutaneous Herceptin over Intravenous
4.5.1.8. Herceptin Likely to be the First Biologic to be Launched in Bolus Injector
4.5.2. MabThera/Rituxan/Zytux (Biogen Idec; Genentech/Roche; Chugai)
4.5.2.1. Background and History of Development
4.5.2.2. Indications and Dosage Forms
4.5.2.3. Target Population
4.5.2.4. Sales, 1999 - 2013
4.5.2.5. Launch of MabThera Subcutaneous
4.5.2.6. Advantages of Subcutaneous MabThera over Intravenous
4.5.3. Neulasta (Amgen)
4.5.3.1. Background and History of Development
4.5.3.2. Indications and Dosage Forms
4.5.3.3. Launch in Prefilled Syringe
4.5.3.4. Sales, 2003-2013
4.5.4. Humira (AbbVie; Eisai)
4.5.4.1. Background and History of Development
4.5.4.2. Indications and Dosage Forms
4.5.4.3. Launch in Prefilled Syringe
4.5.4.4. Sales, 2003 – 2013
4.5.5. Enbrel (Amgen; Pfizer; Takeda)
4.5.5.1. Indications and Dosage Forms
4.5.5.2. Move from Vial to Syringes
4.5.5.3. Sales, 2002 - 2013
4.5.6. Leading Subcutaneous Biologics (By Sales), 2013
4.6. Subcutaneous Drugs in Pipeline
4.6.1. Pipeline Analysis
4.6.1.1. Distribution by Type of Molecule
4.6.1.2. Distribution by Phase of Development
4.6.1.3. Distribution by Indication
5. TECHNOLOGIES FOR SUBCUTANEOUS FORMULATION OF BIOLOGICS
5.1. Chapter Overview
5.2. Technology Profiles
5.2.1. XeriJect (Xeris Pharmaceuticals)
5.2.1.1. Technology Description
5.2.1.2. Advantages
5.2.1.3. Drugs Using this Technology
5.2.2. XeriSol (Xeris Pharmaceuticals)
5.2.2.1. Technology Description
5.2.2.2. Advantages
5.2.2.3. Developments
5.2.2.4. Drugs Using this Technology
5.2.3. BioChaperone (ADOCIA)
5.2.3.1. Technology Description
5.2.3.2. Advantages
5.2.3.3. Developments
5.2.3.4. Drugs Using this Technology
5.2.4. High Concentration Formulation (HCF) Technology(Integrity Bio)
5.2.4.1. Technology Description
5.2.4.2. Advantages
5.2.5. Crystalomics Technology (Ajinomoto Althea)
5.2.5.1. Advantages
5.2.5.2. Developments
5.2.6. ENHANZE Technology (Halozyme Therapeutics)
5.2.6.1. Technology Description
5.2.6.2. Advantages
5.2.6.3. Developments
5.2.6.4. Drugs Using this Technology
5.2.7. Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate Technology (Alnylam Pharmaceuticals)
5.2.7.1. Advantages
5.2.7.2. Developments
5.2.7.3. Drugs Using this Technology
5.2.8. Medusa (Flamel Technologies)
5.2.8.1. Advantages
5.2.8.2. Developments
5.2.8.3. Drugs Using this Technology
5.2.9. Controlled Release Technology (MedinCell)
5.2.9.1. Advantages
5.2.9.2. Drugs Using this Technology
5.2.10. TransCon Technology (Ascendis Pharma)
5.2.10.1. Advantages
5.2.10.2. Developments
5.2.10.3. Drugs Using this Technology
5.2.11. Antibody Stabilization Technology (Garvan Researchers)
5.2.11.1. Advantages
5.2.11.2. Drugs Using this Technology
5.2.12. LNP technology (Tekmira)
5.2.12.1. Advantages
5.2.12.2. Drugs Using this Technology
6. DRUG DELIVERY SYSTEMS FOR SUBCUTANEOUS DELIVERY OF BIOLOGICS
6.1. Chapter Overview
6.2. Types of Subcutaneous Delivery Systems
6.3. Selection of a Suitable Delivery Device
6.4. Wearable Injectors
6.4.1. Types of Wearable Injectors
6.4.1.1. Insulin Pumps with Infusion Sets
6.4.1.2. Insulin Patch Pumps
6.4.1.3. Transdermal Patch
6.4.1.4. Bolus Injectors
6.5. Prefilled Syringes
6.5.1. Classification of Prefilled Syringes
6.5.2. Prefilled Syringe Systems Available in the Market
6.5.3. Benefits of Prefilled Syringes over Traditional Injectable Devices
6.5.4. Products Available in Prefilled Syringes
6.6. Auto-injectors
6.6.1. Pen-injectors vs. Auto-injectors
6.6.2. Safety Options in Self Injectors
6.7. Drug Reconstitution Delivery Systems
6.7.1. Types of Drug Constitution Systems
6.7.2. Drug Reconstitution Systems for Subcutaneous Delivery
6.7.3. Benefits of Advanced Reconstitution Systems
6.8. Needle Free Injections
7. MARKET SIZING AND FORECAST
7.1. Chapter Overview
7.2. Market for Subcutaneous Biologic Drugs
7.2.1. Forecast Methodology
7.2.2. Subcutaneous Biologics Market, 2014 – 2025
7.3. Market for Drug Delivery Systems
7.3.1. Prefilled Syringes for Subcutaneous Administraiton, Market Forecast, 2014 - 2025
7.3.2. Large Volume Wearable Injectors for Subcutaneous Administration Market Forecast, 2014 - 2025
7.3.3. Novel Drug Reconstitution Systems Market Forecast, 2014 - 2025
7.4. Technology Licensing Payments
8. CASE STUDIES: TECHNOLOGY DEVELOPERS
8.1. Chapter Overview
8.2. Halozyme Therapeutics
8.2.1. Company Overview
8.2.2. Pipeline Overview
8.2.3. Financial Performance
8.2.4. Manufacturing/Technology
8.2.5. Recent Partnerships/Developments
8.2.6. Future Outlook
8.3. Xeris Pharmaceuticals
8.3.1. Company Overview
8.3.2. Pipeline Overview
8.3.3. Technology
8.3.4. Recent Partnerships/Developments
8.3.5. Future Outlook
8.4. Integrity Bio
8.4.1. Company Overview
8.4.2. Technology
8.5. Alnylam Pharmaceuticals
8.5.1. Company Overview
8.5.2. Pipeline Overview
8.5.3. Financial Information
8.5.4. Manufacturing/Technology
8.5.5. Recent Partnerships/Developments
8.5.6. Future Outlook
8.6. Ajinomoto Athlea
8.6.1. Company Overview
8.6.2. Financial Overview
8.6.3. Manufacturing/technology
8.6.4. Recent Partnerships/Developments
8.6.5. Future Outlook
8.7. ADOCIA
8.7.1. Company Overview
8.7.2. Pipeline Overview
8.7.3. Financial Overview
8.7.4. Manufacturing/ Technology
8.7.5. Recent Developments/Partnerships
8.7.6. Future Outlook
8.8. Flamel Technologies
8.8.1. Company Overview
8.8.2. Pipeline Overview
8.8.3. Financial Overview
8.8.4. Manufacturing/Technology
8.8.5. Recent Partnerships/Developments
8.8.6. Future Outlook
8.9. MedinCell
8.9.1. Company Overview
8.9.2. Manufacturing/Technology
8.9.3. Recent Partnerships/Developments
8.9.4. Future Outlook
8.10. Ascendis Pharma
8.10.1. Company Overview
8.10.2. Manufacturing/Technology
8.10.3. Partnerships
8.10.4. Future Outlook
9. SWOT ANALYSIS
9.1. Chapter Overview
9.2. Strengths
9.3. Weaknesses
9.4. Opportunities
9.5. Threats
10. INTERVIEW TRANSCRIPTS
11. CONCLUSION
11.1. Transition from Intravenous to Subcutaneous: A Powerful Concept
11.2. Multiple Drivers to Fuel the Growth
11.3. A Multi-Billion Dollar Rapidly Growing Market
11.4. A Whole New Set of Opportunities for Multiple Stakeholders
12 APPENDIX 1: TABULATED DATA
13 APPENDIX 2: LIST OF COMPANIES
Figure 4.1 Numbers of Biologics Approved by the USFDA, 2009-2013
Figure 4.2 Leading Subcutaneous Biologics By Sales, 2013 (USD Million)
Figure 4.3 HER2 Expression in Breast Cancer Patients (%)
Figure 4.4 Herceptin Sales, 1999 - 2013 (CHF Billion)
Figure 4.5 MabThera: Target Population for Follicular Non-Hodgkin’s Lymphoma)
Figure 4.6 MabThera: Target Population for Diffuse Large B-cell Non-Hodgkin’s Lymphoma
Figure 4.7 MabThera: Target Population for Chronic Lymphocytic Leukemia
Figure 4.8 Rituximab Sales, 1999 - 2013 (CHF Billion)
Figure 4.9 Neulasta Sales, 2003 - 2013 (USD Billion)
Figure 4.10 Humira Global Sales, 2003-2013 (USD Billion)
Figure 4.11 Enbrel US Sales, 2002-2013 (USD Million)
Figure 4.12 Subcutaneous Biologics Pipeline: Distribution by Type of Molecule
Figure 4.13 Subcutaneous Biologics Pipeline: Distribution by Phase of Development
Figure 4.14 Subcutaneous Biologics Pipeline: Leading Indications/ Therapeutic Areas
Figure 5.1 XeriJect Technology: Process
Figure 5.2 Medusa Formulation Technology: Process
Figure 5.3 Controlled Release Technology: Process
Figure 6.1 Subcutaneous Drug Delivery Systems: Injection Volume Range
Figure 6.2 Benefits of Large Volume Wearable Injectors to Stakeholders
Figure 6.3 Prefilled Syringes: Market Landscape by Manufacturer
Figure 7.1 Subcutaneous Biologics Market, 2014 – 2025: Base Scenario (USD Billion)
Figure 7.2 Global Prefilled Syringes, Forecast Number of Units, 2014 - 2025 (Billions)
Figure 7.3 Global Prefilled Syringes, Sales Forecast, 2014 - 2025 (USD Billion)
Figure 7.4 Overall Large Volume Wearable Injectors Market (Number of Devices, Millions), 2014 - 2025
Figure 7.5 Overall Large Volume Wearable Injectors Market (USD Million), 2014 - 2025
Figure 7.6 Novel Drug Reconstitution Systems Market for Subcutaneous Administration, 2014-2025
Figure 7.7 Upfront Payments: Scatter Plot Representation
Figure 7.8 Milestone Payments: Scatter Plot Representation
Figure 8.1 Pipeline: Halozyme Therapeutics
Figure 8.2 Halozyme Therapeutics: Revenues, 2009 – 2013 (USD Million)
Figure 8.3 Halozyme Therapeutics: Revenues by Business Divisions, FY 2013 (USDMillion)
Figure 8.4 Pipeline: Xeris Pharmaceuticals
Figure 8.5 Pipeline: Alnylam Pharmaceuticals
Figure 8.6 Alnylam Pharmaceuticals: Revenues, 2009-2013 (USD Million)
Figure 8.7 Alnylam Pharmaceuticals: Net Revenues from Collaborators, FY 2013 (USD Million)
Figure 8.8 Ajinomoto Co: Revenues, 2009-2013 (JPY Billion)
Figure 8.9 Ajinomoto Co: Revenues by Business Segments, FY 2014 (JPY Billion)
Figure 8.10 Pipeline: ADOCIA
Figure 8.11 ADOCIA: Revenues, 2011-2013 (EUR Million)
Figure 8.12 ADOCIA: Revenues by Business Segments, FY 2013 (EUR Million)
Figure 8.13 Pipeline: Flamel Technologies
Figure 8.14 Flamel Technologies: Annual Revenue, 2009-2013 (USD Million)
Figure 8.15 Flamel Technologies: Distribution of Annual Revenue by Operating Region, FY 2013 (USD’ 000)
Figure 11.1 Subcutaneous Biologics Market (USD Billion): Comparative Scenarios, 2014, 2019 and 2025
Table 3.1 Biotherapeutics: Physical and Chemical Instabilities
Table 4.1 List of Marketed Subcutaneous Biologics
Table 4.2 Subcutaneous vs. Intravenous Herceptin
Table 4.3 Subcutaneous vs. Intravenous Rituximab
Table 4.4 List of Pipeline Subcutaneous Biologics
Table 5.1 Technologies for Subcutaneous Delivery of Biologics
Table 5.2 Drugs Using the Xerisol Technology
Table 5.3 Drugs using BioChaperone Technology
Table 5.4 Drugs Using the Enhanze Technology
Table 5.5 Drugs Using the (ESC)-GalNAc-conjugate Technology
Table 5.6 Drugs Using Medusa Technology
Table 5.7 Pipeline Products Using TransCon Technology
Table 6.1 Large Volume Wearable Injectors under Development
Table 6.2 Large Volume Wearable Injectors: Benefits v/s Perceived Issues
Table 6.3 Classification of Prefilled Syringes
Table 6.4 Prefilled Syringe Systems Available in the Market, 2014: A Comparison, By Manufacturer
Table 6.5 Drugs Approved in Prefilled Syringes, 2013-2014
Table 6.6 Auto-injector/Pen-injector Systems Approved in 2013-2014
Table 6.7 Auto-injector/Pen-injector Systems (Using Prefilled Syringes) Available in the Market
Table 6.8 Drug Reconstitution Systems for Subcutaneous Administration
Table 6.9 List of Needleless Injection Systems
Table 7.1 Technology Licensing Deals
Table 8.1 Ajinomoto Althea: Medium Term Management Plan
Table 8.2 ADOCIA: Short-term Plans for Pipeline Products
Table 9.1 SWOT Analysis
Table 9.2 Recall of Auto-injectors
Table 9.3 Prefilled Syringe Recalls, 2003-2014
Table 12.1 Leading Subcutaneous Biologics by Sales, 2013 (USD Million)
Table 12.2 Herceptin Sales, 1999 - 2013 (CHF Billion)
Table 12.3 MabThera Sales, 1999 - 2013 (CHF Billion)
Table 12.4 Neulasta Sales, 2002 - 2013 (USD Billion)
Table 12.5 Humira Global Sales, 2004-2013 (USD Billion)
Table 12.6 Enbrel Global Sales, 2002-2013 (USD Billion)
Table 12.7 Subcutaneous Biologics Pipeline: Distribution by Type of Molecule
Table 12.8 Subcutaneous Biologics Pipeline: Distribution by Phase of Development
Table 12.9 Subcutaneous Biologics Pipeline: Leading Indications/ Therapeutic Areas
Table 12.10 Halozyme Therapeutics, Revenues: 2009 – 2013 (USD Million)
Table 12.11 Halozyme Therapeutics, Revenues by Business Divisions: 2013 (USD Million)
Table 12.12 Alnylam Pharmaceuticals: Revenues, 2009-2013 (USD Million)
Table 12.13 Alnylam Pharmaceuticals: Net Revenues from Collaborators, 2013 (USD Million)
Table 12.14 Ajinomoto Co., Inc.: Annual Revenue 2009-2013 (in JPY million)
Table 12.15 Ajinomoto Co., Inc.: Distribution of Revenue by Operating Segments 2014
Table 12.16 ADOCIA: Revenues, 2011-2013 (EUR Million)
Table 12.17 ADOCIA: Distribution of Revenues by Operating Segments, 2013
Table 12.18 Flamel Technologies: Annual Revenue 2009-2013 (USD Million)
Table 12.19 Subcutaneous Biologics Market, 2014 – 2025: Base Scenario (USD Billion)
Table 12.20 Subcutaneous Biologics Market, 2014 – 2025: Conservative Scenario (USD Billion)
Table 12.21 Subcutaneous Biologics Market, 2014 – 2025: Optimistic Scenario (USD Billion)
Table 12.22 Global Prefilled Syringes for Subcutaneous Biologics, Forecast Number of Units, 2014 - 2025 (Billions)
Table 12.23 Global Prefilled Syringes, Sales Forecast, 2014 - 2025 (USD Billion)
Table 12.24 Overall Large Volume Wearable Injectors Market (Number of Devices, Millions), 2014 – 2025
Table 12.25 Overall Large Volume Wearable Injectors Market (USD Million), 2014 - 2025
Table 12.26 Novel Drug Reconstitution Systems Market for Subcutaneous Administration (USD Billion), 2014-2025
The following companies have been mentioned in this report.
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