Subcutaneous Biologics: Products, Technologies and Delivery Systems

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  1. Pharmaceutical giants,such as Roche,are involved in development of subcutaneous formulations for their approved therapies in order to enhance their use and adoption. Herceptin SC and MabThera SC represent some of the successful examples of this novel approach.
  2. With formulation being a crucial aspect, technology developers have carved an important role for themselves in the market. During our research, we identified nine such companies which are involved in development and commercialization of technologies to form stable subcutaneous formulations of proteins, peptides, antibodies and other large molecules. Halozyme is a pertinent example; the company has entered into numerous deals with big pharmaceutical firms to develop subcutaneous formulations for their products.
  3. The pipeline of subcutaneous biologics represents one of the underlying drivers of the market. In addition to the 55 marketed subcutaneous biologics, there are 196other such molecules in clinical development. Though biologics are being developed targeting numerous diseases across the therapeutic spectrum, inflammatory and metabolic disorders are amongst the prime focus areas.
  4. We expect the overall market of subcutaneous biologics to grow at a CAGR of 7.0% over the next decade; factors such as the advantages of subcutaneous administration and the growing trend for self-injection medications will drive this uptake.
  5. In terms of delivery systems, we expect the annual market for prefilled syringes, novel drug reconstitution systems and bolus injectors for subcutaneous administration of biologics to be worth USD 1.4 billion, USD 0.9 billion and USD 8.1 billion respectively by 2025.
  6. The technology developers stand to benefit from technology licensing deals; these generally present strong financial incentives to the licensors in the form of upfront payments (USD 8 – 20 million) and milestone payments (USD 100 – 300 million).

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.


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.

Table of Contents

1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
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
4.1. 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) Background and History of Development Indications and Dosage Forms Target Population Sales, 1999 - 2013 Launch of Subcutaneous Formulation ENHANZE™: The Technology behind Subcutaneous Formulation of Herceptin (Halozyme Therapeutics) Advantages of Subcutaneous Herceptin over Intravenous Herceptin Likely to be the First Biologic to be Launched in Bolus Injector
4.5.2. MabThera/Rituxan/Zytux (Biogen Idec; Genentech/Roche; Chugai) Background and History of Development Indications and Dosage Forms Target Population Sales, 1999 - 2013 Launch of MabThera Subcutaneous Advantages of Subcutaneous MabThera over Intravenous
4.5.3. Neulasta (Amgen) Background and History of Development Indications and Dosage Forms Launch in Prefilled Syringe Sales, 2003-2013
4.5.4. Humira (AbbVie; Eisai) Background and History of Development Indications and Dosage Forms Launch in Prefilled Syringe Sales, 2003 – 2013
4.5.5. Enbrel (Amgen; Pfizer; Takeda) Indications and Dosage Forms Move from Vial to Syringes Sales, 2002 - 2013
4.5.6. Leading Subcutaneous Biologics (By Sales), 2013
4.6. Subcutaneous Drugs in Pipeline
4.6.1. Pipeline Analysis Distribution by Type of Molecule Distribution by Phase of Development Distribution by Indication
5.1. Chapter Overview
5.2. Technology Profiles
5.2.1. XeriJect (Xeris Pharmaceuticals) Technology Description Advantages Drugs Using this Technology
5.2.2. XeriSol (Xeris Pharmaceuticals) Technology Description Advantages Developments Drugs Using this Technology
5.2.3. BioChaperone (ADOCIA) Technology Description Advantages Developments Drugs Using this Technology
5.2.4. High Concentration Formulation (HCF) Technology(Integrity Bio) Technology Description Advantages
5.2.5. Crystalomics Technology (Ajinomoto Althea) Advantages Developments
5.2.6. ENHANZE Technology (Halozyme Therapeutics) Technology Description Advantages Developments Drugs Using this Technology
5.2.7. Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate Technology (Alnylam Pharmaceuticals) Advantages Developments Drugs Using this Technology
5.2.8. Medusa (Flamel Technologies) Advantages Developments Drugs Using this Technology
5.2.9. Controlled Release Technology (MedinCell) Advantages Drugs Using this Technology
5.2.10. TransCon Technology (Ascendis Pharma) Advantages Developments Drugs Using this Technology
5.2.11. Antibody Stabilization Technology (Garvan Researchers) Advantages Drugs Using this Technology
5.2.12. LNP technology (Tekmira) Advantages Drugs Using this Technology
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 Insulin Pumps with Infusion Sets Insulin Patch Pumps Transdermal Patch 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
7.1. 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
8.1. 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
8.7.1. 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
9.1. Chapter Overview
9.2. Strengths
9.3. Weaknesses
9.4. Opportunities
9.5. Threats
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

List of Figures

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

List of Tables

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

Listed Companies

The following companies have been mentioned in this report.

  1. Abbott Laboratories
  2. Activa
  3. Adamis Pharmaceuticals Corporation
  5. Advantage Health Services 
  6. Aguettant
  7. Ajinomoto Althea Inc.
  8. Alnylam Pharmaceuticals
  9. Amgen
  10. Antares Pharma
  11. Aptar Pharm
  12. Aradigm Corporation
  13. Arte Corporation
  14. Ascendis Pharma
  15. AstraZeneca
  16. Bang and Olufsen
  17. Battelle
  18. Baxter
  19. Bayer
  20. Becton Dickinson
  21. Bespak
  22. Biogen Idec
  23. Bioject Medical Technologies, Inc.
  24. Bristol-Myers Squibb Co
  25. Calibra Medical
  26. CeQur SA
  27. Chengdu Instituteof Biologic Products, Biogenetech
  28. CNS Therapeutics (acquired by Mallinckrodt)
  29. CSL Behring
  30. Duoject
  31. Eagle Pharmaceuticals
  32. Elcam Medical
  33. Eli Lilly
  34. EMD Serono
  35. Emergent Biosolutions
  36. Enable Injections
  37. Eternity Healthcare
  38. Evans enterprise
  39. Flamel Technologies
  40. Future injection technologies
  41. Genzyme
  42. Gerresheimer
  43. Grifols Therapeutics (acquired Talecris Biotherapeutics)
  44. GSK
  45. Halozyme
  46. Haselmeier
  47. Health-Mor
  48. Injex - Equidyne Systems
  49. Integrity Bio
  50. Janssen Biotech, Inc.
  51. Kaleo Inc.
  52. Mediject
  53. MedinCell
  54. MedPro
  55. Merck
  56. Meridian
  57. National Medical Products, Inc.
  58. Nipro (acquired MGlas AG)
  59. NouvaOmpi
  60. Novartis
  61. Novo Nordisk
  62. Owen Mumford
  63. PA Consulting
  64. Penjet corporation
  65. Pfizer
  66. Plas-Tech Engineering
  67. Ratio Inc.
  68. Roche
  69. Roselabs Bioscience
  70. Sanofi
  71. Scandinavian Health Limited (SHL Medical)
  72. Schering Corporation (Merck Serono)
  73. Schott
  74. Sensile Medical
  75. Shandong Weigao
  76. Sobi
  77. SteadyMed
  78. Taisei Kako
  79. Tekmira
  80. Terumo Corporation
  81. The Medical House
  82. UCB
  83. Unilife Corporation
  84. United Therapeutics
  85. Valeritas
  86. Vetter Pharma
  87. West Pharmaceutical Solutions
  88. Xeris Pharmaceuticals
  89. Ypsomed


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