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Subcutaneous Biologics: Products, Technologies and Delivery Systems

  • January 2015
  • -
  • Roots Analysis Private Ltd.
  • -
  • 219 pages

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INTRODUCTION
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.

EXAMPLE HIGHLIGHTS
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).

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information

CHAPTER OUTLINES
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 7includes 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.

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