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Biotherapeutics: Novel Formulation and Delivery Approaches (Focus on Antibodies and Proteins), 2015-2025

  • November 2015
  • 301 pages
  • Roots Analysis Private Ltd.
Report ID: 3411191

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INTRODUCTION

Biopharmaceuticals is currently one of the fastest growing segments in the pharmaceutical industry. They have a vital use in the treatment of chronic diseases and also result in high profit margins for the drug developers. There are several therapeutic areas for which biopharmaceuticals are being investigated; these include oncology, metabolic disorders, viral infections, genetic disorders and immunological disorders. Biotherapeutics (both approved and under investigation) include monoclonal antibodies, cell therapies, clotting factors, cytokines, enzymes, hormones and vaccines. In fact, several antibody based therapies have already been approved across the globe. Humira®, by AbbVie, is a well-known example; the drug has been generating multibillion dollar sales annually for several years.

The major challenge for biologics has been the mode of administration. For most large molecule drugs, IV is an established route. Through this method, the drug directly enters systemic circulation bypassing degradation in the gastrointestinal (GI) tract. However, there are other challenges; these include the requirement of healthcare experts for drug administration (in turn, increasing the cost of therapy) and associated pain during therapy administration (negatively impacting patient compliance).Companies developing biologics are continuously on the lookout for novel formulation and delivery systems in order to exploit their full therapeutic and commercial potential. Amongst the various aspects being studied, technologies for facilitating oral, subcutaneous (SC) and transdermal delivery of biologics are highly sought after and have received widespread attention from researchers and manufacturers across the globe.

Several start-ups, with innovative technologies, have surfaced in the past decade and have continuously encouraged the use of biotherapeutics by providing novel approaches to improve patient compliance. These technologies are broadly classified either as formulation technologies (approaches with primary objective of changing the formulation of drug, thereby facilitating an alternate route of administration in many cases) or delivery systems (approaches with primary objective of developing a physical system to deliver the drug via an alternate route).

The overall interest continues to rise as is evident from the number of partnerships / agreements that have taken place amongst the stakeholders. Technology licensing agreements have been very common and are likely to play an active role in industry’s development. In addition, several venture capitalists have led multiple funding rounds in these companies, acting as a key enabler behind the evolution.

SCOPE OF THE REPORT

The ‘Biotherapeutics: Novel Formulation and Delivery Approaches (Focus on Antibodies and Proteins)’report provides a comprehensive analysis of the current market landscape and the future outlook of technologies focused on the formulation and delivery of biotherapeutics, primarily proteins and antibodies. Biopharmaceuticals has become an area of heavy interest for many pharmaceutical companies; they make up about one-third of all the drugs that are currently in development. The industry is growing at a healthy pace resulting in a substantial shift from conventional chemical synthesis to biotechnological processes in the way drugs are now produced.

Intravenous (IV) route has been the most popular route for administering large molecule drugs such as proteins and antibodies. However, with the rising popularity of biologics and biosimilars, several companies are now looking forward to technologies that can be used for delivering biotherapeutics via a route other than IV injection or infusion. Technologies focused on oral, SC and transdermal routes are becoming more popular and, therefore, are expected to be the major contributors to the overall drug delivery technologies market. In addition, there are other novel targeted approaches, such as bypassing blood brain barrier, which are likely to change the industry paradigm in the long run.

During the course of our research, we identified 122 such companies that are developing either formulation technologies or novel systems for delivery of large molecule drugs. The study not only provides the list of technologies but also includes a detailed analysis on the overall market for these technologies. We have looked at the investments that have been made into these technologies and have provided detailed information of the various collaborations / licensing agreements amongst the stakeholders. This advancing trend of transition from IV to alternate delivery mechanisms highlights the crucial role of technology developers in this field.

The base year for the report is 2015. The report provides the market forecast for the period 2015-2025. The research, analysis and insights presented in this report are backed by a deep understanding,developed from both primary and secondary research, of key drivers behind the growth.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered via secondary research. For all our projects, we conduct 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 evolve across different regions and technology 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
-Industry analysts’ views

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 study. The summary offers a high level view on the likely market evolution of the drug delivery technologies for biotherapeutics.

Chapter 3 is an introductory chapter on biotherapeutics. It includes the various advantages and challenges faced by technology developers in developing systems for delivering biotherapeutics. We have also presented, in detail, a discussion on the approved antibody therapeuticsin the market, signifying the growing trend towards alternate delivery mechanisms.

Chapter 4 identifies the various approaches / technologies / systems that can be used to formulate and administer biologics. The classification system for the technologies mentioned in this chapter helps develop a deeper understanding of the market.

Chapter 5 reviewsthe key technologies available for oral delivery of biotherapeutics. We have presented profiles of several leading technologies covering information on their origin, mechanism, molecules based on these technologies and associated companies.

Chapter 6 includes profiles of key technology developers specialising in formulating and delivering biotherapeutics via the SC route. Each profile includes information such as technology overview, pipeline review, funding details and recent developments.

Chapter 7reviews the major technologies available for transdermal/intradermal administration of biotherapeutics. Several leading companies, along with their technologies, have been profiled in this chapter. As in earlier chapters, these profiles provide an overview of the technology developers, mechanism of technologies, drugs in the pipeline based on specific technologies and associated recent developments.

Chapter 8 discusses technologies focused on other alternative administration routes (other than oral, SC and transdermal). The chapter includes key insights on technologies that alter the release kinetics and pharmacokinetics of the drug. In addition, certain technologies focused on targeted delivery, such as delivery across the blood-brain-barrier, have also been covered in this chapter.

Chapter 9 highlights the recent partnerships that have taken place in the industry. We have also discussed the various partnership models in existence and the most common forms of deals/agreements that have evolved over time.

Chapter 10provides information on several funding instances that have driven research and development of formulation and delivery technologies for biotherapeutics. Our analysis reveals interesting insights on the growing interest of venture capitalists and other stakeholders in this market.

Chapter 11 presents a detailed ten year forecast highlighting the potential for technology developers engaged in developing technologies for delivery of biotherapeutics. Due to the uncertainty surrounding some of the key assumptions, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios. Our insights are backed by discussions with several stakeholders in the industry.

Chapter 12 provides a SWOT analysis of the drug delivery technologies market for biotherapeutics, giving strategic insights to the major factors that are likely to drive future growth whilst highlighting the weaknesses and threats that may negatively impact the industry’s evolution.

Chapter 13 is a collection of transcripts of interviews conducted with key players during the course of this study.

Chapter 14 summarises the overall report. In this chapter, we provide a recap of the key takeaways and an independent future outlook based on the research and analysis described in earlier chapters.

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which provides a list of companies and organisations mentioned in the report.

EXAMPLE HIGHLIGHTS

1. There are over 150 technologies, being developed by around 120 companies, which are focused on developing novel formulations and / or systems for delivering antibodies and proteins. Amongst the delivery systems, prime focus of the stakeholders is on oral, SC and transdermal drug delivery technologies.
2. The market has attracted several start-ups; these companies, in collaboration with big pharma, are expected to foster more innovation in the near future. Some of the well-known players with proprietary technologies are (in alphabetical order) Adocia, Aegis Therapeutics, Arecor, Corium International, Cosmo Pharmaceuticals, Durect Corporation, Emisphere Technologies, Excelse Bio, Generex Biotechnology, Halozyme Therapeutics, Merrion Pharmaceuticals, Oramed Pharmaceuticals, Rani Therapeutics, Xeris Pharmaceuticals and Zosano Pharma (complete list in Chapter 4 of the report).

3. These approaches focus on a wide range of mechanisms; amongst others, these include modifying the release properties along with pharmacokinetic properties, creating cold-chain free and stable liquid formulations of the drug and delivering the drugs in a targeted manner.

4. Within the technologies focused on targeted delivery, there seems to be heavy focus on delivery of drugs across the Blood Brain Barrier (BBB). Delivery across the BBB has been a big challenge in case of large sized biologics. We have identified over 15 players, which aim to successfully overcome this challenge in the coming few years.
5. Venture capitalists have shown an enormous amount of interest and confidence in the technology developers. In total, we traced over 200 instances of funding with the total investment amounting to an encouraging sum of USD 2.9 billion over the last decade. In addition, government agencies, such as the NIH, have also encouraged technology developers by issuing grants for a wide range of research projects.

6. Driven by several factors, such as rising incidence of chronic diseases, growing popularity of biologics / biosimilars and use of delivery / formulation technologies as life cycle management tools for near patent expiry drugs, the market for such technologies is expected to grow aggressively at a healthy annual growth rate of 9.6% between 2015 and 2025.

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