Biotherapeutics: Novel Formulation and Delivery Approaches Focus on Antibodies and Proteins 2015 - 2025
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.
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.
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).
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.
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.
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.
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.
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
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 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.
LIST OF COMPANIES AND ORGANISATIONS
Following companies have been mentioned in this report.
Advanced Accelerator Applications
Albany Medical College
Applied Molecular Transport
Aquarius Biotechnologies (Acquired by Matinas Biopharma)
Asahi Kasei Pharma
Caleva Process Solutions
ETI Karle Clinical
Integrated Animal Health
Intranasal Technology Inc (ITI)
Johnson and Johnson
Laser Detect Systems
Le Métier de Beauté
Liquidia Technologies/ Envisia Therapeutics
MIS Dental Implants Technologies
Mountain View Pharmaceuticals
MSD Animal Health
Nano Precision Medical
ProCore Bio Med
Swiss Caps AG
Tamarisk Technologies Group
Targeted Cell Therapies
XL Protein GmbH
Following VC Firms have been mentioned in the report
7 Med Health Ventures
Advanced Technology Ventures
Aegis Capital Corp
AGF Private Equity
Alpes Developpement Durable Investissement
Altitude Life Sciences Ventures
ARCH Venture Partners
Ascension Health Ventures
Astellas Venture Management
Bill & Melinda Gates Foundation
Boehringer Ingelheim Venture Fund
Boston Harbor Angels
Burrill and Company
Business Development Bank of Canada
Capital Royalty Partners II
Central Texas Angel Network
Cherrystone Angel Group
Chicago Growth Partners
CHL Medical Partners
Crystal Horizon Investments
Deutsche Banc Alex. Brown
DNA Biomedical Solutions Ltd.
Edward P. Bass group
Essex Woodlands Health Ventures
Firelake Capital Management
Fletcher Spaght Ventures
Glide Healthcare Partners
Granite State Angels
Hambrecht & Quist
Harbor Light Capital Partners
Harkness & Hill
Hatteras Venture Partners
Hercules Technology Growth Capital
HLM Venture Partners
Hygea VCT Plc
Investment Accelerator Fund-Life Sciences
Israel HealthCare Ventures
J&J Development Corporation
Jerusalem Global Ventures
Kaiser Permanante Ventures
Ladenburg Thalmann & Co.
LaunchPad Venture Group
Life Science Angels
Maryland Venture Fund
Mass Medical Angels
Maxim Group LLC
Medical Research Commercialisation Fund
MHR Funding Management
Mitsui & Co. Global Investment
Montaur Capital Partners
New Enterprise Associates
New Leaf Ventures
New River Management V
Nexus Medical Partners
Nomura Phase4 Ventures
North Bridge Venture Partners
North Country Angels
Novartis Venture Fund
Oxford Finance Corporation
Pacific Venture Opportunity Fund
Pitango Venture Capital
Polaris Venture Partners
Province of Nova Scotia
Quantum Technology Partners
RA Capital Management
Rock Springs Capital
Rodman & Renshaw, Ladenburg Thalmann & Co.
Scale Venture Partners
SG Asset Management Private Equity
Siemens Venture Capital
Silicon Valley Bank
Sud Rhone-Alpes Capital
SV Life Sciences
Tech Coast Angels
Texas Venture Labs
The Halifax Group
The Stevanato Group
Think Equity Partners
Thomas McNerney & Partners
Vatera Healthcare Partners
Warburg Dillon Read LLC, and Adams
Welsh, Carson, Anderson & Stowe
Western Life Sciences Venture Fund
White Oak Global Advisors
WR Hambrecht + Co
Wuzhou Zhongheng Group
Yissum Research Development
Following Institutes / Universities / Organisations have been mentioned in this report.
National Institute of Diabetes and Digestive and Kidney Disease
National Institute of Mental Health
National Institute of Standards and Technology
Bispebjerg University Hospital
Brigham and Women’s Hospital
Infectious Disease Research Institute
Laboratory for Drug Delivery (Georgia Institute of Technology)
The School of Pharmacy, University of London
Technical University Munich (TUM)
University of Cambridge