NEW YORK, July 5, 2016 /PRNewswire/ -- INTRODUCTION
As defined by the National Nanotechnology Initiative, nanotechnology is the branch of science that deals with materials smaller than 100 nanometers. Nanomedicines are nanosized particles that help in the diagnosis, treatment and monitoring of therapeutic agents. The discovery of several nanocarriers such as polymers, proteins, micelles, dendrimers, liposomes, emulsions, nanoparticles, each with a unique structure, has provided the drug developers with options to improve the pharmacokinetics and release properties of their existing drugs.
Within the biomedical sector, nanocarriers have an array of therapeutic and diagnostic applications. These include drug delivery, targeted therapy, gene therapy, development of diagnostic assays, molecular imaging and a number of research applications. Specifically, drug delivery has emerged as one of the most popular applications that enhances the therapeutic efficacy of biomolecules. Several competing drug delivery approaches are being explored for their efficacy with various routes of administration.
Dendrimers, owing to their structural flexibility, hold potential for several medical and non-medical applications; however, their use in the biomedical field is yet to be fully explored. Several academic institutes and organizations are conducting intense research to explore the therapeutic and diagnostic potential of dendrimers. With a number of commercial dendrimers-based products (both biomedical and agro-based), Starpharma is a prominent player in this domain.
On the other hand, polymer drug conjugates is a well-established segment with several commercialized products. The current polymer drug conjugates market has over 10 approved drug candidates for a wide range of molecular targets and disease areas. Examples include (in alphabetical order) Adynovate by Baxalta, Doxil® by Pfizer/ Sun Pharmaceuticals, Krystexxa® by Savient Pharmaceuticals / Crealta Pharmaceuticals, Movantik™ by AstraZeneca, Oncospar® by Enzon Pharmaceuticals, Plegridy® by Biogen. Despite an already well-established market, the field has gathered interest of several other players to explore the complete potential of polymer drug conjugates in different therapeutic areas. The clinical outcomes and the success of the current clinical molecules will decide the fate of the future market.
SCOPE OF THE REPORT
The "Dendrimers and Polymer Drug Conjugates Market, 2016-2026" report delivers a comprehensive study on the emergence of nanocarriers as a significant tool for drug delivery, therapeutics and diagnostics. For the purpose of this report, we have primarily focused on the following two types of nanocarriers.
Polymer drug conjugates
Dendrimers, the nanoscale hyper-branched structures, are evolving in the healthcare sector to enhance the properties of existing therapeutic compounds as well as for introduction of novel therapeutic/diagnostic products. VivaGel® by Starpharma is a commercially available therapeutic product; in addition, transfection kits and diagnostic assays are also available. However, from a commercial perspective, market of dendrimers is still in its infancy within the biomedical sector. The domain is gradually gaining traction with several technologies and approaches being designed for improving drug release properties. In addition to drug delivery, which is the key application area, some other potential applications of dendrimers being actively pursued in research include disease diagnosis, targeted therapy, MRI imaging, tissue regeneration, cell repair and vaccine development.
A parallel field of polymer therapeutics includes introduction of polymers with conventional drugs; these are more commonly known as polymer drug conjugates. Conjugation of drugs with polymers has demonstrated a marked improvement in their efficacy and release profiles. For the purpose of our study, we have included the molecules in the clinical/preclinical development (defined as per the Ringsdorf Model). Numerous polymer drug conjugates have already been commercialized for a wide range of therapeutic areas; our study provides an analysis of key disease areas being targeted by the developers of polymer drug conjugates. Several well-known anti-cancer drugs such as docetaxel, paclitaxel and doxorubicin have been conjugated with polymers such as PEG, HPMA and PLA to enhance their water solubility, half-life, efficacy and body clearance.
The report assesses key drivers that have governed the evolution of polymer drug conjugates over the past several years and determines the market in a long term (2016-2026). The research, analysis and insights presented in this report include potential sales of the drugs in phase III and phase II of development. To add robustness to our forecast model, we have provided three market scenarios. The conservative, base and optimistic scenarios represent three different tracks of market evolution. In addition, we have provided a detailed discussion on the future trends and the key opportunity areas for dendrimers that are likely to shape the market in the coming years.
All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.
Most of the data presented in this report has been gathered via secondary and primary 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 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 report. It offers a high level view on the present scenario of dendrimers and polymer drug conjugates and where they are headed in the mid to long term.
Chapter 3 provides a general introduction to nanotechnology with a detailed discussion on its applications in the biopharmaceutical industry. This chapter discusses the various types of nanocarriers that have revolutionized drug delivery and other biomedical applications.
Chapter 4 includes information on nearly 40 polymer drug conjugates that are being evaluated in different stages of development (both clinical and preclinical/discovery). In this chapter, we have identified the companies that are active in this market and conducted a detailed pipeline analysis including information on type of polymers, type of drugs, most commonly targeted indications and the phase of development. In addition, we have provided a list of the different classes of dendrimers highlighting their developer, core molecules and surface groups.
Chapter 5 provides an in-depth introduction to dendrimers. In this chapter, we have captured the most popular dendrimers used for development of diagnostics, therapeutics and other biomedical products; these are accompanied with detailed information on their structure, research applications and detailed product profiles of the commercialized products.
Chapter 6 comprises of a comprehensive discussion on the advantages, applications and target disease areas of polymer drug conjugates. In addition, the chapter gives detailed profiles of phase III and phase II molecules including information of their developer, clinical trials and primary/secondary endpoints.
Chapter 7 offers a comprehensive view on the market forecast of polymer drug conjugates measuring the opportunity in the next ten years. Due to the uncertainty surrounding some of the key assumptions, we have presented three different evolution scenarios for the overall market. In addition, we have presented a qualitative analysis of the opportunity areas of dendrimers highlighting their future potential.
Chapter 8 summarizes the overall report. In this chapter, we have provided a recap of the key takeaways and our overall opinion on where the market is headed in the mid-long term.
Chapter 9 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 10 is an appendix, which provides a list of companies and organizations mentioned in the report.
1. Nearly 40 polymer drug conjugates are currently in clinical and preclinical stages of development; molecules in phase III and II account for nearly 19% of the pipeline while 26% is captured by molecules in phase I/II and I.
2. There are several types of dendrimers being used for both commercial and research purposes in the pharmaceutical domain; the dendrimers most widely used for industry applications include PAMAM, PLL, Priostar®, Astramol®. However, with over 4000 papers published between 2006 and 2016 (as reported in PubMed), dendrimers are being extensively explored by researchers in the non-industry / academic institutes.
3. With one commercialized therapeutic product (VivaGel®) and several other marketed dendrimer-based products (SuperFect®, Stratus® CS, PrioFect™, Alert Ticket™), Starpharma has emerged as a forerunner in the dendrimer market.
4. Amongst the different biomedical applications that dendrimers and polymer drug conjugates serve, drug delivery holds a large opportunity. Several big pharma players as AstraZeneca, Eli Lilly, GSK's Stiefel have collaborated with dendrimer technology developers (such as DEP® Technology by Starpharma) to improve the therapeutic efficacy and drug delivery properties of their existing products. Additionally, polymer drug conjugates have expanded their focus to a broad range of diseases exploring different routes of administrations for better drug delivery.
5. The polymer drug conjugates market momentum will be driven by the success of current batch of late stage clinical molecules; these primarily include NKTR-181 (by Nektar Therapeutics), NKTR-102 (by Nektar Therapeutics), CRLX-101 (by Cerulean Pharma) and Opaxio™ (by CTI BioPharma).
6. Specific molecules such as NKTR-181 and NKTR-102 are anticipated to achieve a blockbuster status in the near future. With eight molecules (two mentioned above and six others in lower stages of development) in development, Nektar Therapeutics is expected to play an important role in the market's evolution.
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