Drug Delivery Technologies: Revolutionizing Cancer Therapies
Use the incisive analysis, commentary, opinions and forecasts provided in this note to:
Whilst significant advances have been made in the treatment of many cancer subtypes, the therapies currently available often require regular visits to the hospital or clinic to receive radioactive therapy or intravenous chemotherapy which are highly toxic, may lead to drug resistance and are poorly tolerated due to limited-tumor specificity leading to many unwanted side-effects and poor compliance.
While the pharmaceutical industry continues to find innovative ways to treat cancer, drug delivery specialists have the task of making sure those treatments reach the correct site in the body in the required quantities and at the right time. The Holy Grail in delivering cancer therapies is the development of a technology platform which targets the therapy only to the tumor, leaving normal cells undamaged. In an ideal world, orally active targeted therapies would be available.
The following report summarizes the latest developments in cancer drug development and analyzes some of the most promising solutions which drug delivery companies are providing in order to address this unmet clinical need.
EIGHT QUESTIONS THIS NOTE ANSWERS:
1. How will the drug delivery technology drivers change in the cancer arena in the next decade and beyond?
2. What are the key delivery technologies in the oncology feld?
3. When are products which utilise these key delivery technologies likely to reach the market?
5. Which companies are the winners in each technology category?
6. How are drug delivery technologies evolving to meet the demands of the oncology market?
7. Where are the market opportunities now and in the future?
8. What do we predict will be the value of the cancer drug delivery market each year until 2012, in 2015 and in 2020?
- gain an in-depth understanding of the technology landscape for active & passive targeting platforms, including injectable & oral systems
- assess the options available for delivering anticancer compounds now & in the future
- gauge the current & future technology requirements of pharma & biotech companies developing oncology products
- analyze how the market is evolving & the infl uence that drug delivery may have on pharma oncology pipelines
- identify key pharma & delivery companies focusing on the improved delivery of existing & novel anticancer agents
- highlight alliances between delivery companies & pharma, and recent market activity
- evaluate where progress has been made in the delivery of potential new oncology products
- 2006 global oncology market worth nearly US$33 billion
- attracted attention of big pharma players such as AstraZeneca, BMS, Lilly, GSK, Merck Serono, Novartis, Pfzer, Roche/Genentech, sanof-aventis & TAP
- >650 products in clinical development however; 4 key challenges remain - ensuring efcient drug delivery, avoiding systemic toxicity & resistance, and improving specifcity
- Analysis of historic (2000-2005) market trends of the oncology pharmaceutical sales and advanced drug delivery sales.
- Forecasts for near-term (2006-2012) and the future (2020) market growth assessed based on the technology platforms evaluated in the report.
- Plus, sales forecasts for approved and pipeline oncology products used as a basis for our oncology drug delivery sales (ODDS) forecasts.
- Drug delivery companies applying a plethora of platforms, including passive and targeted systems, to overcome the above challenges.
- Increasingly multifunctional systems being applied to overcome pharmacodynamic issues and targeted delivery in a single solution.
- Many revamped products will reach the market over the next 6 years, driving future market growth. Teir success is analyzed in detail and case studies provided to highlight the progress of each technology.
- As the oncology market evolves and patients are diagnosed and treated earlier during the course of the disease, both in the post-adjuvant and neo-adjuvant setting, the need for oral agents will grow. Several drug delivery companies are working towards this goal including: Access, ALZA, Emisphere and Labopharm. Each has adopted a diferent strategy and all are analyzed in detail.
Whilst significant advances have been made in the treatment of many cancer subtypes, the therapies currently available often require regular visits to the hospital or clinic to receive radioactive therapy or intravenous chemotherapy which are highly toxic, may lead to drug resistance and are poorly tolerated due to limited-tumor specificity leading to many unwanted side-effects and poor compliance.
While the pharmaceutical industry continues to find innovative ways to treat cancer, drug delivery specialists have the task of making sure those treatments reach the correct site in the body in the required quantities and at the right time. The Holy Grail in delivering cancer therapies is the development of a technology platform which targets the therapy only to the tumor, leaving normal cells undamaged. In an ideal world, orally active targeted therapies would be available.
The following report summarizes the latest developments in cancer drug development and analyzes some of the most promising solutions which drug delivery companies are providing in order to address this unmet clinical need.
EIGHT QUESTIONS THIS NOTE ANSWERS:
1. How will the drug delivery technology drivers change in the cancer arena in the next decade and beyond?
2. What are the key delivery technologies in the oncology feld?
3. When are products which utilise these key delivery technologies likely to reach the market?
5. Which companies are the winners in each technology category?
6. How are drug delivery technologies evolving to meet the demands of the oncology market?
7. Where are the market opportunities now and in the future?
8. What do we predict will be the value of the cancer drug delivery market each year until 2012, in 2015 and in 2020?
1 THE CANCER MARKET AND DRUG DELIVERY TECHNOLOGY OPPORTUNITIES
1.1 Introduction
1.2 Overview of the market
1.2.1 Market size
1.2.2 Key pharma players
1.2.3 Growth areas for drug delivery
1.3 Product pipeline
1.3.1 Key cancer subtypes
1.3.2 Drug delivery improving probability
2 MARKET DRIVERS AND OPPORTUNITIES FOR DRUG DELIVERY TECHNOLOGIES
3 KEY DRUG DELIVERY COMPANIES AND ACADEMIC RESEARCHERS IN CANCER RESEARCH
4 CURRENT DRUG DELIVERY ISSUES AND OPPORTUNITIES IN CHEMOTHERAPY
4.1 Active targeting
4.2 Passive targeting
4.3 Orally active targeting
5 ACTIVE TARGETED DRUG DELIVERY PLATFORMS
5.1 Tumor-specific antigens and receptors as carriers
5.1.1 Case Study: Avidimer Nanoparticles/ATI-001 (Avidimer Therapeutics)
5.1.2 Case Study: IL13-PE38 (NeoPharm/Nippon Kayaku)
5.2 Peptide-based drug delivery
5.2.1 Case Study: Vectocell Technology/DTS-108 (Diatos)
5.2.2 Case Study: TSP Technology/DTS-201 (Diatos)
5.3 Antibody-based drug delivery
5.3.1 Case Study: radio-imunotherapy/IMMU-107 (Immunomedics/UCB)
5.3.2 Case Study: antibody drug conjugates/SGN-35 & SGN-75 (Seattle Genetics)
5.3.3 Case Study: tumor-activated prodrug (TAP)/HuN901-DM (ImmunoGen) and Trastuzumanb-MCC-DM1 (ImmunoGen/Genentech)
5.4 Second-generation antibody fragments for drug delivery
5.4.1 Case Study: single-chain antibodies (SCAs) (Enzon)
5.4.2 Case Study: SS1(dsFv) PE38 (NeoPharm)
5.5 ADEPT
5.5.1 Case Study: ADEPT platform/ZD2767P (academic institutions)
5.6 Nucleic acid-based drug delivery
5.6.1 Case Study: Aptamer-conjugated nanoparticles (Harvard Medical School/MIT)
5.5 Our Opinion on Active Targeting Technologies
6 PASSIVE TARGETED PLATFORMS
6.1 Case Study: Nanoparticle albumin bound formulation/Abraxane (Abraxis BioSciences/AstraZeneca)
6.2 Liposomal encapsulation
6.2.1 Case Study: NeoLipid technology/LE-SN38 (NeoPharm)
6.2.2 Case Study: STEALTH liposome technology/Doxil (ALZA)
6.2.3 Case Study: sphingosome technology (INEX/Hana Biosciences)
6.3 Synthetic polymers
6.3.1 Case Study: Platinate polymers/ProLindac (Access Pharmaceuticals)
6.3.2 Case Study: Polyglutamate drug delivery/Xyotax (Cell Therapeutics)
6.4 Pegylation
6.4.1 Case Study: Customized Linker TechnologyTM/PEG-SN38 (Enzon)
6.5 Second-generation smart bioerodible polymer systems
6.5.1 Case Study: ReGel® polymer technology/DTS-301 (Protherics/Diatos)
6.6.1 Case Study: Bioerodible polymers/Locteron (OctoPlus/Biolex)
6.6 Our opinion on passive targeting technologies
7 ORAL TARGETED DRUG DELIVERY PLATFORMS
7.1.1 Case Study: eligen technology/oral gallium (Emisphere Technologies/Genta)
7.1.2 Case Study: Contramid (Labopharm)
7.1.3 Case Study: Polymeric Nano-Delivery System (Labopharm/ Debiopharm)
7.1.4 Case Study: BiotransportTM Nanomedicine/SP1049C (Supratek)
7.1.5 Case Study: Lipid Polymer Micelle (LPM™) system/LPM Leuprolide (DOR BioPharma)
7.1.6 Case Study: Cobalamin™-mediated drug delivery (Access Pharmaceuticals)
7.2 Our opinion on oral drug delivery technologies in cancer
8. MARKET TRENDS IN DRUG DELIVERY IN CANCER
8.1 Key drug delivery players in the oncology arena
8.2 Recent partnerships and acquisitions
8.2.1. Specialist technology and cross-platform providers
8.2.2. Emerging specialty pharma companies
8.2.3. Spin-off companie
8.2.4. Pharma acquisitions
8.3 Market trends now 2006-2012
8.3.1 Historical drug delivery market 2000-2005
8.3.2 Global drug delivery market 2006-2012
8.3.3 Global advanced cancer drug delivery market 2006-2012
8.3.4 Pharma drivers and drug delivery trends by 2012
8.4 Market by 2020
8.4.1 Global advanced drug delivery market by 2020
8.4.2 Global advanced cancer drug delivery by 2020
8.4.3 Pharma drivers and drug delivery trends by 2020
8.3.5 Drug delivery trends by 2020
9 SUMMARY & CONCLUSIONS
10 BIBLIOGRAPHY
11 ACKNOWLEDGEMENTS
1.1 Introduction
1.2 Overview of the market
1.2.1 Market size
1.2.2 Key pharma players
1.2.3 Growth areas for drug delivery
1.3 Product pipeline
1.3.1 Key cancer subtypes
1.3.2 Drug delivery improving probability
2 MARKET DRIVERS AND OPPORTUNITIES FOR DRUG DELIVERY TECHNOLOGIES
3 KEY DRUG DELIVERY COMPANIES AND ACADEMIC RESEARCHERS IN CANCER RESEARCH
4 CURRENT DRUG DELIVERY ISSUES AND OPPORTUNITIES IN CHEMOTHERAPY
4.1 Active targeting
4.2 Passive targeting
4.3 Orally active targeting
5 ACTIVE TARGETED DRUG DELIVERY PLATFORMS
5.1 Tumor-specific antigens and receptors as carriers
5.1.1 Case Study: Avidimer Nanoparticles/ATI-001 (Avidimer Therapeutics)
5.1.2 Case Study: IL13-PE38 (NeoPharm/Nippon Kayaku)
5.2 Peptide-based drug delivery
5.2.1 Case Study: Vectocell Technology/DTS-108 (Diatos)
5.2.2 Case Study: TSP Technology/DTS-201 (Diatos)
5.3 Antibody-based drug delivery
5.3.1 Case Study: radio-imunotherapy/IMMU-107 (Immunomedics/UCB)
5.3.2 Case Study: antibody drug conjugates/SGN-35 & SGN-75 (Seattle Genetics)
5.3.3 Case Study: tumor-activated prodrug (TAP)/HuN901-DM (ImmunoGen) and Trastuzumanb-MCC-DM1 (ImmunoGen/Genentech)
5.4 Second-generation antibody fragments for drug delivery
5.4.1 Case Study: single-chain antibodies (SCAs) (Enzon)
5.4.2 Case Study: SS1(dsFv) PE38 (NeoPharm)
5.5 ADEPT
5.5.1 Case Study: ADEPT platform/ZD2767P (academic institutions)
5.6 Nucleic acid-based drug delivery
5.6.1 Case Study: Aptamer-conjugated nanoparticles (Harvard Medical School/MIT)
5.5 Our Opinion on Active Targeting Technologies
6 PASSIVE TARGETED PLATFORMS
6.1 Case Study: Nanoparticle albumin bound formulation/Abraxane (Abraxis BioSciences/AstraZeneca)
6.2 Liposomal encapsulation
6.2.1 Case Study: NeoLipid technology/LE-SN38 (NeoPharm)
6.2.2 Case Study: STEALTH liposome technology/Doxil (ALZA)
6.2.3 Case Study: sphingosome technology (INEX/Hana Biosciences)
6.3 Synthetic polymers
6.3.1 Case Study: Platinate polymers/ProLindac (Access Pharmaceuticals)
6.3.2 Case Study: Polyglutamate drug delivery/Xyotax (Cell Therapeutics)
6.4 Pegylation
6.4.1 Case Study: Customized Linker TechnologyTM/PEG-SN38 (Enzon)
6.5 Second-generation smart bioerodible polymer systems
6.5.1 Case Study: ReGel® polymer technology/DTS-301 (Protherics/Diatos)
6.6.1 Case Study: Bioerodible polymers/Locteron (OctoPlus/Biolex)
6.6 Our opinion on passive targeting technologies
7 ORAL TARGETED DRUG DELIVERY PLATFORMS
7.1.1 Case Study: eligen technology/oral gallium (Emisphere Technologies/Genta)
7.1.2 Case Study: Contramid (Labopharm)
7.1.3 Case Study: Polymeric Nano-Delivery System (Labopharm/ Debiopharm)
7.1.4 Case Study: BiotransportTM Nanomedicine/SP1049C (Supratek)
7.1.5 Case Study: Lipid Polymer Micelle (LPM™) system/LPM Leuprolide (DOR BioPharma)
7.1.6 Case Study: Cobalamin™-mediated drug delivery (Access Pharmaceuticals)
7.2 Our opinion on oral drug delivery technologies in cancer
8. MARKET TRENDS IN DRUG DELIVERY IN CANCER
8.1 Key drug delivery players in the oncology arena
8.2 Recent partnerships and acquisitions
8.2.1. Specialist technology and cross-platform providers
8.2.2. Emerging specialty pharma companies
8.2.3. Spin-off companie
8.2.4. Pharma acquisitions
8.3 Market trends now 2006-2012
8.3.1 Historical drug delivery market 2000-2005
8.3.2 Global drug delivery market 2006-2012
8.3.3 Global advanced cancer drug delivery market 2006-2012
8.3.4 Pharma drivers and drug delivery trends by 2012
8.4 Market by 2020
8.4.1 Global advanced drug delivery market by 2020
8.4.2 Global advanced cancer drug delivery by 2020
8.4.3 Pharma drivers and drug delivery trends by 2020
8.3.5 Drug delivery trends by 2020
9 SUMMARY & CONCLUSIONS
10 BIBLIOGRAPHY
11 ACKNOWLEDGEMENTS
LIST OF FIGURES
Figure 1.1: Global Oncology Market Sales 2006
Figure 1.2: Leading oncology brands 2006
Figure 1.3: Global oncology market players and leading brands 2006
Figure 1.4: Global oncology sales 2006 – cancer subtypes
Figure 1.5: Oncology medicines in development 2006
Figure 2.1: Drug delivery opportunities in cancer
Figure 2.2: Cancer patients still under treatet
Figure 5.1: ATI-001 Avidimer Therapeutics Smart drug
Figure 5.2: Application of antibody-based targeted therapy
Figure 5.3: Schematic of ImmunoGen’s TAP technology
Figure 5.4: Schematic of mAb and SCA
Figure 5.5 Schematic of ADEPT theory
Figure 5.6 Schematic of A) aptamer-conjugated nanoparticles and B) scanning electron microscopy image of docetaxel encapsulated nanoparticles
Figure 6.1: Nanoparticle albumin-bound (nab) platform technology
Figure 6.2: Clinical efficacy of Abraxane versus Taxol
Figure 6.3: Pharmacokinetics of STEALTH® liposomes in preclinical and clinical studies
Figure 6.4: Specificity and enhanced activity of sphingosomal vincristine
Figure 6.5: Access Pharmaceuticals’ nanoparticle polymer platform technology
Figure 6.6: Daunorubicin with Polymer & Cobalamin-targeted
Figure 6.7: PolyActive controlled release of interferon alpha & its application for therapeutic proteins
Figure 7.1: Cobalamin™-mediated oral delivery
Figure 8.1: Progression of oncology products fuelled by drug delivery by 2012
Figure 8.2: Progression of oncology products fuelled by drug delivery by 2020
Figure 1.1: Global Oncology Market Sales 2006
Figure 1.2: Leading oncology brands 2006
Figure 1.3: Global oncology market players and leading brands 2006
Figure 1.4: Global oncology sales 2006 – cancer subtypes
Figure 1.5: Oncology medicines in development 2006
Figure 2.1: Drug delivery opportunities in cancer
Figure 2.2: Cancer patients still under treatet
Figure 5.1: ATI-001 Avidimer Therapeutics Smart drug
Figure 5.2: Application of antibody-based targeted therapy
Figure 5.3: Schematic of ImmunoGen’s TAP technology
Figure 5.4: Schematic of mAb and SCA
Figure 5.5 Schematic of ADEPT theory
Figure 5.6 Schematic of A) aptamer-conjugated nanoparticles and B) scanning electron microscopy image of docetaxel encapsulated nanoparticles
Figure 6.1: Nanoparticle albumin-bound (nab) platform technology
Figure 6.2: Clinical efficacy of Abraxane versus Taxol
Figure 6.3: Pharmacokinetics of STEALTH® liposomes in preclinical and clinical studies
Figure 6.4: Specificity and enhanced activity of sphingosomal vincristine
Figure 6.5: Access Pharmaceuticals’ nanoparticle polymer platform technology
Figure 6.6: Daunorubicin with Polymer & Cobalamin-targeted
Figure 6.7: PolyActive controlled release of interferon alpha & its application for therapeutic proteins
Figure 7.1: Cobalamin™-mediated oral delivery
Figure 8.1: Progression of oncology products fuelled by drug delivery by 2012
Figure 8.2: Progression of oncology products fuelled by drug delivery by 2020
LIST OF TABLES
Table 1.1: Inherent risks of drug development
Table 2.1: US patent expiration of leading oncology brands
Table 3.1: Leading drug delivery technology companies in the cancer arena
Table 3.2: Leading academic research laboratories in cancer drug delivery technology
Table 5.1: Tumor-specific antigens for drug delivery
Table 5.2: Leading drug delivery companies & academic institutes evaluating active targeted delivery
Table 5.3: Immunotherapeutic monoclonal antibodies approved to treat cancer
Table 5.4: Antibody-based therapies in development to treat cancer
Table 5.5: Summary of antibody fragments and engineered variants
Table 5.6: Antibody-based therapies under evaluation by NCI
Table 6.1: Leading companies & academic research groups in polymer development for drug delivery
Table 6.2: Commercially available polymers for drug delivery
Table 6.3: FDA approved PLA/PLGA cancer products
Table 8.1: Summary of leading oncology-focused drug delivery companies
Table 8.2: Summary of recent alliances, agreements and acquisitions with drug delivery companies
Table 8.3: Forecast of global pharmaceutical market and drug delivery market (2000-2005)
Table 8.4: Forecast of global drug delivery market 2006-2012
Table 8.5: Forecasts of approved drug delivery-driven cancer products 2006-2012 (US$m)
Table 8.6: Forecasts of pipeline drug delivery driven oncology products 2006-12 (US$m)
Table 8.7: Forecast of drug delivery market 2012-2020 (US$ billion)
COMPANIES MENTIONED:
Ablynx, Abraxis BioSciences, Access Pharmaceuticals, Acusphere, Adherex, Adhesives Research, AlphaVax, ALZA, Amgen, AstraZeneca, Avidimer Terapeutics, BioDelivery Sciences International, BioProgress, BioVation, Bristol-Myers Squibb, Cell Terapeutics, Cephalon, Corixa, Daiichi, Debiopharm, DelSite Biotechnologies, Delth Systems, Dianisco, Diatos, DOR BioPharma, Eli Lilly, Emisphere Technologies, Enzon Pharmaceuticals, Expression Genetics (EGEN), Genencor, Genentech, Generex Biotechnology, GSK, Guilford, Hana Biosciences, Hanmi Pharmaceuticals, MIT, IDEA, ImClone, INEX Pharmaceutical, Inovio BioMedical Corporation, Institut Pasteur, Labopharm, Light Sciences, Lipoxen, MaxCyte, Merck Serono, Millennium, Miravant, Mountain View Pharmaceuticals, Murus, Nektar Terapeutics, NeoPharm, Neurotech, Nippon Kayaku, Nitto Denko Technical Corporation, NOF Corporation, Norwood Immunology, Novartis, Oakwood Laboratories, OctoPlus, Pfzer, PG-XTL, Protherics, QLT Inc, Roche, sanof-aventis, Schering AG, Seattle Genetics, SkyePharma, Sonus Pharmaceu-ticals, Starpharma, SunBio, Supratek, TAP, UCB, Valentis, Valera Pharmaceuticals, Ventaria Pharmaceuticals, Wyeth
Table 1.1: Inherent risks of drug development
Table 2.1: US patent expiration of leading oncology brands
Table 3.1: Leading drug delivery technology companies in the cancer arena
Table 3.2: Leading academic research laboratories in cancer drug delivery technology
Table 5.1: Tumor-specific antigens for drug delivery
Table 5.2: Leading drug delivery companies & academic institutes evaluating active targeted delivery
Table 5.3: Immunotherapeutic monoclonal antibodies approved to treat cancer
Table 5.4: Antibody-based therapies in development to treat cancer
Table 5.5: Summary of antibody fragments and engineered variants
Table 5.6: Antibody-based therapies under evaluation by NCI
Table 6.1: Leading companies & academic research groups in polymer development for drug delivery
Table 6.2: Commercially available polymers for drug delivery
Table 6.3: FDA approved PLA/PLGA cancer products
Table 8.1: Summary of leading oncology-focused drug delivery companies
Table 8.2: Summary of recent alliances, agreements and acquisitions with drug delivery companies
Table 8.3: Forecast of global pharmaceutical market and drug delivery market (2000-2005)
Table 8.4: Forecast of global drug delivery market 2006-2012
Table 8.5: Forecasts of approved drug delivery-driven cancer products 2006-2012 (US$m)
Table 8.6: Forecasts of pipeline drug delivery driven oncology products 2006-12 (US$m)
Table 8.7: Forecast of drug delivery market 2012-2020 (US$ billion)
COMPANIES MENTIONED:
Ablynx, Abraxis BioSciences, Access Pharmaceuticals, Acusphere, Adherex, Adhesives Research, AlphaVax, ALZA, Amgen, AstraZeneca, Avidimer Terapeutics, BioDelivery Sciences International, BioProgress, BioVation, Bristol-Myers Squibb, Cell Terapeutics, Cephalon, Corixa, Daiichi, Debiopharm, DelSite Biotechnologies, Delth Systems, Dianisco, Diatos, DOR BioPharma, Eli Lilly, Emisphere Technologies, Enzon Pharmaceuticals, Expression Genetics (EGEN), Genencor, Genentech, Generex Biotechnology, GSK, Guilford, Hana Biosciences, Hanmi Pharmaceuticals, MIT, IDEA, ImClone, INEX Pharmaceutical, Inovio BioMedical Corporation, Institut Pasteur, Labopharm, Light Sciences, Lipoxen, MaxCyte, Merck Serono, Millennium, Miravant, Mountain View Pharmaceuticals, Murus, Nektar Terapeutics, NeoPharm, Neurotech, Nippon Kayaku, Nitto Denko Technical Corporation, NOF Corporation, Norwood Immunology, Novartis, Oakwood Laboratories, OctoPlus, Pfzer, PG-XTL, Protherics, QLT Inc, Roche, sanof-aventis, Schering AG, Seattle Genetics, SkyePharma, Sonus Pharmaceu-ticals, Starpharma, SunBio, Supratek, TAP, UCB, Valentis, Valera Pharmaceuticals, Ventaria Pharmaceuticals, Wyeth
