Antibody Drug Conjugates Market, 2012-2023

NEW YORK, June 27, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Antibody Drug Conjugates Market, 2012-2023

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Antibody Drug Conjugates (ADC) are a new class of biologic therapeutics. These are complex molecules comprising of an antibody linked to few cytotoxin molecules through linker technology. This class of biologics is attracting the attention of drug developers, with several large and small companies entering the market through collaboration and licensing agreements with technology providers.

The ADC market is still in its infancy. So far, three ADCs have received market approval. However, the first ADC, Mylotarg, was withdrawn from the market by its developer Pfizer. As such, there are only two marketed drugs in 2013. During the journey of these molecules from pipeline to the market, there have been some regulatory and commercial setbacks. However, the recent launch of Roche's much awaited Kadcyla (T-DM1) has provided a positive outlook to the future of the market.

The pipeline is rich, though not many molecules are in the pivotal trial stage yet. It will be a few years before the market picks up pace with the launch of several pipeline drugs. Majority of the ADCs currently under development are for oncological indications, driven by the availability of monoclonal antibodies targeting various types of cancer. However, some drug developers are now also looking outside the oncology domain to develop ADCs, though, such ADCs are only in preclinical or discovery stage of development.

Although the market now has presence of several large pharmaceutical companies, the technological capabilities for development of ADC still lies with a few technology providers. ImmunoGen and Seattle Genetics are amongst the pioneers in the field of ADC, with most pipeline ADCs using their technology. Most development to date has been carried under technology license agreements. However, as the market matures, we expect to see more co-development agreements in the future.

Amongst other things, this report provides a detailed overview of the most promising pipeline ADCs, with our analysis of the future of eight ADCs. Furthermore, it also includes our view of the market for contract manufacturing of ADCs. We have identified contract manufacturing organisations with capabilities in various stages of ADC development and manufacturing.

One of the key objectives of this report is to understand the current and future state of the antibody drug conjugates market. This is done by analysing

• Products currently available in the market and those under development,

• Pharmaceutical companies active in the market,

• Technology providers and key developments supporting the development of improved ADCs, and

• Development and sales potential for key marketed and pipeline ADCs.

The base year for the report is 2012, with actual sales data presented for marketed ADCs during the year and the global ADC market. The report provides short-mid term and long term market forecasts for the period 2013 - 2018 and 2019 - 2023, respectively. We have discussed, in detail, the key drivers behind the growth of this market. The research, analysis and insights presented in this report include the sales of eight marketed and pipeline ADCs, which together comprise our total ADC market.

Owing to niche nature of the market, with most products in the pipeline, we provide three scenarios for our market forecast to add robustness to our model. The conservative, base and optimistic scenarios are considered for the forecasting of each of the eight drugs constituting the ADC market.

All actual figures have been sourced and analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.

Key Highlights

1. The ADC market was estimated to be worth USD 138 MM in 2012, with Adcetris being the sole participant in the market in the year.

2. Very few molecules are in late stage clinical trial; molecules in phase I account for 69.7% of ADCs in clinical development.

3. Cytotoxins are of crucial importance for the effectiveness of the ADC. Most commonly used cytotoxins for ADCs under clinical development include auristatin, calicheamicin, maytansine and duocarmycin. Auristatin dominates the market and accounts for 60.0% of the ADCs in clinical development.

4. The linker and cytotoxic drug technology for majority of the pipeline ADCs is provided either by Seattle Genetics or ImmunoGen.

5. The companies providing ADC components are dependent on contract manufacturing organisations (CMOs) to supply the components. There are limited number of contract manufacturers with capabilities for development of linkers and cytotoxins. In addition, even fewer CMOs provide conjugation services for ADC.

6. The technology licensing model has been the most widely adopted model in the ADC market to date.

7. There have been several technological developments in the recent past with more stable linkers and potent cytotoxins allowing the development of next generation ADCs with improved safety/efficacy profile.

8. The complexity of the ADC molecules adds to the uncertainty in the market. There are opportunities for pharmaceutical companies to replenish their diminishing pipelines and gain first mover advantage in the market.

1. EXECUTIVE SUMMARY

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

1.4. Key Highlights

1.4.1. Adcetris was the Sole Participant in the Market in 2012

1.4.2. Approval of Kadcyla Likely to Strengthen ADC Market

1.4.3. Oncology Dominates the Field of ADC

1.4.4. Seattle Genetics and ImmunoGen are the Leading Technology Providers

1.4.5. Technology Licensing is the Preferred Model for ADC Development

2. INTRODUCTION

2.1. Chapter Overview

2.2. The Traditional Treatments: Naked Antibody and Cytotoxins

2.2.1. Naked Antibodies

2.2.1.1. How Monoclonal Antibody Therapy Works

2.2.2. Cytotoxins

2.3. Conjugated or Armed Antibodies

2.4. The Revolutionary Technology: ADCs

2.5. Advantages of ADC over Traditional Therapeutics

2.6. Parts of an ADC

2.6.1. Antibody

2.6.2. Cytotoxin

2.6.3. Linker: Function and Types

3. ADC THERAPEUTICS: OVERVIEW AND BACKGROUND

3.1. Chapter Overview

3.2. Kadcyla Becomes Third ADCs to Reach Market

3.2.1. Mylotarg (Pfizer)

3.2.1.1. Mechanism of Action

3.2.1.2. Approval and Discontinuation of Mylotarg in the US

3.2.1.3. Reasons for Poor Clinical Benefits of Mylotarg

3.2.2. Adcetris (Seattle Genetics/Takeda Oncology Company)

3.2.3. Kadcyla (Roche/Genentech)

3.3. Companies Active in the ADC Market

3.3.1. Large Pharmaceutical Companies Taking Interest

3.4. Companies Providing ADC Technology

3.5. Role of Venture Capitalists

3.6. Analysis of the Development Pipeline

3.6.1. Limited Number of Molecules in Late Stage Development

3.6.2. Cancer is the Leading Indication, with ADCs Against Blood Cancer Dominating

3.6.3. Auristatins are the Most Popular Toxin Being Studied

3.6.4. ADC Market by Type of Linker

4. ADC MARKET, 2012 - 2023

4.1. Chapter Overview

4.2. ADC Market, 2012

4.2.1. Adcetris was the Sole Participant in the Market in 2012

4.3. Overall ADC Market Forecast, 2013-2023

4.3.1. Scope and Limitations

4.3.2. Assumptions for Market Forecast

4.3.3. Overall ADC Market Forecast: Short-Midterm, 2013-2018

4.3.4. Overall ADC Market Forecast: Long Term, 2019-2023

4.4. Adcetris (Seattle Genetics / Millennium)

4.4.1. Mechanism of Action

4.4.2. The Cost of Treatment with Adcetris and Reimbursement

4.4.3. Factors Supporting the High Price

4.4.4. Adcetris Sales, 2011-Q1 2013

4.4.5. Strategies for Market Expansion

4.4.6. Adcetris Sales Forecast: Short-Mid Term, 2013-2018

4.4.7. Adcetris Sales Forecast: Long Term, 2019-2023

4.5. Kadcyla / T-DM1 (Genentech / Roche)

4.5.1. The Drug Specifications

4.5.2. Launch and Pricing

4.5.3. Roche's Survival Kit

4.5.4. Long Route to Approval

4.5.5. Kadcyla Sales

4.5.6. Current State of Development: Indications and Timeline

4.5.7. Kadcyla Sales Forecast, 2013-2018

4.5.8. Kadcyla Sales Forecast: Long Term, 2019-2023

4.6. Inotuzumab Ozogamicin/CMC-544 (Pfizer)

4.6.1. The Drug Specifications

4.6.2. Current Development Status

4.6.3. Inotuzumab Ozogamicin / CMC-544 Sales Forecast, 2013-2018

4.6.4. Inotuzumab Ozogamicin / CMC-544 Sales Forecast: Long Term, 2019-2023

4.7. Glembatumumab Vedotin / CDX-011 (Celldex Therapeutics)

4.7.1. The Drug Specifications

4.7.2. Clinical Development

4.7.2.1. EMERGE Trial

4.7.3. CDX-011 Sales Forecast, 2013-2018

4.7.4. CDX-011 Sales Forecast: Long Term, 2019-2023

4.8. Lorvotuzumab Mertansine / IMGN901 (ImmunoGen)

4.8.1. Drug Specifications

4.8.2. Clinical Development

4.8.3. IMGN901 Sales Forecast: Short-Midterm, 2013-2018

4.8.4. IMGN901 Sales Forecast: Long Term, 2013-2018

4.9. SAR3419 (Sanofi Aventis)

4.9.1. The Drug Specifications

4.9.2. Structure, Administration and Dosage

4.9.3. Current State of Development

4.9.4. Competition for SAR3419

4.9.5. SAR3419 Sales Forecast: Short-Midterm, 2013-2018

4.9.6. SAR3419 Sales Forecast: Long Term, 2019-2023

4.10. BT-062 (Biotest)

4.10.1. Drug Specifications

4.10.2. Clinical Development

4.10.3. Market Opportunity and Sales Forecast

4.10.4. BT-062 Sales Forecast: Long Term, 2019-2023

4.11. PSMA-ADC (Progenics)

4.11.1. Drug Specifications

4.11.2. PSMA ADC Development for Prostate Cancer

4.11.3. Competition for PSMA ADC

4.11.4. PSMA ADC Sales Forecast, 2019-2023

5. Manufacturing of ADCs

5.1. Chapter Overview

5.2. Steps Involved in Manufacturing an ADC

5.3. Challenges Facing the ADC Manufacturers

5.4. Presence of Contract Manufacturers

5.4.1. Linkers

5.4.2. Cytotoxins

5.4.3. Conjugation

5.5. Leading ADC Contract Manufacturers

5.5.1. SAFC

5.5.2. Piramal Healthcare

5.5.3. Lonza

5.6. CMOs Investing in ADC Capabilities

5.7. Contract Manufacturers Collaborating to Provide ADC Capabilities

6. PIPELINE AND MARKET DEVELOPMENTS

6.1. Chapter Overview

6.2. Pipeline Drug Profile

6.2.1. RG7593 and RG7596 (Roche/Genentech)

6.2.2. BAY 94-9343 (Bayer Pharma)

6.3. Recent Partnerships

6.3.1. Partnership Models

6.4. Technological Developments

6.4.1. Emerging Cytotoxins/Payload

6.4.2. Linker Technologies

6.4.3. Site-Specific Conjugation Technology

6.4.4. Use of Antibody Fragments in Place of Whole Antibody

7. PROFILES OF LEADING COMPANIES

7.1. Chapter Overview

7.2. ImmunoGen

7.2.1. Targeted Antibody Payload (TAP) Technology

7.2.1.1. Linker Technology

7.2.2. Marketed and Pipeline Products

7.2.2.1. Marketed ADCs

7.2.2.2. Pipeline ADCs

7.2.3. Business Model

7.2.3.1. Types of Agreements

7.2.4. In-House Manufacturing Capabilities

7.2.5. Financial Performance

7.3. Seattle Genetics

7.3.1. ADC Technology

7.3.2. Exploring New Technologies

7.3.2.1. Novel Cytotoxins

7.3.2.2. Site-Specific Conjugation Technology

7.3.3. Business Model

7.3.3.1. Types of Agreements and Current Partners

7.3.4. Marketed and Pipeline Products

7.3.4.1. Marketed ADCs

7.3.4.2. Pipeline ADCs

7.3.5. Financial Performance

7.4. Immunomedics

7.4.1. Marketed and Pipeline Products

7.4.2. Financial Performance

7.5. Spirogen

7.5.1. Pyrrolobenzodiazepines (PBDs) Technology

7.5.2. ADC Development and Collaborations

7.6. Pfizer

7.6.1. Marketed and Pipeline Products

7.6.2. Collaboration with Seattle Genetics

7.6.3. Financial Performance

7.7. Roche/Genentech

7.7.1. Evaluating Technology from ImmunoGen and Seattle Genetics

7.7.2. Development Pipeline: Nine Molecules in Clinical Development

7.7.3. Financial Performance

8. SWOT Analysis

8.1. Strengths

8.1.1. Lifecycle Management Tool

8.1.2. Presence of Most Large Pharmaceutical Companies

8.2. Weaknesses

8.2.1. Limited Number of Technology Providers

8.2.2. Final ADCs are Often Heterogeneous

8.2.3. Association with Multiple CMOs

8.3. Opportunities

8.3.1. Contract Manufacturing of ADC Components and Conjugation

8.3.2. Site-Specific Conjugation

8.4. Threats

8.4.1. Lack of Clear Regulatory Guidelines

8.4.2. High Failure Rate May Lessen the Confidence in Technology

8.4.3. Competing Technology

9. CONCLUSIONS

9.1. ADC: Expanding the Pipeline of Biologics

9.2. Market is in its Infancy, with Huge Potential for Growth

9.3. An Attractive Market for Large Pharmaceutical Companies

9.4. Concluding Remarks

List of Figures

Figure 2.1 Parts of Antibody Drug Conjugate

Figure 3.1 Companies Active in the ADC Market: Number of Molecules in Development

Figure 3.2 ADCs in Clinical Development: Share (%) by Phase of Development

Figure 3.3 ADCs in Clinical Development: Share (%) by Cytotoxin Used

Figure 4.1 ADC Market (USD MM), Short-Midterm Forecast: 2012-2018 (Base Scenario)

Figure 4.2 ADC Market (USD MM), Long Term Forecast: 2019-2023 (Base Scenario)

Figure 4.3 Adcetris Quarterly Sales, 2011-2013 (USD MM)

Figure 4.4 Adcetris Market (USD MM), Short-Midterm Forecast: 2013-2018 (Base Scenario)

Figure 4.5 Adcetris Market (USD MM), Long Term Forecast: 2019-2023 (Base Scenario)

Figure 4.6 Kadcyla / T-DM1 Market (USD MM), Short-Midterm Forecast: 2013-2018 (Base Scenario)

Figure 4.7 Kadcyla / T-DM1 Market (USD MM), Long Term Forecast: 2019-2023 (Base Scenario)

Figure 4.8 Inotuzumab Ozogamicin / CMC-544 Market (USD MM), Short-Midterm Forecast: 2015-2018 (Base Scenario)

Figure 4.9 Inotuzumab Ozogamicin / CMC-544 Market (USD MM), Long Term Forecast: 2019-2023 (Base Scenario)

Figure 4.10 Glembatumumab Vedotin / CDX-011 Market (USD MM), Short-Midterm Forecast: 2016-2018 (Base Scenario)

Figure 4.11 Glembatumumab Vedotin / CDX-011 Market (USD MM), Long Term Forecast: 2019-2023 (Base Scenario)

Figure 4.12 Lorvotuzumab Mertansine /IMGN901 Market (USD MM), Short-Midterm Forecast, 2017-2018 (Base Scenario)

Figure 4.13 Lorvotuzumab Mertansine /IMGN901 Market (USD MM), Long Term Forecast, 2019-2023 (Base Scenario)

Figure 4.14 SAR3419 Market (USD MM), Short-Midterm Forecast, 2017-2018 (Base Scenario)

Figure 4.15 SAR3419 Market (USD MM), Long Term Forecast, 2019-2023 (Base Scenario)

Figure 4.16 BT-062 Market (USD MM), Short-Midterm Forecast, 2017-2018 (Base Scenario)

Figure 4.17 BT-062 Market (USD MM), Long Term Forecast, 2019-2023 (Base Scenario)

Figure 4.18 PSMA ADC Sales Forecast (USD MM), 2019-2023 (Base Scenario)

Figure 7.1 Seattle Genetics: Sales Performance (USD MM), 2011 and 2012

Figure 7.2 Pfizer Sales Performance (USD MM), 2011 and 2012

Figure 7.3 Roche Group Sales Performance (USD MM), 2011 and 2012

Figure 7.4 Roche Group HER2 Franchise Sales Performance (USD MM), 2012 and 1Q 2013

Figure 9.1 ADC Market (USD MM) Forecast: 2012, 2018 and 2023

The following companies have been mentioned in this report:

1. 5AM Ventures

2. Abbott

3. AbbVie (Abbott Contract Manufacturing)

4. ADC Therapeutics

5. Agensys

6. Albany Molecular Research, Inc. (AMRI)

7. AltaPartners

8. Ambrx

9. Ambrx

10. AmerisourceBergen Corporation

11. Amgen

12. Amgen Ventures

13. Apposite Capital

14. Aravis General Partner

15. Astellas Pharma

16. Baxter BioPharma Solutions

17. Bayer Healthcare

18. biOasis Technologies

19. Biocon

20. BioInvent International

21. Biotest

22. BioXpress Therapeutics

23. Boehringer Ingelheim

24. Bristol Myers Squibb

25. BSP Pharmaceuticals

26. Cambrex Corporation

27. Carbogen Amcis

28. Cardinal Health

29. Celledex Therapeutics

30. Celltrion

31. Celtic Therapeutics

32. Chugai Pharmaceutical

33. CMEA Capital

34. Cytovance Biologics LLC

35. Daiichi Sankyo

36. Dendreon Corporation

37. Dong-A Pharmaceutical

38. Eli Lilly

39. Endocyte

40. Fujifilm Diosynth Biotechnologies

41. Genentech

42. Genmab

43. Glycotope

44. Hanwha Chemical

45. Heidelberg Pharma

46. Immunogen

47. Immunomedics

48. Intellect Neurosciences

49. ISU Abxis

50. Johnson & johnson

51. Laureate Biopharma

52. Lilly Ventures

53. Lonza

54. Maverick Capital

55. McKesson Corporation

56. Medivation

57. Meiji Seika Pharma

58. Merck

59. Mersana Therapeutics

60. Micromet

61. Millennium

62. MorphoSys

63. Mylan

64. New Enterprise Associates

65. Nippon Kayaku

66. Novasep

67. Pfizer

68. Philochem

69. PhotoBiotics

70. Pierre Fabre Medicament Production

71. Piramal Healthcare Pharma Solutions

72. PlantForm Corporation

73. PolyTherics

74. Progenics

75. Redwood Bioscience

76. Roche

77. Sanofi

78. Seattle Genetics

79. Shanghai CP Guojian

80. Sigma Aldrich Fine Chemicals (SAFC)

81. Skyline Ventures

82. Società Italiana Corticosteroidi S.r.l

83. Spirogen

84. Sutro Biopharma

85. SV Life Sciences

86. Synthon

87. Takeda Pharmaceuticals

88. Tavistock Life Sciences

89. UCB Pharma

90. Ventana Medical Systems

91. Versant Ventures

92. Viventia Biotechnologies

93. Watson Pharmaceuticals

The following organisations have been mentioned in this report:

1. Food and Drug Administration (FDA)

2. Committee for Medicinal Products for Human Use (CHMP)

3. Ministry of Health, Labour and Welfare (MHLW)

4. European Medicines Agency (EMA)

5. American Society of Clinical Oncology (ASCO)

6. American Cancer Society

7. American Association for Cancer Research

8. National Cancer Institute (NCI)

To order this report:

Biopharmaceutical Industry: Antibody Drug Conjugates Market, 2012-2023

Contact Clare: [email protected]
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Intl:+1 339 368 6001

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