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Global Antibody Drugs Market Analysis with Forecasts to 2022 | Growth Opportunities

  • ID : 687242539  |  
  • Published : Sep-2017  |  
  • Region : Global  |  
  • Pages : 115   |  
  • Publisher : BCC Research

Report Scope:

This study offers a global view of the antibody drugs used in the pharmaceutical and biopharmaceutical markets. This report analyzes and assesses therapeutic applications of monoclonal antibodies (mAbs) in human medicine, including the combination of mAbs when they are attached to cytotoxic agents such as antibody drug conjugates.

BCC Research analyzes and makes projections for each market and its applications, the regulatory environment, new products and technological advances. Also included in the report are relevant patent analysis and profiles of leading companies in the antibody drug industry, such as AbbVie Inc., Amgen Inc., Biogen Inc., Johnson & Johnson Inc., Merck KGaA, Novartis AG, F. Hoffmann-La Roche Ltd. and Merck & Co.

The report covers the major markets of the U.S. and Europe, as well as emerging markets in India, China, Japan, Korea, Taiwan, Africa, Australia, New Zealand, Canada, etc.

Monoclonal antibodies are protein-based therapies/drugs that are finding use in the treatment of number of chronic diseases. This report focuses on the global market for antibody drug products and provides an updated review on their applications in various disease sectors. The overall market for antibody drug products includes four main areas of applications: autoimmune diseases; solid tumors; lymphoma and leukemia; and other diseases such as asthma, osteoporosis and cardiovascular diseases.

The report covers technology trends, including the human anti-mouse antibody (HAMA) problem caused by murine antibodies and how it was resolved by replacing murine antibodies with chimeric, human and humanized antibodies.

Excluded from this report are polyclonal antibodies; screening kits; and diagnostic uses of mAbs. Also excluded are research applications of mAbs and therapeutic antibodies for veterinary use.

Report Includes:

- An overview of the global market for therapeutic monoclonal antibody (mAb) drugs and related applications and technologies.

- Analyses of global market trends, with data from 2014, 2015 and 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022.

- Analysis and assessment of the therapeutic applications of mAbs in human medicine.

- A look at the antibody industry as a whole, as well as a discussion of the pending huge impact of genomics and the emergence of biotechnology firms into the mainstream market.

- Comprehensive profiles of companies that lead the biotechnology and pharmaceutical industries in the research and development of antibody drugs and the innovative products that those companies have launched or have in development.

Table of Contents

Chapter 1: Introduction ......................................................................................... 1

Study Goals and Objectives........................................................................................................................... 1

Reasons for Doing This Study ........................................................................................................................ 1

Scope of Report ............................................................................................................................................. 1

Information Sources ...................................................................................................................................... 2

Methodology ................................................................................................................................................. 2

Geographic Breakdown ................................................................................................................................. 3

Analyst's Credentials ..................................................................................................................................... 6

Related BCC Research Reports...................................................................................................................... 6

Chapter 2: Summary and Highlights ....................................................................... 8

Chapter 3: Market and Technology Background ................................................. 11

Antibodies and Antigens ............................................................................................................................. 11

Antibody Functions ..................................................................................................................................... 11

Monoclonal Antibodies ............................................................................................................................... 11

History of Monoclonal Antibodies........................................................................................................... 12

Advantages and Disadvantages of Monoclonal Antibodies .................................................................... 13

Types of Monoclonal Antibodies ............................................................................................................. 13

Manufacturing Technologies of Monoclonal Antibodies ........................................................................ 16

Applications of Monoclonal Antibodies .................................................................................................. 20

Chapter 4: Market Breakdown by Technology Type ............................................ 24

Market by Type ........................................................................................................................................... 24

Market Overview ..................................................................................................................................... 25

Market Revenue ...................................................................................................................................... 26

Market Share ........................................................................................................................................... 27

Market by Region ........................................................................................................................................ 28

Market Overview ..................................................................................................................................... 28

Market Revenue ...................................................................................................................................... 29

Market Share ........................................................................................................................................... 30

Murine Monoclonal Antibodies .............................................................................................................. 31

Chimeric Monoclonal Antibodies ............................................................................................................ 33

Human Monoclonal Antibodies............................................................................................................... 35

Humanized Monoclonal Antibodies ........................................................................................................ 36

Market by Manufacturing Process .............................................................................................................. 38

Market Overview ..................................................................................................................................... 39

Market Revenue ...................................................................................................................................... 39

Market Share ........................................................................................................................................... 40

Market of Murine Monoclonal Antibodies by Manufacturing Process................................................... 41

Market Analysis of Chimeric Monoclonal Antibodies by Manufacturing Process .................................. 43

Market Analysis of Human Monoclonal Antibodies by Manufacturing Process ..................................... 44

Market Analysis of Humanized Monoclonal Antibodies by Manufacturing Process .............................. 46

Chapter 5: Market Breakdown by Application ..................................................... 49

Market by Diseases ..................................................................................................................................... 49

Market Overview ..................................................................................................................................... 49

Market Revenue ...................................................................................................................................... 49

Market Share ........................................................................................................................................... 51

Autoimmune Disease .............................................................................................................................. 52

Solid Tumors ............................................................................................................................................ 58

Lymphoma and Leukemia ....................................................................................................................... 62

Others ...................................................................................................................................................... 67

Chapter 6: Industry Structure .............................................................................. 73

Murine Monoclonal Antibodies .................................................................................................................. 73

Market Leaders ....................................................................................................................................... 73

Market Share ........................................................................................................................................... 73

Chimeric Monoclonal Antibodies ................................................................................................................ 73

Market Leaders ....................................................................................................................................... 73

Market Share ........................................................................................................................................... 74

Humanized Monoclonal Antibodies ............................................................................................................ 75

Market Leaders ....................................................................................................................................... 75

Market Share ........................................................................................................................................... 76

Human Monoclonal Antibodies .................................................................................................................. 77

Market Leaders ....................................................................................................................................... 77

Market Share ........................................................................................................................................... 78

Chapter 7: Regulatory Aspects ............................................................................. 81

New Approvals of Monoclonal Antibodies ................................................................................................. 81

Recalls ......................................................................................................................................................... 83

Safety Alerts ................................................................................................................................................ 83

Chapter 8: Patent Review/ New Developments ................................................... 86

Patent Review ............................................................................................................................................. 86

Patents by Year ........................................................................................................................................ 86

Patents by Type ....................................................................................................................................... 87

Patents by Company................................................................................................................................ 88

Patents by Country .................................................................................................................................. 90

Patents by Assignee ................................................................................................................................. 92

New Developments ..................................................................................................................................... 93

Phase I clinical trials ................................................................................................................................ 93

Phase II clinical trials ............................................................................................................................... 95

Phase III Clinical Trials ............................................................................................................................. 97

Phase IV Clinical Trials ............................................................................................................................. 99

Mergers and Acquisitions ......................................................................................................................... 100

Chapter 9: Analysis of Market Opportunities ..................................................... 103

Technical Issues ......................................................................................................................................... 103

Human anti-mouse antibody (HAMA) Problem ........................................................................................ 103

Factors Affecting mAb Drugs .................................................................................................................... 103

Increasing Prevalence of Chronic Diseases ........................................................................................... 104

Aging Population ................................................................................................................................... 104

Price Regulation..................................................................................................................................... 104

Regulatory Approvals ............................................................................................................................ 104

Increasing Competition between Drug Makers .................................................................................... 104

Advances in Manufacturing Technologies ............................................................................................ 105

Biosimilars ............................................................................................................................................. 105

Mergers and Acquisitions ...................................................................................................................... 105

Licensing Agreements ........................................................................................................................... 105

Chapter 10: Company Profiles ........................................................................... 108

Appendix: Abbreviations .................................................................................... 121

About BCC Research ......................................................................................... 123

About BCC Research.................................................................................................................................. 124

BCC Membership ...................................................................................................................................... 124

BCC Custom Research ............................................................................................................................... 124

List of Tables

Summary Table Global Market for Antibody Drugs, by Disease, Through 2022 ($ Millions) ...................... 9

Table 1 Evolution of Monoclonal Antibodies ............................................................................................. 12

Table 2 Advantages and Disadvantages of Monoclonal Antibodies .......................................................... 13

Table 3 Murine Monoclonal Antibodies .................................................................................................... 14

Table 4 Chimeric Monoclonal Antibodies .................................................................................................. 14

Table 5 Humanized Monoclonal Antibodies .............................................................................................. 15

Table 6 Human Monoclonal Antibodies ..................................................................................................... 16

Table 7 Differences between Hybridoma and Recombinant Technologies ............................................... 18

Table 8 Murine Monoclonal Antibodies and Their Applications ............................................................... 20

Table 9 Chimeric Monoclonal Antibodies and Their Applications ............................................................. 21

Table 10 Human Monoclonal Antibodies and Their Applications.............................................................. 21

Table 11 Humanized Monoclonal Antibodies and Their Applications ....................................................... 22

Table 12 Global Sales of Antibody Drugs, by Type, Through 2022 ($ Millions) ......................................... 26

Table 13 Market Shares for Antibody Drugs, by Type, 2016 (%) ............................................................... 27

Table 14 Global Sales of Antibody Drugs, by Region, Through 2022 ($ Millions) ...................................... 30

Table 15 Market Shares for Antibody Drugs, by Region, 2016 (%) ............................................................ 31

Table 16 Global Market for Murine Monoclonal Antibodies, by Region, Through 2022 ($ Millions) ....... 32

Table 17 Global Market for Chimeric Monoclonal Antibodies, by Region, Through 2022 ($ Millions) ..... 34

Table 18 Global Market for Human Monoclonal Antibodies, by Region, Through 2022 ($ Millions)........ 36

Table 19 Global Market for Humanized Monoclonal Antibodies, by Region, Through 2022 ($ Millions) . 38

Table 20 Global Market for Monoclonal Antibodies, by Manufacturing Process, Through 2022 ($ Millions) .................................................................................................................................................. 40

Table 21 Market Shares for Antibody Drugs, by Manufacturing Process, 2016 (%) .................................. 41

Table 22 Global Market for Murine Antibody Drugs, by Manufacturing Process, Through 2022 ($ Millions) .................................................................................................................................................. 42

Table 23 Global Market for Chimeric Monoclonal Antibodies, by Manufacturing Process, Through 2022 ($ Millions) .................................................................................................................................................. 43

Table 24 Global Market for Human Monoclonal Antibodies, by Manufacturing Process, Through 2022 ($ Millions) .................................................................................................................................................. 45

Table 25 Global Market for Humanized Monoclonal Antibodies, by Manufacturing Process, Through 2022 ($ Millions) ......................................................................................................................................... 47

Table 26 Global Sales of Antibody Drugs, by Disease, Through 2022 ($ Millions) ..................................... 50

Table 27 Market Shares for Antibody Drugs, by Disease, 2016 (%) ........................................................... 51

Table 28 Types of Autoimmune Diseases .................................................................................................. 53

Table 29 Global Market for Antibody Drugs in Autoimmune Diseases, by Type, Through 2022 ($ Millions) .................................................................................................................................................. 55

Table 30 Global Market for Antibody Drugs in Autoimmune Diseases, by Region, Through 2022 ($ Millions) .................................................................................................................................................. 57

Table 31 Types of Cancer by the Tissue of Origin ...................................................................................... 58

Table 32 Global Market for Antibody Drugs in Solid Tumors, by Type, Through 2022 ($ Millions) .......... 59

Table 33 Global Market for Antibody Drugs in Solid Tumors, by Region, Through 2022 ($ Millions) ....... 61

Table 34 Types of Leukemia ....................................................................................................................... 63

Table 35 Global Market for Antibody Drugs in Lymphoma and Leukemia, by Type, Through 2022 ($ Millions) .................................................................................................................................................. 64

Table 36 Global Market for Antibody Drugs in Lymphoma and Leukemia, by Region, Through 2022 ($ Millions) .................................................................................................................................................. 66

Table 37 Global Market for Antibody Drugs in Other Diseases, by Type, Through 2022 ($ Millions) ....... 69

Table 38 Global Market for Antibody Drugs in Other Diseases, by Region, Through 2022 ($ Millions) .... 70

Table 39 Leading Manufacturer of Murine Monoclonal Antibodies, 2016 ............................................... 73

Table 40 Leading Manufacturers/Suppliers of Chimeric Monoclonal Antibodies, 2016 ........................... 74

Table 41 Market Shares of Manufacturers/Suppliers of Chimeric Monoclonal Antibodies, 2016 (%) .... 74

Table 42 Leading Manufacturers/Suppliers of Humanized Monoclonal Antibodies, 2016 ....................... 76

Table 43 Market Shares of Manufacturers/Suppliers of Humanized Monoclonal Antibodies, 2016 (%) . 76

Table 44 Leading Manufacturers/Suppliers of Human Monoclonal Antibodies, 2016.............................. 78

Table 45 Market Shares of Manufacturers/Suppliers of Human Monoclonal Antibodies, 2016 (%) ...... 79

Table 46 New Approvals of Monoclonal Antibodies, 2014-January 2017 ................................................. 81

Table 47 Recalls, 2014-January 2017 ......................................................................................................... 83

Table 48 Safety Alerts, 2014-January 2017 ................................................................................................. 84

Table 49 Number of Patents, by Year, 2014-January 2017 ........................................................................ 87

Table 50 Number of Patents, by Type, 2014-January 2017 ....................................................................... 88

Table 51 Number of Patents, by Company, 2014-January 2017 ............................................................... 89

Table 52 Number of Patents, by Country, 2014-January 2017 .................................................................. 90

Table 53 Share of Patents by Country, 2014-January 2017 (No./%) .......................................................... 91

Table 54 Number of Patents, by Assignee, 2014-January 2017................................................................. 92

Table 55 Monoclonal Antibodies in Phase I Clinical Trials ......................................................................... 94

Table 56 Monoclonal Antibodies in Phase II Clinical Trials ........................................................................ 96

Table 57 Monoclonal Antibodies in Phase III Clinical Trials ....................................................................... 98

Table 58 Monoclonal Antibodies in Phase IV Clinical Trials ..................................................................... 100

Table 59 Mergers and Acquisitions of Top Pharmaceutical Companies, 2014-January 2017 ................. 101

Table 60 Abbreviations Used in the Antibody Drug Industry ................................................................... 121

List of Figures

Summary Figure Global Market for Antibody Drugs, by Disease, 2014-2022 ($ Millions) .......................... 9

Figure 1 Global Sales of Antibody Drugs, by Type, 2014-2022 ($ Millions) ............................................... 27

Figure 2 Market Shares of Antibody Drugs, by Type, 2016 (%) ................................................................. 28

Figure 3 Global Sales of Antibody Drugs, by Region, 2014-2022 ($ Millions) ............................................ 30

Figure 4 Market Shares for Antibody Drugs, by Region, 2016 (%) ............................................................. 31

Figure 5 Global Market for Murine Monoclonal Antibodies, by Region, 2014-2022 ($ Millions) ............. 33

Figure 6 Global Market for Chimeric Monoclonal Antibodies, by Region, 2014-2022 ($ Millions) ........... 34

Figure 7 Global Market for Human Monoclonal Antibodies, by Region, 2014-2022 ($ Millions) ............. 36

Figure 8 Global Market for Humanized Monoclonal Antibodies, by Region, 2014-2022 ($ Millions) ....... 38

Figure 9 Global Market for Monoclonal Antibodies, by Manufacturing Process, 2014-2022 ($ Millions) 40

Figure 10 Market Shares for Antibody Drugs, by Manufacturing Process, 2016 (%)................................. 41

Figure 11 Global Market for Murine Antibody Drugs, by Manufacturing Process, 2014-2022 ($ Millions) .................................................................................................................................................. 42

Figure 12 Global Market for Chimeric Monoclonal Antibodies, by Manufacturing Process, 2014-2022 ($ Millions) .................................................................................................................................................. 44

Figure 13 Global Market for Human Monoclonal Antibodies, by Manufacturing Process, 2014-2022 ($ Millions) .................................................................................................................................................. 45

Figure 14 Global Market for Humanized Monoclonal Antibodies, by Manufacturing Process, 2014-2022 ($ Millions) .................................................................................................................................................. 47

Figure 15 Global Sales of Antibody Drugs, by Disease, 2014-2022 ($ Millions)......................................... 51

Figure 16 Market Shares for Antibody Drugs, by Disease, 2016 (%) ......................................................... 52

Figure 17 Global Market for Antibody Drugs in Autoimmune Diseases, by Type, 2014-2022 ($ Millions) .................................................................................................................................................................... 56

Figure 18 Global Market for Antibody Drugs in Autoimmune Diseases, by Region, 2014-2022 ($ Millions) .................................................................................................................................................................... 57

Figure 19 Global Market for Antibody Drugs in Solid Tumors, by Type, 2014-2022 ($ Millions) .............. 60

Figure 20 Global Market for Antibody Drugs in Solid Tumors, by Region, 2014-2022 ($ Millions) ........... 62

Figure 21 Global Market for Antibody Drugs in Lymphoma and Leukemia, by Type, 2014-2022 ($ Millions) .................................................................................................................................................. 65

Figure 22 Global Market for Antibody Drugs in Lymphoma and Leukemia, by Region, 2014-2022 ($ Millions) .................................................................................................................................................. 66

Figure 23 Global Market for Antibody Drugs in Other Diseases, by Type, 2014-2022 ($ Millions) ........... 69

Figure 24 Global Market for Antibody Drugs in Other Diseases, by Region, Through 2022 ($ Millions) .. 71

Figure 25 Market Shares of Manufacturers/Suppliers of Chimeric Monoclonal Antibodies, 2016 (%) .... 75

Figure 26 Market Shares of Manufacturers/Suppliers of Humanized Monoclonal Antibodies, 2016 (%) ............................................................................................................................................................... 77

Figure 27 Market Share of Manufacturers/Suppliers of Human Monoclonal Antibodies, 2016 (%)......... 79

Figure 28 Number of Patents, by Year, 2014-January 2017 ...................................................................... 87

Figure 29 Number of Patents, by Type, 2014-January 2017 ...................................................................... 88

Figure 30 Share of Patents, by Country, 2014-January 2017 (%)............................................................... 92

Figure 31 Number of Patents, by Assignee, 2014-January 2017 ............................................................... 93

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