Biobetter Market - Forecasts from 2019 to 2024
The global biobetter market is projected to grow at a CAGR of 30.64% to reach US$64.041 billion by 2024, from US$12.884 billion in 2018. The low development cost of biobetters as compared to the biologics will augment the market growth during the given forecast period.
Biobetters are improved versions of originator biologics which are similar to existing biologics entities by action, potency and by other factors. Biobetters are formed as a result of chemical modification, protein fusion, altered amino acid sequence, or humanization of the glycosylation pattern, which aims for the same target as the original biological, but has its effect longer period of time, typically at lower doses and with fewer side effects. Biobetters differ from biosimilars in that they are not identical to the original product and have been designed to have some advantage. Biobetters are handled exactly as innovator molecules in the United States, and similar regulatory standards are expected elsewhere. They are new molecular entities and will be subject to the standards applied to all new drugs
A biosimilar has no clinically meaningful differences in terms of safety and effectiveness from its reference product. In contrast, a biobetter can be thought of as an improved version of an existing biological product. There may be a change in structure that makes it safer or more effective or a change in the formulation that makes it easier to administer. A biobetter may have an easier clinical road since it benefits from prior knowledge of clinically effective targets/pathways. Biobetters allows companies to target an established mechanism, safety, and efficacy profile but gain the benefit of the patent protection and sales of a new molecular entity with significantly higher chances of successful registration.
The market is expected to show modest growth during the forecast period due to major manufacturers investing in the development of the biobetters in the face of impending biosimilar competition. The low development cost of biobetters as compared to the biologics will also augment the market growth during the given forecast period. Moreover, many blockbuster biologics are going off-patent by 2023, providing ample opportunities for the companies to develop biobetter, thus, positively impacting the market. However, lack of awareness among the patient population in regards to the betters will restrain the growth of the global biobetter market during the given forecast period.
By Type
By type, the global biobetter market is segmented as monoclonal antibodies, vaccines, recombinant proteins, and others. Monoclonal antibodies are expected to hold a significant share which may be attributed to the favorable regulatory policies, and high adoption rate of therapeutic antibodies in emerging economies.
By Geography
Geographically, the global biobetter market is segmented as North America, South America, Europe, Middle East and Africa, and Asia Pacific. The Europe is expected to hold a significant share which may be attributed to the well-defined approval guidelines and the number of researches going in the region for the biobetter development.
Segmentation
The global biobetter market has been segmented by type, application, end-user, and geography.
Biobetters are improved versions of originator biologics which are similar to existing biologics entities by action, potency and by other factors. Biobetters are formed as a result of chemical modification, protein fusion, altered amino acid sequence, or humanization of the glycosylation pattern, which aims for the same target as the original biological, but has its effect longer period of time, typically at lower doses and with fewer side effects. Biobetters differ from biosimilars in that they are not identical to the original product and have been designed to have some advantage. Biobetters are handled exactly as innovator molecules in the United States, and similar regulatory standards are expected elsewhere. They are new molecular entities and will be subject to the standards applied to all new drugs
A biosimilar has no clinically meaningful differences in terms of safety and effectiveness from its reference product. In contrast, a biobetter can be thought of as an improved version of an existing biological product. There may be a change in structure that makes it safer or more effective or a change in the formulation that makes it easier to administer. A biobetter may have an easier clinical road since it benefits from prior knowledge of clinically effective targets/pathways. Biobetters allows companies to target an established mechanism, safety, and efficacy profile but gain the benefit of the patent protection and sales of a new molecular entity with significantly higher chances of successful registration.
The market is expected to show modest growth during the forecast period due to major manufacturers investing in the development of the biobetters in the face of impending biosimilar competition. The low development cost of biobetters as compared to the biologics will also augment the market growth during the given forecast period. Moreover, many blockbuster biologics are going off-patent by 2023, providing ample opportunities for the companies to develop biobetter, thus, positively impacting the market. However, lack of awareness among the patient population in regards to the betters will restrain the growth of the global biobetter market during the given forecast period.
By Type
By type, the global biobetter market is segmented as monoclonal antibodies, vaccines, recombinant proteins, and others. Monoclonal antibodies are expected to hold a significant share which may be attributed to the favorable regulatory policies, and high adoption rate of therapeutic antibodies in emerging economies.
By Geography
Geographically, the global biobetter market is segmented as North America, South America, Europe, Middle East and Africa, and Asia Pacific. The Europe is expected to hold a significant share which may be attributed to the well-defined approval guidelines and the number of researches going in the region for the biobetter development.
Segmentation
The global biobetter market has been segmented by type, application, end-user, and geography.
- By Type
- Monoclonal Antibodies
- Vaccines
- Recombinant Proteins
- Others
- By Application
- Oncology
- Neurology
- Nephrology
- Others
- By End-User
- Biopharmaceuticals
- Research Organisations
- By Geography
- North America
- USA
- Canada
- Mexico
- South America
- Brazil
- Argentina
- Others
- Europe
- Germany
- France
- United Kingdom
- Spain
- Others
- Middle East and Africa
- Saudi Arabia
- Israel
- UAE
- Others
- Asia Pacific
- China
- Japan
- South Korea
- India
- Others
1. INTRODUCTION
1.1. Market Definition
1.2. Market Segmentation
2. RESEARCH METHODOLOGY
2.1. Research Data
2.2. Assumptions
3. EXECUTIVE SUMMARY
3.1. Research Highlights
4. MARKET DYNAMICS
4.1. Market Drivers
4.2. Market Restraints
4.3. Porters Five Forces Analysis
4.3.1. Bargaining Power of Suppliers
4.3.2. Bargaining Power of Buyers
4.3.3. Threat of New Entrants
4.3.4. Threat of Substitutes
4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
5. GLOBAL BIOBETTER MARKET ANALYSIS, BY TYPE
5.1. Introduction
5.2. Monoclonal Antibodies
5.3. Vaccines
5.4. Recombinant Proteins
5.5. Others
6. GLOBAL BIOBETTER MARKET ANALYSIS, BY APPLICATION
6.1. Introduction
6.2. Oncology
6.3. Neurology
6.4. Nephrology
6.5. Others
7. GLOBAL BIOBETTER MARKET ANALYSIS, BY END USER
7.1. Introduction
7.2. Biopharmaceuticals
7.3. Research Organisations
8. GLOBAL BIOBETTER MARKET ANALYSIS, BY GEOGRAPHY
8.1. Introduction
8.2. North America
8.2.1. USA
8.2.2. Canada
8.2.3. Mexico
8.3. South America
8.3.1. Brazil
8.3.2. Argentina
8.3.3. Others
8.4. Europe
8.4.1. Germany
8.4.2. France
8.4.3. United Kingdom
8.4.4. Spain
8.4.5. Others
8.5. Middle East and Africa
8.5.1. Saudi Arabia
8.5.2. Israel
8.5.3. UAE
8.5.4. Others
8.6. Asia Pacific
8.6.1. China
8.6.2. Japan
8.6.3. South Korea
8.6.4. India
8.6.5. Others
9. COMPETITIVE ENVIRONMENT AND ANALYSIS
9.1. Major Players and Strategy Analysis
9.2. Emerging Players and Market Lucrativeness
9.3. Mergers, Acquisitions, Agreements, and Collaborations
9.4. Vendor Competitiveness Matrix
10. COMPANY PROFILES
10.1. Galil-Ofek
10.2. AstraZeneca
10.3. Compass Biotechnologies, Inc.
10.4. GC Pharma
10.5. Celltrion
10.6. Ildong Pharma
*list is not exhaustive
11. APPENDIX
1.1. Market Definition
1.2. Market Segmentation
2. RESEARCH METHODOLOGY
2.1. Research Data
2.2. Assumptions
3. EXECUTIVE SUMMARY
3.1. Research Highlights
4. MARKET DYNAMICS
4.1. Market Drivers
4.2. Market Restraints
4.3. Porters Five Forces Analysis
4.3.1. Bargaining Power of Suppliers
4.3.2. Bargaining Power of Buyers
4.3.3. Threat of New Entrants
4.3.4. Threat of Substitutes
4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
5. GLOBAL BIOBETTER MARKET ANALYSIS, BY TYPE
5.1. Introduction
5.2. Monoclonal Antibodies
5.3. Vaccines
5.4. Recombinant Proteins
5.5. Others
6. GLOBAL BIOBETTER MARKET ANALYSIS, BY APPLICATION
6.1. Introduction
6.2. Oncology
6.3. Neurology
6.4. Nephrology
6.5. Others
7. GLOBAL BIOBETTER MARKET ANALYSIS, BY END USER
7.1. Introduction
7.2. Biopharmaceuticals
7.3. Research Organisations
8. GLOBAL BIOBETTER MARKET ANALYSIS, BY GEOGRAPHY
8.1. Introduction
8.2. North America
8.2.1. USA
8.2.2. Canada
8.2.3. Mexico
8.3. South America
8.3.1. Brazil
8.3.2. Argentina
8.3.3. Others
8.4. Europe
8.4.1. Germany
8.4.2. France
8.4.3. United Kingdom
8.4.4. Spain
8.4.5. Others
8.5. Middle East and Africa
8.5.1. Saudi Arabia
8.5.2. Israel
8.5.3. UAE
8.5.4. Others
8.6. Asia Pacific
8.6.1. China
8.6.2. Japan
8.6.3. South Korea
8.6.4. India
8.6.5. Others
9. COMPETITIVE ENVIRONMENT AND ANALYSIS
9.1. Major Players and Strategy Analysis
9.2. Emerging Players and Market Lucrativeness
9.3. Mergers, Acquisitions, Agreements, and Collaborations
9.4. Vendor Competitiveness Matrix
10. COMPANY PROFILES
10.1. Galil-Ofek
10.2. AstraZeneca
10.3. Compass Biotechnologies, Inc.
10.4. GC Pharma
10.5. Celltrion
10.6. Ildong Pharma
*list is not exhaustive
11. APPENDIX
