人工血液: 2028年までの世界市場

Report Overview

The global artificial blood market reached $23.9 million in 2022, should reach $26.1 million by 2023 and $40.5 million by 2028 with a compound annual growth rate (CAGR) of 9.2% during the forecast period of 2023-2028.

Summary:

The human body contains a vital fluid called blood, which delivers oxygen and nutrients to the body’s cells and carries waste products away from the cells in a gas exchange process. The artificial blood being developed is intended to satisfy some of the functions of biological blood, particularly in humans.

Currently, two fundamental approaches to artificial blood are being taken: perfluorocarbons and hemoglobin-based oxygen carriers.

Safe and timely access to blood transfusion is crucial for saving lives and enhancing health. Unfortunately, numerous patients needing transfusions face difficulty obtaining secure blood supplies promptly. Blood transfusions are done for several conditions, such as severe injury or trauma with significant blood loss, surgery, childbirth, anemia, cancer, kidney failures and others. The blood shortage and the risks and challenges associated with donor blood have led to the development of artificial blood. Notably, the potential market for artificial blood is very high, and estimated to be around $REDACTED billion in 2028 and hence the market needs products which would cater to such high unmet need.

The research for finding a potential alternative for blood, has been ongoing for centuries, but the results have been disappointing. This is mainly because of the adverse reactions associated with the developed products. Because of this, these products have been terminated or discontinued during clinical development. The poor success rate of the products led to losses for the companies, because of which they have filed for bankruptcy or are out of business.

Recently, it has been observed that companies are focusing on developing products that would address the shortcomings of the failed or existing products in the pipeline. Some of these include the development of freeze-dried HBOCs, Erythromer (from Kalocyte) (which is based on nanocapsule technology), and biosynthetic red blood cells (producing red blood cells from stem cells), being developed by companies such as Erypharma and Red C Biotech. Researchers are also focusing on the development of artificial whole blood by combining three synthetic components: freeze-dried platelet surrogates, freeze-dried red blood cell surrogates, and freeze-dried plasma.

The artificial blood market was estimated to be $REDACTED million in 2022 and is forecasted to grow at a compound annual growth rate (CAGR) of REDACTED% to reach a value of $REDACTED million through 2028. The market value is low because there are no approved products for artificial blood. Hemopure is the only marketed product for anemia and is approved in South Africa and Russia and used under an expanded access program in the U.S. Currently, the company doesn’t have the infrastructure and funds to produce the product and the company reported no revenue in 2021. In 2022, HemO2life from Hemarina was approved for use as an additive for kidney grafts in the European Union. There are no approved
products for routine clinical use in the U.S., which is the primary market. A similar product for graft preservation is being developed by VirTechBio—OxyBridge—which is in development and anticipated to enter the U.S. market by 2026. There are companies with products in Phase II and Phase II/III development, but the products might not be approved in the forecast period or enter the market by 2028. However, future approvals will help cater to the high unmet need in the market.

Factors leading to the growth of the market are increasing demand for blood transfusions and risks and challenges associated with blood transfusions and shortage of blood supply. Factors such as low rate of approvals, product acceptance, and higher pricing act as barriers to the market. The market is dominated by startup and private biotech companies. Key players in the market include Hemarina, NuvOx Pharmaceuticals, VirTech Bio, and Prolong Pharmaceuticals.

Report Scope:

The scope of this study encompasses an investigation of the global market for artificial blood, focusing on various important aspects of the market, such as research and development, clinical trial outcomes, approval status, and the potential commercial demand for artificial blood products. The report includes a discussion of artificial oxygen carrier products. BCC Research analyzes each market segment and provides a forecast for six years. The current report analyzes the market’s drivers, challenges, and opportunities. The report also covers market projections for 2028 and the market analysis for key market players. The report includes the company profiles of the key players with detailed information about their business segments, financials, product portfolios, and recent developments. The report also provides information on emerging technologies, the impact of COVID-19, product analysis, deals, and investment outlook.

Report Synopsis

Report Includes:

• 41 tables
• An overview of the global markets for artificial blood
• Estimation of market size and analyses of global market trends, with data from 2020-2022, estimates for 2023, and projections of compound annual growth rates (CAGRs) through 2028
• Highlights of the market potential and characterization of artificial blood market by product, application, and region
• Examination of the key drivers and constraints that will shape the market and discussion on the upcoming market opportunities and areas of focus to forecast the market into various segments and sub-segments
• Coverage of recent advances, emerging technologies, and developments of the industry
• Evaluation of key industry acquisitions and strategic alliances and market share analysis of the leading suppliers of the industry
• Company profiles of major players within the industry, including Hemarina, VirTechBio, and NuvOx Pharma

Table of Contents

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
What’s New in This Update?
Methodology
Information Sources
Geographic Breakdown
Chapter 2 Summary and Highlights
Market Overview
Chapter 3 Market Overview
Introduction
Is There a Problem with Human Blood?
Emerging Needs for Artificial Blood
Artificial Blood Will Be Useful in Dealing with the Risks of Infection
Artificial Blood Will Help to Decrease the Load on the Donor Blood Supply
Artificial Blood Is Needed to Deal with Unexpected Demands on the Blood System
Hurdles in the Development of Artificial Blood Products
Ideal Characteristics of Artificial Blood
Artificial Blood Over Human Blood
Applications
Surgeries
Emergency Resuscitation
For Short-term Use
Where More Effective Than Human Blood
Rejections Due to Religious Beliefs
Challenges in Artificial Blood Development
Chapter 4 Market Dynamics
Drivers
Increasing Demand for Blood Transfusions
Risks and Challenges Associated with Blood Transfusions
Shortage of Blood Supply
Barriers
Low Rate of Product Approvals
Product Acceptance
Product Pricing
Opportunities
Impact of COVID-19
Chapter 5 Artificial Blood by Source
Introduction
Artificial Blood Developed from Human Blood
Artificial Blood Developed from Animal Blood
Artificial Blood Developed Using Recombinant Technology
Surface Modified Hemoglobin
Cross-Linked Hemoglobin
Polymerized Hemoglobin
Encapsulation
Genetically Engineered Recombinant Hemoglobin
Natural Hemoglobin
Chapter 6 Artificial Blood by Type
Introduction
Perfluorocarbon Emulsions
General Characteristics of Perfluorocarbons
Emulsion Selection
Historical Developments of Perfluorocarbon Emulsions
First Generation of PFCs
Second Generation of PFCs
Third Generation of PFCs
Hemoglobin-based Oxygen Carriers
General Characteristics of HBOCs
Historical Events: Hemoglobin Solutions
Chapter 7 Market Estimation
Introduction
Potential Market for Artificial Blood
Artificial Blood Market, by Source
Blood (Animal/Human)
Synthetic Polymers
Artificial Blood Market, by Type
Hemoglobin-based Oxygen Carriers
Perfluorocarbon-based Products
Artificial Blood Market, by Region
North America
Europe
Emerging Markets
Chapter 8 Emerging Technologies and Developments
Overview
Emerging Technologies
Nanocapsule Technology
Stem Cells
Other Ongoing Research for Blood Substitutes
Chapter 9 Product Analysis
Introduction
Product Safety
Product Effectiveness
Product Cost
Legal Implications
Product Analysis of Some of the Products Under Development
Hemopure
HemO2life
HemoTech
NanO2 (DDFPe)
Sanguinate
Vidaphor
Clinical Trials
Product Description of Some of the Products in Preclinical and Early Phase I Stage
ErythroMer
Hemoglobin vesicles
OxyVita
OxyBridge
Chapter 10 Patent Analysis
Introduction
FDA Regulation
FDA Good Manufacturing Practices and Reporting
Patent Analysis
Chapter 11 Competitive Intelligence
Strategic Developments
Competitive Analysis
Chapter 12 Company Profiles
AURUM BIOSCIENCES
ERYPHARM
HEMOGLOBIN OXYGEN THERAPEUTICS LLC.
HEMARINA
KALOCYTE INC.
NANO SANGUIS S.A
NUVOX PHARMA LLC.
PROLONG PHARMACEUTICALS, LLC
RED C BIOTECH
VIRTECH BIO

List of Tables
Summary Table : Global Market for Artificial Blood, Through 2028
Table 1 : Historical Events Related to Blood Transfusion, 1628-2022
Table 2 : Potential Benefits and Application Areas of Artificial Blood
Table 3 : Average Number of Blood Units Required During Particular Medical Conditions
Table 4 : The Challenges Associated with the Development of Artificial Blood
Table 5 : Common Challenges to the Blood Transfusion Continuum in LMICs.
Table 6 : Sources of Hemoglobin Molecules Used to Prepare Free Hemoglobin Solutions
Table 7 : Pros and Cons of Artificial Blood Developed from Human Blood
Table 8 : Pros and Cons of Artificial Blood Developed from Animal Blood
Table 9 : Pros and Cons of Artificial Blood Developed from Recombinant Blood
Table 10 : Summary of Acellular Hb-Based Oxygen Carriers
Table 11 : Examples of Hemoglobin-based Oxygen Carrier Products and Approval Status
Table 12 : Potential Clinical Applications of Oxygen Carriers
Table 13 : Composition of PFC Emulsion-Based Artificial Blood Products
Table 14 : First Generation Perfluorocarbon Emulsions Used in Medicine and Biology
Table 15 : Comparative Study of Second-Generation PFCs
Table 16 : PFC Emulsion Products and Current Status
Table 17 : Comparative Study Between RBCs and HBOCs
Table 18 : HBOC Solutions Transfusion: Side Effects and Possible Causes
Table 19 : Examples of HBOC Products Developed, by Various Companies
Table 20 : Global Market for Artificial Blood, Through 2028
Table 21 : Current Cell Sources and Strategies for Ex-vivo RBC Generation
Table 22 : List of Discontinued Blood Substitutes
Table 23 : Hemopure: Raw Material and Method Overview
Table 24 : Hemopure: Product Characteristics
Table 25 : Hemopure: Advantages and Disadvantages
Table 26 : Summary of Clinical Trials of Hemopure (HBOC-201), 2023
Table 27 : HemO2life: Raw Material and Method
Table 28 : HemO2life: Advantages and Disadvantages
Table 29 : HemO2life: Product
Table 30 : Ex vivo, In vivo and Clinical Studies involving HemO2life (M101) Use
Table 31 : Hemotech: Raw Material and Method Overview
Table 32 : HemoTech: Advantages and Disadvantages
Table 33 : NanO2 (DDFPe): Raw Material and Method Overview
Table 34 : NanO2 (DDFPe): Advantages and Disadvantages
Table 35 : NanO2 (DDFPe): Clinical Trials, 2023
Table 36 : Sanguinate: Raw Material and Method Overview
Table 37 : Sanguinate: Advantages and Disadvantages
Table 38 : Sanguinate: Clinical Trials, 2023
Table 39 : Vidaphor: Raw Material and Method Overview
Table 40 : Vidaphor: Advantages and Disadvantages
Table 41 : Vidaphor: Clinical Trials, 2023

List of Figures
Summary Figure : Global Market for Artificial Blood, 2020-2028
Figure 1 : The Blood Continuum
Figure 2 : Medical Use of Human Red Blood Cells in the U.S., 2019
Figure 3 : Estimated Number of New Cancer Cases from 2020 to 2040
Figure 4 : Discards of Blood Donations, by Reason, 2018
Figure 5 : Artificial Blood Manufactured from Different Sources
Figure 6 : History of HBOCs Developed Using Recombinant Technology
Figure 7 : Classification of Modified Hemoglobin Solution Based on Methods
Figure 8 : Classification of Different Types of Oxygen Carriers
Figure 9 : Generations of Perfluorocarbon Emulsions
Figure 10 : Advantages and Disadvantages of PFC Emulsions
Figure 11 : Evolution of HBOCs
Figure 12 : Advantages and Disadvantages of HBOCs
Figure 13 : Global Potential Market for Artificial Blood, by Application, 2028
Figure 14 : Biosynthetic RBC vs Artificial Blood Substitutes
Figure 15 : Artificial Blood: Parameters for Product Analysis
Figure 16 : Hemopure: Product Analysis
Figure 17 : HemO2life: Product Analysis
Figure 18 : NanO2 (DDFPe): Product Analysis
Figure 19 : Sanguinate: Product Analysis
Figure 20 : Current Competition in the Global Artificial Blood Market