生物工学によるタンパク質医薬品の世界市場：2027年までに5,213億ドル規模へ

出版：BCC Research（BCCリサーチ）　出版年月：2023年3月

Global Markets for Bioengineered Protein Drugs
生物工学によるタンパク質医薬品の世界市場：2027年までに5,213億ドル規模へ

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Report Highlights

The global market for bioengineered protein drugs is estimated to increase from $354.1 billion in 2022 to reach $521.3 billion by 2027, at a compound annual growth rate (CAGR) of 8.0% from 2022 through 2027.

Summary:

Bioengineered protein drugs are widely used due to their high specificity, enhanced efficacy, affinity, solubility, and low toxicity. Advances in protein synthesis have increased the complexity of bioengineered proteins being produced for therapeutic purposes. Continued development in protein drug manufacturing technologies, growing incidence of chronic diseases, the larger elderly population, improved protein-based drug efficacy, and advancements in drug delivery systems will boost the bioengineered protein drugs market. Innovations in protein drugs are accelerating quickly. For example, in the last two years (2021 and 2022), REDACTED, or REDACTED% of all novel drug and biological product approvals, were for bioengineered protein drugs. The presence of high unmet needs and the vast potential for innovation offers tremendous growth potential for the market.

The cost of developing and producing bioengineered protein drugs is dramatically higher than for conventional (small molecule) medications and involves lengthy complex manufacturing processes and stringent regulatory requirements. The market is less susceptible to generic competition than small molecule drugs. Large molecule or protein drugs do not have the same kind of generic competition as small molecule drugs and have a longer shelf-life in terms of patent protection. Over the past three decades, bioengineered protein drugs have revolutionized the treatment of infectious diseases, cancer, and chronic immunological diseases. Pharmaceutical manufacturers are focused on developing and manufacturing novel bioengineered protein drugs for cancer, autoimmune disorders, and other life-threatening disease treatments. This is evidenced by the growing competition in the bioengineered protein drugs market.

The global bioengineered protein drugs market was estimated to have been worth $REDACTED billion in 2021. Between 2022 and 2027, the bioengineered protein drugs market is predicted to grow at a compound annual growth rate (CAGR) of REDACTED%, leading to a market value of $REDACTED billion in 2027. An aging population with a myriad of chronic diseases, the need for more effective and targeted therapeutics, and continuous innovation in bioengineered protein drugs are driving the bioengineered protein drugs market.

Report Scope:

This report aims to provide a comprehensive study of the global market for bioengineered protein drugs, both in terms of quantitative and qualitative data, to help readers develop business/growth strategies, assess the market landscape, analyze their position in the current marketplace and make informed business decisions regarding bioengineered protein drugs. Segmentation is based on the drug type, disease type, and region.

Industry growth drivers, restraints, trends, and opportunities in bioengineered protein drugs are also discussed in detail. The report also provides information on the bioengineered protein drug market competitive landscape, features detailed company profiles, and discusses the impact of COVID-19 on the market.

Report Includes:

– 28 data tables and 23 additional tables
– An up-to-date overview and analysis of the global markets for bioengineered protein drugs
– Analyses of the global market trends, with historic market revenue data (sales figures) from 2019-2021, estimates for 2022, forecasts for 2023, and projections of compound annual growth rates (CAGRs) through 2027
– Highlights of the emerging technology trends, opportunities and gaps estimating current and future demand for bioengineered protein drugs market, and major regions and countries involved in market developments
– Estimation of the actual market size and revenue forecast for global bioengineered protein drugs market in USD million terms, and corresponding market share analysis by drug type, disease type, and region
– In-depth information (facts and figures) concerning the major factors influencing the progress of this market (benefits, and industry-specific challenges) with respect to specific growth trends, upcoming technologies, future prospects, and contributions to the overall biopharmaceutical industry
– Discussion of the regulatory aspects and standards for bioengineered protein therapeutics, newly approved products, underlying clinical trials for all phases and list of vaccines, and the COVID-19 impact on the progress of this market
– Insight into the recent industry structure, competitive aspects of each product segment, increasing investment on R&D activities to develop new and improved therapies, market development strategies, and company value share analysis
– Identification of the major companies involved in the production and modification of protein drugs, and analysis of the company competitive landscape based on their recent developments, financial performance, and segmental revenues
– Descriptive company profiles of the leading global players, including AbbVie Inc., AstraZeneca plc, GlaxoSmithKline (GSK), Bristol-Myers Squibb (BMS) Co., Pfizer Inc., Merck and Co., and Sanofi S.A.

目次

Table of Contents
Chapter 1 Introduction
1.1 Study Goals and Objectives
1.2 Scope of This Report
1.3 Methodology and Information Sources
1.4 What’s New in This Update?
1.5 Geographic Breakdown
1.6 Analyst’s Credentials
1.7 BCC Custom Research
1.8 Related BCC Research Reports
Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
3.1 Protein Drugs Overview
3.2 Bioengineered Protein Drugs
3.3 Manufacturing Technologies
3.3.1 Fractionation/Extraction from Natural Sources (Human/Animal)
3.3.2 Microbial Fermentation and Bioreactors
3.3.3 Transgenics
3.3.4 Mammalian Cell Culture
Chapter 4 Market Dynamics
4.1 Market Drivers
4.1.1 Growing and Aging Population
4.1.2 Increasing Prevalence of Chronic Diseases
4.1.3 Advancements in Manufacturing Technologies
4.1.4 New Product Launches and Label Expansions
4.1.5 Premium Pricing
4.1.6 Collaborations and Licensing Agreements
4.2 Market Challenges
4.2.1 Evolving Regulatory Scenario
4.2.2 Accelerating Biosimilars Market
Chapter 5 Market Breakdown by Drug Type
5.1 Overview
5.2 Monoclonal Antibodies (mAbs)
5.2.1 Types of mAbs
5.3 Peptide Hormones
5.3.1 Types of Peptide Hormones
5.4 Vaccines
5.4.1 Types of Vaccines
5.5 Fusion Proteins
5.5.1 Types of Fusion Proteins
5.6 Blood Factors
5.6.1 Types of Blood Factors
5.7 Peptide Antibiotics
5.7.1 Types of Peptide Antibiotics
5.8 Cytokines
5.8.1 Types of Cytokines
5.9 Therapeutic Enzymes
5.9.1 Types of Therapeutic Enzymes
5.10 Global Market for Bioengineered Protein Drugs, by Type
5.10.1 Monoclonal Antibodies (mAbs)
5.10.2 Peptide Hormones
5.10.3 Vaccines
5.10.4 Blood Factors and Peptide Antibiotics
5.10.5 Fusion Proteins
5.10.6 Cytokines
5.10.7 Therapeutic Enzymes
Chapter 6 Market Breakdown by Disease
6.1 Overview
6.2 Autoimmune Diseases and Other Immunodeficiency Disorders
6.3 Solid Tumors
6.4 Diabetes
6.4.1 Type 1 Diabetes
6.4.2 Type 2 Diabetes
6.4.3 Gestational Diabetes
6.5 Infectious Diseases
6.5.1 Pneumococcal
6.5.2 Diphtheria, Tetanus
6.5.3 Human Papillomavirus (HPV)
6.5.4 MMR
6.5.5 Influenza
6.5.6 Hepatitis A
6.5.7 Others
6.6 Blood Disorders
6.6.1 Bleeding Disorders
6.6.2 Anemia
6.6.3 Blood Cancer
6.6.4 Paroxysmal Nocturnal Hemoglobinuria
6.7 Growth Hormone Disorders, Enzyme Deficiency Disorders, and Infertility
6.8 Others
6.8.1 Osteoporosis
6.8.2 Asthma
6.8.3 Eye Disorders and Diseases
6.8.4 Transplants
6.8.5 Cardiovascular Diseases
6.8.6 Respiratory Syncytial Virus Infection
6.8.7 Skin Diseases
6.9 Global Market for Bioengineered Protein Drugs, by Disease
6.9.1 Autoimmune Diseases and Other Immunodeficiency Disorders
6.9.2 Solid Tumors
6.9.3 Diabetes
6.9.4 Infectious Diseases
6.9.5 Blood Disorders
6.9.6 Growth Hormone Disorders, Enzyme Disorders, and Infertility
6.9.7 Others
Chapter 7 Market Breakdown by Region
7.1 Global Markets for Bioengineered Protein Drugs, by Region
7.1.1 North America Market Revenue, by Drug Type
7.1.2 Europe Market Revenue, by Drug Type
7.1.3 Emerging Markets Revenue, by Drug Type
Chapter 8 Regulatory Aspects and New Approvals
8.1 New Approvals
8.1.1 Monoclonal Antibodies (mAbs)
8.1.2 Peptide Hormones
8.1.3 Vaccines
8.1.4 Blood factors
8.1.5 Peptide Antibiotics
8.1.6 Therapeutic Enzymes
8.1.7 Cytokines
8.1.8 Fusion Protein
Chapter 9 Competitive Landscape
9.1 Overview
9.2 Blockbuster Bioengineered Protein Pharmaceutical Brands
9.3 Monoclonal Antibodies
9.3.1 Market Share
9.3.2 Ten Top-Selling Monoclonal Antibodies
9.4 Peptide Hormones
9.4.1 Market Share
9.5 Vaccines (Excluding COVID-19)
9.5.1 Market Share
9.6 Blood Factors and Peptide Antibiotics
9.6.1 Key Players in Recombinant Blood Factors Market
9.6.2 Key players in Peptide Antibiotics Market
9.7 Fusion Proteins
9.7.1 Market Share
9.8 Cytokines
9.8.1Market Share
9.9 Therapeutic Enzymes
9.9.1 Market Share
Chapter 10 Emerging Trends/Upcoming Technologies in the Market
10.1 Bi- and Multi-Specific Antibodies
10.1.1 Oral GLP-1 Therapy
10.1.2 Accelerating Rare Disease Research Worldwide
10.2 Key Trends in Biopharmaceutical Industry
Chapter 11 Impact of COVID-19 Pandemic
11.1 Overview
11.2 Impact on Bioengineered Protein Drugs Market
11.2.1 Impact on the mAbs Market
11.2.2 Impact on Peptide Hormone Market
11.2.3 Impact on Vaccines Market
11.2.4 Impact on Blood Factors and Peptide Antibiotics Market
11.2.5 Impact on Fusion Protein Market
11.2.6 Impact on Cytokines Market
11.2.7 Impact on Therapeutic Enzyme Market
Chapter 12 Company Profiles
ABBVIE INC.
ADMA BIOLOGICS INC.
AMGEN INC.
ASTRAZENECA PLC
BAYER PHARMACEUTICALS
BIONTECH SE
BRISTOL-MYERS SQUIBB
CSL LTD.
ELI LILLY AND CO.
F. HOFFMANN-LA ROCHE AG
GLAXOSMITHKLINE PLC
GRIFOLS S.A.
JOHNSON & JOHNSON
MERCK & CO., INC.
NOVARTIS AG
NOVO NORDISK A/S
OCTAPHARMA AG
PFIZER INC.
REGENERON PHARMACEUTICALS INC.
SANOFI
TAKEDA PHARMACEUTICAL CO., LTD.

List of Tables
Summary Table : Global Market for Bioengineered Protein Drugs, by Drug Type, Through 2027
Table 1 : Characteristics of Large Molecule/Protein Drugs
Table 2 : Bioengineered Protein Drugs vs. Chemically Synthesized Drugs
Table 3 : Selected Protein Drugs Made, by Fractionation
Table 4 : Selected Therapeutic Drugs Produced by Microbial Fermentation
Table 5 : Selected Protein Drugs Produced, by Transgenic Animals, Plants, and Microorganisms
Table 6 : Selected Protein Drugs Made, by Cell Culture
Table 7 : Number and Distribution of Persons Aged 60+, by Region, 2019 and 2050
Table 8 : Global Pipeline Molecules, by Type, Through 2021
Table 9 : Advantages and Disadvantages of mAbs
Table 10 : Vaccines by Disease Type
Table 11 : Percentage of Major Proteins Present in Different Fractions After Cohn’s Fractionation Method
Table 12 : Global Market for Bioengineered Protein Drugs, by Drug Type, Through 2027
Table 13 : Global Market for mAbs, by Region, Through 2027
Table 14 : Global Market for Peptide Hormones, by Region, Through 2027
Table 15 : Global Market for Vaccines (Excluding COVID-19 Vaccines), by Region, Through 2027
Table 16 : Global Market for Blood Factors and Peptide Antibiotics, by Region, Through 2027
Table 17 : Global Market for Fusion Proteins, by Region, Through 2027
Table 18 : Global Market for Cytokines, by Region, Through 2027
Table 19 : Global Market for Therapeutic Enzymes, by Region, Through 2027
Table 20 : Types of Autoimmune Diseases
Table 21 : Types of Cancer by the Tissue of Origin
Table 22 : Estimated Numbers for All Cancers, Excluding Non-melanoma Skin Cancer, 2020
Table 23 : Global Diabetes Estimates and Projections, 2019-2045
Table 24 : Global Market for Bioengineered Protein Drugs, by Disease, Through 2027
Table 25 : Global Market for Bioengineered Protein Drugs for Autoimmune Diseases and Other Immunodeficiency Disorders, by Region, Through 2027
Table 26 : Global Market for Bioengineered Protein Drugs for Solid Tumors, by Region, Through 2027
Table 27 : Global Market for Bioengineered Protein Drugs for Diabetes, by Region, Through 2027
Table 28 : Global Market for Bioengineered Protein Drugs for Infectious Diseases, by Region, Through 2027
Table 29 : Global Market for Bioengineered Protein Drugs for Blood Disorders, by Region, Through 2027
Table 30 : Global Market Bioengineered Protein Drugs for Growth Hormone Disorders, Enzyme Disorders, and Infertility, by Region, Through 2027
Table 31 : Global Market for Bioengineered Protein Drugs for Other Diseases, by Region, Through 2027
Table 32 : Global Market for Bioengineered Protein Drugs, by Region, Through 2027
Table 33 : North American Market for Bioengineered Protein Drugs, by Drug Type, Through 2027
Table 34 : European Market for Bioengineered Protein Drugs, by Drug Type, Through 2027
Table 35 : Emerging Markets for Bioengineered Protein Drugs, by Drug Type, Through 2027
Table 36 : Newly Approved Monoclonal Antibodies (mAbs), January 2021–December 2022
Table 37 : Newly Approved Peptide Hormones and Drugs, January 2021–December 2022
Table 38 : Newly Approved Vaccines, January 2021–December 2022
Table 39 : Vaccine Candidates in Clinical Phase, January 2021–December 2022
Table 40 : Newly Approved Blood Factors, January 2021–December 2022
Table 41 : Newly Approved Peptide Antibiotics, January 2021–December 2022
Table 42 : Newly Approved Therapeutic Enzymes, January 2021–December 2022
Table 43 : Newly Approved Cytokines, January 2021–December 2022
Table 44 : Newly Approved Fusion Protein, January 2021–December 2022
Table 45 : The 30 Top-Selling Bioengineered Protein Drugs, 2021
Table 46 : Selected Bi-Specific Antibodies in Phase 3 Clinical Trials, 2023
Table 47 : WHO-Approved COVID-19 Vaccine Companies, Technology Adopted
Table 48 : Global Market Shares of Leading Vaccine Manufacturers, Including COVID-19 and Excluding COVID-19 Vaccines, 2021
Table 49 : Eli Lilly and Co.: Business Segments
Table 50 : Pfizer: Biopharma Business Segment

List of Figures
Summary Figure : Global Market for Bioengineered Protein Drugs, by Drug Type, 2019-2027
Figure 1 : Approved Antibody Therapeutics in the U.S. and EU, 2010-2021
Figure 2 : Global Market for Bioengineered Protein Drugs, by Drug Type, 2019-2027
Figure 3 : Global Market Shares of Bioengineered Protein Drugs, by Drug Type, 2021
Figure 4 : Global Market for mAbs, by Region, 2019-2027
Figure 5 : Global Market for Peptide Hormones, by Region, 2019-2027
Figure 6 : Global Market for Vaccines (Excluding COVID-19 Vaccines), by Region, 2019-2027
Figure 7 : Global Market for Blood Factors and Peptide Antibiotics, by Region, 2019-2027
Figure 8 : Global Market for Fusion Proteins, by Region, 2019-2027
Figure 9 : Global Market for Cytokines, by Region, 2019-2027
Figure 10 : Global Market for Therapeutic Enzymes, by Region, 2019-2027
Figure 11 : Estimated Global Incidence of Blood Cancer, by Type, 2020
Figure 12 : Global Market for Bioengineered Protein Drugs, by Disease, 2019-2027
Figure 13 : Global Market Shares of Bioengineered Protein Drugs, by Disease, 2021
Figure 14 : Global Market for Bioengineered Protein Drugs for Autoimmune Diseases and Other Immunodeficiency Disorders, by Region, 2019-2027
Figure 15 : Global Market for Bioengineered Protein Drugs for Solid Tumors, by Region, 2019-2027
Figure 16 : Global Market for Bioengineered Protein Drugs for Diabetes, by Region, 2019-2027
Figure 17 : Global Market for Bioengineered Protein Drugs for Infectious Diseases, by Region, 2019-2027
Figure 18 : Global Market for Bioengineered Protein Drugs for Blood Disorders, by Region, 2019-2027
Figure 19 : Global Market for Bioengineered Protein Drugs for Growth Hormone Disorders, Enzyme Disorders, and Infertility, by Region, 2019-2027
Figure 20 : Global Market for Bioengineered Protein Drugs for Other Diseases, by Region, 2019-2027
Figure 21 : Snapshot of Global Market for Bioengineered Protein Drugs, by Region
Figure 22 : Global Market Shares of Bioengineered Protein Drugs, by Region, 2021
Figure 23 : North American Market for Bioengineered Protein Drugs, by Drug Type, 2019-2027
Figure 24 : North American Market Shares of Bioengineered Protein Drugs, by Drug Type, 2021
Figure 25 : European Market for Bioengineered Protein Drugs, by Drug Type, 2019-2027
Figure 26 : European Market Shares of Bioengineered Protein Drugs, by Drug Type, 2021
Figure 27 : Emerging Markets for Bioengineered Protein Drugs, by Drug Type, 2019-2027
Figure 28 : Emerging Markets Shares of Bioengineered Protein Drugs, by Drug Type, 2021
Figure 29 : NDAs and BLA Approvals in Market for Bioengineered Protein Drugs, by Drug Type, 2021 and 2022
Figure 30 : Share of NDAs and BLA Approvals in Market for Bioengineered Protein Drugs, by Drug Type, 2021 and 2022
Figure 31 : Bioengineered Protein Drug Approvals, by Drug Type, 2021 and 2022
Figure 32 : Distribution Share of Top 50 Best-Selling Drug Brands, by Drug Type, 2021
Figure 33 : Top 50 Best-Selling Drug Brand Revenue Share, by Drug Type, 2021
Figure 34 : Top 50 Best-Selling Drugs Brands, by Drug Type, 2021
Figure 35 : Global Market Shares of Monoclonal Antibodies, by Company, 2021
Figure 36 : Ten Top-Selling Monoclonal Antibodies, 2021
Figure 37 : Global Market Shares of Peptide Hormones, by Company, 2021
Figure 38 : Global Market Shares of Vaccines (Excluding COVID-19), by Company, 2021
Figure 39 : Global Market Shares of Peptide Antibiotics, by Company, 2021
Figure 40 : Global Market Shares of Fusion Proteins, by Company, 2021
Figure 41 : Global Market Shares of Cytokines, by Company, 2021
Figure 42 : Global Market Shares of Therapeutic Enzymes, by Company, 2021
Figure 43 : AbbVie Inc.: Annual Revenue, 2019-2021
Figure 44 : AbbVie Inc.: Revenue Share, by Business Segment, 2021
Figure 45 : AbbVie Inc.: Revenue Share, by Region, 2021
Figure 46 : ADMA Biologics Inc.: Annual Revenue, 2019-2021
Figure 47 : ADMA Biologics Inc.: Revenue Share, by Business Segment, 2021
Figure 48 : ADMA Biologics Inc.: Market Shares, by Region, 2021
Figure 49 : Amgen Inc.: Annual Revenue, 2019-2021
Figure 50 : Amgen Inc.: Revenue Share, by Product, 2021
Figure 51 : Amgen Inc.: Revenue Share, by Region, 2021
Figure 52 : AstraZeneca: Annual Revenue, 2019-2021
Figure 53 : AstraZeneca: Revenue Share, by Segment, 2021
Figure 54 : AstraZeneca: Revenue Share, by Region, 2021
Figure 55 : Bayer Pharmaceuticals: Annual Revenue, 2019-2021
Figure 56 : Bayer AG: Revenue Share, by Region, 2021
Figure 57 : BioNTech: Annual Revenue, 2020-2021
Figure 58 : Bristol-Myers Squibb Co.: Annual Revenue, 2019-2021
Figure 59 : Bristol-Myers Squibb Co.: Revenue Share, by Product, 2021
Figure 60 : Bristol-Myers Squibb Co.: Revenue Share, by Region, 2021
Figure 61 : CSL Ltd.: Annual Revenue, 2019-2021
Figure 62 : CSL Ltd.: Revenue Share, by Country, 2021
Figure 63 : CSL Ltd.: Revenue Share, by Business Segment, 2021
Figure 64 : Eli Lilly and Co.: Annual Revenue, 2019-2021
Figure 65 : Eli Lilly and Co.: Revenue Share, by Segment, 2021
Figure 66 : Eli Lilly and Co.: Revenue Share, by Region, 2021
Figure 67 : Roche: Pharmaceutical Division Annual Revenue, 2019-2021
Figure 68 : Roche: Pharmaceuticals Division Revenue Share, by Therapeutic Area, 2021
Figure 69 : Roche: Pharmaceuticals Division Revenue Share, by Region, 2021
Figure 70 : GlaxoSmithKline plc: Pharmaceuticals and Vaccine Segment Annual Revenue, 2019-2021
Figure 71 : GlaxoSmithKline plc: Pharmaceutical Segment Revenue Share, by Therapeutic Area, 2021
Figure 72 : GlaxoSmithKline plc: Vaccine Segment Revenue Share, by Category, 2021
Figure 73 : GlaxoSmithKline plc: Revenue Share, by Region, 2021
Figure 74 : Grifols S.A.: Annual Revenue, 2019-2021
Figure 75 : Grifols S.A.: Revenue Share, by Segment, 2021
Figure 76 : Grifols S.A.: Revenue Share, by Region, 2021
Figure 77 : Johnson & Johnson: Pharmaceutical Division Annual Revenue, 2019-2021
Figure 78 : Johnson & Johnson: Pharmaceutical Division Revenue Share, by Therapeutic Area, 2021
Figure 79 : Johnson & Johnson: Pharmaceuticals Division Revenue Share, by Region, 2021
Figure 80 : Merck & Co., Inc.: Pharmaceutical Segment Annual Revenue, 2019-2021
Figure 81 : Merck & Co., Inc.: Pharmaceutical Segment Revenue Share, by Product, 2021
Figure 82 : Merck & Co., Inc.: Pharmaceutical Segment Revenue Share, by Region, 2021
Figure 83 : Novartis: Annual Revenue, 2019-2021
Figure 84 : Novartis: Revenue Share, by Business Segment, 2021
Figure 85 : Novartis: Revenue Share, by Region, 2021
Figure 86 : Novo Nordisk: Annual Revenue, 2019-2021
Figure 87 : Novo Nordisk: Revenue Share, by Business Segment, 2021
Figure 88 : Novo Nordisk: Revenue Share, by Region, 2021
Figure 89 : Octapharma: Annual Revenue, 2019-2021
Figure 90 : Pfizer: Annual Revenue, 2019-2021
Figure 91 : Pfizer: Biopharma Business Revenue Share, by Segment, 2021
Figure 92 : Pfizer: Revenue Share, by Region, 2021
Figure 93 : Regeneron Pharmaceuticals Inc.: Annual Revenue, 2019-2021
Figure 94 : Regeneron Pharmaceuticals Inc.: Revenue Share, by Product, 2021
Figure 95 : Sanofi: Annual Revenue, 2019-2021
Figure 96 : Sanofi: Revenue Share, by Business Segment, 2021
Figure 97 : Sanofi: Revenue Share, by Region, 2021
Figure 98 : Takeda Pharmaceutical: Annual Revenue, 2020-2022
Figure 99 : Takeda Pharmaceutical: Revenue Share, by Business Segment, 2022
Figure 100 : Takeda Pharmaceutical: Revenue Share, by Region, 2022