生物学的製剤：各種技術と世界市場

世界の生物学的製剤の市場規模は、2023年の4,529億米ドルから、予測期間中は12.7%のCAGRで推移し、2028年末には8,234億米ドルの規模に成長すると予測されています。

治療用タンパク質の部門は2023年の2,485億米ドルから、同期間中13.6%のCAGRで推移し、2028年末には4,704億米ドルの規模に成長すると予測されています。また、細胞および遺伝子治療の部門は、2023年の604億米ドルから、14.6%のCAGRで推移し、2028年末には1,194億米ドルの規模に成長すると予測されています。

当レポートでは、世界の生物学的製剤の市場を調査し、市場および技術の背景、市場影響因子および市場機会の分析、市場規模の推移・予測、各種区分・地域別の詳細分析、技術動向、ESGの展望、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 イントロダクション

第2章 サマリー・ハイライト

• 市場概要

第3章 市場および技術の背景

• バイオ医薬品産業の構造
• バイオテクノロジーの起源
• 大手製薬会社の関与
• 生物学的製剤の概要
• 生物学的製剤の製造
• バイオ医薬品の製造プロセス
• 製剤プロセス
• 治療用タンパク質製造のための発現システム
• 微生物製造における大腸菌の利点
• 哺乳類細胞の治療用タンパク質の製造
• 生物学的製剤のFDA規制

第4章 市場力学

• 市場促進要因
• 概要
• 慢性疾患の有病率の上昇
• 生物学的製剤の進歩
• 細胞および遺伝子治療手法の開発
• 感染症および慢性疾患の増加
• 市場抑制要因
• バイオシミラーの出現
• 生物学的製剤の高価なコスト
• 市場機会
• 新興国における機会

第5章 市場内訳：製品別

• 世界の生物学的製剤市場：製品別
• 治療用タンパク質
• ワクチン
• 細胞および遺伝子治療
• その他

第6章 市場内訳：用途別

• 世界の生物学的製剤市場：用途別
• 癌
• 自己免疫疾患
• 美容
• 眼疾患
• その他

第7章 市場内訳：ソース別

• 世界の生物学的製剤市場：ソース別
• 人間
• 動物
• 微生物
• 発酵細胞
• その他

第8章 市場内訳：地域別

• 世界の生物学的製剤市場：地域別
• 北米
• 欧州
• アジア太平洋
• その他の地域
• GCC諸国
• ブラジル
• その他の国

第9章 生物学的製剤製造のための最新技術

• AcceTTおよびBacSec技術
• シングルユース技術
• 細胞および遺伝子治療 (CGT)
• ドギーボーンDNA (dbDNA)
• 動物血漿分離
• ハイブリドーマ生成
• B細胞スクリーニング
• ディスプレイ技術
• 新興生物学的製剤の発見・生成技術
• 生物学的製剤製造技術の新たな動向
• 新規開発事例：企業別
• Samsung Biologics
• AstraZeneca
• Genentech Inc.

第10章 バイオ医薬品および生物学的製剤産業の持続可能性：ESGの観点

• バイオ医薬品製造業界におけるESGの重要性
• ESG評価と指標：データの理解
• バイオ医薬品および生物学的製剤製造業界におけるESGの実践
• BCCによる見解

第11章 M&Aおよびベンチャー資金調達の見通し

• M&A分析
• M&A取引
• 生物学的製剤の主要スタートアップ企業
• 好調のバイオテクノロジースタートアップ

第12章 FDA承認済みモノクローナル抗体

第13章 競合情勢

• ポーターのファイブフォース分析

第14章 企業プロファイル

• ABBVIE INC.
• AMGEN INC.
• BAXTER INTERNATIONAL INC.
• BOEHRINGER INGELHEIM INTERNATIONAL GMBH
• CSL LTD.
• DENDREON PHARMACEUTICALS LLC.
• ELI LILLY AND CO.
• F. HOFFMANN-LA ROCHE LTD.
• GLAXOSMITHKLINE PLC
• GLYCOTOPE GMBH
• GRIFOLS S.A.
• JSC PHARMSTANDARD
• KEDRION S.P.A.
• LONZA
• MERCK & CO. INC.
• NOVARTIS AG
• OCTAPHARMA AG
• RELIANCE LIFE SCIENCES
• SANOFI
• TEVA PHARMACEUTICAL INDUSTRIES LTD.

List of Tables

• Summary Table : Global Market for Biological Therapeutic Drugs, by Product Segment, Through 2028
• Table 1 : Biologic Orphan Drugs, by Trade Name and Indication
• Table 2 : Global Cancer Incidence: Both Sexes
• Table 3 : Approved Cellular and Gene Therapy Products
• Table 4 : Global Market for Biological Therapeutic Drugs, by Product Segment, Through 2028
• Table 5 : Global Market for Biological Therapeutic Proteins, by Region, Through 2028
• Table 6 : Global Market for Biological Therapeutic Vaccines, by Region, Through 2028
• Table 7 : Global Market for Cell and Gene Therapy, by Region, Through 2028
• Table 8 : Global Market for Other Biological Therapeutic Drug Products, by Region, Through 2028
• Table 9 : Global Market for Biological Therapeutic Drugs, by Application, Through 2028
• Table 10 : Global Market for Biological Therapeutics in Cancer Applications, by Region, Through 2028
• Table 11 : Global Market for Biological Therapeutics in Autoimmune Condition Applications, by Region, Through 2028
• Table 12 : Global Market for Biological Therapeutics in Aesthetic Applications, by Region, Through 2028
• Table 13 : Global Market for Biological Therapeutics in Eye Disorder Applications, by Region Through 2028
• Table 14 : Global Market for Biological Therapeutics in Other Applications, by Region, Through 2028
• Table 15 : Global Market for Biological Therapeutic Drugs, by Source, Through 2028
• Table 16 : Global Market for Human Sources of Biological Therapeutics, by Region, Through 2028
• Table 17 : Global Market for Animal Sources of Biological Therapeutics, by Region, Through 2028
• Table 18 : Global Market for Microorganism Sources of Biological Therapeutics, by Region, Through 2028
• Table 19 : Global Market for Fermented Cell Sources of Biological Therapeutics, by Region, Through 2028
• Table 20 : Global Market for Other Sources of Biological Therapeutics, by Region, Through 2028
• Table 21 : Global Market for Biological Therapeutic Drugs, by Region, Through 2028
• Table 22 : North American Market for Biological Therapeutic Drugs, by Product Segment, Through 2028
• Table 23 : North American Market for Biological Therapeutic Drugs, by Application Segment, Through 2028
• Table 24 : North American Market for Biological Therapeutic Drugs, by Source Segment, Through 2028
• Table 25 : North American Market for Biological Therapeutic Drugs, by Country, Through 2028
• Table 26 : European Market for Biological Therapeutic Drugs, by Product Segment, Through 2028
• Table 27 : European Market for Biological Therapeutic Drugs, by Application Segment, Through 2028
• Table 28 : European Market for Biological Therapeutic Drugs, by Source Segment, Through 2028
• Table 29 : European Market for Biological Therapeutic Drugs, by Country, Through 2028
• Table 30 : Asia-Pacific Market for Biological Therapeutic Drugs, by Product Segment, Through 2028
• Table 31 : Asia-Pacific Market for Biological Therapeutic Drugs, by Application Segment, Through 2028
• Table 32 : Asia-Pacific Market for Biological Therapeutic Drugs, by Source Segment, Through 2028
• Table 33 : Asia-Pacific Market for Biological Therapeutic Drugs, by Country, Through 2028
• Table 34 : Japanese Market Statistics
• Table 35 : Rest of World Market for Biological Therapeutic Drugs, by Product Segment, Through 2028
• Table 36 : Rest of World Market for Biological Therapeutic Drugs, by Application Segment, Through 2028
• Table 37 : Rest of World Market for Biological Therapeutic Drugs, by Source Segment, Through 2028
• Table 38 : Rest of World Market for Biological Therapeutic Drugs, by Country, Through 2028
• Table 39 : Brazilian Approved Biologics/Biosimilars, 2023
• Table 40 : Emerging Trends in Biologics
• Table 41 : ESG Understanding Data
• Table 42 : ESG: Environmental Performance
• Table 43 : ESG: Social Performance
• Table 44 : ESG: Governance Performance
• Table 45 : Recently Received Awards by Major Companies
• Table 46 : ESG Rankings for Major Research Antibody Companies, 2023*
• Table 47 : U.S. FDA-approved Monoclonal Antibodies in the Market, 2023
• Table 48 : Porter's Five Forces Analysis
• Table 49 : AbbVie Inc.: Company Snapshot
• Table 50 : AbbVie Inc.: Product Portfolio
• Table 51 : Amgen Inc: Company Snapshot
• Table 52 : Amgen Inc.: Product Portfolio
• Table 53 : Baxter International Inc.: Company Snapshot
• Table 54 : Baxter International Inc.: Product Portfolio
• Table 55 : Baxter International Inc.: Recent Developments, 2021
• Table 56 : Boehringer Ingelheim International GmbH: Company Snapshot
• Table 57 : Boehringer Ingelheim International GmbH: Annual Revenue, 2022
• Table 58 : Boehringer Ingelheim International GmbH: Products
• Table 59 : CSL Ltd: Company Snapshot
• Table 60 : CSL Ltd.: Products Portfolio
• Table 61 : CSL Ltd.: Recent Developments, 2023
• Table 62 : Dendreon Pharmaceuticals LLC.: Company Snapshot
• Table 63 : Dendreon Pharmaceuticals LLC: Product Portfolio
• Table 64 : Eli Lilly and Co.: Company Snapshot
• Table 65 : Eli Lilly and Co.: Product Portfolio
• Table 66 : F. Hoffmann-La Roche Ltd.: Company Snapshot
• Table 67 : F. Hoffmann-La Roche Ltd.: Financials, 2021-2022
• Table 68 : F. Hoffmann-La Roche Ltd.: Product Portfolio
• Table 69 : GlaxoSmithKline Plc: Company Snapshot
• Table 70 : GlaxoSmithKline Plc: Products and Services
• Table 71 : Glycotope GmbH: Company Snapshot
• Table 72 : Glycotope GmbH: Product Portfolio
• Table 73 : Grifols S.A.: Company Snapshot
• Table 74 : Grifols S.A.: Product Portfolio
• Table 75 : Grifols S.A.: Recent Developments, 2020
• Table 76 : JSC Pharmstandard: Company Snapshot
• Table 77 : JSC Pharmstandard: Product Portfolio
• Table 78 : Kedrion S.p.A.: Company Snapshot
• Table 79 : Kedrion S.p.A.: Products and Services
• Table 80 : Kedrion S.p.A.: Recent Developments, 2020
• Table 81 : Lonza: Company Snapshot
• Table 82 : Lonza: Product Portfolio
• Table 83 : Merck & Co. Inc.: Company Snapshot
• Table 84 : Merck & Co. Inc.: Annual Revenue, 2022
• Table 85 : Merck & Co. Inc.: Products
• Table 86 : Novartis AG: Company Snapshot
• Table 87 : Novartis AG: Product Portfolio
• Table 88 : Octapharma AG: Company Snapshot
• Table 89 : Octapharma AG: Products and Services
• Table 90 : Octapharma AG: Recent Developments, 2020
• Table 91 : Reliance Life Sciences: Company Snapshot
• Table 92 : Reliance Life Sciences: Product Portfolio
• Table 93 : Sanofi: Company Snapshot
• Table 94 : Sanofi: Products and Services
• Table 95 : Teva Pharmaceutical Industries Ltd.: Company Snapshot
• Table 96 : Teva Pharmaceutical Industries Ltd.: Product Portfolio

List of Figures

• Summary Figure : Global Market Shares of Biological Therapeutic Drugs, by Product Segment, 2022
• Figure 1 : Approved Biologics, in 2022
• Figure 2 : Biological Therapeutic Drugs Market Dynamics
• Figure 3 : FDA-approved Cell and Gene Therapies
• Figure 4 : Global Projected Diabetes, Patients Aged 20-79, 2010 and 2030
• Figure 5 : Global Infectious Diseases Outbreak, between 2020 and 2022
• Figure 6 : Global Infectious Diseases Outbreak, 2022
• Figure 7 : Global Market Shares of Biological Therapeutic Drugs, by Product Segment, 2022
• Figure 8 : Global Market for Biological Therapeutic Proteins, 2020-2028
• Figure 9 : Global Market for Biological Therapeutic Proteins, by Region, 2020-2028
• Figure 10 : Global Market for Biological Therapeutic Vaccines, 2020-2028
• Figure 11 : Global Market for Biological Therapeutic Vaccines, by Region, 2020-2028
• Figure 12 : Global Market for Cell and Gene Therapy, 2020-2028
• Figure 13 : Global Market for Cell and Gene Therapy, by Region, 2020-2028
• Figure 14 : Investments in Cell and Gene Therapy Companies
• Figure 15 : Global Market for Other Biological Therapeutic Drug Products, 2020-2028
• Figure 16 : Global Market for Other Biological Therapeutic Drug Products, by Region, 2020-2028
• Figure 17 : Global Market Shares of Biological Therapeutic Drugs, by Application, 2022
• Figure 18 : Global Market for Biological Therapeutics in Cancer Applications, 2020-2028
• Figure 19 : Global Market for Biological Therapeutics in Cancer Applications, by Region, 2020-2028
• Figure 20 : Global Market for Biological Therapeutics in Autoimmune Condition Applications, 2020-2028
• Figure 21 : Global Market for Biological Therapeutics in Autoimmune Condition Applications, by Region, 2020-2028
• Figure 22 : Global Market for Biological Therapeutics in Aesthetic Applications, 2020-2028
• Figure 23 : Global Market for Biological Therapeutics in Aesthetic Applications, by Region, 2020-2028
• Figure 24 : Global Market for Biological Therapeutics in Eye Disorder Applications, 2020-2028
• Figure 25 : Global Market for Biological Therapeutics in Eye Disorder Applications, by Region, 2020-2028
• Figure 26 : Global Market for Biological Therapeutics in Other Applications, 2020-2028
• Figure 27 : Global Market for Biological Therapeutics in Other Applications, by Region, 2020-2028
• Figure 28 : Global Market Shares of Biological Therapeutic Drugs, by Source, 2022
• Figure 29 : Global Market for Human Sources of Biological Therapeutics, 2020-2028
• Figure 30 : Global Market for Human Sources of Biological Therapeutics, by Region, 2020-2028
• Figure 31 : Global Market for Animal Sources of Biological Therapeutics, 2020-2028
• Figure 32 : Global Market for Animal Sources of Biological Therapeutics, by Region, 2020-2028
• Figure 33 : Global Market for Microorganism Sources of Biological Therapeutics, 2020-2028
• Figure 34 : Global Market for Microorganism Sources of Biological Therapeutics, by Region, 2020-2028
• Figure 35 : Global Market for Fermented Cell Sources of Biological Therapeutics, 2020-2028
• Figure 36 : Global Market for Fermented Cell Sources of Biological Therapeutics, by Region, 2020-2028
• Figure 37 : Global Market for Other Sources of Biological Therapeutics, 2020-2028
• Figure 38 : Global Market for Other Sources of Biological Therapeutics, by Region, 2020-2028
• Figure 39 : Global Market for Biological Therapeutic Drugs, by Region, 2020-2028
• Figure 40 : Global Market Shares of Biological Therapeutic Drugs, by Region, 2022
• Figure 41 : North American Market Shares of Biological Therapeutic Drugs, by Product Segment, 2022
• Figure 42 : North American Market Shares of Biological Therapeutic Drugs, by Application Segment, 2022
• Figure 43 : North American Market Shares of Biological Therapeutic Drugs, by Source Segment, 2022
• Figure 44 : North American Market Shares of Biological Therapeutic Drugs, by Country, 2022
• Figure 45 : U.S. Market for Biological Therapeutic Drugs, 2020-2028
• Figure 46 : Canadian Market for Biological Therapeutic Drugs, 2020-2028
• Figure 47 : Mexican Market for Biological Therapeutic Drugs, 2020-2028
• Figure 48 : European Market Shares of Biological Therapeutic Drugs, by Product Segment, 2022
• Figure 49 : European Market Shares of Biological Therapeutic Drugs, by Application Segment, 2022
• Figure 50 : European Market Shares of Biological Therapeutic Drugs, by Source Segment, 2022
• Figure 51 : European Market Shares of Biological Therapeutic Drugs, by Country, 2022
• Figure 52 : German Market for Biological Therapeutic Drugs, 2020-2028
• Figure 53 : U.K. Market for Biological Therapeutic Drugs, 2020-2028
• Figure 54 : French Market for Biological Therapeutic Drugs, 2020-2028
• Figure 55 : Italian Market for Biological Therapeutic Drugs, 2020-2028
• Figure 56 : Spanish Market for Biological Therapeutic Drugs, 2020-2028
• Figure 57 : Dupixent Unit Sales by Specialty in Danish Healthcare Region, 2020 and 2021
• Figure 58 : Rest of European Market for Biological Therapeutic Drugs, 2020-2028
• Figure 59 : Asia-Pacific Market Shares of Biological Therapeutic Drugs, by Product Segment, 2022
• Figure 60 : Asia-Pacific Market Shares of Biological Therapeutic Drugs, by Application Segment, 2022
• Figure 61 : Asia-Pacific Market Shares of Biological Therapeutic Drugs, by Source Segment, 2022
• Figure 62 : Asia-Pacific Market Shares of Biological Therapeutic Drugs, by Country, 2022
• Figure 63 : Chinese Market for Biological Therapeutic Drugs, 2020-2028
• Figure 64 : Japanese Market for Biological Therapeutic Drugs, 2020-2028
• Figure 65 : Indian Market for Biological Therapeutic Drugs, 2020-2028
• Figure 66 : Australia and New Zealand Market for Biological Therapeutic Drugs, 2020-2028
• Figure 67 : Rest of Asia-Pacific Market for Biological Therapeutic Drugs, 2020-2028
• Figure 68 : Rest of World Market for Biological Therapeutic Drugs, 2020-2028
• Figure 69 : Rest of World Market Shares of Biological Therapeutic Drugs, by Product Segment, 2022
• Figure 70 : Rest of World Market Shares of Biological Therapeutic Drugs, by Application Segment, 2022
• Figure 71 : Rest of World Market Shares of Biological Therapeutic Drugs, by Source Segment, 2022
• Figure 72 : Rest of World Market Shares of Biological Therapeutic Drugs, by Country, 2022
• Figure 73 : GCC Countries Market for Biological Therapeutic Drugs, 2020-2028
• Figure 74 : Brazilian Market for Biological Therapeutic Drugs, 2020-2028
• Figure 75 : Rest of Row Countries Market for Biological Therapeutic Drugs, 2020-2028
• Figure 76 : New Forms of DNA
• Figure 77 : Snapshot - Key Trends in the Growth of Biologics Production Technologies
• Figure 78 : Snapshot - Key ESG Trends in Biopharmaceutical and Biologics Industry
• Figure 79 : Global Manufacturer Market Shares of Biological Therapeutics, 2022
• Figure 80 : AbbVie Inc.: Annual Revenue, 2020-2022
• Figure 81 : AbbVie Inc.: Revenue Share, by Products, 2022
• Figure 82 : AbbVie Inc.: Revenue Share, by Country, 2022
• Figure 83 : Amgen Inc.: Annual Revenue, 2019-2022
• Figure 84 : Amgen Inc.: Revenue Share, by Products, 2022
• Figure 85 : Amgen Inc.: Revenue Share, by Country, 2022
• Figure 86 : Baxter International Inc.: Annual Revenue, 2019-2022
• Figure 87 : Baxter International Inc.: Revenue Share, by Business Unit, 2022
• Figure 88 : Baxter International Inc.: Revenue Share, by Region, 2022
• Figure 89 : Boehringer Ingelheim International GmbH: Annual Revenue, 2021 and 2022
• Figure 90 : Boehringer Ingelheim International GmbH: Revenue Shares, by Business Unit, 2022
• Figure 91 : Boehringer Ingelheim International GmbH: Revenue Shares, by Country/Region, 2022
• Figure 92 : CSL Ltd.: Financials, 2020-2022
• Figure 93 : CSL Ltd.: Revenue Share, by Segment, 2022
• Figure 94 : CSL Ltd.: Revenue Share, by Country/Region, 2022
• Figure 95 : Eli Lilly and Co.: Annual Revenue, 2020-2022
• Figure 96 : Eli Lilly and Co.: Revenue Share, by Products, 2022
• Figure 97 : Eli Lilly and Co.: Revenue Share, by Region, 2022
• Figure 98 : F. Hoffmann-La Roche Ltd.: Financials, 2021 and 2022
• Figure 99 : F. Hoffmann-La Roche Ltd.: Revenue Shares, by Business Unit, 2022
• Figure 100 : F. Hoffmann-La Roche Ltd.: Diagnostic Revenue Shares, by Country/Region, 2022
• Figure 101 : GlaxoSmithKline Plc: Annual Revenue, 2020-2022
• Figure 102 : GlaxoSmithKline Plc: Revenue Share, by Business Segment, 2022
• Figure 103 : GlaxoSmithKline Plc: Revenue Share, by Region, 2022
• Figure 104 : Grifols S.A.: Financials, 2020-2022
• Figure 105 : Grifols S.A.: Revenues Share, by Segment, 2022
• Figure 106 : Grifols S.A.: Revenue Share, by Region, 2022
• Figure 107 : Kedrion S.p.A.: Financials, 2020-2022
• Figure 108 : Lonza: Annual Revenue, 2020-2022
• Figure 109 : Lonza: Revenue Shares, by Region, 2022
• Figure 110 : Lonza: Revenue Shares, by Business Segment, 2022
• Figure 111 : Merck & Co. Inc.: Revenue Shares, by Business Unit, 2022
• Figure 112 : Merck & Co. Inc.: Annual Revenue, 2021 and 2022
• Figure 113 : Merck & Co. Inc.: Revenue Shares, by Country/Region, 2022
• Figure 114 : Novartis AG.: Annual Revenue, 2020-2022
• Figure 115 : Novartis AG: Revenue Share, by Region, 2022
• Figure 116 : Novartis AG: Revenue Share, by Business Segment, 2022
• Figure 117 : Octapharma AG: Financials, 2020-2022
• Figure 118 : Sanofi: Annual Revenue, 2020-2022
• Figure 119 : Sanofi: Revenue Share, by Business Segment, 2022
• Figure 120 : Sanofi: Revenue Share, by Region, 2019
• Figure 121 : Teva Pharmaceutical Industries Ltd.: Annual Revenue, 2020-2022
• Figure 122 : Teva Pharmaceutical Industries Ltd.: Revenue Share, by Business Segment, 2022
• Figure 123 : Teva Pharmaceutical Industries Ltd.: Revenue Share, by Region, 2022

Highlights:

The global market for biological therapeutic drugs is expected to increase from $452.9 billion in 2023 to $823.4 billion by the end of 2028, with a compound annual growth rate (CAGR) of 12.7% during the forecast period of 2023-2028.

Therapeutics and proteins market for biological therapeutic drugs is expected to increase from $248.5 billion in 2023 to $470.4 billion by the end of 2028, with a CAGR of 13.6% during the forecast period of 2023-2028.

Cell and gene therapy market for biological therapeutic drugs is expected to increase from $60.4 billion in 2023 to $119.4 billion by the end of 2028, with a CAGR of 14.6% during the forecast period of 2023-2028.

Report Scope:

The current report offers a detailed picture of the biologics market.

This report highlights the current and future market potential for biologics and provides a detailed analysis of the competitive environment, regulatory scenario, drivers, restraints, opportunities and trends in the market. The report also covers market projections through 2028, as well as key market players.

This report details market shares for biologics based on product, source, application and geography. Based on product, the market is segmented into therapeutic proteins, cell and gene therapy, vaccines, and other segments. Based on application, the market is segmented into cancer, autoimmune conditions, aesthetics, eye disorders, and others. Based on source, the market is segmented into human, animal, micro-organism, fermented cell and others

Based on geography, the market has been segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Detailed analyses of major countries (the U.S., Canada, Germany, the U.K., France, Spain, Italy, Japan, China and India) are covered in regional segments. For market estimates, data has been provided for 2022 as the base year, with forecasts for 2023 through 2028. Estimated values are based on product manufacturers' total revenues. Projected and forecasted revenue values are in constant U.S. dollars that have not been adjusted for inflation.

Report Includes:

• 38 data tables and 59 additional tables
• An overview of the global markets for biologic therapeutic drugs.
• Analyses of the global market trends, with historical market revenue data (sales figures) from 2021 to 2022, estimates for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028.
• Estimate of the actual market size and revenue forecast, and a corresponding market share analysis by product type, therapeutic area and region.
• A discussion of the market's opportunities and challenges, as well as emerging technologies and regulations.
• Overview of the sustainability trends, with emphasis on consumer attitudes, companies' ESG scores, the future of ESG, case studies and the ESG practices of companies.
• A discussion of the technological means that the leading biopharmaceutical companies are using.
• Evaluation of the ongoing clinical trials and R&D activity for biologics production.
• A look at the key drugs on the market and recent approvals, sales statistics and past performance of the top selling biologics, as well as their patent expiries.
• Review of emerging technologies and patents.
• An overview of the competitive landscape, including a look at the major vendors' market shares, recent M&A activity, and venture funding outlook.
• Company profiles of major players within the industry, including Amgen Inc., Abbive Inc., Eli Lilly And Co., Novartis Ag, and Glaxosmithkline Plc

Table of Contents

Chapter 1 Introduction

• Introduction
• Study Goals and Objectives
• Reasons for Doing This Study
• Scope of Report
• What's New in this Update?
• Methodology
• Information Sources
• Geographic Breakdown
• Segmentation Breakdown

Chapter 2 Summary and Highlights

• Market Overview

Chapter 3 Market and Technology Background

• Biopharmaceutical Industry Structure
• Origins of Biotechnology
• Involvement of Large Pharmaceutical Companies
• Overview of Biologics
• Biologics Manufacturing
• Biopharmaceutical Manufacturing Process
• The Preparation Process
• Expression Systems for Therapeutic Protein Production
• Advantages of E. coli for Microbial Production
• Mammalian Cell Therapeutic Protein Production
• FDA Regulation of Biologics

Chapter 4 Market Dynamics

• Market Drivers
• Overview
• Rising Prevalence of Chronic Diseases
• Advancement in Biologics
• Development in Cell and Gene Therapy Methodology
• Increase in Infectious and Chronic Diseases
• Market Restraints
• Emergence of Biosimilars
• Expensive Cost of Biologics
• Market Opportunities
• Opportunities in Emerging Nations

Chapter 5 Market Breakdown by Product Segment

• Global Market for Biological Therapeutic Drugs by Product
• Therapeutic Proteins
• Vaccines
• Cell and Gene Therapy
• Others

Chapter 6 Market Breakdown by Application

• Global Market for Biological Therapeutic Drugs by Application
• Cancer
• Autoimmune Conditions
• Aesthetics
• Eye Disorder
• Others

Chapter 7 Market Breakdown by Source

• Global Market for Biological Therapeutic Drugs by Source
• Human
• Animal
• Microorganisms
• Fermented Cells
• Other Sources

Chapter 8 Market Breakdown by Region

• Global Market for Biological Therapeutic Drugs by Region
• North America
• Europe
• Asia-Pacific
• Rest of World
• GCC Countries
• Brazil
• Rest of World Countries

Chapter 9 Emerging Technology for Biologics Manufacturing

• Introduction
• AcceTT & BacSec Technologies
• Single-use Technologies
• Cell and Gene Therapy (CGT)
• Doggybone DNA (dbDNA)
• Animal Plasma Isolation
• Hybridoma Generation
• B Cell Screening
• Display Technologies
• Emerging Biologics Discovery and Generation Technologies
• Emerging Trends in Biologic Production Technologies
• Example of New Developments by Companies
• Samsung Biologics
• AstraZeneca
• Genentech Inc. (Member of Roche family)

Chapter 10 Sustainability in the Biopharmaceuticals and Biologics Industry: An ESG Perspective

• Importance of ESG in the Biopharmaceuticals Manufacturing Industry
• ESG Ratings and Metrics: Understanding the Data
• ESG Practices in the Biopharmaceuticals and Biologics Manufacturing Industry
• BCC Research Viewpoint

Chapter 11 M&A and Venture Funding Outlook

• M&A Analysis
• M&A Deals 2018-2023
• Top Biologic Drug Startups
• Flourishing Biotech Startups (2023)

Chapter 12 FDA Approved Monoclonal Antibodies, 1986-2023

Chapter 13 Competitive Landscape

• Porter's Five Forces Analysis
• Bargaining Power of Suppliers
• Bargaining Power of Buyers
• Threat of New Entrants
• Threat of Substitutes
• Competitive Rivalry/Degree of Competition

Chapter 14 Company Profiles

• ABBVIE INC.
• AMGEN INC.
• BAXTER INTERNATIONAL INC.
• BOEHRINGER INGELHEIM INTERNATIONAL GMBH
• CSL LTD.
• DENDREON PHARMACEUTICALS LLC.
• ELI LILLY AND CO.
• F. HOFFMANN-LA ROCHE LTD.
• GLAXOSMITHKLINE PLC
• GLYCOTOPE GMBH
• GRIFOLS S.A.
• JSC PHARMSTANDARD
• KEDRION S.P.A.
• LONZA
• MERCK & CO. INC.
• NOVARTIS AG
• OCTAPHARMA AG
• RELIANCE LIFE SCIENCES
• SANOFI
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