生物学的製剤の技術と世界市場

Biologic Therapeutic Drugs: Technologies and Global Markets

生物学的製剤の技術と世界市場

商品番号 : SMB-50198

出版社BCC Research
出版年月2025年5月
ページ数170
価格タイプシングルユーザライセンス
価格USD 4,650
種別英文調査報告書

本レポートは、世界の生物学的治療薬市場の概要を示し、市場動向を分析しています。2023年の基準年データおよび2024年の推定データの世界売上(百万米ドル)が含まれています。予測期間は2024年から2029年です。

市場は、製品タイプ、用途、ソース、地域に基づいてセグメント化されています。製品別では、モノクローナル抗体、ワクチン、ペプチドホルモン、細胞および遺伝子治療、その他に細分化されています。

ソース別では、哺乳類、微生物、その他に細分化されています。用途別では、腫瘍学、自己免疫疾患、感染症、その他に細分化されています。

本調査でカバーされている地域は、北米、ヨーロッパ、アジア太平洋、中東、アフリカ、南米で、これらの地域の主要国に焦点を当てています。北米地域には、米国、カナダ、メキシコが含まれます。ヨーロッパには、ドイツ、英国、イタリア、フランス、スペイン、その他のヨーロッパが含まれます。アジア太平洋地域には、中国、日本、インド、韓国、およびその他のアジア太平洋地域が含まれます。

Report Highlights

The global market for biologic therapeutic drugs is estimated to increase from $499.2 billion in 2024 to reach $794.5 billion by 2029, at a compound annual growth rate (CAGR) of 9.7% from 2024 through 2029.

生物学的治療薬の世界市場は、2024年から2029年にかけて年平均成長率(CAGR)9.7%で拡大し、2024年の4,992億ドルから2029年には7,945億ドルに達すると予測されています。

Summary:

The pharmaceutical industry is undergoing tremendous transformations by focusing more on targeted and personalized therapies. The industry is witnessing a shift from traditional synthetic drugs to biologic therapeutic drugs, which are more efficacious, have better patient outcomes and improve quality of life. Biologic drugs are primarily classified into monoclonal antibodies; vaccines; peptide hormones; cell and gene therapies; and others, which include protein therapeutics (e.g., cytokines, enzymes, blood factors, fusion proteins) and other drugs (e.g., RNA-based therapies).

製薬業界は、標的治療と個別化治療への注力により、大きな変革期を迎えています。従来の合成医薬品から、より有効性が高く、患者の転帰を改善し、生活の質を向上させる生物学的製剤への移行が進んでいます。生物学的製剤は主に、モノクローナル抗体、ワクチン、ペプチドホルモン、細胞・遺伝子治療薬、そしてタンパク質治療薬(サイトカイン、酵素、血液因子、融合タンパク質など)やその他の薬剤(RNAベースの治療薬など)に分類されます。

The biopharmaceutical industry has recently been witnessing tremendous growth due to the increasing demand for innovative therapies, such as monoclonal antibodies, cell and gene therapies and vaccines. The demand for these therapies is primarily driven by such factors as the increasing prevalence of chronic diseases, rising healthcare expenditures, increasing awareness, novel product launches and strong pipelines. The biologic approvals by the U.S. Food and Drug Administration (FDA) are increasing year on year, and 2023 was marked by the approval of two breakthrough therapies: the gene editing therapy Casgevy from Vertex Pharmaceutical and Leqembi (lecanemab) from Eisai Inc.

The global biologic therapeutic drug market was valued at $456.9 billion in 2023, and it is expected to grow at a compound annual growth rate (CAGR) of 9.7% during the forecast period from 2024 to 2029. The entry of biosimilars into the market is expected to erode the revenues of the current branded products upon patent expiry. The complex manufacturing process, a lack of skilled workforce and high development costs translate to a high cost of therapy, which acts as a major barrier to the market.

Report Scope

This report provides an overview of the global biologic therapeutic drug market and analyzes market trends. It includes global revenue ($U.S. millions) for base year data for 2023 and estimated data for 2024. The forecast period is 2024 through 2029. The market is segmented based on product type, application, source and region. By product, the market is segmented into monoclonal antibodies, vaccines, peptide hormones, cell and gene therapies and others. By source, it is segmented into mammalian, microbial and others. By application, the market is segmented into oncology, autoimmune diseases, infectious diseases and others. The regions covered in this study are North America, Europe, Asia-Pacific, Middle East and Africa, and South America, focusing on the major countries in these regions. The North American region includes the U.S., Canada and Mexico. Europe includes Germany, the U.K., Italy, France, Spain and the Rest of Europe; Asia-Pacific includes China, Japan, India, South Korea and the Rest of Asia-Pacific.

The report focuses on the significant driving trends and challenges that affect the market and vendor landscape. It analyzes corporate environmental, social and governance (ESG) developments and discusses emerging technologies related to the market.

The report concludes with an analysis of the competitive landscape, which provides the ranking and share of key players in the global biologic therapeutic drug market. It also has a section dedicated to company profiles that covers such details as overview, key financials, product portfolio and recent developments of key market players.

Report Synopsis

Report MetricsDetails
Base year considered2023
Forecast period considered2024-2029
Base year market size$456.9 billion
Market size forecast$794.5 billion
Growth rateCAGR of 9.7% for the forecast period of 2024-2029
Units considered$ Millions
Segments coveredType, Source, Application, Region
Regions coveredNorth America, Europe, Asia-Pacific, Rest of the World
Countries coveredU.S., Canada, Mexico, U.K., Germany, France, Spain, Italy, China, India, Japan, Australia, South America, Middle East and Africa
Key Market Drivers
  • Growing Demand for Biologics
  • Rising Investments in Biopharmaceuticals
  • Product Development Collaborations and Agreements
  • Transition Toward Personalized Medicines
  • Rising Aging Population and the Growing Prevalence of Chronic Diseases
Companies studied
ABBVIE INC.AMGEN INC.
ASTRAZENECABRISTOL-MYERS SQUIBB CO.
ELI LILLY AND CO.F. HOFFMANN-LA ROCHE LTD.
GILEAD SCIENCES INC.GSK PLC.
JOHNSON & JOHNSON SERVICES INC.MERCK & CO. INC.
NOVARTIS AGNOVO NORDISK A/S
PFIZER INC.REGENERON PHARMACEUTICALS INC.
SANOFI

Report Includes

– 49 data tables and 58 additional tables

– An overview of the current and future global markets for biologic therapeutic drugs and technologies

– An analysis of the global market trends, with market revenue data from 2021 to 2023, estimates for 2024, and projected CAGRs through 2029

– Estimates of the size and revenue prospects of the global market, along with a market share analysis by product type, application, source and region

– Facts and figures pertaining to market dynamics, technological advances, regulations, and the impact of macroeconomic factors

– 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

– An analysis of patents, emerging trends and other developments in the industry

– Analysis of the industry structure, including companies’ market shares and rankings, strategic alliances, M&A activity and a venture funding outlook

– Overview of sustainability trends and ESG developments, with emphasis on consumer attitudes, and the ESG scores and practices of leading companies

– Company profiles of major players within the industry, including Merck & Co. Inc., F. Hoffmann-La Roche Ltd., Johnson & Johnson Services Inc., Pfizer Inc., and Bristol-Myers Squibb Co.

Table of Contents

Chapter 1 Executive Summary

Market Outlook

Scope of Report

Market Summary

Overview

Current Market Scenario

Segmental Analysis

Technological Advances

Conclusion

Chapter 2 Market Overview

Overview

Biologic and Synthetic Drug Comparison

Biologic Manufacturing

Biopharmaceutical Manufacturing Process

Macroeconomic Factors Analysis

Porter’s Five Forces Analysis

Supply Chain Analysis

Cell and Gene Therapy Supply Chain

Chapter 3 Market Dynamics

Market Dynamics

Market Drivers

Growing Demand for Biologics

Rising Investments in Biopharmaceuticals

Product Development Collaborations and Agreements

Transition Toward Personalized Medicines

Rising Aging Population and the Growing Prevalence of Chronic Diseases

Market Restraints

Emergence of Biosimilars

Complex Manufacturing, Lack of Skilled Professionals and High Production Costs

Market Opportunities

Rising Demand for Biopharmaceuticals in Emerging Countries

Technological Innovations in Biologics

Chapter 4 Regulatory Landscape

U.S. Approval Process

European Union Approval Process

Asia-Pacific Approval Process

Chapter 5 Emerging Technologies and Developments

Emerging Technologies

Advances in Monoclonal Antibodies

Antibody-Drug Conjugates

Bispecific Antibodies

Nanobodies

Single-Chain Variable Fragments Antibodies

Antibody Mimetics

Antibody Fusion Proteins

Advances in Vaccines

Advances in Cell and Gene Therapies

Chapter 6 Market Segmentation Analysis

Overview

Segmentation Breakdown

Market Analysis by Product Type

Monoclonal Antibodies

Vaccines

Peptide Hormones

Cell and Gene Therapy

Others

Market Analysis by Source Type

Mammalian

Microbial

Others

Market Analysis by Application

Oncology

Autoimmune Disease

Infectious Diseases

Others

Geographic Breakdown

Market Analysis by Region

North America

Europe

Asia-Pacific

Rest of the World

Chapter 7 Competitive Intelligence

Overview

Highest Selling Biologic Therapeutic Drugs

Market Share Analysis

Monoclonal Antibodies

Vaccines

Peptide Hormones

Cell and Gene Therapy

Strategic Initiatives

Agreements, Collaborations and Partnerships

Acquisitions

Other Strategies

Chapter 8 Sustainability in Biologics Therapeutic Drug Market: An ESG Perspective

Introduction to ESG

Sustainability Trends and Initiatives

Environmental

Social and Governance Initiatives

ESG Risk Ratings

Concluding Remarks

Chapter 9 Appendix

Research Methodology

Emerging Start-ups/Market Disruptors

Sources

Abbreviations

Company Profiles

ABBVIE INC.

AMGEN INC.

ASTRAZENECA

BRISTOL-MYERS SQUIBB CO.

ELI LILLY AND CO.

HOFFMANN-LA ROCHE LTD.

GILEAD SCIENCES INC.

GSK PLC.

JOHNSON & JOHNSON SERVICES INC.

MERCK & CO. INC.

NOVARTIS AG

NOVO NORDISK A/S

PFIZER INC.

REGENERON PHARMACEUTICALS INC.

SANOFI

List of Tables

Summary Table : Global Market for Biologic Therapeutic Drugs, by Region, Through 2029

Table 1 : Global Incidence and Mortality Cancer Rates, by the WHO Region, 2022

Table 2 : Global Market for Biologic Therapeutic Drugs, by Product Type, Through 2029

Table 3 : Top-Selling Monoclonal Antibodies, in 2023

Table 4 : Global Market for Monoclonal Antibodies, by Region, Through 2029

Table 5 : Global Market for Vaccines, by Region, Through 2029

Table 6 : Global Market for Peptide Hormones, by Region, Through 2029

Table 7 : Cell and Gene Therapy Approvals, 2023 and 2024

Table 8 : Global Market for Cell and Gene Therapy, by Region, Through 2029

Table 9 : Global Market for Other Biologic Drugs, by Region, Through 2029

Table 10 : Global Market for Biologic Therapeutic Drugs, by Source Type, Through 2029

Table 11 : Global Market for Mammalian Cells, by Region, Through 2029

Table 12 : Global Market for Microbial Cells, by Region, Through 2029

Table 13 : Global Market for Other Cells, by Region, Through 2029

Table 14 : Global Market for Biologic Therapeutic Drugs, by Application Type, Through 2029

Table 15 : Global Market for Biologic Therapeutic Drugs in Oncology, by Region, Through 2029

Table 16 : Global Market for Biologic Therapeutic Drugs for Autoimmune Diseases, by Region, Through 2029

Table 17 : Global Market for Biologic Therapeutic Drugs for Infectious Diseases, by Region, Through 2029

Table 18 : Global Market for Biologic Therapeutic Drugs for Other Diseases, by Region, Through 2029

Table 19 : Global Market for Biologic Therapeutic Drugs, by Region, Through 2029

Table 20 : North American Market for Biologic Therapeutic Drugs, by Product Type, Through 2029

Table 21 : North American Market for Biologic Therapeutic Drugs, by Source Type, Through 2029

Table 22 : North American Market for Biologic Therapeutic Drugs, by Application Type, Through 2029

Table 23 : North American Market for Biologic Therapeutic Drugs, by Country, Through 2029

Table 24 : FDA-Approved Biologics, 2023

Table 25 : European Market for Biologic Therapeutic Drugs, by Product Type, Through 2029

Table 26 : European Market for Biologic Therapeutic Drugs, by Source Type, Through 2029

Table 27 : European Market for Biologic Therapeutic Drugs, by Application Type, Through 2029

Table 28 : European Market for Biologic Therapeutic Drugs, by Country, Through 2029

Table 29 : Asia-Pacific Market for Biologic Therapeutic Drugs, by Product Type, Through 2029

Table 30 : Asia-Pacific Market for Biologic Therapeutic Drugs, by Source Type, Through 2029

Table 31 : Asia-Pacific Market for Biologic Therapeutic Drugs, by Application Type, Through 2029

Table 32 : Asia-Pacific Market for Biologic Therapeutic Drugs, by Country, Through 2029

Table 33 : Biologics Approved in China, in 2023

Table 34 : Rest of the World Market for Biologic Therapeutic Drugs, by Product Type, Through 2029

Table 35 : Rest of the World Market for Biologic Therapeutic Drugs, by Source Type, Through 2029

Table 36 : Rest of the World Market for Biologic Therapeutic Drugs, by Application Type, Through 2029

Table 37 : Rest of the World Market for Biologic Therapeutic Drugs, by Sub-Region, Through 2029

Table 38 : Agreements, Collaborations and Partnerships in the Biologic Therapeutic Drug Market, 2022-2025

Table 39 : Acquisitions in the Biologic Therapeutic Drug Market, 2022-2024

Table 40 : Others Strategic Initiatives in the Biologic Therapeutic Drug Market, 2022-2024

Table 41 : Environmental Initiatives by Various Biologic Therapeutic Drug Manufacturers

Table 42 : Key Social and Governance Issues Biologic Therapeutic Drug Market

Table 43 : ESG Risk Rankings for Biologic Therapeutic Drug Companies, 2023

Table 44 : List of a Few Emerging Startups in the Biologic Therapeutic Drugs Market

Table 45 : Information Sources in this Report

Table 46 : Abbreviations Used in the Global Biologic Therapeutic Drugs Market

Table 47 : AbbVie Inc.: Company Snapshot

Table 48 : AbbVie Inc.: Financial Performance, FY 2023 and 2024

Table 49 : AbbVie Inc.: Product Portfolio

Table 50 : AbbVie Inc.: News/Key Developments, 2022–2024

Table 51 : Amgen Inc.: Company Snapshot

Table 52 : Amgen Inc.: Financial Performance, FY 2023 and 2024

Table 53 : Amgen Inc.: Product Portfolio

Table 54 : Amgen Inc.: News/Key Developments, 2021-2024

Table 55 : AstraZeneca: Company Snapshot

Table 56 : AstraZeneca: Financial Performance, FY 2023 and 2024

Table 57 : AstraZeneca: Product Portfolio

Table 58 : AstraZeneca: News/Key Developments, 2021−2024

Table 59 : Bristol-Myers Squibb Co.: Company Snapshot

Table 60 : Bristol-Myers Squibb Co.: Financial Performance, FY 2023 and 2024

Table 61 : Bristol-Myers Squibb Co.: Product Portfolio

Table 62 : Bristol-Myers Squibb Co.: News/Key Developments, 2022–2025

Table 63 : Eli Lilly and Co.: Company Snapshot

Table 64 : Eli Lilly and Co.: Financial Performance, FY 2023 and 2024

Table 65 : Eli Lilly and Co.: Product Portfolio

Table 66 : Eli Lilly and Co.: News/Key Developments, 2023 and 2024

Table 67 : F. Hoffmann-La Roche Ltd.: Company Snapshot

Table 68 : F. Hoffmann-La Roche Ltd.: Financial Performance, FY 2023 and 2024

Table 69 : F. Hoffmann-La Roche Ltd.: Product Portfolio

Table 70 : F. Hoffmann-La Roche Ltd.: News/Key Developments, 2022–2025

Table 71 : Gilead Sciences Inc.: Company Snapshot

Table 72 : Gilead Sciences Inc.: Financial Performance, FY 2023 and 2024

Table 73 : Gilead Sciences Inc.: Product Portfolio

Table 74 : Gilead Sciences Inc.: News/Key Developments, 2022−2024

Table 75 : GSK PLC.: Company Snapshot

Table 76 : GSK PLC.: Financial Performance, FY 2023 and 2024

Table 77 : GSK PLC.: Product Portfolio

Table 78 : GSK PLC.: News/Key Developments, 2024

Table 79 : Johnson & Johnson Services Inc.: Company Snapshot

Table 80 : Johnson & Johnson Services Inc.: Financial Performance, FY 2023 and 2024

Table 81 : Johnson & Johnson Services Inc.: Product Portfolio

Table 82 : Johnson & Johnson Services Inc.: News/Key Developments, 2022−2024

Table 83 : Merck & Co. Inc.: Company Snapshot

Table 84 : Merck & Co. Inc.: Financial Performance, FY 2023 and 2024

Table 85 : Merck & Co. Inc.: Product Portfolio

Table 86 : Merck & Co. Inc.: News/Key Developments, 2022–2024

Table 87 : Novartis AG: Company Snapshot

Table 88 : Novartis AG: Financial Performance, FY 2023 and 2024

Table 89 : Novartis AG: Product Portfolio

Table 90 : Novartis AG: News/Key Developments, 2022-2025

Table 91 : Novo Nordisk A/S: Company Snapshot

Table 92 : Novo Nordisk A/S: Financial Performance, FY 2023 and 2024

Table 93 : Novo Nordisk A/S: Product Portfolio

Table 94 : Novo Nordisk A/S: News/Key Developments, 2021–2025

Table 95 : Pfizer Inc.: Company Snapshot

Table 96 : Pfizer Inc.: Financial Performance, FY 2023 and 2024

Table 97 : Pfizer Inc.: Product Portfolio

Table 98 : Pfizer Inc.: News/Key Developments, 2023–2024

Table 99 : Regeneron Pharmaceuticals Inc.: Company Snapshot

Table 100 : Regeneron Pharmaceuticals Inc.: Financial Performance, FY 2023 and 2024

Table 101 : Regeneron Pharmaceuticals Inc.: Product Portfolio

Table 102 : Regeneron Pharmaceuticals Inc.: News/Key Developments, 2022-2024

Table 103 : Sanofi: Company Snapshot

Table 104 : Sanofi: Financial Performance, FY 2023 and 2024

Table 105 : Sanofi: Product Portfolio

Table 106 : Sanofi: News/Key Developments, 2022–2024

List of Figures

Summary Figure : Global Market Shares of Biologic Therapeutic Drugs, by Region, 2023

Figure 1 : Differences Between Synthetic and Biologic Drugs

Figure 2 : Porter’s Five Forces Analysis of the Biologic Therapeutic Drugs Market

Figure 3 : Supply Chain of Biopharmaceutical Drugs

Figure 4 : Market Dynamics of Biologic Therapeutic Drugs

Figure 5 : Venture Averages for Biopharma Therapeutics and Platform Companies, 2010–2024

Figure 6 : Personalized Medicines’ Contribution to the Total FDA Approvals, 2015–2023

Figure 7 : Emerging Technologies in Monoclonal Antibodies

Figure 8 : Global Market Shares of Biologic Therapeutic Drugs, by Product Type, 2023

Figure 9 : Global Vaccination Coverage, by Vaccine, 2023

Figure 10 : Global Market Shares of Biologic Therapeutic Drugs, by Source Type, 2023

Figure 11 : Global Market Shares of Biologic Therapeutic Drugs, by Application Type, 2023

Figure 12 : Global Market Shares for Biologic Therapeutic Drugs, by Region, 2023

Figure 13 : North American Market Shares of Biologic Therapeutic Drugs, by Country, 2023

Figure 14 : European Market Shares of Biologic Therapeutic Drugs, by Country, 2023

Figure 15 : Asia-Pacific Market Shares of Biologic Therapeutic Drugs, by Country, 2023

Figure 16 : Rest of the World Market Shares of Biologic Therapeutic Drugs, by Sub-Region, 2023

Figure 17 : Top 10 Blockbuster Biologic Therapeutic Drugs, by Sales Revenue, 2023

Figure 18 : Global Market Shares for Monoclonal Antibodies, by Key Players, 2023

Figure 19 : Global Market Shares for Vaccines, by Key Players, 2023

Figure 20 : Global Market Shares for Peptide Hormones, by Key Players, 2023

Figure 21 : Global Market Shares for Cell and Gene Therapy, by Key Players, 2023

Figure 22 : AbbVie Inc.: Revenue Share, by Business Unit, FY 2024

Figure 23 : AbbVie Inc.: Revenue Share, by Country/Region, FY 2024

Figure 24 : Amgen Inc.: Revenue Share, by Business Unit, FY 2024

Figure 25 : Amgen Inc.: Revenue Share, by Country/Region, FY 2024

Figure 26 : AstraZeneca: Revenue Share, by Business Unit, FY 2024

Figure 27 : AstraZeneca: Revenue Share, by Region/Country, FY 2024

Figure 28 : Bristol-Myers Squibb Co.: Revenue Share, by Business Unit, FY 2024

Figure 29 : Bristol-Myers Squibb Co.: Revenue Share, by Country/Region, FY 2024

Figure 30 : Eli Lilly and Co.: Revenue Share, by Business Unit, FY 2024

Figure 31 : Eli Lilly and Co.: Revenue Share, by Country/Region, FY 2024

Figure 32 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Business Unit, FY 2024

Figure 33 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Country/Region, FY 2024

Figure 34 : Gilead Sciences Inc.: Revenue Share, by Business Unit, FY 2024

Figure 35 : Gilead Sciences Inc.: Revenue Share, by Country/Region, FY 2024

Figure 36 : GSK PLC.: Revenue Share, by Business Unit, FY 2024

Figure 37 : GSK PLC.: Revenue Share, by Country/Region, FY 2024

Figure 38 : Johnson & Johnson Services Inc.: Revenue Share, by Business Unit, FY 2024

Figure 39 : Johnson & Johnson Services Inc.: Revenue Share, by Country/Region, FY 2024

Figure 40 : Merck & Co. Inc.: Revenue Share, by Business Unit, FY 2024

Figure 41 : Merck & Co. Inc.: Revenue Share, by Country/Region, FY 2024

Figure 42 : Novartis AG: Revenue Share, by Business Unit, FY 2024

Figure 43 : Novartis AG: Revenue Share, by Country/Region, FY 2024

Figure 44 : Novo Nordisk A/S: Revenue Share, by Business Unit, FY 2024

Figure 45 : Novo Nordisk A/S: Revenue Share by Country/Region, FY 2024

Figure 46 : Pfizer Inc.: Revenue Share, by Business Unit, FY 2024

Figure 47 : Pfizer Inc.: Revenue Share, by Country/Region, FY 2024

Figure 48 : Regeneron Pharmaceuticals Inc.: Revenue Share, by Business Unit, FY 2024

Figure 49 : Regeneron Pharmaceuticals Inc.: Revenue Share, by Country/Region, FY 2024

Figure 50 : Sanofi: Revenue Share, by Business Unit, FY 2024

Figure 51 : Sanofi: Revenue Share, by Country/Region, FY 2024