バイオシミラー受託製造市場- 世界の産業規模、シェア、動向、機会、予測、製品別、技術別、用途別、地域別セグメント、競合、2020年～2030年

バイオシミラー受託製造の世界市場規模は2024年に93億7,000万米ドルで、予測期間中のCAGRは16.59%で2030年には235億4,000万米ドルに達すると予測されています。

バイオシミラー受託製造の世界市場は、様々な慢性疾患の有病率の増加により、大きな成長を遂げています。さらに、低価格で手頃な治療が可能ながんバイオシミラーの増加や、世界中で費用対効果の高いヘルスケアシステムの導入が進んでいることも、バイオシミラー受託製造の需要を高めています。さらに、さまざまな種類の慢性疾患に罹患しやすい老年人口が世界中で増加していることも、バイオシミラー受託製造の需要をさらに増加させると予想されます。

市場促進要因

生物製剤の特許切れによるバイオシミラー開発の促進

市場の課題

バイオシミラー製造の複雑さとコストの高さ

主要市場動向

バイオシミラー製造におけるシングルユースバイオプロセシング技術の台頭

目次

第1章 概要

• 市場の定義
• 市場の範囲
  • 対象市場
  • 調査対象年
  • 主要市場セグメンテーション

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界のバイオシミラー受託製造市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 製品別（組み換え非糖化タンパク質、組み換え糖化タンパク質）
  • 技術別（哺乳類、非哺乳類）
  • 用途別（オンコロジー、血液疾患、成長ホルモン欠乏症、慢性疾患および自己免疫疾患、関節リウマチ、その他）
  • 地域別
  • 企業別（2024）
• 市場マップ
  • 製品別
  • 技術別
  • 用途別
  • 地域別

第6章 北米のバイオシミラー受託製造市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • カナダ
  • メキシコ

第7章 欧州のバイオシミラー受託製造市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋地域のバイオシミラー受託製造市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 日本
  • 韓国
  • オーストラリア

第9章 南米のバイオシミラー受託製造市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカのバイオシミラー受託製造市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品上市
• 最近の動向

第13章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威/サービス

第14章 競合情勢

• Catalent, Inc.
• Boehringer Ingelheim GmbH
• Alcami Corporation, Inc.
• Almac Group
• Lonza Group AG
• Biocon Limited
• Avid Bioservice, Inc.
• Rentschler Biopharma SE
• Fujifilm Kyowa Kirin Biologics Co., Ltd.
• WuXi Biologics, Inc.

第15章 戦略的提言

第16章 調査会社について・免責事項

Global Biosimilar Contract Manufacturing Market was valued at USD 9.37 billion in 2024 and is expected to reach USD 23.54 billion by 2030 with a CAGR of 16.59% during the forecast period. The global market for Biosimilar Contract Manufacturing is experiencing significant growth, driven by the growing prevalence of various chronic diseases. Additionally, increasing availability of cancer biosimilars with lowered prices and affordable treatment, along with the growing adoption of cost-effective healthcare systems across the globe, have increased the demand for biosimilar contract manufacturing. Additionally, the growing geriatric population across the globe, susceptible to different kinds of chronic diseases, is further expected to increase the demand for biosimilar contract manufacturing.

Key Market Drivers

Patent Expiry of Biologics Encouraging Biosimilar Development

The expiration of patents on many blockbusters biologic drugs has created a significant opportunity for biosimilar development, directly driving the demand for contract manufacturing organizations (CMOs) that specialize in biosimilar production. Biologics such as trastuzumab, bevacizumab, and adalimumab have either lost or are nearing the expiration of their exclusivity periods in multiple regions including the U.S., Europe, and parts of Asia. This opens the door for biosimilar manufacturers to introduce more cost-effective alternatives.

CMOs play a pivotal role in facilitating this transition by providing the infrastructure, expertise, and regulatory guidance required to bring these complex products to market efficiently. According to the U.S. Food and Drug Administration (FDA), as of 2024, over 40 biosimilars have been approved in the United States, a marked increase compared to just 11 approvals five years earlier. The European Medicines Agency (EMA) also reports steady growth in biosimilar approvals since its first authorization in 2006, reflecting a regulatory climate conducive to biosimilar uptake. The challenge of producing biologics-due to their complexity, the need for sterile environments, and sophisticated analytical testing-makes contract manufacturing a strategic choice for many biosimilar developers. Rather than investing in costly facilities and process development, pharmaceutical companies are increasingly outsourcing CMOs that already possess these capabilities, thus speeding up time-to-market and reducing capital expenditure.

Key Market Challenges

High Complexity and Cost of Biosimilar Manufacturing

Despite their economic appeal, biosimilars are biologically complex molecules that require sophisticated manufacturing infrastructure, highly skilled personnel, and rigorous quality control systems. Developing biosimilars involves extensive comparative analytical studies and process validation steps to ensure therapeutic equivalence to the original biologic, which significantly increases development time and cost. Even with outsourcing to CMOs, the cost of manufacturing biosimilars can be prohibitively high, particularly for smaller biotech firms or those targeting niche therapeutic areas. Governments such as the U.S. FDA and EMA require a comprehensive dossier of quality, safety, and efficacy data before approving a biosimilar, further increasing regulatory and financial burdens.

Moreover, CMOs must make substantial upfront investments in specialized bioreactors, cell culture facilities, and cleanroom environments to accommodate biosimilar projects. These capital-intensive requirements limit the number of CMOs equipped to handle large-scale biosimilar contracts, creating a bottleneck in supply and potentially slowing market growth.

Key Market Trends

Rise of Single-Use Bioprocessing Technologies in Biosimilar Manufacturing

One of the most prominent trends reshaping the biosimilar contract manufacturing landscape is the widespread adoption of single-use bioprocessing technologies. Single-use systems-comprising disposable bioreactors, mixing systems, and filtration units-offer significant advantages over traditional stainless-steel equipment, including reduced contamination risk, lower cleaning validation costs, and faster turnaround times between batches.

These benefits are particularly relevant in the biosimilar space, where cost efficiency and speed to market are critical. CMOs are increasingly incorporating single-use technologies to enhance their operational flexibility and meet the unique production needs of multiple clients simultaneously. According to the U.S. Department of Commerce, biopharmaceutical manufacturers who adopt single-use systems report a 30-50% reduction in production costs, making this approach especially attractive for biosimilar developers operating on tight margins.

Furthermore, these technologies support small and medium-sized batches, aligning well with the growing trend of personalized medicine and targeted biosimilars. The ability to quickly scale up or down based on demand also makes contract manufacturing more agile and responsive to fluctuating market needs.

Key Market Players

• Catalent, Inc.
• Boehringer Ingelheim GmbH
• Alcami Corporation, Inc.
• Almac Group
• Lonza Group AG
• Biocon Limited
• Avid Bioservice, Inc.
• Rentschler Biopharma SE
• Fujifilm Kyowa Kirin Biologics Co., Ltd.
• WuXi Biologics, Inc.

Report Scope:

In this report, the Global Biosimilar Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biosimilar Contract Manufacturing Market, By Product:

• Recombinant Non-glycosylated Proteins
• Recombinant Glycosylated Proteins

Biosimilar Contract Manufacturing Market, By Technology:

• Mammalian
• Non-Mammalian

Biosimilar Contract Manufacturing Market, By Application:

• Oncology
• Blood Disorders
• Growth Hormonal Deficiency
• Chronic & Autoimmune Disorders
• Rheumatoid Arthritis
• Others

Biosimilar Contract Manufacturing Market, By Region:

• North America
  • United States
  • Mexico
  • Canada
• Europe
  • France
  • Germany
  • United Kingdom
  • Italy
  • Spain
• Asia-Pacific
  • China
  • India
  • South Korea
  • Japan
  • Australia
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biosimilar Contract Manufacturing Market.

Available Customizations:

Global Biosimilar Contract Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Service Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Biosimilar Contract Manufacturing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins)
  • 5.2.2. By Technology (Mammalian, Non-Mammalian)
  • 5.2.3. By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic & Autoimmune Disorders, Rheumatoid Arthritis, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map
  • 5.3.1. By Product
  • 5.3.2. By Technology
  • 5.3.3. By Application
  • 5.3.4. By Region

6. North America Biosimilar Contract Manufacturing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Technology
  • 6.2.3. By Application
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biosimilar Contract Manufacturing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By Technology
      • 6.3.1.2.3. By Application
  • 6.3.2. Canada Biosimilar Contract Manufacturing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By Technology
      • 6.3.2.2.3. By Application
  • 6.3.3. Mexico Biosimilar Contract Manufacturing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By Technology
      • 6.3.3.2.3. By Application

7. Europe Biosimilar Contract Manufacturing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Technology
  • 7.2.3. By Application
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Biosimilar Contract Manufacturing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By Technology
      • 7.3.1.2.3. By Application
  • 7.3.2. Germany Biosimilar Contract Manufacturing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By Technology
      • 7.3.2.2.3. By Application
  • 7.3.3. United Kingdom Biosimilar Contract Manufacturing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By Technology
      • 7.3.3.2.3. By Application
  • 7.3.4. Italy Biosimilar Contract Manufacturing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By Technology
      • 7.3.4.2.3. By Application
  • 7.3.5. Spain Biosimilar Contract Manufacturing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By Technology
      • 7.3.5.2.3. By Application

8. Asia-Pacific Biosimilar Contract Manufacturing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Technology
  • 8.2.3. By Application
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Biosimilar Contract Manufacturing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By Technology
      • 8.3.1.2.3. By Application
  • 8.3.2. India Biosimilar Contract Manufacturing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By Technology
      • 8.3.2.2.3. By Application
  • 8.3.3. Japan Biosimilar Contract Manufacturing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By Technology
      • 8.3.3.2.3. By Application
  • 8.3.4. South Korea Biosimilar Contract Manufacturing Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By Technology
      • 8.3.4.2.3. By Application
  • 8.3.5. Australia Biosimilar Contract Manufacturing Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By Technology
      • 8.3.5.2.3. By Application

9. South America Biosimilar Contract Manufacturing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Technology
  • 9.2.3. By Application
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Biosimilar Contract Manufacturing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Technology
      • 9.3.1.2.3. By Application
  • 9.3.2. Argentina Biosimilar Contract Manufacturing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Technology
      • 9.3.2.2.3. By Application
  • 9.3.3. Colombia Biosimilar Contract Manufacturing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Technology
      • 9.3.3.2.3. By Application

10. Middle East and Africa Biosimilar Contract Manufacturing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Technology
  • 10.2.3. By Application
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Biosimilar Contract Manufacturing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Technology
      • 10.3.1.2.3. By Application
  • 10.3.2. Saudi Arabia Biosimilar Contract Manufacturing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Technology
      • 10.3.2.2.3. By Application
  • 10.3.3. UAE Biosimilar Contract Manufacturing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Technology
      • 10.3.3.2.3. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products/Services

14. Competitive Landscape

• 14.1. Catalent, Inc.
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Boehringer Ingelheim GmbH
• 14.3. Alcami Corporation, Inc.
• 14.4. Almac Group
• 14.5. Lonza Group AG
• 14.6. Biocon Limited
• 14.7. Avid Bioservice, Inc.
• 14.8. Rentschler Biopharma SE
• 14.9. Fujifilm Kyowa Kirin Biologics Co., Ltd.

14.10 WuXi Biologics, Inc.

15. Strategic Recommendations

16. About Us & Disclaimer