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生物製剤原薬製造の世界市場：洞察、競合情勢、市場予測：2032年

Biologics Drug Substance Manufacturing - Market Insights, Competitive Landscape, and Market Forecast - 2032

出版日
発行
DelveInsight
ページ情報
英文 150 Pages
納期
2～10営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
生物製剤原薬製造の世界市場：洞察、競合情勢、市場予測：2032年
出版日: 2025年01月01日
発行: DelveInsight
ページ情報: 英文 150 Pages
納期: 2～10営業日
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  • 概要
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概要

生物製剤原薬製造の市場規模は、2024年には4,363億6,000万米ドルとなりました。同市場は、2025年から2032年までの予測期間中に10.59％のCAGRで拡大し、2032年には9億6,832万米ドルに達すると予測されています。生物製剤原薬製造市場は、主に慢性疾患の蔓延が生物学的製剤の開発・製造需要を煽り、大きな成長を遂げています。このプラス成長の主な要因としては、生物製剤製造の技術的進歩、研究開発活動の活発化、業界大手による製品上市の急増などが挙げられます。さらに、生物学的製剤の採用が拡大していることも、市場の拡大を後押ししています。これらの要因は、2025年から2032年にかけての生物製剤原薬製造市場の成長に極めて重要な役割を果たすと予想されます。

慢性疾患の有病率の上昇が市場成長の原動力になると予想されます。GLOBOCANが2023年に提供した最新データによると、2022年の推定新規がん患者数は2,000万人で、2045年には世界中で3,260万人に増加すると予測されています。

さらに、2023年の英国がん調査の最新データによると、英国では年間38万5,000人以上の新規がん症例が報告されています。この憂慮すべき統計は、効果的な治療オプションの緊急の必要性を強調しています。生物学的製剤は、様々ながん種に対処するための有望かつ革新的なアプローチとして認識されており、生物学的製剤の需要拡大に大きく貢献しています。

2023年の国際糖尿病連盟のデータによると、2021年には20歳から79歳の成人の約5億3,700万人が糖尿病を患っています。この数字は、2030年には6億4,300万人、2045年には7億8,300万人にエスカレートすると予測されています。

2022年の世界肥満連盟のデータによると、2023年までに全世界で約10億人（女性の5人に1人、男性の7人に1人）が肥満とともに暮らすと予測されています。このような肥満の増加は、長期的かつ継続的な治療を必要とする慢性疾患の増加とも密接に関連しています。その結果、生物学的製剤に対する安定した需要が生まれ、市場の成長を大きく後押ししています。

生物製剤、特にワクチンの採用拡大が市場成長を大きく促進すると予想されます。2024年7月の世界保健機関（WHO）のデータによると、2023年には世界の乳幼児の約84％、約1億800万人がジフテリア・破傷風・百日咳（DTP3）ワクチンを3回接種しており、感染症に対する重要な予防となっています。このようなワクチンの利用と受け入れの増加は、生物製剤の原薬製造需要を促進し、市場の拡大を促しています。

同市場の主要企業は、生物製剤製造を強化するための革新的技術に注力しています。例えば、2024年10月、Forge Biologicsは、FUEL（TM）製造プラットフォームの発売を発表しました。このプラットフォームは、AAV遺伝子治療開発者が新しいプログラムを進め、より広範な疾患を対象とする際に、より効率的で迅速な製造基盤を提供するように設計されています。

当レポートでは、世界の生物製剤原薬製造市場について調査し、市場の概要とともに、生物製剤タイプ別、製造別、製造原料別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 生物製剤原薬製造市場レポートのイントロダクション

第2章 生物製剤原薬製造市場のエグゼクティブサマリー

第3章 競合情勢

第4章 規制分析

  • 米国
  • 欧州
  • 日本
  • 中国

第5章 生物製剤原薬製造市場の主な要因分析

  • 生物製剤原薬製造市場の促進要因
  • 生物製剤原薬製造市場の抑制要因と課題
  • 生物製剤原薬製造市場の機会

第6章 生物製剤原薬製造市場におけるポーターのファイブフォース分析

第7章 生物製剤原薬製造市場評価

  • 生物製剤タイプ別
    • モノクローナル抗体
    • 組み換えタンパク質
    • 成長ホルモン
    • ワクチン
    • 治療用酵素
    • その他
  • 製造別
    • 社内
    • アウトソーシング
  • 製造原料別
    • 細胞株/細胞培養
    • 遺伝子工学
    • 微生物発酵
  • 地域別
    • 北米
    • 欧州
    • アジア太平洋
    • その他の地域

第8章 生物製剤原薬製造市場の企業と製品プロファイル

  • Lonza
  • Pfizer Inc.
  • Catalent, Inc
  • Boehringer Ingelheim International GmbH
  • Samsung Biologics
  • WuXi AppTec
  • Thermo Fisher Scientific Inc.
  • Asahi Kasei Corporation
  • Recipharm AB
  • Evotec
  • Novo Nordisk A/S
  • Siegfried Holding AG
  • Enzene Biosciences Ltd.
  • Forge Biologics
  • BeiGene LTD.
  • FUJIFILM Holdings Corporation
  • TOYOBO CO., LTD.
  • AJINOMOTO CO., INC.
  • Biocon
  • Eurofins Scientific

第9章 KOLの見解

第10章 プロジェクトのアプローチ

第11章 DelveInsightについて

第12章 免責事項とお問い合わせ

図表

List of Tables

  • Table 1: Competitive Analysis
  • Table 2: Biologics Drug Substance Manufacturing Market in Global (2022-2032)
  • Table 3: Biologics Drug Substance Manufacturing Market in Global by Biologics Type (2022-2032)
  • Table 4: Biologics Drug Substance Manufacturing Market in Global by Manufacturing (2022-2032)
  • Table 5: Biologics Drug Substance Manufacturing Market in Global by Production Source (2022-2032)
  • Table 6: Biologics Drug Substance Manufacturing Market in Global by Geography (2022-2032)
  • Table 7: Biologics Drug Substance Manufacturing Market in North America (2022-2032)
  • Table 8: Biologics Drug Substance Manufacturing Market in the United States (2022-2032)
  • Table 9: Biologics Drug Substance Manufacturing Market in Canada (2022-2032)
  • Table 10: Biologics Drug Substance Manufacturing Market in Mexico (2022-2032)
  • Table 11: Biologics Drug Substance Manufacturing Market in Europe (2022-2032)
  • Table 12: Biologics Drug Substance Manufacturing Market in France (2022-2032)
  • Table 13: Biologics Drug Substance Manufacturing Market in Germany (2022-2032)
  • Table 14: Biologics Drug Substance Manufacturing Market in United Kingdom (2022-2032)
  • Table 15: Biologics Drug Substance Manufacturing Market in Italy (2022-2032)
  • Table 16: Biologics Drug Substance Manufacturing Market in Spain (2022-2032)
  • Table 17: Biologics Drug Substance Manufacturing Market in Rest of Europe (2022-2032)
  • Table 18: Biologics Drug Substance Manufacturing Market in Asia-Pacific (2022-2032)
  • Table 19: Biologics Drug Substance Manufacturing Market in China (2022-2032)
  • Table 20: Biologics Drug Substance Manufacturing Market in Japan (2022-2032)
  • Table 21: Biologics Drug Substance Manufacturing Market in India (2022-2032)
  • Table 22: Biologics Drug Substance Manufacturing Market in Australia (2022-2032)
  • Table 23: Biologics Drug Substance Manufacturing Market in South Korea (2022-2032)
  • Table 24: Biologics Drug Substance Manufacturing Market in Rest of Asia-Pacific (2022-2032)
  • Table 25: Biologics Drug Substance Manufacturing Market in Rest of the World (2022-2032)
  • Table 26: Biologics Drug Substance Manufacturing Market in the Middle East (2022-2032)
  • Table 27: Biologics Drug Substance Manufacturing Market in Africa (2022-2032)
  • Table 28: Biologics Drug Substance Manufacturing Market in South America (2022-2032)

List of Figures

  • Figure 1: Competitive Analysis
  • Figure 2: Biologics Drug Substance Manufacturing Market in Global (2022-2032)
  • Figure 3: Biologics Drug Substance Manufacturing Market in Global by Biologics Type (2022-2032)
  • Figure 4: Biologics Drug Substance Manufacturing Market in Global by Manufacturing (2022-2032)
  • Figure 5: Biologics Drug Substance Manufacturing Market in Global by Production Source (2022-2032)
  • Figure 6: Biologics Drug Substance Manufacturing Market in Global by Geography (2022-2032)
  • Figure 7: Biologics Drug Substance Manufacturing Market in North America (2022-2032)
  • Figure 8: Biologics Drug Substance Manufacturing Market in the United States (2022-2032)
  • Figure 9: Biologics Drug Substance Manufacturing Market in Canada (2022-2032)
  • Figure 10: Biologics Drug Substance Manufacturing Market in Mexico (2022-2032)
  • Figure 11: Biologics Drug Substance Manufacturing Market in Europe (2022-2032)
  • Figure 12: Biologics Drug Substance Manufacturing Market in France (2022-2032)
  • Figure 13: Biologics Drug Substance Manufacturing Market in Germany (2022-2032)
  • Figure 14: Biologics Drug Substance Manufacturing Market in United Kingdom (2022-2032)
  • Figure 15: Biologics Drug Substance Manufacturing Market in Italy (2022-2032)
  • Figure 16: Biologics Drug Substance Manufacturing Market in Spain (2022-2032)
  • Figure 17: Biologics Drug Substance Manufacturing Market in Rest of Europe (2022-2032)
  • Figure 18: Biologics Drug Substance Manufacturing Market in Asia-Pacific (2022-2032)
  • Figure 19: Biologics Drug Substance Manufacturing Market in China (2022-2032)
  • Figure 20: Biologics Drug Substance Manufacturing Market in Japan (2022-2032)
  • Figure 21: Biologics Drug Substance Manufacturing Market in India (2022-2032)
  • Figure 22: Biologics Drug Substance Manufacturing Market in Australia (2022-2032)
  • Figure 23: Biologics Drug Substance Manufacturing Market in South Korea (2022-2032)
  • Figure 24: Biologics Drug Substance Manufacturing Market in Rest of Asia-Pacific (2022-2032)
  • Figure 25: Biologics Drug Substance Manufacturing Market in Rest of the World (2022-2032)
  • Figure 26: Biologics Drug Substance Manufacturing Market in the Middle East (2022-2032)
  • Figure 27: Biologics Drug Substance Manufacturing Market in Africa (2022-2032)
  • Figure 28: Biologics Drug Substance Manufacturing Market in South America (2022-2032)
  • Figure 29: Market Drivers
  • Figure 30: Market Barriers
  • Figure 31: Marker Opportunities
  • Figure 32: PORTER'S Five Force Analysis
目次
Product Code: DIMDCL0602

Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence chronic diseases and technological advancements in biologics manufacturing

The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032. The market for biologics drug substance manufacturing is experiencing significant growth, primarily driven by the increasing prevalence of chronic diseases, which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.

Biologics Drug Substance Manufacturing Market Dynamics:

The growing prevalence of chronic disease is expected to drive the market growth. According to recent data provided by GLOBOCAN in 2023, the estimated new number of cancer cases was 20 million in 2022, and the projection is estimated to increase to 32.6 million by 2045 around the world.

Furthermore, according to recent data from Cancer Research UK in 2023, over 385,000 new cancer cases are reported annually in the United Kingdom. This alarming statistic underscores the urgent need for effective treatment options. Biologics are recognized as a promising and innovative approach for addressing various cancer types, significantly contributing to the growing demand for biologic drugs.

The data from the International Diabetes Federation in 2023, indicates that approximately 537 million adults aged 20 to 79 were living with diabetes in 2021. This figure is projected to escalate to 643 million by 2030 and 783 million by 2045 globally.

According to the data from World Obesity Federation in 2022, it was projected that, approximately 1 billion people, representing 1 in 5 women and 1 in 7 men, will be living with obesity by 2023 across the globe. This rise in obesity is closely linked to the increasing incidence of chronic diseases, which require long-term and continuous treatment. As a result, there is a consistent demand for biologic drugs, significantly driving market growth.

The growing adoption of biologics, particularly vaccines, is expected to significantly propel market growth. According to the data from the World Health Organization in July 2024, approximately 84% of infants worldwide; around 108 million received three doses of the diphtheria-tetanus-pertussis (DTP3) vaccine in 2023, providing crucial protection against infectious diseases. This increasing utilization and acceptance of vaccines is driving demand for biologics drug substance manufacturing, thereby fostering market expansion.

Key players in the market are focusing on innovative technologies to enhance biologics manufacturing. For instance, in October 2024, Forge Biologics announced the launch of its FUEL(TM) manufacturing platform, designed to offer AAV gene therapy developers a more efficient and accelerated foundation for production as they advance new programs and target a broader range of diseases.

Additionally, major players are expanding their capabilities in biologics manufacturing through strategic mergers and acquisitions. For instance, in October 2024, Lonza completed its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, California, from Roche for USD 1.2 billion. This acquisition significantly enhances Lonza's capacity for mammalian manufacturing in the United States. Such strategic moves by key players are expected to further stimulate market growth.

However, the high development and production costs of biologics and stringent regulatory requirements, among others are some of the key constraints that may limit the growth of the biologics drug substance manufacturing market.

Biologics Drug Substance Manufacturing Market Segment Analysis:

Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the biologics type segment of the biologics drug substance manufacturing market, the monoclonal antibodies category is estimated to account for the largest market share in the biologics drug substance manufacturing market in 2024. This can be attributed to the growing prevalence of cancer and infectious diseases, among other factors. According to recent data from the Global Burden of Disease (2023), approximately 1 in 20 people globally suffer from chronic respiratory diseases. Furthermore, data from GLOBOCAN indicates that in 2022, there were an estimated 2.48 million new cases of trachea, bronchus, and lung cancer worldwide, with projections expected to rise to 4.25 million by 2045. Monoclonal antibodies are increasingly utilized in targeted cancer therapy, making the rising prevalence of cancer a significant driver of demand for these biologics. Consequently, this heightened demand is propelling the capabilities of biologics drug substance manufacturing, leading to robust market growth.

Major players in the market are increasingly focusing on the development of innovative technologies to enhance their monoclonal antibody manufacturing capabilities. For instance, in April 2024, Evotec Biologics launched the J.CHO(TM) high expression system, designed for the continuous manufacturing of antibodies. As part of Evotec Biologics' advanced continuous bioprocessing platform, J.CHO(TM) optimizes both clinical and commercial biologics production processes by delivering higher productivity and ensuring the high quality of complex antibody formats, including candidate antibodies, Fc-fusions, and bispecific antibodies. This innovation is expected to significantly contribute to the efficiency and effectiveness of monoclonal antibody manufacturing, thereby promoting market growth.

North America is expected to dominate the overall biologics drug substance manufacturing market:

North America is projected to account for leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.

According to the American Cancer Society's Cancer Facts & Figures in 2024, nearly 2 million new cancer cases were expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023.

According to the data from the GLOBOCAN in 2024, North America saw an estimated number of 2,673,174 million new cases of cancer in 2022, with forecasts indicating a rise to 3,828,805 million by 2045. Chronic conditions such as cancer and autoimmune diseases can be treated with biologics and specialty drugs, which are complex molecules and require advanced manufacturing processes. Therefore, the increasing prevalence of cancer is driving the market growth.

Also, according to data from the American Diabetes Association (2023), approximately 38.4 million people, or 11.6% of the population, were living with diabetes in 2021 in the United States. Among these individuals, 29.7 million had received a diagnosis, while an estimated 8.7 million were undiagnosed. The rising prevalence of such conditions has driven demand for more effective treatments. Biologics are increasingly used in these areas due to their specificity and lower toxicity compared to small-molecule drugs.

The growing number of chronic diseases such as cancer requires the development of novel biological drugs for effective treatment, which leads to increased biological drug substance manufacturing, thereby driving the market growth.

Key players in the region are actively establishing biological manufacturing facilities to strengthen their market position. For instance, in July 2024, BeiGene Ltd. announced the opening of its flagship U.S. facility in Hopewell, N.J., located at the Princeton West Innovation Campus. This facility boasts state-of-the-art biologics manufacturing capabilities, alongside a clinical research and development center that enhances the company's reputation as an oncology innovator. The site features approximately 400,000 square feet dedicated to commercial-stage biologic pharmaceutical manufacturing, with the capacity for future expansion. Such activities are expected to drive the market growth in the region.

Therefore, the above-mentioned factors will contribute to the growth of the biologics drug substance manufacturing market in North America.

Biologics Drug Substance Manufacturing Market Key Players:

Some of the key market players operating in the biologics drug substance manufacturing market include Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, and others.

Recent Developmental Activities in the Biologics Drug Substance Manufacturing Market:

  • In September 2024, Samsung Biologics launched biologics' innovative development platforms - S-AfuCHOTM and S-OptiChargeTM. S-AfuCHOTM is an innovative cell line platform designed to produce fucosylated antibodies, which demonstrate enhanced antibody-dependent cellular cytotoxicity (ADCC) activity, leading to increased therapeutic efficacy. In parallel, S-OptiChargeTM serves as an upstream process platform capable of modulating a molecule's charge variant distribution.
  • In June 2024, Bionova Scientific, a U.S.-based biologics contract development and manufacturing organization (CDMO) within the Asahi Kasei Group, announced plans to establish a new facility in Texas. This expansion aims to enhance its capabilities in biologics manufacturing and support the growing demand for biopharmaceutical products.
  • In January 2024, Enzene Biosciences announced the launch of its first manufacturing site in the United States, situated in Hopewell, near Princeton, New Jersey. The company has leased 54,000 square feet of space to accommodate multiple manufacturing lines utilizing its continuous manufacturing technology platform, EnzeneX(TM). This facility is designed to integrate Enzene's patented EnzeneX(TM) platform, allowing for efficient and scalable production of biologics.
  • In October 2023, WuXi Biologics announced the launch of its new proprietary bioprocessing platform, WuXiUITM. This ultra-intensified, fed-batch solution is designed to enhance the productivity and quality of various CHO (Chinese Hamster Ovary) and other mammalian cell lines, as well as different product modalities. The WuXiUITM platform significantly improves both productivity and quality while reducing the cost of goods sold (COGS) in commercial manufacturing.

Key Takeaways from the Biologics Drug Substance Manufacturing Market Report Study

  • Market size analysis for current Biologics Drug Substance Manufacturing Market size (2024), and market forecast for 8 years (2025 to 2032)
  • Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
  • Key companies dominating the Biologics Drug Substance Manufacturing market.
  • Various opportunities available for the other competitors in the Biologics Drug Substance Manufacturing Market space.
  • What are the top-performing segments in 2024? How these segments will perform in 2032?
  • Which are the top-performing regions and countries in the current Biologics Drug Substance Manufacturing market scenario?
  • Which are the regions and countries where companies should have concentrated on opportunities for Biologics Drug Substance Manufacturing market growth in the coming future?

Target Audience who can be benefited from this Biologics Drug Substance Manufacturing Market Report Study

  • Biologics Drug Substance Manufacturing product providers
  • Research organizations and consulting companies
  • Biologics Drug Substance Manufacturing related organizations, associations, forums, and other alliances
  • Government and corporate offices
  • Start-up companies, venture capitalists, and private equity firms
  • Distributors and Traders dealing in Biologics Drug Substance Manufacturing
  • Various end-users who want to know more about the Biologics Drug Substance Manufacturing Market and the latest technological developments in the Biologics Drug Substance Manufacturing Market.

Frequently Asked Questions for the Biologics Drug Substance Manufacturing Market:

1. What are Biologics Drug Substance Manufacturing?

  • Biologics drug substance manufacturing is the process of producing biologic drugs, which are medicines made from living organisms. This includes growing cells to produce proteins, purifying those proteins, and preparing them for use in treatments, like vaccines or therapies for diseases.

2. What is the market for Biologics Drug Substance Manufacturing?

  • The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032.

3. What are the drivers for the Biologics Drug Substance Manufacturing market?

  • The biologics drug substance manufacturing market is poised for significant growth, driven by factors such as the rising prevalence of chronic diseases which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.

4. Who are the key players operating in the Biologics Drug Substance Manufacturing market?

  • Some of the key market players operating in the biologics drug substance manufacturing market include Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, and others.

5. Which region has the highest share in the Biologics Drug Substance Manufacturing market?

  • North America is projected to account for the leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.

Table of Contents

1. Biologics Drug Substance Manufacturing Market Report Introduction

  • 1.1. Scope of the Study
  • 1.2. Market Segmentation
  • 1.3. Market Assumption

2. Biologics Drug Substance Manufacturing Market Executive Summary

  • 2.1. Market at Glance

3. Competitive Landscape

4. Regulatory Analysis

  • 4.1. The United States
  • 4.2. Europe
  • 4.3. Japan
  • 4.4. China

5. Biologics Drug Substance Manufacturing Market Key Factors Analysis

  • 5.1. Biologics Drug Substance Manufacturing Market Drivers
    • 5.1.1. The growing prevalence of chronic diseases
    • 5.1.2. Technological advancements in biologics manufacturing
    • 5.1.3. Rise in R&D activities and a surge in product launches by leading industry players
    • 5.1.4. The growing adoption of biologic drugs
  • 5.2. Biologics Drug Substance Manufacturing Market Restraints and Challenges
    • 5.2.1. High development and production costs of biologics
    • 5.2.2. Stringent regulatory requirements
  • 5.3. Biologics Drug Substance Manufacturing Market Opportunity
    • 5.3.1. Integration of automation and smart manufacturing
    • 5.3.2. Growing emphasis on personalized medicine

6. Biologics Drug Substance Manufacturing Market Porter's Five Forces Analysis

  • 6.1. Bargaining Power of Suppliers
  • 6.2. Bargaining Power of Consumers
  • 6.3. Threat of New Entrants
  • 6.4. Threat of Substitutes
  • 6.5. Competitive Rivalry

7. Biologics Drug Substance Manufacturing Market Assessment

  • 7.1. By Biologics Type
    • 7.1.1. Monoclonal Antibodies
    • 7.1.2. Recombinant Protein
    • 7.1.3. Growth Hormones
    • 7.1.4. Vaccines
    • 7.1.5. Therapeutic Enzyme
    • 7.1.6. Others
  • 7.2. By Manufacturing
    • 7.2.1. In-house
    • 7.2.2. Outsourced
  • 7.3. By Production Source
    • 7.3.1. Cell Line/Cell Culture
    • 7.3.2. Genetic Engineering
    • 7.3.3. Microbial Fermentation
  • 7.4. By Geography
    • 7.4.1. North America
      • 7.4.1.1. United States Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.1.2. Canada Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.1.3. Mexico Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
    • 7.4.2. Europe
      • 7.4.2.1. France Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.2.2. Germany Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.2.3. United Kingdom Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.2.4. Italy Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.2.5. Spain Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.2.6. Rest of Europe Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
    • 7.4.3. Asia-Pacific
      • 7.4.3.1. China Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.3.2. Japan Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.3.3. India Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.3.4. Australia Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.3.5. South Korea Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.3.6. Rest of Asia-Pacific Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
    • 7.4.4. Rest of the World (RoW)
      • 7.4.4.1. Middle East Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.4.2. Africa Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
      • 7.4.4.3. South America Biologics Drug Substance Manufacturing Market Size In USD Million (2022-2032)

8. Biologics Drug Substance Manufacturing Market Company and Product Profiles

  • 8.1. Lonza
    • 8.1.1. Company Overview
    • 8.1.2. Company Snapshot
    • 8.1.3. Financial Overview
    • 8.1.4. Product Listing
    • 8.1.5. Entropy
  • 8.2. Pfizer Inc.
    • 8.2.1. Company Overview
    • 8.2.2. Company Snapshot
    • 8.2.3. Financial Overview
    • 8.2.4. Product Listing
    • 8.2.5. Entropy
  • 8.3. Catalent, Inc
    • 8.3.1. Company Overview
    • 8.3.2. Company Snapshot
    • 8.3.3. Financial Overview
    • 8.3.4. Product Listing
    • 8.3.5. Entropy
  • 8.4. Boehringer Ingelheim International GmbH
    • 8.4.1. Company Overview
    • 8.4.2. Company Snapshot
    • 8.4.3. Financial Overview
    • 8.4.4. Product Listing
    • 8.4.5. Entropy
  • 8.5. Samsung Biologics
    • 8.5.1. Company Overview
    • 8.5.2. Company Snapshot
    • 8.5.3. Financial Overview
    • 8.5.4. Product Listing
    • 8.5.5. Entropy
  • 8.6. WuXi AppTec
    • 8.6.1. Company Overview
    • 8.6.2. Company Snapshot
    • 8.6.3. Financial Overview
    • 8.6.4. Product Listing
    • 8.6.5. Entropy
  • 8.7. Thermo Fisher Scientific Inc.
    • 8.7.1. Company Overview
    • 8.7.2. Company Snapshot
    • 8.7.3. Financial Overview
    • 8.7.4. Product Listing
    • 8.7.5. Entropy
  • 8.8. Asahi Kasei Corporation
    • 8.8.1. Company Overview
    • 8.8.2. Company Snapshot
    • 8.8.3. Financial Overview
    • 8.8.4. Product Listing
    • 8.8.5. Entropy
  • 8.9. Recipharm AB
    • 8.9.1. Company Overview
    • 8.9.2. Company Snapshot
    • 8.9.3. Financial Overview
    • 8.9.4. Product Listing
    • 8.9.5. Entropy
  • 8.10. Evotec
    • 8.10.1. Company Overview
    • 8.10.2. Company Snapshot
    • 8.10.3. Financial Overview
    • 8.10.4. Product Listing
    • 8.10.5. Entropy
  • 8.11. Novo Nordisk A/S
    • 8.11.1. Company Overview
    • 8.11.2. Company Snapshot
    • 8.11.3. Financial Overview
    • 8.11.4. Product Listing
    • 8.11.5. Entropy
  • 8.12. Siegfried Holding AG
    • 8.12.1. Company Overview
    • 8.12.2. Company Snapshot
    • 8.12.3. Financial Overview
    • 8.12.4. Product Listing
    • 8.12.5. Entropy
  • 8.13. Enzene Biosciences Ltd.
    • 8.13.1. Company Overview
    • 8.13.2. Company Snapshot
    • 8.13.3. Financial Overview
    • 8.13.4. Product Listing
    • 8.13.5. Entropy
  • 8.14. Forge Biologics
    • 8.14.1. Company Overview
    • 8.14.2. Company Snapshot
    • 8.14.3. Financial Overview
    • 8.14.4. Product Listing
    • 8.14.5. Entropy
  • 8.15. BeiGene LTD.
    • 8.15.1. Company Overview
    • 8.15.2. Company Snapshot
    • 8.15.3. Financial Overview
    • 8.15.4. Product Listing
    • 8.15.5. Entropy
  • 8.16. FUJIFILM Holdings Corporation
    • 8.16.1. Company Overview
    • 8.16.2. Company Snapshot
    • 8.16.3. Financial Overview
    • 8.16.4. Product Listing
    • 8.16.5. Entropy
  • 8.17. TOYOBO CO., LTD.
    • 8.17.1. Company Overview
    • 8.17.2. Company Snapshot
    • 8.17.3. Financial Overview
    • 8.17.4. Product Listing
    • 8.17.5. Entropy
  • 8.18. AJINOMOTO CO., INC.
    • 8.18.1. Company Overview
    • 8.18.2. Company Snapshot
    • 8.18.3. Financial Overview
    • 8.18.4. Product Listing
    • 8.18.5. Entropy
  • 8.19. Biocon
    • 8.19.1. Company Overview
    • 8.19.2. Company Snapshot
    • 8.19.3. Financial Overview
    • 8.19.4. Product Listing
    • 8.19.5. Entropy
  • 8.20. Eurofins Scientific
    • 8.20.1. Company Overview
    • 8.20.2. Company Snapshot
    • 8.20.3. Financial Overview
    • 8.20.4. Product Listing
    • 8.20.5. Entropy

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10. Project Approach

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