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市场调查报告书
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1351099

2030 年生物製药 CMO 市场预测：按产品、原产地、服务和地区进行的全球分析

Biopharmaceutical CMO Market Forecasts to 2030 - Global Analysis By Product (Biologics, Biosimilars and Other Products), Source, Service and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 175+ Pages | 商品交期: 2-3个工作天内

价格

根据Stratistics MRC预测，2023年全球生物製药CMO市场规模将达151.8亿美元，预计2030年将达到394.1亿美元，预测期内年复合成长率为14.6%。

生物製药 CMO，通常称为合约製造组织，是为生物製药行业的其他企业（包括包装和药品製造）提供合约服务的企业。这使得主要的生物製药公司能够外包其製造流程，并专注于新药的开发和行销。由于缺乏内部生产能力，许多小型生物技术公司透过外包其填充和成品製造要求来避免资本投资。

据印度药品工业协会（IDMA）称，截至2021年7月，基本药物原材料（即製药行业的API）成本已较疫情前水平飙升约140%，给印度医药行业带来了挑战。工业.马苏.

原料药生产需求不断增加

活性药物原料药(API) 的生产需求持续成长。这是由于与老化和癌症相关的疾病日益患病、全球仿製药生产能力不断提高以及生物创新。因此，市场参与企业将重点放在开拓生物原料药和扩大原料药产能。因此，预计生物製药和小分子原料药领域都有更好的预测，并且这种趋势预计将在整个预测期内持续下去。

严格的指导方针和要求

CRO（委外研发机构）由 FDA（食品药物管理局）定义和管理。 FDA 也有权要求 CRO 直接对其在临床实验申请中承担的申办者责任负责。 FDA 必须确保临床实验正确进行并符合良好临床实务和协调的标准。严格的法律规范和法规是阻碍市场扩张的主要要素之一。

强大的生物製剂管道

随着製药和生物技术公司在合约製造和开发服务上投入更多资金，该行业将继续扩大。生物製药受託製造厂商市场预计将出现两位数成长，中小型 CMO 的成长速度预计将快于大型 CMO。高成长率主要是由于计划推出的生物製剂管道数量不断增加。随着开发中的生物製药数量不断增加，对外包服务的需求将大幅增加。

推出成本高且外包有限

在一定程度上限制市场扩张的主要挑战包括建立生产设施所需的高昂初期成本以及以更快的速度扩大生物製造所需的额外资本投资。服务本身的复杂性和法律环境都被认为使 CMO 与客户谈判合约变得困难。由于智慧财产权、保固、成本和交货日期等问题，客户和 CMO 之间的谈判非常困难。

COVID-19 的影响：

疫情已成为全球重大公共卫生议题。这场大流行的影响最初是在中国发现的，现在已经波及到其他地区。医疗保健行业的收入成长受到显着影响。然而，全球市场都出现了有利的需求衝击。成长率的大幅成长主要是由于 CMO 增加了生物製药合约的分配。在生物製药领域，随着COVID-19的影响持续蔓延，我们正专注于开发高效、安全的疫苗来预防感染，并创造和研究新药物来治疗病毒感染者。

预计哺乳动物市场在预测期内将是最大的市场

由于该行业缺乏专业知识，预计哺乳动物市场在预测期内将成为最大的市场。他们透过类人转译后修饰增强复杂蛋白质加工的能力证明了这一点。已经鉴定多种微生物，并且正在利用创造性策略来挖掘它们的潜力。该领域还受益于新的和改进的表达系统的开发、製程监控解决方案的增加、细胞株工程工具、自动筛选技术和一次性设备。

合约製造领域预计在预测期内年复合成长率最高。

合约製造领域预计在预测期内年复合成长率最高。该地区拥有许多 CMO，它们积极为生物製药公司提供从细胞培养到填充和加工服务等广泛的端到端服务。客户产品开发计画的製造部门也获得了大量投资。随着专注于开拓生物製药市场的新参与企业选择合约研究服务来寻找新候选化合物，该领域的成长预计将加速。

占比最大的地区：

预计北美在预测期内将占据最大的市场份额。这是由于同一地区存在多个服务提供者。此外，美国核准的产品中很大一部分是由集体生产组织生产的。还有许多中小型生物製药公司缺乏建造资源齐全的设施所需的资金和资源。结果，集体管理组织和中小企业之间的相互依赖增加，导致市场寡占。

复合年复合成长率最高的地区：

由于聚合物产量高，预计亚太地区在预测期内将维持最高的年复合成长率。全球生物相似药核准法规缺乏一致性，对该市场造成了重大影响。该地区的强劲成长主要归功于越来越多的 CMO 在各国开设製造工厂。由于该地区人口众多以及糖尿病、癌症和其他慢性病等各种疾病的患病不断上升，预计市场参与者将享有良好的成长预测。

免费客製化服务：

订阅此报告的客户可以存取以下免费自订选项之一：

  • 公司简介
    • 其他市场参与者的综合分析（最多 3 家公司）
    • 主要企业SWOT分析（最多3家企业）
  • 区域分割
    • 根据客户兴趣对主要国家的市场估计、预测和年复合成长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第1章执行摘要

第2章前言

  • 概述
  • 利害关係人
  • 调查范围
  • 调查方法
    • 资料探勘
    • 资料分析
    • 资料检验
    • 研究途径
  • 调查来源
    • 主要调查来源
    • 二次调查来源
    • 先决条件

第3章市场趋势分析

  • 促进因素
  • 抑制因素
  • 机会
  • 威胁
  • 产品分析
  • 新兴市场
  • 新型冠状病毒感染疾病（COVID-19）的影响

第4章波特五力分析

  • 供应商的议价能力
  • 买方议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 竞争公司之间的敌对关係

第5章全球生物製药 CMO 市场：按产品

  • 生物製品
    • 反义、RNAi、分子治疗
    • 重组蛋白
    • 单株抗体 (MAb)
    • 疫苗
    • 其他生物製品
  • 生物相似药
  • 其他产品

第6章全球生物製药 CMO 市场：依来源分类

  • 非哺乳动物
  • 哺乳动物的
  • 其他产地

第7章全球生物製药 CMO 市场：依服务分类

  • 合约起草（名词
    • 分析和品质控制研究
    • 填充和整理操作
    • 製程开发
      • 下游
      • 上游
    • 包装
  • 委託研究
    • 发炎和免疫学
    • 神经科学
    • 肿瘤学
    • 心臟病学
  • 其他服务

第8章全球生物製药CMO市场：按地区

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲

第9章进展

  • 合约、伙伴关係、协作和合资企业
  • 收购和合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第10章公司简介

  • JRS Pharma
  • Toyobo Co., Ltd.
  • Rentschler Biopharma SE
  • Inno Biologics Sdn Bhd
  • Fujifilm Diosynth Biotechnologies USA, Inc.
  • Laboratory Corporation of America Holdings
  • Biomeva GmbH
  • Samsung Biologics
  • ProBioGen AG
  • Boehringer Ingelheim GmbH
  • Lonza Group AG
  • CMC Biologics
  • ICON Plc
  • AbbVie Inc.
  • Thermo Fisher Scientific Inc（Patheon & PPD）
Product Code: SMRC23786

According to Stratistics MRC, the Global Biopharmaceutical CMO Market is accounted for $15.18 billion in 2023 and is expected to reach $39.41 billion by 2030 growing at a CAGR of 14.6% during the forecast period. A biopharmaceutical CMO, often referred to as a contract manufacturing organization, is a business that provides contract services to other businesses in the biopharmaceutical industry, including packaging and drug manufacture. This enables large biopharmaceutical companies to outsource their manufacturing process, allowing them to concentrate on the development and marketing of new drugs. Because they don't have the internal production capacity, many small biotechnology businesses outsource their fill and finish manufacturing requirements, which helps them avoid having to make capital investments.

According to the Indian Drug Manufacturers Association (IDMA), as of July 2021, the cost of raw materials for essential drugs, called APIs in the pharma sector, has seen a steep rise of around 140% since the pre-pandemic levels, posing a challenge for the industry.

Market Dynamics:

Driver:

Growing demand for API production

The manufacture of Active Pharmaceutical Ingredients (API) is experiencing a constant increase in demand. This is due to an increase in the prevalence of age- and cancer-related disorders, increased worldwide generic production capacities, and biologic innovation. As a result, market participants are concentrating on developing biological APIs and expanding their API production capabilities. Better prospects are anticipated as a result, both in the biopharmaceutical and small molecule API sectors, and it is anticipated that this trend will continue throughout the course of the forecast year.

Restraint:

Strict guidelines and requirements

Contract research organizations (CROs) are defined and governed by the Food and Drug Administration (FDA), which also has the authority to hold CROs directly liable for any sponsor responsibilities they take on in connection with an investigational new drug application. It must guarantee that the drug study is correctly run and complies with the standards for good clinical practice and harmonisation. The strict regulatory framework or rules and regulations are one of the main things that are anticipated to impede market expansion.

Opportunity:

Robust biologics pipeline

As pharmaceutical and biotechnology companies spend more on contract manufacturing and development services, this industry will keep expanding. The market for biopharmaceutical contract manufacturing organizations is predicted to increase by double digits, with smaller CMOs anticipating faster growth than bigger CMOs. The high growth rate is mostly attributable to the expanding number of biologics pipelines that are planned for release. The demand for outsourcing services will be significantly increased by the growth in the number of biopharmaceuticals in development.

Threat:

High startup costs and limited outsourcing

The significant challenges limiting the market expansion to some level include the high initial expenditure needed for the creation of manufacturing facilities and investments in additional equipment to start bio manufacturing at a faster rate. The complexity of the service itself and the legal environment have both been recognized to make contract negotiations between CMOs and customers challenging. Because of issues including intellectual property rights, warranties, cost, and timeliness, negotiations between clients and CMOs are difficult.

COVID-19 Impact:

The pandemic has become a huge public health concern around the world. The pandemic's impacts, which were initially discovered in China, are now being felt elsewhere. The healthcare sector's revenue growth was significantly impacted. But the market saw a favorable demand shock all around the world. The sudden increase in growth rate can be largely attributed to the CMOs' increased allocation of biopharmaceutical contracts. The biopharmaceutical sector is concentrating on the development of efficient and safe vaccinations to prevent infection as the impact of COVID-19 grows, as well as on the creation and research of new medicines to treat those who have been infected with the virus.

The mammalian segment is expected to be the largest during the forecast period

The mammalian segment is expected to be the largest during the forecast period owing to the lack of internal expertise in the industry. This is demonstrated by their capacity to enhance complicated protein treatments with post-translational modifications that are human-like. Diverse microorganisms are being identified and their potential is being explored through the use of creative tactics. The segment has also profited significantly from the development of novel and improved expression systems, increased process monitoring solutions, cell line engineering tools, automated screening techniques, and disposable devices.

The contract manufacturing segment is expected to have the highest CAGR during the forecast period

The contract manufacturing segment is expected to have the highest CAGR during the forecast period. The region is home to a sizable number of CMOs that are actively engaged in offering biopharma companies a wide range of services, including end-to-end coverage from cell cultivation to fill/finish services. The manufacturing component of clients' product development programs is also receiving significant investment. It is projected that new market entrants and small businesses who are focused on the development of biopharmaceuticals will choose contract research services for their discovery programs of new candidates, which will accelerate the segment's growth.

Region with largest share:

North America is projected to hold the largest market share during the forecast period. This can be attributed to the local presence of several service providers in the region. Furthermore, CMOs produce a sizeable portion of the approved products in the US. Numerous small- and mid-sized biopharmaceutical companies are present, but they lack the funding and resources necessary to build facilities with adequate resources. As a result, the interdependence between CMOs and SMEs has grown, leading to the market's domination.

Region with highest CAGR:

Asia Pacific is projected to hold the highest CAGR over the forecast period, due to the high volume of large molecule production in this country. The market has been heavily influenced by the lack of global regulatory consistency for biosimilar approval. The region's robust growth is mostly attributable to the rising number of CMOs opening manufacturing facilities across nations. It is projected that the region's high population and rising prevalence of various ailments like diabetes, cancer, and other chronic diseases will present market players with lucrative growth prospects.

Key players in the market:

Some of the key players in Biopharmaceutical CMO market include: JRS Pharma, Toyobo Co., Ltd., Rentschler Biopharma SE, Inno Biologics Sdn Bhd, Fujifilm Diosynth Biotechnologies U.S.A., Inc., Laboratory Corporation of America Holdings, Biomeva GmbH, Samsung Biologics, ProBioGen AG, Boehringer Ingelheim GmbH, Lonza Group AG, CMC Biologics, ICON Plc, AbbVie Inc. and Thermo Fisher Scientific Inc (Patheon & PPD).

Key Developments:

In June 2023, FUJIFILM Corporation announced that it will launch a commercial office*1 in Tokyo to provide enhanced sales support and customer service for Contract Development and Manufacturing services for Biologics and Advanced Therapies to Asia-based pharmaceutical and biotechnology companies.

In June 2023, Lonza to acquired Synaffix and strengthen antibody-drug conjugates offering. Acquisition will further strengthen Lonza's bioconjugates offering through the integration of the industry-leading proprietary Synaffix technology platform and R&D capabilities, including payload and site-specific linker technology

In May 2022, Germany's Boehringer Ingelheim (BI) has announced that it has acquired approval from the Central Drugs Standard Control Organization (CDSCO) to market its medicine Jardiance (empagliflozin) in India, for the whole spectrum of heart failure disorders regardless of ejection fraction.

Products Covered:

  • Biologics
  • Biosimilars
  • Other Products

Sources Covered:

  • Non-mammalian
  • Mammalian
  • Other Sources

Services Covered:

  • Contract Manufacturing
  • Contract Research
  • Other Services

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Product Analysis
  • 3.7 Emerging Markets
  • 3.8 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Biopharmaceutical CMO Market, By Product

  • 5.1 Introduction
  • 5.2 Biologics
    • 5.2.1 Antisense, RNAi, & Molecular Therapy
    • 5.2.2 Recombinant Proteins
    • 5.2.3 Monoclonal antibodies (MAbs)
    • 5.2.4 Vaccines
    • 5.2.5 Other Biologics
  • 5.3 Biosimilars
  • 5.4 Other Products

6 Global Biopharmaceutical CMO Market, By Source

  • 6.1 Introduction
  • 6.2 Non-mammalian
  • 6.3 Mammalian
  • 6.4 Other Sources

7 Global Biopharmaceutical CMO Market, By Service

  • 7.1 Introduction
  • 7.2 Contract Manufacturing
    • 7.2.1 Analytical & QC Studies
    • 7.2.2 Fill & Finish Operations
    • 7.2.3 Process Development
      • 7.2.3.1 Downstream
      • 7.2.3.2 Upstream
    • 7.2.4 Packaging
  • 7.3 Contract Research
    • 7.3.1 Inflammation & Immunology
    • 7.3.2 Neuroscience
    • 7.3.3 Oncology
    • 7.3.4 Cardiology
  • 7.4 Other Services

8 Global Biopharmaceutical CMO Market, By Geography

  • 8.1 Introduction
  • 8.2 North America
    • 8.2.1 US
    • 8.2.2 Canada
    • 8.2.3 Mexico
  • 8.3 Europe
    • 8.3.1 Germany
    • 8.3.2 UK
    • 8.3.3 Italy
    • 8.3.4 France
    • 8.3.5 Spain
    • 8.3.6 Rest of Europe
  • 8.4 Asia Pacific
    • 8.4.1 Japan
    • 8.4.2 China
    • 8.4.3 India
    • 8.4.4 Australia
    • 8.4.5 New Zealand
    • 8.4.6 South Korea
    • 8.4.7 Rest of Asia Pacific
  • 8.5 South America
    • 8.5.1 Argentina
    • 8.5.2 Brazil
    • 8.5.3 Chile
    • 8.5.4 Rest of South America
  • 8.6 Middle East & Africa
    • 8.6.1 Saudi Arabia
    • 8.6.2 UAE
    • 8.6.3 Qatar
    • 8.6.4 South Africa
    • 8.6.5 Rest of Middle East & Africa

9 Key Developments

  • 9.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 9.2 Acquisitions & Mergers
  • 9.3 New Product Launch
  • 9.4 Expansions
  • 9.5 Other Key Strategies

10 Company Profiling

  • 10.1 JRS Pharma
  • 10.2 Toyobo Co., Ltd.
  • 10.3 Rentschler Biopharma SE
  • 10.4 Inno Biologics Sdn Bhd
  • 10.5 Fujifilm Diosynth Biotechnologies U.S.A., Inc.
  • 10.6 Laboratory Corporation of America Holdings
  • 10.7 Biomeva GmbH
  • 10.8 Samsung Biologics
  • 10.9 ProBioGen AG
  • 10.10 Boehringer Ingelheim GmbH
  • 10.11 Lonza Group AG
  • 10.12 CMC Biologics
  • 10.13 ICON Plc
  • 10.14 AbbVie Inc.
  • 10.15 Thermo Fisher Scientific Inc (Patheon & PPD)

List of Tables

  • Table 1 Global Biopharmaceutical CMO Market Outlook, By Region (2021-2030) ($MN)
  • Table 2 Global Biopharmaceutical CMO Market Outlook, By Product (2021-2030) ($MN)
  • Table 3 Global Biopharmaceutical CMO Market Outlook, By Biologics (2021-2030) ($MN)
  • Table 4 Global Biopharmaceutical CMO Market Outlook, By Antisense, RNAi, & Molecular Therapy (2021-2030) ($MN)
  • Table 5 Global Biopharmaceutical CMO Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
  • Table 6 Global Biopharmaceutical CMO Market Outlook, By Monoclonal antibodies (MAbs) (2021-2030) ($MN)
  • Table 7 Global Biopharmaceutical CMO Market Outlook, By Vaccines (2021-2030) ($MN)
  • Table 8 Global Biopharmaceutical CMO Market Outlook, By Other Biologics (2021-2030) ($MN)
  • Table 9 Global Biopharmaceutical CMO Market Outlook, By Biosimilars (2021-2030) ($MN)
  • Table 10 Global Biopharmaceutical CMO Market Outlook, By Other Products (2021-2030) ($MN)
  • Table 11 Global Biopharmaceutical CMO Market Outlook, By Source (2021-2030) ($MN)
  • Table 12 Global Biopharmaceutical CMO Market Outlook, By Non-mammalian (2021-2030) ($MN)
  • Table 13 Global Biopharmaceutical CMO Market Outlook, By Mammalian (2021-2030) ($MN)
  • Table 14 Global Biopharmaceutical CMO Market Outlook, By Other Sources (2021-2030) ($MN)
  • Table 15 Global Biopharmaceutical CMO Market Outlook, By Service (2021-2030) ($MN)
  • Table 16 Global Biopharmaceutical CMO Market Outlook, By Contract Manufacturing (2021-2030) ($MN)
  • Table 17 Global Biopharmaceutical CMO Market Outlook, By Analytical & QC Studies (2021-2030) ($MN)
  • Table 18 Global Biopharmaceutical CMO Market Outlook, By Fill & Finish Operations (2021-2030) ($MN)
  • Table 19 Global Biopharmaceutical CMO Market Outlook, By Process Development (2021-2030) ($MN)
  • Table 20 Global Biopharmaceutical CMO Market Outlook, By Downstream (2021-2030) ($MN)
  • Table 21 Global Biopharmaceutical CMO Market Outlook, By Upstream (2021-2030) ($MN)
  • Table 22 Global Biopharmaceutical CMO Market Outlook, By Packaging (2021-2030) ($MN)
  • Table 23 Global Biopharmaceutical CMO Market Outlook, By Contract Research (2021-2030) ($MN)
  • Table 24 Global Biopharmaceutical CMO Market Outlook, By Inflammation & Immunology (2021-2030) ($MN)
  • Table 25 Global Biopharmaceutical CMO Market Outlook, By Neuroscience (2021-2030) ($MN)
  • Table 26 Global Biopharmaceutical CMO Market Outlook, By Oncology (2021-2030) ($MN)
  • Table 27 Global Biopharmaceutical CMO Market Outlook, By Cardiology (2021-2030) ($MN)
  • Table 28 Global Biopharmaceutical CMO Market Outlook, By Other Services (2021-2030) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.