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1351099

2030 年生物製藥 CMO 市場預測：按產品、原產地、服務和地區進行的全球分析

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個工作天內

價格

根據Stratistics MRC預測，2023年全球生物製藥CMO市場規模將達151.8億美元，預計2030年將達到394.1億美元，預測期內年複合成長率為14.6%。

生物製藥 CMO，通常稱為合約製造組織，是為生物製藥行業的其他企業（包括包裝和藥品製造）提供合約服務的企業。這使得主要的生物製藥公司能夠外包其製造流程，並專注於新藥的開發和行銷。由於缺乏內部生產能力，許多小型生物技術公司透過外包其填充和成品製造要求來避免資本投資。

據印度藥品工業協會（IDMA）稱，截至2021年7月，基本藥物原料（即製藥行業的API）成本已較疫情前水平飆升約140%，給印度醫藥行業帶來了挑戰。工業.馬蘇.

原料藥生產需求不斷增加

活性藥物原料藥(API) 的生產需求持續成長。這是由於與老化和癌症相關的疾病日益患病、全球學名藥生產能力不斷提高以及生物創新。因此，市場參與企業將重點放在開拓生物原料藥和擴大原料藥產能。因此，預計生物製藥和小分子原料藥領域都有更好的預測，並且這種趨勢預計將在整個預測期內持續下去。

嚴格的指導方針和要求

CRO（委外研發機構）由 FDA（食品藥物管理局）定義和管理。 FDA 也有權要求 CRO 直接對其在臨床實驗申請中承擔的申辦者責任負責。 FDA 必須確保臨床實驗正確進行並符合良好臨床實務和協調的標準。嚴格的法律規範和法規是阻礙市場擴張的主要要素之一。

強大的生物製劑管道

隨著製藥和生物技術公司在合約製造和開發服務上投入更多資金，該行業將繼續擴大。生物製藥受託製造廠商市場預計將出現兩位數成長，中小型 CMO 的成長速度預計將快於大型 CMO。高成長率主要是由於計劃推出的生物製劑管道數量不斷增加。隨著開發中的生物製藥數量不斷增加，對外包服務的需求將大幅增加。

推出成本高且外包有限

在一定程度上限制市場擴張的主要挑戰包括建立生產設施所需的高昂初期成本以及以更快的速度擴大生物製造所需的額外資本投資。服務本身的複雜性和法律環境都被認為使 CMO 與客戶談判合約變得困難。由於智慧財產權、保固、成本和交貨日期等問題，客戶和 CMO 之間的談判非常困難。

COVID-19 的影響：

疫情已成為全球重大公共衛生議題。這場大流行的影響最初是在中國發現的，現在已經波及到其他地區。醫療保健行業的收入成長受到顯著影響。然而，全球市場都出現了有利的需求衝擊。成長率的大幅成長主要是由於 CMO 增加了生物製藥合約的分配。在生物製藥領域，隨著COVID-19的影響持續蔓延，我們正專注於開發高效、安全的疫苗來預防感染，並創造和研究新藥物來治療病毒感染者。

預計哺乳動物市場在預測期內將是最大的市場

由於該行業缺乏專業知識，預計哺乳動物市場在預測期內將成為最大的市場。他們透過類人轉譯後修飾增強複雜蛋白質加工的能力證明了這一點。已經鑒定多種微生物，並且正在利用創造性策略來挖掘它們的潛力。該領域還受益於新的和改進的表達系統的開發、製程監控解決方案的增加、細胞株工程工具、自動篩選技術和拋棄式設備。

合約製造領域預計在預測期內年複合成長率最高。

合約製造領域預計在預測期內年複合成長率最高。該地區擁有許多 CMO，它們積極為生物製藥公司提供從細胞培養到填充和加工服務等廣泛的端到端服務。客戶產品開發計畫的製造部門也獲得了大量投資。隨著專注於開拓生物製藥市場的新參與企業選擇合約研究服務來尋找新候選化合物，該領域的成長預計將加速。

佔比最大的地區：

預計北美在預測期內將佔據最大的市場佔有率。這是由於同一地區存在多個服務提供者。此外，美國核准的產品中很大一部分是由集體生產組織生產的。還有許多中小型生物製藥公司缺乏建造資源齊全的設施所需的資金和資源。結果，集體管理組織和中小企業之間的相互依賴增加，導致市場寡占。

複合年複合成長率最高的地區：

由於聚合物產量高，預計亞太地區在預測期內將維持最高的年複合成長率。全球生物相似藥核准法規缺乏一致性，對該市場造成了重大影響。該地區的強勁成長主要歸功於越來越多的 CMO 在各國開設製造工廠。由於該地區人口眾多以及糖尿病、癌症和其他慢性病等各種疾病的患病不斷上升，預計市場參與者將享有良好的成長預測。

免費客製化服務：

訂閱此報告的客戶可以存取以下免費自訂選項之一：

  • 公司簡介
    • 其他市場參與者的綜合分析（最多 3 家公司）
    • 主要企業SWOT分析（最多3家企業）
  • 區域分割
    • 根據客戶興趣對主要國家的市場估計、預測和年複合成長率（註：基於可行性檢查）
  • 競爭基準化分析
    • 根據產品系列、地理分佈和策略聯盟對主要企業基準化分析

目錄

第1章 執行摘要

第2章 前言

  • 概述
  • 利害關係人
  • 調查範圍
  • 調查方法
    • 資料探勘
    • 資料分析
    • 資料檢驗
    • 研究途徑
  • 調查來源
    • 主要調查來源
    • 二次調查來源
    • 先決條件

第3章 市場趨勢分析

  • 促進因素
  • 抑制因素
  • 機會
  • 威脅
  • 產品分析
  • 新興市場
  • 新型冠狀病毒感染疾病（COVID-19）的影響

第4章 波特五力分析

  • 供應商的議價能力
  • 買方議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭公司之間的敵對關係

第5章 全球生物製藥 CMO 市場：按產品

  • 生物製品
    • 反義、RNAi、分子治療
    • 重組蛋白
    • 單株抗體 (MAb)
    • 疫苗
    • 其他生物製品
  • 生物相似藥
  • 其他產品

第6章 全球生物製藥 CMO 市場：依來源分類

  • 非哺乳動物
  • 哺乳動物的
  • 其他產地

第7章 全球生物製藥 CMO 市場：依服務分類

  • 合約起草（名詞
    • 分析和品質控制研究
    • 填充和整理操作
    • 製程開發
      • 下游
      • 上游
    • 包裝
  • 委託研究
    • 發炎和免疫學
    • 神經科學
    • 腫瘤學
    • 心臟病學
  • 其他服務

第8章 全球生物製藥CMO市場：按地區

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲

第9章 進展

  • 合約、夥伴關係、協作和合資企業
  • 收購和合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第10章 公司簡介

  • 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.