基于(关键地区、市场参与者、规模和份额)的生物制药合同制造市场 - 到 2031 年的预测

  • Report Code : TIPRE00005512
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 211
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[研究报告]生物制药合同制造市场预计将从2021年的157.3504亿美元增至2028年的278.685亿美元;预计2021年至2028年复合年增长率为8.5%。

制药公司外包的增加是推动该行业增长的最关键因素之一。市场。几年前,合同制造行业是一个利基服务市场,为制药公司提供额外的制造能力或特定服务。药品生产失败数量的增加推动了 CMO 的兴起。过去,制药公司承担生产设施来开发创新药物。但为了降低产能过剩风险,制造业外包需求不断上升。最近,Revolo Biotherapeutics 与合同开发和制造组织 (CDMO)——Northway Biotech——建立了合作伙伴关系,生产 Revolo 的结合免疫调节蛋白 1805。该合作伙伴关系包括从细胞系开发到制造蛋白质的服务,并具有质量保证和监管合规支持。同样,自 2021 年以来,Gland Pharma 一直在为包括 Mylan 在内的四家公司生产瑞德西韦。此外,由于公司的高需求,该组织还增加了生产配额。 2019年,三星生物制品公司与GI Innovation公司签署了免疫化疗合同。根据该协议,三星生物制品公司将提供从 f 细胞系开发到 I 期原料药生产的服务。生物制药公司与合同制造公司之间的合同数量不断增加,表明生物制药合同制造市场的市场规模不断扩大。

北美可能会继续在生物制药合同制造中占据主导地位2021-2028 年市场。美国占据北美市场最大份额,预计在预测期内将继续这一趋势。临床试验需求的增加、制药和医疗器械行业的发展、医疗保健支出的增加、研发支出的增加以及该地区提供制造、存储、物流和其他服务的主要市场参与者的存在可能会增强市场在该国的增长。例如,Alderley Analytical、Almac 等都是著名的制造组织,为 600 多家制药和生物技术公司提供广泛的综合服务。该地区生物制药公司的存在及其在收入、技术和就业机会方面的重大影响预计将有助于该地区市场的增长。

战略见解

生物制药合同制造市场利润丰厚的区域

市场洞察

生物制剂需求不断增长市场增长

由于生物制剂管道不断增加、制造复杂性以及公司将重点转向核心活动,生物制剂合同制造市场正在以前所未有的速度增长。目前,许多制药和生物技术公司外包从早期药物开发到商业规模制造的各种服务。需要外包来加快研发、加快市场进入、提供新技术、监管专业知识并以有竞争力的成本降低风险。生物制剂开发和生产的复杂性以及日益严格的质量标准促使药品制造商更喜欢合同制造商服务。此外,许多公司选择 CMO 服务来加快开发过程并降低生产成本。例如,赛诺菲已将其生物制剂管道的制造外包给勃林格殷格翰。此外,太脉生物的伊巴利珠单抗(FDA指定孤儿药)由CMO药明康德生产。此外,2021年,三星生物制品公司从2020年起扩大了与阿斯利康的合作。该合同包括生产阿斯利康的COVID-19长效抗体组合药物,以及从2022年开始生产癌症免疫治疗产品。

基于产品的洞察

基于产品,生物制药合同制造市场分为生物仿制药和生物制剂。由于预测期内对生物制剂的需求不断增加,以及针对慢性适应症开发新药的研究和开发活动不断增加,生物制剂领域在 2021 年占据了最大的市场份额。该细分市场进一步细分为单克隆抗体、重组蛋白、疫苗等。由于重磅药物的专利到期和管道不断增加,预计生物仿制药市场在预测期内将实现最高的复合年增长率。

生物制药合同制造市场,按产品分类2021年和2028年

服务洞察

生物制药合同制造市场按服务细分为工艺开发、灌装和完成操作、分析和质量控制研究以及包装。 2021年,由于更加注重从中试到商业化的放大工艺开发、细胞系开发和其他工艺,工艺开发在全球生物制药合同制造市场中占据了最大的市场份额。然而,由于严格的监管规定和生物制剂复杂的制造要求,分析和质量控制研究预计在预测期内将以显着的复合年增长率增长。

在以下地区运营的公司生物制药合同制造市场采用产品创新策略来满足世界各地不断变化的客户需求,这也使他们能够在全球市场上保持自己的品牌声誉。此外,市场上的公司与生物制药公司建立合作伙伴关系、合作和合同,以进一步推动市场收入。

生物制药合同制造市场 -细分

根据产品,生物制药合同制造市场分为生物制剂和生物仿制药。生物制品细分市场进一步细分为单克隆抗体、重组蛋白、疫苗等。

按服务划分,生物制药合同制造市场细分为工艺开发、灌装和生产。完成操作、分析和质量控制研究以及包装。

根据来源,生物制药合同制造市场分为哺乳动物和微生物生物制剂/非生物制剂哺乳动物。

生物制药合同制造市场 –按地域划分

按照地域划分,生物制药合同管理市场主要分为北美、欧洲、亚太地区、中东和非洲以及南美洲和中美洲。北美市场进一步细分为美国、加拿大和墨西哥。欧洲生物制药合同管理市场细分为德国、法国、英国、西班牙、意大利和欧洲其他地区。亚太地区的市场细分为中国、印度、日本、澳大利亚、韩国和亚太其他地区。中东和非洲的生物制药合同管理市场进一步细分为沙特阿拉伯、阿联酋、南非以及中东和非洲其他地区。南美洲和中美洲市场细分为巴西、阿根廷以及南美洲和中美洲其他地区。

公司简介

  • Lonza AG
  • Boehringer Ingelheim Biopharmaceuticals GmbH
  • Inno Bio Ventures Sdn Bhd
  • Thermo Fisher Scientific, Inc.
  • Inno Bio Ventures Sdn Bhd
  • Thermo Fisher Scientific, Inc.
  • >
  • 艾伯维公司
  • 药明生物制品公司
  • 通用电气公司
  • 三星生物制品有限公司
  • 默克公司
  • 味之素有限公司
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


What is biopharmaceuticals contract manufacturing?

Biopharmaceuticals contract manufacturing refers to biopharmaceutical companies outsourcing the development and manufacturing of drugs substances and products to contract manufacturers with the necessary resources to manufacture their products. Biopharmaceutical contract manufacturing organizations (CMOs) have become a known name among pharmaceutical companies due to their cost effective services that require minimal capital investments by the biopharmaceutical company. The CMOs offer a wide range of services including process development, analytical and quality control studies, fill and finish operations, and packaging. Moreover, the growing biopharma industry is offering lucrative opportunities for the growth of the market.

What are the driving factors for the biopharmaceuticals contract manufacturing market across the globe?

The factors that are driving the growth of the market are increasing demand for biologics, growing biosimilar pipelines, stringent regulatory guidelines, and increasing outsourcing by pharmaceutical companies. Moreover, emerging markets are offering lucrative opportunities owing to the increasing number of contract manufacturers in developing countries.

Who are the major players in the biopharmaceuticals contract manufacturing market?

The biopharmaceutical contract manufacturing market majorly consists of the players such as Lonza AG, Boehringer Ingelheim Biopharmaceuticals GmbH, Inno Bio Ventures Sdn Bhd, Thermo Fisher Scientific, Inc., AbbVie, Inc., WuXi Biologics, Inc., General Electric Co., Samsung Biologics Co. Ltd., Merck KGaA, and Ajinomoto Co. Inc., among others.

The List of Companies - Biopharmaceuticals Contract Manufacturing Market

  1. Lonza AG
  2. Boehringer Ingelheim Biopharmaceuticals GmbH
  3.  Inno Bio Ventures Sdn Bhd
  4. Thermo Fisher Scientific, Inc.  
  5. AbbVie, Inc.
  6. WuXi Biologics, Inc.
  7. General Electric Co.
  8. Samsung Biologics Co. Ltd.
  9. Merck KGaA
  10. Ajinomoto Co. Inc.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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