生物生产市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

Publication Month : Nov 2023

  • Report Code : TIPRE00030322
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 209
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【研究报告】生物生产市场规模预计将从2022年的223.3724亿美元增长到2030年的633.9393亿美元;预计 2022 年至 2030 年市场复合年增长率为 13.9%。
市场洞察和分析师观点:
自动化可以为细胞疗法开发商带来许多好处,包括降低污染风险、提高一致性和降低成本的生产。许多公司都提供了实现自动化的设备,例如 Miltenyi 的 Lonza Cocoon 和 CliniMACS Prodigy 系统,这些系统旨在实现单个系统内 CAR-T 流程的大多数连续单元操作的自动化。越来越多的细胞疗法已将全球细胞治疗产品的生产从小批量转向大批量。此外,细胞疗法从学术和临床环境到大规模生产和商业化的发展正在增加对制造自动化的需求。细胞疗法研究活动的增加导致对先进制造解决方案的需求增加。有鉴于此,许多参与者正在提供产品来满足学术研究人员和大型生物技术公司的数字需求。例如,2019 年 5 月,GE Healthcare 推出了 Chronicle Web 应用程序,以支持完整的细胞治疗工作流程。 Chronicle 自动化软件是一款符合良好生产规范 (GMP) 的数字解决方案,旨在优化复杂的细胞治疗工艺开发和制造。
各公司也正在进入细胞治疗自动化的战略和技术开发。例如,2020 年 7 月,Thermo Fisher Scientific Inc. 和 Lyell Nutrition 合作开发和制造工艺,为癌症患者设计有效的细胞疗法。根据这一合作伙伴关系,两家公司的目标是提高 T 细胞的适应性,并支持开发符合现行良好生产规范 (cGMP) 的综合平台(系统和软件)以及试剂、耗材和仪器。 2019年3月,Lonza与以色列Sheba医疗中心合作,利用其护理点Cocoon细胞疗法制造平台提供自动化和封闭式CAR-T制造。因此,细胞治疗制造商越来越多地采用自动化预计将推动生物生产市场。
增长动力:
重磅生物制剂的专利到期为生物生产市场创造了机会
生物制剂代表了治疗以前无法治愈的疾病的有前途的新疗法,并且在制药市场中变得非常重要。原创生物制品的专利预计将在未来几年到期。
下表列出了最畅销生物制品的预计专利和独占权到期日期。
生物制品
到期日期
Avastin
2022 年 1 月
Cyramza
2023 年 5 月
Adcetris
2023 年 8 月
Abthrax
2024 年 10 月
Gazyva/Gazyvaro
2024 年 11 月
Darzalex
2026 年 5 月< Ocrevus
2027 年 4 月
Emgality
2028 年 9 月
Hemlibra
2028 年 2 月
Llumetri
2028 年 3 月
Imfinzi
2028 年 9 月
Mylotarg
2028 年 4 月
Imfinzi
2028 年 9 月
Mylotarg
2028 年 4 月
Sylvant
2034 年 7 月
来源:仿制药和生物仿制药计划 (GaBI) 杂志
专利到期和原研生物制品的其他知识产权将导致未来需要推出新的生物仿制药。因此,未来几年该行业市场参与者之间的竞争将加剧。因此,重磅生物制剂的专利到期预计将在预测期内为生物生产市场创造利润丰厚的机会。
战略见解
报告细分和范围:
“生物生产市场”根据以下因素进行细分:产品、应用、设备和最终用户。生物生产市场按产品细分为生物制品和生物仿制药、疫苗、细胞和基因疗法、核酸疗法等。 2022 年,生物制剂和生物仿制药领域占据最大市场份额;预计 2022 年至 2030 年,细胞和基因治疗领域的复合年增长率最高。根据应用,生物生产市场分为类风湿性关节炎、血液系统疾病、癌症、糖尿病、心血管疾病等。癌症细分市场在 2022 年占据最大市场份额,预计 2022 年至 2030 年复合年增长率最高。在设备方面,生物生产市场分为消耗品及配件、下游设备、生物反应器和上游设备。消耗品和配件领域在 2022 年占据最大的市场份额,预计在 2022 年至 2030 年期间将以最快的速度增长。生物生产市场按最终用户细分为生物制药公司、合同制造组织等。生物制药公司细分市场在 2022 年占据最大的市场份额。合同制造组织细分市场预计将在 2022 年至 2030 年期间实现最高的复合年增长率。
细分分析:
生物生产市场按产品细分生物制品和生物仿制药、疫苗、细胞和基因疗法、核酸疗法等。生物制剂和生物仿制药领域在 2022 年占据最大的市场份额。预计细胞和基因疗法领域在 2022 年至 2030 年期间的市场复合年增长率最高。细胞治疗和基因治疗是生物医学治疗和研究中的重叠领域。这两种疗法都旨在预防、治疗或潜在治愈疾病。此外,这两种疗法都可以改善遗传性疾病和后天性疾病的根本原因。细胞疗法旨在通过在注射到患者体内之前恢复或修改体外的几组细胞或使用细胞在全身进行治疗来治疗疾病。基因疗法旨在通过在体外(离体)或体内(体内)恢复或将新基因引入细胞来治疗疾病。基因疗法通过调整特定类型细胞中的基因并将其整合到体内来发挥作用。
生物生产市场,按产品 - 2022 年和 2030 年
按应用,生物生产市场分为类风湿关节炎、血液系统疾病、癌症、糖尿病、心血管疾病等。癌症细分市场在 2022 年占据最大市场份额,预计 2022 年至 2030 年复合年增长率最高。医疗费用的增加与癌症治疗的进步同时发生。生物仿制药的开发源于美国和全球优先考虑的降低昂贵肿瘤药物总体成本的战略和成本控制技术。由于多种原因,生物制剂在癌症治疗中至关重要。生物药物可以帮助患者的身体识别和对抗癌细胞。某些生物制剂通过干扰癌细胞的生长信号来直接靶向癌细胞。化疗后,各种生物制剂可以帮助对抗感染。在美国,结肠癌、胃癌和乳腺癌以及其他恶性肿瘤都可以使用 FDA 批准的生物仿制药进行治疗。它们还可以用于解决癌症治疗的副作用,例如白细胞计数减少,从而增加感染的可能性。生物制品在癌症治疗中被用作治疗剂和支持性护理剂。曲妥珠单抗(赫赛汀)是生物药物的一个例子,是一种用于治疗晚期胃癌和乳腺癌的靶向癌症药物。该药物的生物仿制药包括 Herzuma 和 Ontruzant。
区域分析:
从地理上看,全球生物生产市场分为北美、欧洲、亚太地区、南美洲和中美洲以及中东和非洲。 2022年,北美在全球生物生产市场中占据最大份额。亚太地区预计 2022 年至 2030 年复合年增长率最高。该地区的市场增长归因于对优质治疗解决方案的需求不断增长、对研发活动的日益关注以及有利的监管环境。此外,增加投资和发展医疗基础设施以促进研究活动预计将在 2022 年至 2030 年期间推动亚太地区生物生产市场的发展。
北美的生物生产市场进一步分为美国、加拿大和墨西哥。该地区的市场增长可归因于糖尿病和不孕症发病率的增加,以及生物仿制药产品开发的不断增加。
遗传和细胞疾病发病率的增加导致对细胞疗法的需求不断增加。 2020 年 PhRMA 关于细胞和基因治疗管道的报告显示,美国有 400 种细胞和基因疗法正在开发中,以针对从癌症到遗传性疾病到神经系统疾病等多种疾病和病症。截至 2020 年 2 月,美国批准了 9 种细胞或基因治疗产品,用于治疗癌症、眼病和罕见遗传病。此外,越来越多的初创企业正在该国创新细胞疗法。
在美国,生物仿制药用于治疗癌症、肾病、糖尿病和其他自身免疫性疾病(如克罗恩病和类风湿关节炎)的患者。据康德乐称,美国 FDA 已批准了 33 种生物类似药,其中 21 种已上市。在市场上的 21 种生物仿制药中,17 种用于治疗癌症,3 种用于治疗自身免疫性疾病,1 种用于治疗糖尿病。生物仿制药的价格预计比生物制剂低 15% 至 30%。仅 2020 年,生物仿制药就节省了 79 亿美元,随着更多的生物仿制药进入市场,节省的成本预计在未来几年将大幅增长。据 Cardinal Health 称,到 2025 年,生物仿制药预计将使美国药品支出减少 1330 亿美元。此外,政府不断加大的支持正在促进细胞疗法的增长,从而影响生物生产市场的增长。
据《癌症医学科学》报道,癌症在 2020 年墨西哥第三大死因中排名第三。墨西哥男性最常见的癌症类型是前列腺癌、结直肠癌、睾丸癌、肺癌和胃癌,而女性则主要罹患癌症来自乳腺癌、甲状腺癌、宫颈癌、子宫体癌和结直肠癌。在墨西哥,生物仿制药也称为生物仿制药。据 GaBI 称,墨西哥目前已批准以下治疗类别的 13 种生物可比药物:红细胞生成刺激剂、粒细胞集落刺激因子、内源性生长激素、卵泡刺激素 (FSH)、胰岛素、肿瘤坏死因子 (TNF) 抑制剂,以及抗病毒药物和干扰素。因此,越来越多的癌症疾病和生物仿制药产品的批准正在推动墨西哥生物生产市场的增长。
行业发展和未来机遇:
下面列出了生物生产市场领先企业的各种战略发展:
2023 年 3 月,Lonza 宣布其位于瑞士 Visp 的 cGMP 临床和商业药品生产线已竣工。新生产线将满足对临床和商业供应药品有一系列生产需求的客户。适用于多种模式的现代液体和冻干小瓶灌装隔离生产线是这个 1,200 平方米 cGMP 设施的一部分,满足无菌产品生产的 GMP 附件 1 要求。该生产线已全面投入运营并拥有cGMP许可证;计划于 2023 年 4 月填充第一批客户批次。
2022 年 5 月,FUJIFILM Irvine Scientific Inc 是开发和制造用于生物生产和细胞疗法制造的无血清和化学成分确定的细胞培养基的全球领导者,宣布其位于中国苏州新区的创新与合作中心落成。
2021 年 12 月,富士胶片欧文科学公司 (FUJIFILM Irvine Scientific Inc) 是一家全球领先的无血清和化学成分确定的细胞培养基开发和制造商,用于生物生产和细胞治疗制造宣布在中国苏州高新区设立创新合作中心。通过这个新中心,专家将与客户合作设计满足其生物制造需求的上游细胞培养工艺。
2023 年 3 月,BiVACOR Inc 的 Cormorant Asset Management 和 OneVentures 通过 OneVentures Healthcare Fund III 为该公司提供了 18 美元的资金万元资本。这些资金将帮助该公司聘请重要的高管,并支持其正在进行的研发以及人体试验的早期可行性研究。利用这笔财政援助,该公司将聘请研发专业人员和最高管理层等重要职位的候选人,作为其业务规模扩大一倍的努力的一部分。 BiVACOR Inc 还希望在 2023 年底之前首次在人类受试者中对其全人工心脏进行早期可行性研究。
竞争格局和主要公司:
Lonza Group AG、bbi-biotech GmbH、丹纳赫公司、Sartorius AG、FUJIFILM Irvine Scientific Inc、Thermo Fisher Scientific Inc、Merck KGaA、F. Hoffmann-La Roche Ltd 和 Bio-Rad Laboratories Inc 是生物生产市场上的知名公司。这些公司专注于新技术、升级现有产品和地域扩张,以满足全球不断增长的消费者需求。
Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

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

Country Scope
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Frequently Asked Questions


What is bioproduction?

Bioproduction is the process by which a living system produces biological molecules (proteins, antibodies, hormones, membranes, and other macromolecules) to treat diseases that are hard to treat with traditional chemical compounds, such as cancer, uncommon, chronic, or degenerative disorders. These cutting-edge treatment approaches include gene therapy, cell therapy, and vaccinations, among others. The expression of bioproduction is predicated on the structure and architecture of the biological system.

What are the driving factors for the bioproduction market across the globe?

The factors that are driving growth of the market are rising adoption of regenerative medicines and increasing prevalence of chronic diseases.

Who are the major players in the bioproduction market?

The bioproduction market majorly consists of the players such as Lonza Group AG, bbi-biotech GmbH, Danaher Corp, Sartorius AG, FUJIFILM Irvine Scientific Inc, Thermo Fisher Scientific Inc, Merck KGaA, F. Hoffmann-La Roche Ltd, and Bio-Rad Laboratories Inc. among others.

Which country is dominated the bioproduction market?

US holds the largest market share in bioproduction market. Growing incidences of genetic and cellular disorders are leading to increasing demand for cell therapies. A 2020 PhRMA report on the cell and gene therapy pipeline revealed that there are 400 cell and gene therapies in development to target a variety of diseases and conditions from cancer to genetic disorders to neurologic conditions in the US.

Which product segment is dominating the bioproduction market?

The bioproduction market, based on product, is segmented into biologics and biosimilars, vaccines, cell and gene therapies, nucleic acid therapeutics, and others. In 2022, the biologics and biosimilars segment held the largest share of the market. Moreover, the cell and gene therapies segment is expected to record higher CAGR during 2022-2030.

Which region is the fastest growing the bioproduction market?

Asia Pacific is expected to be the fastest growing region in the bioproduction market. The growth of the market in Asia Pacific is anticipated to grow at a faster pace owing to factors such as growing need for superior treatment solutions, increasing focus on research and development activities, and favorable regulatory scenarios. Additionally, increasing investments and developing healthcare infrastructure to boost research activities are estimated to drive the Asia Pacific bioproduction market during 2022–2030.

Which application segment is dominating the bioproduction market?

The bioproduction market, based on application, is segmented into, rheumatoid arthritis, hematological disorders, cancer, diabetes, cardiovascular diseases, and others. The cancer segment held a larger market share in 2022 and is anticipated to register a highest CAGR during 2022–2030.

Which end user segment is dominating the bioproduction market?

The bioproduction market, based on end user, classified into biopharmaceutical companies, contract manufacturing organizations, and others. The biopharmaceutical companies segment held the largest share of the market in 2022. However, the contract manufacturing organizations is anticipated to register the highest CAGR in the market during 2022–2030.

The List of Companies - Bioproduction Market

  1. Thermo Fisher Scientific Inc           
  2. Merck KGaA         
  3. F. Hoffmann-La Roche Ltd              
  4. Bio-Rad Laboratories Inc                  
  5. Lonza Group AG  
  6. bbi-biotech GmbH  
  7. Danaher Corp      
  8. Sartorius AG         
  9. FUJIFILM Irvine Scientific 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.

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

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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:

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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.

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  • 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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