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1557254

全球細胞株開發市場 - 2024 年至 2029 年預測

Global Cell Line Development Market - Forecasts from 2024 to 2029
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 140 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

細胞株開發市場預計將從 2024 年的 42.97 億美元增至 2029 年的 80.47 億美元，預測期內複合年成長率為 13.37%。

細胞株係被定義為可以在培養物中長期維持的細胞群。細胞株開發是一種細胞機器產生治療性蛋白質的技術。這使得生物醫學研究人員能夠以具有成本效益的規模最佳化和生產藥物。

細胞株開發市場成長的關鍵驅動力之一是製藥和醫療市場的擴張。全球製藥和醫療產品的成長使製造商能夠開發更具成本效益的藥物並進入商業市場。歐盟統計局表示，該地區藥品進口額將從2022年的約1,200億美元（1,120億歐元）增加到2023年的約1,287億美元（1,190億歐元）。在進口方面，比利時是該地區最大的藥品進口國，2023年進口額約281億美元（260億歐元），其次是德國216億美元（200億歐元）和荷蘭173億歐元其次是160 億美元（160 億歐元）。

此外，在全球細胞疫苗開發研究計畫增加的推動下，細胞株開發市場預計將迅速擴大。預計這將在預測期內對市場產生積極影響。此外，抗體的不斷進步預計將進​​一步增加全球對細胞株開發服務的需求。

推動細胞株開發市場的因素

  • 對單株抗體和疫苗的需求不斷增加預計將推動細胞株開發市場的發展。

單株抗體是實驗室開發的抗體變體，可作為替代抗體，也可以模擬對免疫系統細胞的攻擊。細胞株開發過程描述了單株抗體和疫苗等多種生物產品的有效工程和生產。全球癌症、COVID-19 和伊波拉出血熱等致命疾病病例的增加預計將促進單株抗體的成長，並擴大細胞株開發的全球市場規模。

隨著全球疾病病例的增加，全球對疫苗的需求也大幅增加。根據世界綜合貿易解決方案，比利時2023年人用醫用疫苗進口總額將為124.33億美元，其次是美國約92.74億美元，歐盟為73.76億美元。 2023年，中國和德國的進口額分別約為62.25億美元和46.65億美元。

細胞株開發市場的限制因素

  • 高投資成本可能會阻礙細胞株開發市場的成長。

由於基礎設施投資成本高昂，全球細胞株開發市場面臨挑戰。此外，建立細胞培養研究設施需要在設備、無塵室設施、品管設備、合格的勞動力、持續的培訓計劃、全面的測試和文件記錄等方面進行大量投資。招募和留住最優秀的研究人員、工程師和專家成本高昂，而滿足監管先決條件則需要更多的時間和金錢。總體而言，這些成本對細胞株開發市場的成長構成了重大挑戰。

細胞株開發市場的地域展望

  • 美國預計將佔據很大的市場佔有率。

預計美國等新興經濟體在細胞株開發市場的預測期內將顯著成長。這是由於研發舉措的增加以及對先進製程的投資增加。

此外，美國公司擴大投資於生物相似藥的研究，這可能會增加未來幾年對細胞株大規模生產的需求。例如，2024年，美國食品藥物管理局（USFDA）核准Bkemv（eculizumab-aeeb）作為第一個可互換的生物相似藥，用於治療兩種罕見疾病。同樣，該機構每年都會批准多種蛋白質，包括重組蛋白質和治療性蛋白質。這代表了對疫苗、生物相似藥、藥品和治療性蛋白質的需求不斷增加，並將支持該地區細胞株開發的擴展。

此外，行業公司對新興市場的開拓預計將有助於長期市場發展。例如，2023年，美國領先主要企業之一的Berkeley Lights, Inc.宣布推出Beacon Select，這是一種用於細胞株開發（CLD）的新型光流控系統。該產品是一種兩晶片信標系統，允許科學家使用一個平台在一次運行中培養、克隆和選擇頂級克隆。這對於中小型生物製藥公司和其他 CRO/CDMO 來說是理想的選擇。

此外，CIRM（加州再生醫學研究所）在 2024 年 4 月的會議上宣布，將投資約 8,900 萬美元用於各種臨床計畫。預計此類干預措施將為細胞株開發市場增添動力，並在預測期內為細胞疫苗新興市場提供有利條件。

細胞株開發的主要市場參與企業：

  • Lonza-Lonza 是提供細胞株開發服務的全球領導者之一。該公司擁有超過 35 年的經驗，持有800 多個來自 GMP 製造的細胞株。該公司為所有分子形式提供一整套細胞株開發 (CLD) 服務。本公司致力於提供哺乳動物細胞培養製程開發服務。我們還提供最佳化和檢驗服務，以滿足從小型到大型實驗室的所有生物製藥開發商的需求。
  • Biofactura - Biofactura 提供了一個生物製造平台，支援快速生成用於生物製藥製造的穩定 NS0細胞株。該公司專注於生物相似藥和生物防禦，提供創新技術，例如用於加速生物製造的 StableFast(TM) 平台。
  • KBI Biopharma - KBI Biopharma 被認為是全球優質先進哺乳動物細胞株開發的主要企業之一。該公司在歐洲和美國經營眾多工廠，專注於高效生產的先進創新。

目錄

第1章簡介

  • 市場概況
  • 市場定義
  • 調查範圍
  • 市場區隔
  • 貨幣
  • 先決條件
  • 基準年和預測年時間表
  • 相關人員的主要利益

第2章調查方法

  • 研究設計
  • 調查過程

第3章執行摘要

  • 主要發現

第4章市場動態

  • 市場促進因素
  • 市場限制因素
  • 波特五力分析
  • 產業價值鏈分析
  • 分析師觀點

第5章全球細胞株開發市場：按類型

  • 介紹
  • 重組細胞株
  • 融合瘤
  • 連續性細胞株
  • 初代細胞系

第6章全球細胞株開發市場：依來源分類

  • 介紹
  • 哺乳動物細胞株開發
  • 非哺乳動物細胞株開發

第7章細胞株開發的全球市場：依應用分類

  • 介紹
  • 藥物發現
  • 研究
  • 其他

第8章全球細胞株開發市場：按地區

  • 介紹
  • 北美洲
    • 按類型
    • 按來源
    • 按用途
    • 按國家/地區
  • 南美洲
    • 按類型
    • 按來源
    • 按用途
    • 按國家/地區
  • 歐洲
    • 按類型
    • 按來源
    • 按用途
    • 按國家/地區
  • 中東/非洲
    • 按類型
    • 按來源
    • 按用途
    • 按國家/地區
  • 亞太地區
    • 按類型
    • 按來源
    • 按用途
    • 按國家/地區

第9章競爭環境及分析

  • 主要企業及策略分析
  • 新興參與企業和巨大的盈利
  • 合併、收購、協議和合作
  • 競爭對手儀表板

第10章 公司簡介

  • Lonza
  • Biofactura
  • WuXi AppTec
  • KBI Biopharma
  • ATUM
  • Fusion Antibodies plc
  • Selexis
  • In Vivo
  • Celonic AG
  • Merck KGaA
  • Imgenex India
  • Bhat Biotech
  • Premas Biotech
  • Aragen Life Science
  • Chitose Group
簡介目錄
Product Code: KSI061612090

The global cell line development market is projected to grow at a CAGR of 13.37% over the forecast period, from US$4.297 billion in 2024 to reach US$8.047 billion by 2029.

The cell line is defined as the population of cells that can be maintained in culture for a longer period. Cell line development is the technique through which the cellular machinery manufactures therapeutic proteins. This enables biomedical researchers to optimize and produce drugs at a cost-efficient scale.

One of the major drivers for the global cell line development market growth can be the expanding pharmaceutical and medicine market. Global pharmaceutical and medicine product growth will enable manufacturers to develop more cost-effective drugs to advance in the commercial market. The Eurostat stated that the region's medicine and pharmaceutical products imports increased from about US$120 billion (Euro 112 billion) in 2022 to about US$128.7 billion (Euro 119 billion) in 2023. In this import, Belgium became the biggest importer of medicinal and pharmaceutical products in the region, importing about US$28.1 billion (Euro 26 billion), followed by Germany and the Netherlands at US$21.6 billion (Euro 20 billion) and US$17.3 billion (Euro 16 billion) respectively, in 2023.

Additionally, the global cell line development market is expected to expand rapidly, fueled by rising research programs for cell-based vaccine development worldwide. This is expected to have a favorable market influence during the projected period. Further, the increase in advancement related to antibodies is expected to further elevate the necessity for cell line development services worldwide.

GLOBAL CELL LINE DEVELOPMENT MARKET DRIVERS:

  • An increase in the demand for monoclonal antibodies and vaccines is expected to boost the global cell line development market.

Monoclonal antibodies are the variants of antibodies developed in research laboratories to work as substitute antibodies, which can also mimic the immune system's attack on cells. The cell line development process provides effective engineering and production of diverse biological products, such as monoclonal antibodies and vaccines. The increase in the worldwide cases of deadly diseases, such as cancer, COVID-19, Ebola, and others, is predicted to bolster the growth of monoclonal antibodies, growing the global market size of cell line development.

With the increase in disease cases globally, the worldwide requirement for vaccines has grown substantially. The World Integrated Trade Solution stated that in 2023, Belgium's total import of vaccines for human medicine accounted for US$12.433 billion, followed by the US at about US$9.274 billion and the EU at US$7.376 billion. The imports of China and Germany in 2023 accounted for about US$6.225 billion and US$4.665 billion, respectively.

GLOBAL CELL LINE DEVELOPMENT MARKET RESTRAINTS:

  • High investment costs could hinder the global cell line development market's growth.

The worldwide cell line development market faces challenges due to high investment costs in infrastructure. Moreover, setting up a cell culture research facility requires significant investments in equipment, cleanroom facilities, quality control equipment, a talented workforce, persistent training programs, and thorough testing and documentation. Hiring and retaining profoundly qualified researchers, engineers, and professionals is costly, and meeting regulatory prerequisites moreover requires noteworthy time and monetary resources. Overall, these costs substantially challenge the global cell line development market's growth.

Global Cell Line Development Market Geographical Outlook

  • The United States region is anticipated to have a significant market share.

Developed economies such as the United States are anticipated to account for significant growth during the projected cell line development market period. This is owing to the rising research and development initiatives coupled with increased investment in advanced processes in the country.

Additionally, the increasing investment in research regarding biosimilars by companies in the United States will drive demand for cell line large-scale production in the coming years. For instance, in 2024, the US Food and Drug Administration (USFDA) approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar for the treatment of two rare diseases. Similarly, the administration authorizes various proteins annually, including recombinant and therapeutic proteins. This shows the increasing requirement for vaccines, biosimilars, pharmaceuticals, and therapeutic proteins that will boost the expansion of cell line development in the region.

Moreover, the major developments in the market by industry players are expected to contribute to its long-term development. For instance, in 2023, Berkeley Lights, Inc., one of the leading companies in the United States, announced the launch of Beacon Select, the new optofluidic system for cell line development (CLD). The product is a two-chip beacon system that enables scientists to culture, clone, and select the top clone in a single run using a single platform. This is ideally most suitable for small to mid-sized biopharma set-ups and other CROs/CDMOs as well.

Moreover, CIRM (California Institute of Regenerative Medicine) announced an investment of around US$89 million in various clinical programs in its 2024 April meeting. Such interventions are expected to provide impetus for the cell line development market and thereby also provide favorable ground for advancement in cell-based vaccines in the forecast period.

Global Cell Line Development Key Market Players:

  • Lonza- Lonza is among the global leaders providing cell line development services. The company has over 35 years of experience, with over 800 cell lines taken from GMP manufacturing. It delivers a complete suite of cell line development (CLD) services for any molecular format. The company strives to provide services for the development of mammalian cell culture processes. It also covers the optimization and validation services to fulfill the needs of all biopharma drug developers, small to large laboratories, among others
  • Biofactura- Biofactura offers its biomanufacturing Platform, which helps rapidly generate stable NS0 cell lines for biopharmaceutical manufacturing. The company strongly focuses on biosimilars and biodefense, providing innovative technology such as StableFast(TM) platform for faster biomanufacturing. The company's experienced group, with a robust track record in the industry, guarantees effective and viable production.
  • KBI Biopharma - KBI Biopharma is regarded as one of the leading players in premium advanced mammalian cell line development worldwide. The company operates numerous facilities in Europe and the US, focusing on progressed innovations for effective production.

Market Segmentation:

Global Cell Line Development Market is segmented and analyzed as below:

By Type

  • Recombinant Cell Lines
  • Hybridomas
  • Continuous Cell Lines
  • Primary Cell Lines

By Source

  • Mammalian Cell Line Development
  • Non-Mammalian Cell Line Development

By Application

  • Drug discovery
  • Research
  • Others

By Geography

  • North America
  • USA
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • United Kingdom
  • Germany
  • France
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • Israel
  • Others
  • Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Indonesia
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base and Forecast Years Timeline
  • 1.8. Key benefits for the stakeholders

2. RESEARCH METHODOLOGY

  • 2.1. Research Design
  • 2.2. Research Process

3. EXECUTIVE SUMMARY

  • 3.1. Key Findings

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis
  • 4.5. Analyst view

5. GLOBAL CELL LINE DEVELOPMENT MARKET BY TYPE

  • 5.1. Introduction
  • 5.2. Recombinant Cell Lines
  • 5.3. Hybridomas
  • 5.4. Continuous Cell Lines
  • 5.5. Primary Cell Lines

6. GLOBAL CELL LINE DEVELOPMENT MARKET BY SOURCE

  • 6.1. Introduction
  • 6.2. Mammalian Cell Line Development
  • 6.3. Non-Mammalian Cell Line Development

7. GLOBAL CELL LINE DEVELOPMENT MARKET BY APPLICATION

  • 7.1. Introduction
  • 7.2. Drug Discovery
  • 7.3. Research
  • 7.4. Others

8. GLOBAL CELL LINE DEVELOPMENT MARKET BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. By Type
    • 8.2.2. By Source
    • 8.2.3. By Application
    • 8.2.4. By Country
      • 8.2.4.1. USA
      • 8.2.4.2. Canada
      • 8.2.4.3. Mexico
  • 8.3. South America
    • 8.3.1. By Type
    • 8.3.2. By Source
    • 8.3.3. By Application
    • 8.3.4. By Country
      • 8.3.4.1. Brazil
      • 8.3.4.2. Argentina
      • 8.3.4.3. Others
  • 8.4. Europe
    • 8.4.1. By Type
    • 8.4.2. By Source
    • 8.4.3. By Application
    • 8.4.4. By Country
      • 8.4.4.1. United Kingdom
      • 8.4.4.2. Germany
      • 8.4.4.3. France
      • 8.4.4.4. Spain
      • 8.4.4.5. Others
  • 8.5. Middle East and Africa
    • 8.5.1. By Type
    • 8.5.2. By Source
    • 8.5.3. By Application
    • 8.5.4. By Country
      • 8.5.4.1. Saudi Arabia
      • 8.5.4.2. Israel
      • 8.5.4.3. Others
  • 8.6. Asia Pacific
    • 8.6.1. By Type
    • 8.6.2. By Source
    • 8.6.3. By Application
    • 8.6.4. By Country
      • 8.6.4.1. Japan
      • 8.6.4.2. China
      • 8.6.4.3. India
      • 8.6.4.4. South Korea
      • 8.6.4.5. Indonesia
      • 8.6.4.6. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Emerging Players and Markey Lucrativeness
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.4. Competitive Dashboard

10. COMPANY PROFILES

  • 10.1. Lonza
  • 10.2. Biofactura
  • 10.3. WuXi AppTec
  • 10.4. KBI Biopharma
  • 10.5. ATUM
  • 10.6. Fusion Antibodies plc
  • 10.7. Selexis
  • 10.8. In Vivo
  • 10.9. Celonic AG
  • 10.10. Merck KGaA
  • 10.11. Imgenex India
  • 10.12. Bhat Biotech
  • 10.13. Premas Biotech
  • 10.14. Aragen Life Science
  • 10.15. Chitose Group