幹細胞製造の市場規模、シェア、成長分析、製品別、用途別、エンドユーザー別、地域別 - 産業予測、2024年～2031年

幹細胞製造の市場規模は2022年に125億8,000万米ドルと評価され、予測期間（2024-2031年）のCAGRは9.4%で、2023年の137億6,000万米ドルから2031年には282億3,000万米ドルに成長する見通しです。

世界の幹細胞製造市場は、慢性疾患の罹患率の上昇と再生医療に対する需要の増加によって力強い成長を遂げています。幹細胞療法は、心血管疾患、神経変性疾患、がんなどの治療において大きな有効性を示しており、製造能力強化の必要性を後押ししています。同時に、幹細胞治療に関する研究開発への旺盛な投資が、この市場の拡大をさらに後押ししています。幹細胞培養技術、バイオリアクター、品質管理システムの進歩を含む技術革新は、製造プロセスのスケーラビリティと再現性を大幅に向上させ、より商業的に実行可能なものとし、さらなる投資を引き寄せています。しかし、幹細胞使用、特に胚性幹細胞の使用をめぐる倫理的・規制的懸念など、治療法開発の妨げとなりかねないハードルにも直面しています。厳しい規制の遵守もまた、製造業者にとって課題となり、市場の成長をさらに複雑にしています。加えて、専門的なインフラ、熟練した労働力、厳格な品質管理措置の必要性からくる高い製造コストは、特に小規模の事業体や研究機関にとっては参入障壁となりうる。さらに、幹細胞特有のばらつきの中で一貫した品質を確保することは、依然として大きな課題です。メーカー各社がプロトコルの標準化に努め、こうした技術的な複雑さに取り組んでいることから、米国の幹細胞製造市場は今後の予測期間においても持続的な成長が見込まれ、再生医療の将来において重要な役割を果たすものと思われます。

目次

イントロダクション

• 調査の目的
• 定義
• 市場範囲

調査手法

• 情報調達
• 二次データソースと一次データソース
• 市場規模予測
• 市場の想定と制限

エグゼクティブサマリー

• 市場概要見通し
• 供給需要動向分析
• セグメント別機会分析

市場力学と見通し

• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題
• ポーターの分析

主な市場の考察

• 主な成功要因
• 競合の程度
• 主な投資機会
• 市場のエコシステム
• 技術分析
• サプライチェーン分析
• バリューチェーン分析
• 価格分析
• 特許分析
• 顧客と購買基準の分析

幹細胞製造市場：製品別

• 市場概要
• 消耗品
  • 培地
  • その他の消耗品
• 機器
  • バイオリアクターとインキュベーター
  • 細胞選別装置
  • その他の楽器
• 幹細胞株
  • 造血幹細胞
  • 間葉系幹細胞
  • 誘導多能性幹細胞
  • 胚性幹細胞
  • 神経幹細胞
  • 多能性成体前駆幹細胞

幹細胞製造市場：用途別

• 市場概要
• 研究用途
  • ライフサイエンス調査
  • 医薬品の発見と開発
• 臨床用途
  • 同種幹細胞療法
  • 自己幹細胞療法
• 細胞および組織バンキング用途

幹細胞製造市場：エンドユーザー別

• 市場概要
• 製薬・バイオテクノロジー企業
• 学術機関、研究機関、受託研究機関
• 病院と外科センター
• 細胞・組織バンク
• その他のエンドユーザー

幹細胞製造市場規模：地域別

• 市場概要
• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ（MEA）
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ地域

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング（2023年）
• 主な市場企業が採用した戦略
• 市場における最近の活動
• 主要企業の市場シェア（2023年）

主要企業プロファイル

• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Lonza Group
• Danaher Corporation
• Sartorius AG
• Becton, Dickinson and Company
• Eppendorf SE
• Corning Incorporated
• Bio-Rad Laboratories, Inc.
• Takara Bio Inc.
• Fujifilm Holdings Corporation
• Getinge AB
• Terumo Corporation
• Bio-Techne Corporation
• Himedia Laboratories Pvt. Ltd.
• Stemcell Technologies, Inc.
• Miltenyi Biotec GmbH
• Promocell
• Anterogen Co. Ltd.
• Cellgenix GmbH
• Pluristem Therapeutics Inc.
• Daiichi Sankyo
• Organogenesis Holdings Inc.
• Vericel Corp.
• American Cryostem Corp.

Stem Cell Manufacturing Market size was valued at USD 12.58 Billion in 2022 and is poised to grow from USD 13.76 Billion in 2023 to USD 28.23 Billion by 2031, at a CAGR of 9.4% during the forecast period (2024-2031).

The global stem cell manufacturing market is witnessing robust growth fueled by the rising incidence of chronic diseases and an increasing demand for regenerative medicine. Stem cell therapies have demonstrated significant efficacy in treating conditions such as cardiovascular diseases, neurodegenerative disorders, and cancer, thereby propelling the need for enhanced manufacturing capabilities. Concurrently, robust investments in research and development initiatives pertaining to stem cell therapies are further bolstering this market expansion. Technological innovations, including advancements in stem cell culture techniques, bioreactors, and quality control systems, have significantly improved the scalability and reproducibility of manufacturing processes, making them more commercially viable and attracting additional investments. However, the market faces hurdles, particularly ethical and regulatory concerns surrounding stem cell use, especially in embryonic cases, which may hinder therapy development. Compliance with stringent regulations also poses challenges for manufacturers, further complicating market growth. Additionally, high manufacturing costs, stemming from the need for specialized infrastructure, skilled labor, and rigorous quality control measures, can create barriers to entry, particularly for smaller entities or research institutions. Furthermore, ensuring consistent quality amid the inherent variability of stem cells remains a significant challenge. As manufacturers strive to standardize protocols and tackle these technical complexities, the U.S. market for stem cell manufacturing is expected to experience sustainable growth in the upcoming forecast period, reinforcing its critical role in the future of regenerative medicine.

Top-down and bottom-up approaches were used to estimate and validate the size of the Stem Cell Manufacturing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Stem Cell Manufacturing Market Segmental Analysis

Global Stem Cell Manufacturing Market is segmented by Product, Application, End User and Region. Based on Product, the market is segmented into Consumables (Culture Media, Other Consumables), Instruments (Bioreactors & Incubators, Cell Sorters, Other Instruments), Stem Cell Lines (Hematopoietic Stem Cells, Mesenchymal Stem Cells, Induced Pluripotent Stem Cells, Embryonic Stem Cells, Neural Stem Cells, Multipotent Adult Progenitor Stem Cells). Based on Application, the market is segmented into Research Applications (Life Science Research, Drug Discovery & Development), Clinical Applications (Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy), Cell & Tissue Banking Applications. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Academic Institutes, Research Laboratories, and Contract Research Organizations, Hospitals & Surgical Centers, Cell & Tissue Banks, Other End Users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Stem Cell Manufacturing Market

The escalating prevalence of chronic diseases, including cardiovascular disorders, neurological conditions, and various types of cancer, is significantly propelling the global stem cell manufacturing market. As these conditions become increasingly common, the quest for innovative and effective treatment modalities intensifies, positioning stem cells at the forefront of regenerative medicine. Their unique ability to differentiate into various cell types and promote tissue repair presents promising therapeutic avenues for these debilitating health issues. Consequently, the rising demand for advanced stem cell therapies fuels the expansion of manufacturing capabilities, enhancing research and clinical applications that can lead to improved patient outcomes and quality of life.

Restraints in the Stem Cell Manufacturing Market

The stem cell manufacturing market faces significant restraints due to the complex and specialized nature of its processes, which require advanced technology and meticulous quality control measures. Such demands lead to elevated manufacturing costs, heavily influenced by the need for skilled personnel, state-of-the-art infrastructure, and comprehensive quality assurance protocols. These high expenses create substantial financial barriers for market players, ultimately restricting the availability and accessibility of stem cell therapies to a wider population. Consequently, this not only hampers market growth but also limits innovation and investment in the development of new therapeutic options within the industry.

Market Trends of the Stem Cell Manufacturing Market

The Stem Cell Manufacturing market is witnessing a significant trend towards ethical and sustainable sourcing, driven by increasing consumer awareness and regulatory pressures. Companies are increasingly prioritizing alternative sources, such as induced pluripotent stem cells (iPSCs) and mesenchymal stem cells (MSCs), which offer promising avenues for reducing reliance on controversial sources. Investments in research and development are accelerating, focusing on innovative and efficient methods for stem cell derivation and culture that align with ethical standards. This shift not only fosters public trust but also enhances the market's credibility, positioning stakeholders to capitalize on emerging opportunities while ensuring social responsibility.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factor
• Degree of Competition
• Top Investment Pockets
• Ecosystem of the Market
• Technology Analysis
• Supply Chain Analysis
• Value Chain Analysis
• Pricing Analysis
• Patent Analysis
• Customer & Buying Criteria Analysis

Stem Cell Manufacturing Market, By Product

• Market Overview
• Consumables
  • Culture Media
  • Other Consumables
• Instruments
  • Bioreactors & Incubators
  • Cell Sorters
  • Other Instruments
• Stem Cell Lines
  • Hematopoietic Stem Cells
  • Mesenchymal Stem Cells
  • Induced Pluripotent Stem Cells
  • Embryonic Stem Cells
  • Neural Stem Cells
  • Multipotent Adult Progenitor Stem Cells

Stem Cell Manufacturing Market, By Application

• Market Overview
• Research Applications
  • Life Science Research
  • Drug Discovery & Development
• Clinical Applications
  • Allogeneic Stem Cell Therapy
  • Autologous Stem Cell Therapy
• Cell & Tissue Banking Applications

Stem Cell Manufacturing Market, By End User

• Market Overview
• Pharmaceutical & Biotechnology Companies
• Academic Institutes, Research Laboratories, And Contract Research Organizations
• Hospitals & Surgical Centers
• Cell & Tissue Banks
• Other End Users

Stem Cell Manufacturing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Thermo Fisher Scientific, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza Group
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Becton, Dickinson and Company
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eppendorf SE
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Corning Incorporated
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Takara Bio Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fujifilm Holdings Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Getinge AB
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Terumo Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Techne Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Himedia Laboratories Pvt. Ltd.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Stemcell Technologies, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Miltenyi Biotec GmbH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Promocell
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Anterogen Co. Ltd.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cellgenix GmbH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pluristem Therapeutics Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Daiichi Sankyo
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Organogenesis Holdings Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Vericel Corp.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• American Cryostem Corp.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments