細胞および遺伝子治療薬製造サービス市場

世界の細胞および遺伝子治療薬製造サービスの市場規模は、2022年の49億米ドル、2023年の57億米ドルから、予測期間中は15.7%のCAGRで推移し、2028年には118億米ドルの規模に成長すると予測されています。

北米地域は、2022年の22億米ドル、2023年の25億米ドルから、16.1％のCAGRで推移し、2028年には54億米ドルの規模に成長すると予測されています。また、アジア太平洋地域は、2022年の11億米ドル、2023年の13億米ドルから、17.2%のCAGRで推移し、2028年には29億米ドルの規模に成長すると予測されています。

本レポートでは、世界の細胞および遺伝子治療薬製造サービスの市場を調査し、市場概要、技術背景、法規制環境、市場影響因子および市場機会の分析、新興技術の動向、市場規模の推移・予測、各種区分・地域別の詳細分析、ESGの分析、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 イントロダクション

第2章 サマリー・ハイライト

第3章 市場概要・技術背景

• 概要
• 遺伝子の追加または増強
• 遺伝子修正
• 遺伝子サイレンシング
• 製造
• サプライチェーン
• 規制状況
• 米国（FDA）
• 欧州
• 製造委託

第4章 市場力学

• 市場に影響を与える要因
• 市場促進要因
• 市場抑制要因
• 市場機会

第5章 新興技術

• 新技術
• オートメーション
• デジタル化
• シングルユース技術
• 新興の製造モデル

第6章 市場内訳：タイプ別

• 概要
• 細胞治療
• 遺伝子治療
• 細胞治療のタイプ
• 自己細胞療法
• 同種細胞療法
• ベクタータイプに基づく細胞および遺伝子治療のタイプ
• ウイルスベクター
• 非ウイルスベクター

第7章 市場内訳：用途別

• 概要
• 臨床製造
• 商業製造

第8章 市場内訳：疾患別

• 概要
• 癌
• 希少疾患
• その他の病気

第9章 市場内訳：エンドユーザー別

• 概要
• 製薬会社およびバイオテクノロジー会社
• 学術研究機関
• その他

第10章 市場内訳：地域別

• 概要
• 北米
• 米国
• カナダ
• 欧州
• 英国
• ドイツ
• フランス
• その他の欧州
• アジア太平洋
• 中国
• 日本
• オーストラリア
• その他のアジア太平洋地域
• その他の地域

第11章 持続可能性：ESGの観点

• 概要
• CGT製造におけるESGの実践
• ケーススタディ：ESG導入の成功例
• 総論

第12章 M&A・資金調達の見通し・競合情勢

• 投資の見通し
• M&A
• 戦略的取り組み
• 競合分析

第13章 企業プロファイル

• CATALENT INC.
• CELL AND GENE THERAPY CATAPULT
• CHARLES RIVER LABORATORIES
• FUJIFILM DIOSYNTH BIOTECHNOLOGIES
• LONZA GROUP AG
• MERCK KGAA
• MILTENYI BIOTEC
• NIKON CELL INNOVATION CO. LTD.
• TAKARA BIO INC.
• THERMO FISHER SCIENTIFIC
• WUXI ADVANCED THERAPIES

List of Tables

• Summary Table A : Global Market for Cell and Gene Therapy Manufacturing Services, Through 2028
• Summary Table B : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
• Table 1 : Global Cancer Statistics, 2020
• Table 2 : Global Market for Cell and Gene Therapy Manufacturing Services, by Type, Through 2028
• Table 3 : Global Market for Cell Therapy Manufacturing Services, by Region, Through 2028
• Table 4 : Global Market for Gene Therapy Manufacturing Services, by Region, Through 2028
• Table 5 : Global Market for Cell Therapy Manufacturing Services, by Type, Through 2028
• Table 6 : Global Market for Autologous Cell Therapy Manufacturing Services, by Region, Through 2028
• Table 7 : Global Market for Allogeneic Cell Therapy Manufacturing Services, by Region, Through 2028
• Table 8 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services, by Vector, Through 2028
• Table 9 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Viral Vectors, by Region, Through 2028
• Table 10 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Nonviral Vectors, by Region, Through 2028
• Table 11 : Global Market for Cell and Gene Therapy Manufacturing Services, by Application, Through 2028
• Table 12 : Global Market for Clinical Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
• Table 13 : Global Market for Commercial Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
• Table 14 : Global Market for Cell and Gene Therapy Manufacturing Services, by Disease, Through 2028
• Table 15 : Global Market for Cell and Gene Therapy Manufacturing Services for Cancer, by Region, Through 2028
• Table 16 : Global Market for Cell and Gene Therapy Manufacturing Services for Rare Diseases, by Region, Through 2028
• Table 17 : Global Market for Cell and Gene Therapy Manufacturing Services for Other Diseases, by Region, Through 2028
• Table 18 : Global Market for Cell and Gene Therapy Manufacturing Services, by End User, Through 2028
• Table 19 : Global Market for Cell and Gene Therapy Manufacturing Services for Pharmaceutical and Biotechnology Companies, by Region, Through 2028
• Table 20 : Global Market for Cell and Gene Therapy Manufacturing Services for Academic and Research Institutes, by Region, Through 2028
• Table 21 : Global Market for Cell and Gene Therapy Manufacturing Services for Other End Users, by Region, Through 2028
• Table 22 : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, Through 2028
• Table 23 : North American Market for Cell and Gene Therapy Manufacturing Services, by Country, Through 2028
• Table 24 : European Market for Cell and Gene Therapy Manufacturing Services, by Country, Through 2028
• Table 25 : Asia-Pacific Market for Cell and Gene Therapy Manufacturing Services, by Country, Through 2028
• Table 26 : ESG Rating/Metric
• Table 27 : Environmental Initiatives by Various CGT Manufacturing CDMOs/Companies
• Table 28 : ESG Rankings for Companies in the CGT Manufacturing Services Market, 2023
• Table 29 : Mergers and Acquisitions, 2020-2022
• Table 30 : Catalent: Financials,2022
• Table 31 : Catalent: News
• Table 32 : Charles River Laboratories: Financials, 2022
• Table 33 : Charles River Laboratories: News
• Table 34 : Charles River Laboratories: Cell and Gene Manufacturing Services Offerings
• Table 35 : FUJIFILM Diosynth Biotechnologies: Financials, 2022
• Table 36 : FUJIFILM Diosynth Biotechnologies: News
• Table 37 : Lonza: Financials, 2022
• Table 38 : Lonza: News
• Table 39 : Lonza: Cell and Gene Services Offerings
• Table 40 : Merck KGaA: Financials, 2022
• Table 41 : Merck KGaA: Cell and Gene Manufacturing Services Offerings
• Table 42 : Merck KGaA: News
• Table 43 : Takara Bio: Financials, 2022
• Table 44 : Takara Bio: Cell and Gene Services Offerings
• Table 45 : Takara Bio.: News
• Table 46 : Thermo Fisher Scientific Inc: Financials, 2022
• Table 47 : Thermo Fisher: Cell and Gene Services Offerings
• Table 48 : Thermo Fisher Scientific Inc.: News
• Table 49 : WuXi Advanced Therapies: Financials, 2022
• Table 50 : WuXi Advanced Therapies: News

List of Figures

• Summary Figure A : Global Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Summary Figure B : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
• Figure 1 : Cell Therapy Manufacturing Process
• Figure 2 : Pharmaceutical Products - Supply Chain
• Figure 3 : Cell Therapy Products - Supply Chain
• Figure 4 : Cell Therapy Products - Regulatory Pathway
• Figure 5 : Centralized Manufacturing Model
• Figure 6 : Decentralized Manufacturing Model
• Figure 7 : Global Market for Cell and Gene Therapy Manufacturing Services, by Type, 2020-2028
• Figure 8 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Type, 2022
• Figure 9 : Global Market for Cell Therapy Manufacturing Services, by Region, 2020-2028
• Figure 10 : Global Market for Gene Therapy Manufacturing Services, by Region, 2020-2028
• Figure 11 : Types of Cell Therapies
• Figure 12 : Advantages and Disadvantages of Cell Therapy Types
• Figure 13 : Global Market for Cell Therapy Manufacturing Services, by Type, 2020-2028
• Figure 14 : Global Market for Autologous Cell Therapy Manufacturing Services, by Region, 2020-2028
• Figure 15 : Global Market for Allogeneic Cell Therapy Manufacturing Services, by Region, 2020-2028
• Figure 16 : Shares of Vectors Used in Clinical Trials on Gene Therapy, 2022
• Figure 17 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services, by Vector, 2020-2028
• Figure 18 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Viral Vectors, by Region, 2020-2028
• Figure 19 : Global Market for Gene-Modified Cell and Gene Therapy Manufacturing Services for Nonviral Vectors, by Region, 2020-2028
• Figure 20 : Global Market for Cell and Gene Therapy Manufacturing Services, by Application, 2020-2028
• Figure 21 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Application, 2022
• Figure 22 : CGT Clinical Pipeline, by Phase and Type
• Figure 23 : Global Market for Clinical Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
• Figure 24 : Global Market for Commercial Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
• Figure 25 : Global Market for Cell and Gene Therapy Manufacturing Services, by Disease, 2020-2028
• Figure 26 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Disease, 2022
• Figure 27 : CGT Oncology Pipeline, by Phase and Type
• Figure 28 : Global Market for Cell and Gene Therapy Manufacturing Services for Cancer, by Region, 2020-2028
• Figure 29 : Global Market for Cell and Gene Therapy Manufacturing Services for Rare Diseases, by Region, 2020-2028
• Figure 30 : Global Market for Cell and Gene Therapy Manufacturing Services for Other Diseases, by Region, 2020-2028
• Figure 31 : Global Market for Cell and Gene Therapy Manufacturing Services, by End User, 2020-2028
• Figure 32 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by End User, 2022
• Figure 33 : Global Market for Cell and Gene Therapy Manufacturing Services for Pharmaceutical and Biotechnology Companies, by Region, 2020-2028
• Figure 34 : CGT Clinical Pipeline, by Sponsor
• Figure 35 : Global Market for Cell and Gene Therapy Manufacturing Services for Academic and Research Institutes, by Region, 2020-2028
• Figure 36 : Global Market for Cell and Gene Therapy Manufacturing Services for Other End Users, by Region, 2020-2028
• Figure 37 : Global Market for Cell and Gene Therapy Manufacturing Services, by Region, 2020-2028
• Figure 38 : Global Market Shares of Cell and Gene Therapy Manufacturing Services, by Region, 2022
• Figure 39 : North American Market for Cell and Gene Therapy Manufacturing Services, by Country, 2020-2028
• Figure 40 : U.S. Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 41 : Canadian Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 42 : European Market for Cell and Gene Therapy Manufacturing Services, by Country, 2020-2028
• Figure 43 : U.K. Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 44 : German Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 45 : French Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 46 : Rest of European Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 47 : Asia-Pacific Market for Cell and Gene Therapy Manufacturing Services, by Country, 2020-2028
• Figure 48 : Chinese Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 49 : Japanese Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 50 : Australian Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 51 : Rest of APAC Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 52 : Rest of the World Market for Cell and Gene Therapy Manufacturing Services, 2020-2028
• Figure 53 : ESG in CGT Manufacturing Industry
• Figure 54 : Investments, by Year, 2017-2022
• Figure 55 : Equity Offering and Venture Financing, 2021 and 2022
• Figure 56 : Public and Private Companies Deal Value, 2021 and 2022
• Figure 57 : Number of Deals, 2021 and 2022
• Figure 58 : M&A Deals, 2021 and 2022
• Figure 59 : Strategic Alliance Deals, 2021 and 2022
• Figure 60 : Global Market Shares of CGT Manufacturing Services, by Manufacturer, 2022
• Figure 61 : Catalent: Financials, 2021 and 2022
• Figure 62 : Catalent: Market Share, by Business Segment, 2022
• Figure 63 : Charles River Laboratories: Financials, 2021 and 2022
• Figure 64 : Charles River Laboratories: Market Share, by Business Segment, 2022
• Figure 65 : Charles River Laboratories: Revenue Share, by Region/Country, 2022
• Figure 66 : FUJIFILM Diosynth Biotechnologies: Financials, 2021 and 2022
• Figure 67 : Lonza: Financials, 2021 and 2022
• Figure 68 : Lonza: Market Share, by Business Segment, 2022
• Figure 69 : Lonza: Revenue Share, by Region/Country, 2022
• Figure 70 : Merck KGaA: Financials, 2021 and 2022
• Figure 71 : Merck KGaA Life Sciences: Market Share, by Region, 2022
• Figure 72 : Merck KGaA Life Sciences: Market Share, by Business Segment, 2022
• Figure 73 : Takara Bio: Financials, 2021 and 2022
• Figure 74 : Takara Bio.: Market Share, by Region, 2022
• Figure 75 : Takara Bio.: Market Share, by Business Segment, 2022
• Figure 76 : Thermo Fisher Scientific Financials, 2021 and 2022
• Figure 77 : Thermo Fisher Scientific Inc.: Market Share, by Region, 2022
• Figure 78 : Thermo Fisher Scientific Inc.: Market Share, by Business Segment, 2022
• Figure 79 : WuXi Advanced Therapies: Annual Revenue, 2021 and 2022

Highlights:

The global cell and gene therapy manufacturing services market reached $4.9 billion in 2022, should reach $5.7 billion by 2023 and $11.8 billion by 2028 with a compound annual growth rate (CAGR) of 15.7% during the forecast period of 2023-2028.

North American cell and gene therapy manufacturing services market reached $2.2 billion in 2022, should reach $2.5 billion by 2023 and $5.4 billion by 2028 with a CAGR of 16.1% during the forecast period of 2023-2028.

Asia-Pacific cell and gene therapy manufacturing services market reached $1.1 billion in 2022, should reach $1.3 billion by 2023 and $2.9 billion by 2028 with a CAGR of 17.2% during the forecast period of 2023-2028.

Report Scope:

The scope of this study encompasses an investigation of cell and gene therapy manufacturing services. BCC Research analyzes the manufacturing services based on therapy type, application, disease, and end user. BCC determines the current market status in each segment, examines its impact on future markets, and presents growth forecasts over the next six years. The recent report provides a detailed analysis of the market's drivers, challenges, and opportunities. The report also covers market projections to 2028 and market share for key market players. The report includes the company profiles of the key players with detailed information about their business segments, financials, product portfolios, and recent developments. The report also provides the ESG perspective, emerging technologies, and investment outlook.

Report Includes:

• 34 data tables and 18 additional tables
• An overview of the global cell and gene therapy manufacturing services market
• Analyses of global market trends, with data from 2020-2022, estimates for 2023, and projections of compound annual growth rates (CAGRs) through 2028
• Highlights of the market potential and quantification of market based on therapy type, application, disease, and end-user
• A look into current technologies underlying the market as well as the effects new technologies will have on the market
• Coverage of clinical trials pipeline, partnership between pharmaceutical companies, and Contract Development & Manufacturing Organization (CDMO)
• Insights into investments from multiple stakeholders, and discussion on increasing focus on personalized medicine for rare and chronic conditions
• Information on recent mergers, acquisitions, collaborations, agreements, product launches, and expansions in the market and a relevant patent analysis
• Company profiles of major players within the industry, including Catalent, Charles River Laboratories, Lonza, Merck KGaA, and Thermo Fisher Scientific

Executive Summary

Summary:

The pharmaceutical industry is changing and moving away from a one-size-fits-all approach to a targeted and personalized approach, in which patients' own genetic information and immune systems are used to treat previously incurable diseases. Cell and gene therapies are different from the traditional biopharma products. Cell and gene therapies (CGT) are a novel therapeutic modality for a range of chronic and age-related conditions. These provide a fundamental treatment option for disease conditions that do not have a cure or cannot be treated with conventional drugs. Initially, cell and gene therapies were highly explored for oncology. However, the research is expanding into other disease areas.

Demand for cell and gene therapies is high and there is a lot of R&D in this segment supported by huge investments and funding for CGTs. According to the Alliance for Regenerative Medicine 2022 report, CGT research raised nearly $19.9 billion in 2020, $22.7 billion in 2021 and $6.3 billion in the first half of 2022 (H1 2022) and overall investment of $12.6 billion. The number of clinical trials and regulatory approvals for cell and gene therapies will increase over the coming years. The FDA estimates that by 2025, it will approve 10-20 cell and gene therapy products per year, and it is forecasted that by 2030 there will be around 75 approved therapies.

Notably, even though awareness and demand are increasing, there is a lack of supply. This is mainly due to limited manufacturing capacity and complex supply chain. Hence, it is important that the organizations scale-up to meet the supply chain requirements. Also, due to stringent, expensive, and complex manufacturing processes, most of the small and medium sized pharma and biotech companies are engaging with contract development and manufacturing organizations (CDMO). This is a contributing factor to the growth of the CGT CDMO's.

Increasing investments, capacity expansions for clinical and commercial manufacturing, increasing prevalence of chronic diseases and focus on rare diseases, and increased healthcare expenditure drive the cell and gene therapy manufacturing services market. Accelerated approvals in recent years, coupled with technological advancements (development of off-the-shelf products, automations, application of advanced gene editing techniques like CRISPR), will lower the complexities involved around manufacturing CGTs and will attract many pharma and biotech companies to enter the market, thus contributing to the market in the forecast period.

The global market for cell and gene therapy manufacturing services was estimated to be $4.9 billion in 2022 and is expected to increase to $11.8 billion by 2028, growing at a CAGR of 15.7%. The cell and gene therapy manufacturing services market is segmented based on application, type, disease, end user, and region. Major players in the market are Lonza, FUJIFILM Diosynth, Charles River, Thermo Fisher, and Merck KGaA.

The North American region has the highest share, followed by Europe. Extensive R&D activities take place in the region, there are major players present, plentiful funding, and increasing prevalence of chronic diseases. All these factors contribute to growth in the market. Based on application, the cancer segment has the highest share

Table of Contents

Chapter 1 Introduction

• Study Goals and Objectives
• Reasons for Doing This Study
• Scope of Report
• Information Sources
• Methodology
• Geographic Breakdown

Chapter 2 Summary and Highlights

• Market Overview

Chapter 3 Market Overview and Technology Background

• Overview
• Gene Addition or Augmentation
• Gene Correction
• Gene Silencing
• Manufacturing
• Supply Chain
• Regulatory Landscape
• U.S. (FDA)
• Europe
• Outsourcing of Manufacturing

Chapter 4 Market Dynamics

• Factors Affecting the Market
• Market Drivers
• Increasing Investment and Funding for CGT Development
• Capacity Expansions for Clinical and Commercial Manufacturing
• Rising Prevalence of Chronic Diseases and Focus on Rare Diseases
• Increasing Strategic Collaborations and Acquisitions
• Market Restraints
• Complex Manufacturing and Supply Chain
• Lack of Skilled Workforce
• Regulatory Hurdles
• Market Opportunities

Chapter 5 Emerging Technologies

• Introduction
• Emerging Technologies
• Automation
• Digitalization
• Single-Use Technologies
• Emerging Manufacturing Models

Chapter 6 Market Breakdown by Type

• Overview
• Cell Therapy
• Gene Therapy
• Cell Therapy Types
• Autologous Cell Therapy
• Allogeneic Cell Therapy
• Cell and Gene Therapy Types Based on Vector Type
• Viral Vectors
• Nonviral Vectors

Chapter 7 Market Breakdown by Application

• Overview
• Clinical Manufacturing
• Commercial Scale Manufacturing

Chapter 8 Market Breakdown by Disease

• Overview
• Cancer
• Rare Diseases
• Other Diseases

Chapter 9 Market Breakdown by End User

• Overview
• Pharmaceutical and Biotechnology Companies
• Academic and Research Institutes
• Others

Chapter 10 Market Breakdown by Region

• Overview
• North America
• U.S.
• Canada
• Europe
• U.K.
• Germany
• France
• Rest of Europe
• Asia-Pacific
• China
• Japan
• Australia
• Rest of Asia-Pacific
• Rest of the World

Chapter 11 Sustainability: An ESG Perspective

• Overview
• ESG Practices in the CGT Manufacturing Industry
• Case Studies: Examples of Successful ESG Implementation
• Conclusion

Chapter 12 M&A, Funding Outlook and Competitive Landscape

• Investments Outlook
• Mergers and Acquisitions
• Strategic Initiatives
• Competitive Analysis

Chapter 13 Company Profiles

• CATALENT INC.
• CELL AND GENE THERAPY CATAPULT
• CHARLES RIVER LABORATORIES
• FUJIFILM DIOSYNTH BIOTECHNOLOGIES
• LONZA GROUP AG
• MERCK KGAA
• MILTENYI BIOTEC
• NIKON CELL INNOVATION CO. LTD.
• TAKARA BIO INC.
• THERMO FISHER SCIENTIFIC
• WUXI ADVANCED THERAPIES