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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