North America Cell and Gene Therapy Manufacturing Services Market Forecast to 2030 - Regional Analysis - by Type, Indication (Cancer, Orthopedics, and Others), Application (Clinical Manufacturing and Commercial Manufacturing), and End User
북미의 세포·유전자 치료용 제조 서비스 시장은 2022년 41억 5,327만 달러에서 2030년에는 147억 1,172만 달러로 성장할 것으로 예측되고 있습니다. 2022-2030년의 CAGR은 17.1%로 추정됩니다.
세포 및 유전자 치료용 제조 아웃소싱의 인기가 높아지면서 북미 세포 및 유전자 치료용 제조 서비스 시장을 주도하고 있습니다.
세포 및 유전자 치료제 제조는 복잡한 공정이기 때문에 적절한 업무 수행과 감독이 매우 중요합니다. 세포 및 유전자 치료제 제조업체는 생물학 및 공정 공학에 정통한 자격을 갖춘 인력이 한정되어 있습니다. 또한 숙련된 팀이 수작업으로 개방형 제조 방법을 사용하여 첫 번째 임상시험에 도달하는 시도를 관리하고 이후 더 상업적으로 적합한 프로세스를 구축하는 것은 까다로운 일입니다. CDMO는 세포 및 유전자 치료제 기업에 제품 개발, 제조, 임상시험 지원 및 상업화 서비스를 계약 기반으로 제공하는 CDMO와 협력하여 임상시험 및 상업화 프로세스를 가속화할 수 있습니다. 2022년 4월, 써모제네시스는 미국 캘리포니아에 CDMO 시설을 설립하여 T세포 수용체(TCR), 키메라 항체 수용체-T세포(TCR), 항체 수용체-항원 수용체-T세포(TCR), 항체 수용체-항원 수용체-T세포(TCR), 항체 수용체-항원 수용체-T세포(TCR-T) 항원수용체-T세포(CAR-T세포), 종양침윤백혈구(TIL), iPSC, 자연살해세포(NK), 중간엽줄기세포(MSC) 제조에 대한 전문성을 활용하여 세포 및 유전자치료제 제조업체에 CDMO 서비스를 제공합니다. CDMO에 세포치료제 및 유전자치료제 제조를 위탁하는 것은 제조업체에게 비용 효율적임이 입증되었습니다. 이처럼 CDMO에 대한 세포 및 유전자 치료제 제조 아웃소싱에 대한 선호도가 높아지면서 북미 세포 및 유전자 치료제 제조 서비스 시장의 성장을 촉진하고 있습니다.
북미 세포 및 유전자 치료제 제조 서비스 시장 개요
세포-유전자치료(CGT)는 치료 수요가 있는 심각한 희귀질환을 앓고 있는 환자들을 치료하는 것으로, CGT의 제조는 매우 복잡한 과정이며, 인프라 및 전문 지식의 부족이 큰 제약요인으로 작용하고 있습니다. CGT의 제조 공정에는 자가 세포를 '아펠레시스'를 통해 추출하고, 전문 실험실로 보내고, 환자에게 투여하기 위해 다시 클리닉으로 보내는 과정이 포함되며, 이 모든 과정은 엄격한 품질 관리 하에 이루어져야 합니다. 이루어져야 합니다. 미국 식품의약국(USFDA)이 승인한 CGT 의약품은 7종에 불과하며, 실험적 치료법으로 1,200여 종에 달하는 신제품 파이프라인이 있습니다. 그 중 절반은 임상 2상 단계에 있으며, 연간 매출 성장률은 Chemical &Engineering News 2022 보고서에 따르면 세포 치료제는 15%, 유전자 치료제는 30%를 나타낼 것으로 예측됩니다. 통증과 관절염을 대상으로 한 줄기세포 프로그램의 임상 데이터를 캐나다 보건부에 제출했다고 발표했습니다. 이와 같이 위의 요인들은 예측 기간 중 세포 및 유전자 치료용 제조 서비스 시장의 성장을 가속할 것으로 예상됩니다. 이와 같이 위의 요인들은 북미 세포 및 유전자 치료용 제조 서비스 시장의 성장 요인으로 작용하고 있습니다.
북미 세포 및 유전자 치료용 제조 서비스 시장 매출 및 2030년까지의 예측(금액)
북미 세포 및 유전자 치료제 제조 서비스 시장 세분화
북미 세포 및 유전자 치료제 제조 서비스 시장은 유형, 적응증, 용도, 최종사용자, 국가별로 분류됩니다.
유형별로 북미 세포 및 유전자 치료 제조 서비스 시장은 세포 치료와 유전자 치료로 나뉘며, 2022년 북미 세포 및 유전자 치료 제조 서비스 시장에서 세포 치료 분야가 가장 큰 비중을 차지할 것으로 예상됩니다. 세포치료 분야는 다시 자가 유래와 동종 이종으로 구분됩니다. 유전자 치료 분야는 다시 바이러스 벡터와 비바이러스 벡터로 구분됩니다.
적응증에 따라 북미 세포 및 유전자 치료 제조 서비스 시장은 암, 정형외과, 기타로 구분되며, 2022년 북미 세포 및 유전자 치료 제조 서비스 시장에서 암 분야가 가장 큰 점유율을 기록할 것으로 예상됩니다.
용도별로 북미 세포 및 유전자 치료 제조 서비스 시장은 임상 제조와 상업 제조로 구분되며, 2022년에는 상업 제조 부문이 북미 세포 및 유전자 치료 제조 서비스 시장에서 가장 큰 점유율을 기록할 것으로 예상됩니다.
최종사용자에 따라 북미 세포 및 유전자 치료 제조 서비스 시장은 제약 및 생명공학 기업과 계약 연구 기관(CRO)으로 양분되며, 2022년 북미 세포 및 유전자 치료 제조 서비스 시장에서 제약 및 생명공학 기업 부문이 더 큰 점유율을 차지할 것으로 예상됩니다. 더 큰 점유율을 기록할 것으로 예상됩니다.
국가별로는 북미 세포 및 유전자 치료 제조 서비스 시장은 미국, 캐나다, 멕시코로 구분되며, 2022년 미국은 북미 세포 및 유전자 치료 제조 서비스 시장에서 가장 큰 점유율을 기록할 것으로 예상됩니다.
Catalent Inc, Charles River Laboratories International Inc, FUJIFILM Holdings Corp, Lonza Group AG, Merck KgaA, National Resilience Inc, Nikon Corp, Oxford BioMedica Plc, Takara Bio Inc, Thermo Fisher Scientific Inc, WuXi AppTec Co Ltd는 북미 세포 및 유전자 치료용 제조 서비스 시장에서 활동하는 주요 기업입니다.
목차
제1장 서론
제2장 주요 요약
제3장 조사 방법
제4장 북미의 세포·유전자 치료용 제조 서비스 시장 - 주요 산업 역학
- 주요 시장 촉진요인
- 세포·유전자 치료 승인 건수의 증가
- 세포·유전자 치료용 제조 아웃소싱의 인기 상승
- 시장 억제요인
- 시장 기회
- 향후 동향
- 영향 분석
제5장 세포·유전자 치료용 제조 서비스 시장 : 북미 시장 분석
- 북미의 세포·유전자 치료용 제조 서비스 시장 매출, 2022-2030년
제6장 북미의 세포·유전자 치료용 제조 서비스 시장 : 매출과 2030년까지의 예측 - 유형별
제7장 북미의 세포·유전자 치료용 제조 서비스 시장 : 분석과 2030년까지의 예측 - 적응증별
제8장 북미의 세포·유전자 치료용 제조 서비스 시장 : 매출과 2030년까지의 예측 - 용도별
제9장 북미의 세포·유전자 치료용 제조 서비스 시장 : 매출과 2030년까지의 예측 - 최종사용자별
- 제약회사 및 바이오테크놀러지 기업
- CRO(임상시험수탁기관)
제10장 북미의 세포·유전자 치료용 제조 서비스 시장 : 매출과 2030년까지의 예측 - 국가별 분석
제11장 북미의 세포·유전자 치료용 제조 서비스 시장 : 업계 상황
- 세포·유전자 치료용 제조 서비스 시장에서의 성장 전략
- 유기적 성장 전략
- 무기적 성장 전략
제12장 기업 개요
- Thermo Fisher Scientific Inc
- Merck KGaA
- Charles River Laboratories International Inc
- Lonza Group AG
- WuXi AppTec Co Ltd
- Catalent Inc
- Takara Bio Inc
- Nikon Corp
- FUJIFILM Holdings Corp
- National Resilience Inc
- Oxford BioMedica Plc
KSA
The North America cell and gene therapy manufacturing services market is expected to grow from US$ 4,153.27 million in 2022 to US$ 14,711.72 million by 2030. It is estimated to grow at a CAGR of 17.1% from 2022 to 2030.
Increasing Popularity of Outsourcing Cell and Gene Therapy Manufacturing Drives North America Cell and Gene Therapy Manufacturing Services Market
Cell and gene therapy manufacturing is a complex process, which makes the proper execution and overseeing of the operation crucial. Cell and gene therapy manufacturers have a limited number of qualified personnel who know biological and process engineering. Moreover, for experienced teams, managing the attempts to reach the first clinical trial using a manual, and open manufacturing method and then building a more commercially suitable process can be tricky. Therefore, these enterprises choose to work with contract development and manufacturing organizations (CDMOs) to accelerate their clinical studies and commercialization process. CDMOs provide product development, manufacturing, clinical trial support, and commercialization services to cell and gene therapy companies on a contract basis. Partnering with a CDMO enables scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies for cell and gene therapy manufacturers. In April 2022, ThermoGenesis established a CDMO facility in California, US to provide CDMO services to cell and gene therapy manufacturers, using its expertise in T-cell receptor (TCR), chimeric antigen receptor-T cell (CAR-T cell), tumor-infiltrating leukocyte (TIL), iPSC, natural killer cell (NK), and mesenchymal stem cell (MSC) manufacturing. Outsourcing cell and gene therapy manufacturing to CDMOs proves cost-effective for manufacturers. Thus, the increasing preference for outsourcing growing cell and gene therapy manufacturing to CDMOs fuels the North America cell and gene therapy manufacturing services market growth.
North America Cell and Gene Therapy Manufacturing Services Market Overview
Cell and gene therapies (CGTs) treat patients suffering from serious and rare diseases with unaddressed therapeutic needs. Manufacturing CGTs is a highly complex process, with the insufficiency of infrastructure and expertise being a major limiting factor. Logistical challenges associated with intermediates and the final product also limit the CGT manufacturing capacity of companies. The CGT manufacturing process involves the extraction of autologous cells through "apheresis," dispatching them to specialized labs, and sending them back to clinics for administration into patients, all of which must be performed with strict quality control. The US Food and Drug Administration (USFDA) has approved only 7 CGT drugs, with the pipeline of new products reaching ~1,200 experimental therapies. Half of these are in Phase 2 clinical trials, with estimates of annual sales growth accounting for 15% for cell therapies and ~30% for gene therapies, as per the estimates of the Chemical & Engineering News report 2022. On March 31, 2022, CELL Technologies Inc. announced the submission of the clinical data of its stem cell program in pain and arthritis for approval by Health Canada to help patients access evidence-based and regulatory-approved stem cell procedures across Canada. Thus, the abovementioned factors are expected to promote the cell and gene therapy manufacturing services market growth during the forecast period. Thus, the abovementioned factors are responsible for the growth of the North America cell and gene therapy manufacturing services market.
North America Cell and Gene Therapy Manufacturing Services Market Revenue and Forecast to 2030 (US$ Million)
North America Cell and Gene Therapy Manufacturing Services Market Segmentation
The North America cell and gene therapy manufacturing services market is segmented into type, indication, application, end user, and country.
Based on type, the North America cell and gene therapy manufacturing services market is bifurcated into cell therapy and gene therapy. In 2022, the cell therapy segment registered a larger share in the North America cell and gene therapy manufacturing services market. The cell therapy segment is further segmented into autologous and allogenic. The gene therapy segment is further segmented into viral and non-viral vector.
Based on indication, the North America cell and gene therapy manufacturing services market is segmented into cancer, orthopedics, and others. In 2022, the cancer segment registered the largest share in the North America cell and gene therapy manufacturing services market.
Based on application, the North America cell and gene therapy manufacturing services market is segmented into clinical manufacturing and commercial manufacturing. In 2022, the commercial manufacturing segment registered the largest share in the North America cell and gene therapy manufacturing services market.
Based on end user, the North America cell and gene therapy manufacturing services market is bifurcated into pharmaceutical and biotechnology companies and contract research organization (CROs). In 2022, the pharmaceutical and biotechnology companies segment registered a larger share in the North America cell and gene therapy manufacturing services market.
Based on country, the North America cell and gene therapy manufacturing services market is segmented into the US, Canada, Mexico. In 2022, the US registered the largest share in the North America cell and gene therapy manufacturing services market.
Catalent Inc, Charles River Laboratories International Inc, FUJIFILM Holdings Corp, Lonza Group AG, Merck KgaA, National Resilience Inc, Nikon Corp, Oxford BioMedica Plc, Takara Bio Inc, Thermo Fisher Scientific Inc, and WuXi AppTec Co Ltd are some of the leading companies operating in the North America cell and gene therapy manufacturing services market.
Table Of Contents
1. Introduction
- 1.1 The Insight Partners Research Report Guidance
- 1.2 Market Segmentation
2. Executive Summary
3. Research Methodology
- 3.1 Coverage
- 3.2 Secondary Research
- 3.3 Primary Research
4. North America Cell and Gene Therapy Manufacturing Services Market - Key Industry Dynamics
- 4.1 Key Market Drivers:
- 4.1.1 Increase in Number of Approval of Cell and Gene Therapies
- 4.1.2 Increasing Popularity of Outsourcing Cell and Gene Therapy Manufacturing
- 4.2 Market Restraints
- 4.2.1 High Cost of Cell and Gene Therapy Manufacturing
- 4.3 Market Opportunities
- 4.3.1 Strategic Initiatives by Companies
- 4.4 Future Trends
- 4.4.1 Automation of Cell and Gene Therapy Manufacturing Services
- 4.5 Impact Analysis:
5. Cell and Gene Therapy Manufacturing Services Market - North America Market Analysis
- 5.1 North America Cell and Gene Therapy Manufacturing Services Market Revenue (US$ Mn), 2022 - 2030
6. North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - by Type
- 6.1 Overview
- 6.2 North America Cell and Gene Therapy Manufacturing Services Market Revenue Share, by Type 2022 & 2030 (%)
- 6.3 Cell Therapy
- 6.3.1 Overview
- 6.3.2 Cell Therapy: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 6.3.2.1 Autologous
- 6.3.2.1.1 Overview
- 6.3.2.1.2 Autologous: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 6.3.2.2 Allogenic
- 6.3.2.2.1 Overview
- 6.3.2.2.2 Allogenic: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 6.4 Gene Therapy
- 6.4.1 Overview
- 6.4.2 Gene Therapy: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 6.4.2.1 Viral Vector
- 6.4.2.1.1 Overview
- 6.4.2.1.2 Viral Vector: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 6.4.2.2 Non-Viral Vector
- 6.4.2.2.1 Overview
- 6.4.2.2.2 Non-Viral Vector: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
7. North America Cell and Gene Therapy Manufacturing Services Market Analysis and Forecasts to 2030 - by Indication
- 7.1 Overview
- 7.2 North America Cell and Gene Therapy Manufacturing Services Market, by Indication 2022 & 2030 (%)
- 7.3 Cancer
- 7.3.1 Overview
- 7.3.2 Cancer: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 7.4 Orthopedics
- 7.4.1 Overview
- 7.4.2 Orthopedics: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 7.5 Others
- 7.5.1 Overview
- 7.5.2 Others: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
8. North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - by Application
- 8.1 Overview
- 8.2 North America Cell and Gene Therapy Manufacturing Services Market Revenue Share, by Application 2022 & 2030 (%)
- 8.4 Clinical Manufacturing
- 8.4.1 Overview
- 8.4.2 Clinical Manufacturing: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 8.5 Commercial Manufacturing
- 8.5.1 Overview
- 8.5.2 Commercial Manufacturing: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
9. North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - by End User
- 9.1 Overview
- 9.2 North America Cell and Gene Therapy Manufacturing Services Market Revenue Share, by End User 2022 & 2030 (%)
- 9.4 Pharmaceutical and Biotechnology Companies
- 9.4.1 Overview
- 9.4.2 Pharmaceutical & Biotechnology Companies: North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 9.5 Contract Research Organizations (CROs)
- 9.5.1 Overview
- 9.5.2 Contract Research Organizations (CROs): North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
10. North America Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - Country Analysis
- 10.1 Overview
- 10.1.1 North America: Cell and Gene Therapy Manufacturing Services Market, by Region, 2022 & 2030 (%)
- 10.1.1.1 US: Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 10.1.1.1.1 US: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
- 10.1.1.1.1.1 US: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
- 10.1.1.1.1.2 US: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
- 10.1.1.1.2 US: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
- 10.1.1.1.3 US: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
- 10.1.1.1.4 US: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
- 10.1.1.2 Canada: Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 10.1.1.2.1 Canada: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
- 10.1.1.2.1.1 Canada: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
- 10.1.1.2.1.2 Canada: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
- 10.1.1.2.2 Canada: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
- 10.1.1.2.3 Canada: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
- 10.1.1.2.4 Canada: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
- 10.1.1.3 Mexico: Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
- 10.1.1.3.1 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
- 10.1.1.3.1.1 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
- 10.1.1.3.1.2 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
- 10.1.1.3.2 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
- 10.1.1.3.3 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
- 10.1.1.3.4 Mexico: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
11. North America Cell and Gene Therapy Manufacturing Services Market - Industry Landscape
- 11.1 Overview
- 11.2 Growth Strategies in Cell and Gene Therapy Manufacturing Services Market
- 11.3 Organic Growth Strategies
- 11.4 Inorganic Growth Strategies
12. Company Profiles
- 12.1 Thermo Fisher Scientific Inc
- 12.1.1 Key Facts
- 12.1.2 Business Description
- 12.1.3 Products and Services
- 12.1.4 Financial Overview
- 12.1.5 SWOT Analysis
- 12.1.6 Key Developments
- 12.2 Merck KGaA
- 12.2.1 Key Facts
- 12.2.2 Business Description
- 12.2.3 Products and Services
- 12.2.4 Financial Overview
- 12.2.5 SWOT Analysis
- 12.2.6 Key Developments
- 12.3 Charles River Laboratories International Inc
- 12.3.1 Key Facts
- 12.3.2 Business Description
- 12.3.3 Products and Services
- 12.3.4 Financial Overview
- 12.3.5 SWOT Analysis
- 12.3.6 Key Developments
- 12.4 Lonza Group AG
- 12.4.1 Key Facts
- 12.4.2 Business Description
- 12.4.3 Products and Services
- 12.4.4 Financial Overview
- 12.4.5 SWOT Analysis
- 12.4.6 Key Developments
- 12.5 WuXi AppTec Co Ltd
- 12.5.1 Key Facts
- 12.5.2 Business Description
- 12.5.3 Products and Services
- 12.5.4 Financial Overview
- 12.5.5 SWOT Analysis
- 12.5.6 Key Developments
- 12.6 Catalent Inc
- 12.6.1 Key Facts
- 12.6.2 Business Description
- 12.6.3 Products and Services
- 12.6.4 Financial Overview
- 12.6.5 SWOT Analysis
- 12.6.6 Key Developments
- 12.7 Takara Bio Inc
- 12.7.1 Key Facts
- 12.7.2 Business Description
- 12.7.3 Products and Services
- 12.7.4 Financial Overview
- 12.7.5 SWOT Analysis
- 12.7.6 Key Developments
- 12.8 Nikon Corp
- 12.8.1 Key Facts
- 12.8.2 Business Description
- 12.8.3 Products and Services
- 12.8.4 Financial Overview
- 12.8.5 SWOT Analysis
- 12.8.6 Key Developments
- 12.9 FUJIFILM Holdings Corp
- 12.9.1 Key Facts
- 12.9.2 Business Description
- 12.9.3 Products and Services
- 12.9.4 Financial Overview
- 12.9.5 SWOT Analysis
- 12.9.6 Key Developments
- 12.10 National Resilience Inc
- 12.10.1 Key Facts
- 12.10.2 Business Description
- 12.10.3 Products and Services
- 12.10.4 Financial Overview
- 12.10.5 SWOT Analysis
- 12.10.6 Key Developments
- 12.11 Oxford BioMedica Plc
- 12.11.1 Key Facts
- 12.11.2 Business Description
- 12.11.3 Products and Services
- 12.11.4 Financial Overview
- 12.11.5 SWOT Analysis
- 12.11.6 Key Developments
