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先進治療薬CDMOの市場規模、シェア、動向分析レポート 製品別(遺伝子治療、細胞治療、組織工学)、フェーズ別、適応症別、地域別、セグメント別予測、2023~2030年


Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report By Product (Gene Therapy, Cell Therapy, Tissue Engineered), By Phase, By Indication, By Region, And Segment Forecasts, 2023 - 2030

先進治療薬CDMO市場の成長・トレンド Grand View Research, Inc.の新しいレポートによると、世界の先進治療薬CDMOの市場規模は、2030年までに188億米ドルに達すると予想されています。この市場は、先進治療薬... もっと見る

 

 

出版社 出版年月 電子版価格 ページ数 言語
Grand View Research
グランドビューリサーチ
2023年1月2日 US$5,950
シングルユーザライセンス(印刷不可)
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157 英語

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先進治療薬CDMO市場の成長・トレンド

Grand View Research, Inc.の新しいレポートによると、世界の先進治療薬CDMOの市場規模は、2030年までに188億米ドルに達すると予想されています。この市場は、先進治療薬の臨床試験の増加や、先進治療の利点に関する研究者の意識の高まりにより、先進治療薬(ATMP)CDMO市場の成長を牽引し、2023年から2030年にかけてCAGR18.8%を記録すると予測されています。組織工学は、近年、技術開発の恩恵を大きく受けています。損傷した組織や臓器の機能は、この技術を使って置換または回復されます。同様に、遺伝子治療や細胞治療は、世界的に発生率が上昇している希少疾患の治療のために、多くの患者を引きつけています。

強固な疾患治療療法への需要が高まる中、主要プレイヤーは、ゲノムレベルで障害の原因を狙う効果的な遺伝子療法の研究開発を強化することに力を注いでいます。ASGCTによると、米国のパイプラインプログラム(第I-III相試験)における細胞療法および遺伝子療法の数は、2021年の483から2022年には529に増加しました。さらに、FDAは、製品製造に関する多くの政策を通じて、遺伝子治療分野のイノベーションに一定の支援を提供しています。2020年1月、FDAは安全で効率的な遺伝子治療製品の製造と臨床開発に関する6つの最終ガイドラインを発表しました。

さらに、ATMPの治療法に関する意識は、これらの製品の利点を一般に知らせることを目的としたイニシアチブによって推進されており、その結果、先進治療の採用が増加し、CDMOの市場成長を後押ししています。例えば、Alliance for Regenerative Medicine Foundation for Cell and Gene Medicineは、再生医療の臨床的・社会的利益を強調する教育プログラムを通じて、一般の人々の意識を高める活動を優先しています。

新製品の発売とともに臨床試験活動が活発化し、市場の成長機会を生み出しています。2022年現在、前臨床段階にあるATMPは1451種類あり、535種類が第1相から第3相試験で検討されています。2020年8月以降、EMAはこれらのATMPのうち6つを追加承認しており、2023年までにさらに5つが承認される予定です。英国では、2021年に進行中の先進治療医薬品の試験が約168件あり、前年の154件から9%増加した。2021年は第1相試験が32%増加しており、実験薬からファースト・イン・ヒューマン試験へと大きくシフトしていることを示しています。

一方、主要企業は新規製品の導入に向けて様々な戦略的取り組みを行っており、これが市場の成長を促進すると予想されます。例えば、2021年3月、CureVac N.V.はCelonic Groupとパートナーシップ契約を締結し、CureVacのmRNAベースのCOVID-19ワクチン候補であるCVnCoVの製造に携わっています。CureVac社のCOVID-19ワクチン候補は、ドイツ・ハイデルベルクにあるCelonic社のATMPsおよび生物製剤の商業製造装置で製造されています。商業供給契約の条件では、セロニックの施設は1億回分以上のCVnCoVを製造することができます。

先進医療用医薬品CDMO市場レポートハイライト

- 製品別では、遺伝子治療薬の臨床試験の増加により、遺伝子治療薬が大きなシェアを占めています。また、新規遺伝子治療薬の開発に向けた共同研究や、それに伴う遺伝子治療応用の拡大が、製造量の増加要因として期待されています。

- 細胞療法は、今後数年間で大きな市場シェアを占めると予想される。研究関心の高まりと先進的な細胞療法の採用が、投資の増加を引き寄せています。この分野は、CDMOが成長する商業市場に対応し、成長と多様化の展望をサポートするために投資を集めていることによって牽引されている

- フェーズ別では、フェーズIセグメントが2022年の市場収益シェアを独占しています。これは、先進的な治療法のためのヒト試験数の増加や研究開発活動の高まりに起因している

- 適応症別では、がん患者数の増加や、がんに関連する細胞・遺伝子治療研究の増加により、2022年にはがん領域が大きなシェアを占めています。さらに、がんワクチンの開発など、技術的な進歩がセグメントの成長をさらにサポートすると予想される

- 医療費の増加や主要プレイヤーの存在により、2022年の世界市場は北米が支配的でした。Novartis AG、Sanofi、Johnson & Johnson Services, Inc.、Viatrisなどの企業が市場成長にプラスの影響を与える

- 例えば、2022年6月、ノバルティスAGはドイツで再発寛解型多発性硬化症(RRMS)患者の治療薬としてフマル酸ジメチルHEXALを発売しました。この戦略的な発売は、ドイツにおけるヘキサールの商業化を目的としたものです

- アジア太平洋地域は、今後大幅な拡大が見込まれます。中国は同地域の主要市場の一つです。市場の成長は、政府投資の増加や医薬品製造に関連する政策の改革に起因しています。中国は細胞・遺伝子治療開発において世界第2位であり、1,000件以上の臨床試験が実施されている。



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目次

Table of Contents

Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Regional Scope
1.1.2 Estimates and forecast timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased database:
1.3.2 GVR’s internal database
1.3.3 Secondary sources
1.3.4 Primary research
1.3.5 Details of primary research
1.4 Information or Data Analysis
1.4.1 Data analysis models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis (Model 1)
1.6.1.1 Approach 1: Commodity Flow Approach
1.7 List of Secondary Sources
1.8 Objectives
1.8.1 Objective 1
1.8.2 Objective 2
1.8.3 Objective 3
1.8.4 Objective 4
Chapter 2 Executive Summary
2.1 Market Snapshot
2.2 Segment Snapshot
2.3 Competitive Landscape Snapshot
Chapter 3 Advanced Therapy Medicinal Products CDMO Market Variables, Trends, and Scope
3.1 Market Dynamics
3.1.1 Market Driver Analysis
3.1.1.1 Rising number of clinical trials for ATMPs
3.1.1.2 Increasing outsourcing activities
3.1.1.3 Growing awareness of the treatment
3.1.2 Market Restraint Analysis
3.1.2.1 Stringent regulatory approvals
3.1.2.2 High cost of outsourcing
3.2 Business Environment Analysis Tools
3.2.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological)
3.2.2 Porter’s Five Forces Analysis
Chapter 4 Advanced Therapy Medicinal Products CDMO Market - Segment Analysis, By Product, 2018 - 2030 (USD Billion)
4.1 Advanced Therapy Medicinal Products CDMO market: Product Movement Analysis
4.2 Gene Therapy
4.2.1 Gene therapy market estimates and forecast, 2018 - 2030 (USD Billion)
4.3 Cell Therapy
4.3.1 Cell therapy market estimates and forecast, 2018 - 2030 (USD Billion)
4.4 Tissue Engineered
4.4.1 Tissue engineered market estimates and forecast, 2018 - 2030 (USD Billion)
4.5 Others
4.5.1 Others market estimates and forecast, 2018 - 2030 (USD Billion)
Chapter 5 Advanced Therapy Medicinal Products CDMO Market - Segment Analysis, By Phase, 2018 - 2030 (USD Billion)
5.1 Advanced Therapy Medicinal Products CDMO market: Phase movement analysis
5.2 Phase 1
5.2.1 Phase 1 market estimates and forecast, 2018 - 2030 (USD Billion)
5.3 Phase 2
5.3.1 Phase 2 market estimates and forecast, 2018 - 2030 (USD Billion)
5.4 Phase 3
5.4.1 Phase 3 market estimates and forecast, 2018 - 2030 (USD Billion)
5.5 Phase 4
5.5.1 Phase 4 market estimates and forecast, 2018 - 2030 (USD Billion)
Chapter 6 Advanced Therapy Medicinal Products CDMO Market - Segment Analysis, By Indication, 2018 - 2030 (USD Billion)
6.1 Advanced therapy medicinal products CDMO market: Indication movement analysis
6.2 Oncology
6.2.1 Oncology market estimates and forecast, 2018 - 2030 (USD Billion)
6.3 Cardiology
6.3.1 Cardiology market estimates and forecast, 2018 - 2030 (USD Billion)
6.4 Central Nervous System
6.4.1 Central nervous system market estimates and forecast, 2018 - 2030 (USD Billion)
6.5 Musculoskeletal
6.5.1 Musculoskeletal market estimates and forecast, 2018 - 2030 (USD Billion)
6.6 Infectious Disease
6.6.1 Infectious disease market estimates and forecast, 2018 - 2030 (USD Billion)
6.7 Dermatology
6.7.1 Dermatology market estimates and forecast, 2018 - 2030 (USD Billion)
6.8 Endocrine, Metabolic, Genetic
6.8.1 Endocrine, metabolic, genetic market estimates and forecast, 2018 - 2030 (USD Billion)
6.9 Immunology & Inflammation
6.9.1 Immunology & inflammation market estimates and forecast, 2018 - 2030 (USD Billion)
6.10 Ophthalmology
6.10.1 Ophthalmology market estimates and forecast, 2018 - 2030 (USD Billion)
6.11 Hematology
6.11.1 Hematology market estimates and forecast, 2018 - 2030 (USD Billion)
6.12 Gastroenterology
6.12.1 Gastroenterology market estimates and forecast, 2018 - 2030 (USD Billion)
6.13 Others
6.13.1 Others market estimates and forecast, 2018 - 2030 (USD Billion)
Chapter 7 Advanced Therapy Medicinal Products CDMO Market: Regional Market Analysis, 2018 - 2030 (USD Billion)
7.1 North America
7.1.1 SWOT Analysis
7.1.1.1 North America Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.1.2 U.S.
7.1.2.1 Key Country Dynamics
7.1.2.2 Target Disease Prevalence
7.1.2.3 Competitive Scenario
7.1.2.4 Regulatory Framework
7.1.2.5 Reimbursement Scenario
7.1.2.6 U.S. Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.1.3 Canada
7.1.3.1 Key Country Dynamics
7.1.3.2 Target Disease Prevalence
7.1.3.3 Competitive Scenario
7.1.3.4 Regulatory Framework
7.1.3.5 Reimbursement Scenario
7.1.3.6 Canada Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2 Europe
7.2.1 SWOT Analysis:
7.2.1.1 Europe Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.2 Germany
7.2.2.1 Key Country Dynamics
7.2.2.2 Target Disease Prevalence
7.2.2.3 Competitive Scenario
7.2.2.4 Regulatory Framework
7.2.2.5 Reimbursement Scenario
7.2.2.6 Germany Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.3 UK
7.2.3.1 Key Country Dynamics
7.2.3.2 Target Disease Prevalence
7.2.3.3 Competitive Scenario
7.2.3.4 Regulatory Framework
7.2.3.5 Reimbursement Scenario
7.2.3.6 UK Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.4 France
7.2.4.1 Key Country Dynamics
7.2.4.2 Target Disease Prevalence
7.2.4.3 Competitive Scenario
7.2.4.4 Regulatory Framework
7.2.4.5 Reimbursement Scenario
7.2.4.6 France Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.5 Italy
7.2.5.1 Key Country Dynamics
7.2.5.2 Target Disease Prevalence
7.2.5.3 Competitive Scenario
7.2.5.4 Regulatory Framework
7.2.5.5 Reimbursement Scenario
7.2.5.6 Italy Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.6 Spain
7.2.6.1 Key Country Dynamics
7.2.6.2 Target Disease Prevalence
7.2.6.3 Competitive Scenario
7.2.6.4 Regulatory Framework
7.2.6.5 Reimbursement Scenario
7.2.6.6 Spain Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.7 Denmark
7.2.7.1 Key Country Dynamics
7.2.7.2 Target Disease Prevalence
7.2.7.3 Competitive Scenario
7.2.7.4 Regulatory Framework
7.2.7.5 Reimbursement Scenario
7.2.7.6 Denmark Advanced therapy Medicinal products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.8 Sweden
7.2.8.1 Key Country Dynamics
7.2.8.2 Target Disease Prevalence
7.2.8.3 Competitive Scenario
7.2.8.4 Regulatory Framework
7.2.8.5 Reimbursement Scenario
7.2.8.6 Sweden Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.9 Norway
7.2.9.1 Key Country Dynamics
7.2.9.2 Target Disease Prevalence
7.2.9.3 Competitive Scenario
7.2.9.4 Regulatory Framework
7.2.9.5 Reimbursement Scenario
7.2.9.6 Norway Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.10 Rest of Europe Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3 Asia Pacific
7.3.1 SWOT Analysis:
7.3.1.1 Key Region Dynamics
7.3.1.2 Asia Pacific Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.2 Japan
7.3.2.1 Target Disease Prevalence
7.3.2.2 Competitive Scenario
7.3.2.3 Regulatory Framework
7.3.2.4 Reimbursement Scenario
7.3.2.5 Japan Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.3 China
7.3.3.1 Target Disease Prevalence
7.3.3.2 Competitive Scenario
7.3.3.3 Regulatory Framework
7.3.3.4 Reimbursement Scenario
7.3.3.5 China Advanced Therapy Medicinal Prodcut CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.4 India
7.3.4.1 Target Disease Prevalence
7.3.4.2 Competitive Scenario
7.3.4.3 Regulatory Framework
7.3.4.4 Reimbursement Scenario
7.3.4.5 India Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.5 South Korea
7.3.5.1 Target Disease Prevalence
7.3.5.2 Competitive Scenario
7.3.5.3 Regulatory Framework
7.3.5.4 Reimbursement Scenario
7.3.5.5 South Korea Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.6 Australia
7.3.6.1 Target Disease Prevalence
7.3.6.2 Competitive Scenario
7.3.6.3 Regulatory Framework
7.3.6.4 Reimbursement Scenario
7.3.6.5 Austrlia Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.7 Thailand
7.3.7.1 Target Disease Prevalence
7.3.7.2 Competitive Scenario
7.3.7.3 Regulatory Framework
7.3.7.4 Reimbursement Scenario
7.3.7.5 Thailand Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.8 Rest of Asia Pacific Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4 Latin America
7.4.1 SWOT Analysis:
7.4.2 KEY Regional DYNAMICS
7.4.2.1 Latin America Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.3 Brazil
7.4.3.1 Target Disease Prevalence
7.4.3.2 Competitive Scenario
7.4.3.3 Regulatory Framework
7.4.3.4 Reimbursement Scenario
7.4.3.5 Brazil Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.4 Mexico
7.4.4.1 Target Disease Prevalence
7.4.4.2 Competitive Scenario
7.4.4.3 Regulatory Framework
7.4.4.4 Reimbursement Scenario
7.4.4.5 Mexico Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.5 Argentina
7.4.5.1 Target Disease Prevalence
7.4.5.2 Competitive Scenario
7.4.5.3 Regulatory Framework
7.4.5.4 Reimbursement Scenario
7.4.5.5 Argentina Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.6 Colombia
7.4.6.1 Target Disease Prevalence
7.4.6.2 Competitive Scenario
7.4.6.3 Regulatory Framework
7.4.6.4 Reimbursement Scenario
7.4.6.5 Colombia Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.7 Chile
7.4.7.1 Target Disease Prevalence
7.4.7.2 Competitive Scenario
7.4.7.3 Regulatory Framework
7.4.7.4 Reimbursement Scenario
7.4.7.5 Chile Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.8 Rest of LATAM Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5 Middle East & Africa (MEA)
7.5.1 SWOT Analysis:
7.5.2 KEY regional DYNAMICS
7.5.2.1 Middle East & Africa advanced therapy medicinal products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.3 South Africa
7.5.3.1 Target Disease Prevalence
7.5.3.2 Competitive Scenario
7.5.3.3 Regulatory Framework
7.5.3.4 Reimbursement Scenario
7.5.3.5 Brazil Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.4 Saudi Arabia
7.5.4.1 Target Disease Prevalence
7.5.4.2 Competitive Scenario
7.5.4.3 Regulatory Framework
7.5.4.4 Reimbursement Scenario
7.5.4.5 Saudi Arabia Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.5 UAE
7.5.5.1 Target Disease Prevalence
7.5.5.2 Competitive Scenario
7.5.5.3 Regulatory Framework
7.5.5.4 Reimbursement Scenario
7.5.5.5 UAE Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.6 Israel
7.5.6.1 Target Disease Prevalence
7.5.6.2 Competitive Scenario
7.5.6.3 Regulatory Framework
7.5.6.4 Reimbursement Scenario
7.5.6.5 Israel Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.7 Egypt
7.5.7.1 Target Disease Prevalence
7.5.7.2 Competitive Scenario
7.5.7.3 Regulatory Framework
7.5.7.4 Reimbursement Scenario
7.5.7.5 Egypt Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.8 Kuwait
7.5.8.1 Target Disease Prevalence
7.5.8.2 Competitive Scenario
7.5.8.3 Regulatory Framework
7.5.8.4 Reimbursement Scenario
7.5.8.5 Kuwait Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.9 Rest of MEA Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 8 Advanced Therapy Medicinal Products CDMO Market: Competitive Analysis
8.1 Strategic Framework
8.2 Company Profiles
8.2.1 CELONIC Group
8.2.1.1 Company Overview
8.2.1.2 Product Benchmarking
8.2.1.3 Strategic Initiatives
8.2.2 Bio Elpida
8.2.2.1 Company Overview
8.2.2.2 Product Benchmarking
8.2.2.3 Strategic Initiatives
8.2.3 Rentschler Biopharma SE
8.2.3.1 Company Overview
8.2.3.2 Product Benchmarking
8.2.3.3 Strategic Initiatives
8.2.4 AGC Biologics
8.2.4.1 Company Overview
8.2.4.2 Product Benchmarking
8.2.4.3 Strategic Initiatives
8.2.5 Catalent, Inc.
8.2.5.1 Company Overview
8.2.5.2 Financial Performance
8.2.5.3 Product Benchmarking
8.2.5.4 Strategic Initiatives
8.2.6 Lonza
8.2.6.1 Company Overview
8.2.6.2 Financial Performance
8.2.6.3 Product Benchmarking
8.2.6.4 Strategic Initiatives
8.2.7 WuXi Advanced Therapies
8.2.7.1 Company Overview
8.2.7.2 Product Benchmarking
8.2.7.3 Strategic Initiatives
8.2.8 Minaris Regenerative Medicine
8.2.8.1 Company Overview
8.2.8.2 Product Benchmarking
8.2.8.3 Strategic Initiatives
8.2.9 Patheon, Inc.
8.2.9.1 Company Overview
8.2.9.2 Financial Performance
8.2.9.3 Product Benchmarking
8.2.9.4 Strategic Initiatives
8.2.10 Cell and Gene Therapy Catapult (CGT Catapult)
8.2.10.1 Company Overview
8.2.10.2 Financial Performance
8.2.10.3 Product Benchmarking
8.2.10.4 Strategic Initiatives

 

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Summary

Advanced Therapy Medicinal Products CDMO Market Growth & Trends

The global advanced therapy medicinal products CDMO market size is expected to reach USD 18.8 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to register a CAGR of 18.8% from 2023 to 2030, owing to rising clinical trials for advanced therapy medicinal products and the increasing awareness among researchers about the benefits of advanced therapies, driving the advanced therapy medicinal products (ATMP) CDMO market growth. Tissue engineering has greatly benefited in recent years from technological development. The damaged tissues and organ function are replaced or restored using this technique. Similarly, gene and cell therapy are attracting a lot of patients for the treatment of rare diseases, whose incidence is rising globally.

With rising demand for robust disease treatment therapies, key players have focused their efforts to ramp up research and development for effective gene therapies that target the cause of disorder at a genomic level. According to ASGCT, the number of cell and gene therapies in the U.S. pipeline programs (phase I-III trials) increased from 483 in 2021 to 529 in 2022. Furthermore, the FDA delivers constant support for innovations in the gene therapy field via a number of policies with regard to product manufacturing. In January 2020, the agency released six final guidelines on the manufacturing and clinical development of safe & efficient gene therapy products.

Moreover, awareness about ATMP treatment options is being driven by initiatives aimed at informing the public about the benefits of these products, which, in turn, is leading to increased adoption of advanced therapies and fueling market growth for CDMOs. For instance, Alliance for Regenerative Medicine Foundation for Cell and Gene Medicine prioritizes activities for increasing public awareness through educational programs, underlining the clinical & societal benefits of regenerative medicine.

Increasing clinical trial activity along with new product launches generates growth opportunities for the market. As of 2022, there are 1451 ATMPs in preclinical stages and 535 are being studied in Phase 1 to 3 studies. Since August 2020, EMA has approved six of these additional ATMPs, and five more will be approved by 2023. In the UK, there were approximately 168 advanced therapy medicinal product trials underway in 2021, up from the 154 studies reported the year before, which is a 9% increase. 2021 saw a 32% increase in phase 1 trials, indicating a significant shift from experimental medicines to first-in-human studies.

On the other hand, key players are undertaking various strategic initiatives to introduce novel products, which is expected to propel market growth. For instance, in March 2021, CureVac N.V. signed a partnership agreement with Celonic Group, engaged in the manufacture of CVnCoV, CureVac’s mRNA-based COVID-19 vaccine candidate. CureVac's COVID-19 vaccine candidate is manufactured at Celonic's commercial manufacturing unit for ATMPs and biologics in Heidelberg, Germany. Under the terms of the commercial supply agreement, the Celonic facility could produce over 100 million doses of CVnCoV.

Advanced Therapy Medicinal Products CDMO Market Report Highlights

• By product, gene therapy accounted for a major share of market space due to increasing clinical trials for gene therapies. Moreover, collaborative efforts for the development of novel gene therapies and the resultant expansion in gene therapy applications are factors expected to drive the volume of manufacturing

• Cell therapy is expected to account for a significant market share in the coming years. A rise in research interests and the adoption of advanced cell therapies are attracting increased investments. The segment is being driven by CDMOs attracting investments to keep up with growing commercial markets and support their growth and diversification prospects

• By phase, the phase I segment dominated the market revenue share in 2022. This is attributed to the growing number of human trials for advanced therapies and rising R&D activities

• By indication, the oncology segment held a major share of the market in 2022 due to the increasing number of cancer patients and increasing cell and gene therapy research related to cancer. Moreover, technological advancements, such as the development of cancer vaccines, are expected to further support segment growth

• North America dominated the global market in 2022, owing to increasing healthcare expenditure and the presence of key players. Companies such as Novartis AG, Sanofi, Johnson & Johnson Services, Inc., and Viatris are positively influencing market growth

• For instance, in June 2022, Novartis AG launched Dimethyl fumarate HEXAL for the treatment of patients with Relapsing-Remitting Multiple Sclerosis (RRMS) in Germany. This strategic launch was aimed at commercializing Hexal in Germany

• The Asia Pacific region is expected to expand considerably in the future. China is one of the major markets in the region. The market growth can be attributed to increasing government investments and reforms in policies related to the manufacturing of pharmaceutical products. China ranked second in the world for cell & gene therapy development with more than 1,000 clinical trials conducted in the country



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Table of Contents

Table of Contents

Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Regional Scope
1.1.2 Estimates and forecast timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased database:
1.3.2 GVR’s internal database
1.3.3 Secondary sources
1.3.4 Primary research
1.3.5 Details of primary research
1.4 Information or Data Analysis
1.4.1 Data analysis models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis (Model 1)
1.6.1.1 Approach 1: Commodity Flow Approach
1.7 List of Secondary Sources
1.8 Objectives
1.8.1 Objective 1
1.8.2 Objective 2
1.8.3 Objective 3
1.8.4 Objective 4
Chapter 2 Executive Summary
2.1 Market Snapshot
2.2 Segment Snapshot
2.3 Competitive Landscape Snapshot
Chapter 3 Advanced Therapy Medicinal Products CDMO Market Variables, Trends, and Scope
3.1 Market Dynamics
3.1.1 Market Driver Analysis
3.1.1.1 Rising number of clinical trials for ATMPs
3.1.1.2 Increasing outsourcing activities
3.1.1.3 Growing awareness of the treatment
3.1.2 Market Restraint Analysis
3.1.2.1 Stringent regulatory approvals
3.1.2.2 High cost of outsourcing
3.2 Business Environment Analysis Tools
3.2.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological)
3.2.2 Porter’s Five Forces Analysis
Chapter 4 Advanced Therapy Medicinal Products CDMO Market - Segment Analysis, By Product, 2018 - 2030 (USD Billion)
4.1 Advanced Therapy Medicinal Products CDMO market: Product Movement Analysis
4.2 Gene Therapy
4.2.1 Gene therapy market estimates and forecast, 2018 - 2030 (USD Billion)
4.3 Cell Therapy
4.3.1 Cell therapy market estimates and forecast, 2018 - 2030 (USD Billion)
4.4 Tissue Engineered
4.4.1 Tissue engineered market estimates and forecast, 2018 - 2030 (USD Billion)
4.5 Others
4.5.1 Others market estimates and forecast, 2018 - 2030 (USD Billion)
Chapter 5 Advanced Therapy Medicinal Products CDMO Market - Segment Analysis, By Phase, 2018 - 2030 (USD Billion)
5.1 Advanced Therapy Medicinal Products CDMO market: Phase movement analysis
5.2 Phase 1
5.2.1 Phase 1 market estimates and forecast, 2018 - 2030 (USD Billion)
5.3 Phase 2
5.3.1 Phase 2 market estimates and forecast, 2018 - 2030 (USD Billion)
5.4 Phase 3
5.4.1 Phase 3 market estimates and forecast, 2018 - 2030 (USD Billion)
5.5 Phase 4
5.5.1 Phase 4 market estimates and forecast, 2018 - 2030 (USD Billion)
Chapter 6 Advanced Therapy Medicinal Products CDMO Market - Segment Analysis, By Indication, 2018 - 2030 (USD Billion)
6.1 Advanced therapy medicinal products CDMO market: Indication movement analysis
6.2 Oncology
6.2.1 Oncology market estimates and forecast, 2018 - 2030 (USD Billion)
6.3 Cardiology
6.3.1 Cardiology market estimates and forecast, 2018 - 2030 (USD Billion)
6.4 Central Nervous System
6.4.1 Central nervous system market estimates and forecast, 2018 - 2030 (USD Billion)
6.5 Musculoskeletal
6.5.1 Musculoskeletal market estimates and forecast, 2018 - 2030 (USD Billion)
6.6 Infectious Disease
6.6.1 Infectious disease market estimates and forecast, 2018 - 2030 (USD Billion)
6.7 Dermatology
6.7.1 Dermatology market estimates and forecast, 2018 - 2030 (USD Billion)
6.8 Endocrine, Metabolic, Genetic
6.8.1 Endocrine, metabolic, genetic market estimates and forecast, 2018 - 2030 (USD Billion)
6.9 Immunology & Inflammation
6.9.1 Immunology & inflammation market estimates and forecast, 2018 - 2030 (USD Billion)
6.10 Ophthalmology
6.10.1 Ophthalmology market estimates and forecast, 2018 - 2030 (USD Billion)
6.11 Hematology
6.11.1 Hematology market estimates and forecast, 2018 - 2030 (USD Billion)
6.12 Gastroenterology
6.12.1 Gastroenterology market estimates and forecast, 2018 - 2030 (USD Billion)
6.13 Others
6.13.1 Others market estimates and forecast, 2018 - 2030 (USD Billion)
Chapter 7 Advanced Therapy Medicinal Products CDMO Market: Regional Market Analysis, 2018 - 2030 (USD Billion)
7.1 North America
7.1.1 SWOT Analysis
7.1.1.1 North America Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.1.2 U.S.
7.1.2.1 Key Country Dynamics
7.1.2.2 Target Disease Prevalence
7.1.2.3 Competitive Scenario
7.1.2.4 Regulatory Framework
7.1.2.5 Reimbursement Scenario
7.1.2.6 U.S. Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.1.3 Canada
7.1.3.1 Key Country Dynamics
7.1.3.2 Target Disease Prevalence
7.1.3.3 Competitive Scenario
7.1.3.4 Regulatory Framework
7.1.3.5 Reimbursement Scenario
7.1.3.6 Canada Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2 Europe
7.2.1 SWOT Analysis:
7.2.1.1 Europe Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.2 Germany
7.2.2.1 Key Country Dynamics
7.2.2.2 Target Disease Prevalence
7.2.2.3 Competitive Scenario
7.2.2.4 Regulatory Framework
7.2.2.5 Reimbursement Scenario
7.2.2.6 Germany Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.3 UK
7.2.3.1 Key Country Dynamics
7.2.3.2 Target Disease Prevalence
7.2.3.3 Competitive Scenario
7.2.3.4 Regulatory Framework
7.2.3.5 Reimbursement Scenario
7.2.3.6 UK Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.4 France
7.2.4.1 Key Country Dynamics
7.2.4.2 Target Disease Prevalence
7.2.4.3 Competitive Scenario
7.2.4.4 Regulatory Framework
7.2.4.5 Reimbursement Scenario
7.2.4.6 France Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.5 Italy
7.2.5.1 Key Country Dynamics
7.2.5.2 Target Disease Prevalence
7.2.5.3 Competitive Scenario
7.2.5.4 Regulatory Framework
7.2.5.5 Reimbursement Scenario
7.2.5.6 Italy Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.6 Spain
7.2.6.1 Key Country Dynamics
7.2.6.2 Target Disease Prevalence
7.2.6.3 Competitive Scenario
7.2.6.4 Regulatory Framework
7.2.6.5 Reimbursement Scenario
7.2.6.6 Spain Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.7 Denmark
7.2.7.1 Key Country Dynamics
7.2.7.2 Target Disease Prevalence
7.2.7.3 Competitive Scenario
7.2.7.4 Regulatory Framework
7.2.7.5 Reimbursement Scenario
7.2.7.6 Denmark Advanced therapy Medicinal products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.8 Sweden
7.2.8.1 Key Country Dynamics
7.2.8.2 Target Disease Prevalence
7.2.8.3 Competitive Scenario
7.2.8.4 Regulatory Framework
7.2.8.5 Reimbursement Scenario
7.2.8.6 Sweden Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.9 Norway
7.2.9.1 Key Country Dynamics
7.2.9.2 Target Disease Prevalence
7.2.9.3 Competitive Scenario
7.2.9.4 Regulatory Framework
7.2.9.5 Reimbursement Scenario
7.2.9.6 Norway Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.2.10 Rest of Europe Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3 Asia Pacific
7.3.1 SWOT Analysis:
7.3.1.1 Key Region Dynamics
7.3.1.2 Asia Pacific Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.2 Japan
7.3.2.1 Target Disease Prevalence
7.3.2.2 Competitive Scenario
7.3.2.3 Regulatory Framework
7.3.2.4 Reimbursement Scenario
7.3.2.5 Japan Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.3 China
7.3.3.1 Target Disease Prevalence
7.3.3.2 Competitive Scenario
7.3.3.3 Regulatory Framework
7.3.3.4 Reimbursement Scenario
7.3.3.5 China Advanced Therapy Medicinal Prodcut CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.4 India
7.3.4.1 Target Disease Prevalence
7.3.4.2 Competitive Scenario
7.3.4.3 Regulatory Framework
7.3.4.4 Reimbursement Scenario
7.3.4.5 India Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.5 South Korea
7.3.5.1 Target Disease Prevalence
7.3.5.2 Competitive Scenario
7.3.5.3 Regulatory Framework
7.3.5.4 Reimbursement Scenario
7.3.5.5 South Korea Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.6 Australia
7.3.6.1 Target Disease Prevalence
7.3.6.2 Competitive Scenario
7.3.6.3 Regulatory Framework
7.3.6.4 Reimbursement Scenario
7.3.6.5 Austrlia Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.7 Thailand
7.3.7.1 Target Disease Prevalence
7.3.7.2 Competitive Scenario
7.3.7.3 Regulatory Framework
7.3.7.4 Reimbursement Scenario
7.3.7.5 Thailand Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.3.8 Rest of Asia Pacific Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4 Latin America
7.4.1 SWOT Analysis:
7.4.2 KEY Regional DYNAMICS
7.4.2.1 Latin America Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.3 Brazil
7.4.3.1 Target Disease Prevalence
7.4.3.2 Competitive Scenario
7.4.3.3 Regulatory Framework
7.4.3.4 Reimbursement Scenario
7.4.3.5 Brazil Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.4 Mexico
7.4.4.1 Target Disease Prevalence
7.4.4.2 Competitive Scenario
7.4.4.3 Regulatory Framework
7.4.4.4 Reimbursement Scenario
7.4.4.5 Mexico Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.5 Argentina
7.4.5.1 Target Disease Prevalence
7.4.5.2 Competitive Scenario
7.4.5.3 Regulatory Framework
7.4.5.4 Reimbursement Scenario
7.4.5.5 Argentina Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.6 Colombia
7.4.6.1 Target Disease Prevalence
7.4.6.2 Competitive Scenario
7.4.6.3 Regulatory Framework
7.4.6.4 Reimbursement Scenario
7.4.6.5 Colombia Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.7 Chile
7.4.7.1 Target Disease Prevalence
7.4.7.2 Competitive Scenario
7.4.7.3 Regulatory Framework
7.4.7.4 Reimbursement Scenario
7.4.7.5 Chile Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.4.8 Rest of LATAM Advanced therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5 Middle East & Africa (MEA)
7.5.1 SWOT Analysis:
7.5.2 KEY regional DYNAMICS
7.5.2.1 Middle East & Africa advanced therapy medicinal products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.3 South Africa
7.5.3.1 Target Disease Prevalence
7.5.3.2 Competitive Scenario
7.5.3.3 Regulatory Framework
7.5.3.4 Reimbursement Scenario
7.5.3.5 Brazil Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.4 Saudi Arabia
7.5.4.1 Target Disease Prevalence
7.5.4.2 Competitive Scenario
7.5.4.3 Regulatory Framework
7.5.4.4 Reimbursement Scenario
7.5.4.5 Saudi Arabia Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.5 UAE
7.5.5.1 Target Disease Prevalence
7.5.5.2 Competitive Scenario
7.5.5.3 Regulatory Framework
7.5.5.4 Reimbursement Scenario
7.5.5.5 UAE Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.6 Israel
7.5.6.1 Target Disease Prevalence
7.5.6.2 Competitive Scenario
7.5.6.3 Regulatory Framework
7.5.6.4 Reimbursement Scenario
7.5.6.5 Israel Advanced Therapy Medicinal product CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.7 Egypt
7.5.7.1 Target Disease Prevalence
7.5.7.2 Competitive Scenario
7.5.7.3 Regulatory Framework
7.5.7.4 Reimbursement Scenario
7.5.7.5 Egypt Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.8 Kuwait
7.5.8.1 Target Disease Prevalence
7.5.8.2 Competitive Scenario
7.5.8.3 Regulatory Framework
7.5.8.4 Reimbursement Scenario
7.5.8.5 Kuwait Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
7.5.9 Rest of MEA Advanced Therapy Medicinal Products CDMO Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
Chapter 8 Advanced Therapy Medicinal Products CDMO Market: Competitive Analysis
8.1 Strategic Framework
8.2 Company Profiles
8.2.1 CELONIC Group
8.2.1.1 Company Overview
8.2.1.2 Product Benchmarking
8.2.1.3 Strategic Initiatives
8.2.2 Bio Elpida
8.2.2.1 Company Overview
8.2.2.2 Product Benchmarking
8.2.2.3 Strategic Initiatives
8.2.3 Rentschler Biopharma SE
8.2.3.1 Company Overview
8.2.3.2 Product Benchmarking
8.2.3.3 Strategic Initiatives
8.2.4 AGC Biologics
8.2.4.1 Company Overview
8.2.4.2 Product Benchmarking
8.2.4.3 Strategic Initiatives
8.2.5 Catalent, Inc.
8.2.5.1 Company Overview
8.2.5.2 Financial Performance
8.2.5.3 Product Benchmarking
8.2.5.4 Strategic Initiatives
8.2.6 Lonza
8.2.6.1 Company Overview
8.2.6.2 Financial Performance
8.2.6.3 Product Benchmarking
8.2.6.4 Strategic Initiatives
8.2.7 WuXi Advanced Therapies
8.2.7.1 Company Overview
8.2.7.2 Product Benchmarking
8.2.7.3 Strategic Initiatives
8.2.8 Minaris Regenerative Medicine
8.2.8.1 Company Overview
8.2.8.2 Product Benchmarking
8.2.8.3 Strategic Initiatives
8.2.9 Patheon, Inc.
8.2.9.1 Company Overview
8.2.9.2 Financial Performance
8.2.9.3 Product Benchmarking
8.2.9.4 Strategic Initiatives
8.2.10 Cell and Gene Therapy Catapult (CGT Catapult)
8.2.10.1 Company Overview
8.2.10.2 Financial Performance
8.2.10.3 Product Benchmarking
8.2.10.4 Strategic Initiatives

 

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