細胞・遺伝子治療製造サービス市場規模・予測（2020年～2030年）、世界・地域シェア、動向、成長機会分析レポート収録範囲タイプ別（細胞療法（自己由来、同種異系）、遺伝子療法（ウイルス、非ウイルスベクター））、適応症別（がん、整形外科、その他）、用途別（臨床製造、商業製造）、エンドユーザー別（製薬会社、バイオテクノロジー企業、CRO）、地域別（北米、欧州、アジア太平洋、中東・アフリカ、中南米

Cell and Gene Therapy Manufacturing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type [Cell Therapy (Autologous and Allogenic) and Gene Therapy (Viral and Non-Viral Vector)], Indication (Cancer, Orthopaedics, and Others), Application (Clinical Manufacturing and Commercial Manufacturing), End User [Pharmaceutical and Biotechnology Companies and Contract Research Organization (CROs)], and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

細胞・遺伝子治療製造サービス市場規模は、2022年の75億8,197万米ドルから2030年には267億2,490万米ドルに成長すると予想され、2022～2030年の年平均成長率は17.1％と推定される。当レポートでは、市場の動向... もっと見る

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細胞・遺伝子治療製造サービス市場規模は、2022年の75億8,197万米ドルから2030年には267億2,490万米ドルに成長すると予想され、2022～2030年の年平均成長率は17.1％と推定される。

当レポートでは、市場の動向と細胞・遺伝子治療製造サービス市場の成長を促進・阻害する要因について明らかにしている。市場の成長は、細胞・遺伝子治療の承認件数の増加と、細胞・遺伝子治療製造のアウトソーシング人気の高まりに起因している。しかし、細胞・遺伝子治療製造の高コストが市場成長の妨げとなっている。

企業の戦略的取り組み

細胞・遺伝子治療製造サービス市場で事業を展開する企業は、提携、拡大、合意、パートナーシップ、新製品発売などの戦略的展開に重点を置いており、売上の向上、地理的範囲の拡大、既存顧客ベースよりも多くの顧客に対応するための能力強化に貢献している。細胞・遺伝子治療製造サービス市場における注目すべき動向のいくつかを以下に挙げる。

- 2023年5月、ロンザ社は、CAR T細胞製造の最適化と合理化のために考案された、化学的に定義された新しい製剤を用いたTheraPEAK T-VIVO細胞培養液を発売した。TheraPEAK T-VIVO細胞培養培地は、他の無血清培地とは異なり、ヒト血清やその成分を添加することなく高い性能を発揮することができる。

- 2022年10月、ファイザー社は、成人におけるエピソード性片頭痛の急性期治療薬および予防薬として承認された革新的な片頭痛治療薬であるNURTEC ODT（リメゲパント）の製造元であるバイオヘイブン・ファーマシューティカル・ホールディング社の買収を完了した。

- 2022年3月、セルボルブ・バイオはシアトル・チルドレンズ・セラピューティクスと提携し、小児がんを対象とした新たなマルチプレックスCARの開発と商業化を目指す。この提携のもと、両社は小児の中枢神経系（CNS）悪性腫瘍を治療するため、5種類のマルチプレックスCARからなるBrainChild研究プログラムに注力する。提携により、両社はシアトル・チルドレンズ・キュア・ファクトリー施設を活用し、新規CARの初期臨床GMP研究を実施する。

- 2022年3月、Twist Bioscience CorporationとKriya Therapeutics, Inc.は、癌治療用途でアデノ随伴ウイルス（AAV）遺伝子治療を用いて送達される抗体に関する抗体探索契約を締結した。両社は提携に際して、ツイストの抗体ライブラリーとクリヤ独自のベクター工学プラットフォームを組み合わせ、クリヤの遺伝子治療技術で送達される特定の標的に対する新規抗体を発見する計画を持っていた。

- 2022年2月、エディジーン社はボストン小児病院（BCH）と、主要遺伝子を破壊することによる胎児ヘモグロビンのアップレギュレーションに関する知的財産権のグローバルライセンス契約を締結した。胎児ヘモグロビンのアップレギュレーションは、異常なヘモグロビン構造に起因する多くの遺伝性疾患（ヘモグロビン異常症）に対する潜在的な治療法であり、欠陥のあるヘモグロビン分子を胎児版と置き換える。

- 2022年1月、富士フイルムはAtara Biotherapeutics, Inc.から細胞治療製造施設を買収することに合意した。この施設は拡張が容易で、同種T細胞療法やCAR T免疫療法を含む臨床用・商業用の細胞療法を柔軟に製造できる。

- 2021年1月、サーモフィッシャーサイエンティフィック社は、ベルギーを拠点とするグループ・ノヴァセップSASのウイルスベクター製造事業であるHenogen S.A.を買収した。ヘノジェン社はバイオテクノロジー企業や大手バイオ医薬品企業にワクチンや治療薬の製造サービスを提供している。この買収により、サーモフィッシャーサイエンティフィックは細胞・遺伝子ワクチンおよび治療薬カテゴリーにおける能力を拡大した。

したがって、ウイルスベクター、細胞治療製造用培地、同種T細胞などの製品の導入、様々な健康問題をターゲットとした革新的製品の開発による新製品や改良品の創出、市場での競争力を維持するための新規事業の立ち上げなど、提携や協力を通じて、細胞・遺伝子治療製造サービスの新たなプラットフォームの開発を加速させることができる。したがって、こうした戦略的イニシアティブは、細胞・遺伝子治療製造サービス市場に大きな成長機会をもたらす。

細胞・遺伝子治療製造コストの高さ

細胞・遺伝子治療は複雑な製造工程を伴い、生物学的成分を使用するため、その価格は法外である。例えば、Kymriahのコストは475,000米ドル、Yescartaのコストは373,000米ドルである。Institute for Clinical and Economic Review（ICER）の分析によると、遺伝子治療の平均コストは1回あたり100万〜200万米ドルである。細胞治療や遺伝子治療の製造には、ブラックボックス効果、失敗の増幅、柔軟性の低下など様々なリスクが伴う。ブラックボックス効果とは、自動化されたシステムで実行される作業やプロセスのことで、プロセスが見えず、進捗状況も見えない。そのため、製造工程が見えないことで失敗が増加し、製造工程に適応する柔軟性が低下する。さらに、製造業者にとって最も重要な課題は、FDAやEMAなどの規制機関から製品の承認を得ること、そして治療薬の副作用から患者の安全を確保することである。

さらに、消耗品や機器のコストははるかに高く、これが細胞治療の割高なコストにつながっている。例えば、Miltenyi Biotec社が提供する試薬キットのコストは500～5,000米ドルである。同様に、装置導入の資本コストは200万米ドル近くになる。このように、治療価格に関する課題が細胞・遺伝子治療製造サービス市場の成長を制限している。

細胞・遺伝子治療製造サービス市場、タイプ別インサイト

細胞・遺伝子治療製造サービス市場は、タイプ別に細胞治療と遺伝子治療に区分される。細胞療法は自己由来と同種異系に区分される。さらに、遺伝子治療はウイルスベクターと非ウイルスベクターに二分される。2022年の市場シェアは、細胞療法分野が大きい。しかし、遺伝子治療セグメントは予測期間（2022-2030年）中に16.6％の最も高いCAGRを記録すると予測されている。遺伝子治療は、遺伝子を用いて医学的疾患や疾病を予防、治療、治癒する技術である。遺伝子治療は多くの場合、患者の細胞内で欠損している遺伝子や壊れている遺伝子のコピーを健康な遺伝子と置き換えることによって行われる。遺伝子治療は、体内だけでなく体外の細胞の改変にも用いることができる。体内の細胞を改変するために遺伝子治療を行う場合、遺伝子を運ぶベクターが患者に直接注入される。一方、体外の細胞を改変するために遺伝子治療を行う場合は、血液、骨髄、あるいは他の組織を取り出し、研究室で特定の細胞タイプを分離する。

細胞・遺伝子治療製造サービス市場、適応症別インサイト

適応症に基づき、細胞・遺伝子治療製造サービス市場はがん、整形外科、その他に分けられる。2022年にはがん分野が最大シェアを占め、同分野は予測期間中に最も高いCAGRで成長すると予測されている。細胞・遺伝子治療の幅広い分野は、がんによる死亡を予防する可能性を秘めた多くの革新的な治療を約束している。Alliance for Cancer Gene Therapy, Inc.の2022年4月のニュースレターによると、6つのCAR T細胞療法が骨髄腫、白血病、リンパ腫の治療薬として米国食品医薬品局（FDA）から承認されている。2022年12月、FDAは、高リスクのバシルス・カルメット・ゲラン（BCG）非応答性の非筋肉浸潤性膀胱がん（NMIBC）で、乳頭状腫瘍の有無にかかわらずCIS（carcinoma in situ）を有する成人患者の治療薬として、非複製アデノウイルスベクターをベースとする遺伝子治療薬Adstiladrinを承認した。2022年、FDAは眼に発生するまれなタイプの黒色腫-ブドウ膜黒色腫-に対するT細胞受容体療法であるキムトラックを承認した。がん治療のための細胞治療や遺伝子治療のFDA承認数が増加するにつれて、これらの治療法の生産もここ数年で増加している。そのため、多数のCDMOががん細胞・遺伝子治療薬の製造サービスの提供に注力している。

用途別では、細胞・遺伝子治療製造サービス市場は臨床製造と商業製造に分類される。商業用製造セグメントは2022年に市場で最大のシェアを占め、予測期間（2020-2030年）には市場で最も高いCAGR 17.1%を記録すると予測されている。CGTは、臨床的有用性、耐久性、総合的な奏効率の組み合わせによって、複数の治療領域にわたって大きな価値を提供している。しかし、これらの治療法はまだ大きな市場規模を獲得するには至っていない。CGTの治療効果は、適切な患者に適切な治療法を提供することに伴う難しさのために過小評価されており、そのため、過去10年間に市場に出たCGTベースの市販製品はわずかである。しかし、第3相臨床試験中のCGTベースの臨床パイプラインは、近い将来、承認数が飛躍的に増加する可能性を示している。著名なCDMOでありWuXi AppTecの完全子会社であるWuXi Advanced Therapies Inc.は、2021年10月に上海に新しいプロセス開発と商業生産施設を開設すると発表した。この新しい製造施設は、GMP商業製造と統合試験サービスを通じて世界的な能力を拡大し、今後数年間のCGT製品の商業化をサポートする。

細胞・遺伝子治療製造サービス市場は、エンドユーザー別に製薬・バイオテクノロジー企業と医薬品開発業務受託機関（CRO）に分類される。製薬・バイオテクノロジー分野は2022年に最大シェアを占め、予測期間中（2020-2030年）の市場CAGRは17.1%と最も高くなると予測されている。米国を拠点とする主な製薬・バイオテクノロジー企業は、従来のアプローチでは対応できない急性疾患や希少疾患の治療を目的としたCGTの提供に取り組んでおり、ElevateBio社やDiscovery Labs社などが含まれる。これらの企業は、医薬品開発・製造受託機関（CDMO）という全く新しい分野の創設に注力している。彼らはCGTに投資することで、互いに、また一握りの巨大サービス企業と競争することになる。

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TABLE OF CONTENTS

1. Introduction
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Cell and Gene Therapy Market Landscape
4.1 Overview
4.2 PEST Analysis
5. Cell and Gene Therapy Market - Key Industry Dynamics
5.1 Key Market Drivers:
5.1.1 Increase in Number of Approval of Cell and Gene Therapies
5.1.2 Increasing Popularity of Outsourcing Cell and Gene Therapy Manufacturing
5.2 Market Restraints
5.2.1 High Cost of Cell and Gene Therapy Manufacturing
5.3 Market Opportunities
5.3.1 Strategic Initiatives by Companies
5.4 Future Trends
5.4.1 Automation of Cell and Gene Therapy Manufacturing Services
5.5 Impact Analysis:
6. Cell and Gene Therapy Market - Global Market Analysis
6.1 Cell and Gene Therapy Market Revenue (US$ Mn), 2022 – 2030
7. Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 – by Type
7.1 Overview
7.2 Cell and Gene Therapy Manufacturing Services Market Revenue Share, by Type 2022 & 2030 (%)
7.3 Cell Therapy
7.3.1 Overview
7.3.2 Cell Therapy: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.3.2.1 Autologous
7.3.2.1.1 Overview
7.3.2.1.2 Autologous: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.3.2.2 Allogenic
7.3.2.2.1 Overview
7.3.2.2.2 Allogenic: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.4 Gene Therapy
7.4.1 Overview
7.4.2 Gene Therapy: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.4.2.1 Viral Vector
7.4.2.1.1 Overview
7.4.2.1.2 Viral Vector: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.4.2.2 Non-Viral Vector
7.4.2.2.1 Overview
7.4.2.2.2 Non-Viral Vector: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
8. Cell and Gene Therapy Manufacturing Services Market Analysis and Forecasts to 2030 – by Indication
8.1 Overview
8.2 Cell and Gene Therapy Manufacturing Services Market, by Indication 2022 & 2030 (%)
8.3 Cancer
8.3.1 Overview
8.3.2 Cancer: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.4 Orthopedics
8.4.1 Overview
8.4.2 Orthopedics: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.5 Others
8.5.1 Overview
8.5.2 Others: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
9. Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 – by Application
9.1 Overview
9.2 Cell and Gene Therapy Manufacturing Services Market Revenue Share, by Application 2022 & 2030 (%)
9.4 Clinical Manufacturing
9.4.1 Overview
9.4.2 Clinical Manufacturing: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
9.5 Commercial Manufacturing
9.5.1 Overview
9.5.2 Commercial Manufacturing: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
10. Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 – by End User
10.1 Overview
10.2 Cell and Gene Therapy Manufacturing Services Market Revenue Share, by End User 2022 & 2030 (%)
10.4 Pharmaceutical and Biotechnology Companies
10.4.1 Overview
10.4.2 Pharmaceutical & Biotechnology Companies: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
10.5 Contract Research Organizations (CROs)
10.5.1 Overview
10.5.2 Contract Research Organizations (CROs): Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11. Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 – Regional Analysis
11.1 North America: Cell and Gene Therapy Manufacturing Services Market
11.1.1 Overview
11.1.2 North America: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.1.3 North America: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.1.3.1 North America: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.1.3.2 North America: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.1.4 North America: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.1.5 North America: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.1.6 North America: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.1.7 North America: Cell and Gene Therapy Manufacturing Services Market, by Region, 2022 & 2030 (%)
11.1.7.1 US: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.1.7.1.1 US: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.1.7.1.1.1 US: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.1.7.1.1.2 US: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.1.7.1.2 US: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.1.7.1.3 US: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.1.7.1.4 US: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.1.7.2 Canada: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.1.7.2.1 Canada: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.1.7.2.1.1 Canada: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.1.7.2.1.2 Canada: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.1.7.2.2 Canada: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.1.7.2.3 Canada: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.1.7.2.4 Canada: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.1.7.3 Mexico: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.1.7.3.1 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.1.7.3.1.1 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.1.7.3.1.2 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.1.7.3.2 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.1.7.3.3 Mexico: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.1.7.3.4 Mexico: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2 Europe: Cell and Gene Therapy Manufacturing Services Market
11.2.1 Overview
11.2.2 Europe: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.3 Europe: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.3.1 Europe: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.3.2 Europe: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.4 Europe: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.5 Europe: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.6 Europe: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2.7 Europe: Cell and Gene Therapy Manufacturing Services Market, by Region, 2022 & 2030 (%)
11.2.7.1 Germany: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.7.1.1 Germany: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.7.1.1.1 Germany: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.7.1.1.2 Germany: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.7.1.2 Germany: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.7.1.3 Germany: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.7.1.4 Germany: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2.7.2 UK: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.7.2.1 UK: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.7.2.1.1 UK: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.7.2.1.2 UK: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.7.2.2 UK: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.7.2.3 UK: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.7.2.4 UK: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2.7.3 France: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.7.3.1 France: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.7.3.1.1 France: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.7.3.1.2 France: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.7.3.2 France: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.7.3.3 France: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.7.3.4 France: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2.7.4 Italy: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.7.4.1 Italy: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.7.4.1.1 Italy: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.7.4.1.2 Italy: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.7.4.2 Italy: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.7.4.3 Italy: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.7.4.4 Italy: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2.7.5 Spain: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.7.5.1 Spain: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.7.5.1.1 Spain: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.7.5.1.2 Spain: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.7.5.2 Spain: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.7.5.3 Spain: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.7.5.4 Spain: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.2.7.6 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.2.7.6.1 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.2.7.6.1.1 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.2.7.6.1.2 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.2.7.6.2 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.2.7.6.3 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.2.7.6.4 Rest of Europe: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market
11.3.1 Overview
.
11.3.2 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.3 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.3.1 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.3.2 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.4 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.5 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.6 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3.7 Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Region, 2022 & 2030 (%)
11.3.7.1 China: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.7.1.1 China: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.7.1.1.1 China: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.7.1.1.2 China: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.7.1.2 China: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.7.1.3 China: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.7.1.4 China: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3.7.2 Japan: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.7.2.1 Japan: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.7.2.1.1 Japan: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.7.2.1.2 Japan: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.7.2.2 Japan: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.7.2.3 Japan: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.7.2.4 Japan: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3.7.3 India: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.7.3.1 India: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.7.3.1.1 India: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.7.3.1.2 India: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.7.3.2 India: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.7.3.3 India: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.7.3.4 India: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3.7.4 Australia: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.7.4.1 Australia: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.7.4.1.1 Australia: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.7.4.1.2 Australia: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.7.4.2 Australia: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.7.4.3 Australia: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.7.4.4 Australia: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3.7.5 South Korea: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.7.5.1 South Korea: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.7.5.1.1 South Korea: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.7.5.1.2 South Korea: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.7.5.2 South Korea: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.7.5.3 South Korea: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.7.5.4 South Korea: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.3.7.6 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.3.7.6.1 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.3.7.6.1.1 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.3.7.6.1.2 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.3.7.6.2 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.3.7.6.3 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.3.7.6.4 Rest of Asia Pacific: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.4 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market
11.4.1 Overview
11.4.2 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.4.3 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.4.3.1 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.4.3.2 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.4.4 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.4.5 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.4.6 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.4.7 Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Region, 2022 & 2030 (%)
11.4.7.1 South Africa: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.4.7.1.1 South Africa: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.4.7.1.1.1 South Africa: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.4.7.1.1.2 South Africa: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.4.7.1.2 South Africa: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.4.7.1.3 South Africa: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.4.7.1.4 South Africa: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.4.7.2 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.4.7.2.1 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.4.7.2.1.1 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.4.7.2.1.2 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.4.7.2.2 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.4.7.2.3 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.4.7.2.4 Saudi Arabia: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.4.7.3 UAE: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.4.7.3.1 UAE: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.4.7.3.1.1 UAE: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.4.7.3.1.2 UAE: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.4.7.3.2 UAE: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.4.7.3.3 UAE: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.4.7.3.4 UAE: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.4.7.4 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.4.7.4.1 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.4.7.4.1.1 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.4.7.4.1.2 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.4.7.4.2 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.4.7.4.3 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.4.7.4.4 Rest of Middle East & Africa: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.5 South & Central America: Cell and Gene Therapy Manufacturing Services Market
11.5.1 Overview
11.5.2 South & Central America: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.5.3 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.5.3.1 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.5.3.2 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.5.4 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.5.5 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.5.6 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.5.7 South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Region, 2022 & 2030 (%)
11.5.7.1 Brazil: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.5.7.1.1 Brazil: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.5.7.1.1.1 Brazil: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.5.7.1.1.2 Brazil: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.5.7.1.2 Brazil: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.5.7.1.3 Brazil: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.5.7.1.4 Brazil: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.5.7.2 Argentina: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.5.7.2.1 Argentina: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.5.7.2.1.1 Argentina: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.5.7.2.1.2 Argentina: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.5.7.2.2 Argentina: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.5.7.2.3 Argentina: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.5.7.2.4 Argentina: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
11.5.7.3 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market – Revenue and Forecast to 2030 (US$ Million)
11.5.7.3.1 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Type, 2020–2030 (US$ Million)
11.5.7.3.1.1 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020–2030 (US$ Million)
11.5.7.3.1.2 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020–2030 (US$ Million)
11.5.7.3.2 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020–2030 (US$ Million)
11.5.7.3.3 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market, by Application, 2020–2030 (US$ Million)
11.5.7.3.4 Rest of South & Central America: Cell and Gene Therapy Manufacturing Services Market, by End User, 2020–2030 (US$ Million)
12. Cell and Gene Therapy Manufacturing Services Market – Industry Landscape
12.1 Overview
12.2 Growth Strategies in Cell and Gene Therapy Manufacturing Services Market
12.3 Organic Growth Strategies
12.3.1 Overview
12.4 Inorganic Growth Strategies
12.4.1 Overview
13. Company Profiles
13.1 Thermo Fisher Scientific Inc
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Merck KGaA
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Charles River Laboratories International Inc
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Lonza Group AG
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 WuXi AppTec Co Ltd?
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Catalent Inc
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Takara Bio Inc
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Nikon Corp
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 FUJIFILM Holdings Corp
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 National Resilience Inc
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
13.11 Oxford BioMedica Plc
13.11.1 Key Facts
13.11.2 Business Description
13.11.3 Products and Services
13.11.4 Financial Overview
13.11.5 SWOT Analysis
13.11.6 Key Developments

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Table of Contents

Summary

The cell and gene therapy manufacturing services market size is expected to grow from US$ 7,581.97 million in 2022 to US$ 26,724.90 million by 2030; it is estimated to register a CAGR of 17.1% during 2022–2030.

The report highlights trends prevailing in the market and the factors driving and hindering the cell and gene therapy manufacturing services market growth. The growth of the market is attributed increase in number of approvals of cell and gene therapies and increasing popularity of outsourcing cell and gene therapy manufacturing. However, high cost of cell and gene therapy manufacturing hinders the market growth.

Strategic Initiatives by Companies

Companies operating in the cell and gene therapy manufacturing services market focus on strategic developments such as collaborations, expansions, agreements, partnerships, and new product launches, which help them improve their sales, expand their geographic reach, and enhance their capacities to cater to a larger than existing customer base. A few of the noteworthy developments in the cell and gene therapy manufacturing services market are mentioned below.

• In May 2023, Lonza launched the TheraPEAK T-VIVO Cell Culture Medium with a novel chemically defined formulation devised to optimize and streamline CAR T-cell manufacturing. The TheraPEAK T-VIVO Cell Culture Medium can exhibit a high performance without the need to add human serum or its components, unlike other serum-free media.

• In October 2022, Pfizer Inc. completed the acquisition of Biohaven Pharmaceutical Holding Company Ltd., the manufacturer of NURTEC ODT (rimegepant), an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults.

• In March 2022, Cellevolve Bio partnered with Seattle Children’s Therapeutics to develop and commercialize new multiplex CARs for paediatric cancers. Under the collaboration, the partners will focus on the BrainChild research program, a suite of five multiplex CARs, to treat pediatric central nervous system (CNS) malignancies. In partnership, they would leverage the Seattle Children’s Cure Factory facility to conduct early clinical GMP research on new CARs.

• In March 2022, Twist Bioscience Corporation and Kriya Therapeutics, Inc. entered an antibody discovery agreement for antibodies delivered using adeno-associated viral (AAV) gene therapy in therapeutic oncology applications. Upon collaboration, the companies had plans of combining Twist’s antibody libraries with Kriya’s proprietary vector engineering platform to discover novel antibodies against specific targets of interest to be delivered with Kriya’s gene therapy technology.

• In February 2022, Edigene Inc. entered into a global license agreement with Boston Children’s Hospital (BCH) for intellectual property rights covering the upregulation of foetal haemoglobin by disrupting a key gene. Upregulation of foetal haemoglobin is a potential treatment for many genetic diseases resulting from abnormal haemoglobin structures (hemoglobinopathies), replacing the defective haemoglobin molecule with its foetal version.

• In January 2022, FUJIFILM Corporation agreed to acquire a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. The facility is readily expandable with the flexibility to produce both clinical and commercial cell therapies, including allogeneic T-cell and CAR T immunotherapies.

• In January 2021, Thermo Fisher Scientific Inc acquired Henogen S.A., the Belgium-based viral vector manufacturing business of Groupe Novasep SAS. Henogen provides vaccine and therapeutics manufacturing services to biotechnology companies and large biopharmaceutical customers. With this acquisition, Thermo Fisher Scientific expanded its capabilities in the cell and gene vaccines and therapies category.

Therefore, introducing products such as viral vectors, media for cell therapy manufacturing, and allogeneic T-cells; the development of innovative products targeting various health issues to create new or improved products; and the initiation of new businesses to remain competitive in the market, all, through collaborations and partnerships can help speed up the development of new platforms for cell and gene therapy manufacturing services. Thus, these strategic initiatives create significant growth opportunities in the cell and gene therapy manufacturing services market.

High Cost of Cell and Gene Therapy Manufacturing

As cell and gene therapies involve a complex manufacturing process and use biological components, these therapies are priced exorbitantly. For instance, the cost of Kymriah is ~US$ 475,000, and Yescarta is ~US$ 373,000, respectively. According to the analysis by the Institute for Clinical and Economic Review (ICER), the average cost of a gene therapy ranges US$ 1–2 million per dose. The manufacturing of cell and gene therapies involves various risks, such as the black-box effect, amplified failure, and reduced flexibility. The black-box effect refers to the tasks and processes performed in an automated system; there is no visibility to the process, and the progress status is hidden. Thus, the lack of visibility to the manufacturing processes increases failure and reduces the flexibility to adapt to the manufacturing processes. In addition, the most critical challenge for the manufacturers is to gain product approval from the regulatory bodies—such as FDA and EMA—and ensure patient’s safety from the side effects of the therapy.

Furthermore, the cost of consumables and equipment is much higher, which leads to the premium cost of cell therapies. For instance, the cost of the reagent kit offered by Miltenyi Biotec ranges from US$ 500 to US$ 5,000. Similarly, the capital cost of installing the equipment is nearly US$ 2 million. Thus, the challenges pertaining to therapy prices limit the cell and gene therapy manufacturing services market growth.

Cell and Gene Therapy Manufacturing Services Market, By Type Insights

Based on type, the cell and gene therapy manufacturing services market is segmented into cell therapy and gene therapy. Cell therapy is segmented as autologous and allogenic. Further, gene therapy is bifurcated into viral vector and non-viral vector. The cell therapy segment held a larger market share in 2022. However, gene therapy segment is anticipated to register the highest CAGR of 16.6% during the forecast period (2022-2030). Gene therapy is a technique that uses a gene(s) to prevent, treat or cure a medical disorder or disease. Gene therapies often works by replacing a defective, or by adding new copies of a gene that is broken or missing gene in a patient’s cells with a healthy version of that gene. Gene therapy can be used to modify cells outside as well as inside the body. A vector is injected carrying the gene directly into the patient when a gene therapy is used to modify cells inside the body. Whereas blood, bone marrow, or another tissue are taken out when gene therapy is used to modify cells outside the body and separate the specific cell types in the lab.

Cell and Gene Therapy Manufacturing Services Market, By Indication-Based Insights

Based on indication, the cell and gene therapy manufacturing services market is divided into cancer, orthopedics, and others. The cancer segment held the largest share of the market in 2022 and same segment is expected to grow at the highest CAGR during the forecast period. The broad field of cell and gene therapy promises many innovative treatments that have the potential to prevent deaths from cancer. According to the April 2022 newsletter by Alliance for Cancer Gene Therapy, Inc., 6 CAR T-cell therapies have been approved by the US Food and Drug Administration (FDA) for the treatment of myeloma, leukemia, and lymphoma. In December 2022, the FDA approved Adstiladrin, a non-replicating adenoviral vector-based gene therapy, for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. In 2022, FDA approved Kimmtrak, a T-cell receptor therapy for a rare type of melanoma in the eye—uveal melanoma. As there is an increase in the number of FDA approvals of cell and gene therapy for the treatment of cancer, the production of these therapies has increased in the last several years. Thus, a large number of CDMOs are focusing on providing manufacturing services for cancer cell and gene therapies.

Based on Application, the cell and gene therapy manufacturing services market is categorized into clinical manufacturing and commercial manufacturing. The commercial manufacturing segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR of 17.1% in the market during the forecast period (2020-2030). CGTs provide significant value across multiple therapeutic areas, driven by a combination of clinical benefit, durability, and overall response rate. However, these therapies are yet to gain a significant market reach. The therapeutic gain of CGTs is underestimated due to the difficulty associated with delivering the right therapy to the right patients, and thus, only a few commercial CGTs-based products have reached the market over the past decade. However, the clinical pipeline of CGT-based products in Phase 3 clinical trials indicates the possibility of a dramatic rise in the number of approvals in the near future. WuXi Advanced Therapies Inc., a prominent CDMO and a wholly subsidiary of WuXi AppTec, announced the opening of new process development and commercial manufacturing facility in Shanghai in October 2021. This new manufacturing facility would help it expand its global capacity through GMP commercial manufacturing and integrated testing services that would support the commercialization of CGT products in the coming years.

The cell and gene therapy manufacturing services market, by end user, is categorized into pharmaceutical & biotechnology companies and contract research organizations (CROs). The pharmaceutical and biotechnology segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR of 17.1% in the market during the forecast period (2020-2030). Major US-based pharmaceutical and biotechnology companies committed to offering CGTs intended to treat acute and rare conditions, which are unresponsive to traditional approaches, include ElevateBio and Discovery Labs. These companies are focused on creating a completely new branch of pharmaceutical contract development and manufacturing organizations (CDMOs). They would compete with one another and with a handful of giant services firms by investing in CGTs.

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本レポートと同分野（医療）の最新刊レポート

The Insight Partners社のバイオテクノロジー分野での最新刊レポート

本レポートと同じKEY WORD（asia pacific）の最新刊レポート

よくあるご質問

The Insight Partners社はどのような調査会社ですか?

The Insight Partnersはインドに本社を置く調査会社です。経験豊富な専門家チームを通じて、お客様に最適な調査と分析を提供することに専念しています。幅広い分野をカバーしていますがヘルスケ... もっと見る

調査レポートの納品までの日数はどの程度ですか?

在庫のあるものは速納となりますが、平均的には 3-４日と見て下さい。
但し、一部の調査レポートでは、発注を受けた段階で内容更新をして納品をする場合もあります。
発注をする前のお問合せをお願いします。

注文の手続きはどのようになっていますか?

1)お客様からの御問い合わせをいただきます。
2)見積書やサンプルの提示をいたします。
3)お客様指定、もしくは弊社の発注書をメール添付にて発送してください。
4)データリソース社からレポート発行元の調査会社へ納品手配します。
5) 調査会社からお客様へ納品されます。最近は、pdfにてのメール納品が大半です。

お支払方法の方法はどのようになっていますか?

納品と同時にデータリソース社よりお客様へ請求書（必要に応じて納品書も）を発送いたします。
お客様よりデータリソース社へ（通常は円払い）の御振り込みをお願いします。
請求書は、納品日の日付で発行しますので、翌月最終営業日までの当社指定口座への振込みをお願いします。振込み手数料は御社負担にてお願いします。
お客様の御支払い条件が60日以上の場合は御相談ください。
尚、初めてのお取引先や個人の場合、前払いをお願いすることもあります。ご了承のほど、お願いします。

データリソース社はどのような会社ですか?

当社は、世界各国の主要調査会社・レポート出版社と提携し、世界各国の市場調査レポートや技術動向レポートなどを日本国内の企業・公官庁及び教育研究機関に提供しております。
世界各国の「市場・技術・法規制などの」実情を調査・収集される時には、データリソース社にご相談ください。
お客様の御要望にあったデータや情報を抽出する為のレポート紹介や調査のアドバイスも致します。

サマリー

目次

Summary

Table of Contents

ご注文は、お電話またはWEBから承ります。お見積もりの作成もお気軽にご相談ください。

本レポートと同分野（医療）の最新刊レポート

The Insight Partners社のバイオテクノロジー分野での最新刊レポート

本レポートと同じKEY WORD（asia pacific）の最新刊レポート

よくあるご質問

The Insight Partners社はどのような調査会社ですか?

調査レポートの納品までの日数はどの程度ですか?

注文の手続きはどのようになっていますか?

お支払方法の方法はどのようになっていますか?

データリソース社はどのような会社ですか?