米国と欧州の細胞・遺伝子治療製造サービス市場の2030年までの予測-タイプ別、適応症別、用途別、エンドユーザー別、：国別分析

米国と欧州の細胞・遺伝子治療製造サービス市場は、2022年に47億7,350万米ドルと評価され、2030年には168億6,910万米ドルに達すると予測され、2022年から2030年までのCAGRは17.1%と推定されます。

米国と欧州の細胞・遺伝子治療製造サービス市場規模の成長に影響を与えている主な要因として、細胞・遺伝子治療の承認件数の増加と細胞・遺伝子治療製造サービスのアウトソーシング人気の高まりが挙げられます。しかし、細胞・遺伝子治療製造サービスの初期費用が高いことが、米国と欧州の細胞・遺伝子治療製造サービス市場の成長を妨げています。

細胞・遺伝子治療（CGT）プログラムは、研究開発から臨床試験、商業承認へと急速に進展しています。強固で反復可能かつ持続可能なプロセスを確立することは、開発を加速させ、製造移転に関連する遅延を回避するのに役立ちます。さらに、細胞・遺伝子治療は、生命を向上させ、治癒力を高める次世代の治療法です。治療法の新たな承認取得に伴い、細胞・遺伝子治療製造サービスの熟練した専門家に対する需要は高まると思われます。

細胞・遺伝子治療製造アウトソーシングの人気の高まり

細胞・遺伝子治療製造は複雑なプロセスであるため、業務の適切な遂行と監督が極めて重要です。細胞・遺伝子治療メーカーは、生物学やプロセス工学に精通した有資格者の数が限られています。さらに、経験豊富なチームにとって、手作業でオープンな製造方法を用いて最初の臨床試験に到達する試みを管理し、その後、より商業的に適したプロセスを構築することは厄介なことです。そのため、これらの企業は、臨床試験と商業化プロセスを加速するために、開発・製造受託機関（CDMO）との協力を選択します。CDMOは、製品開発、製造、臨床試験サポート、商業化サービスを細胞・遺伝子治療企業に契約ベースで提供します。CDMOと提携することで、細胞・遺伝子治療メーカーにとって、スケーラビリティ、市場投入までのスピード、オーバーヘッドコストのない技術的専門知識へのアクセス、コスト効率が可能になります。

2020年1月、Deerfield Management CompanyとMLP VenturesのThe Discovery Labsは、米国ペンシルバニア州にCenter for Breakthrough Medicinesを設立しました。この新しいCDMO施設は、The Discovery Labsが創設したキャンパスの40％以上を占めることになります。そのスペースに、CDMOはプラスミド・スイート10室、ウイルスベクター・スイート20室、万能細胞処理スイート36室、現行の適正製造基準（cGMP）試験、プロセス開発、細胞バンク・スイート20室を設置します。ディアフィールド・マネジメント・カンパニーとディスカバリー・ラボは、11億米ドルを投資し、細胞・遺伝子治療薬の製造をサポートする技術開発施設を設立しました。この施設は、人工多能性幹細胞（iPSC）を用いたFCDIの再生医療パイプラインの製造に使用され、iPSCおよびiPSC由来の分化細胞の製造のためのCDMOサービスを提供します。2022年4月、サーモジェネシスは米国カリフォルニア州にCDMO施設を設立し、T細胞受容体（TCR）、キメラ抗原受容体-T細胞（CAR-T細胞）、腫瘍浸潤性白血球（TIL）、iPSC、ナチュラルキラー細胞（NK）、間葉系幹細胞（MSC）の製造に関する専門知識を活用して、細胞・遺伝子治療メーカーにCDMOサービスを提供します。

細胞治療や遺伝子治療の製造をCDMOに委託することは、メーカーにとって費用対効果が高いです。さらに、技術的に高度なインフラとCDMOの専門知識を利用することができます。CDMOは細胞治療や遺伝子治療の製造に適切でマッピングされたプロセスを採用しています。このように、CDMOへの細胞・遺伝子治療製造のアウトソーシング志向の高まりが、米国と欧州の細胞・遺伝子治療製造サービス市場の成長を後押ししています。

セグメント別分析

エンドユーザーに基づく洞察

エンドユーザーに基づき、市場は製薬・バイオテクノロジー企業と医薬品開発業務受託機関（CRO）に区分されます。製薬・バイオテクノロジー企業セグメントは、2022年の市場でより大きなシェアを占めており、同セグメントは予測期間中、市場でより高いCAGRを記録すると予測されています。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社などが含まれます。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を創設することに注力しています。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ります。前述したような要因が、各分野の成長に影響力を及ぼし、2022年から2030年にかけての米国と欧州の細胞・遺伝子治療製造サービス市場の成長を支配することになると思われます。

適応症の洞察

適応症に基づき、米国と欧州の細胞・遺伝子治療製造サービス市場は、がん、整形外科、その他に分けられます。がん分野は2022年に市場の最大シェアを占め、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ます。

タイプ別洞察

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ます。細胞療法は自己由来と同種異系に区分されます。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ます。細胞療法は、特定の細胞群を修復・変化させたり、体内で治療を行うための細胞を提供したりすることで、障害や疾患の治療に役立ちます。細胞療法は、患者に導入する前に、体外で細胞を形成または変化させる。細胞は患者に由来するもの（自己細胞）とドナーに由来するもの（同種細胞）があります。細胞療法分野の成長は、市場に参入する製品数の増加、自己免疫疾患、がん、感染症治療への細胞療法の応用の可能性、進行中の臨床試験の多さなどに起因しています。CAR-T細胞療法やその他の細胞ベースの療法に焦点を当てた360以上の臨床試験が、様々な疾患の適応症に対するこれらの療法の可能性を解釈するために研究されています。そのため、先端療法製造サービスに対する需要は今後数年間で増加すると予想されます。

米国と欧州の細胞・遺伝子治療製造サービス市場に関する報告書を作成する際に参照した主な一次情報源と二次情報源には、国立衛生研究所財団（Foundation for the National Institutes of Health）、国立医療サービス（National Health Services）、医薬品・ヘルスケア製品規制庁（Medicines and Healthcare Products Regulatory Agency）などがあります。

目次

第1章 イントロダクション

第2章 米国と欧州の細胞・遺伝子治療製造サービス市場-要点

第3章 調査手法

• 調査範囲
• 2次調査
• 1次調査

第4章 米国と欧州の細胞・遺伝子治療製造サービス市場- 市場情勢

• 概観
• PEST分析
  • 米国PEST分析
  • 欧州PEST分析
• 専門家の見解

第5章 米国と欧州の細胞・遺伝子治療製造サービス市場：主要市場力学

• 市場促進要因
  • 細胞・遺伝子治療の承認件数の増加
  • 細胞・遺伝子治療製造アウトソーシングの人気の高まり
• 市場抑制要因
  • 細胞・遺伝子治療製造の高コスト
• 市場機会
  • 企業による戦略的取り組み
• 今後の動向
  • 細胞・遺伝子治療製造サービスの自動化
• 影響分析

第6章 米国と欧州の細胞・遺伝子治療製造サービス市場：国別・地域別分析

• 米国と欧州の細胞・遺伝子治療製造サービス市場の収益予測と分析
• 主要参入企業の市場ポジショニング

第7章 米国と欧州の細胞・遺伝子治療製造サービス市場：2030年までの収益と予測：タイプ別

• 概要
• 米国と欧州の細胞・遺伝子治療製造サービス市場、2022年および2030年、タイプ別売上高シェア（%）
• 細胞療法
• 遺伝子治療

第8章 米国と欧州の細胞・遺伝子治療製造サービス市場：2030年までの収益と予測：適応症別

• 概要
• 米国と欧州の細胞・遺伝子治療製造サービス市場、2022年および2030年、適応症別売上高シェア（%）
• がん
• 整形外科
• その他

第9章 米国と欧州の細胞・遺伝子治療製造サービス市場：2030年までの収益と予測：用途別

• 概要
• 米国と欧州の細胞・遺伝子治療製造サービス市場、2022年および2030年、用途別売上高シェア（%）
• 臨床製造
• 商業用製造

第10章 米国と欧州の細胞・遺伝子治療製造サービス市場：2030年までの収益と予測：エンドユーザー別

• 概要
• 米国と欧州の細胞・遺伝子治療製造サービス市場、2022年および2030年、エンドユーザー別売上高シェア（%）
• 製薬企業およびバイオテクノロジー企業
• CRO（医薬品開発業務受託機関）

第11章 米国と欧州の細胞・遺伝子治療製造サービス市場：2030年までの収益と予測：国別・地域別分析

• 欧州米国と欧州の細胞・遺伝子治療製造サービス市場

第12章 米国と欧州の細胞・遺伝子治療製造サービス市場：業界情勢

• 概要
• 米国と欧州の細胞・遺伝子治療製造サービス市場における成長戦略
• 有機的成長戦略
• 無機的成長戦略

第13章 企業プロファイル

• 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

第14章 付録

List Of Tables

• Table 1. US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 2. US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 3. US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 4. US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 5. US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 6. US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 7. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 8. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 9. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 10. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 11. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 12. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 13. Germany US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 14. Germany US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 15. Germany US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 16. Germany US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 17. Germany US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 18. Germany US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 19. UK US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 20. UK US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 21. UK US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 22. UK US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 23. UK US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 24. UK US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 25. France US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 26. France US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 27. France US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 28. France US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 29. France US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 30. France US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 31. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 32. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 33. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 34. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 35. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 36. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 37. Spain US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 38. Spain US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 39. Spain US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 40. Spain US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 41. Spain US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 42. Spain US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 43. Rest of Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type - Revenue and Forecast to 2030 (US$ Million)
• Table 44. Rest of Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 45. Rest of Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy - Revenue and Forecast to 2030 (US$ Million)
• Table 46. Rest of Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication - Revenue and Forecast to 2030 (US$ Million)
• Table 47. Italy US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application - Revenue and Forecast to 2030 (US$ Million)
• Table 48. Rest of Europe US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User - Revenue and Forecast to 2030 (US$ Million)
• Table 49. Recent Organic Growth Strategies in US and Europe Cell and Gene Therapy Manufacturing Services Market
• Table 50. Recent Inorganic Growth Strategies in the US and Europe Cell and Gene Therapy Manufacturing Services Market
• Table 51. Glossary of Terms

List Of Figures

• Figure 1. US and Europe Cell and Gene Therapy Manufacturing Services Market Segmentation
• Figure 2. US and Europe Cell and Gene Therapy Manufacturing Services Market, by Region
• Figure 3. US and Europe Cell and Gene Therapy Manufacturing Services Market Overview
• Figure 4. Cell Therapy Segment Held Largest Share of Type Segment in US and Europe Cell and Gene Therapy Manufacturing Services Market
• Figure 5. US and Europe Cell and Gene Therapy Manufacturing Services Market, by Country & Region (US$ Million)
• Figure 6. US and Europe Cell and Gene Therapy Manufacturing Services Market - Leading Country Markets (US$ Million)
• Figure 7. US and Europe Cell and Gene Therapy Manufacturing Services Market - Industry Landscape
• Figure 8. US: PEST Analysis
• Figure 9. Europe: PEST Analysis
• Figure 10. Experts' Opinion
• Figure 11. US and Europe Cell and Gene Therapy Manufacturing Services Market: Key Industry Dynamics
• Figure 12. US and Europe Cell and Gene Therapy Manufacturing Services Market: Impact Analysis of Drivers and Restraints
• Figure 13. US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue Forecast and Analysis - 2021-2030
• Figure 14. Market Positioning of Key Players in US and Europe Cell and Gene Therapy Manufacturing Services Market
• Figure 15. US and Europe Cell and Gene Therapy Manufacturing Services Market Revenue Share, by Type 2022 & 2030 (%)
• Figure 16. Cell Therapy: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 17. Autologous: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 18. Allogenic: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 19. Gene Therapy: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 20. Viral Vector: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 21. Non-Viral Vector: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 22. US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application 2022 & 2030 (%)
• Figure 23. Cancer: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 24. Orthopedics: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 25. Others: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 26. US and Europe Cell and Gene Therapy Manufacturing Services Market Revenue Share, by Application 2022 & 2030 (%)
• Figure 27. Clinical Manufacturing: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 28. Commercial Manufacturing: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 29. US and Europe Cell and Gene Therapy Manufacturing Services Market Revenue Share, by End User 2022 & 2030 (%)
• Figure 30. Pharmaceutical & Biotechnology Companies: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 31. Contract Research Organizations (CROs): US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 32. United States: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Key Country - Revenue (2022) (US$ Million)
• Figure 33. US: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 34. Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Key Country - Revenue (2022) (US$ Million)
• Figure 35. Europe US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 36. Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Country, 2022 & 2030 (%)
• Figure 37. Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 38. UK: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 39. France: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 40. Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 41. Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 42. Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
• Figure 43. Growth Strategies in US and Europe Cell and Gene Therapy Manufacturing Services Market

The US and Europe cell and gene therapy manufacturing services market was valued at US$ 4,773.5 million in 2022 and is projected to reach US$ 16,869.1 million by 2030; it is estimated to register a CAGR of 17.1% from 2022 to 2030.

An increase in number of approvals of cell and gene therapies and increasing popularity of outsourcing cell and gene therapy manufacturing services are among the major contributing factors influencing the growth of US and Europe cell and gene therapy manufacturing services market size. However, high initial cost of cell and gene therapy manufacturing services hinders the growth of the US and Europe cell and gene therapy manufacturing services market.

Cell and gene therapy (CGT) programs are rapidly advancing from research & development to clinical trials and commercial approval. Establishing a robust, repeatable, and sustainable process help to accelerate the development, avoiding manufacturing transfer-related delays. Additionally, cell and gene therapy comprises the next generation of life-enhancing and curative therapies. With therapies experiencing new approvals, the demand for skilled professionals in cell and gene therapy manufacturing services will rise.

Increasing Popularity of Outsourcing Cell and Gene Therapy Manufacturing

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 January 2020, Deerfield Management Company and The Discovery Labs of MLP Ventures established the Center for Breakthrough Medicines in Pennsylvania, US. This new CDMO facility would occupy more than 40% of the campus created by The Discovery Labs. In that space, the CDMO would install 10 plasmid suites; 20 viral vector suites; 36 universal cell processing suites; and 20 current good manufacturing practice (cGMP) testing, process development, and cell banking suites. Deerfield Management Company and The Discovery Labs have invested US$ 1.1 billion to raise a technologically developed facility to support the manufacturing of cell and gene therapies. Further, in March 2020, Fujifilm Cellular Dynamics (FCDI) invested US$ 21 million in the cGMP-compliant production facility, which would be used for manufacturing FCDI's pipeline of regenerative medicine therapies using induced pluripotent stem cells (iPSCs) and to provide CDMO services for production of iPSCs and iPSC-derived differentiated cells. 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. Moreover, they gain access to the technologically advanced infrastructure and expertise of CDMOs. CDMOs employ proper, mapped processes for manufacturing cell and gene therapies. Thus, the increasing preference for outsourcing growing cell and gene therapy manufacturing to CDMOs fuels the US and Europe cell and gene therapy manufacturing services market growth.

Segmental Analysis

End User-Based Insights

Based on end user, the market is segmented into pharmaceutical and biotechnology companies and contract research organizations (CROs). The pharmaceutical and biotechnology companies segment held a larger share of the market in 2022 and the same segment is anticipated to register a higher CAGR in the market during the forecast period. 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. The aforementioned factors will be responsible for influential segmental growth thereby dominating the US and Europe cell and gene therapy manufacturing services market growth during 2022-2030.

Indication Insights

Based on indication, the US and Europe 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.

Type Insights

Based on type, the cell and gene therapy manufacturing services market is segmented 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. Cell therapy helps treat disorders and diseases by restoring or changing certain groups of cells or providing cells to carry therapy through the body. Cell therapy forms or modifies cells outside the body before introducing into the patient. The cells may derive from the patient (autologous cells) or a donor (allogeneic cells). The growth of the cell therapy segment is attributed to the increasing number of products entering the market, the potential application of cell therapies in the treatment of autoimmune diseases, cancer, and infectious diseases, and the high number of ongoing clinical trials. More than 360 clinical trials focusing on CAR-T cell therapies and other cell-based therapies are being studied to interpret the potential of these therapies for treating various disease indications. Therefore, the demand for advanced therapy manufacturing services is anticipated to increase in the coming years.

A few of the major primary and secondary sources referred to while preparing the report on the US and Europe cell and gene therapy manufacturing services market are the Foundation for the National Institutes of Health, National Health Services, and Medicines and Healthcare Products Regulatory Agency.

Reasons to Buy:

• Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the US and Europe cell and gene therapy manufacturing services market.
• Highlights key business priorities in order to assist companies to realign their business strategies.
• The key findings and recommendations highlight crucial progressive industry trends in the US and Europe cell and gene therapy manufacturing services market, thereby allowing players across the value chain to develop effective long-term strategies.
• Develop/modify business expansion plans by using substantial growth offering developed and emerging markets.
• Scrutinize in-depth market trends and outlook coupled with the factors driving the US and Europe cell and gene therapy manufacturing services market, as well as those hindering it.
• Enhance the decision-making process by understanding the strategies that underpin security interest with respect to client products, segmentation, pricing, and distribution.

Table Of Contents

1. Introduction

• 1.1 Scope of the Study
• 1.2 The Insight Partners Research Report Guidance
• 1.3 Market Segmentation
  • 1.3.1 US and Europe Cell and Gene Therapy Manufacturing Services Market - by Type
  • 1.3.2 US and Europe Cell and Gene Therapy Manufacturing Services Market - by Indication
  • 1.3.3 US and Europe Cell and Gene Therapy Manufacturing Services Market - by Application
  • 1.3.4 US and Europe Cell and Gene Therapy Manufacturing Services Market - by End User
  • 1.3.5 US and Europe Cell and Gene Therapy Manufacturing Services Market - by Country & Region

2. US and Europe Cell and Gene Therapy Manufacturing Services Market - Key Takeaways

3. Research Methodology

• 3.2 Coverage
• 3.3 Secondary Research
• 3.4 Primary Research

4. US and Europe Cell and Gene Therapy Manufacturing Services Market - Market Landscape

• 4.1 Overview
• 4.2 PEST Analysis
  • 4.2.1 US PEST Analysis
  • 4.2.2 Europe PEST Analysis
• 4.3 Expert's Opinion

5. US and Europe Cell and Gene Therapy Manufacturing Services Market - Key Market Dynamics

• 5.1 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. US and Europe Cell and Gene Therapy Manufacturing Services Market - Country & Regional Analysis

• 6.1 US and Europe Cell and Gene Therapy Manufacturing Services Market Revenue Forecast and Analysis
• 6.2 Market Positioning of Key Players

7. US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - by Type

• 7.1 Overview
• 7.2 US and Europe 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: US and Europe 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: US and Europe 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: US and Europe 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: US and Europe 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: US and Europe 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: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)

8. US and Europe Cell and Gene Therapy Manufacturing Services Market Analysis and Forecasts to 2030 - by Indication

• 8.1 Overview
• 8.2 US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication 2022 & 2030 (%)
• 8.3 Cancer
  • 8.3.1 Overview
  • 8.3.2 Cancer: US and Europe 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: US and Europe 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: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)

9. US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - by Application

• 9.1 Overview
• 9.2 US and Europe 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: US and Europe 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: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)

10. US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - by End User

• 10.1 Overview
• 10.2 US and Europe 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: US and Europe 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): US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)

11. US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 - Country & Regional Analysis

• 11.1 US: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
  • 11.1.1 Overview
  • 11.1.2 US: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
    • 11.1.2.1 US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.1.2.1.1 US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.1.2.1.2 US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
    • 11.1.2.2 US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
    • 11.1.2.3 US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
    • 11.1.2.4 US: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
• 11.2 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market
  • 11.2.1 Overview
  • 11.2.2 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
  • 11.2.3 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
    • 11.2.3.1 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
    • 11.2.3.2 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
  • 11.2.4 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
  • 11.2.5 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
  • 11.2.6 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
  • 11.2.7 Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Country, 2022 & 2030 (%)
    • 11.2.7.1 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.1.1 Overview
      • 11.2.7.1.2 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.1.3 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.2.7.1.3.1 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.2.7.1.3.2 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
      • 11.2.7.1.4 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
      • 11.2.7.1.5 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
      • 11.2.7.1.6 Germany: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
    • 11.2.7.2 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.2.1 Overview
      • 11.2.7.2.2 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.2.3 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.2.7.2.3.1 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.2.7.2.3.2 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
      • 11.2.7.2.4 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
      • 11.2.7.2.5 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
      • 11.2.7.2.6 UK: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
    • 11.2.7.3 France: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.3.1 Overview
      • 11.2.7.3.2 France: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.3.3 France: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.2.7.3.3.1 France: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.2.7.3.3.2 France: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
      • 11.2.7.3.4 France: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
      • 11.2.7.3.5 France: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
      • 11.2.7.3.6 France: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
    • 11.2.7.4 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.4.1 Overview
      • 11.2.7.4.2 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.4.3 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.2.7.4.3.1 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.2.7.4.3.2 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
      • 11.2.7.4.4 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
      • 11.2.7.4.5 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
      • 11.2.7.4.6 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
    • 11.2.7.5 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.5.1 Overview
      • 11.2.7.5.2 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.5.3 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.2.7.5.3.1 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.2.7.5.3.2 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
      • 11.2.7.5.4 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
      • 11.2.7.5.5 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
      • 11.2.7.5.6 Spain: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)
    • 11.2.7.6 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.6.1 Overview
      • 11.2.7.6.2 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market - Revenue and Forecast to 2030 (US$ Million)
      • 11.2.7.6.3 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Type, 2020-2030 (US$ Million)
      • 11.2.7.6.3.1 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Cell Therapy, 2020-2030 (US$ Million)
      • 11.2.7.6.3.2 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Gene Therapy, 2020-2030 (US$ Million)
      • 11.2.7.6.4 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Indication, 2020-2030 (US$ Million)
      • 11.2.7.6.5 Italy: US and Europe Cell and Gene Therapy Manufacturing Services Market, by Application, 2020-2030 (US$ Million)
      • 11.2.7.6.6 Rest of Europe: US and Europe Cell and Gene Therapy Manufacturing Services Market, by End User, 2020-2030 (US$ Million)

12. US and Europe Cell and Gene Therapy Manufacturing Services Market - Industry Landscape

• 12.1 Overview
• 12.2 Growth Strategies in US and Europe 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

14. Appendix

• 14.1 About The Insight Partners
• 14.2 Glossary of Terms