細胞・遺伝子治療バイオ分析検査サービス市場、2028年-世界の産業規模、動向、機会、予測、2018年-2028年

細胞・遺伝子治療のバイオ分析検査サービスの世界市場は、2022年に4億1,101万米ドルと評価され、2028年までのCAGRは8.18%で、予測期間中に目覚ましい成長を遂げると予測されています。

細胞・遺伝子治療の分野は近年目覚ましい進歩を遂げており、さまざまな遺伝性疾患や慢性疾患の治療に新たな希望をもたらしています。これらの画期的な治療法は、個別化された非常に効果的な治療選択肢を提供し、ヘルスケアの状況を一変させる可能性を秘めています。しかし、細胞・遺伝子治療の開発と商業化には、厳しい規制要件や強固な生物分析検査サービスの必要性など、特有の課題が伴う。

細胞・遺伝子療法は、患者自身の細胞の力を利用することで、病気の根源から治療するという画期的なアプローチです。これらの治療法は、遺伝子の変異を修正したり、病気と闘う身体の能力を強化するために遺伝子を修正したり置き換えたりするもので、がん、希少な遺伝性疾患、自己免疫疾患などの治療において大きな可能性を示しています。細胞療法と遺伝子療法の研究開発が拡大し続けるにつれ、その安全性と有効性を保証するための厳格な生物分析試験サービスに対する需要も拡大しています。

世界の細胞・遺伝子治療バイオ分析試験サービスの急成長には、いくつかの要因が寄与しています。政府、製薬会社、ベンチャーキャピタルは、細胞・遺伝子治療の開発に多額の投資を行っています。このため、臨床試験が急増し、製品のライフサイクルを通じて包括的な検査サービスの必要性が高まっています。米国食品医薬品局（FDA）や欧州医薬品庁（EMA）などの規制機関は、細胞・遺伝子治療薬に対して厳しいガイドラインを設けています。これらの規制を遵守するためには、安全性、有効性、品質評価を含む広範な生物分析試験が必要です。質量分析、フローサイトメトリー、次世代シーケンシングなどの分析技術の進化により、より精密で効率的なバイオ分析試験が可能になり、市場をさらに押し上げています。細胞治療や遺伝子治療に対する認識が高まり、アンメットメディカルニーズに対応できる可能性が出てきたことで、患者やヘルスケア提供者の需要が高まっています。その結果、より包括的な検査サービスへのニーズが高まっています。

細胞・遺伝子治療の生物学的分析試験サービス市場は大幅な成長を遂げようとしているが、規制ガイドラインの調和の必要性や、この専門分野における熟練した専門家の不足など、いくつかの課題に直面しています。しかし、技術の進歩が続けば、これらの課題も解決されるものと期待されます。新興国市場では今後数年間、製薬企業、CRO、学術機関の協力関係が強化され、開発プロセス全体を通じて包括的な試験が実施されるようになるとみられます。さらに、高度な分析技術と自動化の出現は、バイオ分析試験の効率と精度を高め、この市場の成長をさらに加速させると思われます。

主要市場促進要因

細胞・遺伝子治療研究開発への投資の増加が、細胞・遺伝子治療バイオ分析試験サービスの世界市場を牽引しています。

細胞・遺伝子治療の分野は近年目覚ましい進歩を遂げ、これまで不治の病であった患者に新たな希望をもたらしています。この革新的な治療法は、患者自身の細胞や遺伝子を改変して、遺伝性疾患、がん、自己免疫疾患などさまざまな病気と闘うものです。細胞・遺伝子治療の可能性がますます明らかになるにつれ、この分野の研究開発（R&D）への投資も急増しています。この分野の発展に欠かせないのが、バイオ分析試験サービスであり、これらの療法の安全性、有効性、品質を保証する上で極めて重要な役割を担っています。

遺伝性疾患と希少疾患の有病率の上昇が世界のメンズヘルスサプリメント市場を牽引している

遺伝性疾患や希少疾患は、しばしば希少疾患と呼ばれ、一般的な疾患と比較して比較的少数の個人が罹患する疾患です。これらの疾患は一般的に遺伝子変異によって引き起こされ、幅広い衰弱症状を引き起こし、罹患者の生活の質に大きな影響を与えます。これらの疾患を特に困難にしているのは、利用可能な治療法がないことであり、アンメット・メディカル・ニーズの重要な分野となっています。近年、遺伝性疾患や希少疾患の有病率は増加傾向にあります。この増加は、診断法の改善、認知度の向上、遺伝子配列決定技術の進歩など、いくつかの要因によるものです。これらの疾患の遺伝的基盤に対する理解が深まるにつれて、より多くの症例が同定され、報告されている有病率の上昇につながっています。

細胞療法や遺伝子療法は、多くの遺伝性疾患や希少疾患に対する有望な解決策として浮上してきました。これらの最先端治療法は、患者の遺伝物質を改変または置換することにより、疾患の影響を修正または軽減するものです。従来の医薬品とは異なり、細胞・遺伝子治療には長期にわたる効果、あるいは治癒効果をもたらす可能性さえあるため、希少で衰弱した疾患を持つ患者にとって非常に望ましい治療法となっています。細胞・遺伝子療法はすでに、脊髄性筋萎縮症、ある種の白血病、遺伝性網膜疾患などの治療において目覚ましい成功を収めています。この分野の進歩に伴い、さまざまな遺伝性疾患や希少疾患に対する治療法の開発が進められています。

細胞治療や遺伝子治療の安全性と有効性を確保することは最も重要です。これらの治療法は複雑なプロセスを伴うため、意図しない遺伝子の変化、免疫系反応、オフターゲット効果などの潜在的なリスクが生じる可能性があります。これらの懸念に対処し、規制要件を満たすためには、これらの治療法の開発と製造を通して、広範な生物分析試験が不可欠です。バイオ分析試験サービスには、遺伝子配列決定、細胞ベースのアッセイ、分析化学的手法など、幅広い技術が含まれます。これらの検査は、細胞および遺伝子治療製品の品質、純度、効力を評価するために設計されています。また、患者の反応をモニタリングし、有害事象を特定する上でも重要な役割を果たしています。

主な市場課題

規制上の課題

細胞・遺伝子治療バイオ分析試験サービス市場が直面する最も重要な課題の1つは、進化し、しばしば厳しくなる規制状況です。世界中の規制当局は、患者の安全性の確保と技術革新の促進とのバランスを取ろうと努力しています。規制遵守の達成は複雑で時間のかかるプロセスであり、治療法の上市の遅れにつながります。

標準化とバリデーション

細胞・遺伝子治療製品に関する標準化された調査手法やバリデーションプロトコールがないことは、大きな課題です。各治療法は独自の試験アプローチを必要とする場合があり、試験機関が一貫した再現性のあるプロセスを確立することは困難です。標準化の努力は行われているが、進展は遅いです。

スケーラビリティとキャパシティの制約

細胞治療と遺伝子治療の生物学的分析試験サービスに対する需要の増大は、試験所の能力を圧迫しています。開発中の治療法の増加や大量生産の必要性に対応するため、試験所は苦闘しており、スケーラビリティは依然として重要な課題です。

データ管理と分析

細胞治療と遺伝子治療の生物学的分析検査は膨大な量の複雑なデータを生成するため、高度なデータ管理と分析能力を必要とします。このデータを扱い、保存し、解釈することは重要な課題です。さらに、データの完全性とセキュリティを確保することは、規制要件を満たすために極めて重要です。

コストと価格の圧力

細胞・遺伝子治療の開発・提供には高いコストがかかるため、メーカーと患者の双方に大きな経済的負担がかかります。バイオ分析検査サービスは、これらのコストのかなりの部分を占めています。手頃な価格と質の高い検査サービスの必要性のバランスをとることは、市場関係者にとって絶え間ない課題です。

人材不足

細胞治療と遺伝子治療のバイオ分析試験の専門的性質は、熟練した労働力を必要とします。しかし、この分野の専門知識を持つ有能な人材は不足しています。優秀な人材の確保と維持は、試験所やバイオテクノロジー企業にとって依然として課題です。

サプライチェーンの脆弱性

COVID-19パンデミックの際に見られたような世界のサプライチェーンの混乱は、細胞・遺伝子治療産業の脆弱性を浮き彫りにしました。重要な試薬や材料の入手可能性を確保することは、検査サービスを中断しないために極めて重要です。

患者アクセスと公平性

細胞・遺伝子治療への公平なアクセスを確保することは、業界が直面する倫理的課題です。これらの治療法は人々の生活を一変させる可能性を秘めているが、コスト、地域、ヘルスケアインフラなどの要因により、アクセス格差が存在します。このギャップを埋めることは、これらの治療法の可能性を最大限に実現するために不可欠です。

主要市場動向

技術の進歩

近年、細胞・遺伝子治療の分野は、医学の領域を変革する力として台頭してきました。広範な疾患に対する個別化された標的治療の可能性を提供する細胞・遺伝子治療は、研究者、臨床医、患者を問わず想像力をかき立ててきました。この分野が拡大し続けるにつれて、高度なバイオ分析検査サービスの需要が急増しています。最先端技術と精密で信頼性の高い検査へのニーズの融合が、世界の細胞・遺伝子治療バイオ分析検査サービス市場の成長に拍車をかけています。

細胞・遺伝子治療のバイオ分析検査における重要な進歩の一つは、単一細胞の分析能力です。従来のバルク分析では、細胞集団内の不均一性が覆い隠されることが多く、治療介入の真の影響を評価することが困難でした。シングルセルRNAシーケンスやシングルセルプロテオミクスなどのシングルセル解析技術により、研究者は細胞の挙動をより深く掘り下げることができ、治療メカニズムや安全性の理解を深めることができます。CRISPR-Cas9遺伝子編集技術の出現は、遺伝子治療研究に革命をもたらしました。この精密で汎用性の高いツールにより、科学者はかつてない精度で遺伝子を編集できるようになっています。バイオ分析検査サービスは、CRISPRベースの治療法に適応し、編集された遺伝子の機能と潜在的なオフターゲット効果の重要な評価を提供しています。最先端の分析機器が利用可能になったことで、バイオ分析検査の質とスピードが大幅に向上しました。質量分析、フローサイトメトリー、次世代シーケンサーなどの技術は、より身近で手頃なものとなり、細胞や遺伝子の成分を包括的かつハイスループットに分析できるようになっています。AIと機械学習アルゴリズムは、データ解析と解釈を改善するために生物学的分析検査に統合されつつあります。これらの技術は、パターンを特定し、結果を予測し、実験デザインを最適化し、検査に関連する時間とコストの両方を削減することができます。技術の進歩により、治療効果や安全性の指標となるバイオマーカーの発見が加速しています。バイオマーカーは、治療反応をより正確にモニタリングすることを可能にし、個別化医療アプローチのための貴重な知見を提供します。

セグメント別インサイト

検査タイプ別インサイト

検査タイプ別では、バイオアベイラビリティ・生物学的同等性試験分野が、2022年の細胞・遺伝子治療バイオ分析検査サービスの世界市場において支配的な地位を占めています。バイオアベイラビリティ試験と生物学的同等性試験は、細胞・遺伝子治療を含む医薬品の開発と承認プロセスにおいて極めて重要です。米国食品医薬品局（FDA）や欧州医薬品庁（EMA）などの規制機関は、新しい治療法の安全性と有効性を評価するためにこれらの試験を要求しています。このような規制上の需要により、この分野のバイオ分析検査サービスの市場は一貫して堅調です。細胞療法や遺伝子療法は複雑で革新的な治療法であることが多く、その安全性と有効性を保証するために厳格な試験を必要とします。生物学的利用能と生物学的同等性試験は、これらの治療薬が体内でどの程度吸収され、分布し、代謝され、排泄されるかを決定するのに役立ちます。この情報は、治療の可能性や潜在的な副作用を評価する上で極めて重要です。細胞・遺伝子治療市場は、バイオテクノロジーの進歩と革新的な治療法の開発により、著しい成長を遂げています。この分野に投資する企業が増えるにつれて、バイオアベイラビリティや生物学的同等性試験を含む生物分析試験サービスの需要が急増しています。

開発段階の洞察

非臨床部門は、予測期間中に急成長すると予測されています。開発者は、細胞治療や遺伝子治療のイノベーションを保護するために特許を申請することを望むかもしれないです。包括的な非臨床データを通じて治療の独自性と有効性を実証することは、知的財産権を確保するために不可欠です。細胞・遺伝子治療のような競争の激しい分野では、非臨床段階で強固な基盤を持つことが競争上の優位性をもたらします。強力な非臨床データを有する企業は、臨床試験に進み、最終的に治療法を市場に投入する上で有利な立場にあります。投資家や製薬パートナー候補を引き付けようとする企業は、非臨床段階から有望なデータをアピールする必要がある場合が多いです。強力な非臨床データは企業の信頼性を高め、資金やパートナーシップを確保する可能性を高める。

地域別の洞察

2022年の世界の細胞・遺伝子治療バイオ分析試験サービス市場では、北米が金額ベースで最大の市場シェアを占め、支配的なプレーヤーに浮上しました。北米、特に米国は、生物医学の研究開発に投資してきた長い歴史があります。この投資により、細胞治療と遺伝子治療の分野で大きな進歩がもたらされました。先駆的な研究機関、大学、バイオテクノロジー企業の多くが北米に立地しているため、この地域は細胞・遺伝子治療の開発と商業化において先行しています。米国はバイオテクノロジーと医薬品に関する規制の枠組みが確立されており、FDA（食品医薬品局）のような機関が細胞・遺伝子治療の開発と承認に関する明確なガイドラインを提供しています。このような規制の明確さが、この業界における技術革新と投資を後押ししています。北米には、ベンチャー・キャピタル、プライベート・エクイティ、株式公開市場にアクセスできる強力な金融エコシステムがあります。このため、バイオテクノロジー企業や新興企業は、研究、臨床試験、商業化のための資金を確保しやすくなっています。

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 細胞・遺伝子治療バイオ分析検査サービスの世界市場展望

• 市場規模・予測
  • 金額別
• 市場シェアと予測
  • 試験タイプ別（バイオアベイラビリティ・生物学的同等性試験、薬物動態学、薬力学、その他の試験タイプ）
  • 製品タイプ別（遺伝子治療、遺伝子改変細胞治療、細胞治療）
  • 開発ステージ別（非臨床、臨床）
  • 適応疾患別（ がん、感染症、神経疾患、希少疾患、その他）
  • 地域別
  • 企業別（2022年）
• 市場マップ

第6章 北米の細胞・遺伝子治療バイオ分析試験サービス市場展望

• 市場規模・予測
  • 金額別
• 市場シェアと予測
  • 検査タイプ別
  • 製品タイプ別
  • 開発ステージ別
  • 適応症別
  • 国別
• 北米：国別分析
  • 米国
  • カナダ
  • メキシコ

第7章 欧州の細胞・遺伝子治療バイオ分析試験サービス市場展望

• 市場規模と予測
  • 金額別
• 市場シェアと予測
  • 検査タイプ別
  • 製品タイプ別
  • 開発ステージ別
  • 適応症別
• 欧州国別分析
  • ドイツ
  • 英国
  • イタリア
  • フランス
  • スペイン

第8章 アジア太平洋地域の細胞・遺伝子治療バイオ分析試験サービス市場展望

• 市場規模と予測
  • 金額別
• 市場シェアと予測
  • 検査タイプ別
  • 製品タイプ別
  • 開発ステージ別
  • 適応症別
• アジア太平洋地域国別分析
  • 中国
  • インド
  • 日本
  • 韓国
  • オーストラリア

第9章 南米の細胞・遺伝子治療バイオ分析試験サービス市場展望

• 市場規模と予測
  • 金額別
• 市場シェアと予測
  • 検査タイプ別
  • 製品タイプ別
  • 開発ステージ別
  • 適応症別
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの細胞・遺伝子治療バイオ分析試験サービス市場展望

• 市場規模と予測
  • 金額別
• 市場シェアと予測
  • 検査タイプ別
  • 製品タイプ別
  • 開発ステージ別
  • 適応症別
• MEA：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品開発
• 最近の動向

第13章 細胞・遺伝子治療バイオ分析検査サービスの世界市場SWOT分析

第14章 競合情勢

• Business Overview
• Age Group Offerings
• Recent Developments
• Key Personnel
• SWOT Analysis
  • BioAgilytix Labs Inc.
  • KCAS Bioanalytical & Biomarker Services
  • IQVIA, Inc.
  • Laboratory Corporation of America Holdings
  • Pharmaceutical Product Development, Inc.（Thermo Fisher Scientific Inc.）
  • Prolytix pvt ltd
  • Pharmaron Biologics（UK）Ltd
  • Charles River Laboratories International, Inc.
  • Syneos Health Ltd
  • Intertek Group Plc

第15章 戦略的提言

第16章 調査会社・免責事項

Global Cell & Gene Therapy Bioanalytical Testing Services Market has valued at USD 411.01 million in 2022 and is anticipated to project impressive growth in the forecast period with a CAGR of 8.18% through 2028. The field of cell and gene therapy has witnessed remarkable advancements in recent years, offering new hope for the treatment of various genetic and chronic diseases. These revolutionary therapies have the potential to transform the healthcare landscape, providing personalized and highly effective treatment options. However, the development and commercialization of cell and gene therapies come with unique challenges, including stringent regulatory requirements and the need for robust bioanalytical testing services.

Cell and gene therapies represent a groundbreaking approach to medical treatment by harnessing the power of a patient's own cells to combat diseases at their source. These therapies involve modifying or replacing genes to correct genetic mutations or enhance the body's ability to fight diseases, and they have shown significant promise in treating conditions such as cancer, rare genetic disorders, and autoimmune diseases. As the research and development of cell and gene therapies continue to expand, so does the demand for rigorous bioanalytical testing services to ensure their safety and efficacy.

Several factors contribute to the rapid growth of the global cell & gene therapy bioanalytical testing services. Governments, pharmaceutical companies, and venture capitalists have been pouring significant investments into the development of cell and gene therapies. This has led to a surge in clinical trials and a greater need for comprehensive testing services throughout the product lifecycle. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established stringent guidelines for cell and gene therapies. Compliance with these regulations necessitates extensive bioanalytical testing, including safety, efficacy, and quality assessments. The evolution of analytical technologies, such as mass spectrometry, flow cytometry, and next-generation sequencing, has enabled more precise and efficient bioanalytical testing, further boosting the market. The growing awareness of cell and gene therapies and their potential to address unmet medical needs has increased patient and healthcare provider demand. This has, in turn, driven the need for more comprehensive testing services.

While the cell & gene therapy bioanalytical testing services market is poised for substantial growth, it faces several challenges, including the need for harmonized regulatory guidelines and the scarcity of skilled professionals in this specialized field. However, as technology continues to advance, these challenges are expected to be addressed. In the coming years, the market is likely to witness increased collaboration between pharmaceutical companies, CROs, and academic institutions to ensure comprehensive testing throughout the development process. Additionally, the emergence of advanced analytical techniques and automation will enhance the efficiency and accuracy of bioanalytical testing, further accelerating the growth of this market.

Key Market Drivers

Increasing Investment in Cell and Gene Therapy Research and Development is Driving the Global Cell & Gene Therapy Bioanalytical Testing Services Market

The field of cell and gene therapy has witnessed remarkable advancements in recent years, offering new hope for patients with previously incurable diseases. This innovative approach to medical treatment involves modifying a patient's own cells or genes to combat various illnesses, including genetic disorders, cancer, and autoimmune diseases. As the potential of cell and gene therapy becomes increasingly evident, there has been a surge in investment in research and development (R&D) in this sector. One vital aspect of advancing this field is bioanalytical testing services, which play a pivotal role in ensuring the safety, efficacy, and quality of these therapies.

The global demand for effective and safe cell and gene therapies has led to a surge in R&D efforts. Governments, pharmaceutical companies, and biotechnology firms have recognized the immense potential of these therapies and are investing heavily in their development. As a result, cell and gene therapy R&D expenditures have increased significantly in recent years.

Governments around the world have established funding programs to support cell and gene therapy research. These initiatives aim to accelerate the development of new therapies and facilitate their clinical translation. For example, in the United States, the National Institutes of Health (NIH) has allocated substantial funding to advance gene therapy research and development. Leading pharmaceutical companies have been actively engaging in partnerships and acquisitions of biotechnology firms specializing in cell and gene therapy. These collaborations are driven by the potential for groundbreaking therapies and the growing demand for bioanalytical testing services to ensure their safety and efficacy. Venture capital and private equity firms are also recognizing the potential for significant returns on investments in cell and gene therapy companies. These financial injections help these companies advance their R&D efforts and expand their capabilities in bioanalytical testing. Bioanalytical testing services are a critical component of cell and gene therapy development. These services encompass a wide range of analytical techniques and assays that assess the quality, safety, and efficacy of therapeutic products. They include pharmacokinetics, pharmacodynamics, immunogenicity, and potency testing, among others. As cell and gene therapies are highly complex and personalized, rigorous testing is essential to ensure their success. Numerous companies specializing in bioanalytical testing services have emerged to cater to the growing demand. Established contract research organizations (CROs) have also expanded their capabilities to provide specialized testing services for cell and gene therapies.

Rising Prevalence of Genetic and Rare Diseases is Driving the Global Men's Health Supplements Market

Genetic and rare diseases, often referred to as orphan diseases, are conditions that affect a relatively small number of individuals compared to more common diseases. These disorders are typically caused by genetic mutations and can result in a wide range of debilitating symptoms, significantly impacting the quality of life for affected individuals. What makes these diseases particularly challenging is the lack of available treatments, making them a significant area of unmet medical need. In recent years, the prevalence of genetic and rare diseases has been on the rise. This increase can be attributed to several factors, including improved diagnostics, increased awareness, and advances in genetic sequencing technologies. With a better understanding of the genetic basis of these diseases, more cases are being identified, leading to a higher reported prevalence.

Cell and gene therapies have emerged as a promising solution for many genetic and rare diseases. These cutting-edge treatments involve modifying or replacing a patient's genetic material to correct or mitigate the effects of the disease. Unlike traditional pharmaceuticals, cell and gene therapies have the potential to provide long-lasting or even curative effects, making them highly desirable for patients with rare and debilitating conditions. Cell and gene therapies have already demonstrated remarkable success in treating diseases like spinal muscular atrophy, certain types of leukemia, and inherited retinal disorders. As the field continues to advance, more therapies are in development for a wide range of genetic and rare diseases.

Ensuring the safety and efficacy of cell and gene therapies is paramount. These therapies involve complex processes that can introduce potential risks, including unintended genetic changes, immune system reactions, and off-target effects. To address these concerns and meet regulatory requirements, extensive bioanalytical testing is essential throughout the development and manufacturing of these therapies. Bioanalytical testing services encompass a wide range of techniques, including genetic sequencing, cell-based assays, and analytical chemistry methods. These tests are designed to assess the quality, purity, and potency of cell and gene therapy products. They also play a critical role in monitoring patient responses and identifying any adverse events.

Key Market Challenges

Regulatory Challenges

One of the most significant challenges facing the cell and gene therapy bioanalytical testing services market is the evolving and often stringent regulatory landscape. Regulators worldwide are striving to strike a balance between ensuring patient safety and fostering innovation. Achieving regulatory compliance can be a complex and time-consuming process, leading to delays in bringing therapies to market.

Standardization and Validation

The lack of standardized testing methodologies and validation protocols for cell and gene therapy products poses a considerable challenge. Each therapy may require unique testing approaches, making it difficult for testing laboratories to establish consistent and reproducible processes. Standardization efforts are underway, but progress has been slow.

Scalability and Capacity Constraints

The growing demand for cell and gene therapy bioanalytical testing services has strained the capacity of testing laboratories. Scalability remains a significant challenge as laboratories struggle to keep pace with the increasing number of therapies in development and the need for large-scale production.

Data Management and Analysis

Cell and gene therapy bioanalytical testing generate vast amounts of complex data, requiring sophisticated data management and analysis capabilities. Handling, storing, and interpreting this data is a significant challenge. Moreover, ensuring data integrity and security is crucial to meet regulatory requirements.

Cost and Pricing Pressures

The high cost of developing and delivering cell and gene therapies places significant financial burdens on both manufacturers and patients. Bioanalytical testing services account for a substantial portion of these costs. Balancing affordability with the need for quality testing services is a constant challenge for market players.

Talent Shortages

The specialized nature of cell and gene therapy bioanalytical testing requires a skilled workforce. However, there is a shortage of qualified personnel with expertise in this field. Attracting and retaining top talent remains a challenge for testing laboratories and biotech companies.

Supply Chain Vulnerabilities

Global supply chain disruptions, as seen during the COVID-19 pandemic, have highlighted the vulnerability of the cell and gene therapy industry. Ensuring the availability of critical reagents and materials is crucial for uninterrupted testing services.

Patient Access and Equity

Ensuring equitable access to cell and gene therapies is an ethical challenge facing the industry. These therapies hold the potential to transform lives, but access disparities exist due to factors like cost, geography, and healthcare infrastructure. Bridging this gap is essential for realizing the full potential of these treatments.

Key Market Trends

Technological Advancements

In recent years, the field of cell and gene therapy has emerged as a transformative force in the realm of medicine. Offering the promise of personalized, targeted treatments for a wide range of diseases, cell and gene therapies have captured the imagination of researchers, clinicians, and patients alike. As this field continues to expand, the demand for advanced bioanalytical testing services has surged. The convergence of cutting-edge technologies and the need for precise, reliable testing has fueled the growth of the Global Cell & Gene Therapy Bioanalytical Testing Services Market.

One of the significant advancements in bioanalytical testing for cell and gene therapies is the ability to analyze single cells. Traditional bulk analysis often masks heterogeneity within cell populations, making it challenging to assess the true impact of therapeutic interventions. Single-cell analysis technologies, such as single-cell RNA sequencing and single-cell proteomics, allow researchers to delve deeper into cell behavior, enhancing our understanding of therapy mechanisms and safety. The emergence of the CRISPR-Cas9 gene-editing technology has revolutionized gene therapy research. This precise and versatile tool enables scientists to edit genes with unprecedented accuracy. Bioanalytical testing services have adapted to accommodate CRISPR-based therapies, providing critical assessments of the edited genes' function and potential off-target effects. The availability of state-of-the-art analytical instruments has greatly enhanced the quality and speed of bioanalytical testing. Technologies like mass spectrometry, flow cytometry, and next-generation sequencing have become more accessible and affordable, allowing for comprehensive and high-throughput analysis of cellular and genetic components. AI and machine learning algorithms are being integrated into bioanalytical testing to improve data analysis and interpretation. These technologies can identify patterns, predict outcomes, and optimize experimental design, reducing both time and costs associated with testing. Technological advancements have accelerated the discovery of biomarkers that can serve as indicators of therapeutic efficacy and safety. Biomarkers enable more precise monitoring of treatment responses and provide valuable insights for personalized medicine approaches.

Segmental Insights

Test Type Insights

Based on the category of Test Type, the bioavailability & bioequivalence studies segment emerged as the dominant player in the global market for Cell & Gene Therapy Bioanalytical Testing Services in 2022. Bioavailability and bioequivalence studies are critical in the development and approval process of pharmaceuticals, including cell and gene therapies. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require these studies to assess the safety and efficacy of new therapies. This regulatory demand ensures a consistent and robust market for bioanalytical testing services in this segment. Cell and gene therapies are often complex and innovative treatments that require rigorous testing to ensure their safety and efficacy. Bioavailability and bioequivalence studies help determine how well these therapies are absorbed, distributed, metabolized, and excreted in the body. This information is crucial for assessing their therapeutic potential and potential side effects. The cell and gene therapy market has been experiencing significant growth due to advancements in biotechnology and the development of innovative therapies. As more companies invest in this sector, the demand for bioanalytical testing services, including bioavailability and bioequivalence studies, has surged.

Stage of Development Insights

The non-clinical segment is projected to experience rapid growth during the forecast period. Developers may want to file patents to protect their cell and gene therapy innovations. Demonstrating the uniqueness and effectiveness of a therapy through comprehensive non-clinical data can be essential for securing IP rights. In a highly competitive field like cell and gene therapy, having a solid foundation in the non-clinical stage can provide a competitive advantage. Companies with strong non-clinical data are better positioned to progress to clinical trials and ultimately bring their therapies to market. Companies looking to attract investors or potential pharmaceutical partners often need to showcase promising data from the non-clinical stage. Strong non-clinical data can enhance a company's credibility and increase the likelihood of securing funding or partnerships, which are crucial for advancing therapies through clinical development.

Regional Insights

North America emerged as the dominant player in the global Cell & Gene Therapy Bioanalytical Testing Services market in 2022, holding the largest market share in terms of value. North America, particularly the United States, has a long history of investing in biomedical research and development. This investment has led to significant advancements in the field of cell and gene therapy. Many pioneering research institutions, universities, and biotech companies are located in North America, which has given the region a head start in the development and commercialization of cell and gene therapies. The United States has a well-established regulatory framework for biotechnology and pharmaceuticals, with agencies like the FDA (Food and Drug Administration) providing clear guidelines for the development and approval of cell and gene therapies. This regulatory clarity has encouraged innovation and investment in the industry. North America has a strong financial ecosystem with access to venture capital, private equity, and public markets. This makes it easier for biotech companies and startups to secure funding for research, clinical trials, and commercialization efforts.

Key Market Players

• BioAgilytix Labs Inc.

• KCAS Bioanalytical & Biomarker Services

• IQVIA, Inc.

• Laboratory Corporation of America Holdings

• Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)

• Prolytix pvt ltd

• Pharmaron Biologics (UK) Ltd

• Charles River Laboratories International, Inc.

• Syneos Health Ltd

• Intertek Group Plc

Report Scope:

In this report, the Global Cell & Gene Therapy Bioanalytical Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Cell & Gene Therapy Bioanalytical Testing Services Market, By Test Type:

• Bioavailability & Bioequivalence Studies
• Pharmacokinetics
• Pharmacodynamics
• Other test type

Cell & Gene Therapy Bioanalytical Testing Services Market, By Product Type:

• Gene Therapy
• Gene-Modified Cell Therapy
• Cell Therapy

Cell & Gene Therapy Bioanalytical Testing Services Market, By Stage of Development:

• Non-Clinical
• Clinical

Cell & Gene Therapy Bioanalytical Testing Services Market, By Indication:

• Oncology
• Infectious Diseases
• Neurological disorders
• Rare Diseases
• Others

Cell & Gene Therapy Bioanalytical Testing Services Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia-Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

• Company Profiles: Detailed analysis of the major companies present in the Global Cell & Gene Therapy Bioanalytical Testing Services Market.

Available Customizations:

• Global Cell & Gene Therapy Bioanalytical Testing Services market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

4. Voice of Customer

5. Global Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Other test Type)
  • 5.2.2. By Product Type ( Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy)
  • 5.2.3. By Stage of Development ( Non-Clinical, Clinical)
  • 5.2.4. By Indication ( Oncology, Infectious Diseases, Neurological disorders, Rare Diseases, Others)
  • 5.2.5. By Region
  • 5.2.6. By Company (2022)
• 5.3. Market Map

6. North America Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Test Type
  • 6.2.2. By Product Type
  • 6.2.3. By Stage of Development
  • 6.2.4. By Indication
  • 6.2.5. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Test Type
      • 6.3.1.2.2. By Product Type
      • 6.3.1.2.3. By Stage of Development
      • 6.3.1.2.4. By Indication
  • 6.3.2. Canada Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Test Type
      • 6.3.2.2.2. By Product Type
      • 6.3.2.2.3. By Stage of Development
      • 6.3.2.2.4. By Indication
  • 6.3.3. Mexico Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Test Type
      • 6.3.3.2.2. By Product Type
      • 6.3.3.2.3. By Stage of Development
      • 6.3.3.2.4. By Indication

7. Europe Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Test Type
  • 7.2.2. By Product Type
  • 7.2.3. By Stage of Development
  • 7.2.4. By Indication
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Test Type
      • 7.3.1.2.2. By Product Type
      • 7.3.1.2.3. By Stage of Development
      • 7.3.1.2.4. By Indication
  • 7.3.2. United Kingdom Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Test Type
      • 7.3.2.2.2. By Product Type
      • 7.3.2.2.3. By Stage of Development
      • 7.3.2.2.4. By Indication
  • 7.3.3. Italy Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecasty
      • 7.3.3.2.1. By Test Type
      • 7.3.3.2.2. By Product Type
      • 7.3.3.2.3. By Stage of Development
      • 7.3.3.2.4. By Indication
  • 7.3.4. France Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Test Type
      • 7.3.4.2.2. By Product Type
      • 7.3.4.2.3. By Stage of Development
      • 7.3.4.2.4. By Indication
  • 7.3.5. Spain Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Test Type
      • 7.3.5.2.2. By Product Type
      • 7.3.5.2.3. By Stage of Development
      • 7.3.5.2.4. By Indication

8. Asia-Pacific Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Test Type
  • 8.2.2. By Product Type
  • 8.2.3. By Stage of Development
  • 8.2.4. By Indication
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Test Type
      • 8.3.1.2.2. By Product Type
      • 8.3.1.2.3. By Stage of Development
      • 8.3.1.2.4. By Indication
  • 8.3.2. India Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Test Type
      • 8.3.2.2.2. By Product Type
      • 8.3.2.2.3. By Stage of Development
      • 8.3.2.2.4. By Indication
  • 8.3.3. Japan Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Test Type
      • 8.3.3.2.2. By Product Type
      • 8.3.3.2.3. By Stage of Development
      • 8.3.3.2.4. By Indication
  • 8.3.4. South Korea Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Test Type
      • 8.3.4.2.2. By Product Type
      • 8.3.4.2.3. By Stage of Development
      • 8.3.4.2.4. By Indication
  • 8.3.5. Australia Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Test Type
      • 8.3.5.2.2. By Product Type
      • 8.3.5.2.3. By Stage of Development
      • 8.3.5.2.4. By Indication

9. South America Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Test Type
  • 9.2.2. By Product Type
  • 9.2.3. By Stage of Development
  • 9.2.4. By Indication
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Test Type
      • 9.3.1.2.2. By Product Type
      • 9.3.1.2.3. By Stage of Development
      • 9.3.1.2.4. By Indication
  • 9.3.2. Argentina Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Test Type
      • 9.3.2.2.2. By Product Type
      • 9.3.2.2.3. By Stage of Development
      • 9.3.2.2.4. By Indication
  • 9.3.3. Colombia Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Test Type
      • 9.3.3.2.2. By Product Type
      • 9.3.3.2.3. By Stage of Development
      • 9.3.3.2.4. By Indication

10. Middle East and Africa Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Test Type
  • 10.2.2. By Product Type
  • 10.2.3. By Stage of Development
  • 10.2.4. By Indication
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Test Type
      • 10.3.1.2.2. By Product Type
      • 10.3.1.2.3. By Stage of Development
      • 10.3.1.2.4. By Indication
  • 10.3.2. Saudi Arabia Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Test Type
      • 10.3.2.2.2. By Product Type
      • 10.3.2.2.3. By Stage of Development
      • 10.3.2.2.4. By Indication
  • 10.3.3. UAE Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Test Type
      • 10.3.3.2.2. By Product Type
      • 10.3.3.2.3. By Stage of Development
      • 10.3.3.2.4. By Indication

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition
• 12.2. Product Development
• 12.3. Recent Developments

13. Global Cell & Gene Therapy Bioanalytical Testing Services Market: SWOT Analysis

14. Competitive Landscape

• 14.1. Business Overview
• 14.2. Age Group Offerings
• 14.3. Recent Developments
• 14.4. Key Personnel
• 14.5. SWOT Analysis
  • 14.5.1. BioAgilytix Labs Inc.
  • 14.5.2. KCAS Bioanalytical & Biomarker Services
  • 14.5.3. IQVIA, Inc.
  • 14.5.4. Laboratory Corporation of America Holdings
  • 14.5.5. Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
  • 14.5.6. Prolytix pvt ltd
  • 14.5.7. Pharmaron Biologics (UK) Ltd
  • 14.5.8. Charles River Laboratories International, Inc.
  • 14.5.9. Syneos Health Ltd
  • 14.5.10. Intertek Group Plc

15. Strategic Recommendations

16. About Us & Disclaimer