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ウイルスクリアランス市場の2030年までの予測-方法別、用途別、エンドユーザー別、地域別の世界分析

Viral Clearance Market Forecasts to 2030 - Global Analysis By Method, Application, End User and By Geography

出版日: 2023年07月01日 | 発行: Stratistics Market Research Consulting

| ページ情報: 英文 175+ Pages | 納期: 2～3営業日

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全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

Stratistics MRCによると、世界のウイルスクリアランス市場は2023年に7億6,464万米ドルを占め、2030年には19億3,815万米ドルに達すると予測され、予測期間中のCAGRは14.21%です。

組換えタンパク質、糖タンパク質、組織・血液由来製品、医療機器、モノクローナル抗体の開発は、すべてウイルスクリアランスプロセスに依存しています。動物やヒトの細胞はウイルスに感染することがあるが、ウイルスは自ら増殖する能力を持っています。さらに、細菌の宿主細胞内で増殖・拡散し、損傷や感染を引き起こす力もあります。ウイルスクリアランス法の重要な要素は、製品をリスクなく生産し、ヒトが使用する製品の安全性を保証する能力を評価することです。原材料、下流工程、細胞培養工程はすべてウイルス感染の影響を受ける。このことは、ウイルス安全性プラクティスの開発とウイルスクリアランスプロセスの実施に貢献すると思われます。

BioSpaceによると、2018年には386の医薬品が臨床開発登録され、医薬品数が178に過ぎなかった2008年から大幅な伸びを示しました。開発プロセスにおける医薬品数の増加は、ウイルスクリアリングサービスの需要を増加させています。

市場力学：

促進要因：

慢性疾患の増加

ウイルス不活性化市場の成長を促進する要因には、慢性ウイルス感染症や疾患の有病率の上昇、効果的な治療法に対する需要の高まりなどがあります。また、ライフサイエンス産業への投資の増加、新薬のイントロダクションの増加、研究開発の革新の増加により、市場の成長が期待されます。

抑制要因

最先端技術別高コスト

市場開拓の妨げとなっているのは、商品や技術にかかる開発コストの高さです。加えて、薬剤の開発プロセスに時間がかかることや、タンパク質の架橋、タンパク質の変性、タンパク質の分解など、ウイルスクリアランスに関連するいくつかの問題が市場の拡大を制限しています。

機会：

ウイルス安全性規制の強化

ウイルスの安全性評価は、製品の安全性を確保するための重要なステップです。規制当局はウイルスの安全性を重視し、特にINDやBLAの承認にはそれを裏付ける高度なデータを要求します。効果的な戦略的計画のためには、規制要件、プロセス、プロセスの重要な領域について知識を持つことが極めて重要です。医薬品開発におけるこのようなウイルス安全性規制は、試験をより成功させるためのサービスへの需要を高めています。

脅威

資格のある専門家の不足

ウイルス除去サービス・プロバイダーは、製薬会社、バイオテクノロジー企業、医療機器企業、研究・学術機関と、有能で経験豊富な科学者の獲得競争を繰り広げるため、高度なスキルを持つ専門家の確保・維持という課題に直面しています。企業は競争に打ち勝つために、より高い報酬やその他のインセンティブを提供しなければならず、その結果、特に小規模な分析試験プロバイダーの財務や業績に影響を及ぼします。このような熟練した専門家の不足は、新しい技術やプロセスの採用を妨げ、今後数年間の市場の成長を制限する可能性があります。

COVID-19の影響：

市場はCOVID-19の大流行によってマイナスの影響を受けた。労働者やスタッフの不足、感染拡大のリスク、バイオ医薬品・バイオテクノロジー分野における製造の停滞などが市場の課題となっています。しかし、2021年には市場の成長が急激に加速しました。この成長は臨床試験の増加に起因しています。SARS-CoV-2ウイルスに対するワクチンや医薬品を開発するため、多くの製薬会社やバイオ医薬品会社が研究開発や製造工程を増やしました。さらに、COVID-19の発生後、COVID-19ワクチン開発のための製薬会社や学術機関との新たな世界的提携や共同研究が数多く行われています。

予測期間中、組換えタンパク質分野が最大になると予想されている：

予測期間中、組み換えタンパク質分野が最大の市場シェアを占めると予想されます。同分野の成長に影響を与える主な要因の1つは、乾癬、多発性硬化症、リウマチ性疾患、炎症性腸疾患などの炎症性疾患を管理するためのバイオ医薬品に対する需要の高まりです。バイオ医薬品の生産と開発は、組換えタンパク質のイントロダクションよって完全に変化しました。現在、組換えタンパク質から作られた数多くの生物製剤やワクチンがパイプラインにあり、FDAの承認を受けると予想されているため、組換え医薬品の数は増加すると予想されます。したがって、前述のすべての要因を考慮すると、市場は成長すると予想されます。

予測期間中にCAGRが最も高くなると予想されるのは、受託研究機関セグメントである：

大手市場参入企業による製品改良のための各種研究機関への投資が拡大していることから、受託研究機関セグメントは今後数年間で力強い市場成長が見込まれます。契約研究機関が創薬インフラに多額の投資を行えること、新興企業、学術機関、製薬会社、小規模バイオテクノロジー企業などの組織によるCROへの創薬サービスのアウトソーシングが増加していることが、世界のウイルスクリアランス市場で異常な成長を遂げる主な要因となっています。

最大シェアの地域：

予測期間を通じて、北米がウイルスクリアランス市場を独占すると予想されます。重要なプレーヤーが存在し、最先端の医療技術を駆使して前進していることが、最大シェアの主な要因です。市場拡大の主な要因は、組換えタンパク質やワクチンの生産量の増加と、それらをウイルスやリスクから守る必要性です。また、バイオ医薬品を使用することのメリットに対する認識が高まり、ウイルス除去関連サービスの需要が高まっています。さらに、米国全体で医薬品への資金援助が増加した結果、市場は拡大しています。

CAGRが最も高い地域：

医学研究への政府投資の増加や医療費の高騰により、アジア太平洋地域は予測期間中に大きく成長することが予想され、中国、日本、インドなどの国々では細胞培養の汚染リスクやCROの存在感が高まる。WHOの統計によると、35歳から69歳までの1,500万人以上が慢性疾患で死亡しており、先進国と発展途上国の両方が早死にの85％を占めています。さらに、特に中国では多くの臨床研究サービスがあり、今後の市場拡大に拍車がかかると予想されます。

主な発展

2022年9月、メルクは2,900万ユーロを投じて新設した中国生物製剤試験センターの第1棟の一部としてウイルスクリアランス（VC）ラボを開設しました。

2022年4月、提携研究機関（PRO）であるアブゼナは、カリフォルニア州サンディエゴにある同社の生物製剤プロセス開発・製造ハブの近くに生物製剤試験ラボを開設すると発表しました。この施設により、パートナーはIND、IMPD、BLA、MAA申請をサポートするための細胞ベースおよびPCR安全性アッセイ、ウイルスクリアランス試験にアクセスできるようになります。

2022年4月、ウーシー・バイオロジクス社は、アジア太平洋バイオプロセシング・エクセレンス・アワード（ABEA）において、ウイルスクリアランスと安全性における2度目のバイオプロセシング・エクセレンスを受賞した。

レポート内容

地域レベルおよび国レベルの市場シェア評価
新規参入企業への戦略的提言
2021年、2022年、2023年、2026年、2030年の市場データを網羅
市場動向
市場推定に基づく主要ビジネスセグメントにおける戦略的提言
主要な共通トレンドをマッピングした競合情勢
詳細な戦略、財務、最近の動向を含む企業プロファイル
最新の技術的進歩をマッピングしたサプライチェーン動向

無料カスタマイズサービス：

本レポートをご購読のお客様には、以下のいずれかの無料カスタマイズオプションをご提供いたします：

企業プロファイル
- 追加市場プレイヤーの包括的プロファイリング（3社まで）
- 主要企業のSWOT分析（3社まで）
地域セグメンテーション
- 顧客の関心に応じた主要国の市場推計・予測・CAGR（注：フィージビリティチェックによる）
競合ベンチマーキング
- 製品ポートフォリオ、地理的プレゼンス、戦略的提携に基づく主要企業のベンチマーキング

北米
- 米国
- カナダ
- メキシコ
欧州
- ドイツ
- 英国
- イタリア
- フランス
- スペイン
- その他欧州
アジア太平洋
- 日本
- 中国
- インド
- オーストラリア
- ニュージーランド
- 韓国
- その他アジア太平洋地域
南米
- アルゼンチン
- ブラジル
- チリ
- その他南米
中東・アフリカ
- サウジアラビア
- アラブ首長国連邦
- カタール
- 南アフリカ
- その他中東とアフリカ

第9章主な発展

契約、パートナーシップ、提携、合弁事業
買収と合併
新製品の上市
事業拡大
その他の主要戦略

第10章企業プロファイル

Avance Biosciences Inc.
BioReliance Corporation
Bioscience Laboratories
BSL Bioservice Scientific Laboratories GmbH
Charles River Laboratories, Inc.
Clean Cells Inc.
Cytovance Biologics Inc.
Eurofins Scientific
F. Hoffmann-La Roche Ltd.
GE Healthcare Life Sciences
Kedrion Biopharma Inc.
Labor Dr. Merk & Kollegen GmbH
Lonza Group AG
Merck KGaA
Nelson Laboratories LLC
Novartis AG
Sartorius AG
Sigma-Aldrich Corporation
Syngene International Limited
Texcell, Inc.
Vironova AB
ViruSure GmbH
WuXi AppTec

図表

List of Tables

Table 1 Global Viral Clearance Market Outlook, By Region (2021-2030) ($MN)
Table 2 Global Viral Clearance Market Outlook, By Method (2021-2030) ($MN)
Table 3 Global Viral Clearance Market Outlook, By Viral Removal (2021-2030) ($MN)
Table 4 Global Viral Clearance Market Outlook, By Chromatography (2021-2030) ($MN)
Table 5 Global Viral Clearance Market Outlook, By Nanofiltration (2021-2030) ($MN)
Table 6 Global Viral Clearance Market Outlook, By Precipitation (2021-2030) ($MN)
Table 7 Global Viral Clearance Market Outlook, By Viral Inactivation (2021-2030) ($MN)
Table 8 Global Viral Clearance Market Outlook, By Low pH (2021-2030) ($MN)
Table 9 Global Viral Clearance Market Outlook, By Solvent Detergent Method (2021-2030) ($MN)
Table 10 Global Viral Clearance Market Outlook, By Heat Pasteurization (2021-2030) ($MN)
Table 11 Global Viral Clearance Market Outlook, By Other Viral Inactivation Methods (2021-2030) ($MN)
Table 12 Global Viral Clearance Market Outlook, By Viral Detection Method (2021-2030) ($MN)
Table 13 Global Viral Clearance Market Outlook, By Application (2021-2030) ($MN)
Table 14 Global Viral Clearance Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
Table 15 Global Viral Clearance Market Outlook, By Blood and Blood Products (2021-2030) ($MN)
Table 16 Global Viral Clearance Market Outlook, By Cellular and Gene Therapy Products (2021-2030) ($MN)
Table 17 Global Viral Clearance Market Outlook, By Vaccines (2021-2030) ($MN)
Table 18 Global Viral Clearance Market Outlook, By Other Applications (2021-2030) ($MN)
Table 19 Global Viral Clearance Market Outlook, By End User (2021-2030) ($MN)
Table 20 Global Viral Clearance Market Outlook, By Pharmaceutical and Biotechnology Companies (2021-2030) ($MN)
Table 21 Global Viral Clearance Market Outlook, By Academic Research Institutes (2021-2030) ($MN)
Table 22 Global Viral Clearance Market Outlook, By Contract Research Organizations (2021-2030) ($MN)
Table 23 Global Viral Clearance Market Outlook, By Other End Users (2021-2030) ($MN)
Table 24 North America Viral Clearance Market Outlook, By Country (2021-2030) ($MN)
Table 25 North America Viral Clearance Market Outlook, By Method (2021-2030) ($MN)
Table 26 North America Viral Clearance Market Outlook, By Viral Removal (2021-2030) ($MN)
Table 27 North America Viral Clearance Market Outlook, By Chromatography (2021-2030) ($MN)
Table 28 North America Viral Clearance Market Outlook, By Nanofiltration (2021-2030) ($MN)
Table 29 North America Viral Clearance Market Outlook, By Precipitation (2021-2030) ($MN)
Table 30 North America Viral Clearance Market Outlook, By Viral Inactivation (2021-2030) ($MN)
Table 31 North America Viral Clearance Market Outlook, By Low pH (2021-2030) ($MN)
Table 32 North America Viral Clearance Market Outlook, By Solvent Detergent Method (2021-2030) ($MN)
Table 33 North America Viral Clearance Market Outlook, By Heat Pasteurization (2021-2030) ($MN)
Table 34 North America Viral Clearance Market Outlook, By Other Viral Inactivation Methods (2021-2030) ($MN)
Table 35 North America Viral Clearance Market Outlook, By Viral Detection Method (2021-2030) ($MN)
Table 36 North America Viral Clearance Market Outlook, By Application (2021-2030) ($MN)
Table 37 North America Viral Clearance Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
Table 38 North America Viral Clearance Market Outlook, By Blood and Blood Products (2021-2030) ($MN)
Table 39 North America Viral Clearance Market Outlook, By Cellular and Gene Therapy Products (2021-2030) ($MN)
Table 40 North America Viral Clearance Market Outlook, By Vaccines (2021-2030) ($MN)
Table 41 North America Viral Clearance Market Outlook, By Other Applications (2021-2030) ($MN)
Table 42 North America Viral Clearance Market Outlook, By End User (2021-2030) ($MN)
Table 43 North America Viral Clearance Market Outlook, By Pharmaceutical and Biotechnology Companies (2021-2030) ($MN)
Table 44 North America Viral Clearance Market Outlook, By Academic Research Institutes (2021-2030) ($MN)
Table 45 North America Viral Clearance Market Outlook, By Contract Research Organizations (2021-2030) ($MN)
Table 46 North America Viral Clearance Market Outlook, By Other End Users (2021-2030) ($MN)
Table 47 Europe Viral Clearance Market Outlook, By Country (2021-2030) ($MN)
Table 48 Europe Viral Clearance Market Outlook, By Method (2021-2030) ($MN)
Table 49 Europe Viral Clearance Market Outlook, By Viral Removal (2021-2030) ($MN)
Table 50 Europe Viral Clearance Market Outlook, By Chromatography (2021-2030) ($MN)
Table 51 Europe Viral Clearance Market Outlook, By Nanofiltration (2021-2030) ($MN)
Table 52 Europe Viral Clearance Market Outlook, By Precipitation (2021-2030) ($MN)
Table 53 Europe Viral Clearance Market Outlook, By Viral Inactivation (2021-2030) ($MN)
Table 54 Europe Viral Clearance Market Outlook, By Low pH (2021-2030) ($MN)
Table 55 Europe Viral Clearance Market Outlook, By Solvent Detergent Method (2021-2030) ($MN)
Table 56 Europe Viral Clearance Market Outlook, By Heat Pasteurization (2021-2030) ($MN)
Table 57 Europe Viral Clearance Market Outlook, By Other Viral Inactivation Methods (2021-2030) ($MN)
Table 58 Europe Viral Clearance Market Outlook, By Viral Detection Method (2021-2030) ($MN)
Table 59 Europe Viral Clearance Market Outlook, By Application (2021-2030) ($MN)
Table 60 Europe Viral Clearance Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
Table 61 Europe Viral Clearance Market Outlook, By Blood and Blood Products (2021-2030) ($MN)
Table 62 Europe Viral Clearance Market Outlook, By Cellular and Gene Therapy Products (2021-2030) ($MN)
Table 63 Europe Viral Clearance Market Outlook, By Vaccines (2021-2030) ($MN)
Table 64 Europe Viral Clearance Market Outlook, By Other Applications (2021-2030) ($MN)
Table 65 Europe Viral Clearance Market Outlook, By End User (2021-2030) ($MN)
Table 66 Europe Viral Clearance Market Outlook, By Pharmaceutical and Biotechnology Companies (2021-2030) ($MN)
Table 67 Europe Viral Clearance Market Outlook, By Academic Research Institutes (2021-2030) ($MN)
Table 68 Europe Viral Clearance Market Outlook, By Contract Research Organizations (2021-2030) ($MN)
Table 69 Europe Viral Clearance Market Outlook, By Other End Users (2021-2030) ($MN)
Table 70 Asia Pacific Viral Clearance Market Outlook, By Country (2021-2030) ($MN)
Table 71 Asia Pacific Viral Clearance Market Outlook, By Method (2021-2030) ($MN)
Table 72 Asia Pacific Viral Clearance Market Outlook, By Viral Removal (2021-2030) ($MN)
Table 73 Asia Pacific Viral Clearance Market Outlook, By Chromatography (2021-2030) ($MN)
Table 74 Asia Pacific Viral Clearance Market Outlook, By Nanofiltration (2021-2030) ($MN)
Table 75 Asia Pacific Viral Clearance Market Outlook, By Precipitation (2021-2030) ($MN)
Table 76 Asia Pacific Viral Clearance Market Outlook, By Viral Inactivation (2021-2030) ($MN)
Table 77 Asia Pacific Viral Clearance Market Outlook, By Low pH (2021-2030) ($MN)
Table 78 Asia Pacific Viral Clearance Market Outlook, By Solvent Detergent Method (2021-2030) ($MN)
Table 79 Asia Pacific Viral Clearance Market Outlook, By Heat Pasteurization (2021-2030) ($MN)
Table 80 Asia Pacific Viral Clearance Market Outlook, By Other Viral Inactivation Methods (2021-2030) ($MN)
Table 81 Asia Pacific Viral Clearance Market Outlook, By Viral Detection Method (2021-2030) ($MN)
Table 82 Asia Pacific Viral Clearance Market Outlook, By Application (2021-2030) ($MN)
Table 83 Asia Pacific Viral Clearance Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
Table 84 Asia Pacific Viral Clearance Market Outlook, By Blood and Blood Products (2021-2030) ($MN)
Table 85 Asia Pacific Viral Clearance Market Outlook, By Cellular and Gene Therapy Products (2021-2030) ($MN)
Table 86 Asia Pacific Viral Clearance Market Outlook, By Vaccines (2021-2030) ($MN)
Table 87 Asia Pacific Viral Clearance Market Outlook, By Other Applications (2021-2030) ($MN)
Table 88 Asia Pacific Viral Clearance Market Outlook, By End User (2021-2030) ($MN)
Table 89 Asia Pacific Viral Clearance Market Outlook, By Pharmaceutical and Biotechnology Companies (2021-2030) ($MN)
Table 90 Asia Pacific Viral Clearance Market Outlook, By Academic Research Institutes (2021-2030) ($MN)
Table 91 Asia Pacific Viral Clearance Market Outlook, By Contract Research Organizations (2021-2030) ($MN)
Table 92 Asia Pacific Viral Clearance Market Outlook, By Other End Users (2021-2030) ($MN)
Table 93 South America Viral Clearance Market Outlook, By Country (2021-2030) ($MN)
Table 94 South America Viral Clearance Market Outlook, By Method (2021-2030) ($MN)
Table 95 South America Viral Clearance Market Outlook, By Viral Removal (2021-2030) ($MN)
Table 96 South America Viral Clearance Market Outlook, By Chromatography (2021-2030) ($MN)
Table 97 South America Viral Clearance Market Outlook, By Nanofiltration (2021-2030) ($MN)
Table 98 South America Viral Clearance Market Outlook, By Precipitation (2021-2030) ($MN)
Table 99 South America Viral Clearance Market Outlook, By Viral Inactivation (2021-2030) ($MN)
Table 100 South America Viral Clearance Market Outlook, By Low pH (2021-2030) ($MN)
Table 101 South America Viral Clearance Market Outlook, By Solvent Detergent Method (2021-2030) ($MN)
Table 102 South America Viral Clearance Market Outlook, By Heat Pasteurization (2021-2030) ($MN)
Table 103 South America Viral Clearance Market Outlook, By Other Viral Inactivation Methods (2021-2030) ($MN)
Table 104 South America Viral Clearance Market Outlook, By Viral Detection Method (2021-2030) ($MN)
Table 105 South America Viral Clearance Market Outlook, By Application (2021-2030) ($MN)
Table 106 South America Viral Clearance Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
Table 107 South America Viral Clearance Market Outlook, By Blood and Blood Products (2021-2030) ($MN)
Table 108 South America Viral Clearance Market Outlook, By Cellular and Gene Therapy Products (2021-2030) ($MN)
Table 109 South America Viral Clearance Market Outlook, By Vaccines (2021-2030) ($MN)
Table 110 South America Viral Clearance Market Outlook, By Other Applications (2021-2030) ($MN)
Table 111 South America Viral Clearance Market Outlook, By End User (2021-2030) ($MN)
Table 112 South America Viral Clearance Market Outlook, By Pharmaceutical and Biotechnology Companies (2021-2030) ($MN)
Table 113 South America Viral Clearance Market Outlook, By Academic Research Institutes (2021-2030) ($MN)
Table 114 South America Viral Clearance Market Outlook, By Contract Research Organizations (2021-2030) ($MN)
Table 115 South America Viral Clearance Market Outlook, By Other End Users (2021-2030) ($MN)
Table 116 Middle East & Africa Viral Clearance Market Outlook, By Country (2021-2030) ($MN)
Table 117 Middle East & Africa Viral Clearance Market Outlook, By Method (2021-2030) ($MN)
Table 118 Middle East & Africa Viral Clearance Market Outlook, By Viral Removal (2021-2030) ($MN)
Table 119 Middle East & Africa Viral Clearance Market Outlook, By Chromatography (2021-2030) ($MN)
Table 120 Middle East & Africa Viral Clearance Market Outlook, By Nanofiltration (2021-2030) ($MN)
Table 121 Middle East & Africa Viral Clearance Market Outlook, By Precipitation (2021-2030) ($MN)
Table 122 Middle East & Africa Viral Clearance Market Outlook, By Viral Inactivation (2021-2030) ($MN)
Table 123 Middle East & Africa Viral Clearance Market Outlook, By Low pH (2021-2030) ($MN)
Table 124 Middle East & Africa Viral Clearance Market Outlook, By Solvent Detergent Method (2021-2030) ($MN)
Table 125 Middle East & Africa Viral Clearance Market Outlook, By Heat Pasteurization (2021-2030) ($MN)
Table 126 Middle East & Africa Viral Clearance Market Outlook, By Other Viral Inactivation Methods (2021-2030) ($MN)
Table 127 Middle East & Africa Viral Clearance Market Outlook, By Viral Detection Method (2021-2030) ($MN)
Table 128 Middle East & Africa Viral Clearance Market Outlook, By Application (2021-2030) ($MN)
Table 129 Middle East & Africa Viral Clearance Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
Table 130 Middle East & Africa Viral Clearance Market Outlook, By Blood and Blood Products (2021-2030) ($MN)
Table 131 Middle East & Africa Viral Clearance Market Outlook, By Cellular and Gene Therapy Products (2021-2030) ($MN)
Table 132 Middle East & Africa Viral Clearance Market Outlook, By Vaccines (2021-2030) ($MN)
Table 133 Middle East & Africa Viral Clearance Market Outlook, By Other Applications (2021-2030) ($MN)
Table 134 Middle East & Africa Viral Clearance Market Outlook, By End User (2021-2030) ($MN)
Table 135 Middle East & Africa Viral Clearance Market Outlook, By Pharmaceutical and Biotechnology Companies (2021-2030) ($MN)
Table 136 Middle East & Africa Viral Clearance Market Outlook, By Academic Research Institutes (2021-2030) ($MN)
Table 137 Middle East & Africa Viral Clearance Market Outlook, By Contract Research Organizations (2021-2030) ($MN)
Table 138 Middle East & Africa Viral Clearance Market Outlook, By Other End Users (2021-2030) ($MN)

Product Code: SMRC23341

According to Stratistics MRC, the Global Viral Clearance Market is accounted for $764.64 million in 2023 and is expected to reach $1938.15 million by 2030 growing at a CAGR of 14.21% during the forecast period. The development of recombinant proteins, glycoproteins, tissue- and blood-derived products, medical devices, and monoclonal antibodies all depend on the viral clearance process. Animal or human cells can become infected by viruses, which have the capacity to multiply on their own. Additionally, they have the power to multiply and spread within the host cell of bacteria, causing damage and infection. An important component of the viral clearance method is the evaluation of the capacity to produce a product without risk and guarantee the product's safety for human use. Raw materials, downstream processing, and cell culture processes are all impacted by viral infections. This would contribute to the development of viral safety practices and the implementation of the virus clearance process.

According to BioSpace, in 2018, 386 drugs were registered for clinical development, observing a significant growth from 2008, when the number of drugs was only 178. The increase in the number of drugs in the development process has increased viral clearing services' demand.

Market Dynamics:

Driver:

Increasing prevalence of chronic diseases

Some of the factors propelling the growth of the viral inactivation market include the rising prevalence of chronic viral infections and diseases and the rising demand for effective treatment methods. Additionally, the market is expected to grow as a result of rising investment in the life sciences industry, the introduction of more new drugs, and increased R&D innovation.

Restraint:

High costs incurred by cutting-edge technologies

The market expansion is being hampered by high development costs for goods and technology. Additionally, the lengthy drug development process and some issues related to virus clearance, such as protein crosslinking, protein denaturation, and protein degradation, are restricting the market's expansion.

Opportunity:

Increasing viral safety regulations

The evaluation of viral safety is an important step in ensuring the safety of products. Regulatory agencies place a lot of emphasis on viral safety and demand high-caliber data to support it, particularly for IND and BLA approvals. For effective strategic planning, it is crucial to be knowledgeable about the regulatory requirements, the process, and the key areas of the process. These viral safety regulations during the development of pharmaceutical products have increased the demand for services to conduct studies more successfully.

Threat:

Scarcity of qualified specialists

Virus removal service providers face challenges in attracting and retaining highly skilled professionals as they compete for qualified and experienced scientists with pharmaceutical companies, biotechnology companies, medical device companies, and research and academic institutions. Companies have to offer higher compensation and other incentives to compete, which affects the finances and performance of players, especially smaller analytics test providers. This scarcity of skilled professionals may hinder the adoption of new technologies and processes, limiting the growth of the market in the coming years.

COVID-19 Impact:

The market was negatively impacted by the COVID-19 pandemic. The market was challenged by a lack of workers and staff, a risk of infection spread, and a slowdown in manufacturing in the biopharmaceutical and biotech sectors. However, the market witnessed a sharp acceleration in growth in 2021. This growth was attributed to an increase in clinical trials. To develop vaccines and medications against the SARS-CoV-2 virus, many pharmaceutical and biopharmaceutical companies increased their R&D and manufacturing processes. Additionally, following the COVID-19 outbreak, there have been numerous new global partnerships and collaborations with pharmaceutical companies and academic institutions for the development of COVID-19 vaccines.

The recombinant proteins segment is expected to be the largest during the forecast period:

During the forecast period, the recombinant proteins segment is anticipated to hold the largest market share. One of the main factors influencing the segment's growth is the rising demand for biopharmaceuticals for managing inflammatory diseases like psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases. The production and development of biotherapeutics have been completely transformed by the introduction of recombinant proteins. As numerous biologics and vaccines made of recombinant proteins are currently in the pipeline and are anticipated to receive FDA approval, it is anticipated that the number of recombinant drugs will increase. The market is therefore anticipated to grow in light of all the aforementioned factors.

The contract research organizations segment is expected to have the highest CAGR during the forecast period:

Due to growing investments by major market players in various research organizations to improve their products, the contract research organizations segment is anticipated to experience strong market growth in the upcoming years. The ability of contract research organizations to make significant investments in drug discovery infrastructure and an increase in the outsourcing of drug discovery services to CROs by organizations like start-ups, academic institutions, pharmaceutical companies, and small biotechnology companies are the main factors behind their extraordinary growth in the global viral clearance market.

Region with largest share:

Throughout the forecast period, North America is anticipated to dominate the viral clearance market. The presence of important players and their use of cutting-edge medical technologies to advance are primarily responsible for the largest share. The primary driver of market expansion is the rise in the production of recombinant proteins and vaccines, as well as the requirement to keep them virus- and risk-free. Additionally, the population is becoming more aware of the benefits of using biopharmaceuticals, which is driving up demand for services related to viral clearance. Furthermore, the market is expanding as a result of increased funding for pharmaceuticals across the United States.

Region with highest CAGR:

Due to rising government investments in medical research and rising healthcare costs, Asia Pacific is expected to grow significantly during the forecast period, which will increase the risk of cell culture contamination and the presence of CROs in nations like China, Japan, and India. According to statistics from the WHO, more than 15 million people between the ages of 35 and 69 die from chronic diseases, and both developed and developing nations account for 85% of premature deaths. Additionally, a large number of clinical research services, particularly in China, are anticipated to fuel market expansion in the upcoming years.

Key players in the market

Some of the key players profiled in the Viral Clearance Market include Avance Biosciences Inc., BioReliance Corporation, Bioscience Laboratories, BSL Bioservice Scientific Laboratories GmbH, Charles River Laboratories, Inc., Clean Cells Inc., Cytovance Biologics Inc., Eurofins Scientific, F. Hoffmann-La Roche Ltd., GE Healthcare Life Sciences, Kedrion Biopharma Inc., Labor Dr. Merk & Kollegen GmbH, Lonza Group AG, Merck KGaA, Nelson Laboratories LLC, Novartis AG, Sartorius AG, Sigma-Aldrich Corporation, Syngene International Limited, Texcell, Inc., Vironova AB, ViruSure GmbH and WuXi AppTec.

Key Developments:

In September 2022, Merck opened a viral clearance (VC) laboratory as part of the first building phase of its new EUR 29 million China Biologics Testing Center.

In April 2022, Abzena, a partner research organization (PRO), announced the opening of a biologics testing laboratory situated near the company's biologics process development and manufacturing hub in San Diego, California. The facility will give partners access to cell-based and PCR safety assays; and viral clearance studies to support their IND, IMPD, BLA, and MAA applications.

In April 2022, WuXi Biologics awarded the bioprocessing excellence in viral clearance and safety accolade for the second time at the Asia Pacific Bioprocessing Excellence Awards (ABEA) event.

Methods Covered:

Viral Removal
Viral Inactivation
Viral Detection Method

Application Covered:

Recombinant Proteins
Blood and Blood Products
Cellular and Gene Therapy Products
Vaccines
Other Applications

End Users Covered:

Pharmaceutical and Biotechnology Companies
Academic Research Institutes
Contract Research Organizations
Other End Users

Regions Covered:

North America
- US
- Canada
- Mexico
Europe
- Germany
- UK
- Italy
- France
- Spain
- Rest of Europe
Asia Pacific
- Japan
- China
- India
- Australia
- New Zealand
- South Korea
- Rest of Asia Pacific
South America
- Argentina
- Brazil
- Chile
- Rest of South America
Middle East & Africa
- Saudi Arabia
- UAE
- Qatar
- South Africa
- Rest of Middle East & Africa

What our report offers:

Market share assessments for the regional and country-level segments
Strategic recommendations for the new entrants
Covers Market data for the years 2021, 2022, 2023, 2026 and 2030
Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
Strategic recommendations in key business segments based on the market estimations
Competitive landscaping mapping the key common trends
Company profiling with detailed strategies, financials, and recent developments
Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

Company Profiling
- Comprehensive profiling of additional market players (up to 3)
- SWOT Analysis of key players (up to 3)
Regional Segmentation
- Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
Competitive Benchmarking
- Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

1 Executive Summary

2 Preface

2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
- 2.4.1 Data Mining
- 2.4.2 Data Analysis
- 2.4.3 Data Validation
- 2.4.4 Research Approach
2.5 Research Sources
- 2.5.1 Primary Research Sources
- 2.5.2 Secondary Research Sources
- 2.5.3 Assumptions

3 Market Trend Analysis

3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Application Analysis
3.7 End User Analysis
3.8 Emerging Markets
3.9 Impact of Covid-19

4 Porters Five Force Analysis

4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry

5 Global Viral Clearance Market, By Method

5.1 Introduction
5.2 Viral Removal
- 5.2.1 Chromatography
- 5.2.2 Nanofiltration
- 5.2.3 Precipitation
5.3 Viral Inactivation
- 5.3.1 Low pH
- 5.3.2 Solvent Detergent Method
- 5.3.3 Heat Pasteurization
- 5.3.4 Other Viral Inactivation Methods
5.4 Viral Detection Method

6 Global Viral Clearance Market, By Application

6.1 Introduction
6.2 Recombinant Proteins
6.3 Blood and Blood Products
6.4 Cellular and Gene Therapy Products
6.5 Vaccines
6.6 Other Applications

7 Global Viral Clearance Market, By End User

7.1 Introduction
7.2 Pharmaceutical and Biotechnology Companies
7.3 Academic Research Institutes
7.4 Contract Research Organizations
7.5 Other End Users

8 Global Viral Clearance Market, By Geography

8.1 Introduction
8.2 North America
- 8.2.1 US
- 8.2.2 Canada
- 8.2.3 Mexico
8.3 Europe
- 8.3.1 Germany
- 8.3.2 UK
- 8.3.3 Italy
- 8.3.4 France
- 8.3.5 Spain
- 8.3.6 Rest of Europe
8.4 Asia Pacific
- 8.4.1 Japan
- 8.4.2 China
- 8.4.3 India
- 8.4.4 Australia
- 8.4.5 New Zealand
- 8.4.6 South Korea
- 8.4.7 Rest of Asia Pacific
8.5 South America
- 8.5.1 Argentina
- 8.5.2 Brazil
- 8.5.3 Chile
- 8.5.4 Rest of South America
8.6 Middle East & Africa
- 8.6.1 Saudi Arabia
- 8.6.2 UAE
- 8.6.3 Qatar
- 8.6.4 South Africa
- 8.6.5 Rest of Middle East & Africa

9 Key Developments

9.1 Agreements, Partnerships, Collaborations and Joint Ventures
9.2 Acquisitions & Mergers
9.3 New Product Launch
9.4 Expansions
9.5 Other Key Strategies

10 Company Profiling

10.1 Avance Biosciences Inc.
10.2 BioReliance Corporation
10.3 Bioscience Laboratories
10.4 BSL Bioservice Scientific Laboratories GmbH
10.5 Charles River Laboratories, Inc.
10.6 Clean Cells Inc.
10.7 Cytovance Biologics Inc.
10.8 Eurofins Scientific
10.9 F. Hoffmann-La Roche Ltd.
10.10 GE Healthcare Life Sciences
10.11 Kedrion Biopharma Inc.
10.12 Labor Dr. Merk & Kollegen GmbH
10.13 Lonza Group AG
10.14 Merck KGaA
10.15 Nelson Laboratories LLC
10.16 Novartis AG
10.17 Sartorius AG
10.18 Sigma-Aldrich Corporation
10.19 Syngene International Limited
10.20 Texcell, Inc.
10.21 Vironova AB
10.22 ViruSure GmbH
10.23 WuXi AppTec