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1540816

コンパニオン診断市場レポート：製品・サービス、技術、適応症、エンドユーザー、地域別、2024～2032年

Companion Diagnostics Market Report by Product & Service, Technology (Immunohistochemistry, Polymerase Chain Reaction, In-situ Hybridization, Real-time PCR, Gene Sequencing, and Others), Indication, End User, and Region 2024-2032
出版日: | 発行: IMARC | ページ情報: 英文 137 Pages | 納期: 2～3営業日

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価格
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本日の銀行送金レート: 1USD=152.86円
コンパニオン診断市場レポート：製品・サービス、技術、適応症、エンドユーザー、地域別、2024～2032年
出版日: 2024年08月10日
発行: IMARC
ページ情報: 英文 137 Pages
納期: 2～3営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界のコンパニオン診断市場規模は2023年に67億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに204億米ドルに達し、2024～2032年の間に12.7％の成長率（CAGR）を示すと予測しています。がん罹患率の上昇、個別化医療に対する需要の増加、次世代シーケンシング（NGS）を含む継続的な技術進歩は、コンパニオン診断市場の成長を促進する主要要因の一部です。

世界のコンパニオン診断市場分析：

主要市場促進要因：より的を絞った効果的ながん治療に対するニーズの高まりが、コンパニオン診断市場展望にプラスの影響を与えています。さらに、患者の特性に合わせた個別化医薬品の利用が増加していることも、コンパニオン診断市場の需要を刺激しています。

主要市場動向：コンパニオン診断市場の価値を押し上げている新たな動向の一つは、様々な神経疾患、心血管系疾患、炎症性疾患を治療するための標的療法や薬剤に対する需要の高まりです。このほか、次世代シーケンサー（NGS）の開発など、診断技術の継続的な進歩がコンパニオン診断市場の収益を刺激する成長要因となっています。

地理的動向：コンパニオン診断市場の調査によると、現在北米が世界市場を独占しています。米国食品医薬品局（米国FDA）をはじめとする当局から認可を受ける試験の数が増加していることが、同地域の市場を拡大しています。さらに、臨床試験にも注力しているため、北米のコンパニオン診断市場収益が刺激されています。

競合情勢：コンパニオン診断市場概要によると、世界市場で著名な企業には、Abbott Laboratories、Agilent Technologies、BioMerieux、Danaher Corporation、Roche Holding AG、Myriad Genetics Inc.、Siemens Healthcare、Thermo Fisher Scientific Inc.などがあります。

課題と機会：コンパニオン診断市場の予測を妨げている主要課題の1つは、臨床試験中の薬剤の減少率が大きいことであり、その結果、診断プロバイダーは財政的な制約を受けることになります。しかし、治療とコンパニオン診断を共同開発することで、医薬品候補の商業化が効率化されつつあります。

世界のコンパニオン診断市場動向：

標的治療に対するニーズの高まり

肺がんにおける標的治療に関する治療の意思決定においてコンパニオン診断（CDX）の採用が増加しており、市場の成長を後押ししています。その他の特典として、初回治療の一環としてコンパニオン診断試験を受けた患者は、試験を受けなかった患者よりも生存期間が延長します。これに加えて、非小細胞肺がん（NSCLC）の有病率の増加が、この疾患に対する腫瘍学コンパニオン診断の使用率を押し上げています。Lung Cancer Research Foundationによると、2022年には米国全体で推定23万6,740人が肺がんと診断され、肺がんのコンパニオン診断の需要に拍車をかけています。また、当局から承認を受ける試験の数が増加していることも市場を強化しています。例えば、2022年8月、米FDAは、非小細胞肺がん（NSCLC）において腫瘍がHER2（ERBB2）活性化変異（SNVs &Exon 20 Insertion）を有する個人を同定するコンパニオン診断（CDx）として、Thermo Fisher ScientificのOncomine Dx Target Testを市販前承認しました。

コンパニオン診断に対する有利な規制状況

各国の政府機関や主要企業は、満たされていないがん治療のニーズに応えるため、医薬品の承認に注力しています。例えば、2022年1月、PREMIA Holdings（HK）LimitedとAmoy Diagnostics Co.Ltd.がAmoyDx Pan Lung Cancer PCR Panel（PLC Panel）を開発しました。同様に、2021年10月には米国食品医薬品局がアジレントのKi-67 IHC MIB-1 pharmDx（Dako Omnis）を承認し、再発リスクの高い早期乳がん（EBC）患者の同定に役立った。さらに、2023年8月には、Agilent Technologiesがコンパニオン診断アッセイの欧州IVDR認証を取得しました。これらの承認は、主要企業によるコンパニオン診断試験の強化を促し、予測期間中の世界市場の拡大が期待されます。

新規試験の開発

主要企業は、他の有力企業との提携により、コンパニオン診断のための先進的な試験の上市に注力しており、その結果、患者の転帰がより良いものとなっています。例えば、2022年2月、早期がんスクリーニング製品、分子プロファイリング試験、コンパニオン診断開発を専門とする中国の大手精密腫瘍学プラットフォーム企業であるGenetron Holdings Limitedは、HUTCHMED（中国）Limitedとコンパニオン診断（CDx）を導入する契約を締結しました。さらに、新興国市場の主要企業も治療オプションの開発を進めています。例えば、2021年7月、LabcorpはTherascreen KRAS PCR Mutation Analysisを発売しました。これは、ルマクラス（ソトラシブ）による治療の対象となる非小細胞肺がん（NSCLC）患者を特定するコンパニオン診断です。

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要業界動向

第5章 世界のコンパニオン診断市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：製品・サービス別

  • アッセイ、キット、試薬
  • ソフトウェアとサービス

第7章 市場内訳：技術別

  • 免疫組織化学（IHC）
  • ポリメラーゼ連鎖反応（PCR）
  • in situーハイブリダイゼーション（ISH）
  • リアルタイムPCR（RT-PCR）
  • 遺伝子配列解析
  • その他

第8章 市場内訳：適応症別

  • がん
    • 市場動向
    • 主要タイプ
      • 肺がん
      • 乳がん
      • 大腸がん
      • 胃がん
      • 悪性黒色腫
      • その他
    • 市場予測
  • 神経疾患
  • 感染症
  • 心血管疾患
  • その他

第9章 市場内訳：エンドユーザー別

  • 製薬・バイオ医薬品企業
  • リファレンスラボ
  • 契約研究機関
  • その他

第10章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ
    • 市場動向
    • 市場内訳：国別
    • 市場予測

第11章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第12章 バリューチェーン分析

第13章 ポーターのファイブフォース分析

  • 概要
  • 買い手の交渉力
  • 供給企業の交渉力
  • 競合の程度
  • 新規参入業者の脅威
  • 代替品の脅威

第14章 価格分析

第15章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Abbott Laboratories
    • Agilent Technologies
    • BioMerieux
    • Danaher Corporation
    • Roche Holding AG
    • Myriad Genetics Inc.
    • Siemens Healthcare
    • Thermo Fisher Scientific Inc.
図表

List of Figures

  • Figure 1: Global: Companion Diagnostics Market: Major Drivers and Challenges
  • Figure 2: Global: Companion Diagnostics Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Companion Diagnostics Market: Breakup by Product & Service (in %), 2023
  • Figure 4: Global: Companion Diagnostics Market: Breakup by Technology (in %), 2023
  • Figure 5: Global: Companion Diagnostics Market: Breakup by Indication (in %), 2023
  • Figure 6: Global: Companion Diagnostics Market: Breakup by End User (in %), 2023
  • Figure 7: Global: Companion Diagnostics Market: Breakup by Region (in %), 2023
  • Figure 8: Global: Companion Diagnostics Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 9: Global: Companion Diagnostics (Assays, Kits and Reagents) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 10: Global: Companion Diagnostics (Assays, Kits and Reagents) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 11: Global: Companion Diagnostics (Software and Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 12: Global: Companion Diagnostics (Software and Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 13: Global: Companion Diagnostics (Immunohistochemistry) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 14: Global: Companion Diagnostics (Immunohistochemistry) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 15: Global: Companion Diagnostics (Polymerase Chain Reaction) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 16: Global: Companion Diagnostics (Polymerase Chain Reaction) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 17: Global: Companion Diagnostics (In-situ Hybridization) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 18: Global: Companion Diagnostics (In-situ Hybridization) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 19: Global: Companion Diagnostics (Real-time PCR) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 20: Global: Companion Diagnostics (Real-time PCR) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 21: Global: Companion Diagnostics (Gene Sequencing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 22: Global: Companion Diagnostics (Gene Sequencing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 23: Global: Companion Diagnostics (Other Technologies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 24: Global: Companion Diagnostics (Other Technologies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 25: Global: Companion Diagnostics (Cancer) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 26: Global: Companion Diagnostics (Cancer) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 27: Global: Companion Diagnostics (Neurological Diseases) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 28: Global: Companion Diagnostics (Neurological Diseases) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 29: Global: Companion Diagnostics (Infectious Diseases) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 30: Global: Companion Diagnostics (Infectious Diseases) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 31: Global: Companion Diagnostics (Cardiovascular Diseases) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 32: Global: Companion Diagnostics (Cardiovascular Diseases) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: Global: Companion Diagnostics (Other Indications) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 34: Global: Companion Diagnostics (Other Indications) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Global: Companion Diagnostics (Pharmaceutical & Biopharmaceutical Companies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 36: Global: Companion Diagnostics (Pharmaceutical & Biopharmaceutical Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 37: Global: Companion Diagnostics (Reference Laboratories) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 38: Global: Companion Diagnostics (Reference Laboratories) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 39: Global: Companion Diagnostics (Contract Research Organizations) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 40: Global: Companion Diagnostics (Contract Research Organizations) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 41: Global: Companion Diagnostics (Other End Users) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 42: Global: Companion Diagnostics (Other End Users) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 43: North America: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 44: North America: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 45: United States: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 46: United States: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 47: Canada: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 48: Canada: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 49: Asia Pacific: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Asia Pacific: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 51: China: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 52: China: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 53: Japan: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 54: Japan: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 55: India: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 56: India: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 57: South Korea: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 58: South Korea: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 59: Australia: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 60: Australia: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 61: Indonesia: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 62: Indonesia: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 63: Others: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 64: Others: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 65: Europe: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 66: Europe: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 67: Germany: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 68: Germany: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 69: France: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 70: France: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 71: United Kingdom: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 72: United Kingdom: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 73: Italy: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 74: Italy: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 75: Spain: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 76: Spain: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 77: Russia: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 78: Russia: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 79: Others: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 80: Others: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 81: Latin America: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 82: Latin America: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 83: Brazil: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 84: Brazil: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 85: Mexico: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 86: Mexico: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 87: Others: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 88: Others: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 89: Middle East and Africa: Companion Diagnostics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 90: Middle East and Africa: Companion Diagnostics Market: Breakup by Country (in %), 2023
  • Figure 91: Middle East and Africa: Companion Diagnostics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 92: Global: Companion Diagnostics Industry: SWOT Analysis
  • Figure 93: Global: Companion Diagnostics Industry: Value Chain Analysis
  • Figure 94: Global: Companion Diagnostics Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Companion Diagnostics Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Companion Diagnostics Market Forecast: Breakup by Product & Service (in Million US$), 2024-2032
  • Table 3: Global: Companion Diagnostics Market Forecast: Breakup by Technology (in Million US$), 2024-2032
  • Table 4: Global: Companion Diagnostics Market Forecast: Breakup by Indication (in Million US$), 2024-2032
  • Table 5: Global: Companion Diagnostics Market Forecast: Breakup by End User (in Million US$), 2024-2032
  • Table 6: Global: Companion Diagnostics Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 7: Global: Companion Diagnostics Market Structure
  • Table 8: Global: Companion Diagnostics Market: Key Players
目次
Product Code: SR112024A2548

The global companion diagnostics market size reached US$ 6.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 20.4 Billion by 2032, exhibiting a growth rate (CAGR) of 12.7% during 2024-2032. The rising incidences of cancer, the increasing demand for personalized medicine, and continuous technological advancements, including next-generation sequencing (NGS), are some of the primary factors driving the companion diagnostics market growth.

Global Companion Diagnostics Market Analysis:

Major Market Drivers: The growing need for more targeted and effective cancer treatments is positively influencing the companion diagnostics market outlook. Additionally, the increasing usage of personalized medicines tailored to each unique characteristics of patients is also stimulating the companion diagnostics market demand.

Key Market Trends: One of the emerging trends propelling the companion diagnostics market value is the inflating demand for targeted therapies and drugs to treat various neurological, cardiovascular, and inflammatory conditions. Besides this, continuous advancements in diagnostic technologies, such as the development of next-generation sequencing (NGS), represent growth factors stimulating the companion diagnostics market revenue.

Geographical Trends: According to the companion diagnostics market research, North America currently dominates the global market. The increasing number of tests receiving approval from governing authorities, including the United States Food and Drug Administration (US FDA), is augmenting the regional market. Furthermore, they are also focusing on clinical trials, thereby stimulating the companion diagnostics market revenue in North America.

Competitive Landscape: According to the companion diagnostics market overview, some of the prominent companies in the global market include Abbott Laboratories, Agilent Technologies, BioMerieux, Danaher Corporation, Roche Holding AG, Myriad Genetics Inc., Siemens Healthcare, and Thermo Fisher Scientific Inc., among many others.

Challenges and Opportunities: One of the primary challenges hindering the companion diagnostics market forecast is the extensive drug attrition rate during clinical trials, which, in turn, poses financial constraints for diagnostics providers. However, the co-development of companion diagnostics, along with therapeutic products, is streamlining the commercialization of drug candidates.

Global Companion Diagnostics Market Trends:

Rising Need for Targeted Therapies

The increasing adoption of companion diagnostic tests (CDXs) in decision-making for treatment related to targeted therapies in lung cancer is augmenting the market growth. Additionally, patients who receive companion diagnostics as part of their initial treatment have more survival benefits than those who are not tested. Besides this, the increasing prevalence of non-small cell lung cancer (NSCLC) is inflating the usage of oncology companion diagnostic tests for the disease. According to the Lung Cancer Research Foundation, an estimated 236,740 individuals were diagnosed with lung cancer in 2022 across the United States, thereby fueling the demand for lung cancer companion diagnostics. The elevating number of tests receiving approval from governing authorities is also bolstering the market. For example, in August 2022, the U.S. FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify individuals whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC).

Favorable Regulatory Landscape for Companion Diagnostics

Government bodies and key companies across the countries are focusing on drug approvals to cater to unmet cancer care needs. For instance, in January 2022, PREMIA Holdings (HK) Limited and Amoy Diagnostics Co. Ltd developed the AmoyDx Pan Lung Cancer PCR Panel (the 'PLC Panel') in Japan as a reimbursed companion diagnostic for numerous anti-cancer agents. Similarly, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which helped in identifying patients with early breast cancer (EBC) at an elevating risk of disease recurrence. In addition, in August 2023, Agilent Technologies, Inc. received European IVDR certification for companion diagnostic assay. These approvals encourage key players to develop enhanced companion diagnostic tests, which are expected to augment the global market over the forecasted period.

Development of Novel Tests

Key players are focusing on launching advanced tests for companion diagnostics by collaborating with other prominent players, thereby resulting in better patient outcomes. For instance, in February 2022, Genetron Holdings Limited, a major precision oncology platform company in China specializing in early cancer screening products, molecular profiling tests, and companion diagnostics development, entered into an agreement with HUTCHMED (China) Limited to introduce a companion diagnostic (CDx). Furthermore, key market players are also developing enhanced therapeutic options. For example, in July 2021, Labcorp launched Therascreen KRAS PCR Mutation Analysis, which is a companion diagnostic to identify patients suffering from non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib).

Companion Diagnostics Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on product & service, technology, indication, and end user.

Breakup by Product & Service:

Assays, Kits and Reagents

Software and Services

Assays, kits and reagents hold the largest market share

The report has provided a detailed breakup and analysis of the companion diagnostics market based on the product & service. This includes assays, kits and reagents, and software and services. According to the report, assays, kits, and reagents represented the largest segment.

Assays, kits, and reagents play important roles in identifying patients who are most likely to benefit from a particular therapeutic product. These diagnostic tools aid in determining the absence or presence of specific biomarkers, protein expressions, genetic mutations, etc., linked to the potential side effects and effectiveness of targeted therapies. This, in turn, is propelling the market growth in this segment.

Breakup by Technology:

Immunohistochemistry (IHC)

Polymerase Chain Reaction (PCR)

In-situ Hybridization (ISH)

Real-time PCR (RT-PCR)

Gene Sequencing

Others

Polymerase chain reaction (PCR) exhibits a clear dominance in the market

The report has provided a detailed breakup and analysis of the market based on the technology. This includes immunohistochemistry (IHC), polymerase chain reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), gene sequencing, and others. According to the report, polymerase chain reaction (PCR) accounted for the largest market share.

The growth in this segmentation is bolstered by the easy availability of polymerase chain reaction (PCR) kits and reagents used for companion diagnostics. Moreover, their widespread applications in detecting gene mutations with low or limited allele frequencies are contributing to their dominance in the global market.

Breakup by Indication:

Cancer

Lung Cancer

Breast Cancer

Colorectal Cancer

Gastric Cancer

Melanoma

Others

Neurological Diseases

Infectious Diseases

Cardiovascular Diseases

Others

Cancer currently accounts for the majority of the total market share

The report has provided a detailed breakup and analysis of the market based on the indication. This includes cancer (lung cancer, breast cancer, colorectal cancer, gastric cancer, melanoma, and others), neurological diseases, infectious diseases, cardiovascular diseases, and others. According to the report, cancer represented the largest segment.

The widespread incidence of cancer is propelling the usage of companion diagnostics, thereby fueling the market growth in this segmentation. According to the American Cancer Society, in January 2022, 1.9 million cancer cases were recorded in the U.S. Consequently, continuous product launches and approvals by government bodies are positively influencing the companion diagnostics market growth in this segmentation. For example, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which assisted in identifying patients with early breast cancer (EBC). Besides this, according to the Lung Cancer Research Foundation, in the United States estimated 236,740 individuals were diagnosed with lung cancer in 2022, thereby propelling the need for lung cancer companion diagnostics.

Breakup by End User:

Pharmaceutical & Biopharmaceutical Companies

Reference Laboratories

Contract Research Organizations

Others

Pharmaceutical & biopharmaceutical companies hold the largest market share

The report has provided a detailed breakup and analysis of the market based on the end user. This includes pharmaceutical & biopharmaceutical companies, reference laboratories, contract research organizations, and others. According to the report, pharmaceutical & biopharmaceutical companies accounted for the largest market share.

The rising adoption of companion diagnostics by pharmaceutical & biopharmaceutical companies in drug development is one of the primary factors propelling the market growth in this segmentation. Moreover, the inflating popularity of companion diagnostics biomarkers is also acting as another significant growth-inducing factor.

Breakup by Region:

North America

United States

Canada

Asia Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

North America leads the market, accounting for the largest companion diagnostics market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America currently dominates the global market, with the United States emerging as a major contributor. Strategic collaborations among biopharmaceutical companies and companion diagnostic manufacturers are primarily augmenting the regional market. For example, QIAGEN and Denovo Biopharma partnered to develop a companion diagnostic test for the treatment of diffuse large B-Cell Lymphoma (DLBCL). Furthermore, the increasing drug approvals by governing authorities, such as the United States Food and Drug Administration (US FDA), are projected to bolster the companion diagnostics market in North America over the forecasted period.

Leading Key Players in the Companion Diagnostics Industry:

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Abbott Laboratories

Agilent Technologies

BioMerieux

Danaher Corporation

Roche Holding AG

Myriad Genetics Inc.

Siemens Healthcare

Thermo Fisher Scientific Inc.

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Global Companion Diagnostics Market News:

March 2024: Thermo Fisher Scientific announced a collaboration with Bayer AG BAYRY to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx).

February 2024: Roche has partnered with PathAI to leverage artificial intelligence (AI) to introduce algorithms for companion diagnostics.

December 2023: A German electronics firm, Siemens, contracted to commercialize and develop companion diagnostics by Pfizer.

Key Questions Answered in This Report

  • 1. What was the size of the global companion diagnostics market in 2023?
  • 2. What is the expected growth rate of the global companion diagnostics market during 2024-2032?
  • 3. What has been the impact of COVID-19 on the global companion diagnostics market?
  • 4. What are the key factors driving the global companion diagnostics market?
  • 5. What is the breakup of the global companion diagnostics market based on the product & service?
  • 6. What is the breakup of the global companion diagnostics market based on the technology?
  • 7. What is the breakup of the global companion diagnostics market based on the indication?
  • 8. What is the breakup of the global companion diagnostics market based on the end user?
  • 9. What are the key regions in the global companion diagnostics market?
  • 10. Who are the key players/companies in the global companion diagnostics market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Companion Diagnostics Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Product & Service

  • 6.1 Assays, Kits and Reagents
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Software and Services
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast

7 Market Breakup by Technology

  • 7.1 Immunohistochemistry (IHC)
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Polymerase Chain Reaction (PCR)
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 In-situ Hybridization (ISH)
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Real-time PCR (RT-PCR)
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast
  • 7.5 Gene Sequencing
    • 7.5.1 Market Trends
    • 7.5.2 Market Forecast
  • 7.6 Others
    • 7.6.1 Market Trends
    • 7.6.2 Market Forecast

8 Market Breakup by Indication

  • 8.1 Cancer
    • 8.1.1 Market Trends
    • 8.1.2 Major Types
      • 8.1.2.1 Lung Cancer
      • 8.1.2.2 Breast Cancer
      • 8.1.2.3 Colorectal Cancer
      • 8.1.2.4 Gastric Cancer
      • 8.1.2.5 Melanoma
      • 8.1.2.6 Others
    • 8.1.3 Market Forecast
  • 8.2 Neurological Diseases
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Infectious Diseases
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Cardiovascular Diseases
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Others
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast

9 Market Breakup by End User

  • 9.1 Pharmaceutical & Biopharmaceutical Companies
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Reference Laboratories
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Contract Research Organizations
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast
  • 9.4 Others
    • 9.4.1 Market Trends
    • 9.4.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
      • 10.1.1.1 Market Trends
      • 10.1.1.2 Market Forecast
    • 10.1.2 Canada
      • 10.1.2.1 Market Trends
      • 10.1.2.2 Market Forecast
  • 10.2 Asia Pacific
    • 10.2.1 China
      • 10.2.1.1 Market Trends
      • 10.2.1.2 Market Forecast
    • 10.2.2 Japan
      • 10.2.2.1 Market Trends
      • 10.2.2.2 Market Forecast
    • 10.2.3 India
      • 10.2.3.1 Market Trends
      • 10.2.3.2 Market Forecast
    • 10.2.4 South Korea
      • 10.2.4.1 Market Trends
      • 10.2.4.2 Market Forecast
    • 10.2.5 Australia
      • 10.2.5.1 Market Trends
      • 10.2.5.2 Market Forecast
    • 10.2.6 Indonesia
      • 10.2.6.1 Market Trends
      • 10.2.6.2 Market Forecast
    • 10.2.7 Others
      • 10.2.7.1 Market Trends
      • 10.2.7.2 Market Forecast
  • 10.3 Europe
    • 10.3.1 Germany
      • 10.3.1.1 Market Trends
      • 10.3.1.2 Market Forecast
    • 10.3.2 France
      • 10.3.2.1 Market Trends
      • 10.3.2.2 Market Forecast
    • 10.3.3 United Kingdom
      • 10.3.3.1 Market Trends
      • 10.3.3.2 Market Forecast
    • 10.3.4 Italy
      • 10.3.4.1 Market Trends
      • 10.3.4.2 Market Forecast
    • 10.3.5 Spain
      • 10.3.5.1 Market Trends
      • 10.3.5.2 Market Forecast
    • 10.3.6 Russia
      • 10.3.6.1 Market Trends
      • 10.3.6.2 Market Forecast
    • 10.3.7 Others
      • 10.3.7.1 Market Trends
      • 10.3.7.2 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Brazil
      • 10.4.1.1 Market Trends
      • 10.4.1.2 Market Forecast
    • 10.4.2 Mexico
      • 10.4.2.1 Market Trends
      • 10.4.2.2 Market Forecast
    • 10.4.3 Others
      • 10.4.3.1 Market Trends
      • 10.4.3.2 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Trends
    • 10.5.2 Market Breakup by Country
    • 10.5.3 Market Forecast

11 SWOT Analysis

  • 11.1 Overview
  • 11.2 Strengths
  • 11.3 Weaknesses
  • 11.4 Opportunities
  • 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

  • 13.1 Overview
  • 13.2 Bargaining Power of Buyers
  • 13.3 Bargaining Power of Suppliers
  • 13.4 Degree of Competition
  • 13.5 Threat of New Entrants
  • 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

  • 15.1 Market Structure
  • 15.2 Key Players
  • 15.3 Profiles of Key Players
    • 15.3.1 Abbott Laboratories
      • 15.3.1.1 Company Overview
      • 15.3.1.2 Product Portfolio
      • 15.3.1.3 Financials
      • 15.3.1.4 SWOT Analysis
    • 15.3.2 Agilent Technologies
      • 15.3.2.1 Company Overview
      • 15.3.2.2 Product Portfolio
      • 15.3.2.3 Financials
      • 15.3.2.4 SWOT Analysis
    • 15.3.3 BioMerieux
      • 15.3.3.1 Company Overview
      • 15.3.3.2 Product Portfolio
      • 15.3.3.3 Financials
      • 15.3.3.4 SWOT Analysis
    • 15.3.4 Danaher Corporation
      • 15.3.4.1 Company Overview
      • 15.3.4.2 Product Portfolio
      • 15.3.4.3 Financials
      • 15.3.4.4 SWOT Analysis
    • 15.3.5 Roche Holding AG
      • 15.3.5.1 Company Overview
      • 15.3.5.2 Product Portfolio
      • 15.3.5.3 SWOT Analysis
    • 15.3.6 Myriad Genetics Inc.
      • 15.3.6.1 Company Overview
      • 15.3.6.2 Product Portfolio
      • 15.3.6.3 Financials
      • 15.3.6.4 SWOT Analysis
    • 15.3.7 Siemens Healthcare
      • 15.3.7.1 Company Overview
      • 15.3.7.2 Product Portfolio
      • 15.3.7.3 Financials
      • 15.3.7.4 SWOT Analysis
    • 15.3.8 Thermo Fisher Scientific Inc.
      • 15.3.8.1 Company Overview
      • 15.3.8.2 Product Portfolio
      • 15.3.8.3 Financials
      • 15.3.8.4 SWOT Analysis