市場調査レポート

商品コード

1800780

コンパニオン診断薬市場レポート：製品・サービス、技術、適応症、エンドユーザー、地域別、2025～2033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 2025-2033

出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 120 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

世界のコンパニオン診断薬市場規模は2024年に76億米ドルに達しました。今後、IMARC Groupは、同市場が2033年までに223億米ドルに達し、2025年から2033年にかけて12.11%の成長率（CAGR）を示すと予測しています。北米が市場をリードしているのは、先進的なヘルスケアインフラ、個別化医療の高い普及率、強力な規制当局の支援によるものです。同地域はまた、研究事業への多額の投資とバイオテクノロジーおよび製薬企業の増加からも恩恵を受けています。がん罹患率の上昇、個別化医療に対する需要の高まり、次世代シーケンシング（NGS）を含む継続的な技術進歩は、市場成長を促進する主な要因の一部です。

患者の遺伝子プロファイルに応じて治療法をカスタマイズする個別化医療は、コンパニオン診断薬市場の需要を促進する重要な要因です。患者の明確な遺伝子プロファイルに特定の治療を適合させるためには、正確な診断ツールが必要であり、その結果、治療結果の改善や副作用の軽減のための治療選択を支援するコンパニオン診断薬のニーズが高まっています。これとは別に、診断技術、特に分子診断学と次世代シークエンシング（NGS）の向上は、コンパニオン診断薬の精度と信頼性を著しく高めています。これらの進歩により、遺伝子変異やバイオマーカーの検出精度が向上し、治療効果が高まり、医療環境におけるコンパニオン診断薬の必要性が高まっています。さらに、ヘルスケアへの投資は、診断テストを使用して治療を調整する精密医療にますます焦点が当てられています。より多くのヘルスケアシステムが標的治療と個別化治療レジメンを採用するにつれ、特に個別化治療が重要な腫瘍学において、コンパニオン診断薬に対する需要が高まっています。

世界のコンパニオン診断薬市場動向：

遺伝子治療と希少疾患診断の進歩

遺伝性疾患に対する遺伝子治療の普及に伴い、これらの治療の安全かつ効率的な使用を保証する診断ツールの需要が増加しています。コンパニオン診断薬は、特に治療効果が特定のバイオマーカーに大きく依存する希少遺伝子疾患において、どの患者が遺伝子治療の対象となるかを決定する上で重要な役割を果たしています。これらの診断法は、治療効果に影響を及ぼす可能性のある既存の抗体や遺伝的要素を特定するのに役立ち、患者が最も適した治療を受けられることを保証します。この重要な役割は、診断業界や製薬業界の主要企業が積極的に取り組んでおり、遺伝子治療の安全かつ効果的な投与を促進するための高度なコンパニオン診断アッセイの開発および規制当局の承認を得ています。2024年、ラボコープはファイザー社の血友病B治療用遺伝子治療薬BEQVEZ（TM）（fidanacogene elaparvovec-dzkt）のコンパニオン診断薬であるnAbCyte（TM）Anti-AAVRh74var HB-FE AssayのFDA承認を取得しました。この承認は、希少遺伝性疾患の遺伝子治療診断における画期的な出来事でした。

診断におけるAIの統合

AIを活用したツールは、遺伝子データや臨床データなどの広範なデータセットを調査し、比類ない精度でバイオマーカーを特定することで、診断検査のスピード、精度、効率を向上させる。AIアルゴリズムは、特定の治療に対する患者の反応を予測するのに役立ち、よりオーダーメイドの治療戦略を可能にします。腫瘍学や様々な複雑な疾患において、AIは臨床試験の患者選択プロセスを強化し、治療から恩恵を受ける可能性が最も高い患者のみが組み入れられることを保証します。この技術的進歩は、企業間の戦略的提携によってさらに強固なものとなり、AIを搭載したソリューションを統合して診断プロセスを洗練させ、臨床試験の進展を加速させる。2024年、アビオンとディープバイオは韓国のソウルで、AIを活用したコンパニオン診断薬とがん臨床試験で協力する覚書を締結しました。このパートナーシップは、ディープバイオのAIを搭載した病理学的ツールをアビオンの医薬品パイプラインに統合し、患者選択の精度を高め、臨床試験の効率を加速させるものです。これは、肺がん治療におけるABIONの進行中の併用試験をサポートしました。

ヘルスケア投資の増加

世界の医療制度が治療結果の向上と費用の削減を目指しているため、ヘルスケアへの投資は市場に影響を与える重要な要因となっています。政府、民間投資家、ヘルスケア機関は、コンパニオン診断薬の活用を直接的に伴う個別化医療や精密医療に注力しています。コンパニオン診断薬は、最も効果的な治療法をピンポイントで特定することで、従来の治療で頻繁に行われていた試行錯誤を最小限に抑え、医療資源の効率的な配分を実現します。さらに、診療報酬を治療量ではなく患者の結果にリンクさせるバリューベースのヘルスケアへの注目が高まっていることは、治療の精度を高めるというコンパニオン診断薬の機能と効果的に対応しています。コンパニオン診断薬が促進する標的治療のコスト効率は、世界のヘルスケアシステムへの組み込みをさらに強化します。ヘルスケアシステムに対する経済的圧力が高まる中、コンパニオン診断薬のような効率的で効果的な治療を強化するツールへの投資が、市場の成長を強化しています。

世界のコンパニオン診断薬市場成長促進要因：

高齢化人口の増加

高齢者人口の増加に伴い、がん、心臓病、神経疾患などの慢性疾患や加齢に関連する疾患の有病率が上昇しています。高齢者は、遺伝子プロファイルに合わせてカスタマイズされた最良の結果をもたらす、よりオーダーメイドの治療を頻繁に必要としています。世界保健機関（WHO）によれば、2030年までに世界の6人に1人が60歳以上になり、この数字は2050年までに21億人に達すると予想されています。この人口動態の変化により、診断サービスの増加・強化が必要となり、優れた診断機器や検査ソリューションに対する需要が高まっています。コンパニオン診断薬は、ヘルスケア専門家が特定の遺伝子プロファイルに従って治療をカスタマイズすることを可能にし、治療結果を向上させ、陰性反応の可能性を低下させる。このような個別化ヘルスケアの動きは、高齢化社会の複雑な要求に対応する上で極めて重要です。

戦略的パートナーシップとコラボレーション

診断薬企業と製薬企業とのパートナーシップや協力関係は、診断ツールと革新的な治療法の融合を促進し、適切な患者が最も効率的な治療を受けられることを保証します。医薬品開発と診断技術の知識を統合することで、これらのコラボレーションはコンパニオン診断薬の創出を促進し、規制当局の承認プロセスを簡素化し、個別化ヘルスケアの選択肢へのアクセスを改善します。精密医療への需要が高まる中、これらの提携は、標的治療の創出を促進する包括的なエンドツーエンドのソリューションを開発することで、市場の提供を拡大するために不可欠です。例えば、2024年、BD（ベクトン・ディッキンソン・アンド・カンパニー）とクエストダイアグノスティックスは、フローサイトメトリーをベースとしたがんやその他の疾患のコンパニオン診断薬を創出するための世界・パートナーシップを発表しました。このパートナーシップは、製薬業界向けに、探索的なパネル開発からFDA承認の診断キットまで、エンドツーエンドのソリューションを提供することを目的としています。その目的は、個別化ヘルスケアを推進し、臨床転帰を改善することでした。

診断薬承認のための規制経路の強化

診断薬承認のための規制プロセスの進歩と改善は、市場成長を促す重要な要因です。規制当局は、精密医療を促進するための重要な貢献を認め、コンパニオン診断薬の承認経路を簡素化しています。審査期間の短縮やコンパニオン診断薬検査の作成と承認のための明確な枠組みにより、規制状況はこの分野における技術革新をますます後押しするものとなっています。このような強化は、新規診断技術の進歩を促進するだけでなく、コンパニオン診断薬に投資する企業により明確な市場アクセスルートを提供します。さらに、規制当局が新規治療の有効性を保証する上でこれらの評価の重要性を認識するにつれ、コンパニオン診断薬企業が繁栄するチャンスが増えつつあります。

北米
- 米国
- カナダ
アジア太平洋地域
- 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

第11章 SWOT分析

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

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 USD), 2019-2024
Figure 3: Global: Companion Diagnostics Market: Breakup by Product & Service (in %), 2024
Figure 4: Global: Companion Diagnostics Market: Breakup by Technology (in %), 2024
Figure 5: Global: Companion Diagnostics Market: Breakup by Indication (in %), 2024
Figure 6: Global: Companion Diagnostics Market: Breakup by End User (in %), 2024
Figure 7: Global: Companion Diagnostics Market: Breakup by Region (in %), 2024
Figure 8: Global: Companion Diagnostics Market Forecast: Sales Value (in Billion USD), 2025-2033
Figure 9: Global: Companion Diagnostics (Assays, Kits and Reagents) Market: Sales Value (in Million USD), 2019 & 2024
Figure 10: Global: Companion Diagnostics (Assays, Kits and Reagents) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 11: Global: Companion Diagnostics (Software and Services) Market: Sales Value (in Million USD), 2019 & 2024
Figure 12: Global: Companion Diagnostics (Software and Services) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 13: Global: Companion Diagnostics (Immunohistochemistry) Market: Sales Value (in Million USD), 2019 & 2024
Figure 14: Global: Companion Diagnostics (Immunohistochemistry) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 15: Global: Companion Diagnostics (Polymerase Chain Reaction) Market: Sales Value (in Million USD), 2019 & 2024
Figure 16: Global: Companion Diagnostics (Polymerase Chain Reaction) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 17: Global: Companion Diagnostics (In-situ Hybridization) Market: Sales Value (in Million USD), 2019 & 2024
Figure 18: Global: Companion Diagnostics (In-situ Hybridization) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 19: Global: Companion Diagnostics (Real-time PCR) Market: Sales Value (in Million USD), 2019 & 2024
Figure 20: Global: Companion Diagnostics (Real-time PCR) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 21: Global: Companion Diagnostics (Gene Sequencing) Market: Sales Value (in Million USD), 2019 & 2024
Figure 22: Global: Companion Diagnostics (Gene Sequencing) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 23: Global: Companion Diagnostics (Other Technologies) Market: Sales Value (in Million USD), 2019 & 2024
Figure 24: Global: Companion Diagnostics (Other Technologies) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 25: Global: Companion Diagnostics (Cancer) Market: Sales Value (in Million USD), 2019 & 2024
Figure 26: Global: Companion Diagnostics (Cancer) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 27: Global: Companion Diagnostics (Neurological Diseases) Market: Sales Value (in Million USD), 2019 & 2024
Figure 28: Global: Companion Diagnostics (Neurological Diseases) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 29: Global: Companion Diagnostics (Infectious Diseases) Market: Sales Value (in Million USD), 2019 & 2024
Figure 30: Global: Companion Diagnostics (Infectious Diseases) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 31: Global: Companion Diagnostics (Cardiovascular Diseases) Market: Sales Value (in Million USD), 2019 & 2024
Figure 32: Global: Companion Diagnostics (Cardiovascular Diseases) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 33: Global: Companion Diagnostics (Other Indications) Market: Sales Value (in Million USD), 2019 & 2024
Figure 34: Global: Companion Diagnostics (Other Indications) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 35: Global: Companion Diagnostics (Pharmaceutical & Biopharmaceutical Companies) Market: Sales Value (in Million USD), 2019 & 2024
Figure 36: Global: Companion Diagnostics (Pharmaceutical & Biopharmaceutical Companies) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 37: Global: Companion Diagnostics (Reference Laboratories) Market: Sales Value (in Million USD), 2019 & 2024
Figure 38: Global: Companion Diagnostics (Reference Laboratories) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 39: Global: Companion Diagnostics (Contract Research Organizations) Market: Sales Value (in Million USD), 2019 & 2024
Figure 40: Global: Companion Diagnostics (Contract Research Organizations) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 41: Global: Companion Diagnostics (Other End Users) Market: Sales Value (in Million USD), 2019 & 2024
Figure 42: Global: Companion Diagnostics (Other End Users) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 43: North America: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 44: North America: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 45: United States: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 46: United States: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 47: Canada: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 48: Canada: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 49: Asia Pacific: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 50: Asia Pacific: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 51: China: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 52: China: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 53: Japan: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 54: Japan: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 55: India: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 56: India: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 57: South Korea: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 58: South Korea: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 59: Australia: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 60: Australia: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 61: Indonesia: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 62: Indonesia: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 63: Others: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 64: Others: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 65: Europe: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 66: Europe: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 67: Germany: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 68: Germany: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 69: France: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 70: France: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 71: United Kingdom: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 72: United Kingdom: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 73: Italy: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 74: Italy: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 75: Spain: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 76: Spain: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 77: Russia: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 78: Russia: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 79: Others: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 80: Others: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 81: Latin America: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 82: Latin America: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 83: Brazil: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 84: Brazil: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 85: Mexico: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 86: Mexico: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 87: Others: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 88: Others: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 89: Middle East and Africa: Companion Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
Figure 90: Middle East and Africa: Companion Diagnostics Market: Breakup by Country (in %), 2024
Figure 91: Middle East and Africa: Companion Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
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, 2024 and 2033
Table 2: Global: Companion Diagnostics Market Forecast: Breakup by Product & Service (in Million USD), 2025-2033
Table 3: Global: Companion Diagnostics Market Forecast: Breakup by Technology (in Million USD), 2025-2033
Table 4: Global: Companion Diagnostics Market Forecast: Breakup by Indication (in Million USD), 2025-2033
Table 5: Global: Companion Diagnostics Market Forecast: Breakup by End User (in Million USD), 2025-2033
Table 6: Global: Companion Diagnostics Market Forecast: Breakup by Region (in Million USD), 2025-2033
Table 7: Global: Companion Diagnostics Market Structure
Table 8: Global: Companion Diagnostics Market: Key Players

Product Code: SR112025A2548

The global companion diagnostics market size reached USD 7.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.3 Billion by 2033, exhibiting a growth rate (CAGR) of 12.11% during 2025-2033. North America leads the market attributed to its advanced healthcare infrastructure, high adoption of personalized medicine, and strong regulatory support. The region also benefits from significant investments in research operations and a growing number of biotechnology and pharmaceutical companies. 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 market growth.

Personalized medicine, which customizes therapies according to a person's genetic profile, is a critical factor propelling the companion diagnostics market demand. Matching particular treatments to a patient's distinct genetic profile necessitates accurate diagnostic tools, resulting in a greater need for companion diagnostics that assist in directing therapeutic choices for improved results and reduced side effects. Apart from this, improvements in diagnostic technologies, particularly in molecular diagnostics and next-generation sequencing (NGS), are notably enhancing the precision and dependability of companion diagnostics. These advancements enable the detection of genetic mutations and biomarkers with improved accuracy, thus increasing the effectiveness of therapies and driving the need for companion diagnostics in medical environments. Furthermore, healthcare investments are increasingly focused on precision medicine, which involves using diagnostic tests to tailor treatments. As more healthcare systems adopt targeted therapies and personalized treatment regimens, there is a higher demand for companion diagnostics, particularly in oncology, where tailored therapies are crucial.

Global Companion Diagnostics Market Trends:

Advancements in Gene Therapy and Rare Disease Diagnostics

With the growing use of gene therapies for genetic disorders, there is an increase in the demand for diagnostic tools that guarantee the safe and efficient use of these therapies. Companion diagnostics play a crucial role in determining which patients qualify for gene therapy, especially in rare genetic disorders where treatment effectiveness significantly relies on specific biomarkers. These diagnostics assist in identifying existing antibodies or genetic elements that may influence therapy effectiveness, guaranteeing that patients get the most suitable treatment. This critical role is actively being addressed by key players in the diagnostic and pharmaceutical industries, who are developing and gaining regulatory approvals for advanced companion diagnostic assays to facilitate the safe and effective administration of gene therapies. In 2024, Labcorp received FDA approval for its nAbCyte(TM) Anti-AAVRh74var HB-FE Assay, a companion diagnostic for Pfizer's gene therapy BEQVEZ(TM) (fidanacogene elaparvovec-dzkt) to treat hemophilia B. The test identified preexisting anti-AAVRh74var antibodies in patients, ensuring safe and effective gene therapy treatment. This approval marked a breakthrough in gene therapy diagnostics for rare genetic disorders.

Integration of AI in Diagnostics

Tools powered by AI improve the speed, accuracy, and efficiency of diagnostic tests by examining extensive datasets, such as genetic and clinical data, to pinpoint biomarkers with unmatched precision. AI algorithms can aid in forecasting patient reactions to particular therapies, allowing for more tailored treatment strategies. In oncology and various complex conditions, AI enhances the process of selecting patients for clinical trials, guaranteeing that only those with the highest potential to benefit from the treatment are included. This technological progress is further solidified by strategic collaborations between companies, integrating AI-powered solutions to refine diagnostic processes and accelerate clinical trial advancements. In 2024, ABION and Deep Bio signed an MOU in Seoul, South Korea to collaborate on AI-driven companion diagnostics and cancer clinical trials. The partnership integrated Deep Bio's AI-powered pathology tools into ABION's drug pipeline to enhance precision in patient selection and accelerate trial efficiency. This supported ABION's ongoing combination trials in lung cancer therapy.

Increased Healthcare Investments

Investments in healthcare is a key factor influencing the market as worldwide healthcare systems aim to enhance treatment results and lower expenses. Governments, private investors, and healthcare organizations are focusing on personalized and precision medicine, which directly entails the utilization of companion diagnostics. By pinpointing the most effective therapies, companion diagnostics can minimize the trial-and-error method frequently encountered in traditional treatments, resulting in a more efficient allocation of healthcare resources. Moreover, the growing focus on value-based healthcare, linking reimbursement to patient results instead of care volume, corresponds effectively with the function of companion diagnostics in enhancing treatment precision. The cost-efficiency of targeted treatments facilitated by companion diagnostics further reinforces their incorporation into global healthcare systems. With rising economic pressures on healthcare systems, investments in tools that enhance efficient and effective care, like companion diagnostics, are strengthening the market growth.

Global Companion Diagnostics Market Growth Drivers:

Rising Aging Population

With the growing geriatric population, there is a rise in the prevalence of chronic and age-related illnesses, such as cancer, heart diseases, and neurological conditions. Older adults frequently need more tailored therapies, which can yield the best outcomes when customized to their genetic profile. The World Health Organization (WHO) states that by 2030, one out of every six individuals worldwide will be 60 years or older, and this figure is expected to climb to 2.1 billion by 2050. This demographic change necessitates increased and enhanced diagnostic services, driving the demand for superior diagnostic instruments and testing solutions. Companion diagnostics allow healthcare professionals to customize treatments according to specific genetic profiles, enhancing treatment results and lowering the likelihood of negative reactions. This movement towards individualized healthcare is crucial for addressing the intricate requirements of aging populations.

Strategic Partnerships and Collaborations

Partnerships and collaborations between diagnostic companies and pharmaceutical firms facilitate the combination of diagnostic tools with innovative therapies, guaranteeing that suitable patients obtain the most efficient treatments. Through the integration of knowledge in drug development and diagnostic technologies, these collaborations expedite the creation of companion diagnostics, simplify the regulatory approval process, and improve the accessibility of personalized healthcare options. With the increase in demand for precision medicine, these collaborations are vital for broadening the market offerings by developing all-encompassing, end-to-end solutions that facilitate the creation of targeted treatments. For example, in 2024, BD (Becton, Dickinson and Company) and Quest Diagnostics announced a global partnership to created flow cytometry-based companion diagnostics for cancer and other diseases. The partnership aimed to offer an end-to-end solution for the pharmaceutical industry, ranging from exploratory panel development to FDA-approved diagnostic kits. The goal was to advance personalized healthcare and improve clinical outcomes.

Enhancing Regulatory Pathways for Diagnostic Approval

The advancement and improvement of regulatory processes for diagnostic approval are a crucial factor impelling the market growth. Regulatory agencies are simplifying the approval pathways for companion diagnostics, acknowledging their vital contribution to facilitating precision medicine. With quicker review periods and explicit frameworks for the creation and authorization of companion diagnostics tests, the regulatory landscape is becoming increasingly supportive of innovation in this area. These enhancements not only promote the advancement of novel diagnostic technologies but also offer more defined routes to market access for firms investing in companion diagnostics. In addition, as regulators recognize the significance of these assessments in guaranteeing the efficacy of novel treatments, they are generating more chances for companion diagnostics companies to prosper.

Companion Diagnostics Industry Segmentation:

Breakup by Product & Service:

Assays, Kits and Reagents
Software and Services

Assays, kits and reagents hold the largest market share

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 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 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 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.

Key Questions Answered in This Report

1.What was the size of the global companion diagnostics market in 2024?
2.What is the expected growth rate of the global companion diagnostics market during 2025-2033?
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?

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

コンパニオン診断薬市場レポート：製品・サービス、技術、適応症、エンドユーザー、地域別、2025～2033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 2025-2033

世界のコンパニオン診断薬市場動向：

世界のコンパニオン診断薬市場成長促進要因：

目次

第1章 序文

第2章 調査範囲と調査手法

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

第5章 世界のコンパニオン診断薬市場

第6章 市場内訳：製品・サービス別

第7章 市場内訳：技術別

第8章 市場内訳：適応症別

第9章 市場内訳：エンドユーザー別

第10章 市場内訳：地域別

第11章 SWOT分析

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

第14章 価格分析

第15章 競合情勢