市場調査レポート
商品コード
1439320
コンパニオン診断 - 世界市場の考察、競合情勢、市場予測(2030年)Companion Diagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
● お客様のご希望に応じて、既存データの加工や未掲載情報(例:国別セグメント)の追加などの対応が可能です。 詳細はお問い合わせください。
コンパニオン診断 - 世界市場の考察、競合情勢、市場予測(2030年) |
出版日: 2024年02月01日
発行: DelveInsight
ページ情報: 英文 150 Pages
納期: 2~10営業日
|
世界のコンパニオン診断の市場規模は、2023年に59億1,000万米ドル、2030年までに118億9,000万米ドルに達し、2024年~2030年の予測期間にCAGRで12.32%の成長が見込まれます。市場の成長は主に、世界中でのがん患者の急激な増加によるものです。加えて、精密医療に関する患者の意識の高まりや、精密医療の開発に関するメーカーの関心の高まりがコンパニオン診断の需要を高めています。さらに、がん以外の疾患に対するコンパニオン診断の開発に向けた研究開発の増加や、市場におけるさまざまなコンパニオン診断の承認や発売の増加は、予測期間(2024年~2030年)に世界のコンパニオン診断市場を拡大すると予測される主な要因の一部です。
コンパニオン診断の市場力学
コンパニオン診断市場は、がん患者における精密医療または個別化医療への選好の高まりにより、かなりの成長が見込まれます。精密医療は、がん患者に対する薬剤の選択や標的治療を改善し、副作用を軽減する可能性があるためです。さらに、個別化医療は、がんの治療レジメンをより費用対効果の高いものにすることで、患者コンプライアンスを向上させます。コンパニオン診断は効果予測バイオマーカーアッセイであり、健康転帰を改善するために遺伝子やゲノムデータを活用する精密医療の発展において重要な役割を果たします。このように、個別化医療への選好の高まりは、コンパニオン診断市場を拡大すると考えられます。
さらに、精密医療やがんのバイオマーカー検査に関する認知度を高める政府や組織の取り組みは、精密医療の採用を増加させる可能性が高く、結果としてコンパニオン診断の需要を高め、市場を活性化させることが予測されます。例えば2022年11月、肺がんに焦点を当てた主な非営利団体であるLUNGevity Foundationは、非小細胞肺がん(NSCLC)における包括的なバイオマーカー検査に対する認識を高めることを目的としたNo One Missedキャンペーンの一環として、1年間にわたる「#KnowYourBiomarker」ソーシャルメディア活動を開始しました。
さらに、アルツハイマー病やハンチントン病など、がん以外のさまざまな疾患に対するコンパニオン診断の開発を主要メーカーが重視するようになったことで、そのような疾患の管理と治療を支援し、患者の転帰を改善するコンパニオン診断ツールの採用が増加することも予測されます。例えば2019年11月、バイオテクノロジーのブランドであるAsuragenは、ハンチントン病のコンパニオン診断を開発するためにWave Life Sciencesと提携しました。
したがって、上記のすべての要因が、今後数年間に世界のコンパニオン診断市場を増強すると予測されます。
しかし、コンパニオン診断の高いコストや、多くの国での限られた償還、これらの機器の承認に関する規制の複雑性などが、コンパニオン診断市場の成長を抑制すると予測されています。
また、COVID-19パンデミックの発生により、コンパニオン診断市場の成長は鈍化しています。これは、ロックダウンの実施、需要とサプライチェーンの制約によるものです。さらに、パンデミック中、世界中の医療システムのガイドラインは一時的にCOVID-19患者の管理に全力を注いでいました。例えば、National Cancer Institute(2022)が提供したデータによると、COVID-19パンデミックによるロックダウン規制に関連する課題のほかに、2020年3月だけでも、COVID-19によって800件以上の肺がん検診の予約延期が余儀なくされたことが確認されています。しかし、世界中で数多くのCOVID-19ワクチンが承認および投与されたおかげで、医療サービスを含むさまざまな領域での活動再開に大きな向上が見られ、コンパニオン診断市場の健全な回復期への道が開かれました。
当レポートでは、世界のコンパニオン診断市場について調査分析し、市場規模と予測、促進要因と課題、企業と製品のプロファイルなどを提供しています。
Companion Diagnostics Market By Type (Product [Assays, Kits & Reagents And Instruments], Services), By Technology (Immunohistochemistry (Ihc), Next-Generation Sequencing (Ngs), Polymerase Chain Reaction (Pcr), Others), By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Others), By End-User (Hospitals, Diagnostic Labs, Others), by geography, is expected to grow at a noteworthy CAGR till 2030 owing to the increase in the cancer burden across the globe and growing focus on personalized medicines
The global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The increase in the market for companion diagnostics is predominantly owing to an exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population as well as the growing focus of the manufacturers concerning the development of precision medicine has bolstered the demand for companion diagnostics. Furthermore, an increase in research and development for developing companion diagnostics for non-cancer disorders, and growing approvals and launches of various companion diagnostic products in the market, among others are some of the key factors anticipated to augment the global market for companion diagnostics during the forecast period (2024-2030).
Companion Diagnostics Market Dynamics:
The market for companion diagnostics is projected to witness considerable growth due to the increase in preference for precision medicine or personalized medicine among cancer patients. This is because precision medicine has the potential to offer an improved medication selection and targeted therapy for cancer patients thereby reducing adverse effects. Moreover, personalized medicine increases patient compliance by making the treatment regimen for cancer more cost-effective. Companion diagnostics are predictive biomarker assays that play a significant role in the development of precision medicine which leverages genetic and genomic data to improve health outcomes. Thus, a growing preference for personalized medicine is likely to increase the market for companion diagnostics.
Furthermore, government, as well as organizations' initiatives to raise awareness regarding precision medicine and biomarker testing for cancer are likely to increase the adoption of precision medicine which in return is expected to raise the demand for companion diagnostics thus, fuelling the market. For instance, in November 2022, LUNGevity Foundation, a leading lung cancer-focused nonprofit organization, launched a year-long #KnowYourBiomarker social media initiative as part of the No One Missed campaign aimed at driving awareness of comprehensive biomarker testing in non-small cell lung cancer (NSCLC).
Additionally, a shift in the focus of key manufacturers on developing companion diagnostics for various non-cancer disorders such as Alzheimer's disorders, Huntington's disease, and others are also expected to increase the adoption of companion diagnostic tools to aid in the management and treatment of such diseases and improve patient outcomes. For instance, in November 2019, Asuragen, a biotechne brand partnered with Wave Life Sciences to develop companion diagnostics for Huntington's Disease.
Thus, all the above factors are expected to augment the global companion diagnostics market in the forthcoming years.
However, the high cost of companion diagnostics coupled with limited reimbursement in many countries and complex regulations for the approval of these devices are expected to impede the market growth for companion diagnostics.
Also, owing to the outbreak of the COVID-19 pandemic, the companion diagnostics market witnessed slow growth. This is due to the implementation of lockdown, and restrictions on demand & supply chain. Moreover, during the pandemic the healthcare system guidelines across the globe temporarily focused all their efforts on the management of COVID-19 patient, due to which the number of cancer screening were reduced. For instance, as per the data provided by the National Cancer Institute 2022, besides the challenges associated with the lockdown restrictions due to the COVID-19 pandemic, it was observed that in March 2020 alone, COVID-19 forced the postponement of more than 800 appointments for lung cancer screening. However, owing to the approval and administration of numerous COVID-19 vaccines across the globe, there was a significant improvement in the resumption of activities across various domains including healthcare services, thereby paving the way for a sound period of recovery for the companion diagnostics market.
Companion Diagnostics Market Segment Analysis:
Companion Diagnostics Market By Type (Product [Assays, Kits & Reagents and Instruments], Services), By Technology (Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Others), By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Others), By End-User (Hospitals, Diagnostic Labs, Others), and By Geography (North America, Europe, Asia-Pacific, and Rest of the World).
In the product type segment of the companion diagnostics market, the assays, kits & reagents subsegment is expected to hold a significant market share in the year 2023. The rise in collaboration among the companies focused on developing diagnostic products and giant pharmaceutical companies for developing companion diagnostics kits to improve cancer treatment and management is expected to augment the market for these product types. For instance, on August 05, 2022, Shanghai Henlius Biotech, Inc. entered into a Collaboration with Promega to Develop the Companion Diagnostic Kit for Henlius' Serplulimab MSI-H Solid Tumours Indication.
Furthermore, the rise in the focus on developing and launching companion diagnostic assays with advanced sequencing techniques and those which require non-invasive samples could also increase the demand for this segment. For instance, in August 2020, the US Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology (Guardant360 CDx assay) to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).
Additionally, companies raising funds to develop companion diagnostic products and strengthen their portfolio to expand the market access are further projected to contribute to the segmental growth of the companion diagnostics market. For instance, in May 2018, Cergentis, a Dutch biotech company, secured a > Euro-1.2 million grant from the European Commission's Horizon 2020 program for the development of cancer companion diagnostics. The company planned to use the funds obtained to optimize and validate the TLA technology for the analysis of (FFPE) tumor biopsies.
Hence, the interplay of all the above-mentioned factors is projected to boost the companion diagnostics market in the upcoming years.
North America is expected to dominate the overall Companion Diagnostics Market:
Among all the regions, North America is expected to hold a major share in the overall Companion Diagnostics market in the year 2023 and will retain its market position during the forecast period. This is due to the rising prevalence and incidence of various cancers in the region. For instance, as per the 2020 data revealed by the GLOBOCAN, the new cancer cases reported in the US, Canada, and Mexico were 2,281,658; 2,74,364; and 1,95,499, respectively.
Moreover, favorable reimbursement policies, approval & launches of various companion diagnostic products in the region, various business expansion activities underwent by the companies present in the region, and others are some of the factors responsible for the companion diagnostics market.
For instance, in 2018, the Centers for Medicare & Medicaid Services (CMS) finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients. The CMS believed when these tests are used as a companion diagnostic to identify patients with certain genetic mutations may benefit from the US Food and Drug Administration (FDA)-approved treatments.
Also, in April 2019, Agilent received an expanded FDA Approval for its companion diagnostic in NSCLC.
Hence, all the above-stated factors are projected to propel the regional market growth of companion diagnostics during the forecast period.
Companion Diagnostics Market Key Players:
Some of the key market players operating in the Companion Diagnostics market include Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd, Myriad Genetics, Inc., Abbott Laboratories., QIAGEN, BIOMERIEUX, Guardant Health Inc., Illumina, Inc., Pillar Biosciences, Inc., Leica Biosystems, Thermo Fisher Scientific Inc., Almac Group, NeoGenomics Laboratories., Invitae Corporation, 3D Medicines Corporation, ASURAGEN, INC. (Biotechne), Invivoscribe, Inc., Amoy Diagnostics Co., Ltd., Laboratory Corporation of AmericaR Holdings., SAGA Diagnostics, and others.
Recent Developmental Activities in the Companion Diagnostics Market:
In March 2022, Myriad Genetics received FDA approval of BRACAnalysis? CDx as a companion diagnostic for Lynparza? in early breast cancer.
In October 2022, Agilent was granted the FDA approval for its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as a companion diagnostics in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio? (abemaciclib) in combination with endocrine therapy is being considered.
In August 2022, Roche received FDA approval for the first companion diagnostic to identify dMMR solid tumor patients eligible for anti-PD-1 immunotherapy.
Key Takeaways from the Companion Diagnostics Market Report Study
Target Audience who can be benefited from the Companion Diagnostics Market Report Study
Frequently Asked Questions for the Companion Diagnostics Market:
A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.
The global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030.
The major factors driving the demand for Companion Diagnostics are the exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population as well as the growing focus of the manufacturers concerning the development of precision medicine has bolstered the demand for companion diagnostics. Furthermore, an increase in research and development for developing companion diagnostics for non-cancer disorders, and growing approvals and launches of various companion diagnostic products in the market, among others are some of the key factors anticipated to augment the global market for companion diagnostics during the forecast period (2024-2030).
Some of the key market players operating in the Companion Diagnostics market include Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd, Myriad Genetics, Inc., Abbott Laboratories., QIAGEN, BIOMERIEUX, Guardant Health Inc., Illumina, Inc., Pillar Biosciences, Inc., Leica Biosystems, Thermo Fisher Scientific Inc., Almac Group, NeoGenomics Laboratories., Invitae Corporation, 3D Medicines Corporation, ASURAGEN, INC. (Biotechne), Invivoscribe, Inc., Amoy Diagnostics Co., Ltd., Laboratory Corporation of America? Holdings., SAGA Diagnostics, and others.
Among all the regions, North America is expected to hold a major share in the overall Companion Diagnostics market in the year 2023 and will retain its market position during the forecast period. This is due to the rising prevalence and incidence of various cancers in the region. Moreover, favorable reimbursement policies, approval & launches of various companion diagnostic products in the region, various business expansion activities underwent by the companies present in the region, and others are some of the factors responsible for the companion diagnostics market.