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市場調査レポート
商品コード
1503318
ELISA法の2030年までの市場予測:手法、技術、用途、エンドユーザー、地域別の世界分析Elisa Tests Market Forecasts to 2030 - Global Analysis By Method, Technology, Application, End User and By Geography |
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ELISA法の2030年までの市場予測:手法、技術、用途、エンドユーザー、地域別の世界分析 |
出版日: 2024年06月06日
発行: Stratistics Market Research Consulting
ページ情報: 英文 200+ Pages
納期: 2~3営業日
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Stratistics MRCによると、世界のELISA法市場は2024年に27億8,000万米ドルを占め、予測期間中のCAGRは8.9%で成長し、2030年には46億3,000万米ドルに達する見込みです。
酵素結合免疫吸着測定法、すなわちエリサ試験は、生体試料に抗体、抗原、タンパク質、ホルモンが含まれているかどうかを調べるために、医療診断で頻繁に使用されています。抗原抗体相互作用の原理は、酵素結合抗体が試料中の標的分子にどのように結合するかを説明するもので、この非常に高感度で特異的なアッセイの基礎となっています。標的物質の存在と量は、酵素反応によって生じる測定可能なシグナル(通常は色の変化)によって示されます。さらに、ELISA法は自己免疫疾患、アレルギー、感染症、その他の健康状態の診断に有用な機器です。
米国心臓協会によると、心臓病は米国の男性、女性、ほとんどの人種および民族の人々の主要な死因です。
感染症の増加
都市化、海外旅行、人口増加などの原因による世界の感染症の増加は、ELISA法のようなタイムリーで正確な診断がいかに重要であるかを強調しています。さらに、COVID-19のようなパンデミックを封じ込めるための絶え間ない努力は、診断技術の研究開発を加速させ、感染症のサーベイランス、診断、モニタリングのための最先端のエリサアッセイの作成と使用を促しています。
コンプライアンスと規制上の問題
ELISA法市場は、規制上の障害やコンプライアンス上の課題、特に製品登録、品質保証、様々な地域における厳格な規制への対応に直面しています。新しいアッセイ法や既存のアッセイ法の変更に時間とリソースを要する規制当局の承認プロセスが必要な場合、製品の発売や市場参入が遅れる可能性があります。さらに、基準や規制環境が変化すると、メーカーや開発者はコンプライアンスを確保するために継続的に監視し、調整しなければならず、その結果、業務上および財務上の負担が増大します。
個別化医療とバイオマーカー同定
ELISA法は、個別化医療とバイオマーカー主導のヘルスケアへの取り組みへの注目が高まっていることから、バイオマーカー探索、バリデーション、臨床導入の機会を有しています。個別化された治療の選択や患者の層別化を可能にするために、エリサアッセイは病気の診断、予後、治療効果に関連するバイオマーカーの探索と測定に不可欠です。さらに、バイオマーカー候補を検証し、臨床的に有用な検査に変換できるハイスループットELISAアッセイのニーズは、バイオマーカー探索のための膨大なデータを提供するプロテオミクス、メタボロミクス、ゲノミクスなどのオミクス技術の発展によって高まっています。
価格競争と市場飽和
同等の製品を提供する複数のメーカーが存在するため、ELISA法市場は市場飽和と激しい価格競争にさらされやすいです。高度にコモディティ化した市場セグメントでは、多数の競合他社が市場シェアを争っているため、利幅が圧迫され、価格が下落する可能性があります。さらに、ジェネリック医薬品や安価な代替品が入手可能になり、有名ブランドの評判や経済的成功を損なう偽物や粗悪な検査薬が急増することで、状況はさらに悪化します。
SARS-CoV-2感染を特定し、病気の進行を追跡するための診断検査ソリューションに対する比類なきニーズをもたらしたCOVID-19の大流行により、ELISA法市場は大きな影響を受けています。このパンデミックにより、エリサアッセイの生産、流通、世界サプライチェーンのすべてが当初中断されました。しかし、メーカー各社は増産、生産能力の増強、COVID-19特異的ELISA法の開発スピードアップにより、需要の急増に迅速に対応しました。
診断薬セグメントは予測期間中最大となる見込み
通常、ELISA(酵素結合免疫吸着測定法)検査市場では、診断分野が最大のシェアを占めています。自己免疫疾患、アレルギー、ホルモンバランスの乱れ、感染症など多くの疾患はELISA法で診断できます。さらに、これらのアッセイは、標的分子を測定する際の感度、特異性、精度が高いことから好まれています。ELISAアッセイは病気のスクリーニング、診断、追跡に診断学分野で使用されるため、世界中の臨床検査室で主力となっています。
予測期間中、製薬企業およびバイオテクノロジー企業セグメントが最も高いCAGRを示すと予測される
ELISA法市場では通常、製薬・バイオテクノロジー企業セグメントが最も高いCAGRを示します。これらの企業は主に、前臨床研究、臨床試験、医薬品開発などの用途でELISAアッセイに依存しています。創薬プロセスの初期段階において、ELISA法は潜在的な標的やバイオマーカーの同定と検証に重要な役割を果たします。さらに、ELISA法は、臨床試験に参加する患者のバイオマーカー濃度をモニターし、医薬品候補の安全性と有効性を評価するためにも、バイオテクノロジー企業や製薬企業によって使用されています。
ELISA法の売上に関しては、通常北米が最大の市場シェアを占めています。前述の優位性は、強固なヘルスケアインフラの存在、高度な診断技術の採用率の上昇、研究開発への多大な投資、製薬・バイオテクノロジー企業の集積といった複数の要因に起因しています。さらに、ヘルスケア構想に対する政府の強力な支援、有利な償還慣行、疾患の早期発見と早期管理の重要性に対する理解の高まりも、この地域に利益をもたらしています。
ELISA法市場では、通常アジア太平洋地域が最も高いCAGRを示します。慢性疾患や感染症の罹患率の上昇、ヘルスケアコストの上昇、ヘルスケアサービスへのアクセス向上、研究開発投資の増加など、数多くの要因がこの成長を後押ししています。さらに、この地域、特に中国やインドのような国々では人口が拡大しているため、ELISAアッセイを含む診断検査用品に対するニーズが非常に高いです。さらに、アジア太平洋地域のELISA法市場は、熟練労働者の大量確保、技術の進歩、ヘルスケアインフラの改善などの要因によって急成長しています。
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
According to Stratistics MRC, the Global Elisa Tests Market is accounted for $2.78 billion in 2024 and is expected to reach $4.63 billion by 2030 growing at a CAGR of 8.9% during the forecast period. Enzyme-linked immunosorbent assays, or Elisa tests, are frequently used in medical diagnostics to find out whether biological samples contain antibodies, antigens, proteins, or hormones. The antigen-antibody interaction principle, which describes how an enzyme-linked antibody attaches to a target molecule in the sample, is the basis for this incredibly sensitive and specific assay. The presence and amount of the target substance are indicated by a measurable signal produced by the enzyme reaction, which is usually a color change. Moreover, Elisa tests are useful instruments for the diagnosis of autoimmune diseases, allergies, infectious diseases, and other health conditions.
According to the American Heart Association, Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.
Rising infectious disease prevalence
The rise in infectious diseases around the world, driven by causes like urbanization, international travel, and population growth, emphasizes how important it is to have timely and accurate diagnostics like Elisa tests. Additionally, continuous efforts to contain pandemics, like COVID-19, have sped up research and development in diagnostic technologies, encouraging the creation and use of cutting-edge Elisa assays for infectious disease surveillance, diagnosis, and monitoring.
Issues with compliance and regulatory difficulties
The market for Elisa tests is confronted with regulatory obstacles and compliance challenges, specifically pertaining to product registration, quality assurance, and compliance with strict regulations in various geographical areas. Product launches and market entry may be delayed if new assays or changes to existing ones require lengthy and resource-intensive regulatory approval processes. Furthermore, as standards and regulatory environments change, manufacturers and developers must continually monitor and adjust to ensure compliance, which increases their operational and financial burdens.
Personalized health care and biomarker identification
Elisa tests have opportunities in biomarker discovery, validation, and clinical implementation due to the increasing focus on personalized medicine and biomarker-driven approaches to healthcare. In order to enable individualized treatment choices and patient stratification, Elisa assays are essential in locating and measuring biomarkers linked to disease diagnosis, prognosis, and treatment response. Moreover, the need for high-throughput Elisa assays that can validate and convert biomarker candidates into clinically useful tests is being driven by the development of omics technologies, including proteomics, metabolomics, and genomics, which offer a plethora of data for biomarker discovery.
Price competition and market saturation
Due to the existence of multiple manufacturers offering comparable products, the Elisa test market is vulnerable to market saturation and intense price competition. In highly commoditized market segments, the multitude of competitors fighting for market share can result in pressure on margins and price erosion. Additionally, the situation is made worse by the availability of generic and less expensive alternatives, as well as by the surge in fake or inferior assays that damage the reputation and financial success of well-known brands.
The market for Elisa tests has been significantly impacted by the COVID-19 pandemic, which has resulted in an unparalleled need for diagnostic testing solutions to identify SARS-CoV-2 infection and track the progression of the disease. Elisa assay production, distribution, and the global supply chain were all initially disrupted by the pandemic. However, manufacturers quickly responded to the spike in demand by increasing production, building up their capacity, and speeding up the development of COVID-19-specific Elisa tests.
The Diagnostics segment is expected to be the largest during the forecast period
The diagnostics segment usually holds the largest share of the market for ELISA (enzyme-linked immunosorbent assay) tests. Many diseases, such as autoimmune disorders, allergies, hormone imbalances, and infectious diseases, can be diagnosed with ELISA tests. Moreover, these assays are preferred due to their high sensitivity, specificity, and precision in measuring target molecules. As ELISA assays are used in the diagnostics segment to screen, diagnose, and track diseases, they are a mainstay in clinical laboratories across the globe.
The Pharmaceutical and Biotech Companies segment is expected to have the highest CAGR during the forecast period
In the ELISA test market, the pharmaceutical and biotech company segment usually shows the highest CAGR. These businesses mainly rely on ELISA assays for preclinical research, clinical trials, and drug development, among other uses. Early on in the drug discovery process, ELISA tests play a crucial role in identifying and validating potential targets and biomarkers. Additionally, ELISA assays are also used by biotech and pharmaceutical companies to monitor biomarker levels in patients participating in clinical trials and to assess the safety and efficacy of drug candidates.
When it comes to ELISA test sales, North America usually commands the largest market share. The aforementioned dominance can be attributed to multiple factors, such as the existence of a robust healthcare infrastructure, elevated adoption rates of sophisticated diagnostic technologies, substantial investments in research and development endeavors, and a substantial concentration of pharmaceutical and biotechnology enterprises. Furthermore, strong government support for healthcare initiatives, advantageous reimbursement practices, and a growing understanding of the significance of early disease detection and management also benefit the region.
In the market for ELISA tests, the Asia-Pacific region usually shows the highest CAGR. Numerous factors, such as the rising incidence of chronic illnesses and infectious diseases, rising healthcare costs, greater access to healthcare services, and rising investments in R&D, are driving this growth. Moreover, there is a huge need for diagnostic testing supplies, including ELISA assays, due to the region's expanding population, especially in nations like China and India. Moreover, the Asia-Pacific region's ELISA test market is growing quickly due to factors like the availability of a large pool of skilled labor, technological advancements, and improvements in healthcare infrastructure.
Key players in the market
Some of the key players in Elisa Tests market include F. Hoffmann-La Roche Ltd., BioLegend, Inc, Siemens Healthineers, Enzo Life Sciences, Inc, Bio-Rad Laboratories, Inc., Merck KGaA , Abbott Laboratories, Eurofins Scientific, General Electric, PerkinElmer, Inc., BioMerieux SA, Sysmex Corporation, Agilent Technologies, Inc., Ortho Clinical Diagnostics, Danaher Corporation, ZEUS Scientific, Inc., R&D Systems, Inc and Thermo Fisher Scientific.
In June 2024, Siemens Healthineers and Hermes Medical Solutions, a molecular imaging software developer, have entered into an agreement to provide Siemens customers with access to Hermia dosimetry products. Hermia Organ Dosimetry will be integrated on syngo.via, the Siemens Healthineers vendor-neutral imaging software platform for 2D, 3D, and 4D reading and advanced visualization.
In May 2024, Merck KGaA has announced it has signed a definitive agreement to acquire Mirus Bio in a deal worth $600m, which will complement its current portfolio of novel modalities. Anticipated to close in the third quarter of 2024, the transaction will help to advance Merck's viral vector manufacturing therapies from preclinical through to commercial production.
In December 2023, Roche announced the entry into a definitive merger agreement to acquire Carmot Therapeutics, Inc. ("Carmot"), a privately owned US company based in Berkeley, California. Carmot's R&D portfolio includes clinical stage subcutaneous and oral incretins with best-in-class potential to treat obesity in patients with and without diabetes, as well as a number of preclinical programs.