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The immunodiagnostics market size is forecast to increase by USD 29.54 billion at a CAGR of 13.64% between 2023 and 2028. The market is experiencing significant growth due to several key trends and drivers. The increased demand for biomarker-based tests, driven by their ability to provide early and accurate diagnosis, is a major growth factor. Additionally, the growth in demand for personalized medicine, which relies on immunodiagnostics to identify specific genetic markers and tailor treatments accordingly, is another significant trend. Furthermore, the complexity of immunodiagnostics tests, which require specialized equipment and expertise, presents challenges for market growth. However, advancements in technology and increasing investments in research and development are expected to mitigate these challenges and drive market expansion. Overall, the market is poised for strong growth in the coming years, driven by these trends and the increasing importance of early and accurate diagnosis in healthcare.
Immunodiagnostics is a crucial segment of the in vitro diagnostics market, focusing on the detection and diagnosis of various diseases, including infectious diseases such as HIV, Hepatitis B, and STIs, cardiovascular diseases, cancer, gastrointestinal diseases, and chronic diseases. The market is driven by demographics, lifestyle changes, and the increasing prevalence of chronic diseases, particularly in the geriatric population. Immunodiagnostics utilizes antigen-antibody reactions, assays, and analyzers to diagnose diseases. Autoimmunity diseases and oncology & endocrinology are significant application areas. Pathologists play a vital role in the diagnosis process, while healthcare expenditures and patient outcomes significantly impact market growth. The supply chain network and cost management are essential considerations for market players. Developed nations prioritize early diagnosis and prevention from diseases, leading to increased demand for immunodiagnostics. Reagents & consumables are essential components of immunodiagnostics, ensuring accurate and reliable test results.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
The reagents and consumables segment is estimated to witness significant growth during the forecast period. The market encompasses various clinical settings, including hospitals and clinics, where laboratory tests play a crucial role in diagnosing HIV, Hepatitis, Dengue, Chikungunya, and autoimmune diseases. Serological labs, pathological labs, clinical microbiology departments, histopathology, hematology sections, and clinical biochemistry laboratories utilize immunodiagnostic technologies such as Enzyme-Linked Immunosorbent Assay (ELISA), Flow cytometer, HPLC, and Biotechnology. These advanced diagnostic platforms facilitate the detection of organisms, natural processes, and biomolecules like proteins. The reagents and consumables segment is experiencing significant growth in the market due to the increasing demand for high-throughput screening using immunoassays. Companies are producing new reagents to detect antigens, integrating fluorescence and chemiluminescence technology for enhanced sensitivity and specificity.
Furthermore, the expanding portfolio of immunodiagnostic tests necessitates the production of a diverse range of reagents. Roche Diagnostics and other companies specialize in manufacturing reagents for specific indications, such as oncology testing. Strategic partnerships between companies broaden their offerings of reagents for immunodiagnostics testing. In-vitro diagnostics, diagnostic technologies, diagnostic platforms, and immunoassay formats continue to evolve, with new product approvals in respiratory infections and the oncology & endocrinology segment driving market growth.
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The reagents and consumables segment was valued at USD 17.73 billion in 2018 and showed a gradual increase during the forecast period.
Europe is estimated to contribute 37% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
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Immunodiagnostics is a significant segment of clinical laboratories and hospital departments, including serological labs, pathological labs, clinical microbiology departments, histopathology, hematology sections, and clinical biochemistry laboratories. These laboratories conduct immunodiagnostic tests for various conditions, such as HIV, Hepatitis, Dengue, Chikungunya, and autoimmune diseases, using advanced diagnostic technologies and platforms. Immunoglobulin tests and rheumatoid factor tests are common immunodiagnostic procedures. Biotechnology plays a crucial role in immunodiagnostics, with natural-based materials, plant material, organisms, natural processes, and biomolecules, including proteins, being utilized to develop diagnostic kits. Enzyme-Linked Immunosorbent Assay (ELISA), Flow cytometer, HPLC, and other diagnostic technologies are employed in immunodiagnostics.
Furthermore, pharmaceutical industries and druggists also use in-vitro diagnostics to detect and diagnose diseases. The Oncology & Endocrinology segment is a growing market for immunodiagnostics, with endocrine diseases being diagnosed using these tests. New product approvals and advancements in diagnostic technologies, such as immunoassay formats like Radioimmunoassay (RIA), and diagnostic platforms, are driving the growth of the market. Respiratory infections are also diagnosed using immunodiagnostic tests, making them essential in clinical settings.
Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The increased demand for biomarker-based tests is the key driver of the market. The global market is experiencing significant growth due to the increasing focus on early disease detection and prevention in developed nations. This trend is leading to increased healthcare expenditures on advanced diagnostic tools and tests, particularly in high-growth clinical areas such as oncology and endocrinology, hepatitis and retrovirus, and cardiac markers. The use of sophisticated R&D in nucleic acid expression, proteomics, and sequencing has led to the development of biomarkers, which are molecular entities including proteins, genes, hormones, and other molecular markers that aid in detecting the presence or absence of diseases. Manufacturers are responding to this demand by developing assays for these clinical areas, with personalized test devices expected to replace traditional drug therapy in the forecast period.
Furthermore, cost-effective biomarker-based tests are also being developed to increase market penetration. Regulatory approvals for these tests, partnerships among vendors, and an increase in product launches are also driving market growth. The supply chain network is being optimized for cost management, ensuring efficient distribution and availability of these advanced diagnostic tools and tests in physician offices and other healthcare facilities.
The growth in demand for personalized medicine is the upcoming trend in the market. Immunodiagnostics is a significant segment in the healthcare industry, particularly in developed nations, where healthcare expenditures continue to rise. Early diagnosis and prevention from diseases are crucial for effective cost management in healthcare. Immunodiagnostics plays a vital role in achieving these objectives by offering precise and accurate diagnostic tests for various diseases.
Furthermore, the market for immunodiagnostics includes reagents and consumables used in the detection and monitoring of biomarkers in oncology and endocrinology, hepatitis and retrovirus, cardiac markers, and other diseases. These tests enable early diagnosis, which is essential for personalized medicine and tailored treatment plans. The supply chain network for immunodiagnostics is intricate, requiring stringent quality control and regulatory compliance. Physician offices and diagnostic laboratories are key customers in this market, seeking high-quality and reliable diagnostic solutions to improve patient outcomes.
The complexity of immunodiagnostics tests is a key challenge affecting the market growth. Immunodiagnostic tests play a crucial role in healthcare by enabling early diagnosis and prevention from various diseases, including oncology and endocrinology, hepatitis and retrovirus, and cardiac markers. However, the complexity of these tests can lead to increased healthcare expenditures due to the need for skilled personnel, specialized equipment, and costly reagents and consumables. The supply chain network for immunodiagnostics is intricate, with various stakeholders involved from sample collection to test result reporting.
Furthermore, the process of sample collection and handling requires expertise and specialized equipment, which can add to the cost and turnaround time of the test. Furthermore, the interpretation of test results can be challenging due to factors such as variability in assay methods, sensitivity and specificity of reagents, and interfering substances in the sample. In developed nations, cost management is a significant concern, and there is a growing focus on improving efficiency and reducing costs in the market. Physician offices and diagnostic laboratories are adopting automation and digital technologies to streamline the testing process and enhance patient outcomes.
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Adaptive Biotechnologies Corp. - The company offers immunodiagnostics solutions such as clonoSEQ and immunoSEQ Dx.
The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
Immunodiagnostics is a significant segment of the in vitro diagnostics market, focusing on the detection and diagnosis of various diseases, including infectious diseases such as HIV, Hepatitis B, and STIs, cardiovascular diseases, cancer, gastrointestinal diseases, and chronic diseases. The market is influenced by demographics, lifestyle, and governing scenarios, with the geriatric population being a key focus due to the higher prevalence of chronic diseases.
Furthermore, diagnosis kits and analyzers are the primary tools used in immunodiagnostics, utilizing immunoassay techniques like antigen-antibody reactions and chemiluminescence immunoassay (CLIA). Autoimmune disorders, endocrinology, oncology, and STI are other significant applications. Technological advancements in biomarker discovery and stringent regulatory requirements ensure accurate and reliable results, addressing concerns over false results. The regulatory framework, healthcare expenditure, and healthcare regulatory scenarios also impact market growth. Pipeline analysis and pricing analysis are crucial factors in the market's competitive landscape. Technical limitations, such as the need for skilled pathologists and specialized equipment in hospitals, remain challenges.
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Market Scope |
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Report Coverage |
Details |
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Page number |
184 |
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Base year |
2023 |
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Historic period |
2018-2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 13.64% |
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Market growth 2024-2028 |
USD 29.54 billion |
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Market structure |
Fragmented |
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YoY growth 2023-2024(%) |
11.73 |
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Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
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Performing market contribution |
Europe at 37% |
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Key countries |
US, UK, Germany, Canada, and China |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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Key companies profiled |
Abbott Laboratories, Adaptive Biotechnologies Corp., AESKU.GROUP GmbH and Co. KG, bioMerieux SA, Danaher Corp., DiaSorin SpA, Exagen Inc., F. Hoffmann La Roche Ltd., HUMAN Gesellschaft fur Biochemica und Diagnostica mbH, Nexus Dx Inc., Omega Diagnostics Group Plc, OraSure Technologies Inc., QuidelOrtho Corp., Seramun Diagnostica GmbH, Siemens AG, SQI Diagnostics Inc., Sysmex Corp., Tecan Trading AG, Thermo Fisher Scientific Inc., and Werfenlife SA |
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Market dynamics |
Parent market analysis, market growth inducers and obstacles, market forecast, fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the forecast period |
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Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Product
7 Market Segmentation by Application
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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