Press release
United States Immunoprotein Diagnostic Testing Market 2025 | Growth Drivers, Key Players & Investment Opportunities
Immunoprotein Diagnostic Testing Market
Global Immunoprotein Diagnostic Testing Market reached US$ 9.4 billion in 2022 and is expected to reach US$ 15.8 billion by 2030 growing with a CAGR of 6.9% during the forecast period 2023-2030.
Key Development:
United States: Recent Industry Developments
✅ In October 2025, Roche Diagnostics, in collaboration with Eli Lilly, received U.S. FDA approval for their blood test measuring pTau181 protein as an aid in the initial assessment of Alzheimer's disease in adults aged 55+. The launch marks a major step in immunoprotein-based diagnostics by offering a less invasive alternative to spinal fluid or PET scans.
✅ In August 2025, a leading U.S. diagnostics company launched a next-generation immunoprotein analyzer platform integrating AI-driven data analytics to improve throughput and sensitivity for immunoglobulin and complement-protein assays in clinical laboratories. The system enhances automation and diagnostic accuracy in protein biomarker testing.
✅ In June 2025, a major clinical laboratory provider began commercial distribution of an expanded immunoglobulin-free-light-chain panel designed for monitoring autoimmune and monoclonal-protein disorders. The launch provides clinicians with broader access to high-precision immunoprotein testing tools.
✅ In April 2025, a U.S.-based diagnostics firm introduced a novel multiplex immunoassay kit for simultaneous quantitation of CRP, haptoglobin, and complement C3 proteins. The kit enables faster, more comprehensive screening for inflammatory and immune-mediated conditions in hospital labs.
Japan: Recent Industry Developments
✅ In June 2025, Sysmex Corporation obtained manufacturing and marketing approval in Japan for its PrismGuideTM APOE Genotyping Kit, the first domestic assay to determine APOE genotype in blood for assessing risk of amyloid-related imaging abnormalities during Alzheimer's therapy. The innovation supports personalized treatment monitoring.
✅ In February 2025, Sysmex began in-house production of its HISCLTM TARC Assay Kit and HISCLTM ANP Assay Kit after regulatory transfer. The move enables local manufacturing of immunoprotein testing reagents used in allergy and cardiovascular disease diagnostics.
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Recent Mergers and acquisitions:
United States: Recent M&A Developments
✅ In July 2025, Waters Corporation announced a merger with Becton, Dickinson and Company's Biosciences & Diagnostic Solutions division in a US$17.5 billion Reverse Morris Trust transaction. The deal strengthens Waters' multiplex diagnostics and immunoassay capabilities, expanding its footprint in precision protein testing technologies.
✅ In June 2025, Thermo Fisher Scientific revealed plans to divest parts of its diagnostics business, including its microbiology and testing unit, for approximately US$4 billion. The move reflects a strategic portfolio realignment to focus on high-growth diagnostics and specialty assay areas.
✅ In March 2025, Advanced Instruments, a subsidiary of Patricia Industries, completed the acquisition of Nova Biomedical for around US$2.2 billion. This acquisition expands its expertise in blood analyzers and protein-based diagnostic technologies, enhancing its clinical testing portfolio.
✅ In February 2025, Quest Diagnostics announced the acquisition of a regional diagnostics business focused on immunoprotein testing and clinical chemistry. The deal supports Quest's strategy to broaden its biomarker-based diagnostic services across U.S. laboratories.
Japan: Recent M&A Developments
✅ In September 2025, Sysmex Corporation entered into a share-transfer agreement with JEOL Ltd. to acquire its clinical chemistry testing business, with completion scheduled for April 2026. The acquisition will strengthen Sysmex's diagnostic reagent and analyzer capabilities.
✅ In July 2025, Asahi Kasei Corporation announced plans to divest its diagnostics division to Nagase & Co., Ltd. The transaction enables both companies to optimize their focus-Nagase on expanding life-science solutions and Asahi Kasei on core chemical operations.
✅ In March 2025, GE HealthCare Technologies completed the acquisition of the remaining 50% stake in Nihon Medi-Physics Co., Ltd. from Sumitomo Chemical Co., Ltd. The deal gives GE full ownership, expanding its radiopharmaceutical and diagnostics presence in Japan.
✅ In February 2025, Mitsui Chemicals initiated a tender offer to acquire a domestic diagnostics-panel company, aiming to strengthen its biomarker and immunoprotein diagnostics capabilities. The move highlights Japan's growing investment in next-generation diagnostic technologies.
Key Players:
=> Abbott Laboratories, Thermo Fisher Scientific Inc, Bio-Rad Laboratories, Inc, Danaher Corporation, F. Hoffmann-La Roche Ag, Enzo Biochem, Inc, Siemens AG, Ortho Clinical Diagnostics, Diasorin S.P.A, and Abcam Plc among others.
Growth Forecast Projected:
The Global Immunoprotein Diagnostic Testing Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.
Research Process:
Both primary and secondary data sources have been used in the global Immunoprotein Diagnostic Testing Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.
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Key Segments:
➥ By Product Type: Instruments and Kits, Reagents
➥ By Test Type: Immunoglobulin Diagnostic Tests, C-Reactive Protein (CRP) Diagnostic Test, Complement System Proteins Diagnostic Test, Free Light Chain Diagnostic Tests, Haptoglobin Diagnostic Tests, Prealbumin Diagnostic Tests
➥ By Application: Autoimmune Disease Testing, Infectious Disease Testing, Oncology Testing, Allergy Testing, Toxicology Testing
➥ By End-User: Hospitals and Clinics, Diagnostic Laboratories, Others
Regional Analysis for Immunoprotein Diagnostic Testing Market:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
Benefits of the Report:
Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.
Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.
Chapter 3: Offers an in-depth look at the competitive landscape among Immunoprotein Diagnostic Testing producers, including revenue shares, strategic moves, and recent mergers and acquisitions.
Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.
Chapters 5 & 6: Analyze Immunoprotein Diagnostic Testing revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.
Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.
Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.
Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.
Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.
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FAQ
What is the current size of the Immunoprotein Diagnostic Testing Market?
A: In 2023, the Immunoprotein Diagnostic Testing Market was valued at US$ 9.4 billion, reflecting its strong industry presence.
Q2: How large is the Immunoprotein Diagnostic Testing Market expected to be by 2031?
A: By 2031, industry forecasts suggest the Immunoprotein Diagnostic Testing Market will grow to around US$ 15.8 billion, demonstrating significant expansion.
Q3: What is the growth rate of the Immunoprotein Diagnostic Testing Market?
A: The market is projected to expand at a compound annual growth rate (CAGR) of 6.9% during the forecast period from 2024 to 2031.
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