Automatic Immunoassay Analyzer Market Trends

Growth Drivers

• Advanced technologies: The implementation of innovations in terms of advanced technologies appreciably drives growth in the market. For instance, Abbott’s hallmark product, called Alinity HQ, which is an AI-based analyzer, reduces operational costs in labs by 26% that capturing 16.5% revenue share in 2024. Besides, the collaboration between Siemens and Dantari developed affordable ELISA analyzers, thereby boosting sales by 13.4%.

• Unmet medical needs in emerging nations: The existence of unmet medical needs and healthcare disparities in emerging nations drives growth in the market. In this regard, MHLW in 2024 unveiled that over 38% of rural clinics in Japan lack immunoassay systems, which encourages international players to establish their footprint in the country. Further, in India, only 29% of labs comprise automated systems, creating a USD 1.2 billion opportunity for the leaders.

Historical Patient Growth and Its Impact on Market Expansion

The global market witnessed notable expansion, constituting an expanded patient base with the growing burden of chronic and infectious diseases over the last decade. There has been a surge in the patient pool requiring routine diagnostic immunoassays across the U.S., Europe, and Asia Pacific owing to the presence of aging populations, disease screening initiatives, and advancements in automated testing technologies. Hence, this has created a significant opportunity for the market with laboratory automation becoming a priority for healthcare facilities.

Historical Patient Growth (2010–2020) in Key Markets

Manufacturer Strategies Driving Market Expansion in Automatic Immunoassay Analyzers

The market comprises the presence of key manufacturers constantly making efforts to strengthen their global ecosystems. Key tactical strategies adopted by the firms include well-planned partnerships, product differentiation, and geographic expansion into emerging nations. For instance, in 2023, the U.S. FDA reported that Roche Diagnostics launched AI-integrated Cobas Pro systems that reduce processing time by 32.5%, and it captured 20.4% market share growth, reflecting a heightened adoption. Further, the future growth of the market relies on cost optimization and regulatory compliance, thereby creating an optimistic opportunity for manufacturers across the world.

Revenue Opportunities for Manufacturers (2023–2025)

Challenges

• Delay in regulatory approvals: The complicated procedures involved in the regulatory approvals create substantial barriers for the market to capture an optimal manufacturing base. For instance, in 2023 in Japan, the PMDA backlog led to six months of delayed approval timelines owing to a stringent clinical review duration. Further, the EU’s IVDR transition created a measurable impact on 32% of niche manufacturers, with a risk of non-compliance threatening supply chain stability.

• Barriers in terms of patient affordability: This is yet another factor negatively impacting the expansion of the market. ICMR report in 2024 notes that in India, over 58% of patients spend USD 60 to USD 250 per immunoassay, making it challenging for patients to afford them. However, to tackle this, Abbott introduced affordable tests with 43% reduced prices in Brazil with domestic production of the Alinity HQ system, there beneficial for the overall market.