The global in vitro diagnostics contract manufacturing market size was estimated at USD 21.1 billion in 2024 and is projected to reach USD 37.45 billion by 2030, growing at a CAGR of 10.4% from 2025 to 2030. A key driver behind this expansion is the continuous advancement of the healthcare sector, which is fueling the demand for more efficient and scalable diagnostic solutions.

One of the primary contributors to this growth is the rising global demand for fast, accurate, and reliable diagnostic testing. In vitro diagnostics play a crucial role in enhancing the speed, precision, and overall quality of disease detection, diagnosis, and prevention, thereby improving patient care outcomes. The increasing burden of chronic diseases worldwide—such as diabetes, cardiovascular conditions, and cancer—has further underscored the need for high-quality diagnostic tools.

Additionally, the growing demand for personalized medicine, which requires tailored diagnostic solutions to guide targeted treatments, is further accelerating the need for advanced IVD manufacturing capabilities. Another significant factor influencing market dynamics is the tightening of regulatory oversight, as authorities aim to ensure the safety, reliability, and efficacy of diagnostic tests.

For example, in July 2023, the U.S. Food and Drug Administration (FDA) renewed its efforts to regulate laboratory-developed tests (LDTs) by classifying them as medical devices. Later, in September 2023, the FDA proposed that LDT manufacturers adhere to existing medical device laws and regulations. The implementation of these regulatory requirements is expected to be phased in gradually from 2024 through 2028.

Moreover, the COVID-19 pandemic significantly boosted the demand for IVD contract manufacturing services, as diagnostic tools became essential for screening, diagnosing, and monitoring the virus. The widespread use of IVDs during this period demonstrated their critical value in public health response efforts. These technologies not only contributed to faster patient diagnosis and treatment but also helped reduce hospital stays, improve overall population health outcomes, lower healthcare costs, and positively impact economic productivity—all of which are further supporting market expansion.

Key Market Trends Insights:

• In 2024, the North America in vitro diagnostics (IVD) contract manufacturing market emerged as the dominant regional market, capturing the largest global share of 41.83%. This strong position is largely attributed to the region’s advanced healthcare infrastructure, high adoption of innovative diagnostic technologies, and the presence of several major contract manufacturing organizations.

• Within North America, the United States represents the largest contributor to the region’s IVD contract manufacturing market. The country’s leadership can be credited to factors such as significant healthcare spending, strong demand for personalized and high-precision diagnostics, and a well-established regulatory framework that supports the development and commercialization of IVD products.

• When segmented by product type, the reagents and consumables category accounted for the largest revenue share of 69.41% in 2024. This dominance highlights the essential role these components play in the operation of diagnostic tests, particularly in high-volume testing environments. The continual demand for reliable, high-quality reagents and consumables is driven by both routine clinical use and the ongoing need for disease surveillance and chronic disease management.

• In terms of service offerings, manufacturing services represented the largest market share in 2024. This reflects the growing trend of outsourcing manufacturing operations to specialized contract manufacturers, enabling diagnostic companies to scale production efficiently, maintain quality, and meet regulatory standards without the need for extensive in-house facilities.

• From a technological perspective, the immunoassays segment led the market with the largest revenue share in 2024. Immunoassays are widely used due to their sensitivity, specificity, and versatility in detecting a broad range of biomarkers. Their applications across infectious disease testing, oncology, and chronic disease monitoring continue to drive demand within the IVD contract manufacturing space.

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Market Size Forecast:

• 2024 Market Size: USD 21.1 Billion

• 2030 Projected Market Size: USD 37.45 Billion

• CAGR (2025-2030): 10.4%

• North America: Largest market in 2024

• Asia Pacific: Fastest growing market

Key Companies Market Share Insights:

Leading players in the in vitro diagnostics contract manufacturing market are actively pursuing a variety of strategic initiatives aimed at strengthening their position within the industry and enhancing their competitive advantage. These initiatives include acquisitions, strategic partnerships, geographical expansions, formal agreements, and collaborative ventures. Such efforts are playing a crucial role in driving overall market growth by enabling companies to broaden their capabilities, diversify their product portfolios, and extend their reach into new and existing markets.

For example, in November 2023, Newland EMEA announced the launch of a new in vitro diagnostics product line specifically tailored for the healthcare sector. This strategic move reflects the company's commitment to expanding its presence in the rapidly growing IVD market and addressing the rising demand for advanced diagnostic solutions. Initiatives like these not only contribute to a company’s growth trajectory but also stimulate innovation and competition within the industry, further accelerating the development and availability of high-quality diagnostic products and services.

Key Players

• Jabil Inc.

• Sanmina Corporation

• TE Connectivity

• Celestica Inc.

• Savyon Diagnostics

• West Pharmaceutical Services, Inc.

• Thermo Fisher Scientific

• KMC Systems

• Cenogenics Corporation

• Novo Biomedical

• Cone Bioproducts

• Invetech

• AVIOQ Inc.

• Meridian Bioscience Inc.

• Nemera

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Conclusion:

The in vitro diagnostics (IVD) contract manufacturing market is undergoing strong expansion, driven by rising global demand for precise, rapid diagnostic testing and a growing reliance on outsourcing to specialized manufacturing partners. Key growth enablers include technological advancements, streamlined and cost-efficient production processes, and heightened regulatory standards that encourage manufacturers to outsource. As healthcare providers and diagnostic developers increasingly focus on innovation and speed to market, they are partnering with contract manufacturing organizations (CMOs/CDMOs) to access scalable, compliant, and technologically advanced manufacturing capabilities.