IVD Contract Manufacturing

Global IVD Contract Manufacturing Market to Reach US$29.5 Billion by 2030

The global market for IVD Contract Manufacturing estimated at US$16.7 Billion in the year 2024, is expected to reach US$29.5 Billion by 2030, growing at a CAGR of 10.0% over the analysis period 2024-2030. Consumables, one of the segments analyzed in the report, is expected to record a 8.5% CAGR and reach US$17.2 Billion by the end of the analysis period. Growth in the Equipment segment is estimated at 12.4% CAGR over the analysis period.

The U.S. Market is Estimated at US$4.5 Billion While China is Forecast to Grow at 13.4% CAGR

The IVD Contract Manufacturing market in the U.S. is estimated at US$4.5 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$6.0 Billion by the year 2030 trailing a CAGR of 13.4% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 7.3% and 8.7% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 7.8% CAGR.

IVD Contract Manufacturing Market – Key Trends & Drivers Summarized

In-vitro diagnostics (IVD) contract manufacturing has become an essential part of the global diagnostic industry, enabling medical device companies to outsource the production of reagents, consumables, and diagnostic instruments to specialized third-party manufacturers. With the rising demand for rapid and accurate diagnostic solutions, IVD companies are increasingly turning to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) to scale production, optimize costs, and accelerate market entry. The growing complexity of molecular diagnostics, immunoassays, point-of-care testing (POCT), and companion diagnostics has further fueled the need for high-quality, regulatory-compliant contract manufacturing solutions.

The expansion of precision medicine, digital diagnostics, and automation in laboratory testing is reshaping the IVD landscape, leading to greater outsourcing of assay development, reagent formulation, and device assembly. With healthcare providers demanding faster, cost-effective, and scalable testing solutions, IVD contract manufacturing is becoming a strategic necessity for companies looking to stay competitive in a rapidly evolving market.

How Are Technological Advancements Enhancing IVD Contract Manufacturing?

The IVD contract manufacturing sector is experiencing significant technological advancements aimed at improving production efficiency, quality control, and scalability. One of the most critical innovations is the integration of automation and robotics into manufacturing workflows. Automated systems are now being used for liquid handling, reagent dispensing, and high-throughput assay production, reducing human error and enhancing process consistency. This is particularly beneficial for molecular diagnostic kits, lateral flow assays, and immunoassays, where precision and reproducibility are crucial.

Another major breakthrough is the adoption of single-use bioprocessing technologies for the manufacturing of IVD reagents and assay components. The use of disposable bioreactors, microfluidic chips, and pre-filled reagent cartridges has improved sterility, contamination control, and batch-to-batch consistency, making contract manufacturing more efficient and cost-effective. Additionally, advances in 3D printing and microfabrication are enabling the rapid prototyping and customization of diagnostic devices, accelerating the development cycle for next-generation IVD solutions.

The rise of molecular diagnostics and personalized medicine has also led to improvements in custom assay development and biomarker-based test manufacturing. IVD contract manufacturers are now utilizing high-throughput sequencing (NGS), CRISPR-based assays, and digital PCR (dPCR) platforms to develop specialized diagnostic solutions tailored to oncology, infectious diseases, and genetic disorders. Moreover, the incorporation of artificial intelligence (AI) and machine learning into quality control processes is improving real-time monitoring, predictive maintenance, and batch optimization in contract manufacturing facilities.

What Market Trends Are Driving the Growth of IVD Contract Manufacturing?

Several key trends are shaping the IVD contract manufacturing industry, driving increased outsourcing and technological innovation. One of the most significant trends is the growing demand for point-of-care testing (POCT) and decentralized diagnostics. The shift from traditional laboratory-based testing to portable, rapid, and user-friendly diagnostic solutions has led to a surge in contract manufacturing partnerships for lateral flow assays, microfluidic test strips, and handheld molecular diagnostics. With global health initiatives emphasizing early disease detection and remote healthcare, IVD companies are outsourcing POCT production to specialized CMOs with expertise in scalable, high-quality manufacturing.

Another major trend is the expansion of molecular and companion diagnostics in response to the rise of precision medicine and targeted therapies. Pharmaceutical companies and biotech firms are increasingly collaborating with IVD manufacturers to develop companion diagnostics (CDx) that enable personalized treatment selection based on genetic and biomarker profiling. This has fueled the need for highly specialized contract manufacturing services that can produce PCR-based, next-generation sequencing (NGS), and CRISPR-enabled diagnostic assays at commercial scale.

The increasing regulatory complexity in IVD manufacturing is also driving companies toward outsourced production solutions. With stricter FDA, EMA, and ISO 13485 requirements for diagnostic devices, many companies are partnering with experienced CDMOs that have established regulatory expertise, validated production lines, and Good Manufacturing Practice (GMP)-compliant facilities. By outsourcing production, IVD firms can accelerate regulatory approvals, reduce compliance risks, and ensure consistent quality control across global markets.

Additionally, supply chain optimization and cost reduction pressures are leading IVD companies to outsource raw material sourcing, reagent formulation, and device assembly to CMOs with well-established procurement networks and cost-efficient production capabilities. With the rise of global supply chain disruptions, manufacturers are seeking contract partners that offer localized production, dual-sourcing strategies, and flexible manufacturing capacities to ensure uninterrupted product availability.

What Is Driving the Growth of the IVD Contract Manufacturing Market?

The IVD contract manufacturing market is expanding rapidly due to several key growth drivers, including increased demand for rapid diagnostics, outsourcing trends in healthcare, and advancements in diagnostic technology. One of the primary factors propelling market growth is the widespread adoption of molecular and immunodiagnostic tests in the detection of infectious diseases, oncology biomarkers, and genetic disorders. With an aging population, rising prevalence of chronic diseases, and global pandemic preparedness, the need for high-throughput, reliable, and cost-effective diagnostic solutions has surged, leading IVD companies to rely on contract manufacturing for large-scale production.

Another major growth driver is the rising adoption of contract manufacturing by small and mid-sized biotech firms. Many startups and emerging diagnostic companies lack in-house manufacturing capabilities and instead leverage CMOs to scale up production, navigate regulatory challenges, and accelerate market entry. By partnering with experienced IVD contract manufacturers, these companies can focus on research and innovation while ensuring high-quality, GMP-compliant production.

The increasing role of AI and digital transformation in diagnostics is also fueling the need for customized contract manufacturing solutions. As AI-powered diagnostics, cloud-based test management platforms, and wearable biosensors gain traction, IVD manufacturers require contract production partners with expertise in smart manufacturing, automated quality control, and real-time analytics. These next-generation manufacturing solutions are helping companies streamline production, improve test accuracy, and enhance scalability.

Additionally, the geographic expansion of IVD manufacturing hubs is driving market growth. While the U.S., Europe, and Japan continue to lead in diagnostic innovation, countries in Asia-Pacific (China, India, South Korea, and Singapore) are emerging as key contract manufacturing destinations due to their cost advantages, skilled labor force, and favorable government policies supporting biotech and medtech investments. Many global IVD companies are shifting manufacturing operations to Asia-Pacific to benefit from lower production costs, strong infrastructure, and high-volume manufacturing capabilities.

Lastly, the increasing focus on sustainability and green manufacturing is reshaping the IVD contract manufacturing landscape. Companies are exploring eco-friendly production techniques, biodegradable test components, and energy-efficient manufacturing processes to minimize waste, reduce carbon footprints, and comply with environmental regulations. As sustainability becomes a key consideration for diagnostic manufacturers and healthcare providers,

SCOPE OF STUDY:

The report analyzes the IVD Contract Manufacturing market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Type (Consumables, Equipment); Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation & Hemostasis, Others); Service (Manufacturing, Assay Development, Others)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 36 Featured) -

• Advanced Powder Products, Inc.
• Argonaut Manufacturing Services
• Avioq, Inc.
• Beacon MedTech Solutions
• Bio-Techne
• Celestica Inc.
• Donatelle
• ERREKA Medical
• Eurogentec
• Fujirebio
• Grand River Aseptic Manufacturing (GRAM)
• Invetech
• IRP Medical
• IVD Research, Inc.
• Jabil Inc.
• Newland AIDC
• Qosina
• Sanmina Corporation
• TE Connectivity
• West Pharmaceutical Services, Inc.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

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