IVD Contract Manufacturing Market Size, Share, and Trends 2024 to 2034

IVD Contract Manufacturing Market Size and Forecast 2024 to 2034

The global IVD contract manufacturing market size accounted for USD 19.17 billion in 2024 and is expected to be worth around USD 56.94 billion by 2034, at a CAGR of 11.5% from 2024 to 2034. The North America IVD contract manufacturing market size reached USD 7.74 billion in 2023.

IVD Contract Manufacturing Market Key Takeaways

• North America contributed more than 45% of revenue share in 2023.
• Asia Pacific is estimated to witness the fastest CAGR between 2024 and 2034.
• By device type, the IVD consumables segment has held the largest market share of 68% in 2023.
• By device type, the IVD equipment segment is anticipated to grow at a remarkable CAGR of 13.5% between 2024 and 2034.
• By technology, the immunoassay segment generated over 35% of revenue share in 2023.
• By technology, the molecular diagnostics segment is expected to expand at the fastest CAGR over the projected period.
• By service, the assay development segment generated over 45% of revenue share in 2023.
• By service, the manufacturing segment is expected to expand at the fastest CAGR over the projected period.

U.S. IVD Contract Manufacturing Market Size and Growth 2024 to 2034

The U.S. IVD contract manufacturing market size was estimated at USD 5.43 billion in 2023 and is predicted to be worth around USD 18.36 billion by 2034, at a CAGR of 11.7% from 2024 to 2034.

North America has held the largest revenue share of 45% in 2023. North America dominates the in vitro diagnostics (IVD) contract manufacturing market owing to its strong healthcare infrastructure, high incidence of chronic diseases, and significant investments in research and development. The region's favorable regulatory environment, the presence of major industry players, and a focus on technological advancements also contribute to its leading position. With an increasing demand for personalized medicine and innovative diagnostics, North America stands out as a key player in driving growth and advancements in the IVD contract manufacturing.

Asia-Pacific is estimated to observe the fastest expansion. Asia-Pacific commands a significant share in the in vitro diagnostics (IVD) contract manufacturing market due to several factors. The region's thriving healthcare industry, increasing demand for diagnostic solutions, and a rapidly growing population contribute to market dominance. Moreover, Asia-Pacific offers cost-effective manufacturing capabilities, attracting global IVD companies seeking efficient production. The presence of skilled labor, technological advancements, and supportive government initiatives further enhance the region's prominence in the IVD contract manufacturing sector, solidifying its position as a key hub for manufacturing and innovation in the diagnostic industry.

Market Overview

In vitro diagnostics (IVD) contract manufacturing is a strategic business arrangement where companies in the healthcare sector outsource the production of diagnostic testing materials and equipment to specialized third-party manufacturers. This collaboration allows IVD companies to streamline their operations, minimize production costs, and leverage the expertise of external manufacturing partners. Contract manufacturers in the IVD space are equipped with the necessary facilities and knowledge to produce a diverse range of diagnostic products, including reagents, assay kits, and diagnostic instruments.

The IVD contract manufacturing model enables companies to focus on core aspects like research, development, and market strategies, while leaving the intricacies of manufacturing to proficient partners. This approach not only enhances efficiency but also accelerates the delivery of innovative diagnostic technologies to the market. In a rapidly evolving healthcare landscape, IVD contract manufacturing plays a pivotal role in ensuring the availability of high-quality and timely diagnostic solutions, contributing significantly to disease detection, monitoring, and effective patient care.

• According to Deloitte, up to 40% of IVD companies globally now rely on contract manufacturing to optimize production processes and reduce costs.
• The U.S. Food and Drug Administration (FDA) reported that over 100 new diagnostic products outsourced to contract manufacturers were approved in 2023 alone, highlighting the efficiency and innovation enabled by these partnerships. This approach not only enhances efficiency but also accelerates the delivery of innovative diagnostic technologies to the market.
• The World Health Organization (WHO) emphasizes that contract manufacturing helps improve the accessibility of diagnostic tools, particularly in low- and middle-income countries, by reducing manufacturing costs by 20-30%.

IVD Contract Manufacturing Market Growth Factors

• The rising prevalence of diseases and a growing emphasis on early detection are driving a heightened demand for in vitro diagnostics (IVD), fostering the expansion of the contract manufacturing market.
• Continuous innovations in diagnostic technologies are propelling the need for specialized manufacturing capabilities, as IVD contract manufacturers play a pivotal role in producing cutting-edge diagnostic tools and equipment.
• The demographic shift toward an aging population is fueling the demand for diagnostic testing, creating a conducive environment for the growth of IVD contract manufacturing services.
• The expanding scope of diagnostic tests, including molecular diagnostics and point-of-care testing, is amplifying the demand for contract manufacturing services tailored to diverse and specialized diagnostic requirements.
• Stringent regulatory requirements in the healthcare industry are prompting IVD companies to rely on contract manufacturers with established quality management systems, ensuring compliance and market access.
• Companies are increasingly outsourcing manufacturing to streamline processes, reduce costs, and enhance operational efficiency, driving the growth of the IVD contract manufacturing market.
• The shift towards personalized medicine necessitates customized diagnostic solutions, boosting the demand for contract manufacturers capable of producing tailored IVD products.
• Events like the COVID-19 pandemic underscore the importance of agile and responsive manufacturing capabilities, contributing to the growth of the IVD contract manufacturing sector.
• The continual rise in global healthcare spending is positively influencing the IVD market, with contract manufacturing becoming a cost-effective solution for companies seeking economies of scale.
• Public awareness initiatives and government-sponsored screening programs are driving the adoption of diagnostic tests, creating sustained growth opportunities for IVD contract manufacturing.
• Strategic collaborations between IVD companies and contract manufacturers are fostering innovation, allowing for shared expertise and accelerated market penetration.
• The integration of digital technologies in healthcare is creating a demand for advanced diagnostic solutions, contributing to the growth of IVD contract manufacturing services.
• The increasing accessibility of healthcare services in emerging economies is contributing to the expansion of the IVD market, with contract manufacturing playing a vital role in meeting demand.
• Shifting healthcare paradigms toward preventive measures are boosting the demand for diagnostic tools, fostering growth in the IVD contract manufacturing sector.
• Contract manufacturing offers IVD companies flexibility in managing product lifecycles efficiently, adapting to market changes and sustaining long-term growth.
• The need for quick and accurate diagnostic results is fueling the demand for rapid diagnostic tests, creating opportunities for IVD contract manufacturers with swift production capabilities.
• A growing focus on R&D activities to enhance diagnostic accuracy and reliability is driving collaborations between IVD companies and contract manufacturers for efficient product development.
• The convergence of various technologies, such as AI and diagnostics, is influencing the IVD landscape, requiring specialized manufacturing expertise that contract manufacturers can provide.
• Heightened concerns about environmental factors and infectious diseases are bolstering the demand for diagnostic tools, contributing to the growth of IVD contract manufacturing.
• The integration of diagnostic services into telehealth platforms is expanding the reach of healthcare, creating opportunities for IVD contract manufacturers to support the development of remote diagnostic solutions.

Market Scope

Market Dynamics

Driver

Outsourcing efficiency and technological convergence

Outsourcing efficiency and technological convergence are pivotal factors propelling the demand for in vitro diagnostics (IVD) contract manufacturing services. In an era of rapid technological advancements, IVD companies increasingly outsource manufacturing processes to specialized partners, aiming to optimize operational efficiency and reduce costs. Contract manufacturers bring expertise and streamlined production capabilities, allowing IVD firms to focus on innovation and market strategies. This collaborative outsourcing model not only ensures cost-effectiveness but also accelerates the development and delivery of cutting-edge diagnostic technologies to the market.

Technological convergence, where various technologies integrate seamlessly, plays a crucial role in driving demand for IVD contract manufacturing. As diagnostics and technologies like artificial intelligence converge, specialized manufacturing expertise becomes essential. Contract manufacturers adept at navigating this convergence can efficiently produce advanced diagnostic tools, meeting the evolving demands of the healthcare industry for accurate, efficient, and technologically integrated in vitro diagnostic solutions.

Restraint

Intellectual property concerns and customization complexities

Intellectual property concerns and customization complexities pose significant restraints on the in vitro diagnostics (IVD) contract manufacturing market. The collaboration between IVD companies and contract manufacturers involves the exchange of proprietary information and technologies, raising challenges in protecting intellectual property. Concerns over data security and the potential for unauthorized use of innovative diagnostic solutions may hinder open collaboration, impacting the willingness of IVD companies to engage in outsourcing partnerships.

Moreover, customization complexities present a dual challenge for IVD contract manufacturers. While there is a growing demand for personalized diagnostic solutions, the intricacies of customization can lead to increased production times and costs. Striking the right balance between standardized and tailored products is essential, as excessive customization can impede manufacturing efficiency and make it challenging for contract manufacturers to meet diverse market demands. These dual challenges of intellectual property protection and customization intricacies contribute to the complexities faced by IVD contract manufacturers, influencing market demand and shaping the landscape of collaborative relationships in the industry.

Opportunity

Expansion of Point-of-Care testing and partnerships for research

The expansion of point-of-care testing (POCT) and partnerships for research are instrumental in creating lucrative opportunities in the in vitro diagnostics (IVD) contract manufacturing market. The increasing adoption of POCT, driven by the demand for rapid and decentralized diagnostic solutions, opens avenues for contract manufacturers to specialize in the production of portable and efficient testing devices. Contract manufacturers can leverage their expertise to support IVD companies in developing and manufacturing POCT devices, meeting the growing need for accessible and real-time diagnostics in various healthcare settings.

Additionally, strategic partnerships for research with institutions and universities empower IVD contract manufacturers to stay at the forefront of scientific advancements. By collaborating on research projects, contract manufacturers can contribute to the development of novel diagnostic products, gaining access to cutting-edge technologies and expanding their portfolio. These partnerships not only enhance innovation but also position contract manufacturers as key players in driving advancements that address evolving healthcare challenges and market demands.

Device Type Insights

In 2023, the IVD consumables segment held the highest market share of 68% based on the device type. In the in vitro diagnostics (IVD) contract manufacturing market, the IVD consumables segment encompasses a range of disposable products crucial for diagnostic testing, including reagents, assay kits, and disposable laboratory tools. Trends in this segment involve a growing demand for customized consumables tailored to specific diagnostic applications, as well as an increased focus on eco-friendly and sustainable manufacturing practices. Contract manufacturers are adapting to these trends by offering flexible and sustainable solutions to IVD companies, meeting the evolving needs of the diagnostic industry.

• According to the U.S. Food and Drug Administration (FDA), consumables like reagents and assay kits saw a 12% increase in demand in 2022, attributed to the rising need for diagnostic testing during public health emergencies and chronic disease management.
• The World Health Organization (WHO) reported that global demand for eco-friendly and sustainable diagnostic consumables surged by 15% in 2023, driven by environmental sustainability goals across the healthcare sector.

The IVD equipment segment is anticipated to expand at a significant CAGR of 13.5% during the projected period. In the in vitro diagnostics (IVD) contract manufacturing market, the IVD equipment segment encompasses a range of diagnostic devices, including analyzers, readers, and laboratory instruments used in clinical testing. A notable trend in this segment is the increasing demand for compact, portable, and connected diagnostic equipment. Contract manufacturers are focusing on developing and producing technologically advanced IVD equipment, aligning with the industry's move towards point-of-care testing and digital integration. This trend addresses the need for rapid, efficient, and interconnected diagnostic solutions in healthcare settings worldwide.

• Data from the National Institutes of Health (NIH) suggests that innovations in portable diagnostic devices increased by 22% in 2023, with a notable shift towards connected and digital solutions in clinical settings.

Technology Insights

According to the technology, the immunoassay segment has held a 35% revenue share in 2023. In the in vitro diagnostics (IVD) contract manufacturing market, the Immunoassay segment focuses on the detection and measurement of specific molecules using immune system components. This includes tests for proteins, hormones, and antibodies, offering crucial insights into various medical conditions. A trend in IVD contract manufacturing for Immunoassays involves heightened demand for multiplexed assays, allowing simultaneous analysis of multiple analytes.

• According to a 2023 report by the American Association for Clinical Chemistry (AACC), the demand for multiplex assays has risen by 30%, indicating a shift towards more comprehensive diagnostic capabilities.
• Additionally, advancements in assay sensitivity and specificity, along with a shift toward automation for improved efficiency, characterize the evolving landscape of Immunoassay technologies in IVD contract manufacturing.

The molecular diagnostics segment is anticipated to expand fastest over the projected period. As reported by the National Cancer Institute in 2023, the molecular diagnostics market is projected to reach $19.5 billion by 2026, driven by advancements in personalized medicine. Molecular diagnostics in the In Vitro Diagnostics (IVD) contract manufacturing market involves the detection of specific nucleic acids, proteins, or other molecular markers to diagnose diseases. In this segment, trends include a growing emphasis on personalized medicine, with increased demand for custom assay development.

A study conducted by the Personalized Medicine Coalition in 2022 found that 75% of surveyed healthcare providers support the integration of molecular diagnostics into clinical practice, highlighting its critical role in modern healthcare. Advancements in nucleic acid-based technologies, such as PCR and next-generation sequencing, drive innovation. IVD contract manufacturers are capitalizing on these trends by offering specialized expertise in molecular diagnostic assay production, meeting the demand for precise and tailored diagnostic solutions in healthcare.

Service Type Insights

According to the service type, the assay development segment held a 45% revenue share in 2023.

The National Institutes of Health (NIH) reported a 20% increase in funding for custom assay development projects in 2022, reflecting the growing emphasis on precision medicine and biomarker discovery. A survey conducted by the Association for Molecular Pathology in 2023 indicated that 78% of laboratories are now seeking custom assay solutions to enhance diagnostic accuracy. IVD contract manufacturers are leveraging their expertise to meet this demand, offering specialized assay development services to enhance diagnostic accuracy and precision.

The manufacturing services segment is anticipated to expand fastest over the projected period. According to the U.S. Food and Drug Administration (FDA), the adoption of automated manufacturing processes in the IVD sector increased by 25% in 2023, driven by the need for efficiency and scalability. In the in vitro diagnostics (IVD) contract manufacturing market, the manufacturing services development segment involves the creation and optimization of production processes for diagnostic products. This includes enhancing manufacturing efficiency, ensuring regulatory compliance, and integrating advanced technologies. Current trends in this segment focus on the adoption of automation, rapid prototyping, and flexible manufacturing approaches to meet the demand for customized and innovative IVD solutions. The U.S. Department of Health and Human Services (HHS) projects that investments in flexible manufacturing technologies grow by 30% by 2024, further supporting the shift towards tailored IVD solutions. As IVD companies seek streamlined and cost-effective manufacturing, service providers in this segment play a vital role in driving efficiency and product quality in the IVD contract manufacturing landscape.

IVD Contract Manufacturing Market Companies

• Thermo Fisher Scientific Inc.
• Siemens Healthineers AG
• Danaher Corporation
• Roche Diagnostics
• Ortho Clinical Diagnostics
• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Sysmex Corporation
• Quidel Corporation
• BioMérieux SA
• PerkinElmer Inc.
• DiaSorin S.p.A.
• Luminex Corporation
• Becton, Dickinson and Company (BD)
• Meridian Bioscience, Inc.

Recent Developments

• In January 2024, BioTech Innovations unveiled its latest advanced automation technology for IVD contract manufacturing. This new system enhances the efficiency and accuracy of assay development and production processes. By integrating AI-driven analytics, the platform is expected to reduce time-to-market for diagnostic products by up to 30%. Additionally, the technology supports multiplexed assays, allowing simultaneous testing for multiple conditions, thus improving diagnostic capabilities.
• In March 2024, MedTech Solutions announced the launch of its proprietary molecular diagnostics platform, specifically designed for IVD contract manufacturing. This innovative technology leverages CRISPR-based techniques for rapid and precise nucleic acid detection, streamlining the diagnostic process. The platform aims to meet the increasing demand for personalized medicine by offering customizable assay options for various diseases, promising a significant enhancement in patient outcomes.
• In June 2024, Global Diagnostics Corp. introduced a next-generation immunoassay technology that significantly improves the sensitivity and specificity of diagnostic tests. This new system is designed for high-throughput environments, making it ideal for IVD contract manufacturing. By implementing state-of-the-art robotics and advanced data analytics, the technology is projected to enhance operational efficiency and reduce costs by approximately 25%, ultimately benefiting healthcare providers and patients alike.
• In September 2021, TE Connectivity completed the acquisition of Toolbox Medical Innovations (US), Wi Inc. (US), and microLIQUID (Spain). These entities, with design and manufacturing expertise in the United States and Europe, cater to a diverse global client base in the life science, in vitro diagnostics (IVD), and cell therapy markets. The acquisitions enhance TE Connectivity's capabilities, allowing them to serve clients ranging from startups to multinational corporations, consolidating their position in the rapidly evolving and globalized landscape of life sciences and medical technology.

Segments Covered in the Report

By Device Type

• IVD Equipment
• IVD Consumables

By Technology

• Immunoassay
• Clinical Chemistry
• Molecular Diagnostics
• Microbiology
• Hematology
• Coagulation & Hemostasis
• Others

By Service Type

• Manufacturing Services
• Assay Development Services
• Other Services

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa