Diagnostic Contract Manufacturing Global Market Report 2024

The diagnostic contract manufacturing market size has grown rapidly in recent years. It will grow from $27.44 billion in 2023 to $31.29 billion in 2024 at a compound annual growth rate (CAGR) of 14%. The expansion observed in the historical period can be attributed to several factors. These include the rising demand for outsourcing, the cost efficiencies attained through outsourced manufacturing processes, heightened regulatory requirements for quality and compliance within the diagnostic industry, the shortened product lifecycles necessitating flexible manufacturing solutions, and the globalization of operations and supply chains among diagnostic companies.

The diagnostic contract manufacturing market size is expected to see rapid growth in the next few years. It will grow to $53.74 billion in 2028 at a compound annual growth rate (CAGR) of 14.5%. The anticipated growth in the forecast period can be attributed to several key factors. These include the increasing demand for personalized diagnostic tests and companion diagnostics, the expansion of point-of-care testing and decentralized diagnostic platforms, stricter regulatory requirements for diagnostic products, a rise in the outsourcing of specialty testing such as molecular diagnostics and immunoassays, and a shift towards more flexible manufacturing approaches. Moreover, significant trends expected in this period encompass the adoption of automation and robotics in diagnostic manufacturing processes, the utilization of 3D printing technologies for rapid prototyping and customization of diagnostic devices, the integration of artificial intelligence (AI) and data analytics into diagnostic manufacturing processes, and the implementation of digital twin technology to simulate and optimize manufacturing processes in the virtual environment before physical implementation.

The diagnostic contract manufacturing market is anticipated to experience growth driven by an increasing emphasis on preventive healthcare. Preventive healthcare involves actions taken to prevent the onset or progression of diseases, injuries, or illnesses. This focus is motivated by factors such as rising healthcare expenses, shifts in healthcare priorities, a surge in chronic diseases, and an aging population. Diagnostic contract manufacturing plays a pivotal role in promoting preventive healthcare by supplying essential diagnostic tools and tests, delivering tailored solutions, ensuring regulatory compliance and quality standards, supporting scalability, and enabling cost-effective approaches to disease prevention and early detection. For example, a report from Eurostat revealed a substantial 88.2% increase in expenditure on preventive healthcare in the EU in 2021 compared to the previous year, reaching 0.65% of GDP. Additionally, the share of total preventive care spending allocated to immunization programs rose significantly from 13.7% in 2020 to 29.1% in 2021, underscoring the importance of preventive healthcare in driving the diagnostic contract manufacturing market forward.

Key players in the diagnostic contract manufacturing sector are embracing strategic partnerships to bolster the production of diagnostic equipment and gain competitive advantages. Strategic partnerships entail collaborative endeavors between multiple organizations pooling their resources, expertise, and efforts to achieve shared objectives. For instance, Highfield Diagnostics Ltd., a UK-based diagnostics company, partnered with SCIENION GmbH, a Germany-based bio convergence company specializing in diagnostic contract manufacturing services, to develop and deploy equipment for mass manufacturing lateral flow tests (LFTs) incorporating HDx's flowDx technology. This collaboration leverages SCIENION's manufacturing capabilities to finalize equipment designs and manufacturing processes for the cost-effective and high-throughput production of flowDx-enabled LFTs. flowDx technology, developed over seven years of academic research, facilitates precise control of fluidic flows in LFTs, enabling parallel multiplexing, improved accuracy, and semi-quantitative results.

In August 2023, RQM Ltd., a US-based MedTech service provider, acquired Kottmann GmbH, aiming to enhance operational efficiency, expedite client market entry, and strengthen its position as a leading MedTech contract research organization (CRO) in Europe and globally. Kottmann GmbH, based in Germany, specializes in conducting clinical studies involving medical devices, in vitro diagnostics (IVDs), and pharmaceuticals.

Major companies operating in the diagnostic contract manufacturing market are Thermo Fisher Scientific Inc., Abbott Laboratories, Jabil Inc., Flex Ltd., Becton Dickinson and Company (BD), TE Connectivity Ltd., Sekisui Diagnostics LLC, Sanmina Corporation, Celestica Inc., Nipro Medical Corporation, Philips-Medisize Corporation, Plexus Corp, West Pharmaceutical Services Inc., Benchmark Electronics Inc., Bio-Rad Laboratories, QIAGEN N.V., Kimball Electronics Inc., Integer Holdings Corporation, Bio-Techne Corporation, Nolato AB, Nova Biomedical Corporation, Meridian Bioscience Inc., Fujirebio Inc., Biokit S.A., Invetech Pty. Ltd., KMC Systems, Savyon Diagnostics Ltd., Prestige Diagnostics U.K. Ltd., Cenogenic Corporation, Avioq Inc.

North America was the largest region in the diagnostic contract manufacturing market in 2023. The regions covered in the diagnostic contract manufacturing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the diagnostic contract manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Diagnostic contract manufacturing pertains to the practice of diagnostic companies outsourcing manufacturing processes and services to specialized contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs). This strategic move aims to streamline production, ensure compliance with quality standards, and improve cost efficiency for diagnostic companies.

The primary categories of services within diagnostic contract manufacturing encompass device development and manufacturing services, quality management services, packaging and assembly services, among others. Device development and manufacturing services encompass the design, development, and production of medical devices, including in vitro diagnostic devices and diagnostic imaging devices. These services find application in various sectors such as in-vitro diagnostic devices, diagnostic imaging devices, among others, and are utilized by end users such as medical device companies, pharmaceutical and biopharmaceutical companies, among others.

The diagnostic contract manufacturing market research report is one of a series of new reports that provides diagnostic contract manufacturing market statistics, including diagnostic contract manufacturing industry global market size, regional shares, competitors with an diagnostic contract manufacturing market share, detailed diagnostic contract manufacturing market segments, market trends and opportunities, and any further data you may need to thrive in the diagnostic contract manufacturing industry. This diagnostic contract manufacturing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The diagnostic contract manufacturing market includes revenues earned by entities through supply chain management, regulatory support, post-market surveillance, logistics, and distribution. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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