IVD Contract Manufacturing Market Size, Share & Trends Analysis Report By Type of Nanoparticle Formulated (Organic, Inorganic, and Carbon-based Nanoparticles), By Organic Nanoparticle Formulated, By Inorganic Nanoparticle Formulated, By Scale of Operation, Region, And Segment Forecasts, 2025-2034

IVD Contract Manufacturing Market Size is valued at 15.88 billion in 2024 and is predicted to reach 50.50 billion by the year 2034 at a 12.4% CAGR during the forecast period for 2025-2034.

Key Industry Insights & Findings from the Report:

• The growing occurence of infectious diseases and the need for early diagnosis drive the demand for IVD devices, which in turn drives the growth of the IVD contract manufacturing market.
• Increasing regulatory complexities are driving IVD companies to outsource manufacturing to contract manufacturers, driving growth in the IVD Contract Manufacturing Market.
• Asia Pacific region dominated the 2023 market and accounted for a global revenue share.
• The certifications and appprovals are one of the key challenges hindering the growth of the IVD contract manufacturing market.

In vitro diagnostics (IVDs) are medical instruments/devices that use biological samples, such as blood or tissue, to diagnose various diseases and infections. IVD tests and assays range from simple tests like SARS-CoV-2 tests to complex laboratory IVD tools.

The global IVD market is the largest segment of the medical technology industry and is expanding with healthcare investments and an increasing focus on early detection and preventive care. The IVD industry is constantly evolving to meet the needs of clinical demands and personalized treatments.

The main reasons for the growth of this market are increasing demand for cheaper and better products, IVD OEMs gaining a foothold in the capital market, and the reduced risk of development failure. Additionally, the emergence of CMO facilities in various countries will likely boost the IVD contract manufacturing market in the next few years. However, growing shortages of skilled workers, the risk of patent infringement and other concerns about intellectual property security are holding back business growth. 

Competitive Landscape:

Some of the Key Players in the IVD Contract Manufacturing Market :

• Avioq Inc.
• Biokit
• Celestica Inc.
• Cenogenics Corporation
• Cone Bioproducts
• Fujirebio
• Invetech
• Jabil Inc.
• Kimball Electronics, Inc.
• Kmc Systems
• Meridian Biosciences
• Nemera
• Nolato Gw, Inc.
• Nova Biomedical
• Phillips Medsize Corporation
• Sanmina Corporation
• Savyon Diagnosticss
• Stratec
• Te Connectivity Ltd.
• Thermofisher
• Viant Medical Holdings Inc.
• West Pharmaceutical Services
• Other Prominent Players

Market Segmentation:

The IVD contract manufacturing market is segmented based on device type, technology, and services. The device type segment comprises IVD Equipment and IVD Consumables. By technology, the market is bifurcated into immunoassay, clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation & hemostasis, and others. By services, the market is categorized into manufacturing services, assay development services, and other services.

The IVD Equipment is expected to drive the IVD contract manufacturing market in the upcoming years

IVD contract manufacturing is surging rapidly. There are many reasons why businesses choose to outsource their IVD production. Maybe they have insufficient facilities for manufacturing large quantities in-house, or they don't have the necessary skills. Here, contractor manufacturers play an essential role in providing high-quality, low-cost, and efficient products as compared to what businesses can achieve on their own. Moreover, contracting companies can often provide more services than the business itself can provide.

This contracting facility is also beneficial for startups and small-scale companies to design, produce and sell their equipment. For instance, in November 2022, Jabil Inc. expanded its developmental capabilities by opening a design center in Wrolaw, Poland. This would allow the company to develop leading-edge technologies for multiple industries, including the automotive and healthcare sectors.

The Assay Development segment is growing at the highest rate in the IVD contract manufacturing market

Many outsourced companies in the IVD field choose to offer assay development services as they have limited financial capacity. Factors such as resource availability, growth and efficiency of R&D, reduced development time, lower cost, high efficiency, and expertise in assay development are considered to be the driving factors for the IVD contract manufacturing market.

Regionally, Asia Pacific led the IVD contract manufacturing market in 2022

Asia Pacific IVD contract manufacturing market dominated in 2022 and is expected to continue the same over the forecast period 2023-2031. The growth of this market can be attributed to rising demand for in vitro diagnostic tests, increased prevalence of diseases & infections, and growing mergers and acquisitions in the IVD sector.

Recent Developments:

• In March 2024, Fujirebio and Beckman Coulter Extended Their Collaboration to Develop Blood-Based Neurodegenerative Disease Diagnostics That Are Patient-Friendly. Fujirebio and Beckman Coulter worked together to develop novel biomarkers that corresponded with monoclonal antibody-based Alzheimer's disease therapeutics that were recently approved.

IVD Contract Manufacturing Market Report Scope:

Segmentation of IVD Contract Manufacturing Market -

IVD Contract Manufacturing Market By Device Type-

• IVD Equipment
• IVD Consumables

IVD Contract Manufacturing Market By Technology-

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

IVD Contract Manufacturing Market By Services-

• Manufacturing Services
• Assay Development Services
• Other Services

IVD Contract Manufacturing Market By Region-

North America-

• The US
• Canada

Europe-

• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific-

• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific

Latin America-

• Brazil
• Argentina
• Mexico
• Rest of Latin America

 Middle East & Africa-

• GCC Countries
• South Africa
• Rest of the Middle East and Africa