IVD Contract Manufacturing Market

IVD Contract Manufacturing Market Size and Share Forecast Outlook (2024 to 2034)

The IVD Contract Manufacturing Market had an estimated market share worth USD 12.9 billion in 2023, and it is predicted to reach a global market valuation of USD 46 billion by 2034, growing at a CAGR of 12.1% from 2024 to 2034.

Report Attribute	Details
Estimated Market Value in 2023	USD 12.9 billion
Expected Market Value in 2024	USD 14.7 billion
Projected Forecast Value in 2034	USD 46 billion
Anticipated Growth Rate from 2024 to 2034	12.1%

Demand Analysis and Future Projections for IVD Contract Manufacturing

• The market for IVD contract manufacturing will expand as a result of the growing emphasis on personalized medicine, which is being driven by genetic profiling, biomarker identification, and targeted medicines. These factors will also increase demand for customized diagnostic solutions.
• Market expansion will be fueled by the outsourcing of diagnostic manufacture to specialized contract manufacturing organizations due to the persistent rise in healthcare spending, especially in emerging regions, and the need for affordable diagnostic solutions.
• IVD contract manufacturing services will be in high demand as a result of ongoing advancements in diagnostic technologies, including digital pathology, next-generation sequencing, and improved imaging modalities, which will help design and build these state-of-the-art diagnostic items.

IVD Contract Manufacturing Demand Analysis from 2019 to 2023 Vs Forecast Outlook for 2024 to 2034

The global demand for the IVD contract manufacturing market was estimated to reach a valuation of USD 7.4 billion in 2019, according to a report from Future Market Insights. From 2019 to 2023, the IVD contract manufacturing market witnessed significant growth, registering a CAGR of 15.1%.

Historical CAGR 2019 to 2023	15.1%
Forecast CAGR 2024 to 2034	12.1%

The introduction of lab-on-a-chip technology represents a significant milestone in the IVD contract manufacturing market. These microfluidic devices allow for automated rapid diagnostic testing with small sample quantities by combining several laboratory tasks onto a single chip. Due to their mobility, affordability, and high throughput, lab-on-a-chip devices are perfect for applications in personalized medicine, environmental monitoring, and point-of-care diagnostics.

This breakthrough has the potential to alter healthcare delivery by delivering advanced laboratory capabilities to a wide range of locations, hence increasing diagnostic testing accessibility and efficiency. It is projected that these modifications would provide new opportunities for the global IVD contract manufacturing market.

Key Factors Driving Growth in the IVD Contract Manufacturing Industry

Shift towards Value Based Healthcare Models to Bolster Growth

Value-based healthcare models are a major factor propelling the IVD contract manufacturing market. Healthcare providers are embracing value-based reimbursement models at an increasing rate as there is a rising focus on lowering costs and improving patient outcomes.

This change provides incentives for the use of advanced diagnostics, which allow for accurate therapy selection, early illness identification, and patient outcome tracking. IVD contract manufacturers are well-positioned to assist healthcare providers in providing value-based care, hence propelling market growth, by providing superior, innovative diagnostic solutions.

Challenges Impeding Growth of the IVD Contract Manufacturing Market

Quality Control and Supply Chain Disruptions to Impede the Market Growth

Few restraints of the market are:

• Maintaining consistent quality standards throughout the production process is critical yet difficult, especially when working with complex diagnostic goods and technology.
• Dependence on an international supply chain exposes companies to risks that affect production schedules and customer satisfaction, such as shortages of raw materials, delays in shipping, and geopolitical unrest.
• Continuous investment in research and development, together with adaptability to changing market trends, are necessary to keep up with the rapid technical developments in diagnostics.

Category-wise Insights into the IVD Contract Manufacturing Sector

This section focuses on providing detailed analysis of two particular market segments for IVD contract manufacturing, the dominant device type and the significant technology. The two main segments discussed below are the IVD equipment and immunoassay.

IVD Equipment to be Widely Used for IVD Contract Manufacturing

Device Type	IVD Equipment
CAGR from 2024 to 2034	11.8%

The IVD equipment segment is anticipated to expand with a 11.8% CAGR through 2034. Since IVD equipment is essential to diagnostic testing, it is expected to be widely used in the IVD contract manufacturing market.

These gadgets, which include analyzers and sample processing tools, are necessary for carrying out a wide range of diagnostic tests effectively and precisely. IVD equipment becomes more important in contract manufacturing services as the need for diagnostic testing increases.

Immunoassay Technology to Gain Popularity in the Global IVD Contract Manufacturing Market

Technology	Immunoassay
CAGR from 2024 to 2034	11.5%

During the forecast period, the immunoassay segment is likely to garner an 11.5% CAGR. With its broad range of applications and adaptability, immunoassay technology is set to become more and more popular in the IVD contract manufacturing market.

As the need for customized medicine and focused treatments grows, immunoassays provide reliable biomarker and analyte detection, enabling precise diagnosis and therapy tracking. Immunoassays are becoming a more appealing alternative for contract manufacturing services due to advancements like multiplexing capabilities and downsizing, which increase throughput and efficiency.

Region-wise Analysis of Global IVD Contract Manufacturing Demand

This section will go into detail on the IVD contract manufacturing markets in a few key countries, including the United States, the United Kingdom, China, Japan and South Korea. This segment will focus on the key factors that are driving up demand in these countries for IVD contract manufacturing.

Countries	Forecast CAGR from 2024 to 2034
The United States	11.9%
The United Kingdom	12.9%
China	12.7%
Japan	13%
South Korea	14.1%

Rising Point of Care Testing Market in the United States to Accelerate Demand

The United States IVD contract manufacturing ecosystem is anticipated to gain a CAGR of 11.9% through 2034. Factors that are bolstering the growth are:

• The point-of-care testing (POCT) industry in the United States has grown rapidly because of developments in portable diagnostic technology, decentralization of healthcare delivery, and the growing desire for quick diagnostic findings.
• Taking advantage of this trend, IVD contract manufacturers are creating and producing POCT devices and assays for a range of uses, including as blood glucose monitoring, cardiac indicators, and infectious disease testing. Contract manufacturers help to improve patient care outcomes and healthcare efficiency in the US by providing dependable and easy-to-use POCT solutions.

NHS to Push Manufacturers towards Effective IVD Contract Manufacturing in the United Kingdom

The IVD contract manufacturing market in the United Kingdom is expected to expand with a 12.9% CAGR through 2034. The factors pushing the growth are:

• The National Health Service (NHS) of the United Kingdom is one of the world's largest healthcare systems, providing treatment to a varied population with a wide range of requirements. Due to the NHS's dedication to enhancing patient outcomes and operational effectiveness, there is a notable need for superior diagnostic products, such as in vitro diagnostics (IVD).
• IVD contract manufacturers may meet this need by providing innovative, reasonably priced diagnostic goods and services that complement the objectives and specifications of the NHS.

Focus on Precision Medicine to Bolster Growth in China

The IVD contract manufacturing ecosystem in China is anticipated to develop with a 12.7% CAGR from 2024 to 2034. The drivers behind this growth are:

• Precision medicine, which includes tailoring medical interventions and treatments based on a patient's genetic composition, lifestyle, and environmental effects, is gaining popularity in China. Sophisticated diagnostic tests are in high demand to assist precision medicine initiatives due to advances in genome sequencing technology and analytics.
• Through the development and production of precision diagnostics that enable targeted medicines and individualized healthcare methods for patients throughout China, IVD contract manufacturers play a crucial part in this paradigm shift.

Market Liberalization and Regulatory Reforms to Accelerate Demand

The IVD contract manufacturing industry in Japan is anticipated to reach a 13% CAGR from 2024 to 2034. The drivers propelling growth forward are:

• Japan has been putting new regulations into place to expedite the licensing procedure for medical equipment, such as in vitro diagnostics. The objectives of these changes are to provide prompt access to advanced diagnostic tools, foster innovation, and improve market competitiveness.
• In light of this, there is an increasing need for IVD contract manufacturing services to help domestic and foreign businesses successfully navigate the regulatory environment and introduce revolutionary diagnostic products to the market.

Smart City Initiatives to Bolster Demand in South Korea

The IVD contract manufacturing ecosystem in South Korea is likely to evolve with a 14.1% CAGR during the forecast period. The factors bolstering the growth are:

• With a focus on cities like Seoul, South Korea's large-scale smart city projects are incorporating technology into many facets of urban life, including healthcare.
• A growing level of focus is being placed on these projects to use health-tech solutions for early illness identification and management.
• IVD contract manufacturers may support these activities by supplying data-driven solutions and smart diagnostic tools that easily fit into the developing smart healthcare ecosystem.

Key Strategies Adopted by Leading Companies and Startups in the IVD Space

Organizations in this market frequently take deliberate action to break negative trends and foster positive development when growth is flagging. Some of them are

In Response to a Downturn in Growth

• Integrating artificial intelligence (AI) along with machine learning algorithms into diagnostic equipment and production processes is a new strategy used by companies in the global IVD contract manufacturing market. Precision medicine, early illness diagnosis, and manufacturing efficiency optimization are made possible by these technologies through predictive analytics.
  • As an illustration of an innovative use of AI in the IVD industry, Siemens Healthineers uses AI-powered imaging systems to improve diagnosis accuracy in medical imaging.

Unique Selling Propositions for New Entrants and Existing IVD Contract Manufacturers

Remaining at the Forefront with the Integration of Advanced Technology

• One company that demonstrates the use of modern technologies in IVD contract manufacturing is Bio-Rad Laboratories, Inc. Bio-Rad makes significant investments in innovative methods that provide more sensitivity and precision than conventional techniques, such as single-cell sequencing and droplet digital PCR (ddPCR).
• Bio-Rad provides its clients with state-of-the-art diagnostic solutions that exhibit exceptional performance and accuracy by integrating these innovative technologies into their contract manufacturing services.

Vertical Integration

• Illumina Inc. is one instance of vertical integration in the IVD contract manufacturing market. Through its subsidiary, Illumina Clinical Services Laboratory, Illumina provides sequencing services in addition to producing sequencing equipment and consumables.
• With the help of this integration, Illumina is able to offer comprehensive genetic testing solutions, including sample preparation and data analysis, giving clients a smooth experience and guaranteeing quality control all along the way.

Competitive Landscape in the Global IVD Contract Manufacturing Market

In order to stay competitive, leading players in the global in vitro diagnostic (IVD) contract manufacturing market are concentrating on technical innovations, strategic alliances, and regional growth. To comply with regulations, they are making investments in innovative production facilities, putting effective supply chain management systems in place, and giving quality control procedures first priority.

These companies also emphasize customization and flexibility in their services to meet the different demands of their clients, positioning themselves as dependable and innovative partners in the IVD market. The key players in this market include:

• Celestica Inc.
• Cenogenics Corporation
• Cone Bioproducts
• Fujirebio
• Invetech
• Jabil Inc.
• Kimball Electronics, Inc.
• Kmc Systems
• Meridian Biosciences
• Nemera
• Nolato GW, Inc.

Significant advancements in the IVD contract manufacturing market are being made by key market participants, and these include:

• In 2023, Cenegenics announced a collaboration with Cleerly, a company whose goal is to eradicate heart attacks by developing a new paradigm for treating cardiac disease.
• Through the cooperation, Cenegenics will assess coronary computed tomography angiography (CCTA) images using Cleerly's AI-enabled platform, making it easier for medical professionals to recognize, classify, and define atherosclerosis (plaque accumulation) in the walls of the heart arteries.
• This platform's individualized reporting can assist clinicians in providing precision therapy throughout the spectrum of heart disease severity, resulting in improved clinical outcomes and significantly lower patient costs.

Key Coverage in the IVD Contract Manufacturing Industry Report

• IVD Contract Manufacturing Market Growth Report
• Medical Device Contract Manufacturing Market Size
• IVD Contract Manufacturing - Diagnostics
• In Vitro Diagnostics (IVD) contract Manufacturing Market
• Contract manufacturing market for IVD products

Scope of the Report

Report Attribute	Details
Growth Rate	CAGR of 12.1% from 2024 to 2034
Market value in 2024	USD 14.7 billion
Market value in 2034	USD 46 billion
Base Year for Estimation	2023
Historical Data	2019 to 2023
Forecast Period	2024 to 2034
Quantitative Units	USD billion for value
Report Coverage	Revenue Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis
Segments Covered	Device Type, Technology, Service Type, End User
Regions Covered	North America; Latin America; Western Europe; Eastern Europe; South Asia and Pacific; East Asia; The Middle East & Africa
Countries Profiled	The United States, Canada, Brazil, Mexico, Germany, The United Kingdom, France, Spain, Italy, Poland, Russia, Czech Republic, Romania, India, Bangladesh, Australia, New Zealand, China, Japan, South Korea, GCC Countries, South Africa, Israel
Key Companies Profiled	Celestica Inc.; Cenogenics Corporation; Cone Bioproducts; Fujirebio; Invetech; Jabil Inc.; Kimball Electronics, Inc.; Kmc Systems; Meridian Biosciences; Nemera; Nolato GW Inc.
Customization Scope	Available on Request

Table of Content

• 1. Executive Summary
• 2. Market Overview
• 3. Market Background
• 4. Global Market Analysis 2019 to 2023 and Forecast, 2024 to 2034
• 5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Device Type
  • 5.1. IVD Equipment
  • 5.2. IVD Consumables
• 6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Technology
  • 6.1. Immunoassay
  • 6.2. Clinical Chemistry
  • 6.3. Molecular Diagnostics
  • 6.4. Microbiology
  • 6.5. Hematology
  • 6.6. Coagulation & Hemostasis
  • 6.7. Others
• 7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Service Type
  • 7.1. Manufacturing Services
  • 7.2. Assay Development Services
  • 7.3. Other Services
• 8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region
  • 8.1. North America
  • 8.2. Latin America
  • 8.3. Western Europe
  • 8.4. Eastern Europe
  • 8.5. South Asia and Pacific
  • 8.6. East Asia
  • 8.7. Middle East and Africa
• 9. North America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 10. Latin America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 11. Western Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 12. Eastern Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 13. South Asia and Pacific Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 14. East Asia Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 15. Middle East and Africa Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
• 16. Key Countries Market Analysis
• 17. Market Structure Analysis
• 18. Competition Analysis
  • 18.1. Celestica Inc.
  • 18.2. Cenogenics Corporation
  • 18.3. Cone Bioproducts
  • 18.4. Fujirebio
  • 18.5. Invetech
  • 18.6. Jabil Inc.
  • 18.7. Kimball Electronics, Inc.
  • 18.8. Kmc Systems
  • 18.9. Meridian Biosciences
  • 18.10. Nemera
  • 18.11. Nolato Gw, Inc.
• 19. Assumptions & Acronyms Used
• 20. Research Methodology