Growth Opportunities—Contract Manufacturing and Outsourcing Opportunities in the In-vitro Diagnostics (IVD) Industry, 2019 to 2022

Growth Opportunities—Contract Manufacturing and Outsourcing Opportunities in the In-vitro Diagnostics (IVD) Industry, 2019 to 2022

Consolidation and Innovative Business Models Will Accelerate IVD Outsourcing Growth

RELEASE DATE
27-Jan-2020
REGION
Global
Research Code: K401-01-00-00-00
SKU: HC03261-GL-MR_24064

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Description

The increasing pressure for cost-driven development and regulatory and regional trends are inducing industry participants to adopt innovative integrated business models so as to align themselves as one-stop-shop solution providers as opposed to the traditional functional service providers, thereby, creating a mutually beneficial symbiotic relationship across the In-vitro Diagnostics (IVD) and Contract Manufacturing and Outsourcing (CMO) industry. CMO is a highly fragmented market with more than 250 participants spread across regions and serving the industry. A moderate 8.8% growth is expected, to reach a size of $11.04 billion by 2022. Despite fragmentation, the top-5 participant’s account for more than 46.1% of the market, indicating their dominance. Owing to a stronger presence of market leaders in North America, the region leads, followed by Europe. APAC is the fastest-growing market. Millipore Sigma, Agilent Technologies, Tecan, Fujifilm Wako Diagnostics, Flex Ltd, rank as the top CMOs

POC MDx will be the fastest-growing segment in the IVD space, providing growth opportunities for manufacturing and development firms. It will target non-traditional laboratory testing in scenarios where quick medical decisions are needed, e.g., infectious disease surveillance, life-threatening diseases that require immediate treatment, or in emerging economies with low technical skills to cope with infectious disease burden. Specialized technology vendors are positioning themselves in the CMO industry with increased consolidation. The US and China trade tiff will lead to an increase in the cost of consumables, electronics, and reagents produced in China.

In terms of opportunities, a rise in molecular diagnostics demand is positioning personalized medicine as a robust opportunity area for CMO outsourcing services. For the personalized medicine focus, CMOs are developing in-house manufacturing capabilities and continue to serve specific segments, maintaining industry collaborations with specialized vendors. Alongside core IVD development, the industry is also exploring co-development with pharma as a major growth area with several CMOs such as Agilent Technologies and Fujifilm Wako Diagnostics working with several top partners to capture market share. There is a general rise of niche-therapy focused CMOs across non-oncology conditions.
Overall, this Growth Opportunities study provides a detailed outline of the CMO ecosystem, trends, and opportunities to enable decision makers to recognize market participants, industry dynamics, as well as current business models. Additionally, a voice of customer survey has been included that provides an understanding of the motivational factors, tactical needs, and levels of satisfaction for CMO participants.

Research Scope

Frost & Sullivan Growth Opportunities research establishes the foundation for this project by detailing the current market dynamics, investment trends, key application areas, vendor ecosystem, customer segments, and evolving business opportunities for CMOs in the IVD industry.


As part of the Growth Opportunities research process, Frost & Sullivan analysts review the activity of CMO participants across the focused IVD value chain. The main purpose of this study is to analyze and call out major growth insights. Frost & Sullivan performed a qualitative factor analysis by evaluating critical attributes to identify and assess the top subsegments in the IVD development landscape. This study analyzes more than 250 global companies. Among these market disruptors, including small, medium and established organizations, which are capable of shaping the future through the implementation of best practices, visionary leadership, and innovation in business models, have been identified. A capability profile for select companies across the identified CMO activity areas has been presented. Additionally, analysis of the recent trends, the evolving vendor ecosystem, business models, and growth opportunities are also presented.

The voice-of-customer survey was performed across various stakeholders ranging from start-up companies to established top-tier IVD participants as well as investors. Secondary research for this study was conducted using proprietary Frost & Sullivan content and by analyzing publicly available sources of information, such as government Web sites, funding and deals databases, trade journals, and online media. This was followed by in-depth interactions to triangulate key findings, validate current commercial adoption trends, and arrive at major Growth Opportunities.


Key Issues Addressed

  • What are some of the current issues that concern the IVD outsourcing industry? How would these impact the different stakeholders in the healthcare landscape? 
  • Which are the major segments of growth, and why are they good for entry and investment? 
  • How can manufacturers and outsourcing organizations identify partners outside the conventional IVD outsourcing realm? 
  • What are the upcoming opportunity areas to watch for in 2019 and beyond? 
  • Which companies are categorized as early disruptors in this space? Which are the possible candidates to acquire, invest and grow one’s business?
  • How will the future vendor ecosystem for IVD manufacturing look like?

Author: Amol Dilip Jadhav

 

RESEARCH: INFOGRAPHIC

This infographic presents a brief overview of the research, and highlights the key topics discussed in it.
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Table of Contents

The Purpose of This Study

5 Step Process to Transformational Growth

Key Findings

Study Scope and Segmentation

Key Questions This Study Will Answer

Top Companies—IVD CMO Market

Big Growth Opportunities—IVD CMO Market

Various Differentiation Strategies to Drive Long-term Profitability of CMOs

Strategic Imperatives for IVD CMOs

Market Segmentation

Market Definition and Segments Covered

Value Chain of IVD Contract Manufacturing and Outsourcing Industry

Macro Trends—IVD CMO Market

Key Market Drivers

Key Market Restraints

Outsourcing Decisions—Motivational Factors

Game-changing IVD CMO Companies

Competitive Playbook—IVD CMO Market Share Analysis

Competitor Matrix by Technology Type—IVD CMO Market

Competitor Matrix by Practice Area—IVD CMO Market

Comparative Capability Analysis of Key Participants—IVD CMO Market

Partnering Opportunities with CMO participants

IVD CMO Market—Revenue Forecast

IVD CMO Market—Revenue Forecast Assumptions

IVD CMO Market—Revenue Forecast Discussion

Segmentation of IVD CDMO Market by Practice Areas

Revenue Forecast by Practice Areas

Revenue Forecast Assumptions by Practice Areas

Revenue Forecast Discussion by Practice Areas

Competitive Environment

Role of CMOs in IVD Development by Practice Area

Top Companies—IVD CMO Market

2018 IVD CMO Market Trends and Participant Strategies—Assays and Consumables

2018 IVD CMO Market Trends and Participant Strategies—Research and Development

2018 IVD CMO Market Trends and Participant Strategies—Full Product Development

2018 IVD CMO Market Trends and Participant Strategies—Testing and Evaluation

2018 IVD CMO Market Trends and Participant Strategies—Clinical Development

Competitive Mapping by Practice Areas

Notable Activities

Notable Activities (continued)

End-user Survey—Outsourcing Decisions’ Motivational Factors

End-user Survey—Outsourcing Decisions’ Tactical Needs

End-user Survey—Types of Services and Projects Outsourced

End-user Satisfaction Levels With Commercial CMO Partners

End-user Survey—Analyst Perspective

Macro to Micro Visioning

Trends/Factors Impacting the IVD CMO Market

Top Predictions for the IVD CMO Market

Levers for Growth

Major Growth Opportunities

Growth Opportunity 1—Factory in a Box

Growth Opportunity 2—Biomedical Big Data

Growth Opportunity 3—Liquid Biopsy and CDx

Growth Opportunity 4—Non-invasive Prenatal Testing

Identifying Your Company’s Growth Zone

Growth Opportunities 1-4—Vision and Strategy

Growth Opportunities Matrix

Growth Strategies for Your Company

Prioritized Opportunities Through Implementation

Transformation in IVD CMO Industry Ecosystem

Global Market Perspective

IVD Outsourcing Trends and Rationale

Emerging IVD CMO Business Model

Various Differentiation Strategies to Drive Long-term Profitability of CMOs

Global IVD CMO Market—Final Word

Legal Disclaimer

List of Exhibits

List of Exhibits (continued)

List of Exhibits (continued)

Related Research
The increasing pressure for cost-driven development and regulatory and regional trends are inducing industry participants to adopt innovative integrated business models so as to align themselves as one-stop-shop solution providers as opposed to the traditional functional service providers, thereby, creating a mutually beneficial symbiotic relationship across the In-vitro Diagnostics (IVD) and Contract Manufacturing and Outsourcing (CMO) industry. CMO is a highly fragmented market with more than 250 participants spread across regions and serving the industry. A moderate 8.8% growth is expected, to reach a size of $11.04 billion by 2022. Despite fragmentation, the top-5 participant’s account for more than 46.1% of the market, indicating their dominance. Owing to a stronger presence of market leaders in North America, the region leads, followed by Europe. APAC is the fastest-growing market. Millipore Sigma, Agilent Technologies, Tecan, Fujifilm Wako Diagnostics, Flex Ltd, rank as the top CMOs POC MDx will be the fastest-growing segment in the IVD space, providing growth opportunities for manufacturing and development firms. It will target non-traditional laboratory testing in scenarios where quick medical decisions are needed, e.g., infectious disease surveillance, life-threatening diseases that require immediate treatment, or in emerging economies with low technical skills to cope with infectious disease burden. Specialized technology vendors are positioning themselves in the CMO industry with increased consolidation. The US and China trade tiff will lead to an increase in the cost of consumables, electronics, and reagents produced in China. In terms of opportunities, a rise in molecular diagnostics demand is positioning personalized medicine as a robust opportunity area for CMO outsourcing services. For the personalized medicine focus, CMOs are developing in-house manufacturing capabilities and continue to serve specific segments, maintaining industry collaborations with specialized vendors. Alongside core IVD development, the industry is also exploring co-development with pharma as a major growth area with several CMOs such as Agilent Technologies and Fujifilm Wako Diagnostics working with several top partners to capture market share. There is a general rise of niche-therapy focused CMOs across non-oncology conditions. Overall, this Growth Opportunities study provides a detailed outline of the CMO ecosystem, trends, and opportunities to enable decision makers to recognize market participants, industry dynamics, as well as current business models. Additionally, a voice of customer survey has been included that provides an understanding of the motivational factors, tactical needs, and levels of satisfaction for CMO participants.--BEGIN PROMO--

Research Scope

Frost & Sullivan Growth Opportunities research establishes the foundation for this project by detailing the current market dynamics, investment trends, key application areas, vendor ecosystem, customer segments, and evolving business opportunities for CMOs in the IVD industry.


As part of the Growth Opportunities research process, Frost & Sullivan analysts review the activity of CMO participants across the focused IVD value chain. The main purpose of this study is to analyze and call out major growth insights. Frost & Sullivan performed a qualitative factor analysis by evaluating critical attributes to identify and assess the top subsegments in the IVD development landscape. This study analyzes more than 250 global companies. Among these market disruptors, including small, medium and established organizations, which are capable of shaping the future through the implementation of best practices, visionary leadership, and innovation in business models, have been identified. A capability profile for select companies across the identified CMO activity areas has been presented. Additionally, analysis of the recent trends, the

More Information
No Index No
Podcast No
Author Amol Dilip Jadhav
Industries Healthcare
WIP Number K401-01-00-00-00
Is Prebook No
GPS Codes 9600-B1,9612-B1,9627-B1