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Consolidation and Innovative Business Models Will Accelerate IVD Outsourcing Growth
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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 CMOsPOC 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.
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
Author: Amol Dilip Jadhav
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