the global ivd market

GLOBAL IVD MARKETS

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Parioforma have been providing bespoke research services to the Healthcare and Life Sciences industries for over 20 years.

We can help you better understand your customer needs, evaluate the competitive landscape or assess the market opportunity for a new product or service.

Research can be global, regional or country-specific and all projects are tailored to individual customer needs – studies typically include aspects of the following:

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Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdomwww.parioforma.com

• Review of the IVD market and/or a specific market segment

• Market analysis: Value Growth rates Sector shares Growth regulators Business trends Technology trends

• Customer analysis: Voice of the customer Customer segmentation

• Competitive environment: Corporate profiles Market shares New entrants

• Partner and/or investor identification



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Diagnostic tests were performed close to 4 billion times in 2013 in the United States:

Highlights of recent research…

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Drivers for the US IVD Market• Technological advances and automation have made

tests easier to use and more accurate, and have led to more precise and more timely results.

• Advances have led to point-of-care tests that facilitate more rapid decision-making by medical practitioners.

• Number of diagnostic tests required being driven by the aging and the growth of the population.

• Increased use of diagnostic tests as quality indicators.• Increased consumer awareness of, and demand for,

tests.• Extension of health insurance coverage by the

Affordable Care Act of 2010.

Restraints for the US IVD Market• Challenges exist in gaining FDA clearance - the level

of evidence required to demonstrate safety and effectiveness, as well as clinical utility continues to grow.

• Difficulties in securing insurance coverage - insurers insist on direct evidence of clinical utility and the impact of a specific test on patient outcomes.

• Reimbursement rates paid for some tests do not cover the costs of providing the service.



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The US Infectious Disease Rapid Testing Market – porter’s analysis:


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Threat of New Entrants+ High barriers to entry- Medium customer loyalty- High profitability attracts new entrants

Low

Threat of Substitutes+ Medium high switching costs (CLIA moderate or above) - Transition to innovative rapid molecular tests

Medium - High

Competitive Rivalry- High for technical, marketing and sales- Consolidation has concentrated the market toward the larger companies

High

Bargaining Power of Buyers

- Many RDT test platforms with similar performance giving customers a lot to choose from- Price sensitivity

High

Bargaining Power of Suppliers

- Reliance upon third-party vendors/ distributors- Consolidation in the lab marketplace+ Increasing POLs and alternative testing sites

Medium



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User perceptions of US rapid test reader devices:


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Price Dual Power – mains &

battery

Portability Connectivity Test Menu CLIA Status Walk- Away Potential

Short-term --

Mid to long-term --

Key: Very Important; Important; -- Neutral; Not important;



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Drivers & restraints in India’s IVD market:


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Customer landscape in India:


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Influencers on the patient choice of SMBG meter in Turkey:


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Interview respondents were asked to rate the extent of influence in the patient choice of meter on a scale of 1-7 [where 1 = low; 7 = high]

The pharmacist has the greatest influence on the buying decision – patients place a lot of trust in this relationship.



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Charles RowlandsSenior Partner

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the global ivd market

Health & Medicine