Track IVD Market Size, Share and Trends

The go-to source for tracking and understanding market size, share and trends in IVD. Granular break-out of data and comprehensive coverage of international and domestic suppliers’ brand share across Asia, Europe, Latin America and the Middle East.

Our Covid-19 impact forecast addresses pressing questions that you have:

IVD Gateway is the go-to source for major IVD players over the past 12 years. In view of the major disruption to IVD testing capacity and demand, Clearstate has assessed the impact of Covid-19 on the market size across all IVD test segments as well as for the Covid-19 market size and trends. Our demand forecast model takes into consideration key clinical and economic factors that directly impact IVD test volume.

What is included in the 2021 data release:
• Latest 2020 IVD market size, share and trends for 5 major IVD segments: Centralised Diagnostics, Molecular Diagnostics, Point-of-Care Testing, Tissue Diagnostics and Sequencing, and relevant sub-segments up to individual tests or diseases.
• Covid-19 impact to 2021 value growth forecast to IVD tests and product segments
• Post Covid-19 normalisation and recovery growth rate prediction from 2021-25
• Market size, share and trends for Covid-19, by technology

What is new in the 2021 data release:
• New market segments available including liquid-based cytology, SARS-CoV-2 tests and more
• Covid-19 testing market data on reagents for SARS-CoV-2 antibody & antigen testing, POC devices and rapid diagnostic tests for SARS-CoV-2 virus (Antigen and Antibody testing)
• Country coverage expanded to 8 more countries in the Middle East
• Infectious Disease Monitor: Combined look at the addressable market for infectious diseases including IA, microbiology, molecular and POC.

Subscribe to IVD Gateway Size & Share Plus to find out IVD test demand by test segments in countries across Asia Pacific, Latin America, Europe, and Middle East.

Why IVD Gateway?

Product benefits

  • Depth of coverage – take a deep dive into global trends and local market / customer data for all major IVD segments in APAC, EU, LATAM and ME.
  • Established up-to-date data – over 10 years of market size, share and growth tracking and lab demand monitoring on an annual basis.
  • Flexible reporting – scientific market modelling techniques enhance the accuracy and predictive effectiveness of our market forecasts and analysis.

What’s included?

IVD Gateway’s two data solutions, Size & Share Plus and LabPRO Plus, provide answers to the what, where and how to attain market share for your chosen products.

What – Understand sizing by assay in sales value:

  • Provides granular segment size in value term based on ex-manufacturer pricing by individual country.

Where – Understand analysis by customer segment:

  • Prioritise target areas for sales and marketing activities by determining demand by customer segment.

How – Understand visibility at individual lab level:

  • Provides individual lab profiles with test volume by assay, installed base of analyser brands, age of instrument, replacement likelihood and future plans.

Use IVD Gateway to:

  • Deliver in-market data and insights to define sales targets and support realistic forecasts.
  • Facilitate targeted selling by identifying customers with the highest ROI; helps improve customer service and relationship management.
  • Help guide product R&D by understanding usage patterns to optimise product design and new launches.
  • Enable winning sales & Go-To-Market strategies by tracking competitors’ share of business and prioritising customer / therapy areas for investment growth.

This service is relevant for:

Market intelligence
Market access
Business strategy

What’s included in IVD Gateway?

Size & Share Plus

For strategic market planning

  • Market data and insights with size, share and growth estimates and forecasts for markets and competitors in all major IVD segments globally.
  • Granular coverage of all major IVD sub-segments in centralised, molecular, point-of-care, tissue diagnostics and next-generation sequencing.

Size & Share data includes:

  • Size of IVD market: in value terms, manufacturer price / at country level, further segmented by: IVD segments and sub-segments with latest data available annually in Q1.
  • Competitive Share: IVD players’ market share by IVD segments and sub-segments / country & region, international vs regional vs domestic players & market share gains/losses.
  • Growth Projection: historical YoY (compare with previous year) & 5 year CAGR forecasts.
  • Drivers of / Barriers to Growth: regulatory, reimbursement, healthcare spending and reforms, epidemiology and treatment trends, technology adoption trends.

LabPRO Plus

For tactical sales and customer mapping

  • Lab by lab profiles of centralised diagnostics labs (CEDx – in Europe) and molecular diagnostics labs (MDx) across hospitals and commercial settings helping your business understand current test, instrument and reagent usage, and identify target customers.
  • LabPRO Plus MDx provides individual MDx lab profiles including volumes, instruments and reagents used for 40 individual analytes including infectious diseases, panels and genetic and oncology testing.
  • LabPRO Plus CEDx profiles individual labs with information on overall test volumes broken out by disciplines, helping your business understand volume segmentation, system utilisation, capacity, lab equipment and lab KPI.

LabPro data includes:

  • Facility details: location (country, city, state/ province, street, post / zip code), type (hospital, commercial lab), facility size and classification (bed size; part of group)
  • Testing profile/details: total annual test volume, breakdown of test volume by test segment, test volume, instrument and reagent (for MDx assays), outsourced vs. in-house testing (%), YoY growth rates of test volume, Level of automation, LIS and middleware, Covid-19 serology test volume
  • For MDx labs: Testing profile, by test: annual test volume, outsourced vs. in-house (%), YoY growth in test volume, instrument and reagents used, cost per assay (APAC)
  • Installed base: total installed base, brands and models of analysers, year installed, daily volume / analyser (for CEDx labs only), MDx instruments bought due to Covid-19

Comprehensive global coverage

IVD Gateway currently provides in-depth data for 40+ countries, including emerging markets in LATAM and Asia.


Latin America

Middle East

North Asia

South / Southeast Asia


Significant depth of data

Covers all major segments in 5 primary IVD test groups

Centralised Diagnostics (CEDx)
• Clinical chemistry: Routine | HbA1c | Specific protein | Drugs of Abuse | TDM
• Immunoassay: Anemia | Autoimmune | Blood Screening | Bone Health | Cardiac markers | Critical care | Fertility/pregnancy | Hormones | Infectious Disease – SARS-CoV-2 | Oncology | Thyroid
• Haematology
• Coagulation
• Urinalysis
• Flow cytometry
• Blood grouping & typing
• Microbiology

Molecular Diagnostics (MDx)
• MDx instruments
• Blood screening (NAT)
• STD: MG | TV | BV/CV | MG/NG resistance | Others
• Bacteriology: CT/NG | MTB | HAI – C diff., MRSA , Others | GAS & GBS
• Microbiology
• Virology: HBV | HCV | HIV | Respiratory – Flu, RSV, Adenovirus, SARS-CoV-2 | Herpes| Tropical Fever
• Gastrointestinal
• Transplant
• Panels: Meningitis | Respiratory | STD | Gastrointestinal | Mycoplasma | Blood culture
• Genetics
• Oncology: KRAS| EGFR| BRAF
• Coagulation
• LDT (for qPCR)

Point-of-Care (POC) Testing
• Cardiac
• Bloodgas & electrolytes
• Urinalysis
• Hospital glucose (connected)
• Hospital glucose (non-connected)
• Chemistry + HbA1c
• Patient monitoring /Coagulation
• Infectious diseases: HIV | STD| Hepatitis | Respiratory | Gastrointestinal | VBD
• MDx infectious diseases: HIV | STD | Respiratory | SARS-CoV-2

Sequencing (NGS)
• Sequencing instruments
• Sample preparation
• Sequencing tests: NIPT | Oncology | Genetics | Infectious diseases

Tissue Diagnostics (TDx)
• Pre-analytical
• Primary staining
• Advanced staining
• Special staining
• Digital pathology

Data solutions

Trusted worldwide

With over a decade of expertise in this area and continuous acquisition of leading businesses in this field, we are confident that IVD Gateway is the most reliable and comprehensive source of IVD market data available.

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