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Diabetes Management Technologies 2022-2032: Markets, Players, and Forecasts

Electrochemical glucose test strips, continuous glucose monitors (CGM) including non-invasive, insulin pumps and pens, closed-loop, artificial pancreas, digital health. Analysis and forecast of diabetes management devices market 2010-2032.

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This report covers the entire landscape for diabetes management devices, including mature, emerging, and future options. We characterise and predict the technological landscape of the industry over the next decade. Strategies of major players in the industry are discussed and analysed. Developments of major milestones, such as the launch of closed-loop systems and non-invasive CGMs, are considered and discussed in our forecasts.
The diabetes management device industry has seen major changes over the past decade. At the centre is the shift from electrochemical test strips towards minimally invasive continuous glucose monitors (CGMs). The billion-dollar test strip industry has been in decline since 2010, while CGMs have only continued to grow. By the year 2032, IDTechEx predicts the test strip industry to make up only 6.7% of the overall diabetes management device market, down from a peak of 63.4% in 2010.
 
Glucose sensors: past, present, and future
 
Diabetes patients have historically used disposable test strips for monitoring blood glucose, creating a $7.4 billion industry based on high profit margins on test strips. However, pricing pressures and more stringent reimbursement policies have been driving decline of the test strip industry between 2010 to 2015. In the EU, test strips face additional pressures of increasing CGM reimbursement since 2015. Combined, these factors have seen former leaders in the test strip industry divest their diabetes divisions: Bayer Healthcare sold their diabetes care business to Panasonic in 2016, and in 2017 Johnson and Johnson sold their Lifescan division to Platinum Equity.
 
On the other hand, the CGM market has seen rapid growth over the last few years. IDTechEx estimates a CAGR of more than 25% between 2010-2021 for the overall CGM industry, driven largely by three major players: Abbott, Medtronic and Dexcom.
 
CGM market size and shares of key players, 2010-2021.
The growth of CGMs and the decline of test strips is expected to continue as CGMs continue to gain prominence, but there remain several emerging markets test strips are expanding into that will slow their decline. In this report, we discuss the outlook for both the test strip and CGM industries moving forward, providing an account for geographical market penetration for both CGMs and test strips, along with market forecasts for both the test strip and CGM industries over the next 10 years.
 
While CGMs already offer considerable advantages over test strips, there remains much room for innovation. These devices can still cause discomfort and irritation, and the time lag of CGM measurements is a characteristic flaw of the mechanism they employ.
 
Digital health: expansion of CGM into type 2 diabetes
 
Today, the glucose sensor industry serves patients with type 1 diabetes due to the need for strict control over blood glucose levels. However, this is a small subset of all people with diabetes, making up only around 5% of the total. As such, many players are now pushing for device adoption from type 2 and prediabetes populations, as these are large untapped markets. This is being done via increasing integration of glucose sensors with digital health options, with major glucose monitoring players looking to develop partnerships with digital health companies for expanded product offerings.
 
Innovation within the diabetes management industry has followed a trend of increasing connectivity. This has been seen in the development of smart insulin pens and connected glucometers, among many other examples. While these have all had their parts to play in the recent development of digital health initiatives, CGMs have been a major enabler of digital health.
 
CGM partnerships with digital health platforms have seen great interest from both ends. CGM data can expand the product offerings of digital health platforms due to this improved data being made available: many diabetes health management apps with CGM pairing offer some form of "diabetes diary" for users to track their blood glucose, with added functionality built on top of this data. On the CGM end, digital health offers the potential for expansion into large untapped type 2 and prediabetes markets. CGM giant Dexcom is the most prominent example of this, partnering with a host of smaller app platforms in addition to an expanded partnership agreement with major telehealth platform Glooko in 2017.
 
Insulin delivery: progress towards closed-loop
 
Insulin delivery is a crucial part of diabetes management. Currently, this is mostly done via insulin pens; these devices form the bulk of the insulin delivery market by volume, as their low unit cost make them accessible to consumers.
 
CGMs have made possible the development of automated ("closed-loop") insulin delivery systems, which could encourage growth of the insulin pump market. This would see major shifts across the insulin delivery industry, with a particularly large impact on insulin pen markets. Within this report, we discuss the development and timelines for such possibilities, along with an analysis and forecast of the impact this would have on the insulin delivery industry over the next decade.
 
Insulin pump market shares of key players in 2021.
Diabetes management device market analysis and forecasts
 
The industries discussed above are highly interlinked; developments within one industry cause significant effects on others. IDTechEx have analysed the entire market to produce a cohesive story, tying together developments and future milestones across the diabetes management industry to provide a realistic forecast of each individual market.
 
While CGMs have been a major focal point of the industry, much notable innovation has occurred across the breadth of the industry. Over the last few years, many new players have entered the diabetes management technology market across multiple industries. This report discusses the market potential of many topics across the entire industry.
 
This report analyses the technological and competitive landscapes, identifying and reviewing over 100 companies and research institutes ranging from industry leaders to start-ups. It identifies key players in each sector along with partnership ecosystems across several industries.
 
Key topics discussed in this report:
  • Outlook for the test strip industry moving forward
  • CGM penetration into Asian markets over the short- and medium-term
  • Barriers of entry into CGM markets
  • Outlook for digital health options in diabetes management
  • Trends and outlook within the insulin delivery industry
  • Timeline and impact of closed loop on overall industry
  • Development and outlook of technologies for complication management
  • Developments of advanced therapies for reversal of diabetes
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1.EXECUTIVE SUMMARY
1.1.Executive introduction
1.2.Background: Introduction to diabetes
1.3.Background: The cost of diabetes
1.4.Diabetes management process
1.5.Scope of the report
1.6.Diabetes management device roadmap: Glucose sensors
1.7.Test strips and glucometers: introduction
1.8.Anatomy of a glucose test strip
1.9.Continuous glucose monitors: introduction
1.10.Anatomy of a typical CGM device
1.11.CGM continues to gain momentum
1.12.Non-invasive glucose monitoring
1.13.Non-invasive glucose monitoring: conclusions
1.14.Diabetes management device roadmap: Insulin delivery
1.15.Insulin pens: overview
1.16.Insulin pumps: overview
1.17.Hybrid closed-loop: introduction
1.18.Status of the insulin delivery industry hinges on the development of closed-loop systems
1.19.Alternative insulin delivery methods have yet to gain a foothold
1.20.Digital health is driven by increasing device connectivity
1.21.Digital health is a growing option for diabetes management
1.22.Managing side effects accounts for 90% of the total cost of diabetes
1.23.Outlook for diabetes complication management
1.24.Advanced therapies for diabetes: roadmap
1.25.Advanced therapies: conclusions
1.26.List of 108 companies mentioned in this report
1.27.Diabetes management devices: annual revenue 2010-2021
1.28.Evaluation of the overall diabetes device industry from 2010-2032
1.29.CGM: annual revenue forecast 2022-2032
1.30.Test strip market forecast 2022-2032
1.31.Insulin pumps revenue forecast 2022-2032
2.INTRODUCTION
2.1.Background: Introduction to diabetes
2.2.The prevalence of diabetes
2.3.Background: Diabetes on the rise
2.4.Background: The cost of diabetes
2.5.Type 1 vs Type 2
2.6.Background
2.7.Self-Management Devices
2.8.Diabetes management device roadmap: Summary
2.9.Diabetes management device roadmap: Glucose sensors
2.10.Diabetes management device roadmap: Insulin delivery
3.GLUCOSE SENSORS
3.1.1.History of glucose monitoring
3.1.2.Players in glucose monitoring
3.1.3.Diabetes management device roadmap: Glucose sensors
3.1.4.Key criteria for assessing accuracy
3.2.Test strips and glucometers
3.2.1.Glucose monitoring through test strips and associated readers
3.2.2.Test strips: business model
3.2.3.Anatomy of a glucose test strip
3.2.4.Electrode deposition: screen printing vs sputtering
3.2.5.Lifescan uses multiple manufacturing methods
3.2.6.An introduction to glucose sensing: glucose oxidase
3.2.7.Glucose sensing via GOx: mechanism
3.2.8.Glucose dehydrogenase: introduction
3.2.9.Glucose dehydrogenase: sensing methods
3.2.10.A comparison of GDH and GOx mechanisms
3.2.11.GDH-FAD have potential for development of "third-generation" sensors
3.2.12.Comparison of GDH and GOx in glucose sensing
3.2.13.Overview of several test strips and enzymes used
3.2.14.Roche: Overview
3.2.15.Roche: Accu-Chek Guide
3.2.16.Roche / Glytec: cobas pulse
3.2.17.Abbott Laboratories: Introduction
3.2.18.Abbott: coulometric methods for test strips
3.2.19.EasyMax Diabetes Care
3.2.20.Innovation shifts from test strip development to increasing digitization
3.2.21.Comparing test strip costs with CGM
3.2.22.Test strips: market outlook
3.3.Continuous glucose monitoring (CGM)
3.3.1.Continuous glucose monitors: introduction
3.3.2.Anatomy of a typical CGM device
3.3.3.CGMs are superseding test strips
3.3.4.CGM: Technology
3.3.5.CGM sensor chemistry
3.3.6.CGM technologies: glucose dehydrogenase
3.3.7.CGM miniaturization and "green" diabetes
3.3.8.CGM sensor manufacturing and anatomy
3.3.9.Sensor filament structure
3.3.10.Foreign body responses to CGM devices
3.3.11.Calibration of glucose monitoring devices
3.3.12.Comparison metrics for CGM devices
3.3.13.Example: Accuracy of CGM devices over time
3.3.14.Interference of medication with CGM accuracy
3.4.CGM: Markets and Key Players
3.4.1.CGM: Overview of key players
3.4.2.Abbott Laboratories: CGM business
3.4.3.Abbott: Freestyle® Libre
3.4.4.Abbott: "Wired enzyme"
3.4.5.Abbott: Device and sensor structure
3.4.6.Dexcom: Introduction
3.4.7.Dexcom: CGM products
3.4.8.Dexcom: Sensor structure
3.4.9.Medtronic: Introduction
3.4.10.Medtronic: Diabetes & CGM business
3.4.11.Roche: Patents in CGM
3.4.12.Ascensia, POCTech and Yuwell
3.4.13.Medtrum
3.4.14.Medtrum: Sensing technology
3.4.15.Medtrum: Outlook
3.4.16.AgaMatrix & WaveForm Technologies
3.4.17.Infinovo
3.4.18.Sano
3.5.Implantable glucose sensors
3.5.1.Implantable glucose sensors: Introduction
3.5.2.Key Players in Implantable Glucose Monitoring
3.5.3.Fluorescence-based glucose detection
3.5.4.Senseonics
3.5.5.Senseonics: Financials and Partnerships
3.5.6.GlySens: Eclipse 3
3.5.7.GluSense
3.6.CGM: conclusions
3.6.1.Focus shifts from test strips to CGM
3.6.2.Global CGM reimbursement
3.6.3.CGM markets in Asia
3.6.4.Outlook for smaller test strip companies
3.6.5.CGM reimbursement for type 2 is currently limited
3.6.6.CGM usage in hospitals
3.7.Non-invasive glucose monitoring
3.7.1.Non-invasive glucose monitoring
3.7.2.Assessment of different analytes for glucose monitoring
3.7.3.In Context: FDA requirements
3.7.4.Non-Invasive Blood and ISF
3.7.5.Non-invasive glucose monitoring: approaches
3.7.6.Companies Using Each Technique
3.7.7.Near-Infrared Spectroscopy
3.7.8.Near-Infrared Spectroscopy - Recent Academic Studies
3.7.9.NIR Companies
3.7.10.CNOGA
3.7.11.Mid Infrared Spectroscopy
3.7.12.MIR Companies
3.7.13.DiaMonTech
3.7.14.Terahertz Spectroscopy
3.7.15.Dielectric Spectroscopy
3.7.16.Alertgy
3.7.17.Know Labs
3.7.18.Afon Technology
3.7.19.Zedsen
3.7.20.Zedsen
3.7.21.Raman Spectroscopy
3.7.22.Kaligia Biosciences
3.7.23.Quantum Operation
3.7.24.RSP Systems
3.7.25.Samsung
3.7.26.Optical Rotation
3.7.27.Transdermal Techniques
3.7.28.Reverse Iontophoresis
3.7.29.Reverse Iontophoresis Companies
3.7.30.Nemaura Medical
3.7.31.PKvitality
3.7.32.Cygnus
3.8.Non-invasive glucose monitoring: other fluids
3.8.1.Companies Using Each Technique (Other Fluids)
3.8.2.Measuring glucose in sweat
3.8.3.Measuring glucose in tears
3.8.4.Measuring glucose in saliva
3.8.5.Measuring glucose in breath
3.8.6.Measuring glucose in urine
3.9.Non-invasive glucose monitoring: conclusions
3.9.1.When will non-invasive glucose monitoring be commercialised?
3.9.2.Notable Quotes on Non-Invasive Glucose Monitoring
4.INSULIN DELIVERY
4.1.1.Insulin: introduction
4.1.2.Delivering insulin is a critical part of diabetes management
4.1.3.Comparison of different types of insulin*
4.1.4.Short-acting (bolus) insulin
4.1.5.Long-acting (basal) insulin
4.1.6.Different types of insulin have different use cases
4.1.7.Insulin Delivery Devices
4.1.8.History of insulin delivery methods
4.1.9.Technological roadmap from two separate perspectives
4.2.Insulin pens
4.2.1.Insulin Pens
4.2.2.Smarter insulin delivery informing decisions
4.2.3.Smart pens are driven by a growing CGM market
4.2.4.Partnership ecosystem for smart insulin pens
4.2.5.Overview of commercial smart pen devices*
4.2.6.Novo Nordisk
4.2.7.Novo Nordisk: NovoPen
4.2.8.Eli Lilly
4.2.9.Eli Lilly: Tempo Smart
4.2.10.Ypsomed
4.2.11.Ypsomed smart devices
4.2.12.Bigfoot Unity Diabetes Management System
4.2.13.Companion Medical / Medtronic: InPen
4.2.14.Outlook for insulin pens
4.3.Insulin pumps
4.3.1.Insulin Pumps
4.3.2.Insulin patch pumps
4.3.3.Pricing models for patch pumps vs traditional options
4.3.4.Insulin pumps currently available
4.3.5.Insulin pump breakdown
4.3.6.Accu-Chek Solo by Roche
4.3.7.DANA-I by SOOIL
4.3.8.Insulin pump market
4.3.9.Insulin pump players and market share
4.3.10.Markets: Patch pumps vs traditional infusion pumps
4.3.11.Comparing insulin pumps and CGM
4.3.12.Insulin pump technology roadmap
4.3.13.Outlook for insulin pumps
4.4.Linking insulin pumps and CGM: Towards closed loop and the artificial pancreas
4.4.1.Today: Hybrid closed loop systems
4.4.2.Hybrid closed-loop to match mealtime surge
4.4.3.The objective: Closing the feedback loop
4.4.4.Example: Progress from Medtronic
4.4.5.Partnership ecosystem for hybrid closed-loop systems
4.4.6.Ultra-fast acting insulin: introduction
4.4.7.The case of ultra-fast insulin in hybrid closed -loop
4.4.8.Actual results: ultra-fast insulin have yet to show significant improvements to hybrid closed-loop
4.4.9.Comparison of hybrid closed-loop systems
4.4.10.Medtronic: Towards closed loop
4.4.11.Medtronic: MiniMed 780G
4.4.12.Dexcom-Tandem partnership: Control-IQ
4.4.13.Insulet: Omnipod 5
4.4.14.CamDiab: CamAPS FX
4.4.15.Beta Bionics: iLet
4.4.16.Tidepool: Tidepool Loop
4.4.17.The ForgetDiabetes Project
4.4.18.Unanswered questions about device security
4.5.Alternative insulin technologies
4.5.1.Non-invasive insulin delivery methods
4.5.2.Comparison of various routes for non-invasive insulin delivery
4.5.3.Inhaled insulin: introduction
4.5.4.MannKind: Afrezza
4.5.5.Inhaled insulin faces challenges in the market
4.5.6.Inhaled insulin: outlook
4.5.7.Oral insulin delivery
4.5.8.Buccal insulin delivery
4.5.9.Transdermal insulin delivery: introduction
4.5.10.Companies looking at transdermal insulin delivery
4.5.11.Non-invasive insulins face several barriers to market adoption
4.5.12.The road towards non-invasive insulin delivery is paved with failure
4.5.13.Some reasons why non-invasive insulin delivery continues to be looked at
4.5.14.Glucose-responsive insulin
4.5.15.Glucose sensing: the Ziylo approach
5.DIABETES MANAGEMENT VIA DIGITAL HEALTH
5.1.1.The scope of digital health in diabetes management
5.1.2.Diabetes is an Early Adopter of Digital Healthcare Initiatives
5.1.3.Diabetes digital health landscape*
5.1.4.Diabetes management ecosystem
5.1.5.Digital health: regulations, legality and privacy
5.2.Blood glucose data in mobile apps
5.2.1.Diabetes Apps
5.2.2.Digital health is driven by increasing device connectivity
5.2.3.CGM integration with mobile apps
5.2.4.Dexcom: retrospective and real time APIs
5.2.5.The Level 2 program leverages the Dexcom app-in-app module
5.2.6.WellDoc: BlueStar
5.2.7.Roche: SugarView
5.3.Apps for lifestyle management
5.3.1.Diabetes management: focal points
5.3.2.Diet for diabetes management has two avenues
5.3.3.Nemaura Medical: MiBoKo
5.3.4.Fitscript: GlucoseZone
5.3.5.SNAQ
5.3.6.SNAQ: machine learning techniques
5.4.Telehealth in diabetes management
5.4.1.Telehealth in diabetes: introduction
5.4.2.Ecosystem of a digital health program for diabetes
5.4.3.Telehealth programs often follow the same recipe
5.4.4.Glooko
5.5.Digital health in diabetes: Conclusions
5.5.1.Prediabetes via digital health?
5.5.2.Digital Health Programs: Evidence for Type 2 Diabetes
5.5.3.Digital health and diabetes: outlook
6.TECHNOLOGY FOR MANAGING DIABETES COMPLICATIONS
6.1.1.Managing side effects accounts for 90% of the total cost of diabetes
6.1.2.Scope of this report
6.2.Diabetic Ketoacidosis
6.2.1.A severe lack of insulin can lead to diabetic ketoacidosis
6.2.2.Ketone monitoring via electrochemical sensors
6.2.3.Ketone monitoring via urine
6.2.4.Ketone monitoring: outlook
6.3.Diabetic neuropathy
6.3.1.Diabetic neuropathy: introduction
6.3.2.Diabetic foot ulcers
6.3.3.Impeto Medical: Sudoscan
6.3.4.Basic requirements of a diabetic footwear
6.3.5.Smart options for diabetic footwear
6.3.6.Orpyx
6.3.7.Siren Care Denmark IVS
6.3.8.Flextrapower
6.3.9.Flextrapower
6.3.10.Diabetes foot ulcers: outlook
6.4.Diabetic retinopathy
6.4.1.Diabetic retinopathy: introduction
6.4.2.Diabetic retinopathy has seen developments in diagnosis and management
6.4.3.Artelus: Detecting DR by ensuring image quality
6.4.4.Wearable vision aids
6.4.5.Diabetic retinopathy: outlook
7.ADVANCED THERAPIES FOR DIABETES TREATMENT
7.1.Advanced therapies for diabetes: roadmap
7.2.Advanced therapies: introduction
7.3.Regenerative medicine is currently rarely used to treat diabetes
7.4.Regenerative medicine for type 1 diabetes: introduction
7.5.Cell Therapy Devices
7.6.Cell encapsulation devices
7.7.Cell therapy devices: clinical trials
7.8.Kriya Therapeutics
7.9.Diamyd Medical: preventive medicine for type 1
7.10.Regenerative medicine for type 2 diabetes: introduction
7.11.Mito Biopharma
7.12.Regenerative medicine: conclusion
8.AI IN DIABETES
8.1.Machine learning in diabetes management
8.2.AI in healthcare: Existing regulations
8.3.AI can show varying levels of intelligence
8.4.Various neural networks and use cases of each for diabetes management
8.5.Overview of various methods for AI
8.6.AI-enabled coaching
8.7.AI image recognition
8.8.AI for non-invasive glucose sensing
9.FORECASTS
9.1.Forecast: introduction
9.2.Forecast method: Company revenue in diabetes management
9.3.Diabetes device industry market forecast 2022-2032
9.4.Diabetes device industry market forecast 2022-2032
9.5.Diabetes device industry historic and forecast data 2010-2032
9.6.Diabetes management devices by proportion of total market revenue 2010-2032
9.7.CGM: annual revenue forecast 2022-2032
9.8.CGM: methodology and assumptions
9.9.CGM: forecasted uptake by type 2 and prediabetes
9.10.CGM: Milestones
9.11.CGMs by population adoption proportion
9.12.Insulin pumps revenue forecast 2022-2032
9.13.Insulin pumps: forecast methodology
9.14.Infusion pumps revenue forecast 2022-2032
9.15.Patch pumps revenue forecast 2022-2032
9.16.Test strip market forecast 2022-2032
9.17.Glucometers revenue forecast 2022-2032
9.18.Insulin pens revenue forecast 2022-2032
10.COMPANY PROFILES
10.1.Links to 16 company profiles
 

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Technologies for diabetes management are expected to reach a total market size of $28.9 bn in 2032.

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