The Global Market for Medical Devices, 11th Edition

Personal protective equipment (PPE) was among the medical device segments that grew due to COVID-19.


COVID-19, mergers & acquisitions, and innovation spurred notable gains in the sale of medical devices in 2020


The global market for medical devices rose to $472 billion in 2020, increasing 5.1% for the year over 2019, according to new data published in The Global Market for Medical Devices, 11th Edition, the latest report by leading medical market research firm Kalorama Information.

The coronavirus pandemic in particular had a notable impact on medical device sales. The report reveals that COVID-19 related product demand impacted all markets, all regions, and all vendors to some degree in 2020, and has continued through the early months of 2021.

Kalorama Information forecasts the global medical device market will continue to grow more than 3% annually through 2025, with sales cooling down in 2022 as markets stabilize and economic recovery becomes prevalent.  In 2023, growth is expected to reemerge and produce steady performance through the end of 2025.

Medical devices include any instrument, apparatus, appliance, machine, contrivance, implant, in-vitro device as well as any accessories or related components that facilitate any or some of the following functions pertaining to a disease, injury, or condition of handicap: diagnosis, prevention or monitoring, and treatment.  Kalorama Information’s research shows that the largest individual categories of medical devices are:

  • dental equipment, including products in the areas of preventive, restorative, orthodontics, endodontics, implants, prosthetics, CAD/CAM restoration systems (CEREC), digital intra-oral, panoramic and 3D imaging systems, dental treatment centers and instruments/handpieces;
  • catheters, including any of the three major types of catheters: coronary, renal, and infusion catheters;
  • dialysis equipment, including hemodialysis machines, bloodlines and dialyzers;
  • endoscopes, which are designed for direct visual inspection of the interior of a body cavity, hollow organ, or structure;
  • minimally invasive surgical instruments, which allow doctors to perform many complicated operations with a short hospital stay; and
  • personal protective equipment (PPE), including various device segments with the indication of protecting both caregivers and patients from contamination or disease risk, such as face masks, surgical masks, filtering facepiece respirators, and protective clothing.

Personal Protective Equipment Segment Sales Increase 190% Due to Pandemic

Out of all the major medical device categories, the COVID-19 pandemic had a major hand in market growth for PPE during 2020.  The market increased by more than 190% over 2019 as a result of the pandemic.  It is expected that for 2021 and potentially some of 2022, health facilities and practitioners will continue to replenish shortages of PPE and prepare for additional unforeseen health pandemics in the future with some degree of stockpiling.  Additionally, several governments around the world have placed orders for PPE in attempts to not be without this essential tool in the event of future pandemics.

M&A Activity Sees Billions of Dollars Exchanged

Beyond the impact of COVID-19, the overall medical device market is ripe with both acquisitions and innovation. Acquisitions drove growth, as there have been more than 300 significant device market mergers and acquisitions (M&A) since 2015.  In total, this amounts to the exchange of more than $400 billion over the six years. And as of early 2021, there is nearly $40 billion in pending M&A activity in the medical device industry.

Innovation Essential to Emerging International Markets

In addition, companies operating in the market remain optimistic and seek innovation. Kalorama Information estimates that medical device companies spent an average of 8.2% of revenue on R&D during 2020, up from 8.1% in 2019.  For example, innovations from Chinese manufacturers working closely with foreign companies include reusable sutures, portable ultrasound products, low-cost stents and patient monitors. Such innovations borne out of the Chinese healthcare market are important not only in steering foreign participants’ business development strategies, but also in establishing China as a base for greater exports to regional and overseas international markets.  China is already home to an estimated 15,000-16,000 domestic medical device manufactures. The United States’ medical device market is the largest in the world, but China is one of several emerging markets that will continue to drive growth and innovation. Other emerging markets include India, Turkey, Romania, South Africa, Saudi Arabia, South Korea, Poland and Brazil.

For more insights like these, purchase The Global Market for Medical Devices, 11th Edition by Kalorama Information at

Kalorama’s new study on hematology and coagulation finds increased uses of coagulation testing  to determine COVID-19’s unfortunate effects on the blood health of patients.

Coagulation is a complex process in which multiple enzymes and proteins regulate blood flow and clot formation. Coagulation (clot formation), fibrinolysis and platelet aggregation are a part of this process. Fibrinolysis refers to the breakup of blood clots. It is a normal body process that keeps naturally occurring blood clots from growing and causing problems. Anticoagulant drugs help prevent blood platelets from sticking or clumping together, reducing the likelihood that arteries will be blocked by a clot, leading to a stroke or heart attack.

The most widely used drug is Coumadin (Warfarin) that is prescribed for patients with atrial fibrillation, artificial valves and phlebitis. People on warfarin need to have their blood monitored regularly (sometimes weekly and sometimes monthly) to ensure that they are taking the right dosage to avoid clotting if the dosage is too low and also unintentional bleeding when the dosage is too high. This is done with a blood clotting test known as the International Normalized Ratio (INR, formerly known as the
Prothrombin Time test). Proponents of self-testing claim that daily or weekly testing at home helps patients maintain better anticoagulant activity – not too much and not too little.

There are newer oral anticoagulants on the market, such as rivaroxaban (Xarelto), apixaban (Eliquis) and dabigatran (Pradaxa). They are at least as safe and effective as warfarin, and they do not require regular coagulation monitoring with a PT/INR. However, hematologists will use immunoassays to measure the amount of drug concentration in a patient’s blood to assure that the amount of drug is in the therapeutic range. This is akin to therapeutic drug monitoring by immunoassay of antibiotics (gentamicin), antiepileptics (such as carbamazepine, phenytoin and valproic acid), and antipsychotics (such as pimozide and clozapine).

Patients with atrial fibrillation and artificial valves are beginning to switch from warfarin to next-generation drugs. Pharmaceutical companies have heavily invested in direct-to-consumer advertising efforts, ultimately extolling the benefits of these drugs. At this time, this provides another test opportunity in coagulation testing. Several companies have already commercialized tests for the monitoring of the new anticoagulant drugs.

Coagulation testing, including d-dimer, is considered to be a growing indicator in the impact and clinical outcomes of patients with COVID-19. Screening with coagulation panels, including d-dimer, prothrombin time, platelet counts, and fibrinogen, is considered to be essential to identifying patients with severe COVID-19 risk and potential negative outcomes. Several international organizations are leading the charge in identifying and publishing recommendations and guidances for coagulopathy management in COVID-19 patients. Organizations endorsing increasing monitoring for patients with thrombotic diseases and implementing early interventions include:

• American College of Cardiology
• British Society of Hematology
• European Society of Vascular Medicine
• International Society of Thrombosis and Haemostasis
• North American Thrombosis Forum


Kalorama Information’s Hematology Markets

This article is based on information  from Kalorama’s partner publication IMV (, a premier source of information for the radiology industry. 
In the 1980s, CT and MR scanners revolutionized the imaging industry by generating images digitally rather than using analog/film-based technology.  Since then, radiology/imaging departments have progressed to being almost fully digitally based, with the large installed base of general radiography units being the last frontier.  Due to the need for relatively large imaging plates to image large body parts in a single view, such as the chest, the image quality of the digital technology had to be perfected by industry and proven to the radiology community.
For general x-ray, the adoption of digital technology has gone through several transitions.  Initially, the most cost effective way to effect the transition was to use computed radiography (CR) technology, where the x-ray image is acquired digitally onto a phosphor plate that is installed in a cassette similar in size to the film cassette.  Once exposed, the CR cassette is physically taken to a CR reader to capture the x-ray image digitally.  With the development of digital radiography (DR) technology, the digital x-ray images are acquired directly into a computer, thereby speeding up the acquisition and processing time for the x-ray images.
As of 2010, just over one quarter of the fixed general x-ray systems installed in U.S. hospitals had DR technology, while 70% were CR-only systems and 4% were still film-based.  With the passing of the Consolidated Appropriations Act of 2016, x-ray imaging providers received an extra push to continue the transition to DR technology, with penalties for non-compliance starting in 2017/18.   IMV has been monitoring this adoption trend over the last decade, and IMV’s 2019 X-ray/DR/CR Market Outlook Report observes that over 80% of the fixed general x-ray installed base in U.S. hospitals uses DR technology, up from half of the installed base in 2015.


“IMV’s 2019 X-ray/DR/CR Market Outlook Report observes that over 80% of the fixed general x-ray installed base in U.S. hospitals uses DR technology, up from half of the installed base in 2015.”


Going forward, IMV anticipates that over the next three years, about three quarters of the remaining CR-only systems currently installed are being planned for replacement with new DR systems or to be retrofitted using DR detector kits.  Some hospitals, such as Critical Access hospitals are exempt from the CMS payment reduction policies, so they may be slower to transition, but a number of these hospitals are still planning to replace their CR technology with DR to benefit from the increased productivity of DR technology.
General radiography is continuing to play a major role as a “primary care” imaging modality in U.S. hospitals, utilized for inpatients, outpatients, and emergency patients.  The top five x-ray procedure types performed are chest, abdomen/pelvis, extremities, and spine studies, and constitute almost 90% of the procedure volume.  At hospitals, fixed and mobile/portable x-ray systems are located, not only in the main radiology department, but also in other departments on hospital campuses and in outpatient clinics, imaging centers, and urgent care centers managed by radiology in the hospitals’ service areas.  As a result, even though CT, MRI, PET, and Nuclear Medicine (NM) technology have higher visibility as the “high tech” imaging modalities, the number of imaging procedures performed on fixed general x-ray systems and mobile/portable x-ray units by U.S. hospitals and their associated locations far exceeds the combined volume of procedures performed on their CT, MRI, PET, and NM imaging systems.  IMV estimates that U.S. hospitals performed a total of 152.8 million procedures on fixed general x-ray systems in 2018, compared to 114.9 million procedures performed using their CT, MR, PET, and NM systems, thereby comprising 57% of the 5-modality total of 267.7 million imaging procedures performed by U.S. hospitals (not including procedures performed in independent imaging centers and office practices).
The IMV X-Ray Market Outlook, from Kalorama’s partner publisher, can be found at:
Moreover, IMV estimates that 61.4 million procedures were performed using mobile/portable general x-ray units by U.S. hospitals, bringing the total number of general x-ray procedures performed in 2018 to an estimated 214.2 million, which accordingly comprises 65% of the 5-modality total in U.S. hospitals and their associated locations.

Now that general radiography has joined the ranks of the digital modalities, future artificial intelligence (AI) and machine learning applications that harness the power of the digital information will be a key factor in facilitating further clinical and workflow improvements for radiology.  While the adoption of AI applications for clinical decision support using general x-ray data is still in its early stages, radiology administrators see great promise for using such tools to improve image quality output, workflow, and to use as clinical decision support for radiologists.

IMV’s 2019 X-ray/DR/CR Market Outlook Report explores trends in U.S. hospital radiology departments for the adoption rate of CR-to-DR technology, x-ray procedure volume, the installed base of fixed and mobile general x-ray DR vs. CR systems, x-ray replacement cycles, purchase plans for DR retrofits and fixed & mobile x-ray systems, manufacturer installed base share and brand loyalty, and site operations characteristics. Respondent opinions on how key issues are affecting their department priorities and outlook are featured, and the report provides 5-year market forecast scenarios addressing the fixed general x-ray unit market.  X-ray manufacturers covered in this report include Agfa, Canon, Carestream, Del Medical, Fujifilm, GE, Konica Minolta, Philips, Samsung, Shimadzu, and Siemens, who provide fixed, mobile/portable general x-ray systems, and/or DR retrofit kits.
The report is based on survey responses to an online survey conducted by IMV in January 2019 with 340 radiology administrators/managers in U.S. short-term general hospitals.  Their responses have been projected to the IMV-identified universe of over 5,300 hospitals in the United States that have at least one fixed general x-ray system installed.  For information about purchasing IMV’s report, visit the corporate website at or call 703-778-3080 to speak with a representative.


LORNA YOUNG is the Senior Director of  Market Research for IMV.  The IMV X-Ray Market Outlook can be found at:

In many ways, the IVD market of today does not resemble the market five years ago.  2018 appears to be the year where a number of trends that had been discussed began to gel.  With that in mind, Kalorama Information will be on hand for UBM’s BIOMedDevice Convention in San Jose, CA next month.   In vitro diagnostics represents a 65 billion-dollar market, according to Kalorama Information’s latest report on the worldwide diagnostic industry.  That makes it a large, competitive and growing market.  But the significance of in vitro diagnostics goes beyond the market numbers.  IVD really is significant because of its reach: testing reaches touches clinical lab services, hospital care provision, pharmaceuticals. These add up to a multi-trillion dollar “Influence Market” for IVD.

Among many trends that Kalorama will discuss at the meeting:

  • Direct-to-consumer testing was a scattered array of projects and small startups prior to 2018.  Now, it is a real factor in the business.  With both Lab Corp and Quest making direct to patient pitches, and 23 and Me’s FDA approval for its consumer-ordered BRCA test, there is an actual market for these products.
  • There are nearly 10,000 locations where a patient now can walk in and secure a healthcare visit with no appointment.
  • Novel biomarkers are being discovered.  The track record of PCT in sepsis treatment and and high-sensitivity troponin markers in detecting heart attacks has been evident from their migration on to large analyzer systems.  This year saw developments in tests for traumatic brain injury and Alzheimer’s Disease, including two FDA approvals for microRNA biomarkers for the latter disease.
  • Sequencing: Clinical systems were introduced and smaller footprint instruments have been developed.  Simplified (NGS in a Box) systems have made gains.   How sequencing will fit into clinical diagnostics is still being determined, but it is clear it will have some impact.

There are many factors causing an increase in the rise of diagnostic services to monitor health, which in turn is stoking the growth of the IVD market. Trends such as technological advancements, rising end-user awareness, and miniaturization is driving the demand for point-of-care products and have increased the access to diagnostic tests near patient site. But with growth comes new regulations and implementation dates put forth for medical device manufacturers active in Europe. Compliance deadlines for 2020 and 2022 are looming.

With this in mind, Kalorama announces that Publisher Bruce Carlson will speak at the BIOMedDevice convention in San Jose, CA, December 4-6th, 2018.  The keynote speech:

The IVD Market Opportunity: Fast-Growth Markets, New Products, Disruptive Trends ( ) will be held on December 5th.

Topics covered include:

  • Retail clinics, Direct-to-Consumer marketing, accelerated aging and trends driving new product development in the IVD space
  • Point-of-Care, digital capillary testing, wearable, and other products moving IVD diagnostics forward
  • Medicare Part B Cuts and New FDA Proposals
  • New European IVDR affecting 80% of IVD products – what you need to know
  • Market Statistics for In Vitro Diagnostics and Contract Manufacturing for In Vitro Diagnostics