Climbing out-of-pocket healthcare costs forecast through 2026


In 2021, total U.S. out-of-pocket healthcare spending by consumers reached an estimated $491.6 billion, up about 10% from the prior year with continued annual growth of 9.9% expected through 2026. This will result in almost $800 billion of consumer out-of-pocket healthcare spending in 2026, reports leading medical market research publisher Kalorama Information in the recent study Out-of-Pocket Healthcare Expenditures in the United States, 5th Edition.

Multiple drivers are contributing to significant out-of-pocket spending growth, including a variety of demographic, business, and government trends, such as:

  • government, regulatory and insurance/payer actions including Managed Care Organization cost shifting, the Affordable Care Act’s Individual Mandate Repeal, and various policy changes that make healthcare more expensive;
  • business and economic trends, including actions taken by the business community and healthcare providers;
  • demographic trends that affect large groups of people such as obesity, aging and chronic conditions. Less common, yet expensive, demographic trends include mental illness and addiction.

Continuing a long-standing trend, out-of-pocket expenditures for healthcare products and services in the United States represent a significant portion of consumers’ incomes as of 2021. This is the result of a variety of factors including an aging population, rising utilization of medical products and services, and ongoing cutbacks to both public and private health coverage.

Over the years, U.S. consumers’ annual out-of-pocket healthcare costs have risen from about $250 per person in 1980 to $1,650 in 2021, with yearly increases of about $40 to $50. Increases for health plan premiums, in particular, have outpaced increases in overall prices and workers’ earnings. Consumers have noticed this trend and are becoming increasingly concerned with their ability to pay for the costs of illness. And for the lowest wage earners, these healthcare costs have become astronomical.

Greater gains in out-of-pocket spending will be mitigated by continued rising usage of lower cost medications (generic drugs, OTC medicines, Rx-to-OTC switches), growing utilization of disease management programs and the proliferation of low premium, high deductible health plans. Furthermore, salary growth will continue to lag healthcare cost increases and as consumers are unable to afford rising expenditures, they will increasingly forgo treatment and/or search for less expensive options such as generic or OTC medications. The economic effects of the Covid pandemic will further dampen spending, although not significantly.

This infographic is based on the report The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, AutoImmune, Others) by leading medical market research publisher Kalorama Information. Purchase the report for more insights on the past, present, and future of this important market.


The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, AutoImmune, Others)

New approaches to treating and monitoring patients–such as telehealth–are emerging in response to increased healthcare needs of an aging population, new wireless technologies, better video and monitoring technologies, decreasing healthcare resources, an emphasis on reducing hospital days, and proven cost-effectiveness.


Before COVID-19, the telehealth industry was evolving slowly with slight gains annually.  Today, the pandemic has thrust the world into a new era of remote life, including managing, monitoring and treating patients and their health conditions at a pace never experienced before.  As a result of COVID-19, the global market for patient monitoring and telehealth increased by more than $2.8 billion in 2020 to reach $54.5 billion, according to leading medical market research publisher Kalorama Information in the new report Remote Patient Monitoring.

There is a new focus on pandemic preparedness and in-place infrastructure development for quick deployment of remote care technologies, which have made telehealth among the most cost-effective ways for the healthcare industry to meet the evolving requirements of patients. Kalorama’s market estimate includes sales of devices, peripherals, software, packaged services, monitoring services and other patient monitoring and telehealth applications.

Telehealth (sometimes also referred to as telemedicine) includes sending images to a specialist, live two-way video consultations between patient and provider, capturing and sending data from monitoring devices, and/or incorporating data and images into EMRs.  Reasons for using telehealth include improved access to healthcare for patients in remote locations, cost effectiveness, and patient demand.

Beyond the impact of COVID-19, the patient monitoring and telehealth market has also benefited from the demand to move to a more wireless and streamline operation both within major health facilities and in-home treatment markets.  The demand to integrate data processing capabilities and electronic medical record (EMR) transfer options has also fueled the market. Further, there is an increasing trend to upgrade to ambulatory and hand-held devices.

Looking ahead, Kalorama Information forecasts the global patient monitoring and telehealth market will experience healthy growth between 2021 and 2025.  Growth in patient monitoring technologies will be due to several factors, including:

  • An aging population
  • Replacement of older, low-technology equipment with new wireless or remote units
  • Growing acceptability and knowledge of technology features and benefits
  • Additional monitoring efforts in an effort to alleviate healthcare problems before they require hospitalization or emergency department visits
  • New technological advancements in the area of wireless connectivity
  • Government incentives and rebates that will grow demands for health facilities
  • Increasing reimbursement coverage for remote care

For more insights and information, purchase Remote Patient Monitoring by Kalorama Information at:

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

Over the years, the increasing introduction of transportable, portable, and handheld medical instruments has resulted in the migration of point-of-care (POC) testing from the hospital environment to a range of medical and non-medical environments including the workplace, home, disaster care and most recently, convenience clinics. In the face of the ongoing global COVID-19 pandemic, the reliance upon and need for testing without the direct involvement of healthcare professionals has become arguably more important now than ever before, according to Kalorama Information in the new report At-Home Testing: COVID-19 Trends and Future Potential.

Rapid tests to detect the presence of the coronavirus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19, even with vaccines readily available.  There are now FDA-authorized COVID-19 tests sold online and in stores that can be used completely at home.  At-home tests allow individuals to collect their own sample and test it with a system that gives results in minutes at home.

It’s been more than one year since the world was thrown into the chaos of the COVID-19 pandemic.  One thing that has become apparent is that early diagnosis is crucial to prevent the spread of such infectious diseases throughout a community.  Rapid diagnosis, such as what is offered through at-home testing, is also key to containing outbreaks by allowing for efficient contact tracing in communities.

In many situations, POC and self-testing at home are tools to overcome roadblocks in testing due to sampling issues and testing delays.  Self-collected samples and home tests are provided by a growing number of hospital and independent laboratories to expand the network of testing options in all major markets in North America and Europe.

Home self-testing is not new: pregnancy tests, urine screening dipsticks, and glucose monitoring products are readily available in pharmacies and retail outlets in various major markets worldwide.  Consumers also make online purchases of kits marketed for STIs, HIV, allergies, vitamin D, food sensitivity, ancestry, and DNA testing.  These kits generally involve the collection of cheek swabs and saliva specimens that are then sent to a laboratory for processing.

From a public health perspective, at-home self-tests can offer advantages when used to complement professionally administered rapid tests or lab-based tests.  They can improve the accessibility to testing.  They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.

Despite the apparent positives, the home-based rapid tests for infectious diseases are a work in progress and have their share of critics. Naysayers contend that preanalytical problems often surface with self-collection methods and home tests that can put patients at risk.  While home sample collection kits are designed to be simple, problems commonly occur with self-collection that can affect the quality of the sample and, therefore, the subsequent test result.

Nevertheless, from a public health perspective, self-tests can offer advantages when used to complement professionally administered rapid tests or lab-based tests.  They can improve the accessibility to testing.  They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.

Self-testing with over counter (OTC) and direct to the consumer (DTC) kits could therefore enhance disease control with efficient identification and isolation of cases. However, there again are potential disadvantages, as shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting, and make response measures such as contact tracing and quarantine of contacts challenging because the test results do not enter a government database.  Current indicators for monitoring the intensity and spread of the COVID-19 pandemic such as testing rates, test positivity rates, and case notification rates, could be affected, and could make it difficult to monitor disease trends over time.  An additional challenge is that samples from self-testing would not be available for viral sequencing and monitoring variants.

For more information on these and other topics related to this market, purchase At-Home Testing: COVID-19 Trends and Future Potential by Kalorama Information at:

At-Home Testing: COVID-19 Trends and Future Potential

Rapid tests to detect the presence of the virus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19.

Kalorama Information reported a mixed result with point of care testing, defined by tests that can deliver a result meaningful during a patient visit with a provider or on their own.  In 2020, sales of POC testing reached $29,316 million, according to Kalorama Information, a sister publication to Lab Pulse.  That’s up double digits from 2019, which would normally be pretty intense growth according to the Arlington, VA-based producer of IVD market research reports, but the growth in sales belies the reduction of business for the average point-of-care test product.  New COVID-19 tests fueled growth while the pandemic ravaged business in other test categories.  This according to Kalorama’s Information The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 8th Edition.

“Everywhere but infectious disease, this is a story of a declining market,” said Bruce Carlson, Publisher of Kalorama Information, a Science and Medicine Group brand.  “But since infectious disease has long been seen as the growth pathway for POC, that counters the long-term damage.  Many companies who make other products just pivoted their brands towards it, and when you combine uber-success in this category with recovery in 2021 in other categories, there’s no permanent damage to overall POCT from the pandemic.

But as Kalorama’s report indicates, for product managers in some routine POC segments, it’s a different story.  Sales were down as COVID-19 caused a contraction of the segment due to lockdown, closures, limited physician visits and a reduction in elective and outpatient surgery.

“It’s point of care-there so has to be a care event for POC to be used,” Carlson said. “And there was a disturbing trend in 2020, less care events; less visits to healthcare practitioners for preventive visits, less ER visits even, and this affected the majority of test products.”

Specifically, Kalorama’s report notes two bread-and-butter categories of testing that were hurt by the pandemic:

  • The POC blood and electrolytes testing market was negatively affected by COVID-19. This was mainly due to lockdowns, limited physician/patient visits and a reluctance of patients to seek medical attention. Routine blood workups were limited along with other non-life-threatening assessments. The market contracted in high single digits for 2019-2020.
  • The POC coagulation testing market was negatively affected by COVID-19. This was mainly due to lockdowns and limited physician/patient visits. The self-testing portion contracted due to patient lockdowns and limited availability to purchase coagulation testing materials. The professional segment also declined significantly due to the aforementioned issues.  The market contracted about more than 20%.

Meanwhile, Kalorama said, the POC infectious disease market grew at over 300%, which made up for the entire market loss in other areas.  That’s COVID-19 mostly, but not solely as a lot of healthcare infection and respiratory condition tests were utilized last year as well.

More information and scores of categories of testing with sizing and forecasts, can be found at

The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 8th Edition

Globally, millions of dollars are spent annually on POC diagnostic testing, both professional testing and self-testing.

There’s much talk about cell and gene therapy but a new report from a leading market research firm says that there’s a growing market over nearly two billion dollars for companies that make the cell and gene therapies.

In 2020, the total global cell and gene therapy BCMO market reached $1,842 million. Over the following 5 years, as cell therapy BCMO services continue to expand strongly along with usage of cell therapies.  This is the finding in Kalorama Information’s new report, The Market for Cell and Gene Therapy Contract Manufacturing Organizations (CMOs).

The report said large CMOs include Lonza, Patheon, Catalent, WuXi and FUJIFilm Diosynth among many others.

Cell and gene therapies are groundbreaking treatments with the potential to actually cure disease rather than simply manage symptoms. They are often designed as one-time treatments, that in some cases, can actually reverse the progression of an illness. With cell therapy, cells are cultivated or modified outside the body then injected into the patient, where they become a “living drug.” With gene therapy, genes are replaced, inactivated or introduced into cells, either outside or inside the body, to treat a disease.

Consequently, cell and gene therapy products are transforming the treatment of cancers and genetic diseases. Additionally, cell and gene therapies are expanding into other areas of medicine including autoimmune diseases, cardiovascular diseases, musculoskeletal disease, dermatological diseases and many others. With an estimated 50 million persons suffering from neurodegenerative diseases in the U.S. alone, the unmet need is great.

With this exciting potential, the science is moving ahead and now the industry needs to industrialize and standardize the manufacturing and commercialization of emerging products. Important next steps include standardized set-up and closed automated systems.

Cost is one of the largest issues facing the industry. The high cost of producing these new therapies is staggering, resulting in prohibitively high product costs. For example, after launching Kymriah, Novartis’s price tag was $475,000 and a second product, Yescarta, cost $375,000. A gene therapy for the eye, Luxturna, was priced at $425,000 per eye. Some therapies are even more expensive, with costs for Zolgensma and Zyntegio estimated at more than $2.1 million and $1.8 million, respectively. The high price tag seems to be related to the high cost of goods (CoG).

Advancements in manufacturing are helping to drive costs down but cell and gene therapy remain an expensive process, with researchers at the Department of Pediatrics at Oregon Health & Science University and Doernbecher Children’s Hospital in Portland recently predicting that of the 40 – 50 gene therapies currently undergoing clinical assessment, each will likely to be priced at more than $1 million per regimen. These high costs present major barriers to affordability and usage, particularly in government-funded healthcare plans such as Medicaid and Medicare. Talks have been ongoing as to how to fund these medicines in the short term and long term through capital markets, a risk pool from insurers or other means.

The current goal of industry is to transition from a manual process to a more standardized and automated set-up, as did monoclonal antibody production. This will take the industry to a platform that will serve large patient populations while reducing both costs and risks. In the meantime, some manufacturers are making progress with insurance reimbursement.

When a product is first introduced, a company must ensure that the pace of manufacturing can keep up with demand, as there will initially be a backlog. This is particularly true for new cell and gene therapies, which offer potentially curative solutions to debilitating illnesses. Experienced CDMOs can meet this need by seamlessly supplying these early customers, avoiding delays that often arise in the build-out of entirely new manufacturing facilities.

Although the logistics of cell and gene therapies are more complicated than for most other drugs, these challenges can be met. For example, Dendreon’s Provenge was initially criticized for its complicated logistics. After a rough start, Provenge has become the most sold cell-based medicinal product, with thousands of shipments worldwide within tight delivery windows.

These trends and more are covered in Kalorama’s report, available at

Total global sales of biomarker test products are projected to reach nearly $63 billion in 2027 with the majority of sales coming from the United States, Western Europe, and Japan, according to new data by leading medical market research publisher Kalorama Information in the report The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, Autoimmune, Others). This amount will correspond to a 5.5% annual gain from levels in 2018.

Biomarkers include more than 1,000 substances that serve as reagents, consumables, and/or test components for several medical-related diagnostic and research applications.  Substances that detect and measure genetic changes in patient samples are also included in Kalorama Information’s sales estimates.  The global market for biomarker products is led by large multinational in vitro diagnostic (IVD) companies, including Abbott Diagnostics, Becton Dickinson, bioMérieux, Bio-Rad Laboratories, Danaher, Hologic, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific.

Specific uses of biomarkers include:

  • detection of human diseases and disorders
  • identification and selection of appropriate therapies for diagnosed conditions
  • monitoring of disease progression
  • monitoring of the effectiveness of selected therapies
  • detection of disease relapse or recurrence
  • evaluation of new drug candidates as to safety and effectiveness

Of the seven major segments of biomarker products, infectious diseases will account for the largest share of worldwide sales over the long term.  Revenues in this segment will continue to rise due to the emergence of new disease threats, an increasing number of conditions attributable to aging demographic patterns, and the expanding availability and use of high value-added molecular tests.

Applications in cancer testing, staging, and treatment assessment will comprise the second-largest segment of biomarker products based on global sales in 2027.  Moreover, this segment will post the fastest worldwide revenue growth for biomarker products as the number of cancer patients continues to rise and medical providers upgrade capabilities for cancer testing, screening, monitoring, and therapy selection.  New products based on liquid biopsies, next generation sequencing, and other advanced technologies will also serve to boost global sales of cancer biomarker products.

Other conditions and applications that will generate sales growth for biomarker products include:

  • Cardiovascular diseases, which are the leading cause of death worldwide. Reagents, test kits, and consumables for the detection of coronary artery disease, high cholesterol, and congestive heart failure will command the largest share of revenues.
  • Applications in regular patient physical examinations and pre- and post-hospital admission testing, which will see gains but will generate comparatively slow revenue growth due to competition from more sensitive molecular and rapid point-of-care (POC) tests.
  • Biomarker products for neurological and autoimmune conditions will expand favorably as medical providers seek to improve testing and monitoring capabilities for increasingly problematic conditions such as Alzheimer’s disease, degenerative nerve and muscle disorders, Hashimoto’s thyroiditis, and inflammatory bowel disease.
  • Inherited diseases, which will generate fast revenue growth among other biomarker product applications as advances in molecular technologies leads to the introduction of new, high value-added genetic tests.

For more insights on this market, purchase Kalorama Information’s The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, Autoimmune, Others)

Not since the Swine Flu epidemic of 2009 has there been this amount of emphasis on vaccines and vaccine development.  This new infectious disease threat with no anti-viral, nor vaccine is causing significant concern among healthcare providers, governments and the public.  Last-resort measures such as school closings and curfews in place in the United States has only increased focus on a vaccine solution that could provide enough protections to individuals.

Kalorama covers vaccines markets from 2018 to projected 2024 markets in its market research study:
A new report will be out in July 2020.

Some diseases have proven extremely difficult to address through vaccines – HIV, for example. However, although much is unknown about COVID-19, it is nonetheless a respiratory disease that belongs to a class of diseases – corona viruses – that is well understood.  This provides more confidence

We talked with our vaccine analysts to get their sense of the landscape with novel coronavirus.

Early Efforts and a First Trial Dose

COVID-19 vaccine candidates are now heading into trials. Companies in various stages of development include Gilead, GlaxoSmithKline, Pfizer, Moderna, Medicago and others.

Pfizer chairman and CEO Dr Albert Bourla said: “Many companies, including Pfizer, are working to develop antiviral therapies to help infected patients fight this emerging virus as well as new vaccines…Pfizer is working to advance our own potential antiviral therapies and is engaged with BioNTech on a potential mRNA coronavirus vaccine.”

Cambridge, MA-based Moderna announced first participant dose in a Phase 1 trial for mRNA-1273 against the novel coronavirus.  Moderna’s mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein. The company’s Phase 1 study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.

This is a major opportunity for vaccine developers, so it is likely that if a developer has a vaccine  that could be even partially effective, they will do everything possible to move it thru trials quickly.   At the same time, governments are looking for more tools to contain the spread. It’s clear that steps taken to date have not been sufficient.   So they are highly motivated to support vaccine development efforts.


Demand is not the issue, according to Kalorama’s vaccine analysts.  The market pull will be there, but in vaccine markets, where customers are generally governments, it comes down to the technology – the products.

Some diseases have proven extremely difficult to address through vaccines – HIV, for example. However, although much is unknown about COVID-19, it is nonetheless a respiratory disease that belongs to a class of diseases – corona viruses – that is well understood.  This provides more confidence that it is possible to create a vaccine that would protect some portion of the population.

Since other countries do have significant vaccine development resources – China, India, Japan, etc. – it is certainly possible that a vaccine could be developed overseas before one is developed in the U.S. In fact, I would guess that Chinese vaccine developers began working on this weeks before U.S. vaccine developers.

The Gaurdian reported that about 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals.

Stat News reported about an interesting synthetic mRNA solution that is being developed. that would be “programmed with the goal of getting our inner machinery to produce certain coronavirus-like proteins — the very proteins that the pathogen uses to gain entry into our cells. Researchers at Moderna and the NIH think that once those homemade dummy virus particles are there, the thinking goes, our bodies will learn to recognize and clobber the real thing.”


Of course, developing a vaccine is only part of the problem. Any vaccine would have to be effectively manufactured and distributed. That could create significant roles for many other players.

Most inactivated influenza vaccines are produced by growing influenza viruses in eggs.  This requires a staggering amount of them. For the H1N1 flu vaccine, a million eggs are required for 3 million doses, more or less.

Egg-based production process begins with candidate vaccine viruses (CVVs) grown in eggs provided by the CDC or approved partner per current FDA regulatory requirements. These CVVs are then injected into fertilized hen’s eggs and incubated for several days to allow the viruses to replicate. The fluid containing virus is harvested from the eggs.

Cell-based flu vaccine has been developed as an alternative to the egg-based manufacturing process. On August 31, 2016, FDA issued an approval for Seqirus, the sole FDA-approved cell-based flu vaccine manufacturer in the United States, to begin using cell-grown CVVs.  Cell culture technology is potentially more flexible than the traditional technology, which relies upon adequate supply of eggs. Recombinant DNA manufacturing is another option. This method does not require an egg-grown vaccine virus and does not use chicken eggs at all in the production process. Instead, manufacturers isolate a certain protein from a flu virus. This proteins are then combined with portions of another virus that grows well in insect cells and allowed to replicate. A protein is harvested from this mix that is used to make the vaccine.

According to a recent article in the Los Angeles times, there are many different vaccine-making platforms, each with its own set of advantages and disadvantages. “For example, a vaccine based on the virus’ genome can be made quickly, in perhaps a month or two, but it may be harder to manufacture in giant quantities. Another option is to take the virus’ genetic snapshot and put it into a different virus for transport. These vaccines take longer to make — say, six to eight months — but they can be scaled up more readily.”

” almost 33% of readers believe it will take over a year, while slightly more 28% are optimistic there could be a vaccine available within three months.” -Pharmaceutical Technology

An article in Pharmaceutical Technology  said that “Readers of Pharmaceutical Technology have been voting on how long they think it will take for a vaccine to be available to patients. With over 164,000 votes cast, the results show than almost 33% of readers believe it will take over a year, while slightly more 28% are optimistic there could be a vaccine available within three months.”

In general,  this is a very major opportunity for the vaccine industry to shine.  We would expect it to rise to the occasion with at least one, if not several, potential products.  Kalorama will of course report on updates in our biennial vaccine market research study.


Highly effective cancer therapies. Handheld hematology analyzers. A new and untapped world market. Social media selling life science tools. Science and Medicine Group publications, including Kalorama Information, Strategic Directions International (SDi), Bioinformatics, and IMV have made various projections for the new year in imaging, diagnostics, biotechnology, and life science instrument and supplies that can help marketers determine their plans next year. These projections are the result of analysis in the scores of detailed publications produced by these brands.

The list below includes the top 10 predictions for 2020:

  1. CAR-T therapy revenue will exceed $1 billion next year: CAR-T cancer therapeutics, which use the patient’s own immune cells to attack cancer, will earn more than $700 million this year for the two companies that market them. And it’s likely these therapies will exceed $1 billion in revenue in 2020 as new products are approved. This is according to Kalorama Information ( The reason is their track record in treating patients with little or no treatment options.  CAR-T therapy involves using T cells from the patient and genetically engineering those cells using a disarmed virus so that the cells produce receptors called CARS that can attack cancer. It has shown effectiveness in some lymphomas and leukemias, and next year one or more products for myeloma are expected. Science and Medicine Group thought leaders and representatives were at the American Society of Hematology meeting in Orlando, FL, where significant studies were released on CAR-T safety and efficacy, as well as new products announced.
  2. Social media will be the best tool for selling life science instruments: According to “Life Science Customer Purchasing Journey: Finding Customers Along the Way” scientists look to other scientists when they need a tool to solve an experimental problem. The report, which describes the purchasing habits of life science tool buyers, is the result of a survey of scientists. Among the findings were that 72% trust their colleagues over websites and 71% look to fellow scientists over sales reps. These are just two of the many facts detailed in the report. Instrument buyers will need to see feedback from their colleagues in order to be influenced in a purchase decision, according to the report. Social media reflects the best forum for this to happen. The report also gets into other topics and finds that good customer service will be essential for sales in 2020.
  3. Instrument makers will target the ASEAN countries: The Association of Southeast Asian Nations (ASEAN) is a multinational economic and political alliance founded in 1967 by Thailand, the Philippines, Malaysia, Singapore, and Thailand. If the ASEAN group were a single nation, it would rank third in population, after India. It would also be the eighth largest market in the world. While not one nation, in 2015, the ASEAN Economic Community was established to create a single market for free trade of goods, services, and labor across the region, similar to the single market free trade within the European Union. According to SDi’s report on the Southeast Asia instrument markets (, this group of Southeast Asian nations is projected to have the fastest growth in the analytical instrumentation market in the next five years due to its burgeoning pharma/bio sector. Furthermore, the ASEAN’s policies and foreign investments will bolster the pharma/bio sector contributing even more to the region’s growth. While places like Singapore and Taiwan have well-established pharma/bio industries, other countries like Thailand and Malaysia look to grow domestic production and research for pharmaceuticals.
  4. Imaging procedure volume, especially for CT and MRI, will increase around the world: Results are in from IMV’s Global Radiologist Survey, part of its “Global Imaging Market Outlook Report” ( Over 300 respondents participated in IMV’s global survey, and they represent key opinion leaders, with nearly half of the respondents being the chair/chief/heads of their radiology departments and over half being practicing radiologists. Overall, these opinion leaders are optimistic about the growth of imaging in their countries, with 80% saying their imaging procedure volume will increase. Respondents in the emerging markets are more optimistic about their outlook for increases in imaging procedures than those in the developed markets. The top two modalities planned in all 10 global regions are CT and MRI.
  5. That doesn’t mean all global hospitals are ready: IMV’s survey also found that solutions to address this procedure growth may be a challenge. Only one-quarter of the respondents feel their “capacity is sufficient to meet their needs over the next two to three years,” but their prospects for acquiring imaging equipment may be inhibited by delays in their internal and governmental approval processes and local economic conditions. Respondents in Latin America, the Middle East, and Africa are particularly concerned about their local economy limiting their capital budgets for imaging equipment, and they are very cost-conscious about equipment and service pricing while seeking reliable equipment and responsive service in their environments.
  6. Preparation for sequencing will be a $2 billion+ market: The increasingly routine use of sequencing in clinical settings is creating tremendous opportunities for suppliers of sequencing instrumentation and consumables, including those required for preanalytical preparation of samples from biological materials. In fact, clinical applications will drive double-digit growth for the NGS sample preparation market over the next five years. SDi’s newly published report, Sample Preparation for Next-Generation Sequencing(, provides an in-depth analysis of how precision medicine and other applications are shaping demand for next-generation sequencing (NGS) sample preparation techniques. The report finds these products earned $1.8 billion this year and will push beyond $2 billion in 2020.
  7. AI will find its best home in imaging: IMV’s Global Radiologists Survey findings also confirmed the future of artificial intelligence (AI) and machine-learning tools for imaging in 2020 and beyond. The top-ranked potential use for AI that respondents cited was “capabilities to more precisely diagnose patient conditions and enhance personalized medicine.” It’s not all positive — in their comments on potential uses, some radiologists see the potential for AI to improve clinical decision support and image quality, but others expressed concern on when and how AI applications will be integrated into their routine practice and daily workflow, as well as work seamlessly with their imaging equipment, PACS, and RIS.
  8. Ascendance of mass spectrometry as a clinical instrument continues: Within the analytical instrumentation industry, mass spectrometry is certainly one of the most dynamic areas for growth over the next several years. Its increasingly sensitive analytical capabilities and enhancements continue to bring the technology to the edge of new scientific discovery and research applications. While SDi covers the market for eight separate mass spectrometry techniques in its flagship publication, the “Global Assessment Report,” it does so from a broad perspective that looks across all end markets. Clinical mass spectrometry, however, is one particular end market that has been at the root of very rapid mass spectrometry growth over the past few years — and will continue to be in 2020 and for the foreseeable future. SDi’s latest publication, “The 2019 Mass Spectrometry Market for Clinical Applications” (, dives into the world of clinical diagnostics to examine how robust the demand from laboratories in this space is shaping the market for mass spectrometry technologies. The report presents market data and insights into six categories of clinical mass spectrometry, although two categories in particular are responsible for the most disruptive market influences in recent years: MALDI-TOF and triple quadrupole LC/MS.
  9. Multiphoton microscopy makes gains: According to SDi’s “2019 Market for Live Cell Imaging” report (, the total market for live cell imaging instruments, assays, and labeling reagents is projected to reach $1.9 billion in five years. Among the factors driving this high growth is the increasing adoption of advanced microscopy techniques for live cell imaging, namely multiphoton microscopy and light sheet microscopy. Multiphoton microscopy, also called two-photon excitation microscopy, makes use of nonlinear optics to provide finely localized, three-dimensional imaging. Instead of using optics to control the light returning to the detector, multiphoton optics ensure that the stimulated part of the sample is restricted to a small point, which reduces the risk of photobleaching effects. Light sheet microscopy, also called single-plane illumination microscopy, illuminates only a thin plane of just a few micrometers at a time using a laser. As the sample is moved through the light sheet, three-dimensional images are generated. Since only a thin slice of the sample is exposed at a time, light sheet microscopy is a relatively gentle technique for live cell imaging and can be used to image cells in living animals.
  10. Hematology testing goes handheld: Hematology is important for a workup in annual exams and hospital inpatients. The basis of hematology testing is the complete blood count (CBC) that provides information on blood components: hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, and platelets. Kalorama Information has covered hematology for decades in its “The Worldwide Market for In Vitro Diagnostic Tests” ( and says these devices are now getting smaller and useable at the point of care (POC) — a trend that will continue in 2020. A number of handheld and benchtop analyzers are available for POC professional hematology procedures. Among the producers of these products are Beckman Coulter, Diatron, GlysBy Diagnostics, HemoCue (Radiometer/Danaher), Horiba, Roche, and Sysmex. Hematology will remain the second-largest volume of global in vitro diagnostic procedures, with the number of tests increasing 5.3% per year to nearly 6.7 billion in 2024. The total worldwide volume of POC professional hematology testing procedures conducted is predicted to expand 4.4% annually to 424 million in 2024. Uses in general health screening and the diagnosis and monitoring of blood-related disorders during hospital stays, emergency room visits, and physicians’ consultations will account for growth. The availability of complete blood counts on high-throughput clinical chemistry systems will moderate a faster rise in procedure volume.