According to the World Health Organization, 235 million people suffer from asthma worldwide.¹ Chronic obstructive pulmonary disease (COPD) sufferers number 251 million, with 65 million having a moderate to severe form of this respiratory condition. Globally, deaths caused by these diseases numbered 383,000 and 3.17 million, respectively.

Inhaled medication, administered via an inhaler, is one common treatment. Inhalers have been used since the late 1700s, but the pressurized metered-dose inhalers that patients use today weren’t invented until 1955, by American doctor George Maison. Maison’s invention allowed the prescribed dose of asthma medication to be expelled into the lungs by pushing a button. These inhalers were meant to be an improvement over nebulizers which some patients found difficult to use and as a result failed to get the proper dose of medicine.

Despite metered-dose inhalers being an improvement from earlier methods of medication delivery, studies have shown that patients who use them make at least one mistake while taking their medication in this manner 70-90% of the time, resulting in only 7-40% of the medication reaching their lungs. The two most common mistakes include a delay between inhalation and administering the dose of medication and not breathing deeply enough.

An improvement over these traditional inhalers may be smart inhalers. Smart inhalers have either built-in sensors or clip-on sensors that turn a traditional inhaler into a smart inhaler. The sensors are used to track the medication, dosage and time taken for each dose. Some have monitors for inspiratory flow rate. These sensors link with an app on a smartphone or tablet, with the data saved to the cloud so that doctors and caregivers can access the data. Doctors can monitor whether patients are taking their medication as prescribed and if they are using their inhaler correctly. The app can also provide reminders to patients when they need to take another dose. All of these innovations are meant to help patients get the proper dose of medication on a more consistent basis so that the use of a rescue inhaler is minimized and their quality of life improves. There are also clip-on sensors for rescue inhalers that monitor usage and send notifications when the users leave their inhalers behind. The data gathered can also be used to determine what triggers their asthma attacks.

Today’s market size shows the global revenue for smart inhalers in 2018 and projected for 2026. The North American market generated the highest revenue in 2018 while the Asia-Pacific region is expected to experience the highest growth over this period. Some leading companies in this industry include Propeller Health; Adherium Ltd.; Teva Pharmaceutical Industries Ltd.; AstraZeneca, PLC and GlaxoSmithKline, PLC.

¹ According to the Global Asthma Network’s report The Global Asthma Report 2018, 339 million people worldwide suffer from asthma.

Geographic reference: World
Year: 2018 and 2026
Market size: $34 million and $1.4 billion, respectively
Sources: “The Global Smart Inhalers Market Size Was Valued at $34 Million in 2018 and Is Estimated to Reach $1,406 Million by 2026, Growing at a CAGR of 58.4% from 2019 to 2026,” CISION PR Newswire, August 7, 2019 available online here; “Asthma,” World Health Organization, August 31, 2017 available online here; “Chronic Obstructive Pulmonary Disease (COPD),” World Health Organization, December 1, 2017 available online here; “Chronic Respiratory Diseases: Burden of COPD,” World Health Organization available online here; “Inhalers,” Brought to Life: Exploring the History of Medicine available online here; Laura Lovett, “Teva Pharmaceutical’s AirDuo Digihaler Gets FDA Green Light,” MobiHealthNews, July 15, 2019 available online here; Dr. Andreas Alt, “Flow Measurement in Smart Inhalers for Connected Drug Delivery,” Medical Product Outsourcing, March 1, 2019 available online here; The Global Asthma Report 2018, Global Asthma Network, 2018 available online here; “Smart Inhalers,” Asthma UK available online here; “Control Your Asthma with FindAir Smart Inhaler,” FindAir, 2018 available online here.
Image source: Bob Williams, “inhaler-breath-asthma-breathing-2520471,” PIxabay, July 19, 2017 available online here. Picture shows a traditional inhaler, not a smart inhaler.

Hospital or healthcare-associated infections (HAIs) are acquired by patients after they are admitted to a hospital or other health care facility. According to the World Health Organization, 7% of hospitalized patients in developed countries and 10% of hospitalized patients in developing countries will acquire at least one HAI. Patients in intensive care units have dramatically higher rates of HAIs. In the United States, 1 in 25 patients develops this type of infection, resulting in 90,000 deaths per year.

Improperly sanitized medical and surgical instruments¹ can transmit infections to vulnerable patients. In 2009, the U.S. Department of Veterans Affairs reported that between 2002 and 2009 nearly 11,000 patients were exposed to HIV, hepatitis B and hepatitis C due to improperly sterilized endoscopes. After a hepatitis C outbreak in a Las Vegas surgery center sickened several people in 2008, the Centers for Medicare and Medicaid Services inspected 1,500 surgery centers and cited 28% of them for deficiencies in equipment cleaning and sterilization. In 2018, outbreaks of infections due to improperly sterilized medical instruments occurred in California, Colorado, Michigan, and New Jersey among others.

At one time, most medical instruments were made of steel or glass. Sterilization was simple. As medical instruments become more specialized, complex and smaller due to the popularity of minimally-invasive surgeries, sterilization procedures have become more complex.

Sterilization, whether by heat, chemicals, irradiation, high pressure or filtration “kills, deactivates, or eliminates all forms of life and other biological agents which are present.”² In order to ensure proper sterilization of medical instruments, the U.S. Centers for Disease Control and Prevention (CDC) recommends monitoring the sterilization process using mechanical, chemical, and biological indicators. Mechanical monitoring involves checking gauges and displays on the sterilization equipment itself to ensure that the temperature, pressure, and exposure time have reached the recommended levels. These readings can be observed while the sterilization process is happening so any anomalies or malfunctions can be caught early in the process. Chemical indicators such as tapes, strips, tabs, or special package markings contain chemicals that change color when exposed to high temperatures or other sterilizing conditions. Packages with chemical indicators allow medical personnel to distinguish between processed and unprocessed instruments, virtually eliminating the possibility of using instruments that have not undergone a sterilization process. The CDC recommends using mechanical and chemical monitoring each time instruments are sterilized. Biological monitoring involves vials, strips, or tape containing highly resistant microorganisms, strains of bacterial spores. The sterilization process is monitored by how well it kills these organisms.

This week’s market size shows the amount spent on biological and chemical sterilization indicators worldwide for 2017 and projected for 2025. Demand is expected to increase due to a growing geriatric population with chronic health conditions. Increasingly stringent regulations regarding the sterility of healthcare products in order to prevent HAIs is also expected to fuel demand for these products. Biological indicators claimed the largest market share in 2017. Leading companies that manufacture sterilization indicators include Getings AB, Cantel Medical Corp., 3M Co., Cardinal Health Inc., Matachana Group, Mesa Laboratories, and Anderson Products Inc.

¹ From here onward “medical instruments” also includes surgical instruments.
² Source: “Sterilization (Microbiology),” Wikipedia, April 3, 2019 available online here

Geographic reference: World
Year: 2017 and 2025
Market size: $548 million and $1.24 billion, respectively
Sources: “Sterility Indicators Market Size, Share & Trends Analysis Report by Type (Chemical, Biological), by Technique (Heat, Low Temperature, Filtration, Radiation, Liquid), by End User, and Segment Forecasts, 2018 – 2025,” Grand View Research Report Summary, November 2018 available online here; “Global Sterility Indicators Market Size, Share & Trends 2014-2018 & 2025 by Type (Chemical, Biological), & Technique (Heat, Low Temperature, Filtration, Radiation, Liquid) – ResearchAndMarkets.com,” Yahoo! Finance, April 25, 2019 available online here; “Health Care-Associated Infections Fact Sheet,” World Health Organization available online here; Joe Eaton, “Filthy Surgical Instruments: The Hidden Threat in America’s Operating Rooms,” The Center for Public Integrity, February 22, 2012, updated May 19, 2014 available online here; “Sterilization (Microbiology),” Wikipedia, April 3, 2019 available online here; “Biological & Chemical Indicators,” STERIS Life Sciences available online here; “Sterilization: Monitoring,” Centers for Disease Control and Prevention, March 22, 2018 available online here; Chris H. Miller, “Sterilization: Instrumental in Patient Safety,” Sterilizers.com available online here; Karen Bouffard, “Dirty Instruments Cause Second DMC Hospital to Fail Federal Inspection,” The Detroit News, November 28, 2018 available online here; Alyssa Rege, “State Declares ‘Immediate Jeopardy’ at UC San Diego Hospital Over Dirty Surgical Instruments,” Becker’s Clinical Leadership & Infection Control, June 8, 2018 available online here; Alyssa Rege, “Bone, Blood, Bugs Found on Instruments at Denver Hospital After Surgical Breach, Report Says,” Becker’s Clinical Leadership & Infection Control, June 14, 2018 available online here; Julia Jones, “3,000 People May Have Been Exposed to Bloodborne Infections at NJ Surgery Facility,” CNN, December 26, 2018 available online here.
Image source: rawpixel, “steel-black-and-white-bw-care-3309870,” Pixabay, April 11, 2018 available online here.

Osteoarthritis is the degeneration of the cartilage that cushions the ends of bones. This causes stiffness, pain, swelling, and loss of mobility in the affected joint. It is the fifth leading cause of disability in the world, affecting 10% of the world’s population 60 years of age and older. In high-income countries, up to 80% of people aged 65 and older will suffer from osteoarthritis. In the United States, it is the most common cause of disability in adults. More than 30 million Americans suffer from this condition and 14 million have symptomatic knee osteoarthritis.

Viscosupplementation is one type of treatment for this condition. It was developed in Europe in the 1980s specifically to treat knee osteoarthritis. In 1997, the U.S. Food and Drug Administration approved it “for the treatment of pain in osteoarthritis … of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g. acetaminophen.”¹

Viscosupplementation is a medical procedure in which a gel-like fluid containing synthetic hyaluronic acid is injected into a joint to treat symptoms of osteoarthritis. The fluid provides cushioning for the bones. Hyaluronic acid is naturally secreted by mesothelial cells present in the joints. Treatments are performed once a week for three to five weeks. Some newer forms only require one injection. Once the pain and swelling from the procedure itself dissipate, some patients experience reduced arthritis pain and better mobility for up to 6 months. Others may not experience any pain relief at all. Viscosupplementation is generally prescribed for people who have early, mild to moderate knee osteoarthritis, patients who previously have taken NSAID pain relievers but whose pain was not alleviated. Some brand names include Synvisc, Euflexxa, Orthovisc, Hyalgan, and Monovisc, to name a few.

Today’s market size shows the amount spent on viscosupplementation worldwide in 2016 and projected for 2026. Demand for viscosupplementation treatments is expected to increase due to the preference for minimally-invasive procedures, the growing geriatric population worldwide and the increase in the number of people who have conditions that make them prone to osteoarthritis such as obesity, diabetes, hypertension, cardiovascular disease, and trauma to the joints due to repetitive movements. Several leading companies in this industry include Sanofi, Allergan, Hoffmann-La Roche, Zimmer Biomet, Smith & Nephew Plc, Anika Therapeutics Inc., Fidia Farmaceutici S.P.A., Ferring B.V., Bioventus, Regen Lab SA, among others.

¹ Source: “American College of Rheumatology Position Statement” available online here.

Geographic reference: World
Year: 2016 and 2026
Market size: $3 billion and $6.6 billion, respectively
Sources: “Viscosupplementation Market by Product (Single Injection, Three Injection, Five Injection), by Region (North America, Europe, Asia Pacific, Latin America, MEA), and Segment Forecasts, 2018 – 2025,” Grand View Research, August 2017 available online here; “Viscosupplementation Market Size to Cross 6.6 billion USD by 2026,” MarketWatch Press Release, April 15, 2019 available online here; “Osteoarthritis,” Mayo Clinic, March 6, 2018 available online here; Beth W. Orenstein, “A Closer Look at Knee Injections,” Healthgrades, Reviewed by William C. Lloyd III June 12, 2017 available online here; “American College of Rheumatology Position Statement” available online here; “Hyaluronic Acid (Injection Route),” Mayo Clinic, February 1, 2019 available online here; Arthritis by the Numbers: Book of Trusted Facts & Figures, Arthritis Foundation, 2018 available online here; “Viscosupplementation Market: Hyaluronic Acid Type (Stabilized Hyaluronic Acid), Procedure Type (Three-Injection Procedure), Application, and Region (Asia-Pacific, Europe, North America, Latin America, and Middle East & Africa) — Global Forecast till 2023,” Market Research Future, March 2019 available online here.
Image source: qimono, “syringe-shot-medicine-bottle-1884758,” Pixabay, December 6, 2016 available online here.

Medicare for All. That’s the new buzz phrase among Democratic Presidential candidates for the 2020 election. But, proposals for a national health insurance program are nothing new. By the 1930s many Western democratic countries were adopting national health insurance programs, but the United States continued to rely on private health insurers. In 1934, in the midst of the Great Depression, President Franklin D. Roosevelt created the Committee on Economic Security. This committee was to draft a bill that would do just that, namely give economic security to Americans. The Social Security Act that was drafted included an old-age pension program, unemployment insurance financed by employers, health insurance for people in poverty, and financial assistance for widows with children and the disabled. However, the bill that Roosevelt signed into law on August 14, 1935, was more limited in scope and did not contain a health insurance component. President Roosevelt wanted to keep provisions for health insurance in the Social Security Act but feared the backlash would jeopardize passage of this legislation. Opponents argued that government-financed health care would allow the government to come between the doctor and the patient, mandating how doctors treat patients and how much they charge.

In 1937, the U.S. Surgeon General proposed that National Health Insurance, which was still being debated in Congress, first include Social Security beneficiaries. Two decades later in 1957, after years of national health insurance proposals going nowhere,¹ Congressmen Aime Forand and Cecil King proposed limiting this type of insurance to only cover some of the medical expenses of those 65 years of age and older, paid for by Social Security payroll taxes. The media dubbed this proposal Medicare. Those in this age cohort required twice as much hospital care as those younger than 65, and despite getting Social Security benefits, could not afford the rising cost of hospitalization. Only half had health insurance. Nearly one in three lived in poverty.

Despite Democratic support in the House and Senate, support from labor unions, and support from the candidate, then President John F. Kennedy, the strong opposition from fiscal conservatives in Congress, the insurance companies and the American Medical Association stalled legislation. It would take more debate, compromise, a landslide victory for Democrats in the 1964 election, reforms and reorganizations of committees and their rules and the newly elected President, Lyndon B. Johnson, to make this program his top priority to get Medicare passed and signed into law on July 30, 1965. When the law took effect in 1966, more than 19 million people enrolled in the program.

Original Medicare, as it is now called, contains Part A, inpatient hospital coverage,² and Part B, outpatient medical coverage,³ for Americans aged 65 and older receiving Social Security or Railroad Retirement benefits. Part B premiums are deducted from beneficiaries’ monthly Social Security or Railroad Retirement payments. In 1972, Medicare eligibility was extended to Social Security Disability Insurance beneficiaries younger than 65 and those with end-stage renal disease.

In June 1980, President Jimmy Carter signed the Social Security Disability Act of 1980 which created Medigap insurance policies. These policies, issued by private insurance companies and paid for by monthly premiums, pay for some or all of what Medicare does not, such as deductibles, coinsurances, and copayments, depending on the policy. Federal standards for these policies were not established until 1990.

The Balanced Budget Act of 1997 established the Medicare+Choice program, now called Medicare Part C or Medicare Advantage.⁴ These plans, alternatives to Original Medicare, are run by private insurance companies and are regulated by the Federal government. They must cover all of the services Original Medicare Part A and Part B covers. Medicare pays Medicare Advantage providers a per-enrollee fee to provide this coverage.⁵ In addition, many plans cover services Original Medicare does not such as vision and dental care. Most also offer prescription drug coverage, although Original Medicare beneficiaries can also opt-in for prescription coverage through Medicare Part D. Medicare Part D is administered by private insurance companies. Regardless of whether Medicare beneficiaries opt for Original Medicare or choose to pay for a Medicare Advantage plan, they must pay the Original Medicare Part B premium, which is $135.50 per month in 2019.⁶

While these plans offered new choices in health coverage for many seniors, they also complicated the process of choosing health coverage. To provide information for seniors about their choices, the Federal government launched the Medicare.gov website in 1998. Starting January 1, 1999, the 1-800-MEDICARE toll-free phone number was available nationwide and the first annual Medicare & You Handbook was mailed to all Medicare beneficiaries. Whether these informational resources help or not is debatable, but more than two decades later, the process is still confusing for many seniors and their loved ones who are trying to help them.⁷

Today’s market size shows the number of enrollees in Medicare Advantage plans in 1999, 2009, and 2018 in the United States. In 1999, 18% of Medicare beneficiaries were enrolled in Medicare Advantage plans; in 2009, 23% and in 2018, 34%. From 1999 to 2004, Medicare Advantage plan enrollment fell from 6.9 million to 5.3 million enrollees. Since then, however, enrollment has grown year after year. In 2018, 67% of Medicare Advantage enrollees had individual plans. Twenty percent were covered by employer- and union-sponsored group plans and the remaining 13% had special needs plans. Special needs plans are tailored to beneficiaries who have certain chronic conditions, are institutionalized, or qualify for both Medicare and Medicaid. While only 20% of enrollees nationwide are covered by Medicare Advantage group plans, nine states have a disproportionately high percentage of enrollees covered by such plans. In Alaska, 100% of Medicare Advantage enrollees were covered by group plans in 2018. The other eight states include West Virginia (53%), Michigan (51%), Illinois (42%), Kentucky (39%), Delaware (37%), Maryland (35%), New Jersey (34%), and Wyoming (30%). As more unions and large employers, including state governments, seek to lower their retiree healthcare costs, more are turning to Medicare Advantage plans to provide healthcare coverage. The Congressional Budget Office predicts that enrollment in all types of Medicare Advantage plans nationwide will include 42% of all Medicare beneficiaries by 2028.

¹ Thanks in part to lobbying efforts by the American Medical Association, which characterized National Health Insurance as “un-American” and implied that those in President Harry Truman’s Administration who supported it were Communists.
² Includes inpatient hospital stays, care in a skilled nursing facility on a short-term basis, hospice care, and some home health care.
³ Includes doctors’ services, outpatient care, medical supplies, and preventative services.
⁴ Medicare+Choice was renamed Medicare Advantage in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, signed by President George W. Bush. This law also established the Medicare Part D prescription drug benefit.
⁵ Before the Affordable Care Act revised payment structures to insurance companies that administer Medicare Advantage plans, the Medicare Payment Advisory Committee found that Medicare was paying 14% more per Medicare Advantage enrollee than the cost of care for an enrollee in Original Medicare due to changes over the years to encourage private plan participation and enrollment.
⁶ In 1965 the monthly premium was $3; in the early 2000s, about $50.
⁷ Judging from the more than 100 comments below the Center for Medicare & Medicaid Services YouTube video titled “Medicare & You: Understanding Your Medicare Choices”.

Geographic reference: United States
Year: 1999, 2009 and 2018
Market size: 6.9 million, 10.5 million and 20.4 million enrollees, respectively
Sources: Gretchen Jacobson, et. al., “A Dozen Facts About Medicare Advantage,” Henry J. Kaiser Family Foundation, November 13, 2018 available online here; Julian E. Zelizer, “How Medicare Was Made,” The New Yorker, February 15, 2015 available online here; History.com Editors, “Social Security Act,” A&E Television Networks, Last updated August 21, 2019 available online here; “National Health Insurance—A Brief History of Reform Efforts in the U.S.” Focus on Health Reform, The Henry J. Kaiser Family Foundation, March 2009 available online here; Nancy De Lew, “Medicare: 35 Years of Service,” Health Care Finance Review, Fall 2000, page 22, Medicare and Medicaid Research Review, U.S. National Library of Medicine, National Institutes of Health available online here; “The Parts of Medicare (A, B, C, D),” Medicare Interactive.org available online here; “Filling Gaps in Medicare Coverage and Getting Help with Medicare Costs,” Medicare Interactive.org available online here; “Medicare Timeline,” Henry J. Kaiser Family Foundation, March 24, 2015 available online here; Medicare & Medicaid Milestones 1937-2015, Center for Medicare & Medicaid Services, July 2015 available online here; “CMS’ Program History,” Center for Medicare & Medicaid Services, June 20, 2018 available online here; CMSHHSgov, “Medicare & You: Understanding Your Medicare Choices,” YouTube, April 30, 2015 available online here; “Medicare.gov” available online here; Chris I. Young, “Medicare vs. Medicare Advantage: How to Choose,” U.S. News & World Report, March 23, 2018 available online here; “Medicare Advantage (Part C),” eHealth Medicare, November 1, 2017 available online here; Steve Anderson, “A Brief History of Medicare in America,” Medicare Resources.org, February 27, 2018 available online here; George B. Moseley III, “The U.S. Health Care Non-System, 1908-2008,” AMA Journal of Ethics,” May 2008 available online here; “Medicare Advantage,” Henry J. Kaiser Foundation, October 10, 2017 available online here.
Image source: Sabine van Erp, “hands-old-old-age-elderly-2906458,” Pixabay, November 1, 2017 available online here.