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Lilly Introduces Disposable Pens

Challenges for Novo and Becton

By David Mendosa

Last Modified On: March 29, 1999

Americans like to think that they lead the world. But when it comes to insulin delivery, the United States lags well behind Europe and Japan in the use of convenient pen devices.

Insulin pens are twice as expensive…

Now, Eli Lilly & Co. (NYSE:LLY) as taken the first serious step toward potential widespread American use of pens. In February, Lilly introduced a line of three disposable pens prefilled with the most widely used insulins.

That removes one obstacle. "If you don't have the market leader—somebody who has an 80 percent share of the insulin market here in the U.S.—if you don't have us involved in driving a particular technology, you are not as likely to see a radical transformation of the marketplace," notes Thane Wettig, Lilly's marketing director for Humulin and Humalog. "We are putting a very firm effort into really making it happen. That's why we are so bullish about pens."

Yet other obstacles to wide acceptance of pen devices here remain.

One is how treatment is administered. "Europe has much more of a team approach led by an endocrinologist with a diabetes educator involved," Wettig says. "Care is more specialty driven in the markets where the pen has really taken off. In the U.S. probably 80 percent of the patients who are on insulin today are seen by a primary care physician and only 20 percent are seen by an endocrinologist."

Probably because a greater proportion of patients sees specialists in Europe, more of them use intensive insulin therapy. "And that's where pens do best," says Dr. Barry Ginsberg, Vice President Medical for Becton Dickinson Diabetes Health Care. Becton, Dickinson and Co. (NYSE:BDX) dominates the market for syringes, which are much more widely used in the United States.

"Treatment with insulin is much more conservative in the U.S. than in Europe or Japan," says Peter Hansen, director of investor relations for Novo Nordisk of North America. Novo Nordisk (NYSE:NVO) currently has the lion's share of the pen device and pen needle business here.

"It is not unusual in the U.S. that you inject yourself only once or twice during the day, while in Europe or Japan you inject yourself three or four times," he says. With more frequent injections the greater convenience of pens become more apparent.

Cost can be a factor, especially for individuals without health insurance. Per unit of insulin delivered, injecting insulin via pens is about twice as expensive as injecting with syringes. The cost of syringes versus pen needles isn't a factor, since a box of 100 syringes retails for approximately the same price as a box of the same brand of pen needles.

The list price for a package of five Lilly pens, each of which come prefilled with 300 units of insulin, is $60, although some discount chains offer them at about $55. That's the equivalent of one and one-half vials of insulin. A vial of Lilly Humulin insulin costs as little as $20.

But the higher cost of pens may be less of an obstacle than some observers believe. Indeed, in Europe government health care systems reimburse patients for pen purchases. But what about insurance here? More than 70 percent of all third-party payment plans already reimburse patients for Lilly's pens here, Wettig says. Still, Medicare does not cover pens.

Whatever the obstacles, the differences between the European and American pen markets are staggering. Data for Europe are less firm than American numbers. Estimates for the pen market share in Europe range from 40 to 80 percent.

Novo, which dominates insulin sales in Europe and Japan probably has the best handle on pen usage there. In Europe 64 percent of insulin sales are in pen cartridges or prefilled devices, Novo's Hansen says. In Japan it's close to 72 percent. The proportion of individual users is higher since they use more insulin than those who use syringes for their injections.

By comparison, just 2.4 percent of the insulin sold in the United States is in pen cartridges or prefilled devices, Hansen says. That's consistent with Lilly's data. In the United States Wettig says that about 3 percent of all insulin units are delivered via pen and cartridge systems. "We extrapolate that to between 4-5 percent of patients utilizing pens and cartridges for their injections at least once a day."

Clearly, there's room for growth in the pen business here. Just how much growth becomes apparent when you look at the numbers of insulin users.

Of all Americans 18 years of age and older with diagnosed diabetes surveyed in the 1989 diabetes supplement to the National Health Interview Survey 43 percent were treated with insulin. All people with type 1 diabetes and 39 percent of people with type 2 were using insulin.

Of those with type 1 diabetes 62 percent took two or more insulin injections daily. Of those with type 2 diabetes the proportion was 48 percent.

While the data on the insulin use are 10 years old, there's no reason to believe the numbers have subsequently declined. Indeed, the Diabetes Control and Complications Trial (DCCT), which was completed in 1993, showed for the first time that intensive therapy greatly reduced the development of three major diabetic complications.

With 10.3 million diagnosed cases of diabetes, the market for pens and other insulin delivery devices is huge. And it's growing rapidly at a rate approaching 8 percent annually, according to U.S. government data.

Until now, Novo Nordisk has owned the minuscule pen market here. This Danish company, which has the largest share of the insulin market worldwide, also dominates the pen business in Europe.

In 1997, Novo sold 80 percent of the pen devices and 90 percent of the pen needles here, according to Frost & Sullivan, a market research consulting firm in Mountain View, California. Its NovoPens are delivery systems for Novolin insulin cartridges, and its Novolin Prefilled disposable pens come filled with 150 units of N, R, or 70/30 Novolin.

Novo's take on the newly competitive pen business here is that while its share will drop, the market will grow. "The increased awareness will do something to our business, because there is a huge potential for both companies to upgrade this market," Novo's Hansen says.

"Lilly has been sitting on this market for years and had no interest this segment," he continues. "They have had some products outside the U.S. that are not really successful, and now they are playing catch up in terms of pen systems with a system out that is more or less like our Novolin Prefilled product," Hansen says.

"We are really not interested in going after the people on a Novo pen," Wettig says. "We are interested in the 95-96 percent of patients who are not on a pen device yet."

Later, Lilly may introduce cartridge pens. "But that's something we have not yet decided. We didn't want to bring them both out at the same time and confuse people."

Until now, the 800-pound gorilla in the insulin delivery market has been Becton Dickinson. Its strength is not in pens but in the much larger syringe business where it commands an 80 percent market share, according to Frost & Sullivan data. Becton is only a minor player in the pen devices and pen needle business, well behind Novo.

Becton commands 63 percent of the entire insulin delivery systems market, Frost & Sullivan says. In 1997 Becton's share of that $236.1 million market would have been $148.7 million. Frost & Sullivan projects a 6.6 percent annual growth in the insulin delivery system market.

Becton's syringes are "the gold standard," says one of its competitors off the record. Their syringes are considerably more expensive than value-priced syringes made by Tyco International Ltd. (NYSE:TYC) and Terumo Corp., the other two players here.

Can-Am Care, a subsidiary of Selfcare Inc. (AMEX:SLF), distributes Tyco's Monoject syringes, and MediSense, a subsidiary of Abbott Laboratories (NYSE:ABT), distributes Terumo's syringes under the Precision Sure-Dose label.

So will a shift from syringe to pen delivery hurt Becton? Becton's Ginsberg thinks not, since it will sell more pen needles to compensate for reduced syringe sales.

"The pen market is not particularly profitable," he says. "The pen needle market on the other hand is actually more profitable for us than syringes."

More worrying for Becton has to be the emergence of conglomerate Tyco as a stronger competitor in the insulin delivery business. "Tyco is building a powerful medical supply company that will have enormous bundling capability that Becton is not accustomed to confronting," says CIBC Oppenheimer analyst John Calcagnini. "Tyco now owns Sherwood and its Monoject syringe, Davis & Geck, Kendall, and U.S. Surgical. So we think that might be a bit of a challenge for Becton."

What's clear is that the formerly placid insulin delivery systems market is facing a period of rapid change. One player has owned each significant segment of this market with near-monopoly numbers. Besides Becton in syringes and Novo in pen devices and pen needles, they are in two less fungible (because more costly) segments—pumps, where MiniMed Inc. (NASDAQ:MNMD) has at least a 75 share—and jet injectors, where Medi-Ject Corp. (NASDAQ:MEDJ) has 60 percent.

"Now pen usage in America may well change and hopefully do a lot of good for patients to get better glucose control," Hansen says. And as America catches up to the rest of the developed world in pen usage this once slumbering market is awake with fresh opportunities. 

 

Insulin Delivery Systems

Percent Retail Market Share

Component

1997 Actual

1998 Estimated

Syringes

78.5

77.6

Jet Injectors

0.7

0.6

Insertion Aids

0.6

0.5

Pen Devices

0.5

0.5

Pen Needles

0.8

0.8

Pumps

18.9

19.9

Source: Frost & Sullivan, Mountain View, California.

 

Insulin Delivery Systems

Percent Retail Market Share by Company

1997

Company

Total

Syringes

Jet Injectors

Insertion Aids

Pen Devices

Pen Needles

Pumps

Becton Dickinson

63

80

 

30

15

10

 

MiniMed

14

         

75

Can-Am Care (Tyco)

7

9

 

9

     

Terumo (Abbott)

7

9

         

Disetronic

5

         

25

Novo Nordisk

       

80

90

 

Owen Mumford

     

24

5

   

Medi-Ject

   

60

       

Activa (Health-Mor)

   

35

       

Bioject (Vitajet)

   

5

       

Palco

     

35

     

All Others

4

2

 

3

     

Source: Frost & Sullivan, Mountain View, California.


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