Miriam E Tucker

December 10, 2015

VANCOUVER, British Columbia — Small manufacturers around the world could potentially increase the insulin supply and improve access to the product in low- and middle-income countries, new research suggests.

The findings were presented December 2 here at the World Diabetes Congress 2015 by Ryan P Knox, a senior at Boston University and research assistant with the university's school of public health. The study, conducted as Mr Knox's senior class project, is part of a larger study on access to insulin conducted by Health Action International, a nongovernmental organization that works to strengthen medicine policies worldwide.

Mr Knox and colleagues analyzed market data for 121 countries, representing 96% of the world's population with diabetes. They identified a total of 42 insulin manufacturers selling their products in various parts of the world. The "Big 3" — Denmark-based Novo Nordisk, United States–based Eli Lilly, and France-based Sanofi — accounted for a total 93% of the insulin market by revenue and 92% by insulin production.

Of the other 39, another four companies — Bioton in Poland, Biocon in India, Wockhardt in India, and Julphar in the United Arab Emirates — currently have their insulins registered and/or sold in 10 to 30 countries each and could potentially expand to help ease access barriers elsewhere, Mr Knox said.

"The global prevalence of diabetes is increasing, and access to insulin is insufficient in many countries, both due to lack of availability and affordability. The market is dominated by three main players, and very little is known about the others," Mr Knox said during a press briefing.

The small multinational and local insulin manufacturers identified in this study "could play a much larger role in the future in improving access, increasing competition, and making insulin more affordable for all," he said.

Two experts in this field told Medscape Medical News that the new findings are indeed a helpful first step, but that there are many hurdles.

David Beran, MSc, PhD, a public-health and policy researcher and lecturer at the University of Geneva, Switzerland, who is involved in the study on wider access to insulin, said, "This is the first [study] of its kind, and the researchers should be congratulated on their approach and findings….As in other disease areas, competition has been one of the drivers in lowering prices, improving access, and affordability."

However, Dr Beran cautioned, "To move this forward, more [information] is needed on these companies in terms of what they produce, how they produce, and how much they produce to see whether they are viable competitors on the global market."

And according to Jing Luo, MD, a research fellow with the program on regulation, therapeutics, and law division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, "It's good that they've done a survey on different types of insulin manufacturers, because at this moment there's not much published in the scientific literature that tells us who has the capacity to make insulin outside of the Big 3."

But, Dr Luo explained, the regulations that cover international purchasing vary from country to country, so it's hard to say who could buy insulin from any of these smaller manufacturers. Some may be making insulin only for domestic use and not marked for export. And if marked for export, other issues include how the product would be purchased and procured.

Potential for Improving Access, Especially in Asia and Latin America

Mr Knox and colleagues used several sources in gathering their data, including literature review for the global market, specific country market data, pharmaceutical industry reports, and direct contact with public-health professionals.

The Big 3 each had their insulin products registered and/or sold in more than 90 countries and were the sole insulin suppliers for 55% of the total 121 countries surveyed. Novo Nordisk topped the list at 111 countries, followed by Sanofi (101) and Eli Lilly (94).

Bioton Poland had its products registered and/or sold in 26 countries, followed by the two India-based companies, with both Wockhardt and Biocon selling to 17 countries each. Julphar's products reached 13 countries.

Not surprisingly, the countries with higher numbers of people with diabetes had more manufacturers with insulin products registered and/or sold. China, which accounted for 26% of the world's diabetes population in 2013, had 10 manufacturers with corporate headquarters there (although the Big 3 are also in the mix there).

India, with 17% of the world's diabetes population in 2013, had three corporate headquarters located there, while Mexico, with 2.3%, had four. (The Big 3 also sell their insulins in both countries.)

Brazil, with 3% of the world's diabetes population, has no corporate headquarters, but it does have two manufacturers in addition to the Big 3 — Wockhardt and Aspen — which register and/or sell their products there.

Excluding the Big 3, several Asian countries — including China and India — have at least six other companies with products registered and/or sold, while individual Latin American countries have between zero and five. "Based on the number of manufacturers in the regions, Asia and Latin America seem to be regions of opportunity for improving access to insulin," Mr Knox said.

Increasing Access and Lowering Price?

Mr Knox told Medscape Medical News that the ultimate aim of this research would be to introduce more manufacturers to low- and middle-income countries, particularly sub-Saharan Africa, where there are only one or two companies and very few market data are available.

The next step of the research will be to examine prices, which could shift now that some of the brand-name insulins are coming off patent. That could clear a path for generic insulin manufacturers such as Biocon, which is a major player in India, to make inroads in other countries.

"Just getting more companies on the market and increasing competition will hopefully drive down prices. Right now it's so limited with the Big 3," Mr Knox said.

So might these smaller manufacturers also enter the markets of developed countries such as the United States to help reduce costs? Maybe, but between the more stringent regulatory requirements and the ongoing patent restrictions it wouldn't be easy, Dr Luo noted.

"We don't see that many Chinese cell phones here, but they have the capacity to make them and they do make them. You need a lot of money, lawyers, and scientists to sell things in lucrative markets like the US. There are dozens of hurdles."

Mr Knox, Dr Luo, and Dr Beran have no relevant financial relationships.

World Diabetes Congress 2015. Presented December 2, 2015.

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