103 years after its discovery, insulin is reinventing itself: from pricing readjustments in major markets to the increasing usage of biosimilars. Historic players like Novo Nordisk and Eli Lilly seek growth outside insulin, with successes notably in obesity management drugs (Wegovy…), paving the way for initiatives led by local manufacturers.
This may redistribute the cards in mid-size markets. Governments are keen on enhancing their sovereignty over medicines supply and tend to favor national champions in this quest.
A case in point is Malaysia, which has been hit by an unprecedented shortage of human insulin.
Pharmaniaga threatens a duopoly
Malaysia is currently supplied by Biocon and Novo Nordisk. Biosimilar maker Biocon already supplies 80% of Malaysia’s human insulin. However, it has been facing manufacturing issues in its Johor plant in the last few months, notably with a Form 483 issued by USFDA. Novo Nordisk does not have any production unit in Malaysia and thus exports the remaining 20% to the country.
The competitive landscape is being reshaped with Pharmaniaga’s foray into insulin production. Pharmaniaga has announced the launch of the first locally owned insulin facility to serve the needs of 4,4 million patients with diabetes. The state-of-art facility based in Puchong has been granted an EU GMP certification so far and is expected to produce an annual 30 million doses of insulin. Vaccines for 13 diseases will also be manufactured in Puchong.
A lot remains to be done for Pharmaniaga. The company still must get the regulatory approvals, and some questions emerge on the partnerships that will enable the company to produce insulin. We only know from Pharmaniaga’s Integrated report 2023 (p.21) that the “group will collaborate with strategic partners from South Korea, Thailand, China and India to facilitate technology transfer and reach.”
Will it be worth for major players to keep supplying Malaysia?
Further south, in Malaysia, close to Singapore’s frontier, US-based device maker Insulet has celebrated the grand opening of its new facility, where Omnipod 5, its tubeless insulin pump will be manufactured. It took a USD 200 million investment to build this 400,000 square-foot plant, that will start with 350 employees and is estimated to be at full steam in 2026 with 1,000 employees.
In South Africa, Novo and Aspen have signed in 2023 a manufacturing agreement to supply insulin. In an unexpected move in June 2024, Novo did not renew its supply contract with SAPHRA for 14 million pens, reportedly prompting patients to switch to vials and syringes.
In Indonesia, a natural export spot for Malaysia, Novo has announced a deal with local manufacturer BioFarma to pack insulin and provide “expertise in diabetes treatment and insulin production”.
In Egypt, Eli Lilly has partnered with Egypt-based Eva Pharma to complete an insulin facility in Cairo.
Such initiatives show that the global competitive landscape is shifting towards a localization of insulin production. The fact that countries know they will rely on their own source of insulin will impact the prices and possibly push major companies to collaborate with local producers.
José Moutinho, competitive intelligence specialist.
Thanks for reading. I help you deploy CI projects.