Mexican Engineers See Market InstabilityWed, 09/05/2018 - 10:23
All products deteriorate over time and with exposure to the elements, but pharmaceuticals are particularly sensitive to this process, making it necessary to ensure they can withstand storage and distribution. To that end, pharmaceutical products must undergo stability tests, explains Miguel Sánchez, Executive Director of Grupo IDEA. “A small percentage of each production batch must be reserved to undergo a stability test that is divided in two parts. The first part requires the sample to be hosted in a controlled environment of temperature and humidity to fasten its degenerative process. Once this step is finished, the second part of the process requires subjecting the same samples to physicochemical and microbiological testing,” says Sánchez. To perform the first type of tests, Grupo IDEA manufactures CAI, or controlled environment rooms, which allow customers to set any conditions they want to subject the product to.
Grupo IDEA, a fully Mexican company with over 18 years of experience, specializes in the design and manufacture of environmental rooms according to its clients’ needs. The company, now also an authorized third party, owns several rooms in which it performs stability tests for third parties. “This required the creation of our own laboratory and we are gradually increasing our services portfolio.” The company has installed over 80 rooms in Mexico during the past six years, mostly for multinational pharmaceutical companies. It also designed K’iin Control, a specialized software for the control of its rooms. “We provide an integral offering, from design of the room to aftersales services, as this is critical equipment that must not fail under any circumstances,” he continues.
Sánchez credits the company’s success to its employees but he says the sector remains wary of local businesses. “Mexican companies do an excellent work,” he says, “but the pharmaceutical sector does not yet trust local companies. Ninety percent of equipment acquired by pharmaceuticals is imported.” Those circumstances also created a complex beginning for Grupo IDEA. “At first, it was hard to find funding because the financial sector is unwilling to back new projects. While there are financing channels, these are often scarce, hidden and hard to access for new companies.”
Another dilemma rests with buyers that are often cautious when launching unfamiliar products due to potential risks to their operations. “They simply prefer to buy what they know,” Sánchez says. To enter the sector the company had to invest a great deal of time to raise awareness of its products and instill trust. “Once a company tried our product and proved its safety and reliance, knowledge spread quickly by word of mouth.”
Grupo IDEA is now preparing to expand its services for sample sheltering and also its laboratory. “2018 has seen many challenges, including the elections, the subsequent change in administration and the policies implemented or being discussed by US President Trump.” In response, Grupo IDEA lowered its market projections for the year. “Considering that most of our clients are international companies, our projects for 2018 were paused until July. Many of our clients have told us that they are just not allowed to invest in infrastructure until the elections are over.”
While some may feel uncertain, Grupo IDEA is forging ahead and it plans to expand into Guadalajara and other states as it looks into widening its sample sheltering business. The company also sees great potential in photo-stability testing and stability testing of products that contain cannabis. “The potential approval of these products is a matter of interest for many Mexican laboratories, so we are evaluating the possibility of becoming authorized third parties for these products. This will also pose its own challenge as, due to the sample’s nature, its transportation, testing and storage will require intense and constant scrutiny.” Furthermore, the company is looking into other sectors such as automotive, aerospace, agricultural and alimentary.
While entering the pharmaceutical sector posed some challenges, Grupo IDEA has grown in this market niche. Sánchez believes that its success can be replicated by more Mexican companies. “The industry is open to try our products for critical processes. What the sector needs is more products developed by Mexican companies. It is time for Mexico to develop more products. There are many opportunities ready to be taken.”