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As consumers shift to more cost-sensitive markets it is possible to see a decrease in producer share in the event that the price of a substitute increases.<br><br>The impact of substitutes on the profits of a business is determined by the cost of switching. A lower-cost substitute can restrict the cost of a product while a more expensive product could increase the probability that a company will choose to switch. The threat of substitutes is therefore less if the product is superior in quality to the original. If the substitute product is able satisfy the requirements of a particular consumer, then the company might not have a lot to worry about.<br><br>Interchangeable<br><br>In order to receive FDA approval interchangeable alternatives to the original product must be able to meet certain criteria and pass additional testing. They also must produce the same clinical results as their reference counterparts and ensure that switching between them is safe and efficient. 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