Contract manufacturers in the USA

Pharmaceutical contract development and manufacturing services market include pharmaceuticals, active pharma ingredients, biologics, capsules, generic pharma, oral liquids, parenteral, tablets, and OTC. It is estimated that global pharmaceutical contract development and the manufacturing market will touch the figures of US$ 126 billion by 2024. The industry is showing a growth rate of 7.1% annually. This rise is attributed to the increased demand for generics, acquisitions by big pharma companies, investment in research and development and shift of the industry to advanced and flexible manufacturing technologies.

There are significant advantages to the drug prices in the US, which can be three times lower than in the UK. It means the US drug prices are not as stringent as in Europe. The contract manufacturers in Europe saw this as an opportunity. They have well utilized the discrepancy by acquisitions and mergers in the US, for example, Recipharm and Fareva. Several contract manufacturers in Europe are also expanding their sale horizon by hiring sales representatives in the USA. This, however, is not changing the competitive and challenging grounds in the CMO market.

The US pharmaceutical contract manufacturing is huge and far ahead the rest of the world in terms of technology and value-addition. Asia Pacific and Europe are following behind but the USA again takes lead in policy and regulations. Getting a product approved is less hectic than in Europe. Your label mustn’t say it is a drug and your product adheres to the FDA health and safety regulations. The same is the case with Canada where local authorities approve the food supplements.

But the picture is not so rosy for contract manufacturers and new entrants in the market. Though contract manufacturers in the United States are getting most of the raw materials from around the world, there are importers posing threat to them with cheaper prices on imported products. This factor has made the competition fierce. The contract manufacturing industry is learning fast from this situation and has started engaging companies in China and India to compete in the market with competitive prices.

This situation has led the pharmaceutical industry in a new situation where generic products produced in China and India are taking away the market share once claimed by few big pharma companies. The shift from Europe to the USA is now turning its head towards China and India. Few have opted for new flexible technologies to conform their products with FDA standards. Several others have opted for outsourcing to contract manufacturers. The fact, however, remains the same, the generics and drugs produced by contract manufacturers need to conform with FDA regulations.

The research collaboration is also playing a vital role in this shift from drugs to generics and nutraceuticals. The companies have started collaborating with research contract manufacturers to launch their products with the claim that their products are tested and vetted by scientific studies.

If you are planning to enter into the sector in the US and or Canadian market, it is better to have a complete scanning of FDA standards and regulations for any niche industry. 

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