After a period of stagnation, short-term projections for the solid dose industry predict growth. Yet manufacturers face a variety of challenges as the industry undergoes numerous changes. Customer demands for novel dosages require the development of new formulations. Increasing regulations have prompted the need to track drugs as well as their constituents. In addition, decreasing revenue has generated a strong movement toward saving costs. Each of these acts as a driving force for the current trends in solid dose manufacturing.
Development of Market Longevity Strategies
With most solid dose manufacturers focused on cost savings, the expense associated with developing and acquiring approval for new drugs is excessive. Moreover, the increased demand for generic solid dose drugs has resulted in a decline in new commercial chemical entities. As a result, solid dose manufacturers seek opportunities for growth in reformulations and combinations of compounds to enhance oral delivery. Manufacturers are responding to demand for solid dose drugs with controlled release, abuse prevention and disguised taste. Innovative solutions are being found for improved drug absorption and better solubility.
Diverse Revenue Streams
As patents owned by many solid dose manufacturers expire, they can no longer rely on proprietary-based revenue. They must search for revenue streams in new markets or by means of supplying drugs to undeveloped regions. Some have branched out into other industries, such as nutrition and animal health. There is a growing trend for pharmaceutical companies to mitigate risks through multiple streams of income.
The increasing regulation of the solid dose industry requires manufacturers to provide traceability of their products’ constituents. Customers seek consistent quality throughout the process, and regulatory agencies aim to stem counterfeit drug sales and abuse. More than 80 percent of the world’s pharmaceutical manufacturers will be required to initiate serialization by 2017. These efforts have brought about equipment acquisitions for bar coding, integration with information technology architecture and upgrading packaging lines. Serialization is changing many facets of operation for solid dose manufacturers.
The recent trend of mergers and acquisitions is expected to continue. Consolidation offers opportunities for partnering in research and development and alternative markets. It also provides a degree of financial stability and can strengthen the marketing and distribution networks. The trend toward consolidation is reducing the number of facilities worldwide. This may significantly lower the cost of production and subsequently reduce the price of drugs. In addition, consolidation creates opportunities for emerging enterprises.
The continued consolidation in the solid dose industry has led to an increase in outsourcing. This is expected to continue in the near future, creating numerous opportunities for contract manufacturers. Outsourcing can offer significant cost savings, flexibility and responsiveness. However, new regulatory requirements for serialization have reduced the number of contract manufacturers available for outsourcing.
Recent changes in the solid dose industry have led to the development of new strategies for cost savings and growth. Developing trends have resulted in innovative solid dose delivery forms and growing opportunities for emerging companies.
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