The pharmaceutical industry faces numerous issues on a day-to-day and yearly basis. Manufacturing, quality control, efficiences, budgets and regulations all must be met or exceeded. Here are ten industry critical issues, I feel the industry will be facing in the coming year.

Costs/Manufacturing Efficiencies

Developing pharmaceuticals is expensive. As long as drug prices were high and new products were in the pipeline manufacturers could tolerate inefficient manufacturing processes. Manufacturing is now under scrutiny to reduce costs and increase efficiencies.

Pipelines
A lack of potential blockbusters in the drug development pipeline and the incredibly high cost of identifying, developing and marketing news drugs has put a strain on financials for big pharma.

Generics

Increased pressure from generic manufacturers, who bear none of the drug development and scale-up costs, and therefore can manufacture drugs cheaper than branded companies has put yet another dent in big pharma’s wallet.

Biopharm/Biosimilars

The biopharm segment of the pharmaceutical industry has seen increased growth in recent years. Small companies are taking advantage of new technology to cost-effectively manufacture drugs for smaller patient populations and still make a profit. Biosimilars are generic versions of branded biopharm products and will eventually have an impact on the biopharm market.

Contract manufacturing/Contract Services
Due to downsizing and layoffs big pharma does not have the facilities and staff they used to rely on. They are now turning to CMOs/CSOs to do the work that used to be done in house.

Counterfeiting/Drug Diversion

Two topics that can erode a company’s bottom line and ruin their reputation.

Supply Chain

As pharma companies become more global and their product lines become more diversified a robust supply chain is essential.

Networked Enterprise

Pharma companies need to manage a complex array of capabilities on a global scale.  A robust networked enterprise is essential.

Regulations

The FDA is the major regulatory body that oversees the U.S. industry. High-profile drug safety recalls and public outcry over lack of FDA quality oversight has forced the agency to implement industry programs and guidance to bolster the public’s confidence in the nation’s drug supply.

Emerging Markets

Demand for medicines in many emerging markets such as India, China and South America have forced major pharma companies to set up operations in these countries. Simultaneously, pharma companies in these areas are now producing products for export – resulting in increased competition to more established companies and increasing the FDA’s inspection burden.