Biopharmaceuticals: saving the future of our industry

The full version of this biopharmaceutical feature can be read in the February issue of our digital magazine: www.pharmtech.com/ptedigital0210

Biopharmaceuticals are becoming increasingly prominent in the pharmaceutical industry and are expected to dominate product use and sales of the future. Research released by PharmaVision in 2009¹ shows that biotherapeutics represent 7.5% of all drugs on the market and account for approximately 10% of the total expenditure for marketed drugs, but their use is growing at more than 20% per year. In fact, biotherapeutics are already administered in life-saving or end-stage applications 74% more than chemically-derived pharmaceuticals.¹ Additionally, biotherapies make up more than 30% of all pipeline research programmes.¹ In terms of market value, the market for biotherapeutics is growing at an annual rate of approximately 15%, compared with only approximately 6–7% for pharmaceuticals, and will be worth more than $200 billion by the end of this year.¹

(COLIN ANDERSON/GETTY IMAGES)

Meanwhile, market analysis firm EvaluatePharma has predicted that the top six selling drugs of 2014 will be biotech products, compared with only five in 2008 and one in 2000.² The top three products expected to dominate sales are Roche's Avastin, Abbott and Eisai's Humira and Roche's Rituxan, respectively. In a statement, EvaluatePharma added that the "weight of evidence for a shift to biotech products as the industry's growth driver is overwhelming".

This huge potential for growth has not gone unnoticed by pharma companies and many big names have been involved in mergers and acquisitions to ensure they take advantage of the promising future of biotherapeutics; for example, Pfizer acquired Wyeth in 2009 to become what Pfizer referred to as a "premier biopharmaceutical company"³ Also in 2009, Roche obtained a stronger presence in the biopharma arena through its acquisition of Genentech in 2009, while Merck gained a sizable biotech unit after merging with Schering-Plough.

It is clear that biopharmaceuticals are going to be important to the future of the pharma industry. Unfortunately, however, biotherapeutics are difficult to manufacture and require specialised (and costly) processing and purification methods. One of the main problems with biotherapeutics is their sensitivity to environmental conditions. Small alterations to a production process may significantly affect the safety and efficacy of the final product, which makes maintaining control over every aspect of the production process crucial for biopharm manufacturers. The difficulties relating to production is partly the reason why there are so few biosimilars available — it is extremely difficult to reproduce an originator's manufacturing process and create an equivalent product.

Looking on the positive side, many advances have been made in bioprocessing, such as the development of disposable systems that can reduce costs and compliance issues, as well as the establishment of specialist CMOs that can help companies scale up to commercial production. However, improvements can still be made to many bioprocessing techniques; in particular, as biopharmaceutical drugs become more specialised and targeted to smaller and more focused markets, which will require smaller batch sizes, there will be a growing need for more flexible production processes and facilities.

This month, Pharmaceutical Technology Europe examines some of the challenges involved in manufacturing biotherapies, as well as the new developments and technologies that will shape the future of bioprocessing.

References

Delivering New Biopharmaceutical Therapies: Challenges & Opportunities (PharmaVision, January 2009). www.pharmavision.co.uk

World Preview 2014 (EvaluatePharma, May 2009). www.evaluatepharma.com

Pfizer, "Pfizer to Acquire Wyeth, Creating the World's Premier Biopharmaceutical Company" (2009). http://mediaroom.pfizer.com

The full version of this biopharmaceutical feature can be read in the February issue of our digital magazine: www.pharmtech.com/ptedigital0210