Biopharma Growth Trends: More Innovation on the Way

Innovation has been and continues to be a driver for the strides being made in biopharma development and manufacturing, noted Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., who addressed “Innovation in Transformative Medicine: What’s Changing the Bioprocessing Landscape.” He shared some results of research conducted by his company on biomanufacturing growth trends.

Since 2014, respondents have chosen manufacturing productivity/efficiency as the single most important trend, and it has grown more popular every year, Langer reported.

Continued increases in outsourcing should be expected, he said, with contract manufacturing organizations (CMOs) anticipated to grow by more than 12%. Today, cell and gene therapy developers use legacy research market supplies, but supply by contract manufacturing organizations is likely to expand to a $2–$3 billion market, depending how the industry builds out capacity. In 8 to 10 years, Langer said, supplies could be a new industry sector, which could rival recombinant proteins/mAb in more than 10 years.

Many new technologies and product classes are being developed, including cell and gene therapies and antibody–drug conjugates. Industry respondents expect increased activity from China and other Asian countries: 86% of China biopharma manufacturers expect to produce products for export to the US and EU, compared to just 25% today, and China is a likely outsourcing market for US manufacturers. Langer noted that cell therapy manufacturing may require dozens of facilities worldwide to fulfill patient needs.

Better cell or virus/vector analytic tests and more contract manufacturing organization options for R&D and clinical production were the top-cited “most needed cell and gene therapy manufacturing improvements, systems, platforms, and infrastructure.”

Other trends noted from the research:

• Average titers were 3.03 g/L, up 50x over time.
• Downstream process remains a problem, although there are many approaches to address the challenge.
• Facility constraints were reported by half of research respondents; it was the top-cited constraint in the past 10 years.
• Continuous digital signal processing (downstream) is expected, and 42% of respondents hope it will address constraints.

Data on efforts to reduce manufacturing costs included:

• The average cost for recombinant proteins now is $307 per gram.
• A target cost is $100 per gram.
• Fifty-three percent of respondents have implemented programs to reduce operating costs.
• Reduced bioprocessing costs have become the norm.
• Some companies pay bonuses for options to reduce costs.

Hiring for biomanufacturing remains a challenge. Downstream process development staff is the biggest pain point, followed by upstream process development staff. Cell and gene therapy staff are also in short supply.

Capacity also affects contract manufacturing organization growth. Langer’s firm has assessed biopharma companies and developed a ranking for each country to identify regional concentration. “Where the staff is, that’s where the need is going to be, not just where the capacity is,” Langer said. The research identified 1,500 global facilities; of these, two-third are in late-stage clinical/commercial capacity, and over a third are in commercial capacity. One-third of marketed products are made by 540 contract manufacturing organizations.

Contract manufacturing organizations will play an increasingly important role in biopharma, Langer said. Contract manufacturing organizations are adding single-use bioreactors that are now becoming the norm. He noted that single-use technology is becoming very reliable, and that the percentage of stainless capacity should decrease as new single-use products “graduate” to commercial scale. However, single-use product manufacturing still faces challenges; his company’s research identifies bag breakage and loss of production material, leachables and extractables, the high cost of disposables, and material incompatibility with process fluids as problem areas.

Substantial testing of continuous manufacturing is underway, but it has yet to move forward because vendor solutions are lacking, he said. The industry still sees perfusion as a problem versus batch-fed manufacturing.