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The majority of biopharma professionals are highly optimistic for the future growth of the biopharma sector, 69 percent, according to a recent survey composed by the National Institute of Bioprocessing Research and Training.

NIBRT based its findings on 101 respondents to whom the survey was sent mid-December of 2016.

“There is a strong consensus that monoclonal antibodies (mAb) are the dominant therapy for the immediate future. However, product pipelines will diversify in a five-10-year period with products such as cell and gene therapies becoming increasingly important,” said the survey

A key challenge, according to respondents, will be establishing cost-effective manufacturing solutions for these newer therapies, as two thirds of respondents agreed that biosimilars would have a major impact on the market, although novel biologics can treat patients effectively as well.

The respondents stated that cost of drugs will be the biggest challenge, as will be market access for biopharma. The uncertainty of reimbursement brings an even greater risk to this process.

In regards to biopharma manufacturing, 67 percent pinpointed cell line development and optimization as the highest priority area for further innovation. As for the technology that would have the most beneficial impact over the next five years, 73 percent indicated Single Use Technologies (SUT). Nevertheless, extractable and leachables (65 percent) and lack of standardization (58 percent) of SUT remain key concerns.

Recruitment and development of talent is seen as a key threat to the future growth of the sector. Particularly, 57 percent of respondents are having a difficult time recruiting bioprocess engineers. Hands-on practical training—either on the job or in training pilot plant environment—are seen as most effective methods. Overall access to skilled staff, manufacturing models for new therapies and cost issues were included as the main challenges to the growth of the sector.

The majority of survey respondents (38.3 percent) identified themselves as biopharma manufacturers, followed by supplier/vendor (23.4 percent), academic organization (21.3 percent), biopharma start-up, government organization and contract manufacturer.

So what do these responses say about the future of biophrama?

"Access to skilled staff, manufacturing models for new therapies and cost issues were included as the main challenges to the growth of the sector," Killian O'Driscoll, NIBRT director of projects told DDD in an exlcusive interview. "Key opportunities identified included cell therapies, gene therapies, biosimilars and standardized platform based, cost effective manufacturing solutions. Overall, the level of optimism among the respondents bodes well for the future growth of the industry."

The NIBRT center, located in Dublin, Ireland, performs high-impact, world class, industry-aligned research in all aspects of bioprocessing, biopharmaceutical manufacturing, therapeutic protein characterization, compliance and regulation.

 

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