Biotherapeutics Outpace Conventional Therapies - As the number of biologics in development increases, growth in infrastructure and process-development capabilities will be required to support this mar

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Biotherapeutics Outpace Conventional Therapies
As the number of biologics in development increases, growth in infrastructure and process-development capabilities will be required to support this market.


BioPharm International Supplements
Volume 25, Issue 3, pp. s20-s23

IMPLICATIONS FOR CMOS

Trying to predict capacity requirements for opportunities presented by biomanufacturing is not simple. While the contract-manufacturing sector has strongly promoted the need for additional capacity, with many organizations investing in microbial and mammalian cell-culture capabilities, big pharmaceutical and biotechnology companies are also increasing capacity based on their product portfolios. These can be split in two main groups—those that focus on early-phase clinical supply and those that deal with large-scale capacity. A development group with access to a small-scale multiproduct production facility is required to support this type of function. For companies with limited product portfolios or those wholly focused on clinical supply, this function is often contracted out. There is a shortage of companies worldwide that can provide the necessary level of support.

FUTURE OUTSOURCING NEEDS

The goal of process optimization is to integrate process development with product development so that there are no surprises when the products are transferred to production. Within pharmaceutical R&D there is a strong correlation between highly effective process development capabilities and the profitability of the associated product and company. Companies with superior process development capabilities have strategic leverage in time-to-market and associated productivity.

Because of the extensive regulatory requirements of drug introduction, it is desirable to delay process development as long as possible and then quickly develop it once approval looks likely. Some companies are much better at this task than others. The design of development processes for scale-up works reasonably well with chemical-process-based drugs. This is not always the case with biologics. The novel nature of each process requires significant learning and flexibility during implementation. Also the transfer of expertise acquired during development for application in new processes varies greatly from company to company. Some companies appear to have more structured knowledge that stems from their particular competencies. Understandably, different segments of the pharmaceutical market have differing approaches to biomanufacturing, although some similarities do exist when it comes to the desire to harmonize or standardize manufacturing across different therapeutic diseases and in the categories of biotherapeutics (i.e., hormones, mAbs, enzymes, or proteins).


Table I: 2012 trends towards biomanufacturing. Numbers 1–5 indicate the rank order of the relevance of the category of biologic based therapy within the development for each segment covered, with 1 being most relevant and 5 being the least.
Based on data from its Q4 Pharmaceutical and Biotechnology Outsourcing survey, which included 2619 individuals in outsourcing-facing roles, Nice Insight found distinct differences across customer groups with respect to biologic-based therapies. Seventy-six percent of respondents from both biotech companies and Big Pharma companies, each with an annual outsourcing spend in excess of $50 million, indicated their business is actively engaged in the development of biotherapeutics (see Table I). These customer segments were second only to emerging biotech companies, in which 82% engage in the development of biologic-based therapies. Just over half of the respondents from specialty pharma companies stated their business develops biotherapeutics and only one-third of emerging pharma companies are developing biologic based therapeutics.

Big Pharma, biotech, and emerging pharma segments are in accordance, with monoclonal antibodies taking top priority, whereas the specialty pharma and emerging biotech segments indicated protein-based therapeutics as their top priority. Enzyme, hormone, and peptide-based therapeutics followed in sequence with respect to relevance across the segments. As mentioned above, standardization is an industry-wide goal when it comes to the development of biologic-based therapies. This was supported by Nice Insight's research, in which 82% of specialty pharma companies engaged in biotherapeutic development stated their organization was trying to standardize the process and 92% of Big Pharma companies stated the same.

On average, the biotech and emerging biotech segments indicated that a slightly larger portion of their outsourcing budget was allocated to large molecule projects, spending 60% and 56% on biologic outsourcing, respectively. Big Pharma followed closely behind, allocating 53% of their budgets to biomanufacturing. Specialty pharma and emerging pharma were the only segments that had a slightly larger percentage of their budgets allocated to traditional, small-molecule projects, with 49% and 47% allocated to biologics.

Trends in biomanufacturing are encouraging, as companies with superior process-design capabilities will be able to extract more profit from their operations and thus become more successful. Accordingly, these companies are likely to produce better products that are more aligned with customer needs.

VICTOR COKER is director of business intelligence at Nice Insight, That's Nice LLC,
.


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