Rise of Disposable Technologies

The biopharmaceutical industry has seen tremendous growth in recent decades driven by the development of novel therapies like monoclonal antibodies, gene therapies, and other biologics. As therapeutics become more complex, production methods must also advance to meet increasingly complex manufacturing demands. One area that has seen significant transformation is the use of single-use or disposable assemblies for bioproduction. Previously restricted to early research and development, single-use technologies are now being adopted for commercial manufacturing of approved drugs.

Advantages of Single-Use Technologies

Numerous advantages have driven the widespread adoption of single-use assemblies across biomanufacturing. First, single-use methods eliminate the time and costs associated with cleaning and sterilization of traditional stainless steel bioreactors between production campaigns. By eliminating cleaning, turnaround time between batches is reduced from weeks to just days. Further, without cleaning validations, facilities have increased flexibility to manufacture different products.

Second,  Single Use Assemblies reduce the risks of product cross-contamination. Traditional systems cannot guarantee complete removal of residues from previous campaigns which poses risks if manufacturing therapeutics for highly sensitive patients. Single-use systems are delivered pre-sterilized and disposed after use, eliminating these risks.

Third, capital and operational costs are lower than traditional stainless steel infrastructure. Single-use facilities require less capital expenditure on facilities and equipment since production equipment is essentially rental rather than a large capital investment. Operational costs related to cleaning, maintenance and validations are also avoided. This has made single-use technologies an attractive option particularly for small-mid scale production.

Advancing Sustainability

While single-use technologies deliver significant efficiencies, concerns around waste generation have been a criticism of these systems. However, manufacturers have been proactively working to advance the sustainability of single-use production methods. Early efforts focused on reducing material use through innovative assembly and component designs. Modern single-use bags, tubing, and connectors use 20-30% less plastics than earlier models through optimized shapes, dimensions and joining methods.

Further advancements are being made in recycling and recovery of plastic materials. Post-use, single-use plastics are often incinerated to avoid any risk of contamination carried over to other production streams. However, several waste management companies are piloting systems to collect, sterilize and shred used single-use plastics for recovery into secondary material streams like plastic lumber, fleece clothing, or fuel supplements. While challenges remain around consistent material quality and purity, recycling offers potential to divert substantial waste volumes from incineration.

Efforts are also underway to develop compostable or biodegradable alternatives to conventional single-use plastics. Early commercial offerings utilize biomaterials like polylactic acid (PLA) and are demonstrating comparable functionality in clinical trials. As experience grows, bio-based single-use assemblies could meaningfully reduce long-term environmental impacts if scaled globally. Alongside, digital tracking systems enable full traceability of single-use plastics from manufacture through disposal, supporting circular economy goals.

Global Adoption and Factors Driving Growth

Reflecting significant benefits and ongoing innovations, single-use technologies are projected to grow rapidly and comprise over 60% of the global bioproduction market by 2025 according to industry analysts. Regional and global factors are accelerating this transition. In Asia Pacific and Latin America, rapid development of local biotech industries is driving demand for cost-effective and time-efficient single-use production methods to facilitate market access.

Growing expectations for personalized medicines are also fueling demand. As therapeutics increasingly target niche patient segments, production technologies must support efficient manufacturing of small batches or patient-specific products. Single-use systems fit this demand profile well and their scalable, modular designs enable flexible ‘pop-up’ manufacturing facilities tailored to each product.

Further, rising environmental and regulatory standards globally are nudging producers towards more sustainable single-use options. Regulations in Europe and some Asia Pacific nations now incentivize or mandate recycling over incineration of used plastics. Coming sustainability regulations under the European Green Deal will heighten this transition. Combined with a growing environmental consciousness, these macro factors indicate steady long-term growth favors single-use bioproduction globally.

Ascending Commercial Adoption

As technologies advance and performance benchmarks improve, commercial large-scale adoption of single-use methods is accelerating across top biomanufacturers. Over 60% of current commercial monoclonal antibody production now utilizes single-use, up from 20% five years ago according to a survey of 25 leading producers.

For vaccines, Merck utilizes 5,000L single-use bioreactors for commercial rotavirus and pneumococcal conjugate 13-valent vaccine production. GSK operates a 200,000 sq.ft single-use facility producing shingles and meningococcal vaccines. Johnson & Johnson has deployed 2000L single-use bioreactors across multiple vaccine programs.

Gene and cell therapy leaders too are shifting towards single-use. Novartis Gene Therapies utilizes 2000L single-use systems for Kymriah manufacturing. Bristol-Myers Squibb operates a 94,000 sq.ft gene therapy facility centered on single-use technologies. Overall, as performance benchmarks are realized at large commercial scales, single-use platforms are positioned to emerge as dominant technologies powering next-generation therapeutics globally.

Future Outlook

As global drivers converge, single-use bioproduction methods have revolutionized biomanufacturing efficiency, flexibility, and sustainability. Commercial adoption reflects maturing technologies capable of reliably producing approved therapeutics at global commercial scales. With a $15 billion current market value expanding to over $30 billion by 2027, single-use assemblies will likely define biomanufacturing worldwide in coming decades.

Ongoing innovations including biomaterial replacements, advanced recycling solutions, and digital process integration offer potential to realize circular economy principles. Their scalable models also support emerging economies striving for self-sufficiency and affordable healthcare. Combined with evolving regulatory standards driving sustainability, single-use platforms appear set to rise further as the preferred production method for next-generation biologics globally and empower

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