The pharmaceutical outsourcing market is uniquely poised for significant growth. A recent market report from Growth+ Markets estimated that the market could grow from a 2021 valuation of $125 billion to as much as $227.8 billion by 2030, with an estimated compound annual growth rate of 6.9% (1). That said, simply measuring net growth lacks the context for actionable information if one fails to identify the market segments that are driving said growth.

One effective way of identifying these growth drivers is to look to the major players in the pharma market. By following the moves of pharma giants, upcoming trends can be identified ahead of their full emergence in the broader outsourcing market. This article examines some recent moves made by big name companies to determine what may be lurking over the horizon.

May 2023 Partnerships for Outsourcing eBook

Grant Playter is associate editor with BioPharm International.

When referring to this article, please cite it as Playter, G. Identifying Outsourcing Market Trends. 

Articles

BioBusiness

Outsourcing collaborations provide insight into the key drivers of market growth.

Identifying Outsourcing Marketing Trends

A biopharmaceutical or biotech innovator’s knowledge and understanding of a manufacturing process is gradually built during the activities that lead up to the product’s commercialization. FDA’s 2011 process validation guidance advises that a lifecycle approach should be taken as the product progresses through clinical trials and approaches potential commercial approval. This process incorporates three stages of process design, process qualification, and continued process verification. With each process designed and built using these three stages, knowledge accumulated will then inform the approach for subsequent product commercialization.

BioPharm International's May 2023 Partnerships for Outsourcing eBook

 is director of Process Development, Catalent Biologics, and 

 is manager, Manufacturing Science & Technology, Catalent Biologics.

When referring to this article, please cite it as Berdugo-Davis, C.; Wittenwyler, D. Streamlining and Standardizing Process Characterization. 

BioPharm International’s Partnerships for Outsourcing eBook 

Process Development

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

Streamlining and Standardizing Process Characterization

The ability of the biopharma industry to meet the worldwide demand for messenger RNA vaccines was facilitated by contract development and manufacturing organizations, which promptly adapted their facilities and capabilities specifically for vaccine production, offering contract fill/finish and cold chain services required to meet demand. Examining the lessons learned from the COVID-19 pandemic, this article provides a perspective on the strategies and tactics taken to deliver a better drug development program and highlights the importance of remembering key lessons as the industry moves toward an era of new drug modalities.

Jeong Jin-hyeok is principal scientist in drug product at Samsung Biologics.

When referring to this article, please cite it as Jin-hyeok, J. Preparing for a New Wave of mRNA Technologies. 

Manufacturing

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Preparing for a New Wave of mRNA Technologies

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With advancements in research and technologies, the diversity of biological drugs available is broad, including monoclonal antibodies (mAbs), prophylactic vaccines, gene therapy viral vectors (mainly lentivirus and adeno-associated virus), cell therapies (e.g., chimeric antigen receptor T-cell therapy and modified stem cells), and oncolytic viruses (e.g., adenoviruses, herpes viruses, and vaccinia virus).

As a result, the bioreactor vendor and contract development and manufacturing organization industries are under pressure to increase production scale. To meet demand, these industries must feasibly scale up while considering safety, manual operator handling, engineering, infrastructure, costs, and finally biological processing itself.

BioPharm International Partnerships for Outsourcing 

Kai Lipinski, PhD, is the chief scientific officer of Vibalogics.

When referring to this article, please cite it as Lipinski, K. Scaling Manufacturing Processes Using Single-Use Technologies. 

BioPharm International, Partnerships for Outsourcing

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling. 

Scaling Manufacturing Processes Using Single-Use Technologies

The relationship between pharmaceutical companies and the contract organizations that perform development and manufacturing services comes with the necessary process of transferring intellectual information, processes, and product from one organization to another. Complex products such as biologics and messenger RNA (mRNA) vaccines come with additional challenges during the tech transfer process.

To gain more insight on the complexities of transfer of pharmaceutical technology between contractors and sponsors, 

® spoke with Petra Dieterich, scientific leader, and Jeffrey Mocny, scientific leader-Early Development, both with Abzena; Peter Ercoli, chief operating officer, Biologics, at BIOVECTRA; Deepak Thassu, PhD, MBA, senior vice president, R&D and Regulatory Submission, at LGM Pharma; Emma Rhodes, head of New Product Introduction at Sterling Pharma Solutions; Sara Schemel, senior process engineer, Dona York, principal process engineer, and Gauri Patki, senior process engineer, all at Catalent Biologics; Uwe Hanenberg, PhD, head of Product Development at Recipharm; and Rebecca Powell, associate director, Tech Transfer at Arranta Bio, a Recipharm company.


eBook: Partnerships for Outsourcing
May 2023
Pages: 32–37

When referring to this article, please cite it as Haigney, S. Communication is Key in Complex Tech Transfer. 

Tech Transfer

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

Communication is Key in Complex Tech Transfer

Contract development and manufacturing organizations (CDMOs) specializing in sterile fill/finish were key to the success of the COVID-19 vaccine roll-out, delivering aseptic manufacturing capacity and expertise. But can CDMOs do better in the future? What lessons can be learned to further speed up sterile processing for the next pandemic?

The development and commercialization of effective vaccines to tackle the COVID-19 pandemic happened at an unprecedented pace and on an unparalleled scale. Billions of doses of a range of approved
vaccines have now been administered to patients across the globe. Millions more continue to be manufactured to provide boosters capable of tackling new variants in an effort to prevent a repeat of the events of spring 2020.

Vaccine spending worldwide was higher in 2021 than any previous year (1). Total cumulative spending for the COVID-19 vaccine program is forecast to hit $157 billion by 2025 (2).

The past two years have demonstrated that it is possible for the pharmaceutical industry to achieve new heights of speed and efficiency in development and manufacturing, all while maintaining optimum levels of quality and safety.

BioPharm International Partnerships for Outsourcing

Roberto Raffaele Addamo is head of Commercial, Sterile Fill & Finish at Recipharm.

When referring to this article, please cite it as Addamo, RR. Fill/Finish Lessons Learned from COVID-19. 

Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?

Partnerships for Outsourcing, May 2023 eBook

Identifying Outsourcing Marketing Trends

Streamlining and Standardizing Process Characterization

Preparing for a New Wave of mRNA Technologies

Scaling Manufacturing Processes Using Single-Use Technologies

Communication is Key in Complex Tech Transfer

Fill/Finish Lessons Learned from COVID-19