What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? ten23 health’s chief enablement officer (CEO), Hanns-Christian Mahler, shares his thoughts with Contract Pharma.

Sustainability
The pharmaceutical Industry, including CDMOs, must re-think the way it operates. Total global emissions from the pharma sector amounted to 52 megatons CO2e (2015)—more than those from the automotive industry in the same year. When operating a pharma and CDMO business, greenhouse gas monitoring and offset won’t suffice. We must also ensure that there are no adverse environmental impacts related to waste, such as plastics, and avoid overconsumption of water and biodiversity losses.

Self-administration of sterile dosage forms/biologics/complex dosage forms
Biologics must be administered by injection or infusion to ensure systematic delivery and efficacy. The standard dosage form is vials, and healthcare professionals (HCP) must prepare and administer injection/infusion to the patient.

Increasingly, including in cancer indications, administration is carried out by the patient themself. This facilitates handling and preparation of the treatment, may reduce medication errors, and allow home treatment by a HCP or the patient. Self-administration can be important in improving quality of life for the patient, reducing overall treatment costs, and increasing patient compliance and adherence. Device products that enable self-administration are likely to become more widely used.

Reliable and agile CDMOs that are experienced in developing, manufacturing, and testing drug/device combination products and/or related, possibly customized primary packaging, will therefore become even more important in the future.

Smaller batch sizes
Technological advances mean that patients may now be screened and diagnosed prior to treatment. In other words, it is possible to pre-select those patients who would benefit from treatment. This, and other related trends, suggest that in the future, medicines are likely to be needed in small batches.

Commercial batches may be in the scale of “a few thousand” per batch, rather than “a few hundred thousand” as in the past. This requires experienced CDMOs, that are both capable and skilled in producing smaller amounts of products, acknowledging, and minimizing product losses.