The highest number of Orphan New Molecular Entities (NMEs) in five years was outsourced to CMOs in 2018, reflecting a general trend for greater outsourcing of new drugs and a future opportunity for contract manufacturing, according to a GlobalData Pharmsource Trend Report published in May.

CMO outsourcing 2018

The CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2019 Edition report provides insights into New Drug Application (NDA) approvals and associated outsourcing, including NMEs; CDMO performance by the number of approvals and share of dosage form approvals; and an assessment of NME outsourcing by sponsors’ market caps.

Covering the manufacturing of drugs for US and EU markets and mentioning over 165 companies, it also includes expert analysis of NME special product approvals such as those with Orphan, Breakthrough Therapy, or Fast Track designations. The report is based on expert research and analysis, key opinion leader (KOL) interviews, and the GlobalData Pharma Intelligence Center databases, including the PharmSource Drugs by Manufacturer Database, integrated with GlobalData earlier this year.

Figure 1, which was presented by Peter Shapiro, senior director of drugs and business fundamentals, GlobalData, at CPhI North America in Chicago, IL, US on 20 April shows that in 2018, 34 orphan NMEs were approved, the highest number in the last 10 years. Special designations are good for CMOs: orphan and other accelerated drugs are more likely to be contract manufactured than products that go through standard review. 65% of orphan NME approvals (22 drugs) were outsourced in 2018, the strongest outsourcing propensity for orphan NMEs since 2014, demonstrating that orphan NMEs are providing greater opportunities for CMOs.

Figures 2 and 3 reported an overall increase in the number of US Food and Drug Administration (FDA) Breakthrough and Fast Track Drug designations, respectively, awarded during 2013–2018.

Breakthrough Therapy designation is awarded to drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. Fast Track designation is awarded to drugs that treat serious conditions and fill an unmet medical need. Accelerated approvals are good for CMOs as these drugs are more likely to be contract manufactured because they are more likely to require special handling and manufacturing skills than products that go through standard review.

Figure 1: Outsourcing of orphan NMEs, 2009–2018

Source: GlobalData Pharmaceutical Intelligence Center Drugs by Manufacturer Database (accessed 8 March 2019)

Figure 2: Breakthrough therapy designations awarded, 2013-2018

Source: GlobalData Pharmaceutical Intelligence Center Drugs by Manufacturer Database (accessed March 8, 2019)

Figure 3: Fast-track designations awarded, 2008-2018

Source: GlobalData Pharmaceutical Intelligence Center Drugs by Manufacturer Database (accessed 8 March 2019)

According to the GlobalData Pharma Intelligence Center databases and the Scorecard report, the FDA approved 137 novel drugs and 64 NMEs in 2018, which represents increases of 36% and 65%, respectively, over the 2012–2017 period. The overall increase in the number of drug approvals has led to greater outsourcing to CMOs. In 2018, 57 NDAs were outsourced to manufacturers, a figure that is higher than the 2009–2016 average (46) and just one short of the 58 approvals recorded in 2012. The number includes twenty products that were dual-sourced (manufactured both in-house and outsourced).

Although CMOs have been presented with greater outsourcing opportunities, it is still evident that outsourcing of NME active pharmaceutical ingredient (API) manufacture is highly dependent on the nature of the drug; the outsourcing of biologic APIs has decreased over the last decade, whereas during the same time outsourcing levels for chemical (small molecule, polymer, and oligonucleotide) APIs have remained fairly stable. The latter corroborates the conclusions of PharmSource founder and former president Jim Miller in his talk on the Drug, Chemical & Associated Technologies Association (DCAT) 2018 Benchmarking Report at DCAT Week in New York, NY, US on 18 March 2019. Miller told the meeting small molecule and solid dose manufacturing will continue to be sought-after CMO services in the immediate to mid future.