Injectables: Market & Technology Trends

What are key trends for injectable drugs and the related market impact? From switches from IV-administered to subcutaneous drug delivery and increased interest for home and self administration, DCAT Value Chain Insights provides the latest. 

By Patricia Van Arnum, Editorial Director, DCAT, [email protected]

Subcutaneous delivery over IV administration.
An important recent trend in parenteral drugs is the development of subcutaneous (i.e., under the skin) delivery through injectables for bio/pharmaceuticals that were administered intravenously (IV). This approach is not only valuable for the patient by providing a more convenient method to deliver a drug, it also represents a method to extend or enhance the product life cycle of a parenteral drug.

Several noteworthy oncology drugs have added subcutaneous delivery in addition to the original IV administration of the drug. Although these drugs still have to be administered in a healthcare setting, the injectable form of the drug helps to provide more options to the healthcare setting in which the drug is administered and reduces the time of administration comparative to IV administration, another gain for the patient.

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Merck & Co.’s subcutaneous version of its immuno-oncology blockbuster drug, Keytruda (pembrolizumab), which was approved by the US Food and Drug Administration (FDA) in 2025 (September 2025), is a recent example. Keytruda Qlex was approved for subcutaneous administration in adults across most solid tumor indications. As a subcutaneous injection, Keytruda Qlex may provide added convenience compared to the IV infusion of Keytruda because it can be administered by healthcare providers in multiple settings from an infusion center to a doctor’s office or a local community-based clinic, thereby providing more options where patients can receive their treatment, according to information from Merck & Co. It is given in a one-minute injection every three weeks or in a two-minute injection every six weeks, thereby requiring less time to administer than the 30-minute IV infusion of Keytruda. Keytruda/Keytruda Qlex had combined 2026 first-half results of $16.4 billion with Keytruda Qlex contributing $590 million.

Johnson & Johnson (J&J) has a subcutaneous form, Darzalex Faspro (daratumumab and hyaluronidase-fihj) of its blockbuster drug, Darzalex (daratumumab), for treating multiple myeloma. Darzalex Faspro was first approved by FDA in 2020 and is approved for 11 indications in multiple myeloma, five of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. Darzalex Faspro was the first subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma, according to information from J&J.

The Darzalex products had combined sales of $12.41 billion for the first nine months of 2026. J&J does not break out sales of Darzalex Faspro separately, but combined revenues for Darzalex/Darzalex Faspro represent the company’s top-selling product. Genmab, a Copenhagen, Denmark-based bio/pharmaceutical company, is partnered with J&J and receives royalties on the worldwide net sales of Darzalex, both the intravenous and subcutaneous products, under an exclusive worldwide license granted to J&J to develop, manufacture and commercialize daratumumab.

A potential competitor to Darzalex Faspro is Sanofi’s Sarclisa Escena (isatuximab-irfc), which was approved by FDA in July (July 2026) as the first subcutaneous anticancer treatment delivered via an on-body injector. It is approved for multiple myeloma indications, and it is administered through both an on-body injector and manual subcutaneous administration. The on-body injector for Sarclisa Escena was developed by Enable Injections, a Cincinnati, Ohio-based healthcare company through its proprietary enFuse On-Body Delivery System, a wearable drug-delivery platform designed to deliver large volumes of medications subcutaneously. Sarclisa Escena was approved with Enable Injections’ CirCLIQ on-body injector developed using the enFuse platform.

J&J is applying a subcutaneous delivery method for another oncology product, Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), which is the subcutaneous form of Rybrevant (amivantamab), which is IV administered. Rybrevant Faspro was approved in adults with EGFR-mutated non-small cell lung cancer including those with certain mutations (exon 19 deletions). Rybrevant Faspro was approved by FDA in December 2025. In July (July 2026), FDA granted priority review for a supplemental biologics license application of Rybrevant Faspro for another indication: recurrent or metastatic head and neck squamous cell carcinoma. For the first six months of 2026, cumulative global sales for Rybrevant (amivantamab) and the Leclaza/Lazcluze (lazertinib) combination therapy was $546 million. The company does not break out sales of Rybrevant Faspro separately.

Another example is Bristol-Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), a subcutaneous form of its immuno-oncology blockbuster drug, Opdivo (nivolumab), which is administered by IV. Opdivo Qvantig was approved in 2024 for subcutaneous injection across multiple solid tumor indications. The uptake for Opdivo Qvantig has been modest relative to the IV version of Opdivo. Opdivo Qvantig posted third-quarter 2026 revenues of only $67 million compared to $2.53 billion for the IV-administered Opdivo.

Self administration: injectables
One of the key growth drivers for the injectables drug market has been the blockbuster success of the glucagon-like peptide-1 (GLP-1) drugs and related drugs for treating Type 2 diabetes and obesity, with the obesity indication being the large contributor to growth. These injectables are self-administered in a home setting. These include Eli Lilly and Company’s Mounjaro/Zepbound (tirzepatide), a dual-activating GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 medication, respectively for treating Type 2 diabetes and obesity, and Novo’ Ozempic/Wegovy (semaglutide), respectively for treating Type 2 diabetes and obesity. Although Novo now has an oral versions of Wegovy (semaglutide) for treating obesity, and Lilly has its own oral obesity drug, Foundayo (orforglipron), a once-daily small-molecule (non-peptide) oral GLP-1 receptor agonist for treating obesity, the injectable forms of obesity drugs in particular paved the way for their blockbuster success. Lilly’s Zepbound (tirzepatide) is available as a single-dose autoinjector pen or multi-dose KwikPen for chronic weight management. Lilly’s Mounjaro (tirzepatide) is formulated in a single-dose pen or KwikPen for Type 2 diabetes management. Novo’s Wegovy/Ozempic (semaglutide) is delivered via pre-filled pen injectors for weight loss and Type 2 diabetes

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