The quiet growth of recombinant enzymes is a success story that has yet to be widely recognized. Taken in the aggregate, this drug class has become an important segment within the biotech sector.

Recombinant enzymes span several therapeutic segments, including fibrinolytics, antineoplastics, acid α-glucosidase deficiency, and even one (Jetrea) that acts as an adhesion inhibitor. But the majority of recombinant enzymes are approved for indications that can be grouped under the heading of enzyme therapy and which are indicated for orphan diseases.

There are currently 10 recombinant enzymes in the enzyme therapy class that have received marketing authorization from the FDA and/or the EMA – 13 if drug products approved with identical trade names are considered separately (Elaprase, Naglazyme, Strensiq). These drugs had  total revenue of $3.2 billion on an ex-manufacturer basis in 2015.

Enzyme Therapy – Recombinant Enzymes Global Revenue (2015)

enzyme-pie-2015-revenue

 

The supply chain for these drugs is diverse and global. Not surprisingly, the top level supply chain (e.g., API manufacturing and final manufacturing) is most often comprised of captive suppliers – divisions or subsidiaries of the labeler. Notable exceptions are for smaller labelers who have contracted with recombinant drug manufacturers with significant experience.

Recombinant Enzymes Indicated for Orphan Diseases – Top Level Supply Chain

Enzyme therapy recombinant enzyme suppliers

Source: Recombinant Drug Market SourceFile (Greystone Research Associates)

Looking ahead, we expect recombinant enzymes that target orphan diseases to continue to proliferate, as market participants take advantage of the market opportunities associated with this class of indications.

AUTHOR’S NOTE: This data was taken from the Recombinant Drug Market SourceFile, a user-interactive information resource created and made available by Greystone Research Associates. For more information, please visit greystoneassociates.org