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Biosimilars Slow to Crack the Erythropoiesis Stimulating Protein Market

Each year, an estimated 1.2 million cancer patients undergo cytotoxic chemotherapy in the United States alone; and approximately 800,000 (67%) will become anemic. Hematopoietic agents stimulate the bone marrow to increase the production of red blood cells and have been shown to result in a clinically significant improvement of anemia associated with chemotherapy.

Neutropenia is a major indication for erythropoiesis stimulating protein market (ESP). Neutropenia is a decrease in circulating neutrophils in the peripheral blood. The absolute neutrophil count (ANC) defines neutropenia. ANC is found by multiplying the percentage of bands and neutrophils on a differential by the total white blood cell count. An abnormal ANC is fewer than 1500 cells per mm3. African Americans have a lower normal ANC value of 1000 cells per mm3 but have a normal total neutrophil content. The severity of neutropenia is categorized as mild with an ANC of 1000-1500 cells per mm3, moderate with an ANC of 500-1000 cells per mm3, and severe with an ANC of fewer than 500 cells per mm3. The risk of bacterial infection is related to the severity and duration of neutropenia. Recurrent infections typically occur with neutropenia, but neutropenia per se is not necessarily a disease.

In 2007, five biosimilar ESPs were approved by the EU EMA.  In spite of these competitors, this market continues to be dominated by established protein drugs.  In 2015, the total global revenue for this class of recombinant proteins was $5.6 billion (ex-manufacturer basis). But eight years after EMA approval, the five biosimilars (Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo), accounted for only $385 million of the market (6.8 percent).

Erythropoiesis Stimulating Protein Market

.Source: Greystone Research Associates

Biosimilar uptake has to date been highly country-specific. This indicates that at least two factors are at play. The first is country-to-country regulatory variability and the element of risk this represents for practitioners. The second is traditional physician-patient relationships, particularly when the condition is potentially life threatening and the biological therapeutic is known to have significant side effects.

Going forward, we expect ESP biosimilar uptake to continue to trail expectations due to the difficulty of prescribers to reach an adequate level of confidence in prescribing an alternate version of a powerful drug.

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The EU Market for Therapeutic Protein Manufacturing

From a geographic perspective, the European Union (EU) s a highly diverse and heterogeneous market for recombinant protein manufacturing. As the EU continues to outpace the US in terms of the type and number of biosimilars that have received marketing authorization, the increasing activity surrounding biosimilars is having a secondary effect on the EU recombinant protein ecosystem.

As is the case in the U.S. the majority of suppliers in the region are captive – divisions, subsidiaries or business units of the labeling company. Not surprisingly, smaller labelers are most likely to contract for protein manufacturing services outside their own organization.

Top Level EU Recombinant Protein Manufacturers

Recombinant Protein Manufacturing

 

Activity in biosimilars is also allowing selected companies who have several proteins in their manufacturing portfolio to enhance their manufacturing resumes. Since the shortest path to biosimilar approval lies in outsourcing not only the functional activity, but the knowledge base and existing art as well, biosimilar labelers in Europe are most often contacting with contact manufacturers with previous clients for the same API.

API Suppliers to Recombinant Protein Manufacturers in the EU

Therapeutic Protein Manufacturing

 

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The Growth of Recombinant Enzymes

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