Competitive by design

New research report estimates near-term market opportunity for emerging biosimilar markets, and examines role of drug delivery device design in competitive differentiation

(Oxford, UK – November 2019) Owen Mumford Pharmaceutical Services, a global industry leader in medical device design and manufacturing, today releases its latest report, scoping the near-term competitive biosimilars markets in the USA and Europe, and outlining the role of drug delivery device design in rising above the competition in the rapidly booming biosimilars market.

Pundits expect the available market for biosimilar manufacturers seeking to compete with original reference biologics coming off patent between late 2018 and 2023 to be very considerable indeed, both in Europe and in the USA. However, even where healthcare regulators, managers and clinicians encourage adoption of biosimilars as appropriate for the patient, there remain some important issues to be tackled to tap into this potential. Specifically:- clinical confidence in the biosimilar; competitive pricing of drugs through greater competition; and patient confidence in the drug delivery device may present an obstacle to adoption or switching.

This latest study reveals the size of the near-term opportunity in competitive biosimilars markets for biologics coming off patent 2018-2023, and offers evidence that device design is a key differentiator in addressing patient adoption.

·         In Europe, the estimated market opportunity[i] for this five year cohort of patent expiries (factoring in competitive discounts and based on 50% market share) for biosimilar manufacturers is $3.12 billion per year based on current revenues;

·         The equivalent market opportunity in the USA comes to $5.24 billion per year.

To harness this opportunity biosimilar producers will need to address the issue of drug delivery carefully: larger molecule biological drugs tend to be more viscous and present challenges with volume of drug to be delivered as well as potential pain on administration. At the same time, healthcare systems across the world are favouring patient self-administration, in order to lighten the burden on hospitals and increase convenience for patients. As a result, precision dosing, ease of use, comfort, and convenience – all reliant on drug delivery device design – have become critically important in ensuring patient adherence to treatment. Familiarity and comfort with a particular delivery device are also seen as discouraging from switching treatment in spite of clinical judgement.

George I’ons at Owen Mumford Pharmaceutical Services comments: “This latest paper highlights some important issues concerning the key role of design for ‘combination products’ where delivery device and drug are seen as single entity by regulators. This highlights the supporting role of device design in ensuring that drugs, especially newly booming biosimilars, enter the market competitively.”

[i] Methodology: Latest patent-protected year revenues for original biologics coming off patent in the period 2018-2023 were researched. These were then reduced by typical discounting levels already experienced in the European and US markets