What’s in Store for Generics/Biosimilars?

The fortunes of the generics/biosimilars market will rest on one of the largest patent cliffs upcoming over the next five years. What do the numbers show, and what key trends are in the mix?

Ramping up the competition in generics/biosimilars market
A focus on healthcare cost containment from both payers and national governments bodes well for generics, but that sector continues to face competitive pressures. On a value basis, the global generics market in 2021 was $305 billion, according to IQVIA estimates, up from a 2016 level of $265 billion. The developed markets of the US, Japan, the EU 4 (France, Germany, Italy, and Spain), and the UK, accounted for a combined 46% of the $305-billion global generics market in 2021.

The generics sector, always highly cost competitive, continues to see pricing pressures, particularly in the US. Indian manufacturers have gained significant share of the US market since 2016, driven by a lower cost base that has allowed for aggressive price discounting. Prices have declined by more than 30% since 2016.

Despite these pressures, the near-term fortunes of the generics and biosimilars sector will largely rest on one of the largest patent cliffs upcoming over the next five years (2022–2026) with a cumulative brand loss by innovators of $188 billion in developed markets (see Figure 1). The resulting revenue opportunities for the generics and biosimilar sectors are significant: $17 billion for generics and $39 billion for biosimilars for the period 2022–2026, according to IQVIA estimates.

US market generics/biosimilars market
Most of the impact from loss of exclusivity of protected brands in 2021 in the US market was from biosimilars introduced in the prior three years, including three molecules in the oncology market—bevacizumab, rituximab, and trastuzumab, according to a new report by the IQVIA Institute for Human Data Science, The Use of Medicines in the U.S. 2022: Usage and Spending Trends and Outlook to 2026. Biologic brand losses were $10 billion in both 2020 and 2021, an increase from the $5 billion in 2019 and totaling $31 billion in the past five years (2017–2021) (see Figure 2). In the same five-year period, small-molecule brand losses were $62 billion, down from $84 billion in the prior five-year period (2016–2020).

Recent Feature Articles

Inflation and Supply-Chain Pressures Easing: What is Outlook for Rest of 2023?

A recent analysis by the management-consulting firm KPMG shows that inflation and supply-chain fears are easing, but that the global economy continues to face uncertainty. Lessening supply-chain pressures and resilient labor markets are supporting economic recovery, but uncertainty remains high. What are the prospects for global GDP growth and inflation for the balance of 2023?

CEOs and Supply Chains: UN Issues New Guidance To Manage Climate Risk

The UN Global Compact, which represents more than 18,000 companies globally and reflects CEOs commitments, has issued a new guidance on sustainable supply chains to help companies better manage climate risks by placing the concept of a Just Transition at the center of transition planning and risk-management strategies.

Congress Seeking To Prevent Drug Shortage With Pending DSCSA Serialization Requirements

Members of Congress are calling for action to prevent drug shortages in light of upcoming issues facing pharmaceutical manufacturers, distributors, and dispensers as they work to bring the drug supply chain into compliance with requirements under the Drug Supply Chain Security Act (DSCSA). Beginning November 27, 2023, all drugs in the US must be able to be tracked electronically on the unit level, and drugs not complying cannot be distributed or dispensed.

The Large Bio/Pharma Highlights: The Highs and Lows in the Bottom Line Thus Far In 2023

What have been some of the highs and lows thus far in 2023 from the large bio/pharmaceutical companies and what may be expected for the rest of the year? From Pfizer’s revenue declines for its COVID-19 products, to rising sales from Lilly and Novo Nordisk for their diabetes and weight-management drugs, to Viatris’ plan for further divestures, DCAT Value Chain Insights sums up the latest developments.