Report Suggests that Biosimilars May Slow Drug Sales Worldwide by 2022

Worldwide prescription drug sales could reach $1.06 trillion by 2022, according to a new report produced by EvaluatePharma. The expansion of existing therapies (including immunotherapy agents such as pembrolizumab, Keytruda), the launch of new therapies (such as Roche’s new multiple sclerosis drug ocrelizumab, or Ocrevus), and the rapidly expanding orphan drug market (which targets the unmet needs of narrow patient populations) all contribute to growth. Yet this substantial earning represents only a 6.5% compound annual growth rate (CAGR) in drug sales over the coming 5 years, and biosimilars may well play a significant role in curbing that growth rate.

According to the report’s authors, approximately $194 billion in sales are at risk between 2017 and 2022 as the pharmaceuticals industry enters “a second patent cliff era” during which top-grossing biologics will be challenged by biosimilar competitors. Sales of top biologics, the report states, could erode by as much as 54% following market penetration by biosimilars.

Oncology is expected to be the fastest-growing therapy area through 2022, with an anticipated 12.7% CAGR. Biosimilar trastuzumab, bevacizumab, and rituximab (referenced on Roche’s Herceptin, Avastin, and Rituxan, respectively) exert a downward pressure on that expected growth, however; absent the impact of biosimilar products, the growth rate could skyrocket with the launches of AstraZeneca’s durvalumab and Incyte’s epacadostat. Roche’s dominance in the oncology market may slip as biosimilars impact its sales, with the report projecting a 14% fall in market share.

Rheumatology could experience even stronger impacts from biosimilars; the anti-rheumatic therapy area is projected to grow at only 0.6% CAGR through 2022, even in light of high-profile launches of drugs such as AbbVie’s ABT-294 (upadacitinib), due to the anticipated market influence of biosimilars, including those for infliximab (challenging Janssen Biotech’s Remicade) and adalimumab (competing with AbbVie’s Humira).

Despite competition from biosimilars, drug manufactures will continue to see strong sales from biologics through 2022, when biologics are expected to represent over half of the 100 top-selling pharmaceutical products as new, innovator biologics gain FDA approval. Adalimumab, however, is expected to remain the top-selling drug in 2022, despite biosimilar products competing for market share.

Even as new innovator products become available, biosimilars will continue to exert a strong impact on the overall futures of top biopharma players, including Roche, Pfizer, and Novartis. For its part, Roche has a large share of its product portfolio at risk of patent expiry in the coming years. Pfizer is “playing on both sides of the fence,” the authors say, by developing both innovator biologics and biosimilars; the company stands to both lose money on its branded etanercept (Enbrel) and to see good returns through its recently acquired biosimilars arm, Hospira. The report’s authors say that Novartis, with its growing portfolio of biosimilars, has the potential to outsell both Roche and Pfizer, by a slight margin, to become the top-earning manufacturer by 2022.

While the significant impacts of biosimilars on innovator products’ sales highlight the challenges that biopharmaceutical manufactures face as they seek to maintain their dominance in the industry, other stakeholders may welcome news that biosimilars are responsible for a slowdown in sales. The greater price competition that biosimilars bring to the market may well result in greater patient access to effective therapies and lower costs to payers.