Report: Current Strength of US Biopharmaceutical Sector Likely to Continue in 2018

Evaluate's EP Vantage pharma and biotech preview of what’s in store for the industry in 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018, with more new medications expected to hit the market and with investors’ support for biopharma remaining strong. In addition, global demographic trends signal a rising demand for healthcare and medications. EP Vantage is the editorial arm of Evaluate Ltd, which provides commercial intelligence forecasts within the global life science industry.

New medicines are reaching the market more quickly than ever before, the report notes, with large and small drug developers successfully launching “transformative” products in a number of therapy areas over the last few years. The report cites the current business-friendly environment at the FDA as supporting the industry and being unlikely to change in the next year. FDA Commissioner Scott Gottlieb, MD, has been widely embraced by industry and investors. The FDA is on track to approve 43 novel drugs before the close of 2017, those drugs are forecast to generate a combined $32 billion in US sales in 5 years, and the FDA is now perceived as allowing greater leniency in its approval process (though the FDA strenuously denies that it has lowered hurdles for approval). The report cites Amicus’s Fabry disease treatment migalastat (Galafold) as an example of a “friendlier” FDA.

The report highlights the following key points:

• In 2018, the promise of novel therapies like chimeric antigen receptor-T (CAR-T) and gene therapies will be tested, the report suggests, as any drugs approved using these technologies would be launched into an increasingly cost-sensitive market.
• Immuno-oncology will be particularly closely watched, the report predicts, because investors are closely watching clinical trial results in that field, where asset values remain very high. Amy Brown, an author of the report stated, “Both public and private investors look set to remain supportive of innovative, early-stage drug developers. However, there is evidence that expectations have got ahead of themselves in certain areas—particularly in immuno-oncology.” Thus, the industry needs to deliver some big pipeline wins, and important new drug launches need to perform. Confidence in the industry’s research and development work could take a hit if new combinations and novel targets fail to deliver, she said.
• Huge leaps forward in cancer care with the anti—PD-(L)1 antibodies and the approval of cutting-edge techniques like CAR-T therapy have raised expectations that the sector can keep delivering at pace, the report states.

• A handful of clinical trials are being monitored particularly closely: success with indoleamine (2,3)-dioxygenase (IDO) inhibition is perhaps the most immediately pivotal.
• The first likely gene therapy in the US will be closely watched, as moves towards regulatory review of ground-breaking RNA-based therapies are likely in 2018.
• Any increase in the uptake of biosimilars in the US is also being closely watched, as a number of significant biological franchises approach the end of their patented lives.
• Gilead’s new HIV triplet is the biggest potential new drug launch of 2018, with 2022 sales projected to reach $5 billion.
• Abbvie’s adalimumab (Humira) will be the biggest-selling drug in 2018, with global sales topping $20 billion.
• Merck’s immunotherapy cancer treatment, pembrolizumab (Keytruda), will add the most new sales next year ($2.3 billion).
• The drug pricing debate is expected to ease because the Trump administration appears to have pulled back from the issue. However, the President’s unpredictability creates uncertainty in this area, and state-level maneuvering could become key, the report states.
• Big pharma's and biotech’s needs to restock pipelines may drive mergers and acquisitions (M&A), the report forecasts, and changes brought about by proposed US tax reform may also encourages M&A, which were slow in 2017.