Drug Pricing Reform

With the increase pressure on the price and accessibility of drugs along with the impending 2020 election, Congress is likely to pass a pricing reform for pharmaceuticals. This could affect the future development of drugs and specialty therapies, while accelerating the release of generics and biosimilars. This ultimately could decrease the accessibility of specialty therapies, making them harder to get to market. This will cause many Pharmaceutical companies to change their pricing models and expand their outsourcing partners. House speaker, Nancy Pelosi, has endorsed a bill that would impose a tax on drug manufacturers if they fail to reach a price agreement with the government under Medicare Part D.

Modernization

With a greater demand for healthcare, the FDA and many Pharmaceutical companies are taking steps to modernize their approval and R&D processes. Digital technologies are anticipated to be “the most transformative force in healthcare in the 2020s”. Electronic submissions, digital care connections, digital advertising, machine learning/AI and data collection are all methods that are actively used by key players in the pharmaceutical industry to accelerate the approval process and increase awareness/accessibility of treatment options to patients.

Increase in Biosimilars & Generics

Due to the increased pressure for pricing reform, more biosimilars and generics will likely be pushed to market in 2020. A record number of generics were approved in 2019 and this is expected to continue in 2020 with political support from both sides. There are currently 26 approved biosimilars in the market and more generic options than ever before are under development. An increase in these drugs will increase accessibility and decrease prices. It is expected that biosimilars will perform better overall than generics.

New FDA leadership in 2020

After a resignation and two acting commissioners in 2019, Steve Hahn took over the role in December. Hahn is a permanent commissioner with presidential appointment so he is expected to be in the role until at least 2021 which will provide stability to the office. With a new leader in place this can also mean new initiatives being pushed forward. It is believed that the FDA will remain focused on many of the 2019 initiatives like tackling opioid addiction and the push for biosimilars while also focusing on: drug compounding oversight, advancing medical device innovation & safety as well as growth in gene & cell therapies.

Oncology will Dominate Growth

Due to the prevalence of cancer worldwide, many companies are shifting their pipelines towards expanding treatment options for cancer patients. Drugs in the oncology space are expected to make up the largest percentage of growth in the upcoming year, after having increased 140% in list price over the last decade. Total oncology sales are expected to be $240 billion annually by 2026.

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