Top 10 Pharma Trends 2020

What key trends or issues emerged in 2019 that are positioned to be on the industry’s radar in 2020? DCAT Value Chain Insights provides a Top 10 ranking. Article by By Patricia Van Arnum – DCAT Editorial Director

1. Drug-pricing reform in the US
Drug pricing is on the top of the policy agenda in the US as healthcare reform is one of the leading issues for the US Presidential election in 2020. Read more

2. New leadership at the FDA and EMA
Also important to the pharmaceutical industry on a policy level in 2020 will be new leadership at both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and what changes, if any, may be forthcoming in the policy direction of those two agencies. Read more

3. Global pharmaceutical trade
Implications of Brexit. The pharmaceutical industry, along with other industries and the world at large, are awaiting for a decision if and how the UK would exit the European Union (EU) (i.e., Brexit). Any trade/customs agreement as part of a negotiated deal between the UK and the EU for the UK’s exit from the EU would impact the flow of pharmaceutical products and ingredients between the UK and EU, so the pharmaceutical industry is waiting to see how supply lines and requirements may be changed or not. Read more

4. Global pharmaceutical trade
China. Trade talks with China represent another geopolitical concern with potential implications for the pharmaceutical industry. While the bio/pharma industry has largely not been targeted with tariffs or other trade barriers in recent trade actions, the industry potentially has risk because of its broad global network of manufacturing sites and suppliers. Read more

5. Drug-manufacturing quality
One of the important news stories that surfaced in 2018 and that continued in 2019 was increased focus on drug-manufacturing quality relating to company recalls and investigations by the FDA and the EMA into nitrosamine impurities into certain active pharmaceutical ingredients (APIs), most notably “sartan”-containing APIs, used in anti-hypertensive and cardiovascular drugs, such as valsartan candesartan, irbesartan, losartan, and Olmesartan, and later into prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach. Read more

6. Pharma innovation
The number of new molecular entities approved by the FDA is an important barometer of pharmaceutical innovation. In 2018, the FDA approved a record 59 NMEs, surpassing the previous record of 53 NME approvals in 1996 and the 46 NMEs approved in 2017. Thus far in 2019 (as of the end of November 2019), the FDA has approved 41 NMEs. So what will 2020 hold? Read more

7.New business models in healthcare delivery
Market solutions to reduce healthcare costs to achieve a competitive advantage will continue to be an issue of note in 2020. The industry has already seen recent mega mergers and the rollout of new companies consolidating pharmacy and insurance companies, such the $69-billion merger of CVS Health Corporation (CVS) Read more

8. Changing fortunes of US generics market
Always a cost-competitive market, the generics market, particularly the US market, has seen recent restructuring due to product and cost pressures and a key issue going forward for 2020 is how the market will Read more

9. Real-world data in drug development
An important issue for 2020 will be the challenge presented to pharmaceutical and life-science companies of their ability to collect and use real-world data for which patient health and outcomes data are gathered outside of randomized controlled trials. This approach is not only important for directing drug development but also a consideration as companies evaluate the use of outcome-based reimbursement models for drugs. Read more

10. Manufacturing innovation
Although manufacturing innovation to improve cost-efficiency product yields, and cycle times is always a goal, look to see if how broader issues, such policy discussions on climate change, will further drive government requirements or business interests to achieve further reductions in carbon footprints and manufacturing innovation can support such activity. Read more

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