What are the prevailing trends in biopharmaceuticals and biosimilars that are shaping the industry landscape today?
Biopharmaceuticals have greatly increased in the market year over year with current analysis indicating an increase in the range of 8-15% during the rest of the decade. As biopharmaceutical products are coming off patent, biosimilars are entering the market at an increasing pace, sometimes with multiple companies entering the market with the same drug.
As companies are able to decrease the cost of manufacturing of these drugs, and additional new drugs are released, the market for biosimilar products will continue to expand. This increases competition with the potential to drive prices down for the consumer.
There is also a trend in identifying new uses for drugs already on the market. Given the competitive landscape, this provides companies that are developing biosimilars with options to decide what treatment/s to target for the drug, creating a way to differentiate their product in the market.
In your opinion, what are the most pressing issues and concerns currently faced by the biopharmaceutical sector, and how are they influencing decision-making and strategy?
Speed to market is a significant focus for biosimilar developers. As a drug comes off patent, there are multiple companies that have a biosimilar ready for market. If a company is not first to market, this could dilute the company’s market shares leading to decreased potential revenue.
The supply chain issues that we have seen since the start of the pandemic, such as longer lead times for raw materials and equipment, have a significant impact in the overall speed to market.
Another contributing factor affecting speed to market is the speed of testing and release of drugs. Whether companies are performing testing in-house or outsourcing to a contract lab, the timeline for testing biosimilar products has condensed due to the competitive nature of the market. Faster turnaround timelines for testing are critical for meeting tight development timelines.
All of these factors can influence a company to focus on being the first to market an affordable product that delivers as indicated.
Can you highlight any noteworthy recent developments or breakthroughs in biopharmaceutical research, manufacturing, or regulation that have the potential to significantly impact the industry?
The most influential development in the market is the use of artificial intelligence (AI). AI can scan multiple potential targets at once, resulting in a reduction in research and development, decreasing timeline and cost to expedite the drug’s speed to market.
Looking ahead, what do you foresee as the most promising opportunities for growth and innovation in the biopharmaceutical and biosimilar space over the next few years?
Personalized medicine is targeted area of growth and innovation for biopharmaceuticals. As we learn more about specific genes affecting a disease, targeted gene therapy is an area of growth within the industry. CRISPR and siRNA gene therapy may have advantages to increase novel new drug development in the industry within the decade.
For the biosimilar market in particular, the opportunity to identify new uses for existing drugs could benefit the market and help to soften the competitive landscape by introducing multiple uses. An example of this is Semaglutide, a diabetes medication, that is now also prescribed for weight loss. As new usages are found, this will only increase market share for biological drugs.
Publication Detail
This article appeared in American Pharmaceutical Review:
Vol. 26, No. 8
Nov/Dec 2023
Pages: 84
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