In 2020, the global biopharmaceuticals market was valued at about 291 billion dollars. By 2030, it was expected to increase to nearly one trillion dollars. Why are biopharmaceuticals in high demand, and how does biopharma compare to the traditional pharmaceutical industry? Keep reading to get a closer look at biopharmaceutical vs pharmaceutical and what it means for the life sciences space.
What is biopharma?
Biopharmaceuticals are a type of drug that is manufactured from biological sources, as opposed to being chemically synthesized. They can be used to treat various diseases, from cancer to multiple sclerosis, and some biologics are even used as life-saving treatments.
While the focus here is mainly on innovation, that isn’t the only reason people leverage this drug type. Biopharma can also be used to create treatments that are similar to pharmaceutical drugs. This makes more choices available to those across the globe.
Biopharma and biosimilarity regulations
Just like traditional pharmaceuticals, treatments developed in the biopharma space need FDA approval to be sold. There are also parameters in place for biopharma treatments that behave similarly to one another.
Biopharmaceuticals that mirror other treatments are sometimes referred to as “biosimilars” or sometimes “biogenerics.” This term refers to identical copies of existing drugs that have been developed through recombinant DNA technology.
The FDA has strict guidelines in place regarding biosimilarity testing and approval. Suppose one biologic is deemed “highly similar” to another one already on the market or in the late stages of clinical trials. In that case, a company may apply to have its product approved under an abbreviated pathway known as biosimilar interchangeability designation.
Achieving interchangeability designation also means that the biopharmaceutical may act as a substitute without the intervention of the healthcare professional who prescribed the initial reference product. This is similar to when we see generic drugs given to patients in place of a brand name option.
How does biopharma work?
In biopharma, biotechnology and pharmaceutical manufacturing come together to create solutions to prevent, relieve or treat specific diseases. Some examples include, but aren’t limited to:
- Hormones, like insulin
- Gene therapy
Biopharmaceuticals are not a new concept. They have been used in medicine for decades. But biopharmaceuticals aren’t drugs in the traditional sense—they can be extracted from animals or plants. This makes both the product development process for them and the regulations different.
Biopharmaceutical vs pharmaceutical: What’s the difference?
Biopharmaceuticals are a type of drug made from a living organism’s cells. They can be produced by genetically engineering bacteria, fungi, and plants to produce human proteins or by inserting and expressing animal genes (such as an antivenom).
These may have the same active ingredients as traditional pharmaceuticals, but they’re less common and more challenging to produce because they require specialized equipment, longer production timeframes, and higher costs.
In contrast, since chemicals are used in pharmaceuticals, they’re often easier to work with than organic materials. Therefore, they tend to have a shorter production window and are cheaper to produce. Still, there are drawbacks to pharmaceuticals. One big drawback is the potential for more side effects, as pharmaceutical drugs typically can treat multiple conditions instead of one specific condition.
The goal of pharma and biopharma is often the same: Treat a disease or condition that a patient is struggling with. The difference comes down to the ingredients and the drug development process used to create that outcome.
Bridging the gap between biopharma and traditional pharma
With the increasing use of biologics, there has been an increasing blurring of the lines between biotech and pharma. Many traditional big pharma companies now develop biologics, in addition to small biotechs collaborating with big pharma for drug discovery and development.
Recently, researchers from the Deloitte Center for Health Solutions interviewed thought leaders to discover how they expected disease identification, prevention, and treatment to evolve between now and 2040. They found that the future will require us to continue reimagining the traditional pharma business model.
These experts predict that there will likely be fewer people with chronic diseases and less need for future therapies that treat those conditions. Both biopharmaceutical companies and traditional pharma companies will need to focus on prevention, early detection, and personalized therapies to continue to find success. Using the right technology and platforms will play a key role in supporting those efforts.
Bottom line: Blending Biopharma and traditional pharma
Biopharma is an exciting field for anyone who wants to be part of a growing industry or help people with their health problems through science. That said, there’s still work to be done to ensure that traditional pharma and biopharma work harmoniously to improve patient outcomes. And biopharma companies still need to overcome similar pharma commercial challenges to execute a successful drug launch strategy and conduct successful pharma marketing efforts.