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The largest biologic players are not just large within the biologic drug space, but the scale of their biologic drug success has made them global pharmaceutical leaders. Examples are Roche, Sanofi, and Amgen. These players face pressure to remain key leaders in their therapeutic areas of focus:

 Revenue erosion. The greatest challenge is the threat of biosimilars eroding revenues. Follow‐on biologics such as PEGylated filgrastim and modern insulins have been successful in capturing and protecting franchise revenue in the past. However, recent follow‐on launches such as those in the insulin space have not performed as well as expected or predicted, leaving many large biologics vulnerable to biosimilar erosion. The current payer environment is not as open to innovation on the franchise model. Follow‐on innovation remains important for improving patient outcomes, but to achieve wider adoption, they must also be designed with the payer's perspective. Roche's subcutaneous formulation of Herceptin® in European markets is an example of when follow‐on can succeed. The new formulation reduces treatment time from 30–90 minutes to 5 minutes, saving time for the patient and bed/staff resources for the clinic. It has taken 28% of human epidermal growth factor receptor 2 (HER2) franchise sales and their share is growing. HER2‐positive breast cancers tend to be more aggressive than other types of breast cancer. They are less likely to be sensitive to hormone therapy, though many people with HER2‐positive breast cancer can still benefit from hormone therapy. Along with the other HER2 follow‐on Roche products, only 43% of the franchise in Europe is currently vulnerable to biosimilar competition.

 Greater competition. Biologic drug classes such as growth factors, insulins, and anti‐TNFs have several comparable products available and are therefore highly competitive areas. It took many years for these competitive environments to develop and for many indications particularly within oncology, the market remains relatively uncompetitive. However, this lack of competition is not an intrinsic property of the biologic market; it is a consequence of their relative novelty. A larger pipeline of biologics has meant that many players are developing treatments for the same indication, sometimes with the same mechanism of action. Previously validated disease/treatment pathways also reduce clinical trial risk, facilitating “fast follower” strategies. The result is that the window of opportunity for a first‐to‐market biologic will be shorter, with less market differentiation. The more competitive future biologic market will impact the return on investment for manufacturers. This can already be seen in many of the recent biologic launches such as immuno‐oncologic, respiratory biologics, and PCSK‐9 inhibitors.

 Maintaining leadership. In times of high innovation output, established players are frequently challenged by new competitors entering their field. These companies can often be more dynamic and agile, making and acting on decisions quickly. Bristol‐Myers Squibb (BMS) is an example of a company that broke into a leadership position through partnering early and investing heavily. BMS moved up from rank 11 in oncology to rank 3 between 2011 and 2016 (DRG, Company & Drugs, April 2016), establishing itself as a long‐term leader in immuno‐oncology and a partner of choice for biotechs. Similarly, Alexion was founded as a small biotech in 1992, but has now become a top 30 biologic player, thanks to its focus on rare diseases. Large established players need to stay on the cutting edge of biologics R&D or risk losing leadership within their space. Business development will remain an important source of this innovation, but the challenge will be to keep it cost‐effective given the greater future competition in the market.¹⁰