Since the publication of our first deep dive into the key features of bispecific antibodies in 2021 and a subsequent second issue where we looked at the effects of pharmacokinetics and drug exposure on safety and advocacy, with a focus on masking technologies and other novel bispecific approaches, significant growth has occurred in the bispecifics market. William Blair analysts believe growth in the number of approved biotherapies and the scale of clinical research and targeted disease areas being evaluated highlight significant opportunities for novel bispecific therapies, particularly their ability to create novel or localized biology that cannot be achieved with other modalities.
In this third issue of Getting Into (Bi)Specifics, our biotechnology equity research team looks at recent bispecific therapy trends and datasets, highlighting recent successes and setbacks in solid tumor indications and how different approaches can impact the efficacy of the therapy. Overall, we believe growth for bispecific therapies will continue to outpace many other modalities as more products reach commercialization and business development continues to expand, both in oncology and other disease settings.
The number of approved bispecifics continues to increase, with 15 therapies now approved by the Food and Drug Administration or European Medicines Agency and one more with positive pivotal data likely to receive approval in the near-term. As bispecific therapies continue to move to earlier lines of therapy in approved settings and have breakthroughs into new indications, our analysts see the market for this broad class of therapies growing significantly. Looking at the market opportunities, we believe the class is still in its infancy with potential for significant expansion into larger market opportunities in the coming years, both from advancement into earlier lines of treatment and the success of novel programs in ongoing pivotal trials. Currently, bispecific therapies generate quarterly sales of over $650 million and $2.5 billion in oncology and non- oncology indications, respectively.
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