The pharmaceutical innovation that is expected to be integrated into the healthcare system in the coming years is beginning to outline a landscape where oncology plays a leading role, accompanied by the growth of advanced therapies and new treatments aimed at diseases that still have significant medical needs.
The first Horizon Scanning report developed by Farmaindustria analyzes 172 active ingredients at various stages of the European regulatory process. The objective is to anticipate which medications may arrive in the coming years and to enable the National Health System to prepare timely resources, infrastructure, diagnostics, and organizational changes that may be required.
This does not mean, therefore, that 172 medications will immediately arrive at pharmacies and hospitals. The analysis includes products at different stages of their regulatory journey, from those evaluated by the European Medicines Agency (EMA) to others that have already received a positive opinion from its Committee for Medicinal Products for Human Use.
It also includes treatments covered under the EMA’s Prime program, created to promote promising medicines specifically aimed at unmet medical needs.
Oncology Concentrates Much of the Innovation
Among the 47 active ingredients currently undergoing evaluation by the EMA, approximately one in four belongs to the area of oncology.
The share of cancer treatments increases among the products that have progressed further in the regulatory process. Of the 28 active ingredients that have already received a positive opinion from the Committee for Medicinal Products for Human Use, 36% corresponds to oncology treatments.
The trend continues among the drugs included in the Prime program, where oncology again appears as the therapeutic area with the greatest presence.
These data reflect the intensity of research that has been conducted in recent years around cancer and the gradual emergence of more specific and personalized treatments.
Pharmaceutical innovation is evolving from more general approaches toward therapies capable of acting on specific molecular or biological characteristics of the disease, a process that is modifying the development of medications, diagnostics, and the organization of healthcare services.
More Medications for Rare Diseases
Another notable element of the report is the significance of orphan drugs, intended for the diagnosis, prevention, or treatment of rare diseases.
Among the 47 active ingredients currently under evaluation by the EMA, 38% fall into this category.
The percentage rises to 54% among the 28 medicines that have already received a positive opinion from the Committee for Medicinal Products for Human Use.
The high presence of these treatments shows how a significant part of pharmaceutical research is directed toward diseases that traditionally have had few therapeutic alternatives.
The development of new diagnostic tools, as well as genetic and molecular understanding of certain conditions and biotechnological advances, is enabling the tackling of diseases for which it was much more difficult to develop specific treatments just a few years ago.
The Advancement of Advanced Therapies
The report also highlights the growth of what are termed advanced therapies.
Of the 47 active ingredients currently evaluated by the EMA, 28% are biological medicines, and 6% are advanced therapies.
Among the products that have already received positive opinions from the scientific committee of the European agency, advanced therapies represent 18%.
This percentage is even higher among the 92 active ingredients included in the Prime program: 47% belong to this category.
This last data point is particularly significant because Prime is geared toward medications that show promising initial results and may offer a significant therapeutic advantage or address unmet medical needs.
Alongside oncology, areas such as endocrinology, gynecology, fertility, and metabolism appear among those with the most activity within this program. Ophthalmology also holds a notable position.
Preparing for Upcoming Medications
The arrival of new treatments poses not just a scientific challenge. It also requires health systems to prepare for their utilization.
Some therapies necessitate new diagnostic tests to identify which patients may benefit from them. Others require specific facilities, specialized professionals, or modifications to care pathways.
Moreover, there is a need to anticipate their budgetary impact.
To precisely anticipate these needs, Farmaindustria has made its Horizon Scanning tool available to the National Health System, an early identification system for pharmaceutical innovations that will have biannual updates.
The model is not new. Various European countries have been using similar mechanisms for years to know in advance which medicines are advancing toward the final stages of development and authorization.
The purpose is not to determine which treatments should be funded or to replace the processes of evaluation, authorization, pricing, or funding. Its function is to provide advance information so that health administrations can prepare before the medications reach clinical practice.
A Transformation Affecting the Entire Healthcare System
The evolution of pharmaceutical research is making innovation increasingly specialized.
The development of personalized therapies, biological drugs, and advanced treatments can offer new alternatives for complex diseases, but it also introduces different demands compared to conventional medications.
The challenge for health systems will be to incorporate this innovation while maintaining clinical evaluation criteria, economic sustainability, and patient access.
The 172 active ingredients identified do not guarantee that all of them will ultimately reach the Spanish market. Their regulatory status, level of development, and timeline vary.
However, monitoring them allows for an anticipation of where a significant part of biomedical innovation is headed: more specialized treatments, greater emphasis on advanced therapies, and intense research activity in oncology and rare diseases.
