Over the past 25 years, groundbreaking advancements in medicine — driven by America’s biopharmaceutical companies — have transformed patient care, from harnessing immune systems to fight cancer and delivering gene therapies for rare diseases to developing faster vaccine technologies and reducing the burden of chronic illnesses.
This progress stems from a robust U.S. biopharmaceutical ecosystem built on stable regulations, strong intellectual property protections and a thriving market-based system — foundational elements that must be preserved to maintain global leadership.
Key Advances in Patient Care
Biopharmaceutical innovations over the last quarter-century have transformed health care, enabling earlier interventions, halting disease progression and offering hope to patients with previously untreatable conditions.
I would like to tell the scientists thank you very much. And that's because, from my standpoint, what they've done and continue to do is stay focused on the patient. And I think that's something that all too often is missing in our health care system.”
Ken
Cancer Survivor
Highlights of Progress
Medicines: A Vital Tool for Healthier Lives
Over the past 25 years, biopharmaceutical innovation has proven its unmatched value — not just for patients but for the entire health care system and society. Medicines help prevent costly interventions like hospital stays, reduce caregiver expenses and minimize physician visits by addressing diseases more effectively.
Medicines also deliver exceptional value compared to traditional medical care. Research reveals medicines generated roughly three times the impact on life expectancy compared to other forms of medical care from 1990 to 2015. Spending on medical care was significantly higher than medicines during this same time period, underscoring the tremendous value of medicines when compared with costlier interventions like hospital stays.
As we look to the future, medicines, vaccines and public health programs will continue to play a crucial role in improving health outcomes and reducing the burden of disease in America.
Thanks to our nation’s incredible biopharmaceutical researchers who work tirelessly to develop treatment options for patients like me, I am able to have a second chance at life. I am blessed to say that now over 25 years later, I am still cancer-free.”
Terry
Cancer Survivor
Smart Policy: Driving U.S. Leadership in Biopharmaceutical Innovation
The U.S. leads the world in biopharmaceutical innovation, giving Americans faster access to groundbreaking medicines. The U.S. first approved over 68% of new drugs in 2024, and Americans benefit from 85% of these new medicines, compared to less than 40% in Europe. This leadership stems from smart policies fostering innovation, competition and affordability.
Key policies like the Hatch-Waxman Act, Orphan Drug Act and FDA User Fee programs encourage research, streamline approvals and expand patient access. These initiatives have resulted in a robust pipeline of medicines, lower-cost generics and biosimilars, with 90% of U.S. prescriptions now filled with generics — saving $445 billion in 2023 alone.
A strong intellectual property system balances innovation and affordability, fueling competition that drives down costs while improving patient outcomes. Critics often undervalue the savings and long-term benefits of medicines, but the evidence is clear: U.S. policies enable faster, more affordable access to life-changing therapies.
- The average time for three same-class products to go to market in the U.S. fell from approximately 15 years (1990–2003) to approximately two years (2013–2021).
- Today, the top drug classes are highly competitive. In 2024, 16 of the top 30 drug classes had more than three approved assets.
The Value of Generics, Biosimilars and Strong Patent Protections
The U.S. patent system drives innovation while paving the way for affordable generics and biosimilars once patents expire. These lower-cost alternatives offset spending on new medicines, keeping drug costs a stable part of health care expenses. Today, 90% of prescriptions in the U.S. are filled with generics — up from 75% in 2009 — with an average patient copay of $6.16, nearly 10 times less than branded medicines. In 2023 alone, generics and biosimilars saved the U.S. $445 billion.
Dispelling Myths About Medicine Costs
Despite claims that innovation drives unsustainable health care costs, the evidence shows that competitive market forces and strong intellectual property protections lower prices and deliver substantial long-term savings for patients and the system. Medicines are a critical tool, offering immense value for patients.
Our Work in Action
With the support of a unique ecosystem and policy environment that foster transformative advancements, this progress positions America as the global leader in biopharmaceutical innovation.
