Meeting the Need: How Innovative Research & Development Models are Driving Global Contraceptive Access

A Stagnating Industry

One of the core realities of contraceptive research & development (R&D) is that many promising products never make it to market. Some stall in early development and others face barriers during clinical trials, regulatory review, or introduction. Developing a new or improved contraceptive is a risky, expensive, and time-consuming process, complicated by:

• Scientific and biological challenges: Human reproduction is complex and controlling a drug’s systemic impact while maintaining high efficacy is difficult, particularly for male contraceptive methods.

• Lack of strong financial incentives: Contraceptives typically have lower profit margins than treatments for chronic disease or life-threatening illness.

• Regulatory hurdles: Since contraception is mainly used by healthy people, there is a very high bar for safety, resulting in expensive clinical trials.

• Social and cultural factors: Persistent stigma and cultural assumptions around contraception negatively impact product uptake.

Given these factors, why does any established company take the risk to develop a contraceptive product? The reality is that most don’t.

Beginning in the early 2000s, many pharmaceutical companies began winding down their contraceptive R&D portfolios, shifting focus towards products with greater potential for financial returns. While some have continued to expand existing contraceptive lines, industry investment in novel product development is minimal.

A Novel Model for Contraceptive Innovation

To address this gap, innovation has increasingly been led by non-profits, academic centers, and small biotech companies who take on early high-risk stages of drug discovery, prototyping, pre-clinical development, and early-stage clinical evaluation. Only once a product is “derisked” do larger pharmaceutical companies consider acquiring it for late-stage development and commercialization.

Academic, non-profit, and mission-oriented private organizations can focus on the opportunity to more completely meet the needs of contraceptive users across life-stages and ensure equitable access to effective options. The Contraceptive Technology Innovation Tracker, a database of information on contraceptive leads and products in development, reports that of the 122 active development platforms, 41 are led by university research teams, 42 by non-profit organizations and research institutes, and 29 by startups. Indeed, essentially all modern contraceptives available today originated outside of traditional pharmaceutical companies.

Collaborations for Access

One such method is the levonorgestrel-releasing intrauterine system, or "hormonal IUD”. In the 1970s, researchers at the Population Council, with support from USAID, undertook the development of a more effective, safer IUD containing the hormone levonorgestrel – 99% effective, long-acting, and reversible, with rapid return to fertility. First marketed in 1990, this revolutionary product was acquired by Bayer AG, who has worked in partnership with the International Contraceptive Access (ICA) Foundation to make the hormonal IUD more accessible around the globe, reflecting the original goals of the product’s developers.

In 2009, the nonprofit women’s health innovation organization Medicines360 was founded to bring a more affordable hormonal IUD to market. Because there was no pathway to approval of a generic, Medicines360 conducted the US’ largest and most diverse pivotal clinical study ever on a hormonal IUD. They designed the study to address common misconceptions, such as who could safely use the product, and generated data to support same-day insertion, reducing the burden of additional clinic visits for women. The trial ultimately supported the extended duration of use for the hormonal IUD to up to 8 years. Through their global program, Medicines360 is working to expand access to the product to women across Africa, South and Southeast Asia, Central America and the Caribbean.

Since 2015, the introduction of the hormonal IUD in LMICs has been driven by the Hormonal IUD Access Group – an alliance of suppliers (ICA Foundation, Bayer AG, and Medicines360), donors, procurers and NGOs. Collaborations like this are essential, not only to develop new contraceptive methods, but to ensure those innovations are accessible to the women and communities they are designed to serve.

A Call to Action

As we look to 2025 and beyond, the responsibility for contraceptive innovation continues to rest with universities, startups, and non-profits like FHI 360, Population Council, and Medicines360. These mission-driven players take on high-risk stages of product development and introduction, pursuing regulatory innovation, forging cross-sectoral partnerships, and centering the preferences and lived experiences of women. Their work prioritizes public health over profit, especially in lower-resources settings where traditional pharma sees limited commercial opportunity.

These organizations have historically benefited from philanthropic and government funding – however, global funding for contraceptive R&D decreased by almost 1/3 between 2019 and 2023, to $103 million, and more recent US government funding cuts accelerate this decline. Continued support for these organizations – financial, regulatory, and political -- means that contraceptive innovation reaches clinics, communities, and women and girls who are too often without real choices. Because the measure of progress isn’t what gets developed, but who it reaches.