The Generic, Biosimilar Medicine Industry Today and What it Can Become in The Next Decade

The International Generic and Biosimilar Medicines Association (IGBA) recently released a report which takes a look at the current global Generic and Biosimilar medicine industry, and released a vision of what the market will be in 2030.

The report, "A Vision for the Global Generic and Biosimilar Medicines Industry," covers the contribution of the pharmaceutical sector to global health outcomes and economies, the opportunities, challenges and disruptions for the industry, as well as its 2030 vision and the actions needed to achieve it.

Key Contributor for Global Health Outcomes
Over the last few decades, the Generics and Biosimilars industry has evolved to become a significant foundation of healthcare systems across the world. According to the IGBA report, Generics represent 60% to 80% of all medicine volume sales in key markets globally. The contributions of the industry were even prominent in times during the COVID-19 pandemic, for example, when it played a vital role in scaling up supply and access to medicines.

This scale combined with the industry’s ability to maintain cost-effective prices has enabled the industry to expand access to several therapies. For example, generic HIV therapies have helped increase treatment coverage three times greater since 2010 in Eastern and Southern Africa, and reduce the number of deaths by 44%, found in the report. Similarly, within a year of launch of generic antivirals for hepatitis C, the number of people who initiated treatment rose by 50%.

COVID-19 also led 18 generic drug manufacturers to become signatories of an open pledge to accelerate global access to effective COVID-19 treatments through a pool for voluntary product licences. Multiple generic manufacturers have formed licensing agreements to produce medicines such as Remdesivir and Molnupiravir to enhance access, including in low- and middle-income countries.

"The generic and biosimilar medicines industry has played and continues to play a crucial role in the ongoing Covid-19 public health crisis and in the overall healthcare ecosystems," commented IGBA Chair, Sudarshan Jain, in the report. "The IGBA 2030 vision reflects our efforts to ensure that this industry can continue to contribute deeply to enhancing reach and access to high quality and cost-effective therapies globally. They are needed more than ever."

A key source for healthcare savings and economic development
Generics and Biosimilars not only improve access to medicines but also create significant amount of cost savings for patients and health systems, internationally. For example, competition by the industry has helped bring down the treatment costs of several life-threatening diseases like Chronic Myeloid Leukemia and Hepatitis C.

Patients and the healthcare system in the U.S. saved approximately $313 billion U.S. dollars in 2019 through the use of generics and an additional $2.2 billion in 2019 through use of biosimilar medicines. Over the last decade, savings add up to $2.2 trillion and $4.5 billion through the use of generic and biosimilar medicines. Biosimilars represent a market of $8.4 billion euros and represent 8% of biologics market volume. The total clinical experience with European-approved biosimilar medicines now exceeds 2 billion patient treatment days in Europe, having doubled every 1.5 years, roughly, for the past 10 years.

Below are key opportunities that can enable the industry:

• Underlying socio-economic fundamentals.
• Continued trajectory in the innovation pipeline.
• Biosimilars opportunity finally coming to fruition.
• Digital as a key enabler to help industry deepen reach and further strengthen operations.
• Continuous innovation to sustain value creation opportunities.
• Blurring of boundaries with adjacent opportunities.

Below are disruptions for the industry:

• Sustained price pressures from regulators and customers.
• Regulatory hurdles slowing down access to Generics and Biosimilars.
• Vulnerability of global manufacturing and supply networks.
• New modalities and technologies in the innovation pipeline increasing risk-profile of investments.
• Emerging market continuing to pose challenges for building presence.
• Gradual shift in commercial models and channel dynamics.

Given the opposing forces, collaboration from the industry and supporting stakeholders will be critical to help the industry to maintain its contributions to the healthcare system and economies, the report said.

2030 Vision for the Generic and Biosimilar Medicines Industry
According to IGBA, there is a four-pillar vision that can mold the industry by the next decade. The first pillar would be to expand patient access to high-quality and affordable medicines across traditional and emerging modalities. Next would be to step up to become a confident, well-respected strategic partner to institutions, globally. Then broadening the role to help form end-to-end healthcare ecosystems along the entire continuum of care can shape the industry. Lastly, the final pillar would be to enable sustained economic contributions for economies, healthcare systems and all stakeholders.

In order to for the industry to achieve this vision by 2030, IGBA recommends focusing on these imperatives:

• Secure impeccable quality and agility in supply chain while strengthening cost position even further.
• Balance portfolio choices across technology/ complexity with high focus on driving R&D efficiency and capability.
• Reimagine commercial models to be ready for disruption.
• Embed digital and analytics as core capability along entire value chain.
• Scale step-outs beyond the core with purposeful reallocation of resources.
• Drive systematic M&A and partnerships to support aspirations.
• Embed agility and new capabilities, while welcoming post-pandemic working models.

“To help the industry achieve its 2030 vision, we need efficient, supportive and consistent regulatory frameworks, equitable patent and litigation systems fostering innovation while enabling access, open international borders and secure trade flows as well as encouragement for investment in new technology and innovation”, said IGBA Secretary General Suzette Kox.