Rare Disease Product Launch Services

Rare Disease Commercialization

Finding the right path for rare and orphan disease therapies


Rare Disease Launch

The market for individual rare and orphan disease therapeutics may be small, but the overall market for rare disease drugs is substantial and competitive. There are over 400 million people worldwide in need of highly-specialized rare or orphan drug treatments, including some 30 million (approximately 1 in 10) living in the U.S.. With 7,000 different rare diseases, each affecting fewer than 200,000 people, only 500 have approved treatments. However, the percentage of drugs approved to treat rare or orphan diseases has been rising considerably in the last decade, with more than half (54%) of the FDA’s novel drug approvals in 2022 going to help patients with rare diseases.

That said, launching a rare disease therapy requires overcoming unique challenges in the form of competitive and pricing pressures, stakeholder and regulatory demands, and patient needs and expectations. Because Two Labs has worked on over 200 unique drugs that have the orphan designation assigned to them by the FDA, our experience gives us the ability to provide the biopharma industry with a detailed understanding of what it takes to successfully launch orphan drugs. Unique challenges require non-traditional strategies, and Two Labs is ready to help your company prepare a holistic launch strategy that capitalizes on data and interacts proactively with physicians, patients, advocacy groups, and other stakeholders.

Featured Services

Product Launch

Having supported over 213 orphan drugs, our team has the experience and expertise needed to develop customized, outcome-driven strategies that bring your rare disease therapy to market, and to the patients that need it.


We have helped launch over 280 biopharma products, so we know how to support your team and optimize your compliance strategy in order to differentiate your product to physicians, payers, patients, and other stakeholders.

Medical Affairs & Communications

Two Labs’ Medical Affairs & Communications provides vital support in finding the correct audience for your product’s scientific data and strategic goals and tailoring a medical communications plan to your needs.

Specialty Channel Strategy and Implementation

With specialty products like orphan disease drugs, we guide you through the entire commercialization process, including pharmacy network selection, therapy management program design, specialty data recommendations, analytics strategy, and more.

Patient Services and Implementation

We provide a comprehensive scope of patient support services to help you find the right patients for your therapy, design and implement a best-in-class patient program, and execute a post-launch assessment to ensure customer satisfaction and program optimization.

What can we help you with today?

No matter where you are in the process, we’re here to support, advise, and implement key strategies to ensure the success of your product.

What can we help you with today?

No matter where you are in the process, we’re here to support, advise, and implement key strategies to ensure the success of your product.

Public Policy Strategy Helps Realize Clear Access Path for Patients

We’ve entered a new era in the U.S. healthcare system with the passage of the Inflation Reduction Act’s (IRA) landmark policy changes. And whether you are an emerging manufacturer bringing your first drug to market or more seasoned about the whole launch process, it’s important to make sure that your strategy includes a focused public policy element.

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Orphan Rare Disease Drug Launch Strategy

Two Labs has a dedicated orphan drug consulting team of analysts and consultants who work with the complex issues that are specific to orphan drug development. We provide our clients with both scientific and business acumen required for accurate analysis of competing MOAs and corporate strategies of companies engaged in drug development in the field of orphan diseases.

3PL Case Study

Rare Disease Insights

Ready to dig a little deeper into Two Labs’ Rare Disease services? Learn more here about our solutions and expertise.

We’re here to support your success from clinical to commercial – and beyond.

How can we help you today?