Why Genchrome?
At Genchrome, we’re acutely aware of the challenges faced when developing innovative biotech medicines. It requires not only scientific expertise, but also business acumen. Genchrome with its ecosystem of pharma experts offers a broad range of services designed to support our biotech clients, from pre-clinical development to product launch.
Biotech Faces Challenges
Given the biotech industry challenges, achieving a successful drug launch requires business input from the earliest stages of development to ensure it aligns with the commercial strategy.
Nearly 50% of biotech launches underperformed
Having breakthrough innovation doesn’t always translate to a successful launch
New Biotech launching themselves generally achieve lower sales than when partnering with pharma
Market Access and Commercialization
Bringing a biotech product to market involves not only scientific and regulatory hurdles but also commercial challenges. Biotech companies must identify target markets, develop effective marketing strategies, and navigate pricing and reimbursement considerations. Competition from established pharmaceutical companies and the need to differentiate their products further add to the complexity of commercialization.
Capital Intensity and Funding Challenges
Biotech research and development (R&D) typically require substantial investments in scientific equipment, laboratory facilities, and skilled personnel. Biotech companies often rely on external funding, such as venture capital or partnerships with larger pharmaceutical companies, to support their R&D activities. However, securing adequate funding can be challenging, particularly for early-stage companies or those with unproven technologies.
AI New Challenges for Biotech
Integrating AI into biotech processes presents a range of challenges. Biotech companies struggle with the complexity of the data generated through their research, encompassing diverse types such as genomics and clinical data. Developing AI models capable of effectively analyzing and extracting meaningful insights from this data is a significant hurdle. Furthermore, navigating regulatory compliance and ethical considerations is crucial when implementing AI in areas like drug discovery, clinical trials, and patient data analysis. Establishing transparent and reliable AI systems that provide explanations is essential to gain acceptance and trust in the biotech industry.
Inflation Reduction Act (IRA) Challenges
The IRA introduces radical changes in the way pharmaceutical drugs are priced, which could influence not only pricing strategies and market access choices; but also merger and acquisition decisions.
The IRA implementation in areas such as drug pricing and Medicare coverage requires careful monitoring of regulatory compliance. The changes may also influence the financial landscape with a 5% potential increase in interest rates affecting the cost of capital, a key consideration for early-stage biotech companies.
In this evolving landscape, biotech companies need to be ready to pivot and identify new opportunities, while preparing to meet the challenges posed by the IRA in terms of new drug development and market entry.
EU New Pharma Legislations
Understanding the new EU Pharma Legislation proposal by the European Commission is crucial due to its significant impact on drug development.
The key change for pharma/biotech companies is the reduction of regulatory data protection from 8 to 6 years. However, under certain defined circumstances, there are opportunities to extend marketing protection up to 12 years. It’s critical to prepare for this new legislation to ensure plans are in place to minimize risks and maximize future launches.
The EU Joint Health Technology Assessment (HTA) aims to reduce the time to access medicines. Companies need to be fully prepared as early as 2025, starting with oncology and Advanced Therapy Medicinal Products (ATMPs), followed by orphan drugs and other areas in a stepwise approach. The anticipation and preparation for this dossier need to start now!
Pioneers/First in Class
Don’t Always Win
Analysis performance for pharma first launches in the U.S. from 2019 through 2021. Comparison of actual launch-year sales to pre-launch forecasts and then placed each drug into one of three categories: met expectations (achieved between 80% and 120% of analyst expectations), overperformed (surpassed 120% of analyst expectations) and underperformed (achieved less than 80% of analyst expectations).