Gene Therapy Trials
Market, Supplier, Risk and
Competitive Intelligence

Industry Outlook & Drivers

Gene Therapy Trials Global Market Outlook:

Market Growth:

The global gene therapy market was estimated at $1.40 billion in 2020, and it is expected to grow at a CAGR of 15–16 percent to reach $3 billion by 2025

Demand Drivers
• Increase in the number of active or recruiting trials is expected to increase the demand for gene therapy manufacturing services
• The limited treatment options available for rare diseases and the need for lifelong medications are further propelling the growth of the gene therapy market

Market Overview

The gene therapy market is growing and collaborations among biotech players have increased, due to increase in number of approvals for gene therapy clinical trials. These therapies are also being accepted largely by physicians as well as patients
• Oncology and monogenic diseases contribute majorly to the overall market share. Viral vector is more preferred over non-viral vectors in gene therapies, because of the various benefits, like high efficiency of gene transduction, specific gene targeting and delivery, safety
• Even though the market is growing, a few hiccups in the gene therapy market are safety and efficacy related, prolonged lab procedures for trial studies, lack of knowledge of product interaction with the host, and the most importantly, the high cost of gene therapy products
• The UK is establishing itself as a hub for cell and gene therapies and contributes to almost 12 percent of all the global clinical trials, its Y-o-Y no. of trials have also doubled. The studies conducted are majorly backed up by international companies, leading them to reach recru itment phase at a faster rate

Insights On Gene Therapy CRO Landscape

Service landscape for gene therapy in rare disease is a fragmented market, wherein the top CRO and niche CRO hold an average experience of conduction on 30
studies
• Supplier selection can be done on case-by-case basis with regards to gene therapy modalities and global trial landscape
• Sponsors prefer engagement with mid-sized CRO, with a niche therapeutic focus given their lean management structure and flexibility
• Long-term collaborations are currently forming the basis of gene therapy engagement

Case Study: A mid-sized pharma company wanted to launch a vaccine using adenovirus vectors. During supplier selection, they took into consideration the platform
expertise, in terms of the kind of partners they had for adenovirus vaccine delivery. Finally, two CROs (one from USA and other vendor from Europe) were selected
on a regional basis and engaged on a project-based model.