Explosive Gene Therapy Pipeline Growth Leads to Demand for New Biologic Contract Manufacturing Services

Cell Therapy

Gene therapies represent a big future. Already, the gene therapy pipeline has been growing exponentially. The FDA will receive more than 200 investigative new drug applications for cell and gene therapies by 2020.   By 2025, it is predicted that 10 to 20 cell and gene therapy products will be approved annually. Gene therapies use the patient’s own body to manufacturer the active ingredient and the treatment specific to that patient. Many human lives will be positively transformed.  Consequently, this growth causes a corresponding boom in outsourced biologic-based manufacturing services.

There is no stopping the inevitable, there will be a huge wave of gene therapy related products on the market within years. To fulfill the imminent manufacturing demand, vendors are building and augmenting their contract services with investment and acquisition activity, reports PharmaTech.


We are convinced there would be even more deals if there were more expertise in viral vector production.

  • Outsourced service provider Catalent acquired Paragon Bioservices, Inc., a viral vector development and manufacturing company for gene therapies with expertise in adeno-associated virus vectors in May 2019.
  • Thermo Fisher Scientific Inc. acquired Brammer Bio for $1.7 billion, a leading viral vector contract development manufacturer, with 600 employees and locations in Massachusetts and Florida.  They have combined to form the Thermo Fisher Pharma Services business.

Challenges with Viral Vectors

Viruses, evolutionary in nature, enter mammalian cells and reproduce themselves and consequently, represent a crucial element in the gene therapy development formula.  Gene therapies harness this feature to transport the genetic material also known as “active ingredients” to target tissues or cells.  Engineered for human safety, viral vectors can target specific cells or tissues in the human body.

Few firms worldwide have the capacity, expertise or resources to manufacture viral vectors.  This represents a potential bottleneck for market-driven emerging growth.  Moreover, there are several types of viral vectors that can be utilized for gene therapy.  The most common, adeno-associated virus (AAV).

Service Expansion and New Entrants

Demand for bioproduction products and services outpaces the market’s ability to satisfy such urges. Consequently, existing vendors, such as Thermo Fisher Scientific, invest heavily in support services and products.

Ultimately, new entrants should be making their way into the vendor field to help fulfill growing demand and impose buyer-driven competitive energies and disciplines. But the challenging nature of gene therapy manufacturing ensures this will not happen overnight.