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The Rising Demand for Cell & Gene Therapies and the Growth of the High-potency Active Pharmaceutical Ingredients (HPAPI) and Antibody-drug Conjugates (ADC) Markets to Offer Opportunities for the Growth of the Pharmaceutical CDMO Industry

   March 31, 2022

Next-generation medicines, such as cell and gene therapies, are creating significant growth opportunities for innovators in the CRO and CDMO markets. Gene therapy alters the genes to cure diseases or improve the body’s ability to fight diseases. Cell therapy involves injecting, grafting, or implanting viable cells into a patient to effectuate a medicinal effect. Potential applications of cell therapies include treating cancers, autoimmune diseases, urinary problems, and infectious diseases, rebuilding damaged cartilage in joints, repairing spinal cord injuries, improving a weakened immune system, and treating neurological disorders.

As of February 2020, there were nine approved cell/gene therapy products in the U.S. for cancer, eye diseases, and rare hereditary diseases. The number of treatments in clinical trials increased by 25% (from 289 to 362) from 2019 to 2020. Also, many therapies in preclinical stages are expected to enter the clinical trials pipeline. Gene therapies under development are designed to address defects in the genetic code that cause a wide range of diseases. It is estimated that 3 out of 10 people in the U.S. have one of the 6,000 identified rare diseases. Currently, the top three areas of focus for gene therapies are retinal diseases, liposomal storage disorders, and hematological disorders. Most gene therapies are delivered via viral vectors, including the adenovirus, the adeno-associated virus (AAV), the lentivirus, and the herpes simplex virus, with AAV accounting for 70% of all delivery vectors.

Many CDMOs are undertaking initiatives to enhance cell and gene therapies to meet the rising demand. In addition, smaller companies are also focused on advancing the manufacture of cell and gene therapies. For instance, in November 2021, Elicera Therapeutics AB (Sweden) signed an agreement with BioNTech SE (Germany) for the contract manufacturing of viral vectors for Elicera’s CAR T-cell therapy ELC-401. Similarly, in February 2021, Catalent Inc. (U.S.) signed an agreement with Trizell GmbH (Germany) to support the manufacture of Trizell’s Phase 1 cell therapy for the treatment of macro and microangiopathies.

In addition to this, the manufacture of High-potency Active Pharmaceutical Ingredients (HPAPIs) and Antibody-drug Conjugates (ADCs) offers significant opportunities for the growth of the CDMO market as HPAPIs require manufacturing under high-containment conditions. Further, specialized operator training based on occupational exposure limits is vital due to the high levels of containment required for HPAPIs manufacturing. In recent years, the oncology drugs market has grown significantly due to the increase in cancer cases and technological advances in the development of safe and effective medicines. Advancements allow compounds to be more selective towards the target of interest, thereby reducing dosing frequencies. This growing need for potent, targeted therapies has increased interest in highly potent new chemical entities (NCEs). HPAPIs are designed to achieve pharmacological activity with very small quantities of the active ingredient, reduced side effects, and minimal damage to the tissues surrounding the diseased area. Thus, the growth of the oncology drugs market has boosted investments in high-potency manufacturing.

The growing demand for HPAPIs has boosted market investments from numerous CDMOs. Additionally, Antibody-drug Conjugates (ADCs) are another segment of targeted therapies with a considerable increase in investments. Some of the key developments in this space are:

  • In February 2022, Piramal Enterprises Ltd. (India) invested $74.56 million in expanding its Antibody-drug Conjugate (ADC) manufacturing capabilities by constructing a new facility in Grangemouth, Scotland (U.K.). The facility will be operational by the third quarter of 2023.
  • In May 2021, Novasep (France) expanded its High-potency Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities at its Le Mans, France site. This expansion was aimed at delivering cGMP ADC batches to customers.

With the rising demand for HPAPI and ADC molecules, the need for additional manufacturing capacities is also increasing. Contract manufacturers with demonstrated success in the development and production of potent Active Pharmaceutical Ingredients (APIs) are therefore helping meet the demand for potent compounds. Thus, according to Meticulous Research®, the Pharmaceutical Contract Development & Manufacturing Market is expected to grow at a CAGR of 7.5% to reach $226.35 billion by 2029.

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