Towards Healthcare
GMP Drug Substance Market to Drive USD 4.64 Billion by 2034

GMP Drug Substance Market Innovations Driving Global Expansion

The global cell and gene therapy GMP drug substance market was USD 0.74 billion in 2024 and is projected to reach USD 1.64 billion by 2034 at a CAGR of 8.2%. Key segments include viral vectors, cell-based therapies, oligonucleotides, and biologics. North America leads, with Asia-Pacific growing fastest. The market features top players like AGC Biologics, Catalent, and Thermo Fisher, covering manufacturers, suppliers, trade, and value chain insights. Growth is driven by advanced therapies, rising clinical trials, and increasing R&D investments.

Content

  • Last Updated: 14 October 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

About The Author

Rohan Patil is a seasoned market research professional with over 5 years of focused experience in the healthcare sector, bringing deep domain expertise, strategic foresight, and analytical precision to every project he undertakes.

He began his journey with Precedence Research, where he played a pivotal role in developing high-impact healthcare market reports. Today, Rohan leads research initiatives at Towards Healthcare, while also contributing to Statifacts, where he supports cross-industry analysis and data-driven storytelling.

Rohan’s core strengths lie in trend analysis and emerging technologies, regulatory monitoring and thought leadership through high-quality report writing. He excels at identifying future-ready opportunities and translating complex data into strategic recommendations. His work spans pharmaceuticals, biotechnology, medical devices, and digital health, assessing everything from market potential and competitive positioning to customer needs and regulatory shifts.

A trusted advisor and a relentless innovator, Rohan continues to push the boundaries of traditional market research, merging scientific rigor with commercial insight to stay ahead in a fast-evolving healthcare landscape.

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FAQ's

The GMP drug substance market stands at USD 2.71 billion in 2025 and is expected to reach USD 4.64 billion by 2034, growing at a CAGR of 6.14% from 2024 to 2034.

North America is leading the GMP drug substance market share 42% due to the growing demand for personalized medicines, the prevalence of chronic and gynecological disorders, and government initiatives promoting health drive market growth.

Some key players include Lonza Group, Samsung Biologics, WuXi Biologics / WuXi AppTec, Catalent, Inc., Thermo Fisher Scientific / Patheon, and Fujifilm Diosynth Biotechnologies, among others.

Rising prevalence of diseases like diabetes, cardiovascular disorders, and cancer increases demand for high-quality APIs and biologics, driving GMP drug substance manufacturing and innovations in therapy development.

Personalized Medicine Coalition, clinicaltrials.gov, North American Menopause Society, WHO, JAMA, GOV.UK, European Medicines Agency, Drug Information Association (DIA), and Indian Drug Manufacturers Association (IDMA), among others.
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