Biological API Drug Manufacturing Market Outlook, Competitive Analysis and Forecast 2024-2031

Global Biological API Drug Manufacturing Market is segmented By Manufacturing Type (In-House manufacturing, API Contract Manufacturing), By Expression Platforms (Mammalian cell culture, Microbial fermentation, Other expression platforms), By Application (Monoclonal antibody (mAb) therapies, Vaccines, Insulin therapies, Interferon therapies, Growth hormones), and by Region (North America, South America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Report Overview

The Biological API Drug Manufacturing Market is expected to grow at a CAGR of 6.2% during the forecast period (2024-2031). 

The biological API involved in the fermentation of microorganisms and cultured in a substrate to produce a substance that is used for treating disease eg: antibiotics, steroids, and vaccines, and other biological molecules used for the production of vaccines and genetically modified vaccines.

Biological API Drug Manufacturing Market Summary

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Biological API Drug Manufacturing Market Drivers

• The surge in demand for biotechnology products and ongoing research by biopharmaceutical companies on therapeutic diseases majorly cancer, followed by autoimmune and cardiovascular diseases are driving the global biological API drug manufacturing.

• The rise in disease population in therapeutic categories will boost the innovation in novel biologic substances is additionally amplifying the growth of the market.

• As of 2018, 12 pharmaceutical and life science companies and 13 nonprofit organizations along with USFDA and NIH joined the AMP program. This program focuses on developing a novel treatments for Alzheimer disease, type2 diabetes, autoimmune disorders, etc.

Biological API Drug Manufacturing Market Segmentation Analysis

• Global biological API drug manufacturing market is segmented by manufacturing type, expression platform, application, and region. Manufacturing type includes In-House manufacturing and API Contract manufacturing, expression platform includes mammalian cell culture, microbial fermentation, and other expression platforms. By application includes monoclonal antibody (mAb) therapies, vaccines, insulin therapies, interferon therapies, and growth hormones.

• API contract manufacturing dominates the global biological API drug manufacturing market during the forecast period due to its extensive usage of CMO’s by small and medium companies due to lack of complex manufacturing capabilities, capital-intensive nature of the business, and high profitability associated with contracting with CMO for both clinical and commercial stage manufacturing.

• According to European Pharmaceutical review in October 2018, currently 2/3rd of manufacturing – whether in the development stage or after commercial launch is outsourced.

Biological API Drug Manufacturing Market Geographical Share

• The global biological API drug manufacturing market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa.

• North America dominates the global biological API drug manufacturing market during the forecast period due to the high presence of key manufacturing service providers (CMO) in the region, shift from chemical synthesis to biological API, government approvals for production of novel drugs, and high investments by the pharmaceuticals companies in R&D of Drugs.

Biological API Drug Manufacturing Market Competition Landscape

• New Product launches and mergers between key players for the development of novel technologies using Biological API are driving the global Biological API Drug Manufacturing Market.

• In September 2017, Lonza Launched XS™ Pichia 2.0 Expression and Manufacturing Platform for Development of Next-Generation Therapeutics.

• In November 2018, Boehringer Ingelheim and Epizyme, Inc. merged for R&D and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer.

• Major market players in the Biological API Drug Manufacturing Market are Lonza, Boehringer Ingelheim BioXcellence, Celltrion, DSM Biologics, Samsung BioLogics, Fujifilm Diosynth Biotechnologies, and Others.

Target Audience

• Equipment Suppliers/ Buyers

• Service Providers/ Buyers

• Industry Investors/Investment Bankers

• Education & Research Institutes

• Research Professionals

• Emerging Companies

• Manufacturer