North America Biopharmaceuticals Contract Manufacturing Market- Growth, Share, Opportunities & Competitive Analysis, 2024 – 2032

Market Overview:

The North America Biopharmaceuticals Contract Manufacturing Market is projected to grow from USD 5,483.81 million in 2023 to USD 19,927.57 million by 2032, at a compound annual growth rate (CAGR) of 15.42%.

The market is driven by several factors, including the increasing demand for cost-effective production solutions, rapid advancements in biopharmaceutical technologies, and the growing adoption of biologics and biosimilars. The rising pressure on pharmaceutical companies to streamline operations, reduce manufacturing costs, and accelerate time-to-market for innovative drugs has significantly contributed to the surge in outsourcing to contract manufacturers. Additionally, the growing prevalence of chronic diseases and the rise in investment for personalized medicine are further driving market growth. Key trends in the market include the integration of automation, artificial intelligence (AI), and digitalization into manufacturing processes, which enhances efficiency and compliance. There is also a growing focus on sustainable and environmentally-friendly production practices, with companies striving to reduce their carbon footprint.

Market Drivers:

Growing Demand for Biologics and Biosimilars:

The demand for biologics and biosimilars is one of the primary drivers of the North American biopharmaceuticals contract manufacturing market. Biologics, which offer targeted treatments for chronic and complex diseases, are becoming more dominant in the healthcare landscape. Alongside this, biosimilars, which provide a cost-effective alternative to expensive biologics, are seeing significant adoption. For instance, the U.S. has seen a surge in biosimilar approvals, with 33 biosimilars approved across 13 molecules as of 2024. Contract manufacturers in North America are well-equipped to handle the complexities of biologics production, including specialized techniques for fermentation, cell culture, and purification processes, thereby driving the growth of the market.

Market Challenges:

Regulatory Complexity and Compliance Risks:

One of the significant challenges faced by the North American biopharmaceuticals contract manufacturing market is navigating the complex and ever-evolving regulatory environment. Biopharmaceutical manufacturing is subject to stringent regulatory standards, including Good Manufacturing Practices (GMP), quality control, and product safety. Contract manufacturers must ensure their processes comply with local, national, and international regulations, which can be time-consuming and resource-intensive. For example, the FDA’s Title 21 of the Code of Federal Regulations outlines comprehensive requirements for GMP that manufacturers must adhere to. Moreover, regulatory agencies like the FDA frequently update guidelines, making it challenging for manufacturers to stay compliant. Any failure to meet these standards can lead to costly penalties, delays, and loss of business, posing a significant risk to contract manufacturing firms.

Segmentation:

By Source:

Mammalian

Non-mammalian

By Service:

Process Development

Downstream

Upstream

Fill & Finish Operations

Analytical & QC Studies

Packaging & Labelling

Others

By Drug Type:

Biologics:

Monoclonal Antibodies (mAbs)

Recombinant Proteins

Vaccines

Antisense, RNAi, & Molecular Therapy

Others

Biosimilars

By Type:

Drug Substance

Finished Drug Product

By Scale of Operation:

Clinical

Commercial

By Therapeutic Area:

Oncology

Autoimmune Diseases

Cardiovascular Diseases

Infectious Diseases

Others

By Geography:

U.S.

Canada

Mexico

Key Players:

Boehringer Ingelheim GmbH

Lonza

JRS PHARMA

AGC Biologics

ProBioGen

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Toyobo Co. Ltd.

Samsung Biologics

Thermo Fisher Scientific, Inc.

Binex Co., Ltd.

WuXi Biologics

AbbVie, Inc.

ADMA Biologics, Inc.

Catalent, Inc.

Cambrex Corporation

Pfizer Inc.

Siegfried Holding AG Show more