North America Pharmaceutical Analytical Testing Outsourcing Market

North America Pharmaceutical Analytical Testing Outsourcing Market Size (2023 to 2028)

The pharmaceutical analytical testing outsourcing market in North America is expected to grow at a CAGR of 8.84% from 2023 to 2028 and be worth USD 4.26 billion by 2028 from USD 2.80 billion in 2023.

An increase in biosimilars is one factor driving the market forward. Biosimilars help reduce the healthcare costs associated with biologics, thereby increasing access to healthcare. The pharmaceutical industry's focus on creating biosimilar products has increased dramatically because of the approval of biosimilar drugs in key regions. The pharmaceutical industry, regulatory agencies, and healthcare systems will depend on biosimilars to meet science-based requirements that ensure patients have access to high-quality biosimilar products.

Increasing R&D is another factor boosting the pharmaceutical analytical testing outsourcing market in the North American region. New drug approval has been increasing each year. The Food and Drug Administration (FDA) approved 38 new drugs annually from 2010 through 2019, 63 percent more than the yearly average over the previous decade. Drug development is an expensive procedure. Only 12% of medications that undergo clinical trials are ultimately given FDA approval for market introduction. On average, less than $1 billion to more than $2 billion is spent on R&D for each new medicine. These estimates reflect the costs of both clinical trials and laboratory research for effective new medications in addition to drug expenditures. As a result, spending on pharmaceutical R&D and the approval of new drugs have increased markedly in recent years. Pharmaceutical manufacturers and biotech companies play an essential role in the early phases of discovering new drugs. Companies are undertaking the development and approval process with the Food and Drug Administration (FDA) to bring the medicine to the U.S. marketplace.

The International Federation of Pharmaceutical Manufacturers and Associations stated its commitment to fight against COVID-19 early in the pandemic. Pharmaceutical companies often transfer all or a part of their analytical development, and testing needs to contract laboratories and contract research organizations (CROs).

However, increasing competition from generic drugs, pharmaceutical fraud, increasing consumer expectations, challenges in maintaining brand health data thefts, further cybersecurity dangers, and interruptions to the supply chain are the factors that restrain the market growth.

This research report on the North American pharmaceutical analytical testing outsourcing market has been segmented and sub-segmented into the following categories.

By Product Type:

• Active Pharmaceutical Ingredient (API)

• Additives

• Finished Products

By Service:

• Bioanalytical Testing

  • Clinical

  • Non-clinical

• Method Development & Validation

  • Extractable & Leachable

  • Impurity Method

  • Technical Consulting

  • Others

• Stability Testing

  • Drug Substance

  • Stability Indicating Method Validation

  • Accelerated Stability Testing

  • Photostability Testing

  • Others

By End-User:

• Biopharmaceuticals and Pharma Companies

• Contract Manufacturing organizations

• Others

By Country:

• The United States

• Canada

• Rest of North America

The American pharmaceutical industry creates various new drugs with significant health benefits. Policymakers would lower drug prices and reduce federal drug expenditures, and such policies would probably reduce the industries to develop new drugs. Many of the drugs have been approved in recent years. These drugs treat chronic, complex, or rare conditions and may also require special handling or monitoring of patients. In 2021, a record 84 new active substances were introduced globally. Moreover, half (40) of the 72 NASs introduced in the U.S. in 2021 carried an orphan drug designation for patients with rare disorders, and a record 44 (over 60%) were assessed by the FDA. The involvement of AI in developing a pharmaceutical product can help rational drug design assist in decision making, including personalized medicines, and manage the clinical data generated and use it for future drug development.

The pharmaceutical sector is one of the most growing industries in Canada. The company's primary purpose is to develop and manufacture innovative medicines, generic pharmaceuticals, and over-the-counter drug products. Nanomedicines and gene and cell therapies are two new fields of biopharmaceuticals. In addition, companies focus on research and development (R&D) to develop new or improved patented therapies. In 2019, Canada's total pharmaceutical sales were around USD 30 billion. Canada brings high-quality, affordable, and innovative generic medicines to market.

KEY MARKET PLAYERS:

SGS SA, Toxikon, Inc., Eurofins Scientific, Pace Analytical Services, Inc., Intertek Group Plc, Pharmaceutical Product Development, LLC., WuXi AppTec, Inc., Boston Analytical, Charles River Laboratories International, Inc., and West Pharmaceutical Services Inc. are some of the noteworthy companies operating in the North American pharmaceutical analytical testing outsourcing market profiled in this report.