Pharmaceutical Contract Manufacturing Market Growth

According to IQ4I, the global Pharmaceutical Contract Manufacturing market is expected to grow at a mid-single-digit CAGR to reach $95,904.9 million by 2025.

Market Growth Drivers

The pharmaceutical market is showing rapid growth due to the rise in population, increased incidence of diseases such as infectious diseases, oncology, and cardiovascular issues, and rising healthcare spending. Pharmaceutical companies are increasingly outsourcing contract manufacturing due to a lack of advanced facilities or time, or to have backup manufacturing support. This trend benefits contract manufacturing service providers and is expected to increase their share in the pharmaceutical manufacturing market.

API and FDF Manufacturing

Pharmaceutical contract manufacturing services focus on the manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Forms (FDF). APIs are categorized into biologics (large molecules) and synthetic (small molecules). According to IQ4I analysis, synthetic molecules account for 65% to 70% of the API market, while biologics represent 30% to 35%.

Global API Market Growth

The increasing availability of small molecule drugs for major diseases and the number of small molecule drugs in the pipeline are significant factors driving the growth of the synthetic API market. The contract manufacturing market for APIs is expected to grow steadily through 2025, driven by the demand for generics, government initiatives, and an increasing number of API manufacturers.

FDF Manufacturing Trends

The FDF market, particularly solid dosage forms, is projected to grow due to evolving consumer demands and advancements in new dosage forms. Injectable dosage forms are the fastest-growing segment, with a projected CAGR of 11.4% from 2018 to 2025, due to the immediate drug delivery it offers in emergency situations.

Regional Insights

North America dominated the market in 2018 and is expected to grow steadily, driven by a developed healthcare sector, increasing clinical trials, and rising demand for generic drugs. Asia-Pacific is the fastest-growing region, with India and China leading due to lower labor costs, regulatory ease, and increasing production capacities.

Healthcare Regulatory Affairs Outsourcing Market Insights

The healthcare regulatory affairs outsourcing market is experiencing significant growth, driven by services to Clinical Research Organizations. Factors such as the rising number of patent expirations and increasing costs of research and development are influencing this expansion. Healthcare and biopharmaceutical organizations are likely to collaborate with outsourcing companies to get their drugs and devices approved in the global market. The approval process can be time-consuming, costly, and heavily reliant on documentation.

To address these challenges, service providers are focusing on outsourcing healthcare regulatory activities to reduce costs and specialize in core competencies. These regulatory service providers offer a range of services including pharmacovigilance, medical writing, and clinical trials to biotech companies across various countries. However, the market faces challenges such as price fluctuations and hidden expenses in regulatory services provided by different Clinical Research Organizations. High risks may also impact the productivity of the healthcare regulatory affairs outsourcing market.

Emerging economies, particularly in the Asia Pacific region, present lucrative growth opportunities for healthcare regulatory affairs outsourcing due to developing infrastructure and investments in healthcare technologies.

Global Healthcare Regulatory Affairs Outsourcing Market Overview

Regulatory policies are implemented to ensure that companies meet specific standards in their operations. In the healthcare industry, these policies aim to safeguard public health and welfare by ensuring the safety of pharmaceutical and healthcare products. Many healthcare companies are now outsourcing their regulatory functions to focus on their core competencies. The increasing number of medicines in the clinical development process is making regulatory affairs outsourcing more significant in the healthcare sector.

Trends and Opportunities

Healthcare institutes and pharmaceutical companies are increasingly outsourcing regulatory affairs to avoid high costs and leverage the expertise of contract research organizations (CROs). Outsourcing regulatory affairs allows these organizations to focus on their core competencies, which drives the growth of the global healthcare regulatory affairs outsourcing market. The benefits of outsourcing include cost-effectiveness, optimized reimbursements, faster product approvals, and increased market share and productivity. These factors contribute to the strong growth forecast for the market.

Regional Outlook

Geographically, the key market segments are Asia Pacific, North America, Europe, and the rest of the world. North America, led by the U.S., is the dominant region in the global healthcare regulatory affairs outsourcing market. Europe follows North America, with an emphasis on reducing investment costs and benefiting from lower labor costs. The focus on optimizing resources and accelerating product approvals is also prominent in Europe.

Emerging countries, particularly in Asia Pacific, are preferred for regulatory affairs outsourcing due to high costs in developed nations. Asia Pacific is experiencing impressive growth and is becoming a significant market for outsourcing due to its large pool of skilled labor at lower costs and the increasing number of pharmaceutical companies.

Vendor Landscape

Leading players in the healthcare regulatory affairs outsourcing market include Charles River Laboratories International, Inc., KAI Research, Inc., Medpace, Inc., and ICON Plc.

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