Regulatory Writing Market
Number of pages: 100 | Report Format: PDF | Published date: March 20, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 1.34 billion |
|
Revenue Forecast in 2031 |
US$ 3.30 billion |
|
CAGR |
10.5% |
|
Base Year for Estimation |
2022 |
|
Forecast Period |
2023-2031 |
|
Historical Year |
2021 |
|
Segments Covered |
Type, End User, and Region |
|
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global regulatory writing market was valued at US$ 1.34 billion in 2022 and is expected to register a revenue CAGR of 10.5% to reach US$ 3.30 billion by 2031.
Regulatory Writing Market Fundamentals
Regulatory writing is a specialized field of technical writing that involves developing documents and materials used to support the regulatory approval process for drugs, medical devices, and other products in the healthcare industry. These documents must be written to meet specific regulatory requirements and critical components of the drug development process. Regulatory writing encompasses various documents, including clinical study reports, investigator brochures (IB), clinical study protocols, and other regulatory documents. These documents provide regulatory agencies with the information they need to assess the safety and efficacy of drugs and medical devices. They play a critical role in the regulatory approval process.
Regulatory writing requires specialized knowledge and expertise in technical writing and the regulatory environment. Regulatory writers must be able to understand complex scientific and medical concepts and communicate them clearly and effectively to regulatory agencies. They must also thoroughly understand the regulatory requirements and guidelines for drug development and approval in different countries and regions.
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Regulatory Writing Market Dynamics
The growing investments in the research and development of drugs and medical devices are the major driver for the revenue growth of the global regulatory writing market. Regulatory writing is a critical component of the drug development process, and companies need high-quality regulatory documents to gain regulatory approval and bring their products to market. For instance, according to the United Nations Educational, Scientific and Cultural Organization (UNESCO) report, global research and development has reached almost 1.7 trillion and is expected to increase in coming years. Regulatory agencies such as the FDA, EMA, and other agencies worldwide have strict drug development and approval guidelines. Companies must meet these guidelines to get their products approved, requiring high-quality regulatory writing services. Growing numbers of drug approvals are also fueling the global regulatory writing market.
Regulatory agencies worldwide are increasingly adopting electronic submission systems, which require specialized regulatory writing expertise, boosting the revenue growth of the global regulatory writing market. Moreover, many pharmaceutical and medical device companies outsource their regulatory writing services to specialized providers. This trend is driven by the need for cost-effectiveness and access to specialized expertise, which will eventually boost the revenue growth of the global regulatory writing market.
However, the regulatory writing market is highly competitive, with many service providers competing for contracts from pharmaceutical and medical device companies. This competition can lead to pricing pressures and reduced profit margins. Furthermore, regulatory writing involves handling sensitive and confidential information, which can be vulnerable to data breaches and cyber-attacks. Service providers must have robust data security measures to protect their client’s information. The lack of skilled professionals, changing regulatory environment, and data security concerns are impeding the overall regulatory writing market revenue growth.
Regulatory Writing Market Ecosystem
The global regulatory writing market is analyzed from three perspectives: type, end user, and region.
Regulatory Writing Market by Type
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Based on the type, the global regulatory writing market is segmented into investigator brochures, case report forms, clinical study reports, informed consent forms (ICF), and others.
IB has become one of the most prominent segments in the regulatory writing market, owing to the revenue growth of the pharmaceutical and medical device industry. An IB is a comprehensive document that provides information about a drug or medical device to clinical trial investigators. The IB aims to ensure investigators have all the information they need to conduct the trial safely and effectively. The IB includes a detailed description of the drug or medical device, including its pharmacology, pharmacokinetics, and toxicology. It also provides information on the drug’s formulation, manufacturing process, and clinical development history. The IB may also include information on the drug’s proposed indications, contraindications, and dosing regimens. The IB is a critical component of the clinical trial process. It provides investigators with the information they need to decide about the drug or medical device they are testing. Moreover, regulatory agencies require IBs as part of the regulatory approval process for drugs and medical devices.
Due to the increasing number of clinical trials, clinical study reports have become an important component of the regulatory writing industry. A clinical study report is a detailed report that provides a comprehensive summary of the clinical trial, including the trial design, results, and conclusions. Clinical study reports are a critical component of the drug development process. They provide regulatory agencies with the information they need to assess the safety and efficacy of drugs and medical devices. The clinical study report is a critical document in the regulatory writing market. It provides a complete picture of the clinical trial, including the study design, patient demographics, efficacy, safety, and statistical analysis. Clinical study reports are a critical component of the regulatory approval process. They provide regulatory agencies with the information they need to make informed decisions about the safety and efficacy of drugs and medical devices. These factors contribute to the revenue growth of the clinical study reports segment.
Regulatory Writing Market by End-user
Based on the end-user, the global regulatory writing market is segmented into contract research organizations, pharmaceutical & biotechnological companies, and others.
The contract research organization is a key segment in the regulatory writing market, with the largest revenue share in 2022. The contract research organizations provide various services to pharmaceutical and medical device companies, including clinical trial management, data management, biostatistics, medical writing, and regulatory affairs. Within the regulatory writing market, contract research organizations offer specialized expertise in regulatory writing, including developing clinical study protocols, clinical study reports, IBs, and other regulatory documents. Contract research organizations may also provide services related to submitting regulatory documents, including preparing and submitting regulatory dossiers and managing interactions with regulatory agencies. The need for contract research organizations in the regulatory writing market has become increasingly popular. It allows pharmaceutical and medical device companies to outsource their regulatory writing needs to specialized service providers with the expertise and experience to develop high-quality regulatory documents that meet regulatory requirements. These factors contribute to the revenue growth of the contract research organizations segment.
The pharmaceutical & biotechnological companies segment accounted for the second-largest revenue share in 2022 due to increased clinical trial and drug launch activities. Pharmaceutical and biotechnological companies develop drugs and medical devices that regulatory agencies must approve before being marketed and sold to the public. These companies require specialized expertise in developing regulatory documents, including clinical study reports, IBs, clinical study protocols, and other regulatory documents. These documents are critical to the regulatory approval process, as they provide regulatory agencies with the information they need to assess the safety and efficacy of drugs and medical devices. Pharmaceutical and biotechnology companies may have in-house teams of regulatory writers. Still, many companies outsource their regulatory writing needs to specialized service providers with the expertise and experience to develop high-quality regulatory documents that meet regulatory requirements. Moreover, pharmaceutical and biotechnology companies may require ongoing support from regulatory writers to create new drugs and medical devices, conduct clinical trials, and seek regulatory approvals in different countries and regions. These factors contribute to the revenue growth of the contract research organizations segment.
Regulatory Writing Market by Region
Geographically, the global regulatory writing market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominated the global regulatory writing market with the largest revenue share in 2022 due to the presence of major pharmaceutical companies and significant drug development operations. Additionally, companies across the region are continuously involved in partnerships, mergers, and acquisitions, which is also helping in the revenue growth of the regulatory writing market. For instance, in September 2022, ProPharma Group, the world’s largest provider of regulatory, clinical, and quality services to the life sciences sector, announced the acquisition of Kateric, a global provider of outsourced medical writing and clinical trials disclosure assistance. ProPharma Group’s entire range of medical writing services is instantly expanded and significantly enhanced due to the acquisitions.
Regulatory Writing Market Competitive Landscape
The prominent players operating in the global regulatory writing market are:
Regulatory Writing Market Strategic Developments
The global regulatory writing market was valued at US$ 1.34 billion in 2022.
Regulatory writing is a specialized field of technical writing that involves developing documents and materials used to support the regulatory approval process for drugs, medical devices, and other products in the healthcare industry.
The global regulatory writing market is expected to reach US$ 3.30 billion by 2031.
The lack of skilled professionals, changing regulatory environment, and data security concerns restrict global market revenue growth to its full potential.
The prominent players operating in the global regulatory writing market are Trilogy Writing & Consulting GmbH, Syneos Health, Nucleus Holdings Ltd., Indegene, and ICON Plc.
*Insights on financial performance are subject to the availability of information in the public domain