Romania Neurology Clinical Trials Market Analysis

Romania Neurology Clinical Trials Market Analysis


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The Romania Neurology Clinical Trials market is projected to grow from $15.2 Mn in 2022 to $23.7 Mn by 2030, registering a CAGR of 5.75% during the forecast period of 2022 - 2030. The market will be driven by collaborations with international research institutions and improved funding for clinical research. The market is segmented by phase, by study design & by indication. Some of the major players include Biogen Inc., Pfizer Inc. & Novartis AG.

ID: IN10ROCT005 CATEGORY: Clinical Trials GEOGRAPHY: Romania AUTHOR: Vidhi Upadhyay

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Romania Neurology Clinical Trials Market Executive Summary

The Romania Neurology Clinical Trials market is projected to grow from $15.2 Mn in 2022 to $23.7 Mn by 2030, registering a CAGR of 5.75% during the forecast period of 2022 - 2030. Romania is the twelfth-largest nation in Europe and the seventh-most populated member state of the European Union, with a rising population of 19,4 million people. With its clinical research activities on the upswing, it now hosts over 500 clinical studies. According to clinicaltrials.gov statistics, oncology has the highest number of current clinical studies (205), followed by neurology (38), gastrointestinal (36) and cardiology (32). (35). The majority of active studies (55%) are in Phase 3. Foreign Sponsors are in charge of 91% of all active studies. According to the most recent WHO statistics, Alzheimer's and Dementia Deaths in Romania reached 2,839, or 1.22% of total deaths, in 2020, while Epilepsy Deaths reached 314, or 0.13% of total deaths.

In Romania, various neurology clinical trials are now underway, covering a wide variety of disorders and therapies. There are trials looking into the use of novel medications to treat multiple sclerosis, Parkinson's disease, and Alzheimer's disease, as well as research looking into new surgical procedures to treat epilepsy and other neurological illnesses. In Romania, there are several high-quality investigational sites, as well as numerous teaching hospitals and university clinics. In Romania, there are 17 medical institutions and 39 university clinics with diagnostic capacities equivalent to the highest international standards. In terms of Romania's innovation hubs, the city of Iasi, which is also the city with the most universities, is highly prominent. The Clinical Trials Information System was recently deployed in Romania (CTIS). The Clinical Trials Information System (CTIS) facilitates the exchange of data among clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) nations, and the European Commission. CTIS launched a searchable public website on January 31, 2022. It sets a 60-day timeframe for a response following filing.

Romania Neurology Clinical Trials Market

Market Dynamics

Market Growth Drivers

Beginning in 2022, the Ministry of Research, Innovation, and Digitization, in collaboration with the POLITEHNICA University of Bucharest, began organising annual "Romania of the Future" forums, that included exhibitions of research and innovation outcomes, as well as committee sessions and conversations on research and entrepreneurship.

Romania has a big patient population, which makes recruiting subjects for clinical trials simpler. Romania has cheaper labour and operational expenses than other European nations, which translates into reduced clinical trial expenditures. Romania has a highly competent medical workforce, with many physicians and nurses who have conducted clinical studies in the past. The Romanian regulatory framework is efficient and supportive of clinical trials, with shortened approvals and study completion procedures. Romania has a well-developed healthcare system, with modern medical facilities and easy access to medical supplies and equipment.

Market Restraints

When it comes to the expansion of neurology clinical trials, Romania encounters a number of problems and constraints. One significant impediment is a lack of funds and resources for clinical research. Several hospitals and research organisations in Romania have low financial resources, making large-scale clinical trials challenging. This may also lead to a scarcity of skilled employees and insufficient infrastructure, impeding the expansion of clinical trials. Another challenge is the small number of patients available for clinical studies. Romania has a population of around 19 million people, which is tiny in comparison to other nations. Moreover, people suffering from neurological illnesses may be unwilling to take part in clinical trials owing to doubts regarding the safety and effectiveness of experimental therapies. Regulatory and regulatory hurdles might potentially impede the progress of neurology clinical trials in Romania. The procedure of gaining regulatory clearance for clinical trials may be time-consuming and difficult, delaying or discouraging researchers from carrying out studies in the nation.

Competitive Landscape

Key Players

  • Biogen Inc.
  • Pfizer Inc.
  • Novartis AG
  • Sanofi S.A.
  • Merck & Co., Inc.
  • Roche Holding AG
  • Eli Lilly and Company
  • GlaxoSmithKline PLC

Notable Deals

January 2020, Pfizer's investigational medication PF-05251749 for neurological diseases has been acquired by Biogen.

Healthcare Policies and Regulatory Landscape

In Romania, clinical trials in neurology are governed by the National Agency for Medicines and Medical Devices (ANMDM), which is in charge of ensuring that all clinical studies adhere to international norms and laws. The ANMDM controls clinical trial approval, analyses the progress of current studies, and guarantees that all trial information is reliable and trustworthy.

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Clinical Trials Regulation in Country
1.6 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share
4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation

6. Methodology and Scope

Neurology Clinical Trials Market Segmentation

By Phase (Revenue, USD Billion):

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Study Design Outlook (Revenue, USD Billion):

  • Epilepsy
  • Parkinson's Disease (PD)
  • Huntington's Disease
  • Stroke
  • Traumatic Brain Injury (TBI)
  • Amyotrophic Lateral Sclerosis (ALS)
  • Muscle regeneration
  • Others

By Indication Outlook (Revenue, USD Billion):

  • Interventional
  • Observational
  • Expanded Access

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers, and researchers across countries through which we engage with local experts to gather key data points and assumptions about each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

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Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

 

 

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameters and micro indicators. The macro parameters include changes in government policies, demand and supply of the market, government intervention programs, and major market share. The micro indicators are GDP growth, market size, market volume, etc. We also understand nuances specific to each country like the US, Canada, India, Germany, etc., and have worked across 60+ countries and hence not only understand global trends but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. starting with the large overall market and segmenting different areas and the bottom-up approach i.e. starting with population and epidemiology and rolling up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases, and company-level averages, etc.

We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analyzed and synthesized. The second series of interviews are done if necessary to check and validate. The future opportunities are analyzed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results is then, interpreted by considering the following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue/volume
  • ​Analyzing current needs and determining penetration to estimate the market

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Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current, and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumption.

The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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Last updated on: 17 March 2023
Updated by: Riya Doshi

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