Market Access is a set of activities that enable companies to enter the market prepared and in the shortest possible time and to position themselves in the market as best as possible. It is not an easy job and involves complex requirements in terms of regulation, competition, sales practices and the macro environment, which have specific characteristics for each particular market.
BioReg can help you with Market Access – to carefully study the market and to prepare the best possible market entry strategy, opening up the space for of up to 50% in the first years of business. Our experts and local partners can focus on a specific market or market segment and quickly and professionally provide you with all the necessary inputs to enter the market and rapid positioning.
Some of these services are as follows:
- Market sizing & structuring
- Market analysis & research
- Marketing Authorization (MA)
- Pricing & reimbursement strategies
- Analysis of decision makers and KOLs
- Negotiations with decision makers and key buyers
- Lobbying decision makers, buyers and other stakeholders
- Networking and bonding with key stakeholders on the market
- Development of risk management and risk mitigation plans
- Design of business infrastructure in the market
- Development of appropriate business models
- Development of Market Access strategy
- Development of Market Access plans
- Continual initial business support
Q&a
What is Market Access?
Market Access is a set of activities that enable companies to enter the market prepared and in the shortest possible time and to position themselves in the market as well as possible.
Why is Market Access important?
Market Access is important because it allows the company to enter the market in the fastest and best way possible, to position itself on the market as well as possible, and to provide adequate solutions to consumers (patients) as soon as possible. All this results in much better performance and results than if the company were to go spontaneously and without adequate preparation for the market.
Is Market Access an expense or an investment?
Market Access is definitely an investment, not an expense. A well-implemented Market Access allows the company to achieve savings that can go up to 50% in the first few years of operation, as well as to develop its business faster compared to an unprepared entry.
How long does the reimbursement process take?
The reimbursement process takes longer than the pricing process, and managed by Health Insurance Funds (HIFs). The length of the process depends on the organization of the service in the country, on the scope of the analyzes that are carried out (e.g., some countries use more complex HTA analyses), as well as on the preparedness of the company itself. The optimal duration of the process is a couple of months, and it usually starts with the public procurement procedure.
Are lobbying and negotiations important?
Yes. Lobbying and negotiations are very important. They are a kind of “ground preparation” for the company’s entry into the market. The better these processes are performed, the more successful the company’s entry into the market will be. These processes develop pre-market demand and facilitate post-market performance. They are important as part of the preparation.
How important are decision makers and KOLs?
Decision makers and KOLs are very important market participants. Modern healthcare systems are increasingly open to negotiations on how to enter the reimbursement system and to various forms of public-private partnerships. This also applies to the private market. On the other hand, KOLs play probably the most important role, especially with medical and health care products (medicines as a typical example). Once the KOLs are favored then the market is ready.
What do Market Access services include?
Market Access services include:
- Market sizing & structuring
- Market analysis & research
- Marketing Authorization (MA)
- Pricing & reimbursement strategies
- Analysis of decision makers and KOLs
- Negotiations with decision makers and key buyers
- Lobbying decision makers, buyers and other stakeholders
- Networking and bonding with key stakeholders on the market
- Development of risk management and risk mitigation plans
- Design of business infrastructure in the market
- Development of appropriate business models
- Development of Market Access strategy
- Development of Market Access plans
- Continual initial business support
- And other services
What is Market Sizing & Structuring?
Market Sizing is an assessment of the size of the market in terms of value (USD, EUR, etc.) and nature (pieces, packages, etc.). It is an assessment of the assimilative capacity of the market in one year. Market Structuring is the analysis of the market according to its structure. For example, in the case of the pharmaceutical market, this includes market breakdown by manufacturer, generic and innovative drugs, Rx and OTC drugs, hospital and other market, etc.
What is Market Analysis & Research?
Market Analysis & Research is the process of obtaining important usable analytical data about the market that helps with sales planning and business development. For example, it can be a survey of the per capita consumption of a certain cardiovascular drug or customer sentiment regarding certain cosmetic product. Market Analysis & Research is often combined with Market Sizing & Structuring, to get better insights based on advanced analytics.
How long does the Marketing Authorization process take?
The duration of the Marketing Authorization process depends on the type of product and the preparation of the documentation. In the case of cosmetic products, food supplements and other non-pharmaceutical products, it lasts on average up to 3 months, as well as in the case of medical devices, while in the case of drugs it lasts on average about 6 months, if there are no clock-stops.
How long does the pricing process take?
The pricing process usually takes a short time – up to several weeks. Sometimes the process can be completed within two weeks, and sometimes, when there are a large number of pending cases, the process can take several weeks. This is certainly a routine process.
How long does the reimbursement process take?
The reimbursement process takes longer than the pricing process, and managed by Health Insurance Funds (HIFs). The length of the process depends on the organization of the service in the country, on the scope of the analyzes that are carried out (e.g., some countries use more complex HTA analyses), as well as on the preparedness of the company itself. The optimal duration of the process is a couple of months, and it usually starts with the public procurement procedure.
Entering the market is not an easy job. Let’s look at some ‘tangles’.
- Regulatory. It is usually a high barrier to entry. High regulation in the markets includes complex processes of importing, Marketing Authorization (MA), pricing & reimbursement, clinical studies, laboratory testing, standardization (ISO, GxP etc.), customs clearance, etc.
- Competition. Different markets have different competitive characteristics. Some markets are unconsolidated, some are consolidated, and some are fragmented. Markets differ in terms of structure between stakeholders (manufacturers, importers, distributors, wholesalers, retailers), product needs (pharmaceuticals, MDs, cosmetics) as well as customer segments.
- Sales practices. Many markets are similar in terms of the sales practices, but there are also important differences. Before entering the market, it is essential to analyze institutions, KOLs, sales process, payment terms, public procurement procedures, cooperation potential, the size and strength of the wholesale and retail market, etc.
- Macro environment. The general environment significantly influences market entry and positioning. Politically unstable markets increase the risk of failure. Fast-growing markets allow business scaling. Technologically saturated markets can be difficult to penetrate. Demographics can be a market driver, while socio-cultural patterns can be restraints.
It should be remembered that some therapies cost more than $1 million per person, that some medical devices are not available in underdeveloped regions, and that there are specific rules that deter manufacturers from entering the market, even though there is a serious market potential.
Market Access is a set of activities that enable companies to enter the market prepared and in the shortest possible time and to position themselves in the market as well as possible. A well-performed Market Access allows the company to achieve good results, consumers to quickly reach the right solutions (e.g., therapy for patients) and the health system to be more efficient.
For more information, please contact the BioReg team.
Q&a
How complex is the Market Access process?
Market Access is basically a complex process because it deals with various aspects of business preparation for market entry – regulatory, market, psychological, analytical, logistical, etc. We are working on this together, but the scope and content of this activity depend on the readiness and capabilities of the company entering the market.
How long does the Market Access process take?
Market Access certainly takes longer than separate activities such as market research, obtaining an MA or reimbursement decision. The average duration of the Market Access process is 4-6 months, with the fact that, depending on the scope of the project itself, that process can be longer and more complex. Continuous support in the first years of business on the market can last even longer.
Why is a partner who knows the local market important?
A partner who knows the local market has knowledge and experience regarding the particular market, has important contacts, can represent and lobby effectively, knows key stakeholders, and generally has lower costs of performing these activities than a company entering the market.
What is Market Analysis & Research?
Market Analysis & Research is the process of obtaining important usable analytical data about the market that helps with sales planning and business development. For example, it can be a survey of the per capita consumption of a certain cardiovascular drug or customer sentiment regarding certain cosmetic product. Market Analysis & Research is often combined with Market Sizing & Structuring, to get better insights based on advanced analytics.
How long does the Marketing Authorization process take?
The duration of the Marketing Authorization process depends on the type of product and the preparation of the documentation. In the case of cosmetic products, food supplements and other non-pharmaceutical products, it lasts on average up to 3 months, as well as in the case of medical devices, while in the case of drugs it lasts on average about 6 months, if there are no clock-stops.
How long does the pricing process take?
The pricing process usually takes a short time – up to several weeks. Sometimes the process can be completed within two weeks, and sometimes, when there are a large number of pending cases, the process can take several weeks. This is certainly a routine process.
What is Market Analysis & Research?
Market Analysis & Research is the process of obtaining important usable analytical data about the market that helps with sales planning and business development. For example, it can be a survey of the per capita consumption of a certain cardiovascular drug or customer sentiment regarding certain cosmetic product. Market Analysis & Research is often combined with Market Sizing & Structuring, to get better insights based on advanced analytics.
How long does the Marketing Authorization process take?
The duration of the Marketing Authorization process depends on the type of product and the preparation of the documentation. In the case of cosmetic products, food supplements and other non-pharmaceutical products, it lasts on average up to 3 months, as well as in the case of medical devices, while in the case of drugs it lasts on average about 6 months, if there are no clock-stops.
How long does the pricing process take?
The pricing process usually takes a short time – up to several weeks. Sometimes the process can be completed within two weeks, and sometimes, when there are a large number of pending cases, the process can take several weeks. This is certainly a routine process.
Are lobbying and negotiations important?
Yes. Lobbying and negotiations are very important. They are a kind of “ground preparation” for the company’s entry into the market. The better these processes are performed, the more successful the company’s entry into the market will be. These processes develop pre-market demand and facilitate post-market performance. They are important as part of the preparation.
How important are decision makers and KOLs?
Decision makers and KOLs are very important market participants. Modern healthcare systems are increasingly open to negotiations on how to enter the reimbursement system and to various forms of public-private partnerships. This also applies to the private market. On the other hand, KOLs play probably the most important role, especially with medical and health care products (medicines as a typical example). Once the KOLs are favored then the market is ready.
What does business infrastructure on the market refer to?
Building a business structure on the market refers to the development of a business model and a system of relations with local stakeholders (importers, distributors, MA holders, wholesalers, etc.), without whose help one cannot perform on the market. This includes the construction of an optimal distribution model, as well as negotiations with partners, before the company enters the market.
What does business model development refer to?
A business model describes how an organization creates, delivers, and captures value. The process of business model construction is also called business model innovation and forma an important part of business strategy. The business model is most often designed in the form of a Business Model Canvas, which includes nine building blocks. It is important for the market entry.
What is the structure of the Market Access strategy?
Market Access strategy is a comprehensive document that provides the company with all the necessary information and guidelines for entering a specific market. This document includes goals, tasks, milestones, performance paths, strategic recommendations, ways of establishing contacts, and so on. This strategy is one of the most important business strategies, especially if it is about entering a significant market by volume or some other parameter.
What is the structure of the Market Access plan?
The Market Access Plan is a document that accompanies the Market Access Strategy. It shows the concrete steps and activities that should be carried out in order to achieve the predetermined goals. This plan also defines the time, resources, manpower and money for the realization of the goals. The Market Access plan, as well as the Market Access strategy, are contingent, which means that they can and should be adjusted (revised) to specific circumstances.
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