The global pharmaceutical industry generates revenues of over $900 billion, with a compound annual growth rate of 7.5 per cent. However, the lack of access to affordable medicines is a global challenge. To tackle this problem, many countries have adopted policies that allow different actors to address market unavailability or failure of generic drugs. Market access in pharma comprises tools used by governments and other stakeholders to achieve better access to healthcare products and services by addressing limitations related to drug availability. These initiatives aim at supporting local production, developing distribution channels, simplifying licensing processes, and reduce costs for innovators.
There are three main strategies for market access: incentive programs, support services, and regulatory streamlining. Each of these approaches can be implemented alone or in combination with other methods as needed based on an organization’s unique circumstances and available resources. Market access helps manufacturers negotiate pricing, terms of sale, logistics, inventory management and other such things they may not have been aware of at the time of contracting with distributors.
With increasing competition and regulatory hurdles, entering new markets remains challenging for many companies operating in this space. With this in mind, let’s take a closer look at market access in the pharmaceutical industry and its role in making products available to all.
In This Article – Market Access in Pharma
- What is Market Access in Pharma?
- Benefits of Market Access
- Strategies for Market Access
- Limitations of Market Access in Pharma
- Key Takeaway & Conclusion
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What is Market Access in Pharma?
Market access in pharma is the process of making a product available to relevant markets. In the pharmaceutical industry, it also refers to making drugs available at affordable prices to a maximum number of patients in different markets. The availability of drugs is often limited by regulatory and economic factors. In developing countries, these barriers are often compounded by issues such as a lack of infrastructure and awareness among healthcare providers and patients. Market Access can be implemented through incentives, support services, and regulatory streamlining to overcome these challenges.
Market Access is an essential component of industry structure and growth. Companies engaged in the pharmaceutical industry are required to have access to a certain minimum number of markets, which can be defined as the number of patients they have to serve. These market access requirements are usually set by industry standards and regulations (i.e., the Pharmaceutical Manufacturers Association, PHA). However, these standards and regulations are not uniform across industry sectors or countries (i.e., U.S., Europe). In some markets, companies with a high market presence may face regulatory obstacles that restrict their ability to enter new markets with established brands.
Market Access and Regulatory Approvals
In general, a company’s presence in one particular market does not mean that it is eligible for FDA approval for its product or brand. In other words, it cannot sell its product in other countries. However, if a company has performed well in this market, it may qualify for regulatory approval under certain conditions by having achieved “market access” status—that is, having been granted permission from relevant regulatory agencies to enter into new product launches or products with established brands through an incentive program or other mechanisms designed to incentivize pharmaceutical companies to enter new markets.
This can be done either by creating a special category from which the company can launch its own branded products through incentives such as cash bonuses or discounts on future sales by creating an additional category called “entry.
Benefits of Market Access in Pharma
The application of market access has become a key strategy for reducing the barriers to access for many aspects of health care delivery in developing countries. Market access helps countries improve their health system by creating an infrastructure for medical education, patient care, and healthcare management. It also helps develop innovative medicines that are less expensive than those produced by private companies or generic drugs that are available in local pharmacies.
This makes them widely available and accessible by all consumers around the world irrespective of where they live or work. The availability of pharmaceutical products creates an international market for medicines that can be easily accessed by consumers worldwide.
Specific Benefits of Market Access in Pharma
1. Improved access to essential medicines
The main objective of market access is to increase the availability and affordability of essential medicines for patients and ensure that no one is left behind. This can improve access to medicines that address critical public health issues such as HIV, TB, malaria, and Hepatitis B and C.
2. Local production and supply chain management
Another key benefit of market access is the production of drugs in the country and the establishment of proper supply chain management to facilitate the distribution of affordable products and services. Governments can also partner with local manufacturers to facilitate the production of affordable generic drugs.
3. Reducing out-of-pocket expenditure
Market access can also be used to reduce out-of-pocket expenditure. This, in turn, can enhance access to healthcare services and increase patient retention.
4. Facilitating e-governance
E-governance is a process that helps organizations operate more efficiently through online services. It is also a key mechanism for improving access to healthcare services.
5. Improving the quality of life
Health is a critical part of daily life for nearly all people in the world, but it is particularly important for those who are less well-prepared. Market access can help improve access to health care services and improve health outcomes.
6. Improving healthcare delivery
Another benefit of market access is improved healthcare delivery. As a result, people’s lives are made better by the availability and affordability of medicines, which are used in countless patients’ everyday lives.
7. Improving patient safety
The use of medicines may be a risk factor for adverse events such as blood clots, heart attacks and stroke. Market access can also help improve patient safety by providing pharmaceutical companies with incentives to develop new drugs that are more effective and safer than existing products.
8. Incentive mechanisms
Another benefit of market access is incentives to develop new medicines that are more effective, safer or both. This can encourage pharmaceutical companies to invest in developing new products that address unmet needs.
Strategies for Market Access in Pharma
- Incentives: Incentives, such as tax holidays, cash grants, and free or discounted equipment, are provided to local manufacturers to encourage them to produce low-cost drugs. In some cases, incentives are also provided to multinational companies for introducing new drugs in the market.
- Support services: Support services, such as training, market research, and project monitoring, help local manufacturers improve their production processes and make drugs available at affordable prices. It is also used to assist organizations with regulatory compliance to facilitate the introduction of new drugs in the market.
- Regulatory streamlining: Regulatory streamlining occurs when the government modifies its licensing rules. For example, testing requirements, to make drugs available at affordable prices. It also occurs when the government modifies rules related to marketing authorization to facilitate the introduction of new drugs in the market.
Limitations of Market Access in Pharma
Like most things in the health sector, market access in pharma has some limitations, which are outlined below.
1. Adequate resources and capacity required
Market access requires organizations to have adequate resources and capacity. This is particularly true for regulatory streamlining, as organizations must modify their products to meet local regulatory requirements.
2. Disadvantages of local production
Local pharmaceutical production comes with several advantages. However, it also has a few disadvantages, such as low production volumes, which can increase the cost of production.
3. Adequate supply
Pharmaceutical production is a costly and inefficient process. It requires a lot of labor, and can also take longer to produce than other industries.
4. Supply chain
Production has to be done through the entire supply chain, including manufacturing as well as distribution. This means that it is difficult for organizations to make changes to their products without affecting the entire supply chain.
5. Cost of production
Pharmaceuticals are expensive because they have high costs related to the manufacturing process, along with high-quality requirements. This makes them very expensive in comparison to other industries.
6. Stability
Pharmaceutical production is a stable industry since there are not many changes in policy or regulatory decisions.
7. Efficiency
When pharmaceuticals are produced locally, it is efficient because the production process does not require much time, and only takes place once every twelve months or so. Because pharmaceuticals are produced locally, they do not have additional costs associated with shipping the finished product worldwide.
8. Availability
Pharmaceuticals can be available in local pharmacies at all times, even during holidays and weekends. This makes them widely available and accessible by all consumers around the world irrespective of where they live or work.
Key Takeaway
Market access is the process of making a product available to relevant markets. It can be implemented through incentives, support services, and regulatory streamlining to overcome the challenges of regulatory and economic factors. It can also help to reduce out-of-pocket expenditure, facilitate e-governance, and increase the availability of low-cost drugs.
Conclusion
Market access in pharma is the process of making a product available to relevant markets. It can be implemented through incentives, support services, and regulatory streamlining to overcome the challenges of regulatory and economic factors. It can also help to reduce out-of-pocket expenditure, facilitate e-governance and increase the availability of low-cost drugs.
