Pharmaceutical Product Feasibility: Why Do You Need It?
The product feasibility study is a scientific assessment process that helps mitigates the chances of product failure. It also helps efficient strategic planning to save costs and time during product development. Product feasibility is a broad-spectrum study that includes market feasibility, geography feasibility, competitive assessments, product viability analysis, etc.
What is product feasibility?
A feasibility study is an analysis that considers all of a project’s relevant factors which include economic, technical, legal, and scheduling considerations, in order to ascertain the likelihood of completing the project successfully.
In a product feasibility study, the analysts conduct a forecast run test of the development steps, product registration, and market analysis to confirm that the product is feasible in all aspects to launch into the market.
That means product feasibility is a process to identify whether the product developed generates enough revenue or sales from consumers.
Why do you need to conduct product feasibility?
Introducing a new product in market without proper research is like driving blind.
Before you develop a product, do you have an answer to the question “Does your product generate enough revenue and give ROI?”. If yes, is there any scientific evidence to build your confidence?
Product feasibility answers, and if your answer is “yes” then there is an 80% of chance that your product will be successful.
Generally, the failure rate of new product introductions is very high. Some estimate that less than 20% of new products succeed. Here, a feasibility study can provide logical answer to discern the potential impact and likely success of your new project.
Companies allot space in their budget to on R&D but often miss the allocation to find whether this product will be successful after launching.
Before launching, feasibility studies help organizations understand and foresee the market scope (product demand) and ROI. Help the developer to decide whether to launch the product or withdraw. That saves both time and wealth.
- Companies conduct a product feasibility study to prove demand for the drug/medical device/health care product/s and make evidence-based recommendations for the next steps before entering the market.
- The third-party market feasibility has more weightage as the analysis from the same organization would bias the results.
- It is wise to perform an early-stage feasibility study (during the pre-development stage), as this would be more advantageous.
- Product feasibility helps to understand the competition and have strategic planning.
Top advantages of conducting product feasibility
There are many advantages of product feasibility, and here are a few of them.
- Provides valuable information for a “go/no-go” decision
- Help understand the product viability
- Provides market insight
- Narrows the business alternatives
- Provides strategic planning
- Mitigate product failures
What all does the product feasibility cover?
Product feasibility is perspective and depends on the stakeholder prerequisite. However, generally, a product includes the following aspects.
- Regulations and regulatory approvals analysis
- Market assessment feasibility
- Product viability and competition
- Geographical feasibility
- Cost & ROI viability
Regulations and regulatory approvals analysis
The regulatory analysis is uncommon in other industries but crucial in the pharma industry. Because regulatory approval for a drug in one country may take a few months, but in another may take a few years. That impacts the product lifecycle and ROI.
After the successful clinical development of healthcare products, the crucial step before you enter any market is the regulatory process and approval. The regulations vary from country to country. The more time it takes for regulatory approval, the more impact on investment costs and the threat from the competitors. Hence the regulations and available data for registration are crucial for the product’s success.
Market assessment feasibility
Market feasibility is a separate chapter from product feasibility. Many stakeholders show interest, particularly in market feasibility, and usually conduct after product development.
Answers you would get from the market feasibility
- The demand for the product?
- What audience(s) should I target?
- Who are the product competitors?
- What is the market share of competitors?
- How much should I sell my product?
- How should I promote my product?
Answers to these questions are sufficient to understand the market and build confidence in your product development.
Product viability and competition
Is your product ready to use in your target market, or does it need modifications to create more impact? A feasibility study finds answers to these questions. It’s obvious that products developed for one country may not project the same results with the other country.
What is the success line of your competitor? The answer will be the success formula for your product. It may be weird, but a keen analysis of a competitor’s product would give a picture of the success rate of your products.
- Is your product competitive?
- What is the impact of your product on the market?
- Are you going to share the market? Beat the market? or Make a loss in the market?
- What advantage would your product have over competitors’ products?
- Fewer side effects?
- Better or effective treatment?
- Is your product cost-effective?
- Geographical feasibility plays a crucial role in a successful product. Launching a product in a region where there is no demand, this would impact the ROI and finally may lead to product failure.
- Cost estimation from product registration to marketing vary country to country. The timeline will have a considerable impact on ROI.
- It is always wise to choose a region where regulatory approvals are quicker and market access is faster.
General outcomes from a geographical feasibility
- Regulatory requirements and ease of approval
- Cost estimation from registration to marketing
- Marketing lifecycle timeline
- Population and market
- Competition in the geography
Cost & ROI viability
The cost analysis looks at all aspects of pricing, from development cost and up to marketing. The cost analysis is incomplete if the Return Of Investment (ROI) is unresolved, as the total goal of any organization would be profits.
The ROI depends on several factors such as
- Market reach
- Competition and similar products
- Marketing costs
In the case of monopoly products where the product is new to the market then the product may have high ROI than regular products due to competitive products. This is one of the deciding factors before gaining regulatory access to launch a product in any country.
This analysis is complex and requires surveys, interaction with consumers, competitive assessments, etc.
Product feasibility for drug/medical device/health care products/ herbal medicines
Product feasibility in Oncology
The ultimate goal of any drug development, including that in oncology, is to register the new medicinal product, market, and gain the ROI.
The need for cancer therapies is rising with the increasing prevalence of cancer cases and deaths globally. Thus, the oncology market is majorly driven by this factor. But interestingly not all oncology drugs in the market are successful.
Failures may be due to product-related issues (more side effects, better alternative treatment methods available), poor marketing, wrong geography selection, etc.
Developing treatments in oncology involves huge investments and clinical development is crucial.
So in such cases, while developing the drug, you need to find answers for the following
- What is the market scope for the drug?
- How about the disease prevalence?
- Is your drug suitable for self-medication or need physicians’ supervision?
- What are the competitive drugs available in the market?
- How many similar competitive drugs are under development?
- What are the alternative treatments available and how the current drug under development is advantageous
- What are the development costs?
- Cost estimate for pre-clinical and clinical development
- Registration costs
- Marketing costs
- Import, storage, and distribution costs
- Which geography suits the most to surge ahead?
- Does the country you have chosen have more prevalence of oncology cases?
- What is the ease of marketing in the country?
- How flexible are the government agencies?
- How about the regulatory aspects and government incentives?
Some regulators offer fast-track approval, and financial incentives, which have a great impact on development costs, and time.
Product feasibility can find answers to all these questions. Hence, product feasibility in oncology would be a must-scientific process before you move ahead to develop a product.
Product feasibility in herbals medicines
Herbals and health care products are gaining much interest in many countries and the various reports show huge prospects for herbals and health care products. The market size is projected to reach USD 86.74 Billion by 2022, at a CAGR of around 6.8% from 2016 to 2022. The growing awareness for preventive healthcare methods is the major driving factor of this market.
The Latin American and Asia-Pacific regions are potential markets for herbal medicines in the pharmaceutical industry, and this is due to increased efficiency in research & development initiatives taken by manufacturers, as well as consumer preference towards natural treatment options.
Regulatory aspects, countries with market, cultural aspects, health care awareness are few key driving factors for such products. Product feasibility in herbal medicines provides guidance in region selection, regulatory considerations, market scope, public reach, and several other important aspects. This helps to shoot the target market and make the product successful.
Health supplement products feasibility
The global dietary supplements market size was valued at USD 136.2 billion in 2020 and is projected to reach USD 204.7 billion by 2026, recording a CAGR of 7.0% during the forecast period. Rising health awareness, growing geriatric population, changing lifestyles, dietary habits, and adoption of a healthy diet are some driving factors for the rise of health supplement markets.
The countries with more aging populations would be the target countries for marketing. Health supplements, unlike other medicines, are long-term medications, and big pharmaceutical players play a key role in this market. Usually, large existing brands present intense competition.
Regulatory aspects, selling regulations, physicians’ role in recommending health supplements, cost of the product, type of supplement (herbal, chemical, etc.), palatability, etc., are few affecting factors. Product feasibility would give a complete scientific analysis of such data to make decisions more efficiently and avoid product failures.
Product feasibility of medical device
In 2020, The global medical devices market reached a value of nearly $456.8 billion. The market expects to grow from $456.8 billion in 2020 to $62.0 billion in 2025 at a rate of 7.7%.
A growing number of healthcare facilities, rapid growth in the elderly population, economic growth in emerging markets, rapid technological advances, increased healthcare expenditure are few driving factors for the medical device market.
To take advantage of the current opportunities, the researchers & manufacturers need to focus on disposable medical products, contactless medical devices, wearable devices, portable medical devices,
In 2020, North America was the largest region in the global medical devices market, accounting for 39.7% of the total, followed by the Asia Pacific, Western Europe and then the other regions. The fastest-growing regions in the medical devices market will be South America and Africa.
The introduction of medical devices in a competitive market is entirely different from entering into a new market. Product feasibility would help identify the target market for your medical device, understand the regulatory aspects, licenses, CE marking or similar assessment requirements, etc., to make go or no-go decisions and strategies to overcome these challenges.
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