Mobile: +91 992-500-9739

Tele: +91 79 403-07106

Email: info@newedgeoverseas.com

Pharmaceutical Industry

An Outline of the Growing Indian Pharmaceutical Industry

While the pandemic was a wave of economic disruptions for many industries, it has blown some exemplary achievements to the Indian pharmaceutical industry. The pharmaceutical industry in India is currently valued at $41.7 bn. However, the pharmaceutical industry in India is expected to reach $65 bn by 2024 and $120 bn by 2030. Moreover, in August 2021, the Indian pharmaceutical market increased at 17.7% annually, up by 13.7% in July 2020. According to India Ratings and Research, the Indian pharmaceutical market revenue will be over 12% Y-o-Y in FY22.

India ranks 3rd worldwide for production by volume and 14th by value. In addition, India has the highest number of US-FDA compliant Pharma plants outside of the USA. It is home to more than 3,000 pharma companies with a strong network of over 10,500 manufacturing facilities.

Andhra Pradesh, Gujarat, Maharashtra, and Goa are the major pharmaceutical manufacturing clusters in the country. The bulk drug clusters are located primarily in Ahmedabad, Vadodara, Mumbai, Aurangabad, Pune, Hyderabad, Chennai, Mysore, Bangalore, and Visakhapatnam (Vizag).

The pharmaceutical hubs offer investment opportunities to produce API or bulk drugs, vaccines, nutraceuticals, food and drug testing, clinical research, research and development, and contract research/manufacturing. Multinational pharmaceutical corporations outsource these various activities and help the sector’s growth. As a result, the Indian Pharmaceutical companies have a promising future. We will discuss prominent aspects of the industry and outline the growing Indian pharmaceutical industry.

Pharmaceutical Industry

India is the largest provider of generic drugs in the global pharmaceutical industry

  • India is the largest provider of generic drugs globally. India’s generic drug producers hold a strong position in the global supply chain and play an integral role in developing the pharmaceutical industry. The pharma industry in India produces around 20% to 24% of the global generic drugs.
  • Indian pharmaceutical sector supplies 40% of generic demand in the US and 25% of all medicines in the UK. The pharmaceutical industry in India offers 60,000 generic brands across 60 therapeutic categories. 
  • Indian pharmaceutical companies supply over 80 percent of the anti-retroviral drugs used globally to combat AIDS (Acquired Immuno Deficiency Syndrome). Furthermore, six domestic firms – Aurobindo, Cipla, Desano, Emcure, Hetero Labs, and Laurus Labs have a sublicense with the UN-backed Medicines Patent Pool to manufacture anti-AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

Pharmaceutical Industry

Increased profits in the pharmaceutical industry from exports of the pharmaceutical products

The country’s pharmaceutical sector contributes 6.6% to the total merchandise exports. India exports around 40% of its pharmaceutical products to more than 200 countries globally. Of these, 55% of the total exports constitute formulations, and the other 45% comprises bulk drugs.

According to the Pharmaceutical Export Council of India (Pharmexil), 55 percent of Indian exports are sent to highly regulated markets. The United States is the most lucrative generics market for India’s pharma industry. It is valued at around $60 billion and accounts for about 25 percent of India’s total shipment. India’s other important export destinations include the United Kingdom, South Africa, Russia, and Nigeria.

The significant growth rate in exports of pharmaceuticals over the past few years can be seen below:

  • In 2017-18, India exported pharmaceutical products worth US$17.27 billion.
  • In 2018-19, India’s pharmaceuticals exports were worth US$19.3 billion, showing a growth of 10.72 percent year on year.
  • In 2019-20, exports grew to US$20.5 billion.
  • By 2020-21, the industry estimates exports to grow to US$25 billion.
  • This year, India’s pharma exports in the first six months amounted to US$11.38 billion, which was nearly 15 percent higher than in the same period last year.

Pharmaceutical Industry

Foreign investments in due to the low cost of productions

With the large concentration of multinational pharmaceutical companies in India, it becomes easier to attract foreign direct investments. Therefore, the pharma industry in India is one of the essential foreign direct investment encouraging sectors. India’s current foreign direct investment (FDI) policy allows acceptance of 100 percent FDI under the automatic route in greenfield pharmaceutical projects. It also allows 74 percent FDI acceptance under the automatic route in brownfield projects – upwards of which can still be allowed through the government approval.

India is also emerging as a preferred destination for contract manufacturing organizations. Indian contract manufacturing companies are gaining popularity because India has a low cost of production, low R&D costs, an innovative scientific workforce, and a large number of national laboratories that have the potential to steer the industry ahead. As per industry analysts, the manufacturing cost in India is approximately 33 percent lower than that of the US. Thus more companies are directing their manufacturing outsourcing in India and focusing more on their new drug discoveries.

Hold of the API industry

The Indian Pharmaceutical Industry is one of the biggest producers of active pharmaceutical ingredients (API) in the international arena. India has more than 262 API manufacturing USFDA approved plants. India is 3rd most prominent market for APIs globally and has an 8% share in the Global API Industry. API pharma companies in India produce 500+ different APIs, and it contributes 57% of APIs to prequalified list of the WHO.

Pharmaceutical Industry

Supply of vaccines during and before the pandemic

India is the largest producer of vaccines worldwide, accounting for around 60% of the total vaccines in 2021. In addition, India’s pharmaceutical industry is among the leading global producers of cost-effective generic medicines and vaccines. It supplies 20 percent of the global demand by volume and 62 percent of the global demand for vaccines. Therefore, it is expected to play a vital role in meeting the global demand for COVID-19 vaccines, especially for low and middle-income countries.

As of May 2021, India supplied a total of 586.4 lakh COVID-19 vaccines, comprising grants (81.3 lakh), commercial exports (339.7 lakh), and exports under the COVAX platform (165.5 lakh) to 71 countries.

The above-discussed facts prove that the pharmaceutical sector is highly profitable for the Indian economy and a global benchmark.

For more such insights, stay tuned to our website https://newedgeoverseas.com/.

Contract Manufacturing Organizations

8 Benefits of Contract Manufacturing Organizations

Contract Manufacturing Organizations, also called trusted strategic partners, are currently in the limelight in the pharmaceutical industry. With the increase in sophisticated technology and to fulfill the demands of the latest trends in the industry, many pharmaceutical companies are shifting their manufacturing to contract manufacturing organizations. As a result, the global contract manufacturing organization (CMO) market size valued at USD 92.42 billion in 2018 is projected to reach USD 188.07 billion by 2026, exhibiting a CAGR of 9.4% during the forecast period.

Further, the pandemic has been a turning point for the Indian CMO market in recent years. As a result, the Indian contract manufacturing organization market is expected to register a CAGR of 13.3% between 2021 and 2026.

With the complex manufacturing procedures and regulatory controls, the pharmaceutical companies seek long-term relationships with the CMO for more beneficial strategic deals. (For detailed insights on the selection of the contract manufacturing organization, kindly refer to our blog “How To Choose The Right CMO And CDMO Partners” on our website. However, we will focus on some key benefits of contract manufacturing organizations here:

1. Utilize their expertise, innovation, and insight to set new trends in the market

The time frame for developing a new medicine through product launch can take up to 15 years. In addition, research and clinical trials demand a lot of investment and specific involvement from many personnel. On the other hand, the CMOs have expert personnel handling the business of many companies for years. Hence, pharmaceutical companies can use their expertise, innovation, and insight to increase their business by outsourcing these activities to CMO. Further, companies also get an avenue for entering emerging markets which is a wiser choice for the unapproved products in the pipeline. New products are crucial for a company’s future. Teaming up with a strategic partner gives an advantage over R&D. Still, they can get their potential revenues.

Contract Manufacturing Organizations

2. Access to the latest equipment and facility

Buying and running a piece of new expensive manufacturing equipment for the mass production of pharmaceuticals is very burdensome. To keep up with this demand, outsourcing manufacturing to CMOs is convenient. They have the latest equipment, qualified workforce, and facilities to carry out larger productions swiftly.

3. Leverage their high capacity framework

When the companies get regulatory approval for their drugs, large quantities of products are required for marketing and distribution. Unfortunately, many companies do not have adequate facilities and equipment to meet more extensive demands. Thus, contract manufacturing organizations can be helpful in this kind of scenario. Companies can use higher capacities of CMOs and focus on other core profit-making activities.

Contract Manufacturing Organizations

4. Superior control over quality and regulations

Contract manufacturers have robust control over quality management. In India, most contract manufacturers follow best manufacturing practices as per India’s Good Manufacturing Practices, under Schedule M of the Drugs and Cosmetics Act, 1940. Therefore, higher quality products give a competitive advantage in the market. In addition, CMOs have their niche in manufacturing practices with better regulatory checks in place. Consequently, the pharmaceutical companies get high-quality products from the contract manufacturers.

5. Cost-effectiveness

Researching and developing a new product can exceed $1 billion. In addition, the manufacturing costs account for roughly one-quarter of the company’s overall costs, which is considerably high. However, the CMOs have advanced manufacturing techniques that save time, cost and reduce wastage. Further, contract manufacturing can help reduce costs in other areas, such as equipment, facilities, operators, product designs, machine maintenance, and labor work. As a result, with comparatively fewer capital assets relative to its operations, a company has more resources to respond to market trends and generate more remarkable recoveries on investments.

Contract Manufacturing Organizations

6. Increasing the scale of the business

Improved scalability is an additional benefit to the CMOs because they have long-term relationships with the vendors and thus can produce bulk material at competitive prices. As a result, companies can increase the scale-up of their business without paying any extensive amount.

7. Risk Mitigation

The contract manufacturers help ensure a constant business flow, and thus, it becomes easy to respond to the varying market demands. It is challenging for the pharma company to commercialize extra capacity if the expected volume does not go well. In contrast, a CMO co-investing with a pharma company can reduce its exposure by marketing excess capacity to other customers and mitigating the risk.

8. Acquiring a competitive advantage in the market

CMOs can help gain pharmaceutical companies easy access to the local markets. In addition, they can get fast tract marketing organizations with their practical strategies as they have an admirable reputation of years with local government. Hence CMOs can help the companies get a competitive edge for entering a new market.

Contract Manufacturing Organizations

Conclusion

Pharmaceutical companies can cost-effectively provide quality products and increase overall productivity and efficiency by partnering with contract manufacturing organizations. The bottom line is that CMOs offer an extensive array of value-added services and preferred partners in current times.

At NEWEDGE Overseas, we offer solutions that are standardized and tailored as per your specific needs and requirements to become your trusted collaborators in the field of contract manufacturing. In addition, with our capability to handle multi-ton synthesis, we can help you reduce the turnaround time and the quality of your supplier portfolio. With all these, we become your one-point solution for all your requirements, reducing your outsourcing qualification interventions for superior supply chain management.

  • We provide API and advanced intermediate synthesis exclusively complying with the latest regulatory requirements as per the highest quality standards and cGMP.
  • We also manufacture early-stage intermediates and building blocks with our non-GMP capabilities and expertise.
  • From start-ups and MSMEs to globally established corporations, we cater to all.
  • Leveraging the latest technologies, we are innovative in our research and chemical experimentation.
  • From grams to tons, our production scale exceeds volumes of your expectations.
  • Our scientifically driven project management team evaluates, manages, and implements different projects per the client’s expectations.
  • For FDFs, we provide every kind of contract manufacturing service irrespective of the dosage form.
Global Pharma

10 Reputed Regulatory Bodies of the Global Pharma Industry

Regulatory agencies aim to protect human health in global pharma. We will discuss ten reputed regulatory bodies of the global pharma industry here.

Regulatory agencies are the governing bodies aiming to protect human health in the global pharmaceutical industry. Therefore, they play a crucial role in meeting the requirements of legal procedures related to drug development. In addition, regulatory agencies ensure healthcare products’ safety, efficacy, and quality, and compliance with statutory duties. Further, the agencies periodically check the production sites for new and previously established products and procedures.

With the growing presence of pharmaceutical companies in more than 100 countries, most countries have established pharmaceutical legislation and regulatory requirements. Regulatory bodies issue various guidelines on the drug development process, licensing, manufacturing, marketing, patenting, registrations, quality control, good laboratory practices, handling of OTC drugs, packaging, labeling, storage, etc.

Furthermore, the pharmaceutical industry must comply with national regulations and international regulations if their product is implied for the international market. They have the authority to impose heavy penalties and product recalls in case of non-compliance. A list of Globally identified websites of medicines regulatory authorities is provided by the WHO. Out of these, we will discuss ten reputed regulatory bodies of the global pharma industry here.

1. FDA

Global PharmaThe Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products. FDA is also responsible for advancing public health by helping to speed innovations that make medicines safer, more effective, and more affordable.

2. MHRA

Global PharmaThe Medicines & Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring the proper use of medicine and medical devices. The MHRA is an executive agency of the Department of Health.

3. ANVISA

Global PharmaThe Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

Anvisa’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing, and use of products and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.

4. TGA

Global PharmaThe Therapeutic Goods Administration (TGA) is the regulatory authority for the Australian pharmaceutical industry. The TGA oversees and regulates numerous therapeutic goods, including prescription medicines, vaccines, and medical devices. The site contains information specific to consumers, health professionals, and industry manufacturers. It also lists recent pharmaceutical recalls and alerts.

5. CDSCO

Global PharmaThe Central Drugs Standard Control Organization in India sets standards and regulatory measures for medications. Further, the organization guides on health issues and medicines. They also regulate the standards of imported drugs and clinical research in India. Various regulatory documents and forms are available to download for free in PDF from the website.

6. WHO

Global PharmaWHO (World Health Organization) is the United Nations specialized agency for health. It is responsible for providing leadership on global health matters shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. In addition, it is the United Nations agency that connects nations, partners, and people to promote health, keep the world safe, and serve the vulnerable. So everyone can attain the highest level of health.

7. ICH

Global PharmaThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss pharma-related scientific and technical aspects and develop guidelines. Since its inception in 1990, ICH has gradually evolved to respond to increasingly global developments in the pharmaceutical sector.

8. EMA

Global Pharma The European Medicines Agency (EMA) protects and promotes public health by evaluating medicines. The EMA provides recommendations on the quality and safety of medicines. In addition, they apply evaluation procedures to help bring new medicines to the European Union.

9. HEALTH CANADA

Global PharmaHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible and works to reduce health risks. They focus on product safety, environmental and workplace health, food and nutrition, health and science research, drugs and health products, etc.

10. Egyptian Drug Authority (EDA)

Global PharmaIn 2008, the Ministry of Health established the Egyptian Drug Authority (EDA) to have an independent regulatory body responsible for all pharmaceutical-related activities. It is similar to the function of India’s FDA in the United States. This establishment was seen as a landmark restructuring in the Egyptian pharmaceutical industry. There had yet to be an independent and organized body to manage pharmaceutical regulatory affairs beforehand.

As a Global Pharma, NEWEDGE Overseas exports a wide range of products to more than 40 countries. Every product that passes through the NEWEDGE supply chain be it raw material or an end-product adheres to all requisite regulatory compliances making it safe for consumption. In addition, our regulatory audits ensure that the products we offer and the processes we employ accurately comply with the regulatory dictates of specific countries.

Global Pharma

6 Risks and Challenges of Export in Global Pharma

The Global Pharma export industry has witnessed unprecedented times in the past few years. While the demand for healthcare products to fight pandemics increased, some products simultaneously faced a downturn. According to the Pharmbiz report, “the growth of global pharma market decreased by 1-2 percent in 2020”. However, the export from the Indian Pharmaceutical companies is currently flourishing. “The exports of drugs and pharmaceuticals from India reported a 4.58 percent growth for the three months ending June 2021 at $5.78 billion compared to $5.53 billion during the same period last year.”

Control of robust export and distribution lines in the pharmaceutical industry is challenging. Although the pharmaceutical industry implements numerous ways to manage exports smoothly, the following are some risks and challenges in pharma export.

1. Maintaining appropriate storage conditions during export

Be it an API, an excipient, or finished goods, maintaining adequate storage conditions is an essential parameter for the safety and efficacy of pharmaceutical products. Storage criteria vary from product to product. For example, most pharmaceuticals require to be stored at room temperature, whereas some unique products require cold storage conditions.

Suppose appropriate storage conditions are not managed during exports. In that case, it directly affects the quality of the product and the consumer’s health. Moreover, suppose the products deteriorate during transport. In that case, it can cause a recall from the market, affecting the manufacturer’s reputation and resulting in wastage. Hence, it becomes an arduous task to maintain storage conditions during export from the warehouse to the pharmacy store.

Global Pharma

2. Maintaining records of the distribution line

The pharmaceutical distribution line consists of an organized network of producers, wholesalers, and distributors who collectively make products available to consumers. To sustain for a longer time in the market, companies need to ensure proper distribution of products. However, in developing countries, where many pharmaceutical companies haven’t adopted digital handling modes of their supply, it isn’t easy to track all the transactions. Sometimes, shipment records are not managed well, and there are no logs of the missing products during transport. Moreover, one major obstacle of this system is that the health authorities have not imposed strict and detailed policies for the pharmaceutical distribution system. As a result, there is a lack of control over the distribution chain to trace the exports.

Global Pharma

3. Handling supply of products during shortage/emergencies

Many countries do not meet the demands of drugs and preventive medical supplies during emergencies, especially during contingencies like disease outbreaks or the onset of a pandemic. With limited manufacturers and suppliers of shortage products, it becomes challenging to meet the requirements in countries with a large population. Moreover, with the travel restrictions and export/import bans, the supply of products gets affected. These factors sometimes lead to fake and illegal supplies of medical products during emergencies.

4. Managing the supply chain effectively

Regulatory agencies have increased pressure for quality pharmaceutical products to ensure consumer protection. Unlike food, consumers can not detect faults in medicinal products through taste, smell, sight, touch, or appearance. Thus, it is imperative to keep the quality of products intact throughout the supply chain. The pharmaceutical products transit from manufacturers/suppliers to pharmacies/clinics in the supply chain. In this process, there are many hurdles such as timely delivery of products, sustenance of temperature, inventory management, track of expired products, etc.

Global Pharma

5. Adhering to rules and regulations of various countries

There is a vast difference in the drug distribution systems of developing and developed countries. Most of the national wholesale drug market is operated by a few firms in advanced countries. In contrast, hundreds or thousands of companies handle the wholesale drug market in developing countries, leading to poor drug distribution management. Moreover, it is difficult to export the same product in various countries, as the regulatory requirements vary from country to country.

6. Fear of counterfeit drugs

Global pharma is currently facing another challenge of counterfeit medicines due to weak supply chains. Counterfeit medicines are deliberately and fraudulently produced and mislabeled concerning identity and source to appear genuine products. One of the most significant risks of counterfeit medicines is that patients may not get the therapeutic benefit expected from the product. Furthermore, it affects the company’s reputation in the market. The industry and regulatory agencies are still working to dismantle this organized crime of counterfeit medicines.

Conclusion

We have discussed potential risks associated with the exports of pharmaceutical products. Therefore, the industry should follow the guidelines on “good distribution practices for pharmaceutical products” and take appropriate measures during exports.

Newedge Overseas exports a wide range of products to more than 40 countries in South East Asia, Latin America, Africa, Middle East, Europe, USA, and CIS region. It represents more than 500+ partnerships in India for our export markets. In addition, we have offices and a robust presence in India, Egypt, Ukraine, Iran, UAE, Colombia, USA, and Germany. With a robust mechanism in place, NEWEDGE Overseas undertakes due diligence of the supply chain and manages all due processes with commendable ease of operations. So kindly get in touch with us for the premium quality services, including competitive prices and timely delivery of consignments of your pharmaceutical requirements.

Nutraceuticals

Classification of Nutraceuticals

Nutraceutical is the amalgamation of two words Nutrients and Pharmaceuticals. Nutraceutical term has been derived from nutrition which is generally derived from plants or animals and used to provide the physiological benefit in protecting or treating the disease. Before further classification of Nutraceuticals, let us discuss an overview of the Nutraceutical industry in India and across the globe.

According to the joint study report by ASSOCHAM and RNCOS, the Indian nutraceuticals market is expected to reach a value of US$ 8.5 Billion by 2022. In addition, India’s nutraceutical industry is expected to hold at least 3.5 percent of the global market share by 2023. Furthermore, as per Allied Market Research, the global Nutraceutical market is growing at a CAGR of 7.04% and will reach USD 302,306 million by 2022. These results are proof of the rapidly growing nutraceutical industry due to their health benefits.

Now, we will drill down on the various types of Nutraceuticals. The food sources used as nutraceuticals are all-natural and can be categorized as below:

1. Dietary Fiber

Dietary fiber is the food material, more precisely the plant material that is not hydrolyzed by enzymes secreted by the digestive tract but digested by microflora in the gut. In simple words, dietary fiber includes the parts of plant foods your body can’t digest or absorb.

Your body breaks down and absorbs other food components such as fats, proteins, or carbohydrates. However, your body doesn’t digest fiber. Instead, it passes relatively intact through your stomach, small intestine, colon, and eventually out of your body.

Dietary fibers may be divided into two forms based on their water solubility.

  • Insoluble dietary fiber: This type of fiber promotes the movement of material through your digestive system and increases stool bulk, so it can benefit those who struggle with constipation or irregular stools. Whole-wheat flour, wheat bran, nuts, beans, and vegetables, such as cauliflower, green beans, and potatoes, are good sources of insoluble fiber.
  • Soluble dietary fiber: This fiber dissolves in water to form a gel-like material. It can help lower blood cholesterol and glucose levels. Soluble fiber is found in oats, peas, beans, apples, citrus fruits, carrots, barley, and psyllium.

Water-soluble dietary fiber and dietary fiber & slim biome are some examples of nutraceutical products.

Nutraceuticals

2. Probiotics

Probiotics are live bacteria and yeasts that are good for you, especially your digestive system. We usually think of these as microorganisms that cause diseases. But your body is full of bacteria, both good and bad. Probiotics are often called “good” or “helpful” bacteria because they help keep your gut healthy.

You can find probiotics in supplements and some foods, like yogurt. Doctors often suggest them to help with digestive problems. More examples of food rich in probiotics are unpasteurized sauerkraut and kimchi, miso soup, soft cheese, enriched milk, naturally fermented sour pickles, and sourdough bread. Probiotics and Enzymes, pre-probiotics, probiotics 10, probiotics 20, probiotics are known nutraceuticals.

3. Prebiotics

Prebiotics are dietary ingredients that beneficially affect the host by selectively altering the composition or metabolism of the gut microbiota. Prebiotic consumption helps improve metabolism as it generally promotes the Lactobacillus and Bifidobacteria growth in the gut.

Scientific literature indicates that increasing prebiotic fiber intake supports immunity, digestive health, bone density, regularity, weight management, and brain health. Foods rich in prebiotic fiber are onions, garlic, wheat bread/bran, asparagus, barley, apple with skin, oatmeal, chicory roots, banana, tomato, beans, peas, etc. Pre-probiotic with zinc for children is an example of a prebiotic nutraceutical product.

Nutraceuticals

4. Polyunsaturated fatty acids

Polyunsaturated fatty acids (PUFAs) are also called “essential fatty acids” as these are crucial to the body’s function and are introduced externally through the diet. They are divided into omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids, differing in the first double C-bound position. Studies suggest that omega-3-fatty acids are helpful in cardiovascular diseases as they prevent irregularities in the force or rhythm of the heart and promote the reduction of lipid concentrations in the serum. Furthermore, omega-3-oils are helpful in premature infant health, bipolar and depressive disorders, dysmenorrhea, and diabetes. Sources of PUFA include walnuts, sunflower seeds, sesame seeds, peanut butter and peanuts, flaxseed, poppy seed, and avocado/ olive/ safflower oils. In addition, omega-3 capsules, gels, fish oil are some popular nutraceutical products.

5. Antioxidant vitamins

Vitamins like vitamin C, vitamin E, and carotenoids are collectively known as antioxidant vitamins. Antioxidants are our first line of defense against free radical damage and are critical for maintaining optimum health and wellbeing. In addition, these vitamins act singly and synergistically to prevent oxidative reactions leading to several degenerative diseases, including cancer, cardiovascular diseases, cataracts, etc. These vitamins are abundant in many fruits and vegetables and exert their protective action by free-radical scavenging mechanisms. Some examples of antioxidant nutraceuticals are Vitamin C (immunity booster), Vitamin E (Hair and skin products), and multivitamins and minerals.

6. Polyphenols

Polyphenols are natural phytochemical compounds in plant-based foods, such as fruits, vegetables, whole grains, cereals, legumes, coffee, wine, and cocoa. There are approximately 8,000 different classes of polyphenols, the essential being flavonols, flavones, flavan-3-ols, flavanones, and anthocyanins.

Dietary polyphenols can affect numerous cellular processes like gene expression, apoptosis, platelet aggregation, intercellular signaling, which have anti-carcinogenic and anti-atherogenic implications. Moreover, polyphenols also possess antioxidant, anti-inflammatory, anti-microbial, and cardioprotective activities and prevent neurodegenerative diseases and diabetes mellitus.
Red wine, dark chocolate, tea, and berries are some of the best-known sources of polyphenols. Yet, many other fruits, vegetables, nuts, grains, and spices also offer significant amounts of these compounds. For example, green tea polyphenols are widely used nutraceuticals in the market.

Nutraceuticals

7. Spices

Spices are esoteric food adjuncts that have been used for thousands of years to enhance the sensory quality of foods. As per recent research, dietary spices in their minute quantities have antioxidative, anti-inflammatory, immune-modulatory effects on cells. As a result, they have an immense influence on human health. Moreover, a wide range of spices is beneficial for gastrointestinal, cardiovascular, respiratory, metabolic, reproductive, neural, and other systems. Some spices like turmeric, red pepper, black pepper, clove, ginger, garlic, coriander, rosemary, saffron, cardamom, coriander seeds, basil, and cinnamon are vigorously used in various products because of their benefits. For example, amla, cardamon, cinnamon are used in the immunity booster product Chavanprash.

For more scientific details on Nutraceuticals, please visit the article on the Role of nutraceuticals in human health.

Conclusion:

There is an excellent market for the manufacturers and suppliers of Nutraceuticals because of their proven disease prevention capabilities. In addition, consumers are choosing more Nutraceutical products to maintain overall health and indulge in some self-medication.

At NEWEDGE Overseas, we provide contract manufacturing, branding, packaging, and labeling of nutraceuticals. Kindly contact us for various standard and made-to-order nutraceuticals in demand due to their additional therapeutic value.

Pharmaceutical Industry

Potential of the Pharmaceutical Industry Across Various Countries

The Pharmaceutical Industry has been working enormously for the well-being of humankind for thousands of years. Over the past few years, the industry has successfully produced advanced medications and drugs to cure many lethal diseases. In addition, pharmaceutical companies constantly strive towards innovations and research for the betterment of patients.

With every innovation, highly skilled job openings are promoted, and industry workers gain more scientific knowledge, expedite capital formation and long-term economic growth. Moreover, the pharmaceutical industry is essential for international competitiveness. As a result, several countries are economically involved in producing, selling, and exporting pharmaceutical products. Here, we will discuss the potential and statistics, and facts of the multi-billion-dollar global pharmaceutical industry across various countries.

Egypt

With over 120 domestic pharmaceutical companies, Egypt is among the largest producers and consumers of pharmaceuticals in Africa and the Middle East. As per the latest report of Egypt Healthcare, Regulatory and Reimbursement Landscape – CountryFocus, “The Egyptian pharmaceutical market was valued at EGP44.70B ($2.66B) in 2019, which is estimated to increase at a Compound Annual Growth Rate (CAGR) of 8% to EGP56.60B ($3.37B) in 2022. Furthermore, the market value is expected to increase to $3.94B by 2024.”

Ukraine

The pharmaceutical industry in Ukraine is amongst the ten biggest pharmaceutical industries in the Central and Eastern European (CEE) region. Ukraine’s drug market has not recovered from the 2014–2015 crisis, but it is constantly growing. The trend is likely to continue in the coming years. As a result, Ukraine’s pharmaceutical sector is one of the fastest-growing and most crisis-resistant consumer industries in the economy. The latest report says that the demand for pharmaceutical products increased in 2016-2020, with a CAGR for a specified period of 11.5%, while capital investments grew at an average rate of 16%.

Pharmaceutical Industry

Turkey

The Turkish pharmaceutical industry ranks 7th in Europe and 16th in the world in market size. However, Turkey has a significant opportunity to become essential services and pharma products supplier for neighboring regions. With a total export potential of USD 8 billion, the market will reach TR 45.6 billion in 2023.

The Turkish pharmaceuticals industry is valued at approximately US$6 billion and represents around 0.5% of the global pharmaceutical market of US$1.2 trillion, having grown steadily in the past decade. Besides increasing its output, the industry has also committed to more R&D projects and manufacturing higher-value drugs.

South Korea

The pharmaceutical market in South Korea is on the increase and is expected to reach more than US$20 billion by 2020. According to a report by research and consulting firm GlobalData, the South Korean pharmaceutical market will observe a Compound Annual Growth Rate (CAGR) of 2.4%, increasing from US$18.6 billion in 2016 to US$20.4 billion by 2020. The government’s increasing focus on generics to reduce healthcare expenditure comes from the robust growth of the pharmaceutical sector.

Pharmaceutical Industry

Colombia

Colombia has a stable and attractive health system. With a population of 50 million, Colombia is the third most populous country in Latin America (after Mexico and Brazil), and 95% of the population is insured under the General Social Security Health System. In addition, Colombia has a diverse product portfolio for the pharmaceutical sector, where half of all sales are in brand-name products and the other half in generic products.

In 2019, the pharmaceutical market in Colombia was worth USD 4.795 billion. That same year, production reached an estimated value of USD 2.944 billion, led by digestive and metabolic health products. Forecasts suggest a sustained growth of 3% for this market by 2022.

Brazil

As the world’s sixth most populous country, Brazil represents an enormous market opportunity in Latin America for multinational pharma companies. Valued at around $23 billion by EY, a global consulting agency, Brazil represented the seventh largest pharma market in the world in 2018.

According to research and consulting firms, the Brazilian pharmaceutical market will expand in value from $29.4 billion in 2014 to reach approximately $47.9 billion by 2020, representing a solid Compound Annual Growth Rate (CAGR) of 8.5% GlobalData.

Mexico

Mexico, which has over a hundred million inhabitants, has become the world’s ninth biggest pharmaceutical market and the largest in Latin America, surpassing Brazil for the first time in its history. The country’s manufacturing infrastructure has also become one of the most modern globally, with many FDA-approved factories.

The sector already represents 1.18% of the national GDP, generating US$9,244 million (source Canifarma). The private sector market is valued at US$7,394 million, and the governmental market, through social security, is estimated at US$1,850 million.

Pharmaceutical Industry

Germany

Germany constitutes the primary European pharmaceutical market and the fourth largest worldwide. More than 500 pharmaceutical companies are located in Germany. Overall, the German pharmaceutical industry has 120,000 people (2019).

The German pharmaceuticals market size was valued at USD 41.4 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 6.0% from 2020 to 2027. Increasing patent applications focused on developing novel drug delivery systems, new drugs, and formulations is anticipated to boost the market for pharmaceuticals.

Conclusion:

Although countries like the USA, U.K., Canada, Japan, India, and Australia, are leading in the pharmaceutical sector, their achievements mentioned above are noteworthy and appreciable.

As a Global Pharma organization, NEWEDGE Overseas exports a wide range of products to more than 40 countries. We have offices and a robust presence in India, Egypt, Ukraine, Iran, UAE, Colombia, USA, and Germany. So kindly contact us for all kind of advanced pharma solutions.

Pharmaceutical APIs

11 Therapeutic Categories of Pharmaceutical APIs and Their uses

The Active Pharmaceutical Ingredients market comprises the largest segment of the Indian pharmaceutical sector. India is the third-largest Pharmaceutical APIs market in Asia-Pacific. As per the BusinessWire report, the Indian API Market stood at USD 11806.93 million in FY 2021 and will grow at a CAGR of 12.24% during the forecast period. The Indian API Market is segmented based on the synthesis, source, therapeutic application, drug type, company, and region. Out of the various therapeutic categories, we will discuss 11 trending therapeutic categories of APIs and their uses. All the therapeutic categories, pharmacologic class, and formulary key drug types are available on the FDA website, and their scientific definitions are available on the Britannica website. However, we have delineated some of the most prominent APIs that rule the markets and are always in demand.

1. Anesthetics

Anesthetics are agents capable of inducing a total or partial loss of sensation, especially tactile sensation and pain. They can be induced as general ANESTHESIA to generate an unconscious state of mind or administered locally to induce numbness or lack of sensation at a targeted site.
Anesthetic drugs are widely used in medical operative procedures. Examples of anesthetics APIs are Lidocaine, Bupivacaine, Levobupivacaine, Ropivacaine, Mepivacaine, Prilocaine, Benzocaine, etc.

Pharmaceutical APIs

2. Analgesics

Analgesics are also called painkillers. Analgesics do not turn off nerves or change the ability to sense your surroundings, or alter consciousness. That is the main difference between Analgesics and Anesthetics. Analgesics may be classified into two types: anti-inflammatory drugs, which alleviate pain by reducing local inflammatory responses, and opioids, which act on the brain.

They are used to relieve pain after surgery, headache, cancer, menstruation, arthritis, nerve damage, etc. Examples of Analgesics are Diclofenac Sodium, Buprenorphine HCl, Phenazone, Sodium Salicylate, Meptazinol HCl, Acetaminophen, Aspirin, etc.

Pharmaceutical APIs

3. Antihistamine

Antihistamines are medicines that treat allergies by blocking the effects of histamine. An allergy is an immune response, or reaction, to substances (allergens) that are usually not harmful. When the oversensitive immune system recognizes an allergen, it launches a response. As a result, chemicals such as histamines are released. These chemicals lead to allergy symptoms.
Antihistamines treat allergy symptoms such as congestion, runny nose, sneezing, itching, hives, skin rashes, runny eyes, etc. Some examples of Antihistamines are Fexofenadine, Chlorpheniramine, Levocetirizine, Pheniramine Maleate, Hydroxyzine, etc.

Pharmaceutical APIs

4. Antifungal

The antifungal drug is the type of substance that acts selectively against fungal pathogens (disease-causing organisms) while treating fungal infections (mycosis). There are three major antifungal groups: the polyenes, the azoles, and the allylamines. These groups are distinguished primarily by chemical structure and mechanism of action.

Antifungals treat skin, nails, mucous membranes infections, jock itch, athlete’s foot, vaginal yeast infection, and ringworms. Some standard Antifungal APIs are Clotrimazole, Fluconazol, Miconazole, Terbinafine, Itraconazole, Piroctone Olamine, etc.

Pharmaceutical APIs

5. Antibiotic

Antibiotics fight bacterial infections/germs in people and animals. They kill the bacteria or keep them from copying themselves or reproducing.
Antibiotics are used to treat ear and sinus infections, dental infections, skin infections, meningitis, strep throat, bladder and kidney infections, bacterial pneumonia, whooping cough, etc. Some commonly used antibiotics are Amoxicillin, Azithromycin, Cefadroxil, Doxycycline, Erythromycin, Mupirocin, Piperacillin, Tedizolid, etc.

Pharmaceutical APIs

6. Antipsychotic

Antipsychotics are used to treat symptoms of psychosis such as delusions, hallucinations, paranoia, or confused thoughts. In addition, they are used to treat schizophrenia, severe depression, and severe anxiety. Antipsychotics are also helpful at stabilizing episodes of mania in people with bipolar disorders. Examples of antipsychotic drugs are Aripiprazole, Asenapine, Cariprazine, Chlorpromazine, Clozapine, Lurasidone, Olanzapine, Quetiapine, Ziprasidone, etc.

Pharmaceutical APIs

7. Vitamins

Vitamins are therapeutic nutrients, minerals, or electrolytes to support the body’s immune and healing systems, thereby altering the course and outcome of a disease process. Vitamin B complex, B1, B3, B12, Vitamin C, Vitamin D, Vitamin K, Vitamin K are vigorously used for various diseases. Some commonly prescribed vitamins are Ascorbic Acid, Benfotiamine, Folic Acid, Niacinamide, Hydroxocobalamin, Calcium Pantothenate, Alfacalcidiol, etc.

Pharmaceutical APIs

8. Antidepressants

Antidepressants are a class of drugs prescribed to relieve or treat symptoms of depression. There are different types of antidepressant drugs which can be popularly categorized as: tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and selective serotonin reuptake inhibitors (SSRIs). Other important groups include the norepinephrine reuptake inhibitors (NRIs), the serotonin-norepinephrine reuptake inhibitors (SNRIs), and the atypical antidepressants, a disparate group of agents with unique structural features and mechanisms of action.

The primary use for antidepressants is treating clinical depression in adults. However, they are also used for other mental health conditions and long-term pain treatment. Some majorly used antidepressants are Amitriptyline, Citalopram, Clomipramine, Doxepin, Escitalopram, Milnacipran, Sertraline, Paroxetine, Venlafaxine, etc.

Pharmaceutical APIs

9. Antidiabetic

Antidiabetics are drugs that work to lower abnormally high glucose (sugar) levels in the blood, which are characteristic of the endocrine system disorder known as diabetes mellitus. Antidiabetic drugs are commonly used to treat and manage diabetes. Antidiabetic drug examples are Alogliptin, Glimepiride, Glipizide, Metformin HCl, Pioglitazone, Saxagliptin, Sitagliptin, etc.

Pharmaceutical APIs

10. Cardiovascular

Cardiovascular drugs affect the function of the heart and blood vessels. Therefore, drugs that act on the cardiovascular system are most widely used in medicine. Examples of disorders in which such drugs may be helpful include hypertension, chest pain, heart failure, high cholesterol, and disturbances of cardiac rhythm. Some commonly used cardiovascular drugs are amlodipine Maleate, Clopidogrel, Dopamine HCl, Levosimendan, Trimetazidine HCl.

Pharmaceutical APIs

11. Anticancer

Anticancer drugs are also called antineoplastic drugs, effective in treating malignant or cancerous diseases. Common anticancer drugs include alkylating agents, antimetabolites, natural products, and hormones. In addition, several drugs do not fall within those classes but demonstrate anticancerous activities and thus are used to treat malignant diseases. Popular anticancerous drugs are Enzalutamide, Palbociclib, Ibrutinib, Ribociclb, Pemetrexed Disodium, etc.

Pharmaceutical APIs

NEWEDGE Overseas has a robust 2000+ Active Pharmaceutical Ingredients portfolio that includes many hard-to-find APIs consolidated over a decade. Kindly contact us for your APIs, FDFs, Intermediates, Nutraceuticals, or other requirements.

supply chain

Supply Chain Management in Pharmaceutical Industry

Successful supply chain management is an essential tool for pharmaceutical companies to boost company sales and lower expenses. To provide quality products at a reasonable cost, companies need to maintain an adequate supply chain across the country and globe. Following are some salient pointers on supply chain management:

What is Supply Chain Management?

Supply chain management is defined as a fusion of the processes starting from procuring raw materials, manufacturing of goods to providing finished products to the customers. It is a systematic business model which integrates supply and demands within stakeholders and customers to gain competitive advantages in business. The primary goal of any supply chain management process is enhancing accessibility, quality, and affordability.

supply chain
How does the Supply Chain Work in the Pharmaceutical Industry

The Pharmaceutical supply chain includes multiple government agencies, hospitals, clinics, drug manufacturers, drug distributors, pharmacy chains, retailers, research organizations, and the FDA. As a result, expectations from the supply chain managers in the pharmaceutical industry are very high as drugs supplied inappropriately can damage customer loyalty and public health.  The flow of the supply chain in the pharmaceutical industry can be described in the following steps:

  • The drug product is manufactured at the company site
  • It is transferred to the wholesale distributors
  • Stocked at pharmacies for retail or online purchase
  • Subjected to price negotiations and processed through quality and utilization management screens by pharmacy benefit management companies
  • Dispensed by pharmacies and ultimately taken by patients

supply chain

Challenges of Supply Chain Management

Here are some significant challenges which can hinder the supply chain and should not be overlooked:

  • Maintaining the quality of drugs
  • Timely delivery of products
  • Sustaining the desired temperature throughout the transport for particular drugs
  • Inventory and warehouse management
  • Order and shipment management
  • Taking care of expiry of products
  • Managing the delivery of drugs during any shortage

Digitalisation as per the current needs

A robust supply chain is essential to meet the dramatic changes of the pharmaceutical industry, and hence digitalization is the key to transformation. As a result, pharmaceutical companies must evaluate their existing supply chain strategies to improve efficiency and ensure optimum product quality. The cornerstone of a multi-enterprise supply chain is a digital business network. Digitalization electronically links all of the supply chain partners across the cloud. It makes it possible for them to work together when pharmaceutical supply chain partners are related and offers end-to-end visibility and an incentive for multiple business interactions to collaborate.

supply chain

How did Covid 19 Pandemic change the dynamics of the Supply Chain?

The covid 19 pandemic has exposed some supply chain deficiencies that must be addressed and corrected for the future. For example, during the lockdown in several countries, the supply of raw materials and APIs were highly affected, resulting in delayed production of finished dosages. Therefore, the industry must not rely on only a few sources of supply to avoid shortages and crises. Today, pharmaceutical companies are vigilant and paying close attention to their suppliers, and maintaining constant contact through digital technologies as a learning lesson.

Conclusion:

The performance of pharmaceutical companies can vary based on the efficiency of supply chain management. Companies have to identify the risks related to the supply chain and prevent them from avoiding business risks. Hence, it is essential to maintain adequate supply chain management in the Pharmaceutical Industry. With a robust mechanism in place, NEWEDGE Overseas undertakes due diligence of the supply chain and manages all due processes with commendable ease of operations. Moreover, our supply chain resilience extends to hard-to-find APIs. Moreover, with tech empowerment and a robust network, we can maintain a speedy supply chain. Kindly contact NEWEDGE Overseas for premium quality services.

Pharmaceutical Industry

5 Latest Trends and Technologies of Pharmaceutical Industry in 2021

The pharmaceutical sector has been witnessing a remarkable transformation in recent years. Unlike other industries, the pharmaceutical industry has its niche for digitalization in research and development, sales and distribution, and other areas. New techniques have significantly increased high quality and low price medicines resulting in the success of the industry.

The Indian pharmaceutical companies have been facing challenges due to the Covid 19 Pandemic such as reliance on raw materials from foreign countries, taxations, market competitiveness, increased regulatory inspection, price controls, etc. However, the time has come to carve the future of Indian Pharmaceutical companies by adapting and following the latest Trends and Technologies of the Pharmaceutical Industry viz.

1. Use of Real World Data

Pharmaceutical Industry
The use of reliable and accurate value data is the prerequisite of the pharmaceutical industry. Hence, Real-world data (RWD) is the industry’s surfacing trend and plays a vital role in healthcare decisions. For example, the USFDA uses real-world data along with real-world evidence to determine a product’s safety and identify adverse events before making regulatory decisions. The product development and approval process function smoothly with the help of RWD. In addition, RWD is used to support pragmatic clinical and large simple trials. Systematic collection of health reports of patients, treatment data, and health status are included in RWD. Mobile phones, computers, biosensors, and wearable devices also collect and store health-related data with advancements in new technology. The analytical proficiency of RWD helps to conduct clinical trials in a better way.

2. Use of Precision Medicine

Pharmaceutical Industry
Precision medicine is one of the most attention-seeking pharmaceutical trends of 2021. As per the CAGR – Report by Market Research Future (MRFR), the market size of precision medicine will be worth USD 126.14 Billion by 2025 at a growth rate of 12.48%. As per the National Library of Medicine, Precision Medicine can be defined as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” Each human body responds to the drugs differently, and hence the idea of precision medicine intervenes. Pharmaceutical companies need to reevaluate their manufacturing practices to incorporate precision medicine as it will require a new regulatory, clinical, economic, and technical structure. Precision medicine gives a contemporary approach to the diagnosis of disease, treatment, and prevention. It supports the setting of dosage forms for patients by taking care of different clinical parameters such as age, sex, human genes, handling of more than one illness, etc.

3. Digitalization and Automation in the Supply Chain

Pharmaceutical Industry
Digitalization and automation in the supply chain are the dire need of companies to increase business in the competitive market. With technological advancements, digital data helps expedite the distribution of products in the market effortlessly. Therefore, to maintain an appropriate supply chain, pharmaceutical companies need a robust digital network. The use of machine learning and artificial intelligence in the supply chain minimizes the overall length of the production cycle, product storage, and distribution. Furthermore, streamlining the supply chain establishes smooth communication between researchers, organizations, and distributors, ultimately resulting in better product efficacy. As a result, many companies have started investing in digital and automatic drug supply chains to increase their efficiency of the business, cost reductions, and, most importantly, patient safety.

4. Use of Artificial Intelligence Technology

Pharmaceutical Industry
Currently, artificial intelligence is playing a pivotal role in the healthcare sector. As per the Grand View Research, “the global artificial intelligence in healthcare market size was valued at USD 6.7 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 41.8% from 2021 to 2028.” With artificial intelligence, drug discovery and development processes are getting accelerated at a significant level in the industry. This technology helps to find molecules for drugs and their development from the initial stage with better adequacy. Moreover, startup companies are using artificial intelligence to assist manufacturing processes, marketing, and post-launch strategies. In addition, artificial intelligence gives a practical approach for patient identification and eligibility for clinical trials. Thus, it makes the process faster and lower in price.

5. Growth in the Contract Manufacturing Organization Market

Pharmaceutical Industry
As per the latest market research, the “global pharmaceutical contract manufacturing market is likely to tread along a healthy growth track over the forecast horizon.” The main reasons for the increasing popularity of contract manufacturing are cost-efficiency and timely delivery of products. In addition to this CMO includes services such as clinical testing, product development, manufacturing of APIs and FDFs, regulatory support, etc. As a result, pharmaceutical companies can utilize their expertise, innovation, and insight to become more successful in the market. Moreover, it benefits the companies with the range of facilities, types of equipment, added drug variations, and meeting of the market demands leading to an improved scale of the business.

Summary:

We have discussed the latest trends and technologies shaping the present and future of the pharmaceutical industry. At NEWEDGE Overseas, with empowered technology and market intelligence, we provide advanced pharmaceutical solutions

Pharmaceutical Industry

Significance of Patents in the Pharmaceutical Industry

Patents in the pharmaceutical industry are significantly crucial to get increased revenues in the commercial market. With tremendous advancements in technology, new drugs are coming into the market rapidly. Drug patents help ensure the safety of the innovation and regain heavy investments for the overall economic growth of the companies. Let us understand the term Drug Patents and the importance of patents in the pharmaceutical industry.

What are Drug Patents?

Pharmaceutical companies go through the development process of a new drug and apply for the patent to gain its exclusivity. When the drug is under patent protection, only the pharmaceutical company that holds the patent can manufacture, market the drug, and eventually profit from it. Patent terms are set by statute. Currently, the term of a new patent is 20 years after filing the patent in the United States. Many other factors can affect the duration of a patent. Other companies can manufacture and sell the drug product after the expiration of the patent period as the generic drug. The brief discussions about the patent and its exclusivity are available on the USFDA website for further insight.

Pharmaceutical Industry

Which are the Types of Pharmaceutical Patents in India?

As per the Indian Patent Law, an invention is patentable if it meets the following requirements.

  • The invention must be new, and it is not a part of any publishing document in India.
  • The patent must be an invention that has both technological advancements and economic growth.
  • The invention that the patent refers to must be capable of industrial utilization.

Pharmaceutical Industry
Classification of patents is described below as per the Guidelines for Examination of Patent Applications.

  • Drug Compound Patents: These patents claim a drug compound as per its chemical structure and are known as Markush type claims. A Markush claim has multiple “functionally equivalent” chemical entities allowed in one or more parts of the drug compound. Drug compound patents provide the broadest protection to the inventor of a drug; these prevent other companies from preparing a similar drug. No one is allowed to produce or sell any formulation involving this drug until the granted patent expires.
  • Synergistic Combination Patents: Drug synergy occurs when two or more drugs interact to magnify or enhance the effects of those drugs. As a result, the companies can obtain patents on new synergistic combinations of the drugs.
  • Technology Patents: These patents are based on the techniques used to solve specific technology-related problems like stabilization, taste masking, increase in solubility, etc.
  • Polymorph Patents: Polymorphs are different physical forms or crystal structures of an already known compound. Polymorphs are usually prepared to reduce impurities or increase the stability of the compounds. These types of patents allow innovative firms to protect the improved versions of their original drugs.
  • Process Patents: A process patent does not claim the product. Instead, it only covers a new and inventive process to produce a particular product.

Why are Patents the most necessary Intellectual Property right?

Patents are the backbone of the pharmaceutical industry among all intellectual property rights. They are the exclusive property rights of the patentee obtained against the invention for 20 years. Patents contribute 70-80% share of the companies’ total revenues in the pharmaceutical sector. Moreover, patents prevent infringement of companies’ products and processes, ultimately giving a competitive advantage in the market. In addition, patents are the vital safeguard of their innovations and to obtain data exclusivity. Thus, companies need a productive intellectual property strategy for solid patent protection.

Pharmaceutical Industry

How are innovations in the Pharmaceutical Industry related to Patents?

Innovation is the main criteria that differentiate research-based companies and generic companies. As a result, pharmaceutical companies invest massively in the innovations, research, and development of new drugs.

Innovation is the driving factor for the success of pharmaceutical drug manufacturers as it provides high returns on investment. In addition, with many risk factors associated with launching a new drug in the market, innovation provides profitability benefits.

Conclusion:

We have discussed the significance of patents in the pharmaceutical industry. After the company gains patent rights, it can transfer the rights through licensing to other companies. Nowadays, many organizations outsource their patents to third parties for increased revenues. At NEWEDGE Overseas, we offer licensing of intellectual properties, patenting of products and processes, facilitating trademark/brand name use, copyrighting of processes and technologies, providing technical advice and assistance, and opportunities to launch differentiated or specialized products.