Drug Formulation: The Complete Pharmaceutical Guide

Drug formulation refers to the process of developing a drug product that contains a specific volume of an active pharmaceutical ingredient (API) and other necessary factors in a form suitable for administration to patients.

Importance of Drug Formulation

The formulation process is critical to the pharmaceutical industry for several reasons:

Enhancing Drug Efficacy

Formulation helps optimize the drug's therapeutic effect and ensure its safety by developing a product that delivers the active component effectively while minimizing adverse effects.

Ensuring Patient Compliance

Formulations are designed to make medicines easier to administer and improve treatment adherence.

Expanding Market Opportunities

Different formulations can target different patient populations, improving access to treatment.

Patent Protection

New formulations can extend patent protection, providing additional exclusivity.

Drug Formulation Development Process

1. Pre-formulation Studies

Characterization of the API's physicochemical properties to identify the most suitable form for formulation.

2. Formulation Design and Optimization

Developing a stable, bioavailable formulation that meets quality, safety and efficacy requirements.

3. Drug Delivery Systems

Designing systems to optimize delivery and improve compliance through various administration routes.

Types of Drug Formulations

Solid Dosage Forms

Tablets, capsules, powders, granules, and sustained-release formulations.

Liquid Dosage Forms

Solutions, suspensions, emulsions, and syrups.

Semisolid Dosage Forms

Creams, ointments, and gels for topical application.

Manufacturing Challenges

Key challenges include maintaining consistency, controlling costs, scaling up production, and ensuring regulatory compliance with GMP standards.

Regulatory Aspects

FDA regulations, Good Manufacturing Practices (GMP), and compliance requirements govern drug formulation to ensure safety and efficacy.

Future of Drug Formulation

Advancements in technology will enable more personalized and precision medicines through innovative delivery systems and targeted therapies.

Pharmaceutical Marketing in UAE: Trends and Future Outlook

Pharmaceutical marketing in UAE has been growing in recent years due to the country's increasing population and high standard of living. The question is whether the existing strategy for pharmaceutical marketing will be effective in the rapidly changing environment of patient advocacy, preventative care, and strict requirements for outcome verification. However, we believe pharmaceutical marketing in UAE has a promising future.

The UAE has a highly developed healthcare system, and many residents have private health insurance. Pharmaceutical companies can utilize this opportunity by marketing their products to private hospitals and clinics. In addition, the UAE has a high level of internet penetration, which provides another avenue for pharmaceutical marketing.

The One-Size-Fits-All Strategy Will No Longer Be Effective

Traditional marketing tactics in this sector have centered on aggressively promoting prescription medications that decision-makers believe would generate revenue. Aggressive digital marketing and promotional efforts are typically directed at physicians and are credited with commercial success. The primary objective hasn't always been to meet the needs and expectations of patients, providers, and payers, but that's about to change.

Pharmaceutical marketing is complicated and often follows two routes: direct-to-consumer or direct-to-provider/payer. Unfortunately, nowadays, pharmaceutical companies rarely make a distinction between these two channels. They frequently adopt a one-size-fits-all strategy. This is contrary to current thinking, which emphasizes personalization, customer experience, and targeted omnichannel marketing utilizing the appropriate product, at the proper time, for the relevant user, and with the suitable media.

Value-Based Healthcare is Now the Norm

More value than ever is expected from pharmaceutical makers in our rapidly evolving industry. Value in this context refers to increased cost-effectiveness, validated patient outcomes, and increased value added along the entire value chain to the patient experience.

Value-based health care continues to be hampered by the strict regulations and environment around pharmaceutical marketing. Notably, little evidence points to a quick improvement in the regulatory environment for marketing pharmaceuticals.

A Multidisciplinary Strategy for Providing Healthcare

The healthcare system is adopting a multidisciplinary approach to healthcare in response to the developing trend toward integrated health management. Pharmaceutical companies are responding with more individualized, enhanced products tailored to satisfy patients' unique needs across the healthcare value chain.

In addition, the UAE's strategic location and status as a regional hub for trade and commerce make it an attractive market for pharmaceutical companies. However, the UAE's pharmaceutical market is still in its early stages of development and lacks regulations and guidelines governing pharmaceutical marketing practices. Therefore, it can create challenges for companies that want to enter pharmaceutical marketing in UAE.

We at Pharmadeel provide pharmaceutical consultancy and medical services in UAE, such as cosmetics, skincare products, pharmaceuticals, vitamins & supplements, nutrition, gym & fitness equipment, etc., at affordable costs.

Top Medical Companies Worth Buying for Long-Term Investment

After the S&P 500 record's 10% year-to-date revision, there's no shortage of attractively valued stocks for long-term investors.

One area that is stacked with inexpensive stocks is healthcare. This sector currently has a forward price-to-earnings (P/E) ratio of 15.1, well below the average forward P/E ratio of 18.6 for the S&P 500 index.

1. CVS Health

CVS Health (CVS) is the second-largest health insurer in the world, just behind UnitedHealth Group. With the growing global healthcare demand, CVS is in a strong position to capitalize on the market's expansion through its Aetna business.

Analysts expect CVS to grow its earnings by 6% annually over the next five years. Investors can also benefit from CVS's 2.1% dividend yield, which is currently available at a forward P/E ratio of just 11.7, making CVS an attractive buy.

2. Amgen

Amgen (AMGN) is one of the world's top 10 pharmaceutical companies with a strong portfolio of drugs, including Prolia, Xgeva, and Otezla. Amgen's future growth looks promising, with 40 compounds currently in clinical trials.

Amgen's earnings are projected to grow by 7% annually over the next five years, and it offers a 3.3% dividend yield. With a forward P/E of 12.2, Amgen offers a compelling mix of growth and income potential.

3. Sanofi

Sanofi (SNY), based in France, is a major player in the pharmaceutical industry with a market cap of $122 billion. Sanofi's blockbuster drugs, such as Dupixent (co-owned with Regeneron), are driving growth, along with a robust pipeline of

Meeting the Growing Demand in Pharmaceutical Manufacturing

Patterns in the present population give pharmaceutical companies a dual challenge. On one side, the aging population is increasing rapidly. A new UN study forecasts that the 65+ age group will rise from 9% to 16% worldwide by 2050, and the 80+ group is projected to triple. Yet, about 30% of the global population lacks access to essential medicines. As people live longer with better access to healthcare, the demand for pharmaceuticals intensifies.

However, increasing production has its hurdles. The pharmaceutical industry faces disruptions, with facility or product quality failures being the leading cause of drug shortages, accounting for 66% of shortages. Manufacturers must adopt innovative technologies to meet this demand and improve the drug lifecycle.

Key Risk Factors for Pharmaceutical Manufacturing

1. Managing Environmental Conditions

Optimal environmental conditions are crucial in production and storage. Poorly managed conditions can lead to quality control failures, regulatory violations, and energy inefficiencies. In fact, 60% of electrical energy is consumed by environmental control, with about 8% wasted annually.

Solution: A dedicated system to monitor and control environmental conditions, continuous energy monitoring, and adherence to regulatory standards can enhance quality and reduce energy usage.

2. Physical Infrastructure Failure

The integrity of utilities and plant equipment is vital. Power disruptions, even minor ones, can cause sterility loss, equipment failure, and product loss. Ensuring a stable power supply is essential for maintaining data integrity and avoiding costly IT failures.

Solution: On/off-site renewable energy sources can help ease the strain on public grids. Advanced technologies like AI, simulations, and IIoT sensors can prevent equipment failures by enabling real-time monitoring and analysis.

3. Non-compliance

Regulatory requirements ensure drug safety. However, data issues account for 79% of FDA warning letters in the last five years. Non-compliance due to missing or incorrect data can lead to production delays, fines, or license suspensions. Cybersecurity threats also play a role in non-compliance, with two-thirds of pharmaceutical companies experiencing data breaches.

Solution: Digitizing workflows and validation processes can help ensure regulatory compliance, improve data integrity, and reduce human error. Implementing cybersecurity measures is also essential to protect data.

4. Being Responsive to Operational Issues

Agility is key for pharmaceutical manufacturers to adapt to incidents and changing needs. Complex systems and a lack of standardized procedures can hinder responsiveness and increase operational costs.

Solution: Implementing standard operating procedures (SOPs) across facilities can help streamline responses to incidents. Digital twins, AI, and cloud technology enable real-time data analysis to improve decision-making and efficiency.

5. Sustainability Challenges

Energy management and sustainability are critical business drivers. Efficient energy, water, and waste management reduce costs and improve brand reputation, contributing to financial gains and investor confidence.

Solution: Centralized platforms for monitoring energy consumption and sustainability KPIs allow companies to track progress towards carbon-neutral goals. Transitioning to renewable energy sources also supports sustainability efforts.

The Power of Digitization

Pharmaceutical companies face immense pressure to meet product demand while achieving operational efficiencies and sustainability goals. Cutting-edge facilities must embrace innovative technologies like AI and data digitization to improve decision-making, ensure regulatory compliance, and drive sustainability in pharmaceutical manufacturing.

Pharmaceutical Cloud Solutions: Transition and Benefits

The transition to digitalization and the movement to the cloud have steadily advanced in the pharmaceutical industry. Many organizations have been held back by outdated digital strategies, a lack of in-house expertise, and concerns about the security risks of cloud migration. However, the long-term savings and operational efficiencies that cloud-based models offer outweigh the short-term costs.

Embracing the Cloud

Recently, pharmaceutical companies are moving into a phase of active cloud adoption, recognizing that this shift is essential for digital transformation. Moving from traditional on-premises software to cloud-based systems, where data is stored on a global network of servers, is becoming more common. Many companies opt for hybrid cloud approaches, combining on-premises infrastructure, private cloud services, and public cloud solutions.

Pharmaceutical Cloud: Accelerating Drug Development

Pharmaceutical digital transformation and the cloud are intrinsically connected. The ongoing drive for faster time-to-market and scalability has been intensified by the COVID-19 pandemic. The rapid rollout of vaccines has set a new standard for speed in drug production, creating pressure for companies to integrate advanced technologies.

Cloud-based models enhance operational efficiency and accelerate drug development by offering better data accessibility and analytics. Today, pharmaceutical companies are adopting hybrid cloud frameworks to relieve IT burden, cut costs, and improve decision-making through data analysis.

Creating a Cloud Strategy

Many companies are implementing cloud-based solutions using AI and predictive analytics to boost efficiency and reduce errors in drug production. Moving data to the cloud allows firms to integrate disparate sources such as manufacturing systems, lab data, and ERP solutions, creating a unified business view for better decision-making.

As data sources grow, so do the opportunities for AI-driven analytics. Cloud solutions facilitate real-time insights and predictive capabilities that minimize equipment downtime and prevent errors before they happen.

Reaping the Benefits of Cloud Solutions

Pharmaceutical companies can achieve significant cost savings by moving to the cloud. On-premise IT setups require significant investment in hardware and ongoing maintenance, which smaller companies often struggle to afford. Cloud-based models eliminate much of this cost, allowing companies to focus on innovation rather than infrastructure.

Cloud solutions also streamline operations by reducing manual processes and enabling automated workflows, ultimately speeding up drug development. This increased efficiency improves reliability in the supply chain, ensuring that products are available when needed.

Moving to the cloud is becoming a critical step for pharmaceutical companies looking to gain a competitive advantage. By utilizing cloud data, companies can make more informed decisions, cut costs, and bring life-saving drugs to market faster.

Pharmaceutical Industry in Jordan: Market Overview and Registration Process

Country Information

Capital: Amman (Population: 2.5 million in 2006).

Main Port: Port of Aqaba.

Population (2021): 10.23 million (including Palestinian, Syrian, and Iraqi refugees).

Top 5 Causes of Death (2019)

1. Ischemic heart disease
2. Stroke
3. Diabetes
4. Chronic kidney disease
5. Hypertensive heart disease

Economy

GDP (2020): USD 43.698 billion

GDP per capita (2020): 4,282 USD

GDP growth rate (2020): -1.55%

Gross National Income (GNI 2020): 10,320 USD (PPP)

Trade

Exports (2019): JD 4.99 billion, including food, livestock, unrefined materials, apparel, and plastic products.

Main Export Destinations: United States, Saudi Arabia, Iraq, Kuwait, UAE, India, and more.

Imports (2019): JD 13.72 billion, a 4.9% decrease from the previous year.

Pharmaceutical Market Status

Jordan's pharmaceutical industry imports most active pharmaceutical ingredients (API) from India and China, while excipients are primarily sourced from Europe.

80% of pharmaceutical products in Jordan are exported, with 20% for domestic use. The pharmaceutical sector is the second-largest export industry after garment manufacturing.

Jordan Drug Registration Process

Drug registration in Jordan involves submitting documentation on the drug’s chemical composition, clinical data, manufacturing facility, and other technical aspects.

Registration generally takes about a year, and the drug must be approved for sale in its country of origin or a JFDA reference country.

Jordan FDA official website: http://www.jfda.jo

PAI Pharmaceutical Expands with Acquisition of Teligent Assets

PAI Acquires Teligent’s U.S. Marketing Authorizations

Pharmaceutical Associates, Inc. (PAI) has acquired all the generic and branded U.S. marketing authorizations from Teligent Inc. (Teligent) for an undisclosed sum. This acquisition marks PAI's entry into sterile injectable and topical products.

Strategic Expansion into Sterile Injectables and Topical Products

The acquisition includes a portfolio of over 60 generic and branded applications, with around 50 approved applications and a pipeline of more than 15 additional filed products. PAI plans to commercialize select products from the portfolio, focusing on key U.S. market opportunities.

Comments from PAI Leadership

The Chief Commercial Officer of PAI stated, "This acquisition broadens our portfolio, specifically in sterile injectable products, and provides PAI with a platform to continue delivering value to our customers."

PAI's Chief Operating Officer added, "This is an exciting time for PAI. We are confident in our ability to launch the products acquired from Teligent, and we will continue to expand our portfolio through a combination of internal R&D and smart business development deals like this one."

Teligent’s Chapter 11 Filing and Asset Sale

In October 2021, Teligent filed for voluntary protection under Chapter 11 of the U.S. Bankruptcy Code. As part of this process, Teligent initiated a sale of its core assets, leading to PAI’s agreement to acquire Teligent’s U.S. filings.

Digitalization in the Pharmaceutical Industry

Digitalization is gaining momentum in many areas of the pharmaceutical business. Marcus Michel, CEO of ACG Engineering, discusses the impact of Industry 4.0 in pharmaceutical manufacturing, focusing on digital advancements such as AI, Big Data, and the Industrial Internet of Things (IIoT).

Key Digitalization Trends

PharmTech: What trends do you see in digitalization for pharmaceutical manufacturing equipment?

Michel (ACG): Industry 4.0, also known as the "Fourth Industrial Revolution," is transforming drug manufacturing. Technologies like Big Data, artificial intelligence, cloud computing, and advanced analytics are being employed to address rising complexities, reduce costs, and improve quality. AI-powered smart factories, predictive analytics, and remote machine maintenance are key innovations reshaping the industry.

Challenges in Digitalization

PharmTech: What do you consider the biggest hurdles to adopting these new technologies?

Michel (ACG): Major challenges include infrastructure integration, data sharing, cybersecurity, regulatory compliance, and workforce upskilling. IIoT infrastructure investments and legacy system upgrades are costly but essential to fully unlock the benefits of digital transformation.

Workforce Training

PharmTech: What are the workforce training needs for adopting Industry 4.0 technologies?

Michel (ACG): Successful adoption of Industry 4.0 requires collaboration between equipment manufacturers and pharma companies. Digital literacy, cybersecurity, and the ability to adapt to new technologies are critical skills needed for workforce development.

The Future of Digitalization in Pharma

With the post-pandemic focus on digital technologies, the pharmaceutical industry is poised for full-scale digital adoption. Increased connectivity, real-time analytics, and AI-driven processes are expected to improve productivity, compliance, and manufacturing efficiency.

Niner Pharmaceuticals LLC

 

Niner Pharmaceuticals LLC is a pharmaceutical company based in Dubai. With a dream to give elite drug items to address the issues of end shoppers, Niner Pharmaceuticals LLC manufactures and supplies quality meds. As a dynamic move Niner Pharmaceuticals is intending to get the assembling offices in India confirmed by USFDA, EU and UK MHRA. This would assist the organization with acquiring better achievability to advertise the expected items across the EU area.

Every one of the items go thorough quality checks and are made according to quality principles of WHO, GMP, and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-activity (PIC/S). Moreover, the organization likewise stresses the bundling of drug items. Niner Pharmaceuticals imagines overcoming any issues between the smallminded-scale drug organizations and the worldwide business sectors. With top notch WHO affirmed and other administrative license items, Niner Pharmaceuticals takes a stab at greatness.

Niner Pharmaceuticals LLC is the main producer of pharmaceutical formulations in Powder Injection, Liquid Injection, Tablet, Bolus, Oral Liquid, Oral Powder, Aerosol External preparations and Ointment. According to the Chairman and Founder of Niner Pharmaceuticals, "My vision is to see Niner Pharma among the top drug organizations. "We are haggling to support Indian mid and limited scope drug organizations, mediators manufacturing organizations and API plants to streamline their creation limit and give them business to trade their items to abroad nations like ASIAN, SAARC, Latin America, Europe and the Middle East.Niner Founder is a MBA graduate and has north of 16 years of involvement across various enterprises. the organization is focused on giving the best quality items at affordable costs.

Niner Pharmaceuticals LLC is focused on the quality of medications, safeguarding patients, helping the public's trust and confidence in drug treatments, empowering individuals to live longer and better. As of now, the organization is providing Coronavirus related medications, Vitamin enhancements to Vietnam, Cuba, Mexico, and the Middle East and is anticipating extending its administrations to the European market before very long.

Saudi Arabia Pharmaceuticals Market Overview

Kingdom of Saudi Arabia

Country Information

Capital: Riyadh

Main cities: Jeddah, Mecca, Medina, Al-Ahsa, Taif, Dammam

Primary Ports: Dammam, Jeddah, Jubail

Population

The complete population of Saudi Arabia in 2020 is 34.8139 million. The male populace is 20.1 million, representing 57.73% of the total population; the female populace is 14.7139 million, representing 42.27%. The metropolitan population is 28.8078 million, and the rural population is 5.4607 million. The urbanization rate is 84.07%. The population aged 0-14 represents 24.87%, the population aged 15-64 represents 71.72%, and the population aged 65 or more represents 3.41%.

NDF Fatality Rate

1. Ischemic heart disease
2. Stroke
3. Chronic kidney disease
4. Cirrhosis
5. Diabetes
6. COPD
7. Congenital defects
8. Alzheimer's disease
9. Colorectal cancer
10. Lung cancer

Financial Overview

GDP (2020): $700.118 billion

GDP Growth Rate: CAGR until 2020 - 4.11%

Currency: Saudi Riyal

Trade Value in USD: 100 Saudi Riyal equals 266.73 US Dollars

Public Economic Development Strategy

"Saudi Arabia Vision 2030"

Gulf Cooperation Council (GCC)

The Gulf Cooperation Council is a global association comprising Saudi Arabia, Kuwait, United Arab Emirates, Qatar, Bahrain, and Oman. Since 2014, these countries have together designed a drug price coordination strategy to normalize drug costs in the region and reduce regulatory barriers.

Status of the Pharmaceutical Market

Saudi Arabia is the most attractive market for global pharmaceutical companies in the Middle East. Due to "Saudi Vision 2030," the expansion of Saudi manufacturing is supported, which is a positive sign for local Saudi businesses and companies in Gulf nations. However, patent approval and strict regulatory frameworks remain significant issues for foreign research-based pharmaceutical companies. Saudi Arabia's long-term goal is to produce 40% of medication locally.

Innovative Drug Market

Due to the local preference for branded medications, Saudi Arabia's market is dominated by foreign drug manufacturers, with local production being limited. Leading local players include Saudi Pharmaceutical Industries and Medical Appliances Company (SPIMACO), Tabuk Pharmaceutical Manufacturing, Jamjoom Pharma, and Saudi Arabian Japan Pharmaceutical Company (SAJA).

Traditional Drug Market

The government is encouraging the traditional medicine market in Saudi Arabia, replacing patented medications with generic drugs to control costs. Generic medications are expected to grow at a faster rate in the short and long term.

Market Volume

In 2018, the Saudi pharmaceutical market grew at a CAGR of nearly 5% to reach approximately $8.2 billion. It is expected to grow at an annual growth rate of 5.4% to $10.89 billion by 2024.

Registered Organization

Saudi Food and Drug Authority
Website: https://www.sfda.gov.sa/en
General registration time: 6-18 months
Registration requirements: [File format]: e-CTD
Plant Inspection: yes

Pharmaceutical Trade

Saudi Arabia's Vision 2030 and National Transformation Plan will encourage the country to expand its domestic pharmaceutical industry, reducing dependence on imported medications while providing export opportunities.

Top Ten Corporations

1. PFIZER
2. SANOFI
3. NOVARTIS
4. TABUK
5. SPIMACO
6. GSK
7. HIKMA PHARMA
8. NOVO NORDISK
9. MSD
10. ASTRAZENECA

Fastest Growing Corporations

1. MSD - 294.43%
2. HIKMA PHARMA - 338.41%
3. MECP - 125.37%
4. AMGEN - 110.31%
5. SANOFI - 535.28%
6. LILLY - 132.26%
7. ASTRAZENICA - 240.21%
8. J&J - 188.20%
9. ALLERGAN - 93.16%

Martin Shkreli Banned from Pharmaceutical Industry Over Daraprim Price Hike

Shamed medication organization leader Martin Shkreli, criticized as the "Pharma Bro," was prohibited from truly carrying on with work again in the drug business, an adjudicator requested on Friday.

Shkreli was likewise requested to pay $64.6 million in benefits he scored from climbing the cost of the medication Daraprim, U.S. Area Court Judge Denise Cote administered in New York.

The court request is attached to a claim, recorded by the Federal Trade Commission and a few states, including New York and California, that blamed the detained Shkreli for monopolistic conduct.

"Shkreli is at risk on each of the cases introduced in this activity. A directive will give prohibiting him for life from taking an interest in the drug business in any way," Cote wrote in her decision.

"He is requested to pay the offended party states $64.6 million in spewing."

As CEO of Turing Pharmaceuticals - later Vyera - Shkreli expanded the cost of Daraprim from $13.50 to $750 per pill, subsequent to acquiring exclusive rights to the many years-old medication in 2015. Daraprim is required by those experiencing an uncommon parasitic infection that strikes AIDS patients, malignant growth casualties, and pregnant ladies.

"Envy, insatiability, desire, and disdain,' don't simply 'separate,' yet they clearly motivated Mr. Shkreli and his partner to illicitly lift the cost of life-saving medication as Americans' experiences remained in a precarious situation," New York Attorney General James said in a proclamation.

In any case, Shkreli is better known in mainstream society for his snide, unashamed persona that procured him the "Pharma Bro" moniker and ridicule from all sides of American life.

He's currently spending time in jail for protections extortion.

"Be that as it may, Americans can relax on the grounds that Martin Shkreli is a pharma pro no more," James said. "A government court has observed that his lead was illicit, yet additionally restricted this sentenced criminal from the drug business forever and expected him to pay almost $65 million."

A lawyer for Shkreli couldn't be quickly gone after remark on Friday.

In spite of broad reaction to Shkreli, the medication organization leader never moved in an opposite direction from exposure.

Strategies for Entering Brazil's Pharmaceutical Market

Specialty pharmaceutical companies face significant barriers when entering Brazil's complex market. While partnerships drive success in the US, EU, and Japan, Brazil requires unique approaches tailored to its regulatory environment and market structure.

Understanding Brazil's Pharmaceutical Landscape

As the world's fifth largest country with 85% urban population, Brazil offers growing opportunities with its USD 8,717 GDP per capita. However, the market remains dominated by local players, with few international companies establishing significant presence despite the potential.

Key Challenges for Foreign Companies

International pharma companies encounter multiple obstacles when entering Brazil:

• Data Gaps: Limited research on Brazil's non-retail segment driven by government tenders
• Portfolio Mismatch: Products successful elsewhere often fail in Brazil
• Market Segmentation: Three distinct segments requiring different strategies
• ANVISA Regulations: Strict requirements for drug equivalency studies and approved CROs
• Manufacturing Restrictions: Contract manufacturing limitations create entry barriers

Proven Market Entry Strategies

Successful market penetration requires tailored approaches at different stages:

Stage 1: Market Entry

New entrants should prioritize regulatory, importer, and QC lab partnerships to navigate Brazil's complex registration process.

Stage 2: Early Presence

Companies with initial experience should focus on marketing authorization partnerships, followed by distributor collaborations for commercialization.

Stage 3: Market Expansion

Established players benefit from local infrastructure investment or acquisitions to deepen market penetration with optimized portfolios.

Conclusion

While Brazil's pharmaceutical market presents unique challenges, strategic partnerships, regulatory compliance, and market-specific portfolios enable successful entry. Companies that adapt to Brazil's business environment can capitalize on this growing healthcare market.

Latin America Pharmaceutical Industry Analysis

The Latin American pharmaceutical market was valued at $60 billion in 2019, with Brazil accounting for nearly half of regional sales. The industry continues to grow with strong generic drug production and increasing biotechnology investments.

The pharmaceutical industry in Latin America is dynamic and consistently developing. Three countries with the strongest presence in the region include Brazil, Argentina, and Mexico. These nations have seen rapid growth in major pharmaceutical players. While the region lags in patent registrations compared to developed markets, it has a robust market for generic drugs, OTC medications, pharmaceutical ingredients, veterinary drugs, and biotechnology ventures.

One notable example is Teva Pharmaceutical Industries' acquisition of Ivax Corporation for $7.4 billion, which included operations across nine Latin American countries. Teva further strengthened its position by acquiring Representaciones e Investigaciones Médicas S.A. in Mexico for $2.3 billion. Today, Teva dominates the generic drug market in Latin America and globally, with annual sales approaching $20 billion.

Brazil: The Regional Leader

Brazil boasts the most significant pharmaceutical industry in Latin America. Key players include:

• Hypera Pharma S.A. (OTC and pharmaceutical ingredients)
• EMS S.A. (generics and branded drugs)
• Aché Laboratórios (biotechnology and distribution)
• Eurofarma (regional operations across Latin America)

Aché Laboratórios has particularly diversified interests, including a joint venture with Canadian Scythian Biosciences for therapeutic cannabis through Green Farma Brasil.

Argentina: Strong Local Players

Argentina's pharmaceutical sector features prominent companies like:

• Laboratorios Roemmers (vertically integrated with vaccine development)
• Insud Pharma (pharmaceutical ingredients and biotechnology)
• Laboratorios Bagó (human and veterinary medicines)

Insud Pharma maintains an especially diverse portfolio through subsidiaries like mAbxience (biotech) and Biogénesis Bagó (veterinary vaccines).

Mexico: Growing Market

Mexico's pharmaceutical industry is expanding with major participants including:

• Laboratorios Pisa S.A. (research-based medicines)
• Genomma Lab Internacional (OTC and generics)
• Teva Mexico (generic pharmaceuticals)

Distribution is dominated by Grupo Casa Saba, one of Latin America's largest pharmaceutical distributors.

Other Key Markets

Venezuela

Despite challenges, Venezuela maintains pharmaceutical operations through companies like Laboratorio Behrens and SM Pharma, though many have relocated operations abroad.

Colombia

Colombia's market features established players like Laboratorios Lafrancol and Laboratorios Junín.

Peru

Peru's industry includes Teva subsidiaries Corporación Medco and Corporación Infarmasa, along with local producer Laboratorios Lansier.

El Salvador

This growing market includes Laboratorios López and Laboratorios Suizos, with distribution handled by Droguería Sinquimia.

Virpax Pharmaceuticals Product Pipeline

Virpax Pharmaceuticals, Inc. accomplished significant milestones related to its pipeline of product candidates as of the end of 2021. "I believe that Virpax has made considerable progress this past year toward our stated objectives," remarked the Chairman and CEO of Virpax. "These achievements include accelerated development of our existing product candidates, expanding our pipeline of product candidates, and leveraging grants where appropriate. We recently announced that we expect to initiate our initial human trial for Epoladerm™ in the second quarter of 2022."

"Virpax initially focused strictly on pain product candidates. However, our proprietary Molecular Envelope Technology ('MET') delivery platform licensed from Monomeric, Ltd. has enabled the development of product candidates for central nervous system ('CNS') and antiviral indications. In late 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter ('OTC') antiviral product candidate formulated to prevent the spread of respiratory infections such as flu, SARS-CoV-2, and rhinovirus. We added VRP324, which is an intranasally delivered cannabidiol ('CBD') formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences ('NCATS') as part of our Cooperative Research and Development Agreement, determined that the MET intranasal delivery formulation bypasses the liver, which we believe reduces drug-drug interaction concerns for medications using this technology."

"On the corporate front, we strengthened our Board by appointing two new members who bring expertise in commercialization and financial strategy. Additionally, in 2021, we raised approximately $58 million in total gross proceeds from our initial public offering and an approved follow-on public offering. These funds are being utilized for research and development activities of our product candidates. We are on track to add milestones in 2022, and I remain confident that we have the significant financial strength to continue advancing our pipeline," said the CEO.

Epoladerm™

Epoladerm is a diclofenac topical spray film product that is being developed for pain related to osteoarthritis of the knee. Virpax recently announced the success of a Charles River Laboratories single-dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the necessary Investigational New Drug Application ('IND') enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight, or dermal irritation noted. The maximum plasma concentration (Cmax) was reached at 4 hours post-dose, and concentrations of plasma Epoladerm remained at 24 hours post-dose for all animals.

Upon completion of all the necessary IND-enabling studies and subsequent review by the FDA, Virpax expects to conduct a Phase 1 study to assess the overall bioavailability and pharmacokinetics of Epoladerm™. Virpax recently announced the execution of a clinical trial agreement with Alta Sciences Company, Inc., to conduct this study in Canada. Virpax expects enrollment of the first patient by early second quarter of 2022.

Probudur™

Probudur is an injectable bupivacaine liposomal hydrogel for postoperative pain management which Virpax believes has improved onset and extended duration of action compared to existing treatment options. Additional preclinical trials are being conducted with Lipocure, the product developer, to improve formulation to potentially enhance manufacturing efficiencies, extend duration, and broaden patent protection. Once completed, we intend to perform seven preclinical animal studies as part of required FDA IND-enabling trials.

Envelta™

Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain related to cancer. This product utilizes Nanomeric's MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal route, allowing the enkephalin to penetrate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS.

Virpax recently reported that under this CRADA, the National Institutes of Health has awarded several contracts to support the research, development, and manufacturing of Envelta. These contracts aim to assist Good Manufacturing Practices ('GMP') production of drug substance and drug product, as well as to support Good Laboratory Practices ('GLP') toxicology, safety studies, and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional preclinical efficacy studies and has acquired a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to produce Leu-enkephalin ('L-ENK'), the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to quickly alleviate pain.

AnQlar™

AnQlar (formerly MMS019) is a high-density intranasal molecular masking spray being developed as an antiviral OTC product for protection against respiratory infections such as SARS-CoV-2 and flu, which Virpax expects will be used as an adjunct to barrier-based personal protective equipment. Virpax recently reported a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar.

Additionally, Virpax engaged with Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in mid-2022.

VRP324

Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children (a rare pediatric condition) and adults.

Under this agreement, Virpax has the global rights to develop, manufacture, market, and sell VRP324, the first investigational formulation delivered through the nasal route to enhance CBD

Dicerna Pharmaceuticals Inc. [NASDAQ: DRNA] Stock Overview

Dicerna Pharmaceuticals Inc. stock closed at $37.92 with a trading volume of 7,906,174 shares. The company announced on November 22, 2021, that it is being investigated for its acquisition by Novo Nordisk. Shareholders will receive $38.25 per share they own.

Analyst Insights and Market Predictions

Wall Street experts have set a target price for DRNA at $34.96 per share, with a current recommendation of 2.20, indicating a Buy rating on a scale from 1 (Strong Buy) to 5 (Strong Sell).

Goldman Sachs maintains a Neutral stance on DRNA stock, while other firms have set price targets ranging from $32 to $38. The Average True Range (ATR) for DRNA is 1.75, and the Price-to-Sales ratio stands at 15.35 for the past year.

DRNA Stock Trading Performance

Over the past few months, DRNA has shown a 24.90% gain. In the last four weeks alone, shares have surged by 73.71%, with a total 66.10% rise over the past year. The stock has been highly active, with a daily trading volume of 7.9M shares, compared to its average of 1.39M shares.

Technical Analysis: RSI and Moving Averages

The Relative Strength Index (RSI) for DRNA currently sits at 88.55, indicating overbought conditions. The stock's 50-day moving average is $22.03, and the 200-day moving average is $27.44, suggesting bullish momentum in recent weeks.

Financial Performance Overview

Dicerna Pharmaceuticals reported a net margin of 68.62% and a Return on Invested Capital (ROIC) of 62.84. The company also has a Return on Equity (ROE) of 77.77%, and a Price-to-Free-Cash-Flow ratio of 344.41.

The company's Quick Ratio is 2.50, reflecting its ability to cover short-term obligations with its most liquid assets.

Earnings Per Share (EPS) Analysis

For the latest quarter, Dicerna Pharmaceuticals reported earnings of $0.49 per share, exceeding analysts' expectations of $0.03 per share, resulting in a surprise factor of 1,533.30%.

Institutional and Insider Ownership

Approximately 83.30% of DRNA stock is held by institutional investors. Major institutional holders include RTW Investments, BlackRock Inc., and State Street Corp. Institutional positions in DRNA increased in November, with 93 institutional investors adding 13.7M shares, while 112 investors reduced their holdings by 11.4M shares.

Pharma SEO Spending Plan: Key Strategies for Budgeting

A consistent vertical pattern in SEO spending shows that advertisers understand the job SEO plays in aiding forthcoming clients track down their contributions. In 2020 alone, US organizations contributed an estimated $79.3 billion to expand their natural footprint.

How Much Should You Spend on SEO?

However, regardless of whether you know how crucial SEO is to your advertising, determining how much to spend is another inquiry. While there's no single formula to set an SEO budget, here are some strategies you can use to find a number that is appropriate for your business.

1. Separating Your Marketing Budget

Late data suggests that B2C organizations spend an average of 5% to 12% of their revenue on marketing, and B2B sets aside around 8% to 9%. Out of that total spend, as reported by Forrester Research, businesses dedicate an average of 50% of their marketing budget to online strategies like SEO, direct email, social media, and data analysis.

2. Test SEO Budget Breakdown

According to the 2021 CMO Survey, nearly 74% of organizations invest in SEO. Each business has specific needs, and the amount you should budget depends on your business model and niche. However, it can still be helpful to look at some models to guide your decision.

5 Key Strategies to Determine SEO Spending

You have options when budgeting for SEO, ranging from rough estimates based on total revenue to more precise calculations based on marketing metrics:

1. Allocate a Percentage of Your Overall Marketing Budget

How it works: Set aside a portion of your digital marketing budget based on how much you rely on website traffic to generate sales. For example, an e-commerce business would likely spend more on SEO than its physical counterpart.

Remember, assigning a fixed percentage of your marketing budget doesn't account for your specific SEO needs. If you're basing your SEO budget on what you can afford, you might not be spending enough to see significant results.

2. Match Your Competition

Businesses with competitors aggressively targeting industry keywords need to invest more in SEO to maintain their share of organic traffic. Compare your current search engine rankings with your competitors and evaluate the opportunity cost of losing customers to them.

3. Consider Your Marketing Objectives

Think about your SEO goals within the broader context of your marketing objectives before allocating a specific dollar amount to your SEO budget.

4. Calculate Your Budget Using Customer Lifetime Value (CLTV)

The benefits of organic traffic extend beyond a one-time purchase. This strategy determines the value of a web page based on CLTV—the amount you can expect to earn from a customer long-term.

5. Measure SEO Effectiveness Against Paid Search Spend

Many companies are comfortable allocating budgets for PPC and tend to spend more on paid ads than SEO. However, SEO typically generates twice as much traffic, with organic search accounting for an average of 53% of site traffic.

Why You Should Increase Your SEO Budget

As you begin calculating how much to spend on SEO, you may arrive at higher figures than you initially expected. Be aware that budget partners may not fully understand the benefits of investing in SEO.

Low-budget SEO won't deliver significant results. Backlinko found that clients who invested more than a minimal amount were 53.3% more likely to be "extremely satisfied" compared to those who spent less.

SEO is highly effective compared to other channels, offering various stats that you can share with stakeholders to highlight its high ROI potential.

CTV Advertising: An Undiscovered Opportunity for Pharma Advertisers

Consistently, pharma organizations burn through billions of dollars in the U.S. on TV publicizing. However, the business' media arranging and purchasing are still grounded in conventional linear TV, despite the fact that TV utilization has become progressively divided across platforms and devices.

Today, advertisements served on web-connected devices, also known as CTV advertising, present an undiscovered opportunity for pharma advertisers. To exploit these, pharma must reevaluate its media strategy and gain a deeper understanding of the role CTV can play in connecting with audiences across devices and formats.

To uncover key insights driving these communications, MM+M collaborated with Pulse-Point on a study entitled "CTV Advertising: An Undiscovered Opportunity for Pharma Advertisers." The study results presented here will help those in pharma marketing and brand management understand emerging CTV trends across the industry and how they can leverage these trends to reach customers in a more targeted manner.

Philosophy

The review was conducted in September 2021 and sent to a list of experts from healthcare and related industries. About half were from agencies (52%) and half identified as being from "non-agencies" (48%). Among the non-agency respondents, 72% were involved in pharma (including Biotech, Device/Diagnostics, and CPG), and 22% said they were associated with Hospital/Health System/Medical Care agencies. Most respondents were either at the VP/SVP/EVP level (37%) or directors (25%), with fewer being administrators (17%) and C-level leaders (16%).

Findings

The numbers are comparable for TV and CTV advertising: Half the survey respondents reported that their brand is currently using TV advertising (50%). Around one-tenth are not currently running TV advertisements for their brand but did so within the last two years (11%). Similarly, half of the respondents are doing CTV advertising, while more than one-tenth (12%) previously used CTV advertising but are not currently doing so.

It's important to note that twice as many agency respondents currently run CTV advertisements compared to non-agency respondents (63% versus 36%). Among those who currently run TV advertising, around four out of five are also using CTV advertising (79%).

When asked how they differentiate their TV and CTV advertising budgets, respondents reported allocating comparable budgets for both, with an average of 49.8% for their TV budget versus 50.2% for the CTV budget.

The study also examined how the respondents purchased CTV advertising. The results show that nearly half of those currently using CTV utilize a digital media agency (48%), while almost a quarter use a TV media agency (23%). Smaller percentages reported using a cross-channel buying platform (15%) or a CTV buying platform (12%).

In terms of timing for purchasing CTV advertising, nearly all reported doing it "consistently" (88%). Other options included "once a year, during upfront," and "once a year during newfront."

The survey investigated how respondents define their audiences for CTV advertising. The majority of those currently purchasing CTV advertising reported using geo-segment targeting (54%). Almost one in five use contingent populations (17%), and one in ten use prior condition content usage (10%). Only 4% reported that they coordinated their CTV purchase with their linear TV purchase.

When asked about the targeted audiences in CTV purchases, nearly six out of ten respondents (58%) reported targeting both healthcare professionals (HCP) and direct-to-consumer (DTC). However, more than one-third are focusing on DTC only (37%), with just 6% targeting HCP only.

No single digital resource stands out in usage by current CTV clients. The survey results show that 33% generally use 30-second ads (preferred by 24% of agency respondents compared to 52% of non-agency respondents). A video resource specifically created for the CTV purchase is used by 31% overall (44% of agency respondents versus 26% of non-agency respondents), and 27% use a 60-second TV ad. Only 8% reported using 90-second TV advertisements.

The top perceived advantage by CTV users for using continuous versus linear TV was "better targeting data" at 60%, followed by an increase in reach (17%), real-time measurement, buying flexibility, and 1:1 measurement, all at 6%, with cross-channel coordination at just 4%.

The final survey questions aimed to reveal the perceived effectiveness of CTV advertising. Most respondents report that they utilize post-exposure impact (measured through offline studies) to determine the effectiveness of their CTV purchase (42%).

Other measures were used less frequently: video completion rate (19%), NRx lift (17%), and audience quality (13%).

Finally, respondents were asked to describe how their CTV advertising performed compared to their TV purchase. Seven out of ten respondents who currently use CTV ads feel that their CTV purchase outperforms their TV purchase (70%), with only 2% of non-agency respondents feeling their CTV purchase performs "worse" than TV, while 6% chose "significantly worse." Notably, no agency respondents reported that their CTV purchases performed worse than TV.

Respondents provided comments regarding their perceptions of CTV performance versus TV, including:

• "Better metrics with CTV, more data is available for ROI analysis."
• "Better and more efficient in terms of cost, but also not as effective in terms of broad reach."
• "Each serves a different purpose. TV for broad branding and awareness; CTV for more specific messaging/action."
• "We get better data with CTV, allowing us to truly see the impact of ad spend."

Brief answers included:

• "Better reach,"
• "Higher response,"
• "Better coverage ratio over broader audiences,"
• "More targeted reach,"
• "More data,"
• "Greater engagement,"
• "More measurable for Rx lift."

One of the few negative remarks received was, "The link zones and broadcast signals are not specific enough geographically for our local advertisers." Another stated, "Better audiences but worse pricing."

Several respondents felt they lacked sufficient experience with CTV to provide input, but one remarked, "Still early in our CTV journey, but we love the reporting transparency, real-time measurements, and more creative options with this platform." Another stated, "We get better data with CTV, allowing us to truly see the impact of ad spend."

As advertising rebounded in 2021, CTV emerged as the fastest-growing video advertising platform across all verticals. Given this trend, it's expected that 2022 will mark the first annual cycle where CTV ads capture a significant market share of life science advertising away from traditional TV, partly due to the decline of linear TV.

The Rise of Turkish Pharmaceutical Companies

Turkey’s Ambition to Become a Global Medicine Hub

Turkey is eager to become a global pharmaceutical center due to its strong production capabilities, strategic location, demographics, and robust infrastructure, according to Savas Malkoc, General Secretary of the Pharmaceutical Manufacturers Association of Turkey (IEIS).

Pharmaceutical Industry Overview

With 100 pharmaceutical and 11 raw material manufacturing facilities, 680 organizations, 33 R&D centers, and over 11,000 employees, Turkey's pharmaceutical sector is producing more than 12,000 products. As of 2020, 88% of pharmaceuticals consumed in Turkey are produced locally.

Strategic Advantages of Turkey’s Pharma Sector

Turkey’s pharmaceutical industry benefits from its favorable geographical location, connecting some of the most dynamic pharmaceutical markets worldwide. In 2020, the Turkish pharma market was the 18th largest globally, with exports reaching nearly 180 destinations, including the European Union, Commonwealth of Independent States (CIS), North Africa, East Asia, and the Middle East.

Challenges and Opportunities in the Turkish Pharma Market

Despite challenges posed by the COVID-19 pandemic, the Turkish pharmaceutical sector continued operations without significant disruptions. Turkey has also started producing medicines used in COVID-19 treatments, which were previously not manufactured locally. Biotechnological products are also gaining momentum in Turkey, with biotechnological drug demand reaching 25% of the total Turkish pharma market in 2020.

Research and Development in Turkey's Pharmaceutical Industry

R&D investments have seen significant growth, reaching 423.8 million liras ($88.3 million) over the past five years. Turkish companies have developed innovative pharmaceuticals, such as sustained-release formulations and combination products that improve patient adherence.

Future Outlook and Biosimilars

Turkish companies are increasingly focusing on producing biosimilar drugs with plans to launch 39 biosimilar products by 2024. To support this growth, a stable regulatory environment is necessary for Turkey to compete effectively on a global scale.

© 2024 Turkish Pharmaceutical Industry Insights. All Rights Reserved.

Omnichannel Pharmaceutical Marketing: Strategies and Challenges

Pharmaceutical companies are increasingly shifting from traditional multichannel advertising to an omnichannel marketing approach. However, the industry faces significant challenges in overcoming siloed operations and embracing a fully integrated marketing strategy. Despite these hurdles, innovative organizations are exploring new ways to gain competitive advantages.

Omnichannel marketing is gaining traction in the pharmaceutical sector, promising to coordinate and enhance marketing efforts across multiple channels and stakeholders simultaneously. This approach provides a clearer view of promotional ROI and helps reduce marketing waste.

Transitioning to an omnichannel model may seem daunting, but pharmaceutical organizations willing to make the shift stand to gain remarkable benefits for their brands and their customers, including patients, healthcare professionals, and payers.

Why is the Shift to Omnichannel Marketing Challenging?

Several factors contribute to the difficulties pharmaceutical companies face in adopting a full omnichannel approach. The traditional multichannel marketing framework is deeply ingrained in the mindset of many organizations and brand marketers, leading to inertia. This longstanding model has seen moderate success over the years, and many teams cling to the mantra, "We've always done it this way."

The existing multichannel marketing structure reflects the fragmented nature of today's organizations. Consequently, brand health and KPIs are often tied to this outdated model, which rewards performance based on legacy metrics. Integrating various components into a cohesive strategy requires effort and patience, which many teams may lack due to time and resource constraints.

What Breaks are Emerging in the Multichannel Model?

Despite the entrenched nature of the multichannel approach, cracks are beginning to show. In a multichannel setup, channel impact or return on investment is assessed on a channel-by-channel basis, often assuming that a single channel is solely responsible for attracting new customers.

As marketers recognize the disconnect between these KPIs and actual business outcomes, they are left questioning how to bridge the gap.

How Can Pharma Move Towards the Omnichannel Approach?

Adopting an omnichannel marketing strategy necessitates a fundamental shift in how marketers simultaneously coordinate and execute their promotional strategies across media channels while addressing the needs of diverse stakeholders, including consumers, healthcare professionals, and payers.

Pharmaceutical organizations generally agree that the omnichannel model represents the future. They acknowledge that integrating channels and audiences is the best way to understand overall impact and optimize their efforts. However, discussions often stall at the implementation stage, as it requires buy-in from influential stakeholders across all brands.

Successful Strategies for Transitioning to Omnichannel Marketing

Here are several ways that leading pharmaceutical companies have effectively begun transitioning to the omnichannel model:

• Leadership: Successful transitions often depend on sponsorship from an individual or group in a position of power. Organizations need the right leader with a clear vision and empowered partners to drive change.
• Resources: Change agents alone are insufficient. Those leading the charge also need adequate resources, time, and budget to effect meaningful change.
• Pilots: If the transition must be gradual before securing organizational buy-in, it may be beneficial to collaborate with IQVIA on a pilot brand. However, the pilot approach can be challenging, as selecting the right brand is crucial. Investing in multiple channels and audiences is essential, as the proof of concept must demonstrate effectiveness rather than remain siloed.

Is Omnichannel Marketing the Future?

The omnichannel marketing approach is the future for pharmaceutical brands and organizations. While achieving broad adoption will be challenging, as it requires dismantling organizational silos and changing mindsets, the potential rewards are compelling. Organizations will benefit internally while delivering improved outcomes for all their clients. Click here to learn how to start making smarter marketing decisions.