About Onyx Biotec Limited

Onyx started its operation in pharmaceutical industry with sterile water for injections in the year 2010. Since then, Onyx has been associated with the healthcare segment and offering Sterile Pharmaceutical products and has become a prominent supplier of sterile products to major corporations, which includes the top pharma companies at pan India level. Onyx is committed to provide high-quality products at affordable price. Presently, the Company manufactures Sterile Water for Injections, and acts as a pharmaceutical contract manufacturer offering a comprehensive range of Dry Powder Injections and Dry Syrup for India and overseas. Their products are being processed and manufactured in accordance with best FDA practices available globally. Their system and product is tested constantly at each level to ensure international standards of quality in-house and FDA Certified Laboratories. Their service also include preparation and filing of regulatory dossiers in the Indian and global markets. The Company has two manufacturing facilities in Himachal Pradesh.

The longstanding relationships with their clients are characterized by a commitment to consistency and trust. As of May 31, 2024, their key clients includes Hetero Healthcare Limited, Mankind Pharma Limited, Sun Pharmaceutical Industries Limited, Aristo Pharmaceuticals Private Limited, Macleods Pharmaceuticals Limited, Mapra Laboratories Private Limited, Axa Parenterals Limited, FDC Limited, Zuventus Healthcare Limited, Akums Drugs and Pharmaceuticals Limited, Reliance Life Sciences Limited, among others. They have benefitted from repeat orders in the past three years from 35 of their more than 100 clients in terms of revenue, as of May 31, 2024.

As on July 31, 2024, Onyx Biotec has 175 employees on payroll. The Banker of the Onyx Biotec is HDFC Bank Limited.

PHARMACEUTICAL INDUSTRY IN INDIA
According to a recent EY FICCI report, as there has been a growing consensus over providing new innovative therapies to patients, Indian pharmaceutical market is estimated to touch US$ 130 billion in value by the end of 2030 and US$ 450 billion market by 2047. India ranks 3rd worldwide for pharmaceutical production by volume and 14th by value. The country has an established domestic pharmaceutical industry, with a strong network of 3,000 drug companies and ~10,500 manufacturing units.

India’s drugs and pharmaceuticals exports stood at US$ 27.82 billion in FY24 (April- March). According to Government data, the Indian pharmaceutical industry is worth approximately US$ 50 billion with over US$ 25 billion of the value coming from exports. About 20% of the global exports in generic drugs are met by India. During FY18 to FY23, the Indian pharmaceutical industry logged a compound annual growth rate (CAGR) of 6- 8%, primarily driven by an 8% increase in exports and a 6% rise in the domestic market. The Indian pharmaceutical industry has seen a massive expansion over the last few years and is expected to reach about 13% of the size of the global pharma market while enhancing its quality, affordability, and innovation. Indian pharmaceutical sector is expected to grow at a CAGR of 22.4% in the near future. The government has set ambitious target to boost the medical devices industry in India, aiming to elevate it from its current US$ 11 billion valuation to US$ 50 billion by 2030. India is the second-largest contributor of global biotech and pharmaceutical workforce. Exports of drugs and pharmaceuticals recorded a strong y-o-y growth of 9.7% during April-March FY24.

The Indian healthcare industry reached over US$ 370 billion in 2022 and is expected to reach over US$ 610 billion by 2026. Indian hospital market valued at US$ 98.98 billion in FY23 and projected to grow by 8% CAGR and reached to US$193.59 billion by FY32. India is among the top 12 destinations for biotechnology worldwide and third largest in Asia Pacific. The country holds 3-5% of the global biotechnology industry pie. In 2022, India’s bioeconomy was valued at US$ 137 billion, and aims to achieve US$ 300 billion mark by 2030.

India has emrged as the medial tourism hub of the world providing cost-effective treatments with the latest technology enabled by several pathbreaking reforms and provisions in healthcare sector. Access to affordable HIV treatment from India is one of the greatest success stories in medicine. India is one of the biggest suppliers of low- cost vaccines in the world, thereby rightly making it the ‘Pharmacy of the World’.

On December 21, 2020, a MoU was signed between Tata Memorial Centre of India and Vietnam National Cancer Hospital to promote exchanges in the areas of training and scientific research, health care services, collaboration in diagnosis and treatment for cancer patients. The total market size of the Indian Pharma Industry is expected to reach US$ 130 billion by 2030 and US$ 450 billion market by 2047. The domestic pharmaceutical industry would likely reach US$ 57 billion by FY25 and see an increase in operating margins of 100-150 basis points (bps). India has the largest number of USFDA-compliant pharmaceutical plants outside the US and over 2,000 WHO-GMP approved facilities, serving demand from 150+ countries worldwide, with 10,500+ manufacturing facilities.

The PLI scheme for pharmaceuticals is being implemented with a total outlay of the US$ 2.04 billion (Rs. 15,000 crore) spanning from 2020-21 to 2028-29, to boost India's manufacturing capacity, elevate investment, and diversify product offerings in the sector. The Union Cabinet, on April 26, 2023, approved the National Medical Devices Policy, 2023. The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. Strengthening of Pharmaceutical Industry (SPI): The Ministry's scheme “Strengthening of Pharmaceutical Industry (SPI) with a total financial outlay of Rs. 500 crore (US$ 60.6 million) extends support required to existing pharma clusters and MSMEs across the country to improve their productivity, quality and sustainability. Pradhan Mantri Bhartiya Jan Aushadhi Kendras (PMBJKs): The Government has set a target to increase the number of PMBJKs to 10,500 by the end of March 2025. Product basket of PMBJP comprises of 1,451 drugs and 240 surgical instruments.

Up to 100%, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects. For Brownfield pharmaceuticals projects, FDI allowed is up to 74% through automatic route and beyond that through government approval. The cumulative FDI equity inflow in the Drugs and Pharmaceuticals industry is US$ 22.52 billion during the period April 2000-March 2024, almost 3.4% of the total inflow received across sectors. In the Interim Budget 2024-25, the government earmarked US$ 120 million (Rs 1,000 crore) for the promotion of bulk drug parks for FY25, a significant increase from the previous year.

Following the introduction of product patents, several multinational companies are expected to launch patented drugs in India. Growth in the number of lifestyle diseases in India could boost the sale of drugs in this segment. High Court allowing to export patent drugs, to foreign players in the Indian market. The presence of a skilled workforce as well as high managerial and technical competence is a source of attraction for private players. Pharma companies have already increased spending in the country to tap rural markets and develop better infrastructure. Promotion of Medical Devices Parks: Objective of the scheme is Creation of world class infrastructure facilities in order to make Indian medical device industry a global leader.

India has the second-highest number of US FDA approved plants outside the US and is the largest provider of generic drugs globally. According to Mr. Bhagwant Khuba, Minister of State (MoS) for Chemicals and Fertilisers, India's pharmaceutical industry is the third largest by volume and the 14th largest by value in the world, generating more than 60,000 generic drugs across 60 therapeutic categories. About 20% of the global exports in generic drugs are met by India. The Union government, in 2022, proposed to introduce over-the- counter (OTC) drugs in India through an amendment in the Drugs and Cosmetics Rules and allow their sale in the retail market without doctors’ prescription. A draft notification issued by the Union health ministry has proposed that the 16 drugs, which include common antipyretic medicine such as paracetamol 500 mg, some laxatives, nasal decongestants and topical antifungal creams be included in the OTC drug category.

About 120 drugs are expected to go off-patent over the next 10 years; with expected worldwide revenue between US$ 80 to 250 billion.

As per Mckinsey’s report (July 2019), > US$ 200 billion to be spent on medical infrastructure in the next decade. New business models expected to penetrate tier-2 and 3 cities. Over 160,000 hospital beds expected to be added each year in the next decade. India’s generic drugs account for 20% of global exports in terms of volume, making the country the largest provider of generic medicines globally. Rising levels of education to increase acceptability of pharmaceuticals. Patients to show greater propensity to self- medicate, boosting the OTC market. Acceptance of biologics and preventive medicines to rise. Surge in medical tourism due to increased patient inflow from other countries.

As of January 2024, the total number of Jan Aushadhi Kendras in the country are 10,607. Prime Minister Mr. Narendra Modi during his Independence Day 2023 speech said that the government has plans to increase the number of 'Jan Aushadhi Kendras' from 10,000 to 25,000. Over 650 million people were expected to be covered by health insurance by 2020. The Government plans to provide free generic medicines to half the population at an estimated cost of US$ 5.4 billion.

Patient pool expected to increase over 20% until 2030, mainly due to rise in population. New diseases and lifestyle changes to boost demand. Increasing prevalence of lifestyle diseases.

India is among the leaders in the clinical trial market. Due to a genetically diverse population and availability of skilled doctors, India has the potential to attract huge investments to its clinical trial market. In October 2021, AstraZeneca India launched a Clinical Data and Insights (CDI) division to further strengthen its global presence and manage data-related aspects of its clinical trials. In November 2021, US-based Akston Biosciences announced that it will start the clinical trial of its second-generation COVID-19 vaccine ‘AKS-452’ in India soon.

Due to increasing population and income levels, demand for high- end drugs is expected to rise. Growing demand could open up the market for production of high- end drugs in India.

With 70% of India’s population residing in rural areas, pharma companies have immense opportunities to tap this market. Demand for generic medicines in rural markets has seen a sharp growth. Various companies are investing in the distribution network in rural areas.

Contractresearch and manufacturing services (CRAMS) is one of the fastest growing segments in the pharmaceutical and biotechnology industry. The pharmaceutical market uses outsourcing services from providers in the form of contract research organizations (CROs) and contract manufacturing organizations (CMOs).

ONYX BIOTEC LIMITED COMPETITIVE STRENGTHS 
1. One of the prominent contract manufacturers in sterile manufacturing 
2. Geographical presence
3. Quality Assurance and Quality Control of our products 
4. Strong, cordial & long term relationship with our clients

ONYX BIOTEC LIMITED STRATEGIES
1. Market Penetration and Geographic Expansion
2. Leverage their position as a contract manufacturer for pharmaceutical companies
3. Leverage their position in the loan licencing to the pharma companies 
4. Focus on their Quality Control
5. Marketing Strategy
6. Growing their business with existing clients with quality products
7. Reduction of operational costs and achieving efficiency

ONYX BIOTEC LIMITED RISK FACTORS & CONCERNS
1. Their manufacturing units are concentrated in Solan, Himachal Pradesh.
2. They rely on domestic and international third-party suppliers for the supply of raw materials.
3. The Company is reliant on the demand from the pharmaceutical industry.
4. They may be unable to grow their business in additional geographic regions or international markets.