The pandemic has brought in its wake, profound changes in the way the global pharma industry operates. The focus is on securing local pharma supplies while retaining the alignment towards accessibility and affordability. At the same time, a nationalistic fervor and a more patient centric approach are also discernable.
Global medicine consumption is projected to surge, with an estimated 3.8 trillion daily doses by 2028, with varying growth rates across different regions. Specialty medications are poised to dominate global spending, exceeding 40% over the next four years (Source: Deloitte Report), with developed markets leading the charge. Key therapeutic areas such as oncology, immunology, diabetes, and obesity are set to drive substantial growth, fueled by ongoing innovation and patent expirations. Oncology, in particular, is anticipated to expand at a robust 14-17% through 2028.
Due to an unprecedented strain on healthcare infrastructures globally, the price and accessibility of generics have become critical. This has led to a renewed emphasis on efficiency, process innovation, and cost savings. There is a further shift towards biosimilars and a move up the value chain through complex generics and building specialty pipelines, all of which are expected to lead to sustainable business streams and maximization of long-term profit margins. To achieve this, digital transformation has emerged as a key strategy, with Gen AI and other AI technologies driving innovation.
Indian pharmaceutical companies have displayed mixed reactions to the changing economic environment. Fully integrated companies with global business models have benefited from tailwinds, while others are grappling with various challenges. These include intellectual property issues, regulatory compliance hurdles, government imposed pricing pressures, rising raw material costs, and supply chain disruptions due to geopolitical conditions. In the U.S., despite a relatively more benign pricing environment, competitive intensity remains very high with reduced pricing leverage for manufacturers of generics, impacting profitability.
The pharmaceutical industry today is at the crossroads of transformation and challenge, driven by technological advancements, shifting global dynamics, and evolving market pressures. Navigating these complexities calls for agility and innovation to capitalize on growth opportunities while mitigating risks in an increasingly interconnected global landscape.
Specialty drugs used to treat rare and chronic diseases such as cancer and multiple sclerosis are driving the demand for more affordable generic versions. This segment is expected to grow at a 12.1% CAGR (Source: KPMG Report) through 2024.
The biosimilars market is anticipated to expand at a 12.5% CAGR (Source: IQVIA Report), offering a less expensive alternative to off-patent drugs. Pharmaceutical companies are increasingly partnering with Contract Research Development Manufacturing Organizations to expedite time to market.
GenAI, other AI technologies, and digital transformation tools are poised to enhance efficiencies and drive process innovation across the life sciences value chain. A significant portion of the value from AI in life sciences is expected to come from R&D, manufacturing, supply chain, and commercial areas.
The U.S. FDA is increasingly interested in understanding patients’ health status through patient-reported outcome measures, prompting pharma companies to include these measures in their assessments.
Pharmaceutical companies are setting ambitious net zero targets, prioritizing improvements in global health infrastructure, and fostering workforce diversity. Future efforts will integrate AI and blockchain for sustainability and transparency, driven by stricter regulations and investor demands.
The pandemic exposed vulnerabilities in the pharmaceutical supply chains, prompting manufacturers to diversify sources and explore additional revenue through forward-backward integration.
Geopolitical uncertainties continue to cast shadows over the global economic landscape, posing potential risks. In the U.S., the proposed Biosecure Act has potential significant implications for companies sourcing products from China, especially for the U.S. market. The ongoing Middle East conflict has exacerbated supply routes, mainly from the Red Sea, leading to an increase in freight costs as well as higher inventory costs, thereby placing greater emphasis on the management of delivery schedules.
As AI adoption accelerates, regulatory bodies are poised to enforce tighter governance to ensure accountability and deliver value. By 2025, stricter regulations are expected to shape AI deployment in the pharmaceutical industry, necessitating compliance and transparency. These regulations will play a critical role in safeguarding patient data and ensuring ethical use of AI technologies.
Pharma companies are exploring novel ways to customize the patient’s journey, improving patient outcomes and experiences. Advances in genomics and biotechnology are paving the way for personalized medicine, where treatments are tailored to individual genetic profiles.
Lupin is strategically positioned to navigate the evolving pharmaceutical landscape, focusing on high growth therapeutic areas, regional market expansion, investments in innovative therapies, and adoption of advanced technologies. With a strong pipeline in the respiratory segment and complex injectables, Lupin remains competitive by constantly investing in research and development to bring innovative products to market. Our established presence in key emerging markets such as the Philippines, South Africa, Brazil and Mexico and ongoing expansion in Europe and other markets such as Australia enable us to capitalize on regional growth trends, enhance distribution networks, and augment local manufacturing capacities. These initiatives align with global industry trends, reinforcing Lupin’s commitment to delivering value to stakeholders and improving patient outcomes worldwide, ensuring sustained growth and value creation.
Despite a challenging environment, Lupin has achieved robust double-digit growth. A strong ESG framework is at the core of all our initiatives, aligning with our business strategy. We will continue our strategic focus on complex generics, particularly inhalation and complex injectables, to achieve our objectives. Lupin remains committed to being a trusted partner for high-quality, affordable medicines, serving all patients and communities.
in Indian Pharma Market
Five-Year CAGR
Ranks in the Top 300 Brands
Lupin’s India Region Formulations business primarily focuses on the chronic segment, contributing 59.8% of its total revenue, with Lupin holding the fifth position in the industry. The top five therapy areas in India - Cardiology, anti-diabetes, Respiratory, Gastrointestinal, and anti-infective, collectively account for 73.6% of Lupin’s sales. Lupin is a leader in the anti-TB segment and ranks second in the Respiratory segment. The Cardiology and anti-diabetes segments generate approximately INR 16,000 Mn and INR 15,000 Mn, respectively, and Lupin ranks third in both these growing areas. The Respiratory therapy segment has surpassed INR 10,000 Mn, and the Gastro+Hepato therapy segment has moved upto INR 7,000 Mn.
In the Respiratory segment, we launched the world’s first Fixed Dose Triple Combination drug, Vilfuro-G, for managing Chronic Obstructive Pulmonary Disease, a leading cause of death and disability. Approved as a Dry Powder Inhaler by the Drug Controller General of India, this innovative therapy brings hope to over 37 million COPD patients in India. This milestone underscores our commitment to expanding our respiratory portfolio and providing essential healthcare solutions to transform lives.
In the anti-diabetes segment, Lupin experienced a steady growth rate of 5.1%, while the Cardiology segment achieved a growth rate of 13.4%, outperforming the market growth rate of 10.0%. In the Respiratory segment too, Lupin’s growth rate of 13.8% was significantly higher than the market growth rate of 2.7%.
Lupin’s unwavering commitment to fostering more robust connections with medical practitioners and driving better patient outcomes is evident through its proactive initiatives. The company has also constantly focused on curating unique scientific platforms that facilitate collaboration and partnerships with leading universities worldwide to enhance the expertise of doctors.
By consistently aligning its business strategies with foresight on future market trends and focusing strongly on innovation, Lupin continues to reinforce its position as a leading player in the Indian pharmaceutical market.
In its efforts to drive positive patient health outcomes globally, Lupin has been at the forefront of leveraging innovative digital strategies to enhance customer engagement. Multichannel initiatives, such as Lupin Konnect and DigiEngage, enable seamless interaction with our core doctors through digital and telecommunication channels, in addition to traditional face-to-face engagements. Through evidence-based practices and clinical guidelines, doctors have access to updates on therapeutic breakthroughs and treatment methods, helping them deliver optimal patient care to improve lives.
Lupin Konnect plays a vital role in enhancing brand awareness among untapped General Practitioners. Through our omni-channel engagements, GPs are constantly kept abreast of the latest scientific updates, specifically tailored to the core Lupin brands. This targeted outreach allows us to build stronger relationships with them and improve brand recall.
Furthermore, we have implemented SmartRep, which is specifically designed for our field force and serves as a comprehensive analytics platform to obtain actionable insights. This platform is fully operational across all divisions within India Region Formulations, seamlessly integrating various resources such as sales performance metrics, coaching modules, a knowledge hub, chemist data, and more. This seamless integration empowers our teams with the necessary tools to provide exceptional service and support to healthcare professionals.
Currently, our adoption rate stands at an impressive 97%, highlighting the effectiveness of this platform in enhancing our field force’s capabilities. Going forward, we will enhance our efforts through AI and Machine Learning based insight programs, to further support our field force. Lupin Gurukul is a centralized repository for brand plans and marketing collateral, providing easy access and reference for our team members. This platform enhances efficiencies, reduces approval time and enables team members to make informed decisions.
Additionally, we have developed Anya, an AI-powered chatbot that delivers medically verified responses and provides valuable insights. Anya is available in 6 languages and covers a wide range of therapy areas, including Cardiology, Diabetes, Respiratory, Dermatology, Tuberculosis, Urology, Orthopaedics, and more. With over 32 lakh queries successfully addressed, Anya has assisted over 5 lakh+ users with not just text responses but infographics as well.
Our dedication to digital engagement is exemplified by our active presence on social media platforms to connect with our audience for positive outcomes. Lupin India has witnessed a remarkable 16% increase in followers, and the Shaping Health platform has seen a notable 10% rise compared to the previous year.
As we continue to grow our online community, we are committed to delivering relevant and informative content that resonates with our followers and reinforces our position as a leader in the digital space.LupinLife Consumer Healthcare, our OTC business, has achieved remarkable growth since its inception in 2017, expanding into multiple categories, including gastro, health supplements, women’s health, and pain management. With a 5-year CAGR outpacing the OTC category, our flagship brand, Softovac®, leads the bulk laxative segment with a 44% market share. Following its transition to a consumer healthcare brand, Aptivate® has carved a niche in child healthcare, demonstrating strong performance. We run innovative engagement programs such as the Aptivate Achhi Bhook Quiz and Aptivate Run.
Strategic brands such as Vimpro and Vovilup strengthen our portfolio, which is supported by an agile retail network and digital marketing strategies. LupinLife continues to grow at 2x the OTC category, achieving an 18% CAGR since FY20, reflecting our commitment to consumer relevance and operational excellence, aided by a robust retail network, digital marketing strategies, and sales force automation.
Since commencing operations in 2021, Lupin Diagnostics has established 38 processing labs across West, East, and South India. By 31 March 2024, we surpassed our revenue of INR 600 Mn, serving over 1.2 million patients. Recognizing that 70% of treatment decisions in India are based on diagnostic tests, we ensure accuracy through stringent quality control and benchmarking against international standards. Over 50% of our labs are NABL accredited, one of the highest in the industry, with a goal to achieve 100% by FY25.
We are expanding in West and East India, focusing on tier 3 and tier 4 cities, and have broadened our portfolio to include oncology, neurology, and genomics. Our network of 750 collection centres support this growth. To maintain sample integrity, we employ over 100 field executives for temperature-controlled transportation. We also offer value-added services such as dynamic smart reports, health monitoring tips, and trend analysis for chronic disease management, enhancing patient care and treatment outcomes.
In FY23, Lupin launched Lupin Digital Health (LDH), marking its foray into the burgeoning field of Digital Therapeutics (DTx). LDH introduced Lyfe™, India’s first evidence based remote cardiac rehabilitation program with Coronary Artery Disease and Acute Coronary Syndrome patients, aimed at reducing heart attack risks and improving patients’ quality of life. The program features a multidisciplinary team offering comprehensive care.
In FY24, we expanded our offerings with the launch of Lyfe HF, catering specifically to patients dealing with heart failure. Over the past year, thousands of patients across 200-plus cities and towns have benefited from our Lyfe programs. We secured an exclusive collaboration with the American College of Cardiology and obtained ISO 27001:2022 certification, along with Central Drugs Standard Control Organization approval for our platform as a Class C Software as a Medical Device.
Looking ahead to FY25, we plan to launch a product targeting early stage heart disease risk factors, emphasizing prevention through lifestyle modifications. Lupin Digital Health is committed to leveraging digital innovations to transform healthcare in India.Atharv Ability, Lupin’s first Neurological Rehabilitation Center, serves as a cutting-edge outpatient facility for both adults and children, and addresses the crucial need for neurorehabilitation in India. Research highlights that multidisciplinary rehabilitation can enhance functional recovery by 30-40% and improve the quality of life for patients. The center specializes in treating post-stroke, traumatic brain injury, spinal cord injury, and various other neurological conditions, including Parkinson’s, cerebral palsy, and multiple sclerosis.
Offering a wide range of treatments under one roof, Atharv Ability’s services include neuro physiotherapy, advanced robotics therapy, speech and language therapy, occupational therapy, cognitive therapy, aqua therapy, pain management, spine rehabilitation, and pediatric neurological rehabilitation. In FY24, Atharv Ability treated over 2,400 patients and conducted nearly 30,000 treatment sessions, including 10,000+ physiotherapy sessions, 2,200+ robotics therapy sessions, and 1,800 aqua therapy sessions.
Since its launch, Atharv Ability has meaningfully touched the lives of over 5,000 patients, exemplifying our commitment to enhancing the lives of those with neurological disabilities, ensuring they regain their abilities and reintegrate into society.
Lupin’s India business continues to move forward and sharpen its focus on chronic and high-growth therapy areas, leveraging its strong market position and expanding its portfolio of high-quality, affordable drugs. By continuing to foster strong relationships with doctors, patients, distribution channels and consumers, and leveraging its digital platforms, Lupin aims to enhance its customer engagement and support.
Our digital initiatives will be further enhanced with the integration of advanced technologies such as AI and machine learning to provide actionable insights and optimize performance. Additionally, we will continue to expand our digital marketing efforts to strengthen our brand presence and reach a broader audience. Our commitment to innovation and excellence will ensure that Lupin remains at the forefront, driving positive health outcomes and delivering value to our stakeholders.
in the U.S. by Prescriptions
of Lupin's Overall FY24 Sales
Products have Market
Share Greater than 50%
The U.S. pharmaceutical market remains the largest globally in terms of dollar value, with a net market value of USD 446 Bn in 2023 and a net CAGR of 5.3% over the last five years (Source: IQVIA Institute for Human Data Science, Global Use of Medicines: Outlook to 2028, January 2024). It is characterized by a significant disparity between branded and generic medicines. Despite accounting for only 8.8% of prescriptions, branded medicines constitute a staggering 85.7% of the market value. On the other hand, unbranded generics dominate in terms of prescription volume, representing 88.4% of prescriptions, however contributing to only 8.0% of revenues. Branded generics serve as a middle ground, accounting for 6.3% of total net sales and 2.8% of prescriptions (Source: IQVIA – US Generics and Biosimilars Trends).
Biologics is another critical component of the U.S. pharmaceutical landscape, currently accounting for 46% of drug spending and exhibiting a very high growth rate (Source: IQVIA – Global Pharma Market Snapshot - 2024). This growth trajectory highlights its increasing importance in the market, a trend that is likely to continue as more biologic treatments gain approval and adoption.
The U.S. market is on the cusp of significant transformations due to impending losses of exclusivity. This is expected to reduce brand spending by USD 145 Bn over the next five years. Small molecule drugs will be the most affected, with an anticipated reduction in brand spending of USD 106 Bn through 2028, more than double the impact over the last five years. Biologics will also face substantial spending reductions, estimated at USD 39 Bn over the same period, as biosimilar market dynamics mature and major products encounter competition (Source: IQVIA Institute for Human Data Science, Global Use of Medicines: Outlook to 2028, January 2024).
In this dynamic and competitive environment, Lupin has consistently played a pivotal role over the last few years by providing high-quality, safe, and affordable medicines to millions of Americans. Despite operating in a challenging environment characterized by high price deflation due to buyers’ consolidation, supply chain disruptions, and rising competition, we have displayed not only a high degree of resilience, but also forged ahead in terms of sales. Our market strategy epitomizes value creation, which helps us thrive wherever we operate.
Our relentless focus on sustainable growth, portfolio diversification, and profitability drives every decision we make. A major growth engine over the last 5 years, both from a top as well as bottom line standpoint, has been the inhalation segment, which has witnessed significant growth. The business, which represented less than 2%, witnessed substantial growth, contributing to almost 40% of the overall U.S. net sales. We expect to sustain the business at high growth levels, ramping up the inhalation business and focusing on new product launches in FY25.
As of March 2024, Lupin is the third-largest pharmaceutical company in the U.S. by filled prescriptions, with a 5.2% market share in generic scripts. Thanks to our portfolio of 150+ commercialized products, a ~30% market share per marketed product. With 100+ products in the pipeline across a wide range of therapeutic areas and dosage forms, we continue to maintain our business momentum, auguring well for the healthcare ecosystem in the U.S.
During the last fiscal year, the U.S. market contributed to 34% of the overall company sales, with INR 67,628 Mn in net revenue, strong growth of 30% over FY23, higher than other geographies. Several key products have contributed to this noteworthy performance. Our strategic pivot to complex generics has yielded remarkable results.
The launch of Tiotropium (Gx Spiriva) in August 2023, the first Dry Powder Inhaler from India for the U.S. market, achieved consistent substitution rates exceeding 30%, underscoring its acceptance and demand. In line with prior years, Albuterol continued to be a top-selling product for Lupin and consistently captured 20%+ of the total reference market. Albuterol and Tiotropium are expected to be major drivers of financial performance through the next few years. Our strategy of integrating inhalation products such as Xopenex® and Brovana® enhances our offerings in the crucial respiratory segment. It will cement Lupin’s position as a top player in the U.S. respiratory space, an area of strategic focus for the company. The successful launch of gSpiriva (Tiotropium) has not only positioned us as a leader in oral solid dosage forms, but has also set the stage for pioneering biosimilars.
Notably, Lupin currently ranks as the second-largest generic pharmaceutical company by sales in the U.S. respiratory segment, reflecting a strong foothold in and focus on this critical therapeutic area. Beyond inhalation products, strong top and bottom line contributions also came from other significant products such as Lisinopril and Bupropion, as well as gastro-intestinal products Gx GaviLyte and Gx Suprep, both of which are manufactured in our Somerset, NJ, plant. In addition to the introduction of Tiotropium, the U.S. business also benefited from 10 more new product launches in FY24, including Darunavir, Gx Prolensa, and Diazepam Rectal Gel. The combination of new product introductions, skillful commercial and supply chain execution, and ongoing measures to enhance operational efficiencies have helped move up our margins over the course of the last year, contributing to a remarkable financial performance. This, in turn serves as a key lever for value creation for all our stakeholders.
Driven by utmost attention to quality across all aspects of the supply chain, right from the procurement of APIs and KSMs to production, skillful commercial execution on inline products, relentless innovation across all therapeutic areas and dosage forms, as well as continuous operational improvements and cost optimization efforts, Lupin U.S. is projected to maintain a leading position and propel the overall company to sustained success in the coming years.
While the downward pricing pressure on oral solids has moderated from double-digit declines in FY23 to mid-high, single-digit percentages in FY24, Lupin’s focus is to strategically shift from traditional oral solid formulations towards complex and differentiated products. During the last year, more than 80% of our new product revenues in the U.S. came from nonoral solid products, platforms such as inhalation and injectables, characterized by less pronounced generic price deflation and reduced competitive pressure. We will build upon scaled product platforms in legacy oral and ophthalmic segments and drive our business around the commercial portfolio over the coming years. To drive this shift, around 70% of the R&D spend over the next five years is projected to be utilized for the development of complex assets in the inhalation and injectables spaces.
Beyond unlocking additional value from the inline commercial portfolio, we will ramp up our introduction of key oral and ophthalmic “first” products as well as a number of injectable assets. These include products such as Liraglutide (Victoza, Saxenda) and Glucagon, all of which are expected to contribute to robust growth in the near and medium term.
In the long term, a strong pipeline of 30+ injectables and 20+ inhalation products, comprising a number of first-to-file, exclusive first-to-file and first-to-market opportunities, will enable a more sustained growth as we continue to pivot to more complex products, in particular inhalation and complex injectables. In this context, Lupin Inhalation Research Center (LIRC), our state-of-the-art, inhalation dedicated R&D center located in Coral Springs, Florida, will play an increasingly significant role in adding value. LIRC will contribute to our business strategy and will be a hotbed for innovation in the respiratory space from a formulation, device and drug-device combination standpoint. With advantages such as a differentiated talent pool, sophisticated technology and scientific equipment, LIRC will be a growth engine for the company. There will be further impetus to research around platforms such as MDIs, DPIs, SMIs, and nasal sprays. LIRC will also push forward our agenda around sustainability with green propellants, which will be fundamental to further establishing our position as a responsible pharmaceutical company.
Additionally, cost optimization efforts will enable us to improve our bottom line. We will also continue to explore inorganic opportunities to complement our existing portfolio of generics and specialty products. Strategic acquisitions and partnerships will be key to enhancing our product offerings, entering new therapeutic areas, and strengthening our market position, particularly in the specialty arena. Overall, we remain dedicated to delivering high-quality, affordable medicines to patients and are confident in our ability to navigate the market landscape effectively. Lupin’s strategic evolution in maintaining growth is multifaceted and deeply rooted in a blend of market diversification, new product portfolio, and operational optimization.
of Global Sales
Broadening of Indications ongoing
Largest Generics Player
in South Africa
With an estimated value of USD 363 Bn, the pharmaceutical market in Europe, Middle East, and Africa (EMEA) accounts for 25% of the global market. Lupin’s sales in the EMEA region constitute 10% of our global sales. Our unique portfolio, which includes niche branded generics, biosimilars, and inhalation products, presents significant growth opportunities within this region.
The pharmaceutical market in Europe is valued at USD 335 Bn, with the generic business contributing over USD 69 Bn. Despite the looming patent cliff with major pharmaceutical brands, particularly biologics, set to expire soon, the European market is poised for significant growth in the coming years.
In FY24, Lupin’s European business recorded sales of INR 19,235 Mn, up by 24% compared to the last year. Key drivers of this growth include the launch of our first respiratory product to several European countries and the extension of NaMuscla® beyond the UK, Germany, and France. Furthermore, our market presence has been strengthened through deep digital engagement with healthcare practitioners and the successful adoption of digital channels for promotion.
NaMuscla®, our flagship product in the neurology segment in Europe, addresses the unmet needs of adult patients suffering from non-dystrophic myotonic disorders, a severe neuromuscular and orphan disease with debilitating effects. Lupin is committed to broadening NaMuscla’s indications to pediatric patients with myotonic disorders and adults with Myotonic Dystrophy through two ongoing clinical studies. Apart from NaMuscla, our first respiratory product in Europe, Beclometasone-Formoterol Gx, is now distributed across several countries.
Lupin has successfully entered the injectable space through the acquisition of Medisol SAS in France. Medisol’s wide portfolio comprises of injectables in pain, anti-inflammatory, and cardiovascular segments. This provides us with a robust foundation to leverage Lupin’s injectable portfolio in France over the next few years. This strategic expansion and innovation in our product offerings underscore Lupin’s dedication to addressing unmet medical needs and driving growth in the European pharmaceutical market.
Our German subsidiary, Hormosan Pharma GmbH, has sustained its growth in the competitive German market. In FY24, Hormosan witnessed positive growth in its established neurology, pain, and sexual health portfolios. The launch of Luforbec®, the first generic Beclometasone/ Formoterol in Germany, marked Hormosan’s expansion into the inhalation field, further enhancing our potential in this segment.
In the face of a declining German contraceptive market, Hormosan has posted an impressive 16% growth compared to the previous year and achieved an 18% four-year CAGR, defying industry trends. At the core of this success lies a strategic investment in service innovation, helping position Hormosan as the fastest growing company in the market. The company’s commitment to meeting market needs led to the creation of the Contraception Prescription Navigator, a ground-breaking tool developed in collaboration with German Key Opinion Leaders, thus making Hormosan a trendsetter in the country.
In the UK, we have moved the needle and enhanced our market share through the penetration of Luforbec®. Amongst the new brands launched over the last four years, Luforbec® is the highest-performing primary care brand in both value and volume (Source: IQVIA report), with over 150,000 patients benefitting from our product. This volume growth is driving significant savings for the UK healthcare system. Additionally, we have enabled our carbon offsetting program, which underscores Lupin Healthcare’s commitment to sustainability alongside value delivery.
In South Africa, the pharmaceutical market is valued at ZAR 54.8 Bn, experiencing a YoY growth of 1.1%. Lupin’s South African subsidiary, Pharma Dynamics, outperformed the market with a MAT growth of 4.4%, with sales of ZAR 1,445 Mn. This growth was driven by sustained performance in key segments such as Cardiovascular and Central Nervous System, despite ongoing pricing pressures from medical aid funding agencies and a challenging economic climate. Additionally, strong growth was observed in our Female Healthcare portfolio and our OTC franchise, led by Efferflu-C Immune Booster.
Pharma Dynamics continues to be the largest CVS company in South Africa, holding a value share of 13.7%. In unit terms, we have 25 products ranked as the top products in their respective categories and 16 products in the second position across various ATC classifications. Pharma Dynamics stands as the 8th largest generic pharmaceutical company in South Africa.
Pharma Dynamics remains committed to complying with the government’s Broad-Based Black Economic Empowerment policy, aimed at enhancing the economic participation of the Black population. Our upcoming verification is expected to reflect an increased compliance level following the successful pursuit of several new initiatives, including participation in the Youth Employment Service.
In FY24, Pharma Dynamics continued to collaborate with the South African Health Products Regulatory Authority to secure 21 product approvals. This year, 11 new products were introduced to the South African market. Pharma Dynamics is set to maintain its growth momentum in FY25, with the planned introduction of eight new products.
The current macroeconomic and geopolitical
situation impacting Europe and the Middle East
present significant challenges for FY25, including
price deterioration and inflation. Despite these
challenges, Lupin is committed to expanding
its product offerings and leveraging various
platforms across the region for expansion. With
top-ranking market positions in key therapeutic
areas, we will continue to focus on building our
specialty care portfolio to drive further growth.
We are also focused on expanding our OTC self
help category in the South African market through
organic as well as inorganic opportunities.
Data Source: IQVIA MAT February 2024
Branded Generic Player in Philippines
Generic Player in Australia
The APAC region continues to be a dynamic and rapidly expanding market for Lupin, with Australia and the Philippines being significant contributors. In Australia, our focus on niche generics and biosimilars is driving steady growth. In the fast-growing pharmaceutical sector in the Philippines, Multicare Pharmaceuticals is leveraging its extensive product portfolio and strategic new launches to gain market share. These efforts are a testament to our commitment to delivering high-quality, affordable medicines across the APAC region, while further widening our footprint in these markets.
The pharmaceutical market in Australia is currently valued at approximately AUD 22 Bn, with an annual growth rate of 3%. The generic (Gx) business accounts for over AUD 3 Bn of this market. In the medium term, the Australian market is projected to grow at 3-5% annually. Australia’s population of around 27 Mn is characterized by an aging demographic, similar to other developed nations. However, a robust immigration program has been a key driver of population growth, resulting in sustained demand for primary as well as chronic care medicines.
The Australian government subsidizes medicines for its population, focusing on cost containment to fund newer and more expensive medications without impacting the national budget. This emphasis on cost control is expected to continue in the medium to long term, with enhanced efforts to facilitate generic penetration. Some of the measures in this direction include simplification of product registrations, reducing compliance burdens, and collaborating with like-minded countries on product approvals with no compromise on quality standards. Additionally, the government has established a framework to facilitate the entry of biosimilars, too. Overall, the Australian market has created a clear pathway for generic and biosimilar companies to enter, develop and grow over the medium to long term.
Generic Health remains the fourth-largest generic player in Australia, with sales of AUD 108 Mn in FY24, up from AUD 96 Mn in FY23, representing a growth rate of 13%. This has been possible due to 12 new product launches during the year and the continued success of our OTC hair loss treatment product, Minoxidil. We have also witnessed an increased market share of existing products; despite competition in our key molecules, innovative and new product launches and strategic market positioning have supported our growth trajectory.
The pharmaceutical market in the Philippines is valued at USD 4.9 Bn, with a robust annual growth rate of 8.7% (based on IQVIA Topline Report MAT March 2024). Multicare Pharmaceuticals, a subsidiary of Lupin Ltd, is ranked the No.1 Indian company in the Philippines and holds the second position among all branded generic companies.
Multicare Pharmaceuticals achieved total sales of PHP 2.35 Bn in FY24, an increase of 35% compared to the previous year. The company has a vast and diverse portfolio of approximately 100 products spanning various therapeutic areas, including Rheumatology, Women’s Health, Oncology, Diabetes, Gastroenterology, Pediatrics, Renal, Respiratory, anti-TB, and Neuroscience.
Multicare Pharmaceuticals was recently certified as a ‘Great Place to Work,’ reflecting the company’s commitment to fostering a highly engaged and productive workforce. This certification on workplace culture underscores the high level of trust within the organization and the consistent positive employee experience that drives performance and productivity.
Looking forward, Multicare has a robust pipeline of new product launches scheduled for FY25 and FY26, which include biosimilars and specialty products. This strategic focus on expanding and diversifying its product offerings is expected to drive continued growth and solidify its market position.
Multicare Pharmaceuticals is well-positioned to capitalize on the growing pharmaceutical market in the Philippines through its extensive product portfolio, strategic new launches, and a dedicated workforce committed to excellence. This aligns with Lupin’s overall strategy to strengthen its presence in key growth markets within the APAC region.
Ophthalmic Player in Mexico
Player in Brazil in Volume
With a market size of USD 11.7 Bn, Mexico is the second largest pharmaceutical market in Latin America. The market experienced a growth of 4.4% in value terms (according to MAT Figures as of February 2024). The primary driver of this growth is the strong dependency of the Mexican pharmaceutical market on patients’ out-of-pocket expenses, coupled with the absence of price controls. Key product categories such as anti-diabetics, vaccines, and respiratory treatments exhibit significant double-digit growth.
In FY24, Laboratorios Grin (Lab Grin), Lupin’s subsidiary in Mexico, primarily focused on ophthalmology within the private market, and achieved significant milestones despite facing many challenges. The temporary closure of our manufacturing facility posed complex supply chain issues; however, Lab Grin demonstrated remarkable resilience and a robust recovery. The closure of our factory for a considerable period created supply issues that required swift and effective management. Through strategic planning, we mitigated the impact of these disruptions and ensured a strong bounce back.
Lab Grin secured an impressive market share of 7.6%, underscoring our commitment to innovation and market penetration. This achievement is particularly notable, given the operational disruptions faced during the year. The successful launch of six new products from our pure innovation pipeline was crucial to our growth. These products, including treatments for dry eye, anti-infectives, and food supplements, have been well-received in the market. Additionally, we maximized the market penetration of our in-licensing portfolio, further enhancing our product offerings and market reach. Financially, Lab Grin delivered a positive EBITDA of INR 239 Mn, reflecting our highly focused approach to the controllable portfolio and driving significant operational efficiencies. These efforts have helped Lab Grin gain market penetration and a higher share within the ophthalmic segment.Looking ahead, Lab Grin is well-positioned to continue its market share gains within the ophthalmic market. The company plans to launch over 20 innovative products in the next five years, with an aim to secure market leadership. Leveraging Lupin’s global product pipeline, Lab Grin also intends to expand beyond ophthalmology by introducing products in the neuroscience and respiratory segments. This strategic expansion aims to transform Lab Grin’s portfolio into one comprising purely innovative and innovative branded generics across various therapy areas.
The Brazilian pharmaceutical market continues to demonstrate robust growth and dynamic shifts, providing significant opportunities for various business models. The ongoing evolution in pharmaceutical retail dynamics presents ample room for expansion. Additionally, an important number of molecules are expected to lose patent protection in the next five years, creating opportunities for the generic and biosimilar markets while posing challenges for reference drugs. Medquimica, Lupin’s Brazil subsidiary, has continued outperforming the market, gaining a share in a highly competitive environment. In FY24, Medquimica achieved sales of BRL 253 Mn, maintaining its position as the 6th largest player in Brazil. The company’s robust performance is driven by a diverse portfolio and strategic market positioning. Medquimica has a broad portfolio encompassing 76 molecules across 50 therapeutic classes, with 18 products ranked within the top 5 in their categories. The OTC portfolio is a leading segment featuring top-selling and rapidly growing products. Continuous expansion through innovative formulations has made OTC the primary revenue source. The company also focuses on rare diseases, such as Wilson disease, a rare genetic disorder affecting approximately 1 in 30,000 to 1 in 50,000 Brazilians annually.
During the year, Medquimica encountered a few challenges on the quality front. However, the company acted swiftly and decisively to address these issues. A robust remediation plan, including a reinforced weekly quality control mechanism, was implemented. This ensured that Medquimica quickly overcame these challenges and was able to significantly enhance its quality management processes, providing a huge fillip for future growth.
Several factors are propelling the growth of Medquimica and the broader pharmaceutical market in Brazil. Increased cost and price pressures from payers and the accelerated launch of new products contribute significantly to market growth. The adoption of new technologies and growing government expenditure on health further bolster the market. The loss of exclusivity, favoring generics and biosimilars, continues to be a critical growth driver.
Medquimica’s outlook for FY25 is promising, with growth expected to be driven by price hikes and the performance of key products. Medquimica has implemented a robust remediation plan, including a reinforced weekly quality control mechanism, to ensure the highest gross margins moving forward. This strategic focus is expected to maintain the company’s growth trajectory and enhance its market position in the Brazilian pharmaceutical industry.
Lupin’s Active Pharmaceutical Ingredient (API) Business is anchored on our extensive expertise in process chemistry including fermentation technology, manufacturing efficiencies, strategic cost management, and procurement. During FY24, we delivered well on our API business, continuing to strengthen our loyal client base and further expand on it. The API division achieved sales of INR 11,415 Mn over the year.
We are currently in the process of developing a robust new product portfolio across various therapeutic areas. The seeding of new products in diverse markets is expected to pave the way for sustainable growth in our API business over the next five years. The Government of India’s Performance Linked Initiative scheme aims to enhance self-reliance in the API sector and reduce import dependency for key products. Lupin has launched several strategic initiatives aligned with this, including additions to our product portfolio and expansion of our API production capacities.
Leveraging our rich expertise in API research and formulation development, our value-added P2P business focuses on developing new molecules and combinations that meet market needs. During the year, the P2P business successfully commercialized new and innovative formulations in the cardiovascular and gastrointestinal therapy segments. Revenue from new products contributed 20% to overall sales, with key launches including Sacubitril-Valsartan and Linagliptin, both as plain formulations and in combination.
In FY24, we had a strategic carve out of our API business, encompassing the manufacturing sites at Dabhasa and Vizag, as well as Fermentation and Enzymatic research at Lupin Research Park - Pune, to form our subsidiary, Lupin Manufacturing Solutions. This initiative aligns with our commitment to exploring new horizons and achieving sustainable growth. LMS aims to maximize our third party API business while expanding into API Contract Development and Manufacturing Operations.
This transition marks a significant step towards positioning Lupin as a trusted partner in the pharmaceutical industry, facilitating the development and manufacturing of safe, effective, and affordable medicines. Our path to success will be defined by collaboration, dedication, and an unwavering commitment to excellence.
Our Global Institutional Business is not just a business venture but a testament to our commitment to a healthier world globally. We collaborate closely with global and national public health institutions in the coordinated fight against TB and HIV.
TB notification rates across high TB-burden countries have been steadily increasing. However, there remains a significant gap between actual TB prevalence and TB notification. For several years now, Lupin has been striving to establish a world free of TB, with high-quality, affordable, and reliable medicines. Our products are distributed in more than 50 countries across Africa, Latin America, the CIS, and Asia. Our firm resolve to combat TB has established us as one of the largest suppliers of firstline anti-TB drugs globally.
New medicines for managing multidrug-resistant TB are currently in development. We are working on a backward integration strategy to manufacture these essential APIs in-house, ensuring reliable supplies, continuous availability, and access to high-quality, affordable medication.
Lupin is proud to be the first generic company in the world to receive the WHO Prequalification status for Bedaquiline, a key drug for managing MDR-TB.
In addition to TB treatment, there is an increased effort to scale up the use of regimens to prevent TB in high-risk individuals, such as those in close contact with TB patients or those with HIV. Our preventive TB regimen features Rifapentine, a fermentation-based product. Lupin’s expertise in fermentation and our large API/formulation manufacturing capacities provide strong growth and leadership opportunities in the preventive TB space. During the year, Lupin became the first company in the world to file for WHO Prequalification approval for Rifapentine 150 mg Dispersible Tablets aimed at preventing TB in children.
We are also actively engaged with global and national public health institutions in an effort to treat HIV patients in low and middle income countries. Similar to our approach to TB, we are backwardly integrated to manufacture new antiretroviral drugs, ensuring we can offer quality-assured medication at affordable prices while mitigating potential supply disruptions.
Lupin is well positioned to capture a significant market share in the ARV segment in access countries, leveraging our backward integration and large manufacturing capacities to meet global demand.
In the coming fiscal year, we are targeting significant growth across our business segments. We are optimistic about the prospects of our API Plus segment, anticipating robust growth driven by strong market demand and strategic initiatives.
Our Formulation arm, encompassing the Global Institutional Business and P2P Business, is set for substantial revenue growth in FY25. The GIB segment, in particular, is expected to achieve a milestone with the sales of key new product launches, including Bedaquiline and Pretomanid, alongside the TB preventive regimen of Rifapentine- INH. Additionally, our P2P business is also on a growth trajectory, with planned expansions in Southeast Asia, CIS, and Africa, further enhancing our market presence.
We are also excited to incorporate significant biological products into our P2P portfolio, with Ranibizumab and Etanercept being key inclusions. We anticipate considerable revenue contributions from new product offerings, mainly from Ezetimibe, Eslicarbazepine, Pirfenidone, Desvenlafaxine, Dapagliflozin, and Mirabegron. With continued momentum on innovation and the introduction of newer products, we are poised for strong performance in the upcoming quarters.
Assurance Statement